Efficacy and tolerability of Boswellia serrata extract in treatment of osteoarthritis of knee--a randomized double blind placebo controlled trial. Effects of Boswellia serrata gum resin in patients with bronchial asthma: results of a double-blind, placebo-controlled, 6-week clinical study. Boswellia serrata extract for the treatment of collagenous colitis. A double-blind, randomized, placebo-controlled, multicenter trial [Therapy of active Crohn disease with Boswellia serrata extract H 15]. Effects of Boswellia serrata gum resin in patients with ulcerative colitis. Effects of topical boswellic acid on photo and age-damaged skin: clinical, biophysical, and echographic evaluations in a double-blind, randomized, split-face study. Effects of gum resin of Boswellia serrata in patients with chronic colitis. Action to Support Practices Implement Research Evidence (ASPIRE): protocol for a cluster-randomised evaluation of adaptable implementation packages targeting ