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"An experimental drug appears to reduce the risk of bone fractures in postmenopausal women with osteoporosis better than a placebo and the currently available drug a new study finds. In this phase trial funded by the drugs maker Radius Health fewer women on the injectable drug abaloparatide had spine fractures . percent than women receiving a placebo . percent and slightly fewer than those taking a similar injectable drug teriparatide Forteo . percent. If this gets approved and there is no reason to think it wont this will be the second drug available for the treatment of highrisk osteoporosis said lead researcher Dr. Paul Miller of the Colorado Center for Bone Research. Forteo has been in use for the past years he said. Abaloparatide works differently from Forteo and improves bone density more than Forteo Miller said. Women taking abaloparatide also had fewer other types of fractures . percent than those who got a placebo . percent and slightly fewer than those on Forteo . percent the researchers found. Miller said many spine fractures are painless. Patients are often unaware they have happened until a doctor measures their height and finds they are up to an inch shorter than before he said. Abaloparatide and Forteo are synthetic peptides that help grow and strengthen bone Miller said. Along with building bone density they are the only ones that increase bone quality he said. Bone quality is an important aspect of bone strength the ability to withstand a break Miller said. He predicts that when abaloparatide is on the market it will compete with Forteo driving down the price of both drugs. I am hoping that having a second drug available that it will help reduce the cost he said. Forteo costs about a month if you dont have insurance. Even if a patient is insured monthly copays can range from to . Forteo is covered by Medicare Miller said. The report was published Aug. in the Journal of the American Medical Association. A study based on U.S. Census data estimated that more than million women between the ages of and have osteoporosis. A yearold woman has a percent lifetime risk of fracture due to low bone density. For the study Miller and colleagues randomly assigned nearly postmenopausal women with osteoporosis to receive daily injections of abaloparatide Forteo or a placebo for months. Their average age was . Among the nearly women who completed the trial increases in bone mineral density were greater with abaloparatide than placebo the researchers found. In addition fewer cases of hypercalcemia abnormally high levels of calcium in the blood occurred among women taking abaloparatide percent than Forteo percent. Hypercalcemia can weaken bones cause kidney stones and interfere with heart and brain function. There were no differences among the groups in other serious side effects such as nausea and heart palpations Miller said. Dr. Caroline Messer director of the Center for Pituitary and Neuroendocrine Disorders at Lenox Hill Hospital in New York City is eager for further research. There needs to be a large headtohead trial between Forteo and abaloparatide she said to really see which drug is better. Everybody is going to want to know if this is inferior or superior to Forteo she said adding that this is an early study. It shows more bone building and fewer fractures than Forteo but whether it will replace that drug is still up in the air. An editorial accompanying the study said which drug is selected may be less important than identifying and starting an approved treatment. The bar is high for any preventive treatment in the efforts to prevent a fracture that may or may not ever occur prescribers do not want to prescribe a therapy that causes a new problem. The way forward for fracture prevention involves not only the development of better therapies . . . and easier delivery systems but also improved adoption of existing osteoporosis therapies for patients with prior fractures and minimization of adverse effects particularly those associated with longterm use the editorial said. The editorial was cowritten by Dr. Anne Cappola of the Perelman School of Medicine at the University of Pennsylvania Philadelphia associate editor of JAMA and Dr. Dolores Shoback of the University of California San Francisco. More information To learn more about osteoporosis visit the American College of Rheumatology http SOURCES Paul Miller M.D. Colorado Center for Bone Research Lakewood Colo. Caroline Messer M.D. director Center for Pituitary and Neuroendocrine Disorders Lenox Hill Hospital New York City Aug. Journal of the American Medical Association"

"The U.S. Food and Drug Administration approved Intrarosa prasterone to treat women experiencing moderate to severe pain during sexual intercourse dyspareunia a symptom of vulvar and vaginal atrophy VVA due to menopause. Intrarosa is the first FDA approved product containing the active ingredient prasterone which is also known as dehydroepiandrosterone DHEA. During menopause levels of estrogen decline in vaginal tissues which may cause a condition known as VVA leading to symptoms such as pain during sexual intercourse. Pain during sexual intercourse is one of the most frequent symptoms of VVA reported by postmenopausal women said Audrey Gassman M.D. deputy director of the Division of Bone Reproductive and Urologic Products DBRUP in the Office of Drug Evaluation III in the FDAs Center for Drug Evaluation and Research CDER. Intrarosa provides an additional treatment option for women seeking relief of dyspareunia caused by VVA. Efficacy of Intrarosa a oncedaily vaginal insert was established in two week placebocontrolled clinical trials of healthy postmenopausal women to years of age who identified moderate to severe pain during sexual intercourse as their most bothersome symptom of VVA. Women were randomly assigned to receive Intrarosa or a placebo vaginal insert. Intrarosa when compared to placebo was shown to reduce the severity of pain experienced during sexual intercourse. The safety of Intrarosa was established in four week placebocontrolled trials and one week openlabel trial. The most common adverse reactions were vaginal discharge and abnormal Pap smear. Although DHEA is included in some dietary supplements the efficacy and safety of those products have not been established for diagnosing curing mitigating treating or preventing any disease. Intrarosa is marketed by Quebecbased Endoceutics Inc. The FDA an agency within the U.S. Department of Health and Human Services protects the public health by assuring the safety effectiveness and security of human and veterinary drugs vaccines and other biological products for human use and medical devices. The agency also is responsible for the safety and security of our nations food supply cosmetics dietary supplements products that give off electronic radiation and for regulating tobacco products."

"A bonestrengthening drug given by IV every months greatly lowered the risk of fracture in certain older women a large study found. The results suggest these medicines might help more people than those who get them now and can be used less often too. Broken bones are a scourge of aging. A hip fracture can start a long decline that lands someone in a nursing home. The risk is most common in women after menopause. According to a study a bonestrengthening drug given intravenously every months greatly lowered the risk of fracture in certain older women. Nam Y. Huh The Associated Press file photo But who should use drugs called bisphosphonates is debatable. Theyre recommended for people with severely brittle bones called osteoporosis but their value is less clear for millions of others with moderate bone loss. Yet thats the group in whom per cent of fractures occur and the new results suggest they also may benefit from treatment said Dr. Ian Reid of the University of Auckland in New Zealand. He led the study reported Monday at an American Society for Bone and Mineral Research meeting in Montreal and published by the New England Journal of Medicine. Estrogen keeps bones strong they weaken after menopause when levels of that hormone drop. It often gets worse after and women of that age are advised to have a bone mineral density scan a lowdose Xray to estimate bone strength. If osteoporosis is found treatment usually is Fosamax Boniva or generic versions of these drugs which help prevent bone from being lost faster than the body is able to renew it. Some people dont stick with the pills or endure digestive side effects so the medicines also can be given by IV usually once a year. However concern about some rare side effects have limited their use along with a lack of evidence that they might help before bone loss becomes severe. The study involved women average age with moderate bone loss. One quarter had previously had a fracture. They were assigned to get a Novartis drug sold as Reclast in the United States and Aclasta elsewhere or a placebo IV solution every months. After six years women in the drug group had broken a bone versus of those on placebo a per cent lowered risk. The drug also cut in half the risk of a vertebral fracture when bone compression causes part of the spine to collapse. For every women like this treated for six years one fracture was prevented a ratio that some experts said makes treatment worth considering. Two rare problems are tied to bisphosphonates deterioration of the jawbone and unusual leg fractures. No cases of either occurred but the study wasnt big enough to rule out this risk. Other results stood out Fewer women in the drug group were found to have cancer versus in the placebo group. However the study was not designed to test for this so other factors such as a family history of cancer may have influenced those numbers. Deaths and heart attacks also were fewer in the drug group but the difference was so small it could have occurred by chance alone. Still doctors said these were encouraging signs also seen in some earlier research. It now raises the question should we be doing additional studies to look for cancer and heart benefits from these drugs said Dr. Michael Econs an Indiana University professor who is president of the bone society. Novartis supplied the drug but had no role in the study a New Zealand government health agency sponsored it. Reid consults for the company and other drugmakers. An IV infusion of generic Reclast costs to depending on insurance and other factors several doctors said. Other bisphosphonates may give similar benefits but we cant be certain of that Reid said. The benefits also cant be assumed to extend to women under or to men said Dr. Clifford J. Rosen of Maine Medical Center Research Institute and an editor at the medical journal. Gauging a patients risk and need for treatment should focus on age and previous broken bones not just the bone mineral density score Rosen said. But if youre at high risk and youre going to be treated this is the kind of therapy you probably should get he said."

"Debbie Spina is a supervisor for the radiology department at the Hospital for Joint Diseases at the NYU Langone Medical Center in New York City. But when CBS News met her this spring she was a patient who was about to undergo sameday hip replacement surgery. The yearold had been having hip pain for the past two years because of arthritis. She had heard a lot of positive feedback from people who had undergone hip replacement surgery https at her hospital. A big attraction for her was the possibility of going home right after the surgery. The option to go home the same day and have that family around me was something that I wanted to do said Spina. She believed she would be able to recuperate more comfortably at home and get back on her feet faster. At most hospitals hip replacement https patients can expect a one to threenight hospital stay. Total hip replacement surgery is increasingly common with more than procedures done every year in the U.S. The surgery is meant to restore range of motion and help relieve arthritic pain. The procedure consists of removing the patients worn out ball and socket joint and inserting an artificial socket. On the femur side a stem is inserted into the bone and a ball is on the tip of it. NYU Langone Medical Center said it became the first academic medical center in New York City to implement a sameday hip replacement program in . Dr. Roy Davidovitch director of NYU Langones Hip Center said he performs around hip replacements a year and approximately percent of those patients will go home the same day. Davidovitch said patients are happier going home sooner. Nothing beats the comfort of your own home for recovery. And to be quite honest if the pain is controlled and the patient is healthy and medically completely stable there is no reason for them to be in the hospital. It really doesnt make sense. There are two common surgical approaches for a total hip replacement anterior which involves entering surgically through the front of the hip and posterior or entering surgically through the side or buttocks. According to research done by the American Academy of Orthopaedic Surgeons http there are no significant differences between either approach in recovery outcomes six months after surgery. Davidovitch favors the anterior approach which he believes has a faster and less painful recovery period in the short term because doctors dont have to cut through muscles or tendons to get to the hip like in the posterior approach. He does agree that in the long term both procedures have the same outcomes for patients. But its not the surgical approach alone that allows some of his patients to go home the same day its a combination of what happens before during and after surgery. At NYU Langone patients have to do whats called prehab. Before the surgery they work with an occupational and physical therapist to learn information on the procedure learn exercises to do after the surgery and how to properly move around while they are recovering. During the surgery Davidovitch uses a shortacting spinal anesthetic that lasts about hours and when closing the wound he injects a cocktail of medications to help with the inflammation and pain. Patients can be up and walking usually within three hours after the surgery. But they must have someone around the first night they are spending at home postsurgery. The people who are against the whole idea for sameday discharge for hip replacement are concerned about the very rare instances where somebody could develop a blood clot that goes to the lung or a fracture of some sort said Davidovitch. The rates of blood clots or pulmonary emboli is exceedingly low. And in general if a patient is identified as a high risk or a higher risk we dont send them home the same day. Davidovitch makes it clear that this kind of surgery is not onesizefitsall. Patients are screened first to make sure they dont have risk factors like obesity chronic liver disease or cardiac problems https Those who have risk factors must plan on staying overnight in the hospital not going right home. However not every surgeon is embracing the sameday trend. Douglas E. Padgett M.D. chief of the joint replacement service at Hospital for Special Surgery in New York is a lot more conservative about who he believes is the optimal patient for going home the same day. The number of patients that are going home at this point in time in our institution is somewhere between one and two percent. So its a relatively small percentage of patients that are going directly home said Padgett. Padgett has seen an increase in the number of hip replacement patients and a decrease in their age some are as young as their s and s. He said his department performs the most hip replacements of any institution in the U.S. doing about a year. While he is not against patients going home the same day he cautions that total joint replacement is a major procedure and doctors need to be careful to avoid sending patients home too soon. While I recognize there is no place like home should there be the need for urgent or medical care the question is will that be available to the patient when theyre in the setting of their own home Padgett said. Debbie Spina met all the requirements to go home the same day. Her surgery lasted about an hour which is the average time for her type of procedure. After the the operation she was able to move around but felt dizzy and nauseous. The occupational and physical therapists waited until evening to try and get her to go up and down steps and walk around which patients must be able to do before they are discharged. But Spina didnt feel well enough so she actually ended up spending the night. Even though her sameday discharge didnt go as planned Spina felt good the following morning and was able to do her exercises and leave the hospital. After her recovery is complete she has a few goals shed like to reach. I had walked prior to this four miles every morning Id like to do that. And Id like to improve my golf game if possible Spina said while smiling. Davidovitchs goal is for patients to return to their normal level of activity as quickly as possible. And with many people wanting to maintain active lifestyles well into their s and beyond he expects to see even greater demand for hip replacement surgery and the sameday option. In general I see this growing to about percent of my practice he said."

"By substituting a healthy gene for a defective one scientists were able to partially restore the hearts ability to pump in heart failure patients researchers report. This is the first time gene therapy has been tested and shown to improve outcomes for patients with advanced heart failure study lead author Dr. Donna Mancini professor of medicine and the Sudhir Choudhrie professor of cardiology at Columbia University College of Physicians and Surgeons in New York City said in a university news release. The therapy works by replenishing levels of an enzyme necessary for the heart to pump more efficiently by introducing the gene for SERCAa which is depressed in these patients. If these results are confirmed in future trials this approach could be an alternative to heart transplant for patients without any other options she added. Mancini presented the results Monday at the annual meeting of the American Heart Association AHA in Chicago. The gene for SERCAa raises levels of the enzyme back to where the heart can pump more efficiently. The enzyme regulates calcium cycling which in turn is involved in how well the heart contracts the researchers said. Heart failure is a defect in contractility related to calcium cycling explained Dr. Robert Eckel past president of the AHA and professor of medicine at the University of Colorado Denver. The study authors hope that if replicated in larger trials the genetherapy treatment could actually delay or obviate the need for heart transplants in patients with heart failure. There are a lot of treatments for heart failure but at some point patients stop responding and then the prognosis is poor said Dr. Rita Redberg AHA spokeswoman and professor of medicine at the University of California San Francisco. After that the only option is a transplant. For this phase study patients with advanced heart failure were randomly chosen to receive either the gene therapy through cardiac catheterization or a placebo. At both six months and a year later the patients who had received the new gene saw their risk for death cardiac transplantation worsening heart failure and hospitalization decline by half. Results were even more heartening at higher doses where participants had an percent decrease in risk for death cardiac transplant hospitalizations and other outcomes the study authors said. Redberg cautioned that the study was still preliminary and requires more investigation. And research presented at meetings isnt subjected to the same level of scrutiny as studies published in peerreviewed journals. The study was funded by the Celladon Corp. of La Jolla Calif. More information The American Heart Association has more on heart failure http_UCM__Article.jsp. SOURCES Rita Redberg M.D. professor of medicine University of California San Francisco and spokeswoman American Heart Association Robert Eckel M.D. professor of medicine University of Colorado Denver and past president American Heart Association study abstract Nov. American Heart Association annual meeting Chicago"

"Among older adults with an unstable ankle fracture the use of a modified casting technique known as close contact casting a molded belowknee cast with minimal padding resulted in similar functional outcomes at months compared with surgery and with fewer wound complications and reduced intervention costs according to a study appearing in the October issue of JAMA. The number of older adults sustaining ankle fractures is increasing. Treatment of unstable fractures is either surgical or nonsurgical using externally applied casts. Neither method yields an entirely satisfactory outcome in older adults. Traditional casting techniques are associated with poor fracture alignment and healing as well as plasterrelated sores. Surgery is often complicated by poor implant fixation bone healing wound problems and infection. A modified casting technique has been developed close contact casting which uses minimal padding compared with traditional casting and achieves fracture reduction by distributing contact pressure by close anatomic fit. Keith Willett M.B.B.S. F.R.C.S. of the University of Oxford United Kingdom and colleagues randomly assigned adults older than years with acute unstable ankle fracture to surgery n or casting n . Casts were applied in the operating room under general or spinal anesthesia by a trained surgeon. Among the adults average age years percent women who were randomized percent completed the study. Nearly all participants percent received assigned treatment of percent who initially received casting later converted to surgery. At months casting resulted in measures of ankle function equivalent to that with surgery. Infection and wound breakdown were more common with surgery percent vs percent as were additional operating room procedures percent vs percent. Radiologic malunion abnormal healing of a fracture was more common in the casting group percent vs percent for surgery. Casting required less operating room time compared with surgery. There were no significant differences in other secondary outcomes quality of life pain ankle motion mobility and patient satisfaction. Close contact casting was delivered successfully for most participants substantially reducing the number of patients requiring invasive surgical procedures at the outset and additional operations during a month period the authors write. The researchers add that close contact casting may be an appropriate treatment for older adults with unstable ankle fracture. doi.jama.. the study is available preembargo to the media at the For the Media website Editors Note Please see the article for additional information including other authors author contributions and affiliations financial disclosures funding and support etc. Editorial Close Contact Casting vs Surgery for Unstable Ankle Fractures The results reported by Willett et al demonstrate that most unstable ankle fractures in older patients can be treated with a cast without the need for surgery writes David W. Sanders M.D. M.Sc. F.R.C.S.C. of Western University London Ontario Canada in an accompanying editorial. However many patients who were initially treated by casting subsequently required repeat casting or surgery. Further studies are needed to help identify which patients will not benefit from casting. Although close contact casting may be unfamiliar to some orthopedic surgeons it can avoid surgery for older patients with ankle fractures yet result in equivalent functional outcomes. This technique is worth considering when treating this challenging clinical problem. doi.jama.. the study is available preembargo to the media at the For the Media website Editors Note The author has completed and submitted the ICMJE Form for Disclosure of Potential Conflicts of Interest and none were reported. To place an electronic embedded link to these articles in your story These links will be live at the embargo time httpjama.jamanetwork.comarticle.aspxdoi.jama.. httpjama.jamanetwork.comarticle.aspxdoi.jama.."

"Many migraine sufferers could have fewer less severe headaches if they took preventive medicines but few eligible patients do say doctors releasing updated treatment guidelines Monday. Not everyone with migraines needs prevention medicine. Not everyone with migraines needs prevention medicine. The guidelines list seven prescription medicines and one herbal remedy backed by strong evidence and include many other treatments that might work for some patients. Migraine is one of the most disabling conditions known to man but patients need to know that there is hope says Stephen Silberstein a neurologist at Thomas Jefferson University in Philadelphia and lead author of the guidelines from the American Academy of Neurology httpcontent.usatoday.comtopicstopicAmericanAcademyofNeurology and the American Headache Society. They were presented at an academy meeting and published in the journal Neurology. Medicines backed by the strongest evidence include antiseizure drugs divalproex sodium sodium valproate and topiramate blood pressure drugs metoprolol propranolol and timolol and for menstrualrelated migraines a medicine called frovatriptan the guidelines say. They also cite strong support for the herbal remedy butterbur and include a longer list of prescription and nonprescription therapies patients can consider. More about migraines Migraines are not ordinary headaches. They cause throbbing pain often on one side of the head and can come with nausea vomiting and sensitivity to light and sound. Visual disturbances or other warning signs called auras may precede the headaches. Migraines are three times more common in women than men. In some susceptible people stress bright lights lack of food or sleep hormonal changes or other triggers may play roles. Source National Institute of Neurological Disorders and Stroke These preventive treatments usually are used daily. The guidelines do not look at the options patients have once symptoms begin. Not everyone with migraines needs prevention medicine. But nearly have headaches that are so frequent at least once a week severe or hardtotreat that they qualify Silberstein says. Studies find that just to use the treatments. Why so few One reason is that its hard to persuade people to take medicines on days when they feel fine says Elizabeth Loder a neurologist at Brigham and Womens Hospital in Boston. Silberstein adds that some patients have not been properly diagnosed or made aware of their options. Still others try the treatments and decide they dont work or have unacceptable side effects. You have a lot of gunshy patients because of a lot of bad experiences says Michael John Coleman founder of the patient group MAGNUM also known as the National Migraine Association. Many spend months or years taking medicines that dont work and make them miserable he says. Thats what happened to Emily Guzan a lawyer from Pittsburgh who was diagnosed with migraine in . She was given a prescription for Topamax topiramate and it was a real nightmare she says. She kept having headaches bad enough to land her in an emergency room once a month and suffered nightmares an altered sense of taste an unwanted pound weight loss and memory problems all of which she attributes to the drug. She tried some other medications but for now shes given up on all of them and says shes getting better results with diet yoga and other lifestyle changes. Finding the right medication for the right patient can take a lot of trial and error and careful dosing Silberstein says. But about will get relief he says defined as a headache reduction of at least after trying three or four drugs alternative remedies and lifestyle changes. Even hardtotreat patients may eventually respond to something Loder says so she urges frustrated patients to keep trying. The life toll that poorly controlled headaches take is really underappreciated she says. You dont get back the time you lost at work or the time you lost with your children. Coleman of Alexandria Va. also urges fellow sufferers to keep working with their doctors His own migraines took years to control. This is not a cookiecutter disease and there is no magic bullet but there is hope."

"An inhaler that protects the lungs against air pollution has been developed by scientists and could help the many millions of people affected by toxic air to avoid its worst effects. The inhaler delivers a molecule first found in bacteria in the Egyptian desert which stabilises water on the surface of the lung cells to form a protective layer. It is expected to be available as an inexpensive overthecounter product. Outdoor air pollution is a global health crisis that kills over million people a year https and it has long been linked to lung and heart disease and strokes. But research is also uncovering new impacts on health including degenerative brain diseases such as Alzheimers https mental illness https_btn_tw and this week diabetes http Advertisement The impact of air pollution costs tn a year https according to a World Bank report published last week. In the UK at least people a year die prematurely https from air pollution with a crossparty committee of MPs calling it a public health emergency https But the governments plans to tackle the issue were heavily criticised this week https just as alerts were issued for extreme air pollution across much of northern England. A day later it was announced that more ambitious plans for London from Mayor Sadiq Khan were overwhelmingly backed by the public https Vehicles are a key contributor to air pollution but a year after the VW emissions scandal broke most new diesel cars still emit far more toxic nitrogen oxides https on the road than the official labbased limit. Action to clean up air is urgently needed across the world but cutting emissions for vehicles and other sources will take years meaning ways to reduce the harm in the meantime could be vital. The new inhaler has been developed by German medical devices company Bitop http and is based on a molecule called ectoine discovered in the s in a desert bacterium which uses the compound to conserve water in C heat. It is quite an inert molecule that does one main thing which is bind water which stabilises cell membrane tissues against physical or chemical damage said Dr Andreas Bilstein at Bitop. It supports the natural barrier. When inhaled this helps prevent the damage caused by air pollution particles that can lead to asthma chronic obstructive pulmonary disease COPD and lung cancer Bilstein said Damage cannot occur as strongly and there is less inflammatory response and so disease progression is reduced. The perfect situation is that the patient inhales in the morning and evening at home. The inhaler has been tested in three small groups of patients particularly at risk from air pollution due to asthma COPD and bronchitis with the positive results due to be published soon Bilstein said. Ectoine does not interact with cell receptors so it is classed as a medical device rather than a drug. This means large clinical trials are not required for official approval and the inhaler could be on sale soon at an estimated cost of a month after Bitop selects a marketing partner. A version of the product for use in nebulisers will be available this year in Germany and Poland while an ectoinebased nasal spray for allergy relief is already available https Bilstein said the inhaler could be useful around the world as particulate air pollution is not just a European problem Especially in Asia China in particular the demand for such a product is even higher. I was in New York last week and the air was also not very clean. The protective effect of ectoine was discovered by Prof Jean Krutmann and colleagues at the Leibniz Research Institute for Environmental Medicine while investigating whether the molecule could protect skin against sun damage. Bitop funded a series of studies now published httpjournals.plos.orgplosonearticleid.journal.pone. in prominent http scientific journals httperj.ersjournals.comcontent. The point that it can prevent the lung inflammation induced by ultrafine particles is established there is no more doubt Krutmann said. Antioxidants can also provide some protection but there has been controversy over the effectiveness of such food supplements he said Personally I think it is much better to eat lots of vegetables and fruit rather than taking any supplements. Dr Richard Russell a consultant respiratory physician in the NHS and medical advisor to the British Lung Foundation who was not involved in the research said the inhaler was both credible and promising Ectoine is a beautifully elegant molecule and it clearly works by helping water to stabilise giving you a film of water in times of stress. The work that has been published thus far in credible internationally recognised journals show that this stuff has positive properties protecting against triggered inflammation he told the Guardian. Russell who also lectures at Imperial College and Oxford University said it might also be useful for the treatment of asthma COPD and other lung diseases not only prevention. It could potentially do so much more. It is actually quite exciting and there is clearly a lot more to come from this story. Krutmann said slashing air pollution remained paramount. It is very nice to be able to protect people against the detrimental effects but this should not be used as an argument that we can now stop working on reducing particulate air pollution. The best thing is that we have clean air because then we dont need any prophylactic treatment. But on the other hand we have to be realistic and in many countries you cannot just switch traffic overnight to electric cars and do other drastic things. It will take many more years especially in countries like China and I think there is an ethical need to provide something to the general population to protect them he said."

"A study shows that not all good fats are the same when it comes to protecting your health. For decades the message about fats has been relatively simple reduce the amount of oils and fats you eat from animal and dairy products less red meat and cheese and substitute them with healthier fats from plants or fish olive oil httptopics.time.comoil omega fatty acids. The difference came down to the specific type of fats that make up these foods animal and dairy fats tend to be saturated which means all of the free bonds available in a chain of carbon atoms are bound to hydrogen atoms while plant fats are unsaturated meaning some of carbon atoms have double bonds with each other. Saturated fats are more likely to build up within artery walls and form plaques that can trigger heart attacks httptopics.time.comheartattacks. But in the latest study on fats published in the BMJ researchers found convincing evidence that not all plant fats are created equal and that linoleic acid or omega fatty acids may be associated with a higher risk of early death from any cause as well as increased risk of heart disease httptopics.time.comheartdisease and death from heartrelated conditions. The study is actually a reanalysis of data that had not been included in the original publication of results from the Sydney Diet Heart Study a trial that was conducted from to . For more than three years researchers at the time followed men aged to years old who had a history of heart disease about half were told to replace the saturated fats they consumed from animal and dairy sources with omega linoleic acid which is commonly found in safflower oil or margarines made from it. The other half were not told to change their diet in any way. When that study was published in researchers noted an increased risk of early death from any cause among the omega group but did not break down the data by what caused the deaths. MORE Study Good Fats Even Better for the Heart Than We Thought httphealthland.time.comstudygoodfatsevenbetterfortheheartthanwethought So Dr. Christopher Ramsden a clinical investigator at the National Institutes of Health who was interested in understanding the effects of linoleic acid on heart health contacted one of the original authors and reviewed data that had not been included in the study. This information involved deaths from heartrelated causes and the new analysis showed that the omega group had a higher risk of dying during the study period from heart disease compared with among the control group. The American Heart Association AHA currently recommends that people replace to of their daily saturatedfat intake with foods containing unsaturated fats such as canola and olive oils. The AHA further breaks down the unsaturatedfat advice by suggesting that people devote about to of their daily calories to foods containing linoleic acid. The recommendation is based on a review of the available data. MORE Study Eating Omegas May Help Reduce Alzheimers Risk httphealthland.time.comeatingomegasmayhelpreducealzheimersrisk The latest results however raise questions about that advice. Ramsden says the findings provide some refined understanding of unsaturated fats which come in different chemical forms that may have varying benefits or risks. I wouldnt necessarily say that the current advice is necessarily completely wrong he says. What happened is that in the s all polyunsaturated fats were considered the same. They were grouped together under one mechanism of being able to lower bloodcholesterol levels. Then over the ensuing decades it became clear as science progressed that there were multiple types of polyunsaturated fats and these compounds potentially have distinct biochemical and health effects. There has been some evidence to suggest that omega fatty acids for example may trigger inflammation a condition that is linked to an increased risk of heart problems while omega fatty acids found in deepwater fish like salmon tend to inhibit inflammatory reactions. Ramsden says the results highlight the need to study dietary ingredients in more detail rather than lumping them together and assuming they have the same effect on the body. MORE Can Olive Oil Help Prevent Stroke httphealthland.time.comcanoliveoilhelppreventstroke Recognizing that need the AHA says it is considering reevaluating all its dietary recommendations and will make the issue of polyunsaturated fats part of this assessment. Reviewing the dietary advice as a whole is important says Alice Lichtenstein a spokesperson for the association since changes in one area could have unexpected and potentially harmful effects on other eating habits. When health organizations advised people to lower their intake of saturated fats for example many replaced the fats with carbohydrates which can increase risk of diabetes and lead to higher levels of another type of fat in the blood triglycerides. One of the things we learned is that we need to look at the whole picture says Lichtenstein. Just looking at one individual component puts undue emphasis on that component and may lead to unanticipated consequences. We need to look at dietary patterns rather than individual nutrients or individual food components. Whether the association will change its advice about consuming linoleic acid isnt clear yet but Ramsden says the results of the latest study could have important implications for the way people eat if they want to stay hearthealthy."

"British scientists conducting earlystage research have found that a potential new drug from GlaxoSmithKline could treat mixedlineage leukemiaMLL the most common form of leukemia in babies. Signage is pictured on the company headquarters of GlaxoSmithKline in west London July . REUTERSToby Melville In a study published in the journal Nature scientists from the British drugmaker collaborating with the charity Cancer Research UK CRUK and Cellzome AG found that the experimental drug called IBET mimics a chemical tag which is key to preventing the process of activating the leukemia genes. This ... is an exciting new avenue for drug discovery which we hope will be useful for other types of cancer in addition to MLLleukaemias said Tony Kouzarides of the Wellcome TrustCRUK Gurdon Institute at Cambridge University who coled the study. Kevin Lee head of epigenetics discovery research at GSK who also worked on the study said he too was excited about the findings although it will probably be many years before the drug could potentially reach the market. Even though this is still labbased ... it validates the idea of developing small molecules against epigenetic switches he said in an emailed comment. It is important to remember we will need to be successful on a number of additional steps before we can move this from the lab to testing this compound in humans. MLL leukemia is thought to account for up to percent of cases of acute leukemia in children below two years old and up to one in cases in adults. Most patients dont respond well to standard leukemia treatments and often the cancer comes back. The disease is caused when a gene called MLL gets fused to another gene. This disrupts the normal function of MLL by creating a new fusion protein that behaves wrongly switching on genes that drive the development of leukemia. Kouzaridess team found that in the disease the MLLfusion proteins are targeted to leukemiacausing genes by proteins from the BET family which recognize certain chemical tags on chromatin the scaffold on which DNA is arranged. Using IBET to treat leukaemias in mice and human cancer cells in a lab the researchers found that the chemical could halt the disease paving the way for more research to be done in firststage or socalled Phase I human trials. We urgently need better ways to treat children with more aggressive forms of leukemia such as MLL said Lesley Walker CRUKs director of information. Although this research is only in the lab at the moment we hope it will move quickly toward clinical trials in patients. Leukemia is the most commonly diagnosed cancer in children and accounts for a around a third of all cancers diagnosed in children. According to Cancer Research UK eight out of children with leukemia in Britain now survive for five years or more compared with one in in the late s. Editing by Sugita Katyal Our StandardsThe Thomson Reuters Trust Principles. httpthomsonreuters.comenaboutustrustprinciples.html"

"Millions of people visit the websites of the Mayo Clinic American Cancer Society and the Centers for Disease Control and Prevention among others seeking authoritative health information. But are they receiving it When it comes to learning about the differences in risk among certain types of nicotine products many government websites are actually misleading or underinforming the public according to two researchers who analyzed the content of numerous health websites. This information quarantine in turn helps explain the woeful lack of public knowledge about relative risks violating basic consumer rights as well as the public health principles of individual rights and health literacy the researchers say. Writing in the International Journal of Drug Policy http Lynn Kozlowski of the University at Buffalo and David Sweanor of the University of Ottawa point out that many websites omit information showing that products such as ecigarettes smokeless tobacco and snus are far less harmful than traditional cigarettes. Public health ethics always has a concern to avoid any net harm to population health explains Kozlowski professor of community health and health behavior at UB and the papers lead author. The fear has been that much safer tobacco and nicotine products like snus smokeless tobacco and vape will possibly cause a net loss to public health because more people will use these products and these products may lead to cigarette use. This fear however is not based on actual evidence and cannot be used to suppress or otherwise keep the public uninformed of what is clearly known about the lower risks of these products adds Kozlowski PhD one of the worlds leading researchers on smoking behavior. An information quarantine functions similarly to a medical quarantine think of your favorite zombie movie or television show in which the infected person is secluded from everyone else to protect the overall public. In order to justify a quarantine there has to be clear evidence that the need to protect population health should overrule personal autonomy. In the case of providing information on differential health risks of nicotine products The evidence to date does not come close to establishing that there would be a loss to public health from making this information widely available from credible sources Kozlowski says. Kozlowski and Sweanor reviewed several major health websites including the CDC Mayo Clinic American Cancer Society Substance Abuse and Mental Health Services Administration and the National Cancer Institute and found three types of examples of information on smokeless tobacco but notomodest efforts to inform consumers of the significantly lower risks compared to cigarettes for lifelong users the researchers write. In fact they found that the Mayo Clinic perpetuated a misrepresentation discovered in erroneously informing visitors that smokeless tobacco was as dangerous as cigarettes. The day after the article was released the Mayo Clinic removed the headline replacing it with the still misleading statement that smokeless tobacco was not a safe product. People can only make as good a decision as the information available to them allows said Sweanor an adjunct professor in the University of Ottawas Faculty of Law who has spearheaded the development of worldleading tobacco control initiatives in Canada since the early s. The public is dramatically misinformed about the relative risks of substitutable tobacco and nicotine products. The risk differentials are huge but this is simply not known by a vast majority of those whose lives are at risk adds Sweanor. England has an example of a website Action on Smoking and Health ASH that gets it right on vaping the researchers said. A briefingDownload pdf http_.pdfqcigarettes posted on the site specifically states Compared to tobacco products electronic cigarettes are significantly safer. In their paper the researchers note that information on comparative risks is common for other products and activities like overthecounter medicines and even safety ratings of vehicles. They argue that the U.S. Food and Drug Administration FDA which regulates the sale of tobacco products isnt doing its part to inform consumers of important differences in harm among tobacco products. To illustrate their point Kozlowski and Sweanor use the example that if one type of alcoholic beverage caused in regular users to die prematurely as is the case with smoking traditional cigarettes while another caused massively fewer deaths consumers would want to know which product was the safer alternative. It would be scandalous even criminal to keep such facts from consumers the researchers write. Yet such facts are being kept from adult consumers of legal tobacconicotine products either by not informing or actively misinforming consumers. It is as if tobacco consumers were blindfolded and not allowed to see dramatic differences in harm from different products."

"A new device worn like a visor can detect emergent largevessel occlusion in patients with suspected stroke with percent accuracy report clinical investigators at the Medical University of South Carolina MUSC Mount Sinai the University of Tennessee Health Sciences Center and elsewhere in an article published online on March in the Journal of Neurointerventional Surgery. Patients with largevessel occlusions can then be routed to a Comprehensive Stroke Center with endovascular capabilities. In contrast a standard physical examination achieved only to percent accuracy in identifying patients with largevessel occlusion who could benefit from endovascular therapy. The volumetric impedance phase shift spectroscopy VIPS device Cerebrotech VisorTM Cerebrotech Medical Systems Pleasanton CA works by sending lowenergy radio waves through the brain that change frequency when passing through fluids. Such waves are reflected back through the brain and then detected by the device. When a patient is having a severe stroke the brains fluids will change producing an asymmetry in the radio waves detected by the VIPS device. The greater the asymmetry the more severe the stroke. Endovascular therapy within hours is the standard of care for emergent largevessel occlusion but the chance of achieving a good outcome decreases by approximately percent for each hour that passes before treatment. The researchers hope that the device will save valuable time especially important in stroke where time is brain when it is deployed with emergency medical personnel in the field. This is because the accuracy of the device simplifies the decision made by emergency personnel about where to take patients first according to Raymond D. Turner M.D. professor of neurosurgery and chief of the Neuroscience Integrated Center of Clinical Excellence at MUSC. Turner served as principal investigator for MUSC in the VIPS for the NonInvasive Detection of Hemispheric Bioimpedance Asymmetry in Severe Brain Pathology VITAL study reported in the article. Transfer between hospitals takes a lot of time said Turner. If we can give the information to emergency personnel out in the field that this is a largevessel occlusion that should change their thought process in triage as to which hospital they go to. In the study the VIPS device was deployed with emergency medical personnel in regions served by five Comprehensive Stroke Centers equipped with the endovascular capabilities to treat largevessel occlusions that underlie severe stroke. Their goal was to use the device to accurately identify severe stroke and then compare the results to established physical examination methods practiced by emergency personnel such as the Prehospital Acute Stroke Severity Scale. Both healthy participants and patients with suspected stroke were evaluated by emergency personnel using the VIPS device. Three readings were taken and averaged a process that takes about seconds. Patients were also later evaluated by neurologists who provided definitive diagnoses using neuroimaging. Compared to the neurologists diagnoses the device displayed percent specificity the ability to detect the difference between patients with severe stroke and those with other conditions such as mild stroke or healthy participants with no brain pathology. This places the VIPS device above standard physical examination tools used by emergency personnel that display specificity scores between and percent. The VIPS device is made by Cerebrotech Medical Systems which paid consultants to analyze the neuroimaging data independently. The neuroimaging data was needed to teach the VIPS device which radio waves were indicative of stroke. Yet the consultants did not have access to the VIPS radio wave data during their review of the images thereby eliminating the potential of the consultants to choose data that might artificially inflate the devices accuracy. It is also not clear how the device would work for patients with cranial implants as metal interferes with the devices operating radio frequencies. The devices success may be found in its ability to give emergency personnel a clear answer as to whether a patient is experiencing a severe stroke. The VIPS device requires very little training to operate compared to that required to learn standard emergency examination skills thereby reducing the possibility of human error during emergency diagnosis. In their next steps the researchers are undertaking the VITAL . study to determine if the VIPS device can use complex machine learning algorithms to teach itself how to discriminate between minor and severe stroke without the help of neurologists. If so the VIPS device could have widespread clinical implications helping emergency personnel decide whether to take a patient to a comprehensive stroke center or a primary stroke center for treatment. Turner likens the use of the VIPS device in detecting severe stroke to the use of electrocardiography ECG to definitively detect acute myocardial infarction. He predicts that the device has the potential to be used widely by emergency personnel but also to appear in other public spaces. This could potentially be something like a defibrillator said Turner. You can find out if a patient is having a stroke just like you can put a defibrillator on a patient to see if theyre having a heart attack. This study was funded by Cerebrotech Medical Systems. About MUSC Founded in in Charleston The Medical University of South Carolina is the oldest medical school in the South. Today MUSC continues the tradition of excellence in education research and patient care. MUSC educates and trains more than students and residents and has nearly employees including approximately faculty members. As the largest nonfederal employer in Charleston the university and its affiliates have collective annual budgets in excess of . billion. MUSC operates a bed medical center which includes a nationally recognized Childrens Hospital the Ashley River Tower cardiovascular digestive disease and surgical oncology Hollings Cancer Center a National Cancer Institute designated center Level I Trauma Center and Institute of Psychiatry. For more information on academic information or clinical services visit musc.edu. For more information on hospital patient services visit muschealth.org."

"Antiinflammatory drugs similar to those used to treat conditions such as rheumatoid arthritis and psoriasis could in future be used to treat some cases of depression concludes a review led by the University of Cambridge which further implicates our immune system in mental health disorders. Researchers from the Department of Psychiatry at Cambridge led a team that analysed data from clinical trials involving the use of anticytokine drugs to treat a range of autoimmune inflammatory diseases. By looking at additional beneficial sideeffects of the treatments the researchers were able to show that there was a significant antidepressant effect from the drugs compared to a placebo based on a metaanalysis of seven randomised controlled trials. Metaanalyses of the other types of clinical trials showed similar results. When we are exposed to an infection for example influenza or a stomach bug our immune system fights back to control and remove the infection. During this process immune cells flood the blood stream with proteins known as cytokines. This process is known as systemic inflammation. Even when we are healthy our bodies carry trace levels of these proteins known as inflammatory markers which rise exponentially in response to infection. Previous work from the team found that children with high everyday levels of one of these markers are at greater risk of developing depression and psychosis in adulthood suggesting a role for the immune system particularly chronic lowgrade systemic inflammation in mental illness. Inflammation can also occur as a result of the immune system mistaking healthy cells for infected cells and attacking the body leading to autoimmune inflammatory diseases such as rheumatoid arthritis psoriasis and Crohns disease. New types of antiinflammatory drugs called anticytokine monoclonal antibodies and cytokine inhibitors have been developed recently some of which are now routinely used for patients who respond poorly to conventional treatments. Many more are currently undergoing clinical trials to test their efficacy and safety. The team of researchers carried out a metaanalysis of these clinical trials and found that the drugs led to an improvement in the severity of depressive symptoms independently of improvements in physical illness. In other words regardless of whether a drug successfully treated rheumatoid arthritis for example it would still help improve a patients depressive symptoms. Their results are published today in the journal Molecular Psychiatry. Dr Golam Khandaker who led the study says Its becoming increasingly clear to us that inflammation plays a role in depression at least for some individuals and now our review suggests that it may be possible to treat these individuals using some antiinflammatory drugs. These are not your everyday antiinflammatory drugs such as ibuprofen however but a particular new class of drugs. Its too early to say whether these anticytokine drugs can be used in clinical practice for depression however adds Professor Peter Jones coauthor of the study. We will need clinical trials to test how effective they are in patients who do not have the chronic conditions for which the drugs have been developed such as rheumatoid arthritis or Crohns disease. On top of this some existing drugs can have potentially serious side effects which would need to be addressed. Dr Khandaker and colleagues believe that antiinflammatory drugs may offer hope for patients for whom current antidepressants are ineffective. Although the trials reviewed by the team involve physical illnesses that trigger inflammation and hence potentially contribute to depression their previous work found a connection between depression and baseline levels of inflammation in healthy people when someone does not have an acute infection which can be caused by a number of factors such as genes and psychological stress. About a third of patients who are resistant to antidepressants show evidence of inflammation adds Dr Khandaker. So antiinflammatory treatments could be relevant for a large number of people who suffer from depression. The current approach of a onesizefitsall medicine to treat depression is problematic. All currently available antidepressants target a particular type of neurotransmitter but a third of patients do not respond to these drugs. We are now entering the era of personalised medicine where we can tailor treatments to individual patients. This approach is starting to show success in treating cancers and its possible that in future we would use antiinflammatory drugs in psychiatry for certain patients with depression. The research was mainly funded by the Wellcome Trust with further support from the National Institute for Health Research NIHR Cambridge Biomedical Research Centre. Reference Kappelmann N et al. Antidepressant activity of anticytokine treatment a systematic review and metaanalysis of clinical trials of chronic inflammatory conditions. Molecular Psychiatry Oct DOI .mp.."

"Current models require users to test a drop of blood twice daily to calibrate or adjust the monitor. The pain of finger sticks and the cost of testing supplies discourage many people from keeping close tabs on their blood sugar which is needed to manage insulin use and adjust what they eat. Abbotts new FreeStyle Libre Flash Glucose Monitoring System approved Wednesday by the Food and Drug Administration uses a small sensor attached to the upper arm. Patients wave a reader device over it to see the current blood sugar level and changes over the past eight hours. Most of the million Americans with diabetes use standard glucose meters which require multiple finger pricks each day and only show current sugar level. Moreaccurate continuous glucose monitoring devices are used by about Americans. But most dont do the finger pricks to calibrate them and may get inaccurate readings said Dr. Timothy Bailey who helped test FreeStyle Libre. Were able to lower blood sugar safely with this technology said Bailey director of the Advanced Metabolic Care and Research Institute in California. He receives consulting fees from various diabetes device makers. Toohigh blood sugar levels can damage organs and lead to heart attacks strokes blindness and amputations. Very low blood sugar can cause seizures confusion and loss of consciousness. Abbotts device was approved for adults with Type or Type diabetes and should be available in pharmacies within months. The company based near Chicago did not disclose the price of the reader or the sensors. Abbotts system cant be used with an insulin pump a device worn against the skin that allows users to inject insulin as needed but the company is planning improvements to eventually enable that. Rival Medtronic this spring launched a device in which the insulin pump automatically responds to blood sugar changes recorded by the sensor and either withholds or injects insulin as needed."

"People with stage III colon cancer who regularly eat nuts are at significantly lower risk of cancer recurrence and mortality than those who dont according to a new large study led by researchers at Yale Cancer Center. The findings were published today in the Journal of Clinical Oncology. The study followed participants in a clinical trial for a median of . years after they were treated with surgery and chemotherapy. Those who regularly consumed at least two oneounce servings of nuts each week demonstrated a improvement in diseasefree survival and a improvement in overall survival. Further analysis of this cohort revealed that diseasefree survival increased by among the subgroup of nut consumers who ate tree nuts rather than peanuts said Charles S. Fuchs M.D. director of Yale Cancer Center and senior author of the study. Tree nuts include almonds walnuts hazelnuts cashews and pecans among others. In contrast peanuts are actually in the legume family of foods. These findings are in keeping with several other observational studies that indicate that a slew of healthy behaviors including increased physical activity keeping a healthy weight and lower intake of sugar and sweetened beverages improve colon cancer outcomes said Temidayo Fadelu M.D. a postdoctoral fellow at DanaFarber Cancer Institute and lead author of the paper. The results highlight the importance of emphasizing dietary and lifestyle factors in colon cancer survivorship. Additionally the researchers emphasized the study highlighted connections between biological mechanisms that worsen disease not just in colon cancer but in certain chronic illnesses such as type diabetes. Many previous studies have reported that nuts among other health benefits may help to reduce insulin resistance a condition in which the body has difficulty processing the insulin hormone. Insulin resistance leads to unhealthy levels of sugar in the blood and is often a predecessor to type diabetes and related illnesses. Earlier research among patients with colon cancer has revealed worse outcomes among those with lifestyle factors such as obesity lack of exercise and a diet with high levels of carbohydrates that heighten insulin resistance and quickly raise levels of blood sugar. These studies support the hypothesis that behaviors that make you less insulinresistant including eating nuts seem to improve outcomes in colon cancer Fuchs said. However we dont know yet what exactly about nuts is beneficial. Nuts also might play a positive role by satisfying hunger with less intake of carbohydrates or other foods associated with poor outcomes Fuchs noted. Patients may not be eating nuts due to concerns about the high fat content said Fuchs. For example a oneounce serving of about almonds holds about calories including grams of fat. People ask me if increasing nut consumption will lead to obesity which leads to worse outcomes he said. But whats really interesting is that in our studies and across the scientific literature in general regular consumers of nuts tend to be leaner. Dietary changes can make a difference. An earlier analysis of diets in the same patient cohort by Fuchs and his colleagues found a significant link between coffee consumption and reduced recurrence and mortality in colon cancer. When Fuchs advises his patients about lifestyle choices first and foremost I talk about avoiding obesity exercising regularly and staying away from a highcarbohydrate diet he said. Then we talk about things like coffee and nuts. If you like coffee or nuts enjoy them and if you dont there are many other helpful steps you can take. Overall we are working to apply the same rigorous science to the understanding of diet and lifestyles in the colon cancer patient population that we apply to defining new drugs Fuchs said. Cocorresponding authors on the paper are Jeffrey Meyerhardt M.D. of DanaFarber and Ying Bao M.D. of Brigham and Womens Hospital. Lead funding for the research was provided by the National Cancer Institute. Support also came from private sponsors including Pfizer Oncology and the International Tree Nut Council Nutrition Research Education Foundation. The private sponsors did not participate in the design conduct or analysis of the study or in review or approval of the paper."

"UNC researchers say the results from the multisite phase and trials of brexanolone injection are not only promising but could change the way postpartum depression PPD is treated. Brexanolone injection works differently than existing antidepressant medications and if approved by the U.S. Food and Drug Administration FDA later this year will be the first new class of antidepressants in decades and the first drug specifically indicated for PPD. With current antidepressant SSRIs selective serotonin reuptake inhibitors it could take four to six weeks to get a treatment response. In the brexanolone trials we saw patients starting to feel better within days said the trials academic principal investigator Samantha MeltzerBrody https MD MPH director of Perinatal Psychiatry Program at the UNC School of Medicine. David Rubinow MD chair of the Department of Psychiatry at the UNC School of Medicine and a coauthor of the paper says time is especially crucial for new mothers experiencing postpartum depression because the weeks and months following birth are a critical period for motherinfant bonding. Common symptoms of PPD a mood disorder in women that can be triggered by fluctuations in reproductive hormones include low mood feeling overwhelmed anxious and ruminating thoughts potential withdrawal from the baby and her family and suicidal thoughts in the most severe cases. PPD is one of the most common complications of pregnancy with between and percent of mothers worldwide experiencing it. Having a drug developed specifically for postpartum depression is a gamechanger for womens health said MeltzerBrody. With our latest results we believe that brexanolone if approved could provide relief for women with a range of postpartum severity. The paper published in The Lancet includes a new integrated analysis of results from three doubleblind placebocontrolled trials that took place at sites in the U.S. including UNCs Perinatal Psychiatry Unit. Eligible women were aged years old and were six months postpartum or less at screening. They also had to be experiencing moderate to severe postpartum depression which was assessed by the Hamilton Depression Rating Scale HAMD. The integrated analysis looked at results of the trials which randomized women to receive a doubleblinded hour infusion of either brexanolone injection gkghr or placebo. A unique dose group of brexanolone gkghr in one of the studies was not included in the integrated efficacy analysis but was included in integrated analyses of safety. Brexanolone injection gkghr was administered to women with moderate or severe PPD who also were evaluated throughout the infusion after the infusion stopped and then periodically for up to days. Another women were administered a placebo and evaluated during the same timeframe. The first statistically significant reduction in depression severity with brexanolone injection relative to placebo was observed as early as hours after dosing. At the end of the hour infusion the average reduction in patients Hamilton Rating Scale for Depression HAMD or depression severity score was . points for women in the brexanolone injection gkghr group versus . in the placebo group p.. The reduction of symptoms in the patients receiving brexanolone injection was maintained throughout the last study visit at Day . The most common of subjects adverse events following during brexanolone injection administration were headache dizziness and somnolence. This is a very different model for how we treat depression. Having a drug approved to treat PPD that works quickly and effectively yet is also durable would be a huge step forward for psychiatry in general MeltzerBrody said. Brexanolone injection is an allosteric modulator of both synaptic and extrasynaptic GABA receptors. In postpartum depression the GABA pathway may play a key role in regulating hormones that researchers believe can lead to PPD. Sage Therapeutics is the developer of brexanolone injection and sponsor of the trials. A New Drug Application is currently under review by the FDA and brexanolone injection has been granted Breakthrough Therapy Designation. The FDA has assigned a Prescription Drug User Fee Act target date of December ."

"Indiana University researchers have found that magnesium intake may be beneficial in preventing pancreatic cancer. Their study Magnesium intake and incidence of pancreatic cancer The VITamins and Lifestyle study recently appeared in the British Journal of Cancer. Pancreatic cancer is the fourth leading cause of cancerrelated death in both men and women in the United States. The overall occurrence of pancreatic cancer has not significantly changed since but the mortality rate has increased annually from to according to the National Cancer Institute. Pancreatic cancer is really unique and different from other cancers said study coauthor Ka He chair of the Department of Epidemiology and Biostatistics at the IU School of Public HealthBloomington. The fiveyear survival rate is really low so that makes prevention and identifying risk factors or predictors associated with pancreatic cancer very important. Previous studies have found that magnesium is inversely associated with the risk of diabetes which is a risk factor of pancreatic cancer. But few studies have explored the direct association of magnesium with pancreatic cancer of those that did their findings were inconclusive said Daniel Dibaba a Ph.D. student at the School of Public HealthBloomington who led the IU study. Using information from the VITamins and Lifestyle study Dibaba and the other coauthors analyzed an enormous trove of data on over men and women ages to looking at the direct association between magnesium and pancreatic cancer and whether age gender body mass index nonsteroidal antiinflammatory drugs use and magnesium supplementation play a role. Of those followed participants developed pancreatic cancer. The study found that every milligramsperday decrease in magnesium intake was associated with a percent increase in the occurrence of pancreatic cancer. The study also found that the effects of magnesium on pancreatic cancer did not appear to be modified by age gender body mass index or nonsteroidal antiinflammatory drug use but was limited to those taking magnesium supplements either from a multivitamin or individual supplement. For those at a higher risk of pancreatic cancer adding a magnesium supplement to their diet may prove beneficial in preventing this disease Dibaba said. While more study is needed the general population should strive to get the daily recommendations of magnesium through diet such as dark leafy greens or nuts to prevent any risk of pancreatic cancer. In addition to He and Dibaba other contributors included Pengcheng Xun a faculty member in IUs Department of Epidemiology and Biostatistics Kuninobu Yokota of The Jikei University School of Medicine in Tokyo Japan and Emily White of the University of Washington in Seattle."

"For patients with advanced inoperable stage lung cancer concurrent chemotherapy and the specialized radiation treatment proton therapy offers improved survival compared to historical data for standard of care according to a new study from The University of Texas MD Anderson Cancer Center. The research published in JAMA Oncology reported an overall survival OS of . months. In contrast the historical OS rate with standard of care concurrent chemotherapy and traditional radiation was months at the time when the study was designed. The findings are the final results of the single institution Phase II study and represent the longest followup to date of stage lung cancer patients who have received proton therapy said Joe Y. Chang M.D. professor Radiation Oncology and the studys corresponding author. Lung cancer is the leading cause of cancer death in both men and women in the U.S. According to the American Cancer Society more than people will be diagnosed and will die from the disease in with the majority of patients still being diagnosed when the disease is in an advanced stage. Advanced lung cancer patients with inoperable disease traditionally have been treated with concurrent chemotherapy and conventional photon radiation therapy. However the therapy can be very difficult for patients due to associated toxicities and because many patients are also dealing with comorbidities explained Chang. Proton therapy is an advanced type of radiation treatment that uses a beam of protons to deliver radiation directly to the tumor destroying cancer cells while sparing healthy tissues. Protons enter the body with a low radiation dose and stop at the tumor matching its shape and volume or depth. They deposit the bulk of their cancerfighting energy right at the tumor thereby reducing the dose to cardiopulmonary structures which impacts the toxicity functional status quality of life and even survival for patients explained Chang. With our study we hypothesized that proton therapy would offer a survival benefit to patients and reduce treatmentassociated toxicities which can be very serious he said. The study opened at MD Anderson in in this research Chang and his colleague report on the studys fiveyear results. For the prospective Phase II trial patients with inoperable Stage III nonsmallcell lung cancer were enrolled. The studys primary endpoint was OS. The researchers hypothesized that the median OS would increase from historical data of months on standard therapy to months. Secondary endpoints included distant metastasis and local and regional recurrence rates. Toxic effects of treatment in both the acute and late settings also were analyzed. Median follow up was . months for all patients and . months for alive patients. At five years the median OS was . months and the corresponding fiveyear OS was percent. Median progressionfree survival was . months with a fiveyear progressionfree survival of percent. In sum patients experienced a relapse with distant sites representing percent of all recurrences. Local and regional recurrence rates were low percent and percent respectively. Among the acute and late toxic effects diagnosed in patients were esophagitis pneumonitis and cardiac arrhythmia. Of note said Chang no patients developed the most severe or grade five toxicities as seen in patients who receive standard of care. Chang noted his study is not without limitations. Of greatest significance the study was designed more than a decade ago. While the studys survival recurrence rates and toxic effects are still favorable when compared to rates associated with the most advanced traditional photon radiation therapy intensity modulated radiation therapy IMRT technology to diagnose and stage the disease as well all treatment modalities have significantly improved. When the study opened PET imaging had just been approved for lung cancer staging. The image quality was poor and didnt include a CT component in most facilities across the country said Chang. Obviously the technology has improved dramatically over the last decade and has made a significant impact on diagnosis and staging. Also delivery of both the conventional intensitymodulated radiation therapy IMRT and proton therapy IMPT have improved thereby reducing side effects for both treatment modalities. For example MD Anderson proton therapy patients with advanced lung cancer now can receive IMPT. The technique uses an intricate network of magnets to aim a narrow proton beam at a tumor and paint the radiation dose onto it layer by layer. Healthy tissue surrounding the tumor is spared and side effects are even more reduced than earlier proton delivery said Chang. A Phase II trial studying IMPT and concurrent chemotherapy is underway. Chang also noted the advancements in cancer biology and immunotherapy and that both are important areas of research focus in combination with proton therapy. In addition to Chang other authors on the allMD Anderson study include Stephen Hahn M.D. Ritsuko Komaki M.D. Pamela K. Allen Ph.D. Zhongxing Liao M.D. Steven H. Lin M.D. Ph.D. Daniel Gomez M.D. James Welsh M.D. Melenda Jeter M.D. James Cox M.D. Michael OReilly M.D. Ming Li M.D. and Wencheng Zhang M.D. all of Radiation Oncology John V. Heymach M.D. Ph.D. and Charles Lu M.D. both of ThoracicHead and Neck Medical Oncology Ronald X. Zhu Ph.D. Xiaodong Zhang Ph.D. Heng Li Ph.D. Radhe Mohan Ph.D. all of Radiation Physics and Ara A. Vaporciyan M.D. Thoracic and Cardiovascular Surgery. Vivek Verma M.D. now at the University of Nebraska Medical Center also contributed to the study."

"The latest advances in Alzheimers disease involve people who dont appear to show any signs of cognitive decline yet. Experts now believe that the biological processes behind the neurodegenerative condition begin years if not decades before memory problems and confusion become noticeable. At the annual Alzheimers Association International Conference https researchers say they have found a series of substances in saliva that can distinguish between people who experience normal aging those with mild cognitive dementia MCI which in some cases can lead to Alzheimers and in other cases not and Alzheimers disease. Presenting at the meeting Shraddha Sapkota a graduate student in neuroscience at University of Alberta and her colleagues described how they carefully analyzed the saliva of a group of volunteers participating in an aging study. Some had been diagnosed with Alzheimers and some with MCI while others did not have any neurological conditions. By comparing their saliva components the scientists found that each of the three groups showed slightly different patterns of compounds which could form the basis of a relatively easy and noninvasive way to determine which people are at higher risk of developing more serious degenerative brain conditions. The results arent conclusive enough yet for doctors to start using them to distinguish people who are more likely to develop Alzheimers but thats the goal says Sapkota. Ideally for example isolating those with MCI might help doctors to focus in on a group of patients who might be at higher risk of developing Alzheimers and therefore might need more intensive and regular testing."

"Both men and women have utilized many resources to combat baldness but now a former NASA scientist is using lasers to regrow hair. Dr. Tamim Hamid is the CEO and inventor of Theradome a helmet that he said uses cold lasers to promote hair growth by stimulating the base of the hair follicle. He based his helmet off the findings of Endre Mester a Hungarian physician who accidentally discovered that lasers can grow hair in mice in . This has been sitting dormant for many many years until about . We discovered that the same wavelength of nanometers was able to stimulate hair on humans as well Hamid told FoxNews.com. To further explain how light grows hair Hamid said the laser light stimulates the mitochondria at the base of the hair follicle which is where the stem cells that grow hair are located. Once the hair follicle is reactivated using light energy the hair reverses the miniaturization process which was induced by the hormone DHT. The challenge that Hamid faced was putting this technology into something that was wearable and easy to use. Board certified dermatologist Dr. Eric Schweiger who has not worked on Theradome told FoxNews.com that there have been other products that use low level laser technology to grow hair but Theradome is the first of its kind to be wearable. It doesnt require anything from the patient apart from wearing the helmet for minutes two times a week. The major benefit of therdome is you wear it as a cap and you dont have to hold it up to your scalp. I think that will increase compliance Schweiger said. Hamid said that Theradome has helped tens of thousands of people. One of those is Sabra Hardy who suffers from alopecia areata an autoimmune disease that left her with huge bald spots on either side of her head. I was using creams that were developed for the coats of animals when they had problems with their coat. I was using oils developed for animals that were dangerous to use and smelled really bad Hardy said. Her hair loss was costly and painful. She spent hundreds of dollars on wigs and was getting steroid injections in her scalp for nearly two years with no signs of progress until she started using Theradome. According to the Theradome website percent of subjects saw positive results after weeks of treatment and they reported a percent increase in hair growth. Schweiger said that Theradome is safe for someone who wants another option in conjunction with other conventional baldness remedies and that its effectiveness should be studied more over time. For patients who are looking for an additional therapy its not unreasonable to use. I think well know more as time goes on Schweiger said. As far as the products safety Schweiger said that since the lights are low energy and are not UV he is confident that Theradome is safe. Theradome is FDA cleared and costs . Patients should always see their physician before trying any new treatments."

"A new study is raising questions about the ageold belief that a calorie is a calorie. Research from a new study funded by the National Institutes of Health finds that dieters were more successful maintaining weight on a lowcarb diet than they were on a lowfat diet. The research finds that dieters who were trying to maintain their weight loss burned significantly more calories eating a lowcarb diet than they did eating a lowfat diet. But some experts say these findings are very preliminary. The study funded by the National Institutes of Health httpcontent.usatoday.comtopicstopicOrganizationsGovernmentBodiesNationalInstitutesofHealth was designed to see if changing the type of diet people consumed helped with weight maintenance because dieters often regain lost weight. So scientists had obese participants ages to lose to of their initial body weight about pounds. After their weight had stabilized each participant followed one of three different diets for four weeks. Participants were fed food that was prepared for them by diet experts. The dieters were admitted to the hospital four times for medical and metabolic testing. Heres a look at the three types of diets used in the new study A lowfat diet which is about of calories from fat from carbohydrates from protein. It emphasizes wholegrain products and fruits and vegetables and cuts way back on oils nuts fatty meats and other highfat foods. A lowcarb diet similar to the Atkins diet with only of calories from carbohydrates from protein from fat. This diet emphasizes beef fish chicken eggs cheese some vegetables and fruits while slashing the consumption of breads pasta potatoes rice cakes cookies and starchy vegetables. A lowglycemic index diet similar to a Mediterranean diet is made up of vegetables fruit beans healthy fats olive oil nuts and mostly healthy grains oldfashioned oats brown rice. It gets about of daily calories from carbohydrates from fat and from protein. Source Journal of the American Medical Association The diets had the same number of calories but the fat protein and carbohydrate content varied. Those diets A lowfat diet which was about of calories from fat and emphasized wholegrain products and fruits and vegetables. A lowcarb diet similar to the Atkins diet with only of calories from carbohydrates. It emphasized fish chicken beef eggs cheese some vegetables and fruits while eliminating foods such as breads pasta potatoes and starchy vegetables. A lowglycemic index diet similar to a Mediterranean diet made up of vegetables fruit beans healthy fats olive oil nuts and mostly healthy grains oldfashioned oats brown rice. These foods digest more slowly helping to keep blood sugar and hormones stable after the meal. Findings published in this weeks Journal of the American Medical Association Participants burned about calories more a day on a lowcarb diet than they did on a lowfat diet. Thats the amount youd burn off in an hour of moderate intensity physical activity without lifting a finger says senior author David Ludwig httpcontent.usatoday.comtopicstopicDavidLudwig director of the New Balance Foundation Obesity Prevention Center at Boston Childrens Hospital. Participants burned calories more on the lowglycemic index diet than the lowfat diet. Thats about an hour of light physical activity he says. The reason for the lowcarb advantage is unclear he says. We think the lowcarb and lowglycemic index diets by not causing the surge and crash in blood sugar dont trigger the starvation response. When the body thinks its starving it turns down metabolism to conserve energy he says. The authors note a downside to the lowcarb diet It appears to raise some risk factors for heart disease. Ludwig says that restricting carbohydrates over the long term may be hard for many people. If youre trying to lose weight you can get a jump start with a lowcarb diet but over the long term a lowglycemic index diet may be better than severely restricting carbohydrates. The lowglycemic index diet seems to be the happy medium says Cara Ebbeling associate director of the Obesity Prevention Center. It didnt slow metabolism as much as the lowfat diet and it didnt seem to have some of the negative effects on cardiovascular disease risk. On a lowglycemic index diet you would avoid highly processed carbs such as white bread white rice many snack foods prepared breakfast cereals sugary desserts and sugary beverages she says. Experts had different responses to the findings. George Bray an obesity researcher at Pennington Biomedical Research Center in Baton Rouge who has also studied this topic and who wrote the accompanying editorial in JAMA says that other studies show that you can do well on any diet as long as you stick to it. Adherence is the major key for weight loss and maintenance. There is no magic in any diet. Eric Westman a Duke University httpcontent.usatoday.comtopicstopicOrganizationsSchoolsDukeUniversity researcher who has conducted several studies on the lowcarb diet and is coauthor of The New Atkins for a New You says this study documents that the lower the carbohydrates the better the metabolic effects. People burn more calories if they eat fewer carbohydrates. Marion Nestle httpcontent.usatoday.comtopicstopicMarionNestle a nutrition professor at New York University httpcontent.usatoday.comtopicstopicOrganizationsSchoolsNewYorkUniversity says longer studies conducted among people in their own environments not with such controlled meals have shown little difference in weight loss and maintenance between one kind of diet and another. More research is needed to show that interesting results like these are applicable in real life she says. In the meantime if you want to lose weight eat less."

"Warfarin is a blood thinner that is commonly prescribed to patients to prevent lifethreatening blood clots. Despite its longtime use warfarin remains tricky to dose because a persons genetic makeup influences how the drug is processed in the body. Too much warfarin can cause internal bleeding too little warfarin fails to prevent blood clots. Now a new study led by Washington University School of Medicine in St. Louis shows that dosing warfarin Coumadin and others is safer producing fewer adverse events such as hemorrhage when key elements of a patients genetic makeup are considered. The research published Sept. in the Journal of the American Medical Association reports results from the clinical trial known as GIFT Genetics Informatics Trial of Warfarin to Prevent Deep Venous Thrombosis. Physicians have been prescribing warfarin since the Eisenhower administration said first author Brian F. Gage MD a professor of medicine at Washington University School of Medicine in St. Louis. Its a widely used anticoagulant but it causes more major adverse events than any other oral drug. Thousands of patients end up in the emergency department or hospital because of warfarininduced bleeding. But we continue to prescribe it because it is highly effective reversible and inexpensive. So our goal is to make warfarin safer. GIFT showed that precisionmedicine based on clinical factors and three genes improves the safety of initiating warfarin therapy. Patients in the trial were randomly assigned to one of two groups. One group received warfarin dosing based on standard factors such as age height and weight the second group was dosed based on these clinical factors plus genetic variants. Participating sites in the trial included Washington University School of Medicine Hospital for Special Surgery in New York Intermountain Healthcare University of Utah and Rush University Medical Center. Of the patients who were dosed in the traditional manner experienced at least one adverse event . percent. Of the patients whose warfarin dosing was guided by genetic testing experienced an adverse event . percent. Compared with patients receiving traditional warfarin dosing patients dosed with the genetic approach had a percent reduction in adverse events which was statistically different. The adverse events were bleeding formation of blood clots in the veins and warfarin overdoses. No patient died during the trial. Earlier studies looking at whether genetic testing could improve warfarin dosing had produced conflicting results. However these studies were smaller and considered fewer genes than GIFT. GIFT enrolled patients age and older at high risk of blood clots because they underwent hip or kneereplacement surgeries. Unlike prior studies GIFT took into account genetic variants in three genes for days of warfarin therapy. Genetic variants were assessed on a commercial platform called GenMarkDx. Variants in one gene affect vitamin K recycling. Variants in another gene affect warfarin sensitivity. Variants in the third gene alter warfarin metabolism in the liver and can cause an overdose if the dose is not adjusted soon enough. There are additional genetic variants that may help to guide warfarin dosing especially among patients with African ancestry Gage said. In the future we hope to quantify how these variants affect warfarin. Gage also noted how healthcare costs relate to dosing warfarin in a genetically guided manner. Although genetic testing is more expensive than clinical dosing the cost is falling he said. In our study we estimated that genetic testing costs less than per person which is less than one month of a newer anticoagulant. This work was supported by the National Heart Lung and Blood Institute NHLBI and the National Center for Advancing Translational Sciences NCATS of the National Institutes of Health NIH grant numbers RHL and ULTR the Centers for Medicare and Medicaid Services grant number CAGN and GenMarkDx which supplied instrumentation. Gage BF Bass AR Lin H Woller SC Stevens SM AlHammadi N Li J Rodriguez Jr. T Miller JP McMillin GA Pendleton RC Jaffer AK King CR DeVore B PorcheSorbet R Napoli L Merritt K Thompson AM Hyun G Anderson JL Hollomon W Barrack RL Nunley RM Moskowitz G DavilaRoman V and Eby CS for the GIFT investigators. Effect of genotypeguided warfarin dosing on clinical events and anticoagulation control among patients undergoing hip or knee arthroplasty the GIFT randomized clinical trial. Journal of the American Medical Association. Sept. . Washington University School of Medicines employed and volunteer faculty physicians also are the medical staff of BarnesJewish and St. Louis Childrens hospitals. The School of Medicine is one of the leading medical research teaching and patientcare institutions in the nation currently ranked seventh in the nation by U.S. News World Report. Through its affiliations with BarnesJewish and St. Louis Childrens hospitals the School of Medicine is linked to BJC HealthCare."

"A Japanese drug company is offering up a big claim Shionogi Co. says it has an experimental pill that can kill the flu virus https within a single day according to news reports. In a clinical trial a single dose of the drug made by the pharmaceutical company eliminated the virus from peoples bodies in a median time of hours The Wall Street Journal https_emailexperimentaldrugpromisestokillthefluvirusinadaylMyQjAxMTIMDEyMTgxOTEWj reported. Both Japanese and American flu patients were included in the trial. The experimental drug worked three times faster than another antiviral drug Tamiflu https the company told the Journal. things you can do right now to help prevent the flu https The drug uses a different approach to fight the flu than other medications. The flu virus https spreads through the body by invading cells. Once inside a cell it hijacks the cells machinery forcing the cell to make copies of the virus. Then the newly copied viruses break out of the cell spreading to other cells nearby and repeating the process. Existing drugs including Tamiflu work to block these viral copies from escaping the cell the Journal reported. The experimental drug however kicks into action earlier working to block the virus https from hijacking cells in the first place the Journal said. Japanese drug regulators could approve the drug for use in Japan by early March the Journal reported. The drugmaker plans to apply for approval in the U.S. this summer however the drug likely wouldnt be available here until next year."

"A daily drink combining several nutrients appears to help people with early Alzheimers disease improve their memory a new study suggests. As Alzheimers progresses patients lose their memory as synapses connections between brain cells deteriorate according to background information included in the study. The new drink called Souvenaid may actually stimulate the growth of new synapses said the drinks inventor Massachusetts Institute of Technology scientist Dr. Richard Wurtman. But more research is needed before the drink could be made available to the public. And even then consumers should exercise caution said William Thies vice president for medical and scientific affairs at the Alzheimers Association. Nutricia a division of Dannon sponsored the study. MIT has a patent on Souvenaid and Nutricia has the exclusive license on the patent. Existing data now suggests that it may be possible to receive something that will sustain cognition in people with Alzheimers disease with a limited concern about side effects Wurtman said. Previous experiments in animals showed that giving them the three compounds included in the drink increased the production of synapses improving brain function he said. For the new study nearly early Alzheimers patients in Europe drank either Souvenaid or a placebo for six months. During the first three months of the study patients in both groups showed improved memory. After that however patients taking the placebo had a decline in memory. In contrast patients taking Souvenaid continued to show improved memory on tests used to assess Alzheimers patients. Whether Souvenaid will slow the progression of Alzheimers isnt known. There is however a longer trial going on that might answer that question Wurtman said. I dont think it has any effect on the fundamental diseases process but well see he said. The report was published in the July online edition of the Journal of Alzheimers Disease. The drink combines three ingredients choline uridine and omega fatty acids. Choline is a B vitamin found in meats nuts and eggs and omega fatty acids are found in fish eggs flaxseed and meat from grassfed animals. Uridine which is produced by the liver and kidneys is also found in some foods as a part of RNA which helps make protein in the body. These nutrients along with other proteins are essential for making braincell membranes that form synapses. To be effective all three compounds must be given together the researchers said. Nearly all patients drank the nutrient cocktail consistently throughout the study and there were no serious side effects the researchers reported. To show the drinks effect on the brain patients underwent electroencephalography EEG throughout the trial. During the study the brains of those taking the drink shifted from patterns of dementia to more normal ones the researchers found. Since EEG patterns reflect the activity of synapses this result suggests that synaptic function increased with treatment the researchers said. An earlier study found that patients with more advanced Alzheimers did not benefit from Souvenaid most likely because brains cells had already been lost so new synapses couldnt develop Wurtman said. There are as yet no plans to market Souvenaid so the cost hasnt been established company spokesman William Green said. Souvenaid is a test product in development which is still undergoing clinical trials Green said. No plans for the introduction of Souvenaid to the market either in Europe or the U.S. have been confirmed. It is probable that any introduction would take place first in Europe. An ongoing study will evaluate the product over two years. If it appears to have a positive effect then it may be something that could benefit patients even before definitive symptoms of Alzheimers appear Wurtman said. Thies of the Alzheimers Association is very cautious about the benefits of Souvenaid. Medical foods do not have a requirement for FDA premarket approval but they do have a requirement for having a scientific foundation and some evidence of efficacy he said. But they dont have the kind of data we would find for a medication. That makes it difficult to make a clearcut statement about the value of the product he said. There isnt a clear diet that prevents you from getting Alzheimers disease or improves your memory Thies said. In addition medical foods for Alzheimers most likely wont be covered by insurance he said. You are making a judgment without the protections you have when dealing with a medication Thies said. Youre going to be making a decision using your own funds and we would advise anybody to make sure they understand what the product offers and make sure they understand what its going to cost. More information For more about Alzheimers disease visit the Alzheimers Association http SOURCES Richard Wurtman M.D. professor emeritus of brain and cognitive sciences Massachusetts Institute of Technology Boston William Thies Ph.D. vice president medical and scientific affairs Alzheimers Association Chicago William Green spokesman Nutricia July Journal of Alzheimers Disease online"

"The U.S. Food and Drug Administration today approved Noctiva desmopressin acetate nasal spray for adults who awaken at least two times per night to urinate due to a condition known as nocturnal polyuria overproduction of urine during the night. Noctiva is the first FDAapproved treatment for this condition. Todays approval provides adults who overproduce urine at night with the first FDAapproved therapeutic option to help reduce the number of times a night they wake up to urinate said Hylton V. Joffe M.D. M.M.Sc. director of the Division of Bone Reproductive and Urologic Products in the FDAs Center for Drug Evaluation and Research. It is important to know that Noctiva is not approved for all causes of nighttime urination so patients should discuss their symptoms with their health care provider who can determine the underlying cause of the nighttime urination and whether Noctiva is right for them. Nocturia wakening at night to urinate is a symptom that can be caused by a wide variety of conditions such as congestive heart failure poorly controlled diabetes mellitus medications or diseases of the bladder or prostate. Before considering Noctiva health care providers should evaluate each patient for possible causes for the nocturia and optimize the treatment of underlying conditions that may be contributing to the nighttime urination. Because Noctiva is approved only for adults with nocturia caused by nocturnal polyuria health care providers should confirm overproduction of urine at night with a hour urine collection if one has not been obtained previously. Health care providers should also be mindful of underlying conditions that can cause nocturia but that make treatment with Noctiva unsafe such as excessive drinking of fluids or symptomatic congestive heart failure. Noctiva is taken daily approximately minutes before going to bed. It works by increasing the absorption of water through the kidneys which leads to less urine production. Noctivas efficacy was established in two week randomized placebocontrolled trials in patients years of age and older with nocturia due to nocturnal polyuria. Although these trials showed a small reduction in the average number of nighttime urinations with Noctiva compared to placebo more patients treated with Noctiva were able to at least halve their number of nighttime urinations and patients treated with Noctiva had more nights with one or fewer nighttime urinations. Noctiva is being approved with a boxed warning and a Medication Guide because it can cause low sodium levels in the blood hyponatremia. Severe hyponatremia can be lifethreatening if it is not promptly diagnosed and treated leading to seizures coma respiratory arrest or death. Health care providers should make sure the patients sodium level is normal before starting Noctiva and should check sodium levels within one week and approximately one month after starting treatment and periodically thereafter. The lower Noctiva dose is recommended as the starting dose for those who may be at risk for hyponatremia such as the elderly. Noctiva should not be used in patients at increased risk of severe hyponatremia such as those with excessive fluid intake those who have illnesses that can cause fluid or electrolyte imbalances certain patients with kidney damage and in those using certain medicines known as loop diuretics or glucocorticoids. Noctiva should also not be used in patients with symptomatic congestive heart failure or uncontrolled hypertension because fluid retention can worsen these underlying conditions. Use of Noctiva should be discontinued temporarily in patients with certain nasal conditions such as colds or allergies until those conditions have resolved. Noctiva is also not recommended for the treatment of nocturia in pregnant women. Nocturia is usually related to normal changes in pregnancy that do not require treatment with Noctiva. Noctiva should not be used in children. The most common side effects of Noctiva in clinical trials included nasal discomfort cold symptoms nasopharyngitis nasal congestion sneezing high or increased blood pressure back pain nose bleeds bronchitis and dizziness. Although there are other FDAapproved medications that also contain desmopressin none of those medications are approved to treat nocturia. Noctiva is manufactured by Renaissance Lakewood LLC for Milford Pennsylvaniabased Serenity Pharmaceuticals LLC. The FDA an agency within the U.S. Department of Health and Human Services protects the public health by assuring the safety effectiveness and security of human and veterinary drugs vaccines and other biological products for human use and medical devices. The Agency also is responsible for the safety and security of our nations food supply cosmetics dietary supplements products that give off electronic radiation and for regulating tobacco products."

"Braeburn Pharmaceuticals and Camurus today announce top line results of a multipledose pivotal Phase study assessing the blockade by CAM of subjective opioid effects of multiple randomized hydromorphone challenges in adults with opioid use disorder. A key objective of medicationassisted treatment for opioid use disorder is to reduce or eliminate the use of illicit opioids. The results from the present Phase study demonstrate that CAM blocks effectively the subjective effects of opioid challenges with hydromorphone including limiting drug liking. This study provides clinical proof of concept that CAM will be an effective treatment for opioid use disorder said Behshad Sheldon President and CEO of Braeburn Pharmaceuticals The current opioid crisis demands innovation and CAMs novel technology is now one step closer to providing physicians and patients with a different approach to treating this deadly chronic disease. The primary endpoint was met for both CAM doses demonstrating blockade of the subjective effects of hydromorphone as measured by the Drug Liking Visual Analog Scale. Furthermore CAM was well tolerated across the course of treatment. The study results show that CAM provides rapid and extended blockade of opioid effects said Fredrik Tiberg President and CEO of Camurus. The results also confirm the dose selection in the current Phase program and the potential of CAM as a future treatment alternative for patients with opioid use disorder from initiation to longterm maintenance. The current study demonstrated that weekly injections of CAM produced significant and robust opioid blockade a critical mechanism of efficacy for medications treating opioid dependence. CAM has the potential to alter the current treatment paradigm for opioid dependence said Sharon Walsh Ph.D Professor of Behavioral Science and Director of the Center on Drug and Alcohol Research University of Kentucky Because of its long acting properties CAM may decrease patient and physician burden improve access to treatment and obviate public health concerns about illicit diversion of buprenorphine. We were pleased to be involved in the development of CAM and are hopeful that it will serve as another safe and effective therapeutic option for patients with opioid use disorder. The ability of CAM to produce a longlasting and robust blockade of hydromorphoneinduced Drug Liking is especially encouraging said Sandra D. Comer Ph.D Professor of Neurobiology Columbia University. Importantly the fact that CAM will be given in the clinic by health providers should address concerns about diversion of buprenorphine for illicit use. We feel that this medication with its ease of administration and flexible dosing capabilities could significantly improve management of patients. About the Phase Trial The Phase study was a threecenter randomized doubleblind inpatient study to evaluate the degree of subjective opioid blocking efficacy of CAM qw in nontreatmentseeking participants with moderatetosevere opioid use disorder. After screening participants were randomized to different CAM qw onceweekly injections for two weeks. During this period four challenge sessions were conducted with a randomized hydromorphone dose to determine subjective liking score based on a visual analogue scale. Additional information on the design of the trial can be found at http . About CAM The investigational CAM buprenorphine subcutaneous injection products for treatment of opioid use disorder are being developed as onceweekly and oncemonthly formulations each with multiple doses to cover all phases of treatment from initiation through maintenance. The CAM products are designed for administration by healthcare personnel to ensure proper delivery that minimizes the risks of diversion abuse misuse and accidental exposure. The CAM products have been evaluated in three Phase clinical trials which evaluated the safety and tolerability as well as pharmacokinetic and pharmacodynamic properties of the products in a total of individuals opioiddependent patients and healthy volunteers under naltrexone blockage. Four more trials including two Phase studies are currently ongoing. CAM is also being developed for treatment of chronic pain. About Braeburn Pharmaceuticals Braeburn Pharmaceuticals an Apple Tree Partners company is a pillfree pharmaceutical company delivering precision medicine in neuroscience. In September the Food and Drug Administration FDA accepted for review Braeburns New Drug Application for its lead candidate Probuphine a sixmonth buprenorphine implant for treatment of opioid addiction. The Agency set May as the target date for action. Longacting therapeutic treatment options can be essential to improving patient outcomes and facilitating recovery in these conditions which are often complicated by stigma and present significant public health challenges. Braeburns investigational product pipeline consists of longacting implantable and injectable therapies for serious neurological and psychiatric disorders including opioid addiction pain and schizophrenia. Candidates include Probuphine a sixmonth buprenorphine implant for treatment of opioid addiction CAM weekly and monthly subcutaneous injection depot formulations of buprenorphine for treatment of opioid addiction and pain a risperidone sixmonth implant for treatment of schizophrenia and a novel molecule ATI for treatment of schizophrenia. More information on Braeburn can be found at http About Camurus Camurus is a Swedish researchbased pharmaceutical company committed to developing and commercialising innovative and differentiated medicines for the treatment of severe and chronic conditions. New drug products with bestinclass potential are conceived based on the proprietary FluidCrystal drug delivery technologies and an extensive RD expertise. Camurus clinical pipeline includes products for treatment of cancer endocrine diseases pain and addiction developed inhouse and in collaboration with international pharmaceutical companies. The companys share is listed on Nasdaq Stockholm under the ticker CAMX. For more information visit http Media contacts Fredrik Tiberg President CEO Tel fredrik.tibergcamurus.com mailtofredrik.tibergcamurus.com http Sherry Feldberg MSLGROUP Boston braeburnpharmamslgroup.com mailtobraeburnpharmamslgroup.com Logo httpphotos.prnewswire.comprnhLOGO Logo httpphotos.prnewswire.comprnhLOGO SOURCE Braeburn Pharmaceuticals Camurus Related Links http"

"A new pill may help in the fight with cystic fibrosis. A study funded in part by Vertex Pharmaceuticals http the drug ivacaftor pronounced eye va kaf tor caused patients with a specific type of cystic fibrosis to improve lung function gain weight and fight other aspects of the disease. This is the first time that we have a therapy that is directed at the cause of cystic fibrosis says Dr. Michael Konstan httpcf.case.eduKonstan.html the chair of the Department of Pediatrics at Rainbow Babies and Childrens Hospital http Cleveland and one of the authors of the study. There is no cure for this disease and existing treatments just help alleviate some of the symptoms. This is a big deal says Robert Beall http the president and CEO of the Cystic Fibrosis Foundation http The fact is it is obviously going to make a very big difference in the lives of patients. Cystic fibrosis is a genetic disease that causes problems with the balance of salt going in and out of cells. A sticky mucus clogs organs particularly the lungs and liver. It can also cause digestive problems. About new cases are diagnosed each year according to the Cystic Fibrosis Foundation and the average person with the disease dies before age . Ivacaftor works for people with the GD mutation of cystic fibrosis. Konstan says that only about of the people with the disease have this specific mutation. It really is a major milestone in the treatment of cystic fibrosis he says. Even thought it only affects a small percentage of patients the hope is there that we can finally do something about this disease. The study published in the New England Journal of Medicine http looked at people who got the drug. Those taking ivacaftor saw improvements within two weeks which continued for the nearly yearlong trial. Drug recipients could blow out more than more air from their lungs compared with patients who were not taking the drug and were about half as likely to have a pulmonary exacerbation or a worsening of their lung disease that often requires hospitalization. On average patients taking the drug grew more and put on more weight than the placebo group according to the study and had lower sweat chloride an indicator of the disease. Beall says the improved lung function helped patients double their ability to walk and one patient even started going the gym for the first time. We have an incredible proof of concept Beall says. He points to other research under way with ivacaftor combined with another drug that could help people with the most common mutation of cystic fibrosis. That trial is ongoing and the treatment is at least four or five years away from approval but if it works Beall says it could help of the people with cystic fibrosis. In an editorial accompanying the study Dr. Pamela Davis httpcasemed.case.eduaboutbrief_bio.cfmdirectory_id of Case Western University paraphrased Winston Churchill This study is also a great victory in the war against genetic diseases and marks the end of the beginning for the treatment of the cystic fibrosis defect. Ivacaftor has been submitted to the FDA for approval and could be available next year according to Konstan. When it goes on sale it will be sold under the brand name Kalydeco pronounced kuhLYEdehkoh."

"Note A media teleconference with researchers and patients from Johns Hopkins and New York University will be held on Wednesday Nov. from a.m. to p.m. ET. To participate U.S.based media may call international media should dial . The access code is . Phone lines open at a.m. and all media should place speakers on mute unless posing a question. Reporters wishing to ask a question should email their name and outlet to david.marchnyumc.org mailtodavid.marchnyumc.org during the briefing so they may be placed in a queue the moderator will call on individual media members to ask a question in the order names and outlets were received. In a small doubleblind study Johns Hopkins researchers report that a substantial majority of people suffering cancerrelated anxiety or depression found considerable relief for up to six months from a single large dose of psilocybin the active compound in hallucinogenic magic mushrooms. The researchers cautioned that the drug was given in tightly controlled conditions in the presence of two clinically trained monitors and said they do not recommend use of the compound outside of such a research or patient care setting. The Johns Hopkins team released its study results involving adult patients concurrently with researchers from New York University Langone Medical Center who conducted a similarly designed study on participants. Both studies are published in the Journal of Psychopharmacology on Dec. . The Johns Hopkins group reported that psilocybin decreased clinician and patientrated depressed mood anxiety and death anxiety and increased quality of life life meaning and optimism. Six months after the final session of treatment about percent of participants continued to show clinically significant decreases in depressed mood and anxiety with about percent showing symptom remission into the normal range. Eightythree percent reported increases in wellbeing or life satisfaction. Some percent of participants reported the experience as one of the top five meaningful experiences in their lives and about percent reported the experience as one of the top five spiritually significant lifetime events. The most interesting and remarkable finding is that a single dose of psilocybin which lasts four to six hours produced enduring decreases in depression and anxiety symptoms and this may represent a fascinating new model for treating some psychiatric conditions says Roland Griffiths Ph.D. http professor of behavioral biology in the Departments of Psychiatry and Behavioral Sciences and of Neuroscience at the Johns Hopkins University School of Medicine. He notes that traditional psychotherapy offered to people with cancer including behavioral therapy and antidepressants can take weeks or even months isnt always effective and in the case of some drugs such as benzodiazepines may have addictive and other troubling side effects. Griffiths says his teams new study grew out of a decade of research at Johns Hopkins on the effects of psilocybin in healthy volunteers which found that psilocybin can consistently produce positive changes in mood behavior and spirituality when administered to carefully screened and prepared participants. The study was designed to see if psilocybin could produce similar results in psychologically distressed cancer patients. A lifethreatening cancer diagnosis can be psychologically challenging with anxiety and depression as very common symptoms says Griffiths. People with this kind of existential anxiety often feel hopeless and are worried about the meaning of life and what happens upon death. For the study the investigators recruited participants diagnosed with lifethreatening cancers most of which were recurrent or metastatic. They were chosen from a total of individuals reached through flyers web advertisements and physician referrals. Most participants had breast upper digestive GI genitourinary or blood cancer and each had been given a formal psychiatric diagnosis including an anxiety or depressive disorder. Half of the participants were female with an average age of . Ninetytwo percent were white percent were AfricanAmerican and percent were Asian. Each participant had two treatment sessions scheduled five weeks apart one with a very low psilocybin dose or milligrams per kilograms taken in a capsule and meant to act as a control placebo because the dose was too low to produce effects. In the other session participants received a capsule with what is considered a moderate or high dose or milligrams per kilograms. To minimize expectancy effects the participants and the staff members supervising the sessions were told that the participants would receive psilocybin on both sessions but they did not know that all participants would receive one high and one low dose. Blood pressure and mood were monitored throughout the sessions. Two monitors aided participants during each session encouraging them to lie down wear an eye mask listen to music through headphones and direct their attention on their inner experience. If anxiety or confusion arose the monitors provided reassurance to the participants. In addition to experiencing changes in visual perception emotions and thinking most participants reported experiences of psychological insight and often profound deeply meaningful experiences of the interconnectedness of all people. The researchers assessed each participants mood attitude about life behaviors and spirituality with questionnaires and structured interviews before the first session seven hours after taking the psilocybin five weeks after each session and six months after the second session. Immediately after the sessions participants completed questionnaires assessing changes in visual auditory and body perceptions feelings of transcendence changes in mood and more. Structured clinical interviews such as the Hamilton Depression Rating Scale and the Hamilton Anxiety Rating Scale and patient questionnaires like the Beck Depression Inventory and the StateTrait Anxiety Inventory assessed depression and anxiety. Other questionnaires assessed quality of life death acceptance meaningful existence optimism and spirituality generally defined as a search for the meaning of life and a connection to something bigger than ones self. To measure the changes in attitudes moods and behavior over time the researchers administered a questionnaire that assessed negative or positive changes in attitudes about life mood and behavior. With regard to adverse effects Griffiths says percent of participants were nauseated or vomited and onethird of participants experienced some psychological discomfort such as anxiety or paranoia after taking the higher dose. Onethird of the participants had transient increases in blood pressure. A few participants reported headaches following the session. Before beginning the study it wasnt clear to me that this treatment would be helpful since cancer patients may experience profound hopelessness in response to their diagnosis which is often followed by multiple surgeries and prolonged chemotherapy says Griffiths. I could imagine that cancer patients would receive psilocybin look into the existential void and come out even more fearful. However the positive changes in attitudes moods and behavior that we documented in healthy volunteers were replicated in cancer patients. Up to percent of people with cancer suffer from a mood disorder according to the National Comprehensive Cancer Network. Anticipating wide interest in the psilocybin research from scientists clinicians and the public the journal solicited commentaries to be copublished with the study results written by luminaries in psychiatry palliative care and drug regulation including two past presidents of the American Psychiatric Association a past president of the European College of Neuropsychopharmacology the former deputy director of the U.S. Office of National Drug Control Policy and the former head of the U.K. Medicines and Healthcare Products Regulatory Authority. In general the commentaries were supportive of the research and of using these drugs in a clinical setting as tools for psychiatry. Additional authors included Matthew Johnson Michael Carducci Annie Umbricht William Richards Brian Richards Mary Cosimano and Margaret Klinedinst all of The Johns Hopkins University. The study was funded by grants from the Heffter Research Institute the RiverStyx Foundation William Linton the Betsy Gordon Foundation the McCormick family the Fetzer Institute George Goldsmith Ekaterina Malievskaia and the National Institute on Drug Abuse RDA."

"Spinal manipulation and home exercise are more effective at relieving neck pain in the long term than medications according to new research. People undergoing spinal manipulation therapy for neck pain also reported greater satisfaction than people receiving medication or doing home exercises. We found that there are some viable treatment options for neck pain said Gert Bronfort vice president of research at the WolfeHarris Center for Clinical Studies at Northwestern Health Sciences University in Bloomington Minn. What we dont really know yet is how to individualize these treatments for each particular patient. All are probably still viable treatment options but what we dont know is what each particular patient will need Bronfort said adding that its possible a combination of treatments might be helpful too. Results of the study are published in the Jan. issue of the Annals of Internal Medicine. Funding for the study was provided by the U.S. National Center for Complementary and Alternative Medicine. Neck pain is an extremely common problem. About threequarters of adults report having neck pain at some point in their lives according to background information in the study. Neck pain is responsible for millions of health care visits each year and it can have a negative impact on quality of life. Spinal manipulation is one type of treatment thats offered for neck pain and it can be administered by chiropractors physical therapists osteopaths and other health care providers according to the study. But there isnt much evidence for treating neck pain with spinal manipulation. There also isnt a great deal of information on how effective medications or home exercise programs are for treating neck pain the researchers noted. Bronfort and colleagues thought that spinal manipulation might prove to be more effective than medications or home exercise therapy. To test their hypothesis they recruited people between the ages of and who had neck pain. Their neck pain had no known cause such as a trauma or pinched nerve and the patients been experiencing the pain for between two and weeks when the study began. The study volunteers were randomly selected for one of three treatment groups. One group received spinal manipulations over a week period. Each individual was allowed to choose the number of spinal manipulations they felt they needed. The second group received medications both over the counter and prescription depending on their needs. Firstline medications included nonsteroidal antiinflammatory medications or acetaminophen Tylenol. If people didnt get relief from these drugs narcotic pain medications and muscle relaxants were offered. The third group was assigned two onehour sessions of home exercise. The goal of the homeexercise program was to improve movement in the neck area. Participants were instructed to do the exercises six to eight times per day. At the th week percent of people receiving spinal manipulation reported at least a percent reduction in pain compared with percent of those on medication and percent doing home exercises. Also at week of people receiving spinal manipulation percent reported feeling a percent reduction in pain compared with percent on medications and percent doing home exercises. At one year percent of those receiving spinal manipulation said they felt a percent reduction in pain versus percent of those on medications and percent of those doing home exercises. For me as an ER doctor this study offers an interesting perspective said Dr. Robert Glatter an attending physician in emergency medicine at Lenox Hill Hospital in New York City. Its a small study but it found that home exercises and spinal manipulation were effective. So should we be referring to physical therapists osteopaths or chiropractors from the ER This study shows that basically neck pain will get better on its own said Dr. Victor Khabie chief of the departments of surgery and sports medicine at Northern Westchester Hospital in Mount Kisco N.Y. It wouldve been good if they had a notreatment group too he added. Everyone heals differently. There are different pathways to healing and whether you feel youre better off with chiropractic home exercises or medications this study shows that all three are basically just as effective. Whatever your pathway to healing in about six to eight weeks you should start to feel better said Khabie. He also noted that its important for anyone receiving spinal manipulation to know that there are rare but serious risks that can occur with neck manipulations. All three experts said anyone experiencing neck pain needs to have it evaluated to make sure there isnt a serious or correctable cause of the pain. This is especially true if youve been in a car accident or if you have any neurological symptoms such as repeatedly dropping things or if you have pain radiating down your arm. More information Learn more about neck pain its causes and treatment from the U.S. National Library of Medicine http SOURCES Gert Bronfort D.C. Ph.D. vice president and professor research WolfeHarris Center for Clinical Studies Northwestern Health Sciences University Bloomington Minn. Robert Glatter M.D. attending physician emergency medicine Lenox Hill Hospital New York City Victor Khabie M.D. codirector Orthopedic and Spine Institute and chief surgery and chief sports medicine Northern Westchester Hospital Mt. Kisco N.Y. Jan. Annals of Internal Medicine"

"Alex Pierce took up distance running with great enthusiasm a couple of years ago. Then she developed knee pain so severe that she could not climb stairs. So Pierce a doctoral student in food science went to see physical therapist Matt Briggs at The Ohio State Wexner Medical Center in Columbus. He performed deep massages suggested changes in her running form and taught her how to exercise her thigh and gluteal muscles to better protect her knees. She believes all of that helped. But Pierce like a growing number of patients had another treatment she is convinced helped even more. Its called dry needling and it involves the insertion of thin nonmedicated solid needles into muscles or connective tissues. Proponents say it can reduce pain and improve movement. Pierce has had the procedure more than half a dozen times and believes it is one reason she will be able to run her fourth marathon in November. This has kind of changed my life she says. Testimonials like that are a big reason dry needling has caught on with some physical therapists athletes and other patients Briggs says. But testimonials are not scientific proof. And there Briggs says is where dry needling is lacking. While some studies have shown promise he says the quality of the evidence is not strong. Thats why Briggs and his colleagues are starting a study looking at dry needling in runners knee the condition that has plagued Pierce. Their goal and the goal of other researchers now looking at dry needling is to produce results rigorous enough to show whether it really works. For now heres what consumers should know Is this acupuncture Physical therapists say it is not though superficially it may look the same says Justin Elliott vice president of government affairs for the American Physical Therapy Association http For one thing he says dry needling as performed by a physical therapist is not rooted in ancient Chinese medicine theres no talk about redirecting the bodys energy flow by placing needles at certain points in the body. Instead needles are placed directly in problem areas. Elliott says dry needling also is practiced by some chiropractors naturopathic physicians and nurses which puts it outside the realm of any one specialty. Acupuncturists beg to differ. What is being called dry needling is clearly a form of acupuncture and should be done only by professionals extensively trained in that discipline says Thomas Burgoon a West Chester Pa. physician who is president of the American Academy of Medical Acupuncture http He says many acupuncturists do exactly what the physical therapists describe with the same kind of needles. Burgoons group has persuaded some states to bar physical therapists from the practice. How might it work One theory is that the needles cause tight muscles to twitch then relax. The needles may also increase blood flow or set off nerve responses that alter pain perception Briggs says. Another possibility Its a placebo effect an improvement triggered by the expectation that a treatment will work rather than by the treatment itself. To look for that possibility the Ohio State study will compare patients who get the real needle treatment to those poked with sham needles that dont pierce the skin. Mark Crislip an infectiousdisease doctor in Portland Ore. who recently wrote about dry needling for ScienceBased Medicine https a website critical of alternative medicine says the version practiced by physical therapists doesnt come with the mystical baggage that accompanies acupuncture. But he says it may well be a theatrical placebo. What do published studies say Its a mixed bag Elliott says. In a review httpfileCUserskpainterDownloadsDryNeedlingResourcePaper.pdf the physical therapy association rated the evidence for dry needling a out of based on the best studies. A formal analysis http_acupunctureanddryneedlingforlowbackpain of trails on acupuncture and dry needling for chronic lower back pain was published by the Cochrane research group in . It found they may be useful additions to standard treatment. But it said higher quality studies were needed. What are the risks Needling can produce minor bleeding and some soreness but in trained hands and with the use of sterile needles and gloves its a very safe procedure Briggs says. In rare cases deep needling can lead to a punctured lung or injuries to nerves and blood vessels and acupuncturists fear nonspecialists will be more likely to make such mistakes Burgoon says. Will insurers pay for this Many will not. Charges for patients can range from to per session says Edo Zylstra CEO of KinetaCore a company that offers intensive threeday weekend courses in dry needling to physical therapists. Do all physical therapists offer this No. The physical therapy association tells members in seven states to steer clear because of recent court or regulatory decisions or language in existing licensing laws. They are California Florida Hawaii Idaho New York South Dakota and Washington. And most of the nations licensed physical therapists are not trained in the technique. About have taken courses in dry needling in the past few years Zylstra says."

"There may soon be a new tool in the fight against childhood obesity http Prebiotics reduce body fat in children who are overweight or obese by altering their gut microbiota according to new research published in Gastroenterology http the official journal of the American Gastroenterological Association AGA http Prebiotics are nondigestible food ingredients such as fiber that act as fertilizers to help stimulate the growth of good bacteria already in the gut different from probiotics which introduce new bacteria into the system. This is a welldesigned trial that demonstrates how a prebiotic could potentially help combat one of the most prevalent and costly conditions afflicting children in the developed world overnutrition by targeting the gut microbiome said Geoffrey A. Preidis MD PhD a member of the AGA Center for Gut Microbiome Research and Education http scientific advisory board. It is promising to see this evidence that alteration of the gut microbiota can be used to restore health. As a clinician I hope that continued research into prebiotics will lead to a new strategy for the treatment of obesity. Method For this study researchers from the University of Calgary Alberta Canada performed a doubleblind placebocontrolled trial with participants. Participants included children to years old who were classified as overweight or obese th percentile of body mass index but otherwise healthy. Participants were randomly assigned to groups given either the prebiotic fiber oligofructoseenriched inulin or a placebo once daily for weeks. The prebiotic was provided as a white powder mixed in water. Powdered fiber mixed in a water bottle taken once a day is all we asked the children to change and we got what we consider some pretty exciting results it has been fantastic added Raylene A. Reimer PhD RD professor and researcher in the Faculty of Kinesiology at University of Calgary who led the study. Results Based on fourmonth intervention data the annual projected body weight increase in the prebiotic group would be kilograms . pounds within the expected healthy range whereas the projected increase in the placebo group was kilograms . pounds almost triple the expected yearly weight increase. Thus supplementation with the prebiotic improved outcomes in children who were overweight or obese. Importantly the researchers show that the prebiotic induced specific gut bacterial shifts compared to placebo. Why is this important This is the first randomized controlled study to assess comprehensive changes in gut microbial composition with prebiotic intervention in children who are overweight and obese. Excess weight in childhood tends to persist into adulthood and is an early risk factor for obesityassociated morbidity and mortality highlighting the importance of early intervention. Whats next The metabolic and microbial findings from this study provide a foundation for a larger clinical trial in the pediatric population. Prebiotics are inexpensive and noninvasive and therefore a plausible dietary treatment in the overweight and obese pediatric population. Resources What is Obesity http_for_patientsobesitywhatisobesity Grant Support This work was supported by grants from the BMO Financial Group Endowed Research Fund in Healthy Living Alberta Childrens Hospital Foundation Alberta Childrens Hospital Research Institute and the Canadian Institutes of Health Research MOP. Clinicaltrials.gov no NCT. Reference Nicolucci A.C. Hume M.P. Martnez I. Mayengbam S. Walter J. Reimer R.A. Prebiotic Reduces Body Fat and Alters Intestinal Microbiota in Children With Overweight or Obesity. Gastroenterology doi .j.gastro... http About the AGA Institute The American Gastroenterological Association is the trusted voice of the GI community. Founded in the AGA has grown to more than members from around the globe who are involved in all aspects of the science practice and advancement of gastroenterology. The AGA Institute administers the practice research and educational programs of the organization. http About Gastroenterology Gastroenterology the official journal of the AGA Institute is the most prominent scientific journal in the specialty and is in the top percent of indexed medical journals internationally. The journal publishes clinical and basic science studies of all aspects of the digestive system including the liver and pancreas as well as nutrition. The journal is abstracted and indexed in Biological Abstracts Current Awareness in Biological Sciences Chemical Abstracts Current Contents Excerpta Medica Index Medicus Nutrition Abstracts and Science Citation Index. For more information visit http Like AGA http and Gastroenterology http on Facebook. Follow us on Twitter AmerGastroAssn http AGA_Gastro httpstwitter.comAGA_Gastro New Check out our videos on YouTube http Join AGA on LinkedIn http"

"Checkups during pregnancy tend to focus around the waist. But theres growing debate about which motherstobe should have a gland in their neck tested too. Numerous studies since have found that an underactive thyroid httpsmedicalxpress.comtagsthyroid can raise a womans risk of miscarriage premature birth or a lower IQ for her baby even if its so mildly sluggish that she feels no symptoms. The problem While serious cases are treated with a hormone pill so far theres little evidence that treating the milder cases makes a difference. So guidelines about who should be tested vary widely. Now a peek at prenatal testing httpsmedicalxpress.comtagsprenataltesting from one of the countrys largest medical labs suggests that nearly a quarter of pregnant women httpsmedicalxpress.comtagspregnantwomen are getting the simple thyroid blood test httpsmedicalxpress.comtagsbloodtest regardless of whether they have symptoms. Researchers at Quest Diagnostics examined records for half a million pregnant women. Of those who got tested a higherthanexpected number percent had an underactive thyroid. Thats fivefold higher than some previous estimates httpsmedicalxpress.comtagsestimates partly because the way in which the condition is diagnosed has changed recently says the study published by the Journal of Clinical Endocrinology Metabolism. The vast majority of those women were in the gray zone with milder cases where no one knows for sure if a diagnosis helps or wastes money on testing and thyroid medication. The finding adds pressure for science to settle this longrunning controversy. We still dont have perfect answers says Dr. Elizabeth Pearce a wellknown endocrinologist at Boston Medical Center where a recent survey found widespread prenatal thyroid testing. But if its my patient in my office or its me or my family member Im going to treat every time. Obstetricians seem more wary. There are studies on both sides of the fence says Dr. Dena Goffman of New Yorks Montefiore Medical Center which tests only women at high risk. If you dont know what to do with the results you probably shouldnt order the test she said. The unassuming thyroid a small bow tieshaped gland nestled in the front of the neck plays a big role in good health for everyone. It produces hormones that regulate metabolism and can affect almost every type of tissue in the body. About million Americans are estimated to have a malfunctioning thyroid that if serious enough can contribute to heart disease bonethinning osteoporosis and infertility. An overactive thyroid called hyperthyroidism speeds up bodily functions causing such symptoms as weight loss nervousness anxiety and increased heart rate and vision problems. Much more common is an underactive thyroid called hypothyroidism. It slows body functions causing such problems as fatigue weight gain depression constipation and dry skin. It even can contribute to high cholesterol according to the National Institutes of Health. Thyroid problems increase with age but they affect far more women than men and pregnancy httpsmedicalxpress.comtagspregnancy puts extra stress on the gland. Having enough thyroid hormones is important for fetal brain development especially during the first trimester when the fetus depends solely on the mother for them. The hormones also play a role in avoiding miscarriage or premature birth httpsmedicalxpress.comtagsprematurebirth. Mothers also may harbor immune system cells called antibodies that subtly attack the gland and likewise are linked to miscarriage and prematurity. Italian researchers found that treating those women lowered their risk of encountering this problem. There is broad agreement that women with overt hypothyroidism a seriously underactive gland should be treated most likely given a onceaday hormone pill long known to be safe in pregnancy. But it takes blood testing to diagnose overt disease because even those women dont always report the vague symptoms. Those blood tests are sure to uncover women with mild hypothyroidism too the people in the socalled gray zone. Some research has raised questions about whether mild cases really pose a pregnancy risk and preliminary results from a large British study recently found no overall IQ benefit to the resulting children if their mothers had been treated. But the damage might already have been done by the time treatment began late in the first trimester notes Bostons Pearce. In the U.S. doctors are anxiously awaiting a similar National Institutes of Health study results arent expected until . Whats the advice until then The American College of Obstetricians and Gynecologists recommends testing only pregnant women who have thyroid symptoms have had previous thyroid problems or have similar autoimmune diseases such as Type diabetes those considered at risk for overt disease. The American Thyroid Association goes further. Last summer it advised also testing all pregnant women age and older and those with enlarged thyroids previous pregnancy problems or those who are obese says Pearce who coauthored the guidelines. Most guidelines cite the lack of evidence for treating mild cases. The thyroid association does urge treatment if those women harbor the worrisome antibodies. A final tip Pregnant women should check that their prenatal vitamins contain iodine important for proper thyroid function Pearce says. Not all do. Most Americans get enough iodine from dairy products bread seafood and iodized table salt. But women httpsmedicalxpress.comtagswomen need extra during pregnancy. Explore further BMC conducts high rates of thyroid testing in pregnant women study finds httpsmedicalxpress.comnewsbmchighthyroidpregnantwomen.html"

"Doctors are experimenting with new technology that could give them a more complete view of the large intestine than ever before improving the odds of finding potentially cancerous growths earlier. Dr. Arie Kaufman of SUNY Stony Brook demonstrated the virtual colonoscopy for CBS New Yorks Dr. Max Gomez. Well have both the computer and the doctors working in tandem to find polyps and find cancers Kaufman said. He added it could lead to better and earlier detection of colon polyps. Virtual colonoscopy screening uses CT scans to create color D images of the colon the final portion of the large intestine. Special computer animation enables a doctor to view the organ in remarkable detail. Regular colonoscopy physically examines the colon by inserting a lighted probe into the intestine and requires a sedative. Both have made early detection and treatment https more precise. This next step in virtual colonoscopy called immersive colonoscopy projects D images of the colon large enough to fill the walls of a room. Doctors can then walk through the colon and explore many different angles. We have the side view and the back view said Kaufman. This will allow the physician to view percent of the surface including lesions which are hidden behind folds maybe seen on the side and back walls. Such highly specific screening may allow doctors to detect more abnormal growths https called polyps when they are as small as . mm so they can be removed before they become fullblown cancer tumors. For the patient a virtual colonoscopy https is low risk but does involve additional exposure to radiation. It may need to be followed with the physical colonoscopy later as well. Colonoscopies are recommended for adults age and over to help detect early signs of colorectal cancer. Colorectal cancer is the second leading cause of death among the combined group of men and women who have cancer according to the National Institutes of Health http The CDC http says colonoscopy may also be recommended for people experiencing stomach pain aches or cramps that dont go away unexplained weight loss and blood in the stool. More routine DNA tests https and stool sampling https which show signs of bleeding caused by irregular growths can also help detect colon polyps and indicate that the need for a full colonoscopy. The CDC says colonoscopy could reduce the number https of colorectal cancer cases by as much as percent. This new wave of radiologybased colonoscopy could improve those odds further."

"Countless people often men with enlarged prostates need to visit the bathroom during the night. But help could soon be at hand in the form of a nasal spray new research suggests. A spritz of a synthetic hormone already used by bedwetting kids might benefit older people struggling with the problem called nocturia. Nocturia is very common in patients over years old and can cause significant problems by causing loss of sleep and injury due to falls said study lead author Dr. Jed Kaminetsky. The millions of people with nocturia wake up two or more times a night to urinate. Besides an enlarged prostate Kaminetsky said common causes are bladder problems poor circulation and obesity. Kaminetsky is a clinical assistant professor of urology at NYU Langone Medical Center in New York City. In the United States theres no approved drug to treat the problem the study authors said. The new drug while promising is of concern because of its potential to lower blood sodium levels in the elderly one doctor said. Meanwhile another researcher suggested that exercise might help stave off nocturia. Known as SER the nasal spray contains desmopressin a lowdose synthetic version of the naturally occurring hormone vasopressin. Vasopressin an antidiuretic reduces urine production. SER appears to delay urine production for four to six hours during sleep said Kaminetsky and wears off by morning when patients awaken and start to drink fluids. He is scheduled to present his teams research Sunday in San Diego at a meeting of the American Urological Association. The research was funded by the sprays manufacturer Serenity Pharmaceuticals. Desmopressin is commonly used to treat bedwetting among children ages and up the study authors pointed out. To assess its potential in adults the study team enlisted nearly men and women and older who had a history of nocturia. For three months participants were randomly assigned to use either the desmopressin spray two doses were tried or a nonmedicinal spray a placebo. Patients kept threeday urination diaries and filled out qualityoflife questionnaires. Desmopressin spray prompted a significant decrease in the frequency of nightly bathroom trips compared with the untreated group Kaminetsky said. On average patients reported at least two fewer episodes a night. The treatment group also experienced a significant increase in the length of time they could sleep before awakening to urinate. That uninterrupted sleep period extended to more than four hours Kaminetsky said. The researchers also found that those in the higherdose spray group experienced a significant improvement in overall quality of life compared with the untreated group. Though SER is still considered investigational Kaminetsky said the U.S. Food and Drug Administration is reviewing the findings with a possible decision late this year. Dr. Tomas Griebling a professor of urology at the University of Kansas described the study results as promising but added a note of caution. Other researchers have examined the utility and safety of desmopressin for the treatment of nocturia in the past he said. However there have been concerns about safety particularly in elderly patients. Griebling said the American Geriatrics Society includes desmopressin in the Beers Criteria for potentially inappropriate medications for older adults primarily because of concerns about resulting low blood sodium levels. But the lower doses used in this study . or . mcg may help to improve the overall safety profile particularly for geriatric patients he said. Additional research will be needed to fully answer this question in the future. The study team said two of the higherdose patients developed significantly low blood sodium levels hyponatremia as did one person taking the placebo. Dr. Julien Dagenais a urologist at Brigham and Womens Hospital in Boston explored nocturia from another angle. He analyzed physical activity data reported by more than men and women aged and older in a U.S. health and nutrition survey conducted between and . People who reported higher levels of exercise were less likely to suffer from nocturia Dagenais found. This suggests that the antiinflammatory impact of routine exercise may minimize nocturia he said. These findings will also be presented at the American Urological Association meeting. Data and conclusions presented at meetings are usually considered preliminary until published in a peerreviewed journal. More information Theres more on nocturia at the National Association for Continence http SOURCES Jed Kaminetsky M.D. clinical assistant professor department of urology NYU Langone Medical Center New York City Tomas L. Griebling M.D. MPH senior associate dean for medical education and professor urology and faculty associate Landon Center on Aging University of Kansas School of Medicine Kansas City American Urological Association meeting San Diego May"

"Researchers have discovered a new class of drug that has the potential to help cancer patients who no longer respond to existing therapies. The drug may not become available to patients for a number of years yet but researchers believe that if clinical trials are successful it could be used to tackle a variety of treatmentresistant cancers. Patients with breast cancer for example frequently become resistant to existing hormonebased treatments leading to the disease becoming fatal. In a bid to come up with new forms of treatment that work in a distinct way from established ones chemists biologists and clinicians at Imperial College London collaborated on creating a new drug the properties of which are reported in the journal Molecular Cancer Therapeutics. The team of scientists at Imperial was funded by Cancer Research UK. The drug was then developed by Imperial in collaboration with Emory University in the USA. Early labbased tests of ICEC were successful in targeting resistant breast cancers and indicated minimal side effects. ICEC was then licenced to Carrick Therapeutics who developed it into a molecule named CT which they have taken to earlystage clinical trials in less than two years. The first patient was given the drug in November as part of Carricks a Phase I clinical trial to assess its safety and how well it can be tolerated. The trial is still ongoing so results are not available yet. Professor Charles Coombes from the Department of Surgery Cancer said Treatmentresistant tumours represent a significant threat for patients as once a cancer stops responding to treatments there is increasingly little clinicians can do. Drugs such as these could help to shift the balance back in favour of the patients potentially providing a new option to patients for who existing treatments no longer work. Professor Tony Barrett from the Department of Chemistry said This work is the result of extensive collaboration between chemists biologists and clinicians which has helped to bring a new treatment from discovery to clinical testing in record time streamlining the process. The drug targets an enzyme called CDK involved in directing cells through their lifecycle which consists of growth DNA replication and cell division. CDK is also involved in the process of transcription a vital step in gene expression the creation of proteins to carry out cell functions. Particular cancers such as treatmentresistant breast cancers have a unique dependence on transcription meaning targeting CDK may be particularly effective. By inhibiting transcription ICEC shuts down the ability of the cancer to spread. As well as breast cancers cancers such as acute myeloid leukaemia and smallcell lung cancer are particularly transcriptiondependent so ICEC may work well for these too especially where they have become resistant to other treatments. The discovery of the drug was spurred by an initial meeting between Professor Anthony Barrett from the Department of Chemistry and oncologist Professor Charles Coombes from the Department of Surgery Cancer. Professor Simak Ali also from the Department of Surgery Cancer was working on understanding the action of CDK in treatmentresistant breast cancer. Professors Coombes and Ali suggested CDK as a drug target leading the collaboration to attempt to design a molecule that would inhibit its action. From early attempts a large collaborative team was eventually founded for drug discovery from bench to bedside directed by Dr Matthew Fuchter in the Department of Chemistry. Possible compounds for CDK inhibition were modelled using computational drug design aided by collaboration with Emory University. Ultimately a candidate molecule called ICEC suppressed tumour growth in a wide range of cancer types in lab tests. In addition laboratory studies showed ICEC worked better in combination with traditional hormone therapies for estrogen receptor positive breast cancer cells which have not yet become resistant. It is this molecule in oral pill form that was taken forward by Carrick as CT and is currently in Phase I clinical trials. If the Phase I trial proves successful the compound must pass further stages of trial over the next few years before it becomes available to patients. Early funding for the study came from the Engineering and Physical Sciences Research Council EPSRC and a major contribution of wholeproject funding was from Cancer Research UK. Licensing of the technology to Carrick Therapeutics was led by Cancer Research UKs Commercial Partnerships Team and Imperial Innovations the Technology Transfer Office of Imperial with support from Emory University. Dr Iain Foulkes Cancer Research UKs executive director of research and innovation said Its exciting to see how Cancer Research UKs partnerships with both academia and industry are bringing urgently needed new tests and treatments to patients. Drug resistance continues to be a major challenge across many cancer types so its vital that we explore new ways to tackle tumours that have stopped responding to standard therapies. We hope that this promising new class of drug will offer more options to patients who have few left available to them and help more people survive their cancer."

"Heres a bit of good news for folks who enjoy sitting in a superheated room and sweating profusely Finnish researchers say regular sauna bathing may help men to live longer. The study which was published Monday in JAMA httpjama.jamanetwork.comjournal.aspx is the latest in a series of papers to explore the potential cardiovascular health benefits of chilling out in a room heated to degrees Fahrenheit. Our results suggest that sauna bathing is a recommendable health habit wrote Dr. Jari Laukkanen a cardiologist a the Institute of Public Health and Clinical Nutrition University of Eastern Finland. The only catch is nobody can explain exactly why this is the case. Further studies are warranted to establish the potential mechanism that links sauna bathing and cardiovascular health wrote Laukkanen and his colleagues. The researchers based their conclusion on a database of of Finnish men who have had their health tracked since . Study participants were all aged to with a median age of . Those men who enjoyed a sauna two or three times a week had a lower risk of experiencing a fatal episode of coronary heart disease or cardiovascular disease compared to those who took just one sauna a week according to researchers. The apparent health benefits for men who used the sauna four to seven times a week was even greater They had a lower risk of similar incidents when compared to men who used the sauna only once a week researchers said. The higher frequency of sauna bathing was related to considerable decreased risks of sudden cardiac death fatal coronary heart disease fatal cardiovascular disease and allcause mortality the authors wrote. The researchers said a similar health benefit was unlikely to be found in steam rooms and hot tubs due to the unique conditions of Finnish saunas. A traditional Finnish sauna has dry air to humidity and a recommended temperature of degrees to degrees. Humidity is increased temporarily by throwing water on the hot rocks of the sauna heater and most Finns are accustomed to using a sauna once a week. On average the men in the study used a sauna twice a week at a temperature of about degrees. The average time spent in the sauna was about minutes researchers say. The superheated conditions of a sauna provoke a variety of physical reactions. Heart rate can climb to or beats per minute similar to low or moderateintensity exercise and sweat is secreted at a rate of about pounds per hour. High temperatures also causes the body to flow more blood to the skin and less to internal organs. Previous studies have suggested that sauna bathing might have some harmful effects whereas our results indicated a protective effect the authors wrote. The researchers noted that only to of sudden deaths occurred within hours of sauna bathing. Alcohol intake was a major contributing factor in those cases authors wrote. In an accompanying editorial Dr. Rita Redberg a cardiologist and professor of medicine at the University of California San Francisco speculated on a number of possible reasons for the observed benefits. Although we do not know why the men who took saunas more frequently had greater longevity whether it is the time spent in the hot room the relaxation time the leisure of a life that allows for more relaxation time or the camaraderie of the sauna clearly time spent in the sauna is time well spent Redberg wrote. Follow montemorin httpstwitter.commontemorin for science news"

"Consuming soy foods such as soy milk tofu and edamame and cruciferous vegetables such as cabbages kale collard greens bok choy Brussels sprouts and broccoli may be associated with a reduction in common side effects of breast cancer treatment in breast cancer survivors say a team of scientists led by Georgetown Lombardi Comprehensive Cancer Center. In the study published in Breast Cancer Research and Treatment higher intake of cruciferous vegetables and soy foods were associated with fewer reports of menopausal symptoms. Higher soy intake was also associated with less reported fatigue. The breast cancer survivors studied included nonHispanic white and Chinese Americans including USborn Chinese and Chinese immigrants. Researchers say breast cancer survivors often experience side effects from cancer treatments that can persist months or years after completion of treatment. For example because many treatments designed to prevent breast cancer recurrence inhibit the bodys production or use of estrogen the hormone that can fuel breast cancer growth breast cancer patients often experience hot flashes and night sweats among other side effects. The lead author on the study Sarah Oppeneer Nomura PhD of Georgetown Lombardi said that while further research is needed in larger study populations and with more detailed dietary data this project addresses an important gap in research on the possible role of lifestyle factors such as dietary habits in relation to side effects of treatments. These symptoms can adversely impact survivors quality of life and can lead them to stopping ongoing treatments she says. Understanding the role of life style factors is important because diet can serve as a modifiable target for possibly reducing symptoms among breast cancer survivors. When study participants were evaluated separately by raceethnicity associations were significant among white breast cancer survivors however while a trend was seen in the benefit for Chinese women results were not statically significant. Researchers explain Chinese women typically report fewer menopausal symptoms. Most of them also consume cruciferous vegetables and soy foods making it difficult to see a significant effect in this subgroup. Indeed in this study Chinese breast cancer survivors ate more than twice as much soy and cruciferous vegetables. Whether the reduction in symptoms accounts for longtime use of soy and cruciferous vegetables needs further investigation says the studys senior author Judy Hueiyu Wang PhD of Georgetown Lombardis Cancer Prevention and Control Program. Results obtained in preclinical studies in animals show that biologically active compounds present in both soy and cruciferous vegetables cause breast cancer cells to grow but have opposite effects in animals that consume these compounds well before cancer is diagnosed and continue consuming them during and after cancer treatments. Until more research is conducted breast cancer patients should not suddenly start eating soy if they have not consumed it before says Leena HilakiviClarke PhD a professor of oncology at Georgetown Lombardi and a coauthor of the study. Researchers also found suggestive associations with lower reporting of other symptoms including joint problems hair thinningloss and memory less in women who consumed more soy foods but these associations did not reach statistical significance. Phytochemicals or bioactive food components such as isoflavones in soy foods and glucosinolates in cruciferous vegetables may be the source of the benefit researchers say. Isoflavones bind to estrogen receptors and exert weak estrogenic effects among other effects. Glucosinolates in cruciferous vegetables influence levels of metabolizing enzymes that can modulate inflammation and levels of estrogen possibly attenuating treatmentrelated symptoms. Coauthors of the study include Chiranjeev Dash MBBS MPH PhD Leena HilakiviClarke PhD and YunLing Zhen MPH PhD from Georgetown Lombardi YiTin Hwang PhD from National Taipei University Taiwan Scarlett Lin Gomez MPH PhD from the Cancer Prevention Institute of California Teresa T. Fung MS ScD from Harvard T. H. Chan School of Public Health ShuLan Yeh PhD from Chang Shan Medical University Taiwan and Serena Phillips RN MPH from Milken Institute School of Public Health George Washington University. The study was funded by a Lance Armstrong Foundation Young Investigator Award and the National Cancer Institute CA. The authors report having no personal financial interests related to the study. About Georgetown University Medical Center Georgetown University Medical Center GUMC is an internationally recognized academic medical center with a threepart mission of research teaching and patient care through MedStar Health. GUMCs mission is carried out with a strong emphasis on public service and a dedication to the Catholic Jesuit principle of cura personalis or care of the whole person. The Medical Center includes the School of Medicine and the School of Nursing Health Studies both nationally ranked Georgetown Lombardi Comprehensive Cancer Center designated as a comprehensive cancer center by the National Cancer Institute and the Biomedical Graduate Research Organization which accounts for the majority of externally funded research at GUMC including a Clinical and Translational Science Award from the National Institutes of Health. Connect with GUMC on Facebook Facebook.comGUMCUpdate httpFacebook.comGUMCUpdate Twitter httpstwitter.comgumedcenterlangen gumedcenter and Instagram https gumedcenter. About Georgetown Lombardi Comprehensive Cancer Center Georgetown Lombardi Comprehensive Cancer Center httpslombardi.georgetown.edu is designated by the National Cancer Institute as a comprehensive cancer center the only cancer center of its kind in the Washington DC area. A part of Georgetown University Medical Center and MedStar Georgetown University Hospital Georgetown Lombardi seeks to improve the diagnosis treatment and prevention of cancer through innovative basic and clinical research patient care community education and outreach and the training of cancer specialists of the future. Connect with Georgetown Lombardi on Facebook httpFacebook.comGeorgetownLombardi and Twitter http LombardiCancer."

"More research is suggesting that heavy smokers may benefit from screening for lung cancer to detect tumors in their earliest stages. A new study finds that regular smokers who received threedimensional Xrays to look for the presence of early tumors had a significantly lower risk of dying over a year period. The results are in keeping with those of a much larger study published last month which showed that these D Xrays or CT scans reduced the death rate among current and former heavy smokers by percent compared with screening using regular chest Xrays. That previous finding was very good news in the field said Dr. Bruce Johnson of the Dana Farber Cancer Institute who treats lung cancer patients and reviewed the results for Reuters Health. This latest study published in the journal Lung Cancer looked at death rates in a different smaller population of heavy smokers and estimated that those who received up to two CT scans would have between a and percent lower risk of dying compared to those who went unscreened. The data are consistent with earlier studies but there are still many issues to resolve regarding lung cancer screening Johnson said. For one scientists havent yet worked out how often to screen people and when to start. It is not clear when or how guidelines for lung cancer screening could be drawn up and until they are insurers including government programs such as Medicare are unlikely to pay the average cost of a scan. Furthermore an April study showed that percent of a patients initial lung CT scans show suspicious lesions that turn out not to be cancer but lead to needless invasive followup procedures and radiation exposure as well as stress and anxiety for patients and their families. The high socalled false positive rate is an issue said Dr. James Hanley of McGill University who also reviewed the findings for Reuters Health but many mammograms also find lesions that turn out to be benign. And for lung cancer doctors know there is a high falsepositive rate and have a set protocol to follow in order to determine which lesions are dangerous added Johnson. Lung cancer kills . million people a year globally and it will kill people in the United States alone this year according to the American Cancer Society. Tobacco use accounts for some percent of lung cancer cases in the U.S. and one estimate puts a smokers lifetime absolute risk of developing lung cancer between percent and percent. Fiveyear survival rates for lung cancer are low. In recent years CT scans in particular have been promoted by some hospitals and advocacy groups for lung cancer screening even though studies had not yet shown definitively whether such screening saves lives. In Dr. Claudia Henschke currently based at Mount Sinai School of Medicine and Arizona State University caused a stir when she published a study concluding that percent of lungcancer deaths could be prevented through widespread use of spiral CT. Her ideas were controversial to start with especially when other researchers found her work had been paid for by a tobacco company. In the current study funded in part by manufacturers of CT scanners along with government and other sources Henschke and her colleagues compared outcomes for nearly smokers and former smokers who volunteered to undergo CT scans to outcomes in two sets of people with smoking histories who were not scanned. The three groups of people had some important differences such as in average age and how long and heavily they had smoked so the researchers had to use mathematical tools to try to eliminate the influence of those differences said Hanley. For instance to compare death rates the researchers tracked how many people died among those who were screened then pulled out all the people with similar underlying characteristics in the other two groups and looked at their death rates Hanley explained. A total of people died in the screened population the authors report but applying the death rate among people with the same underlying characteristics in one of the unscreened populations they estimated that the number of deaths would have been . This translates into a percent lower risk of dying among the screened population. Applying the same methods to the other unscreened population the authors estimated that screening was associated with a percent lower risk of dying. Overall research is suggesting that CT scans of people at risk of lung cancer might make a dent in cancer mortality and its possible that more frequent screening might make an even bigger dent Hanley noted. If screening is going to work youve got to keep at it. SOURCE link.reuters.comquvr httplink.reuters.comquvr Lung Cancer online December . Our StandardsThe Thomson Reuters Trust Principles. httpthomsonreuters.comenaboutustrustprinciples.html"

"Immunotherapy reduces cardiovascular risk in patients with rheumatoid arthritis according to research presented today at Frontiers in CardioVascular Biology FCVB by Professor Aida Babaeva head of the Department of Internal Medicine Volgograd State Medical University Volgograd Russia. The combination of two extralow dose anticytokine drugs reduced rheumatoid arthritis disease activity and cardiovascular events. Rheumatoid arthritis is an autoimmune disease in which cytokines such as tumour necrosis factor TNF and interferon IFN which normally protect the body attack healthy cells said Professor Babaeva. Patients have painful and inflamed joints. They are also at increased cardiovascular risk particularly if their rheumatoid arthritis is not controlled. Professor Babaevas previous research showed that treatment with anticytokine drugs can decrease the activity of rheumatoid arthritis. Extralow dose antiTNFa reduced levels of inflammatory mediators and cytokines including Creactive protein CRP rheumatoid factor TNF interleukin IL and interleukin IL. The effect was more apparent and developed earlier when patients were treated with a combination of antiTNFa and antiIFN both at extralow doses. The current study investigated the impact of the combination of drugs on cardiovascular events. It included patients who had suffered from active rheumatoid arthritis for at least five years. Patients were randomised to receive the combination of antiTNFa and antiIFN plus standard diseasemodifying therapy patients or placebo plus standard therapy patients. During the three year follow up period the investigators monitored rheumatoid arthritis disease activity and cardiovascular events. Patients taking the combination of anticytokines had a lower rheumatoid arthritis disease activity score as measured by the DAS and more dramatic decreases in IL IL and TNFa than the group on standard therapy alone. The incidence of cardiovascular events unstable angina severe hypertensive crisis and deterioration of chronic heart failure was more than double in the group on conventional diseasemodifying drugs alone compared to those also taking the combination of anticytokines . Professor Babaeva said Our findings suggest that the decreased rheumatoid arthritis disease activity with the combination of anticytokines translates into decreased cardiovascular risk. Rheumatoid arthritis promotes the development of cardiovascular disease in a number of ways. Therefore decreasing disease activity may also reduce cardiovascular risk by slowing down or halting these processes. For example rheumatoid arthritis is associated with dysfunction of the blood vessel lining called endothelium which leads to lipid accumulation in the artery wall plaque formation and atherosclerosis. Increased disease activity is also linked with a procoagulant state in which patients are more prone to blood clots and thrombosis. Patients with active disease have an increase in molecules that promote inflammation which has been associated with an increased risk of cardiovascular disease. In patients with hypertension target blood pressure was reached in of those taking the combination of anticytokines compared to just of patients on standard therapy alone. Professor Babaeva said This doesnt mean that the two drugs directly impact on blood pressure. But the combination can improve endothelial function and it could be that blood pressure is more stable when disease activity is low. We found that the combination of two anticytokines containing extralow doses of antibodies against TNFa and IFN can improve the efficacy of standard rheumatoid arthritis therapy and decrease cardiovascular risk said Professor Babaeva. She concluded We do not think that all patients with rheumatoid arthritis should be treated with this combination. In patients with highly active disease the standard biologics are better at preventing severe complications such as progressive joint destruction andor systemic manifestations vasculitis uveitis involvement of internal organs. We recommend this new approach for preventing cardiovascular events in patients with moderate disease activity who are not receiving the standard biologics and who do not have severe complications."

"It was launched decades ago as an anesthetic for animals and people became a potent battlefield pain reliever in Vietnam and morphed into the trippy club drug Special K. Now the chameleon drug ketamine is finding new life as an unapproved treatment for depression and suicidal behavior. Clinics have opened around the United States promising instant relief with their unique doses of ketamine in IVs sprays or pills. And desperate patients are shelling out thousands of dollars for treatment often not covered by health insurance with scant evidence on longterm benefits and risks. Chicago preschool teacher Lauren Pestikas long struggled with depression and anxiety and made several suicide attempts before trying ketamine earlier this year. The price tag so far is about but its worth every dime and penny said the yearold. Pestikas said she feels much better for a few weeks after each treatment but the effects wear off and she scrambles to find a way to pay for another one. For now ketamine has not received approval from the U.S. Food and Drug Administration for treating depression though doctors can use it for that purpose. Ketamine has been around since the s and is widely used as an anesthesia drug during surgery because it doesnt suppress breathing. Compared to opioids such as morphine ketamine isnt as addictive and doesnt cause breathing problems. And some studies have shown that ketamine can ease symptoms within hours for the toughest cases. Its potential effects on depression were discovered in animal experiments in the late s and early s showing that glutamate a brain chemical messenger might play a role in depression and that drugs including ketamine that target the glutamate pathway might work as antidepressants. Conventional antidepressants like Prozac target serotonin a different chemical messenger and typically take weeks to months to kick in a lag that can cause severely depressed patients to sink deeper into despair. Ketamines potential for almost immediate if temporary relief is what makes it so exciting said Dr. Jennifer Vande Voort a Mayo Clinic psychiatrist who has used ketamine to treat depression patients since February. We dont have a lot of things that provide that kind of effect. What I worry about is that it gets so hyped up she said. The strongest studies suggest its most useful and generally safe in providing shortterm help for patients who have not benefited from antidepressants. That amounts to about onethird of the roughly million people with depression worldwide. It truly has revolutionized the field changing scientists views on how depression affects the brain and showing that rapid relief is possible said Yale University psychiatrist Dr. Gerard Sanacora who has done research for or consulted with companies seeking to develop ketaminebased drugs. But to become standard depression treatment he said much more needs to be known. Last year Sanacora coauthored an American Psychiatric Association task force review of ketamine treatment for mood disorders that noted the benefits but said major gaps remain in knowledge about longterm effectiveness and safety. Most studies have been small done in research settings and not in the real world. When delivered through an IV ketamine can cause a rapid increase in heart rate and blood pressure that could be dangerous for some patients. Ketamine also can cause hallucinations that some patients find scary. There are some very real concerns Sanacora said. We do know this drug can be abused so we have to be very careful about how this is developed. Dr. Rahul Khare an emergency medicine specialist in Chicago first learned about ketamines other potential benefits a decade ago from a depressed and anxious patient he was preparing to sedate to fix a repeat dislocated shoulder. He said Doc give me what I got last time. For about three weeks after I got it I felt so much better Khare recalled. Khare became intrigued and earlier this year began offering ketamine for severe depression at an outpatient clinic he opened a few years ago. He also joined the American Society for Ketamine Physicians formed a year ago representing about U.S. doctors nurses psychologists and others using ketamine for depression or other nonapproved uses. There are about U.S. ketamine clinics compared with about three years ago said society cofounder Dr. Megan Oxley. Khare said the burgeoning field is like a new frontier where doctors gather at meetings and compare notes. He has treated about patients with depression including Pestikas. Theyre typically desperate for relief after failing to respond to other antidepressants. Some have lost jobs and relationships because of severe depression and most find that ketamine allows them to function Khare said. Typical treatment at his clinic involves six minute sessions over about two weeks costing each. Some insurers will pay about half of that covering Khares office visit cost. Patients can receive booster treatments. They must sign a fourpage consent form that says benefits may not be longlasting lists potential side effects and in bold letters states that the treatment is not governmentapproved. At a recent session Pestikass seventh she leaned back on a reclining white examiningroom chair as a nurse hooked her up to a heart and blood pressure monitor. She grimaced as a needle was slipped into the top of her left palm. Khare reached up with a syringe to inject a small dose of ketamine into an IV bag hanging above the chair then dimmed the lights pulled the window curtains and asked if she had questions and was feeling OK. No questions just grateful Pestikas replied smiling. Pestikas listened to music on her iPhone and watched psychedelic videos. She said it was like a controlled acid trip with pleasant hallucinations. The trip ends soon after the IV is removed but Pestikas said she feels calm and relaxed the rest of the day and that the mood boost can last weeks. Studies suggest that a single IV dose of ketamine far smaller than used for sedation or partying can help many patients gain relief within about four hours and lasting nearly a week or so. Exactly how ketamine works is unclear but one idea is that by elevating glutamate levels ketamine helps nerve cells reestablish connections that were disabled by depression said ketamine expert Dr. Carlos Zarate chief of experimental therapies at the National Institute of Mental Health. A small Stanford University study published in August suggested that ketamine may help relieve depression by activating the brains opioid receptors. Janssen Pharmaceuticals and Allergan are among drug companies developing ketaminelike drugs for depression. Janssen leads the effort with its nasal spray esketamine. The company filed a new drug application in September. Meanwhile dozens of studies are underway seeking to answer some of the unknowns about ketamine including whether repeat IV treatments work better for depression and if theres a way to zero in on which patients are most likely to benefit. Until there are answers Zarate of the mental health institute said ketamine should be a lastresort treatment for depression after other methods have failed. It was launched decades ago as an anesthetic for animals and people became a potent battlefield pain reliever in Vietnam and morphed into the trippy club drug Special K. Now the chameleon drug ketamine is finding new life as an unapproved treatment for depression and suicidal behavior. Clinics have opened around the United States promising instant relief with their unique doses of ketamine in IVs sprays or pills. And desperate patients are shelling out thousands of dollars for treatment often not covered by health insurance with scant evidence on longterm benefits and risks. Chicago preschool teacher Lauren Pestikas long struggled with depression and anxiety and made several suicide attempts before trying ketamine earlier this year. The price tag so far is about but its worth every dime and penny said the yearold. Pestikas said she feels much better for a few weeks after each treatment but the effects wear off and she scrambles to find a way to pay for another one. For now ketamine has not received approval from the U.S. Food and Drug Administration for treating depression though doctors can use it for that purpose. Ketamine has been around since the s and is widely used as an anesthesia drug during surgery because it doesnt suppress breathing. Compared to opioids such as morphine ketamine isnt as addictive and doesnt cause breathing problems. And some studies have shown that ketamine can ease symptoms within hours for the toughest cases. Its potential effects on depression were discovered in animal experiments in the late s and early s showing that glutamate a brain chemical messenger might play a role in depression and that drugs including ketamine that target the glutamate pathway might work as antidepressants. Conventional antidepressants like Prozac target serotonin a different chemical messenger and typically take weeks to months to kick in a lag that can cause severely depressed patients to sink deeper into despair. Ketamines potential for almost immediate if temporary relief is what makes it so exciting said Dr. Jennifer Vande Voort a Mayo Clinic psychiatrist who has used ketamine to treat depression patients since February. We dont have a lot of things that provide that kind of effect. What I worry about is that it gets so hyped up she said. The strongest studies suggest its most useful and generally safe in providing shortterm help for patients who have not benefited from antidepressants. That amounts to about onethird of the roughly million people with depression worldwide. It truly has revolutionized the field changing scientists views on how depression affects the brain and showing that rapid relief is possible said Yale University psychiatrist Dr. Gerard Sanacora who has done research for or consulted with companies seeking to develop ketaminebased drugs. But to become standard depression treatment he said much more needs to be known. Last year Sanacora coauthored an American Psychiatric Association task force review of ketamine treatment for mood disorders that noted the benefits but said major gaps remain in knowledge about longterm effectiveness and safety. Most studies have been small done in research settings and not in the real world. When delivered through an IV ketamine can cause a rapid increase in heart rate and blood pressure that could be dangerous for some patients. Ketamine also can cause hallucinations that some patients find scary. There are some very real concerns Sanacora said. We do know this drug can be abused so we have to be very careful about how this is developed. Dr. Rahul Khare an emergency medicine specialist in Chicago first learned about ketamines other potential benefits a decade ago from a depressed and anxious patient he was preparing to sedate to fix a repeat dislocated shoulder. He said Doc give me what I got last time. For about three weeks after I got it I felt so much better Khare recalled. Khare became intrigued and earlier this year began offering ketamine for severe depression at an outpatient clinic he opened a few years ago. He also joined the American Society for Ketamine Physicians formed a year ago representing about U.S. doctors nurses psychologists and others using ketamine for depression or other nonapproved uses. There are about U.S. ketamine clinics compared with about three years ago said society cofounder Dr. Megan Oxley. Khare said the burgeoning field is like a new frontier where doctors gather at meetings and compare notes. He has treated about patients with depression including Pestikas. Theyre typically desperate for relief after failing to respond to other antidepressants. Some have lost jobs and relationships because of severe depression and most find that ketamine allows them to function Khare said. Typical treatment at his clinic involves six minute sessions over about two weeks costing each. Some insurers will pay about half of that covering Khares office visit cost. Patients can receive booster treatments. They must sign a fourpage consent form that says benefits may not be longlasting lists potential side effects and in bold letters states that the treatment is not governmentapproved. At a recent session Pestikass seventh she leaned back on a reclining white examiningroom chair as a nurse hooked her up to a heart and blood pressure monitor. She grimaced as a needle was slipped into the top of her left palm. Khare reached up with a syringe to inject a small dose of ketamine into an IV bag hanging above the chair then dimmed the lights pulled the window curtains and asked if she had questions and was feeling OK. No questions just grateful Pestikas replied smiling. Pestikas listened to music on her iPhone and watched psychedelic videos. She said it was like a controlled acid trip with pleasant hallucinations. The trip ends soon after the IV is removed but Pestikas said she feels calm and relaxed the rest of the day and that the mood boost can last weeks. Studies suggest that a single IV dose of ketamine far smaller than used for sedation or partying can help many patients gain relief within about four hours and lasting nearly a week or so. Exactly how ketamine works is unclear but one idea is that by elevating glutamate levels ketamine helps nerve cells reestablish connections that were disabled by depression said ketamine expert Dr. Carlos Zarate chief of experimental therapies at the National Institute of Mental Health. A small Stanford University study published in August suggested that ketamine may help relieve depression by activating the brains opioid receptors. Janssen Pharmaceuticals and Allergan are among drug companies developing ketaminelike drugs for depression. Janssen leads the effort with its nasal spray esketamine. The company filed a new drug application in September. Meanwhile dozens of studies are underway seeking to answer some of the unknowns about ketamine including whether repeat IV treatments work better for depression and if theres a way to zero in on which patients are most likely to benefit. Until there are answers Zarate of the mental health institute said ketamine should be a lastresort treatment for depression after other methods have failed."

"None PHOENIX Oct. PRNewswire Creative Medical Technology Holdings OTCQB CELZ announced today completion of the safety data analysis on patients with pharmacologicallyresistant erectile dysfunction treated with the Companys patented CaverStem procedure. The trial sponsored by Creative Medical Technology Holdings was conducted at the University of California Los Angeles Harbor HospitalLA Biomed under Institutional Review Board IRB approval. An independent medical safety monitor was also appointed to review the patient data for safety and feasibility of administering bone marrow derived stem cells into patients with erectile dysfunction. The goal of this procedure is to regenerate blood vessels and smooth muscle parts of the penis that are not functioning properly in this patient population. Based on establishment of safety of the CaverStem procedure in a formal universitybased clinical trial and independent confirmation of efficacy in an European clinical trial we have launched commercialization for the CaverStem procedure said Timothy Warbington President and Chief Executive Officer of Creative Medical Technology Holdings. Amongst other top urologists we have recruited a worldrenowned urologist as a lead physician to rollout the procedure. We anticipate that the procedure will be available to patients that meet the eligibility criteria within the next days. According to the National Institutes of Health approximately million men in the United States suffer from Erectile Dysfunction of which million do not respond to pharmacological treatments such as Viagra Levitra and Cialis. The CaverStem procedure involves obtaining a small amount of bone marrow from the patient purifying the stem cells using a closed system device that is FDA cleared and then administering these cells in the same procedure into the patients penis said Thomas Ichim Ph.D Chief Scientific Officer and CoFounder of the Company. Having published the first peerreviewed paper on this procedure back in together with internationally renowned urologists and stem cell experts it is very exciting for me to watch this translate from bench to bedside. About Creative Medical Technology Holdings Creative Medical Technology Holdings Inc. is a clinical stage biotechnology company currently trading on the OTCQB under the ticker symbol CELZ. For further information about the company go to creativemedicaltechnology.com. Yiou et al. Intracavernous Injections of Bone Marrow Mononucleated Cells for Postradical Prostatectomy Erectile Dysfunction Final Results of the INSTIN Clinical Trial.Eur Urol Focus. Jun . pii S https https Ichim et al. Intracavernous administration of bone marrow mononuclear cells a new method of treating erectile dysfunction J Transl Med. Jun . https ForwardLooking Statements OTC Markets has not reviewed and does not accept responsibility for the adequacy or accuracy of this release. This news release may contain forwardlooking statements including but not limited to comments regarding the timing and content of upcoming clinical trials marketing efforts funding etc. Forwardlooking statements address future events and conditions and therefore involve inherent risks and uncertainties. Actual results may differ materially from those currently anticipated in such statements. See the periodic and other reports filed by Creative Medical Technology Holdings Inc. with the Securities and Exchange Commission and available on the Commissions website at Related Links httpcreativemedicaltechnology.com httpcaverstem.com SOURCE Creative Medical Technology Holdings Inc. Related Links httpcreativemedicaltechnology.com"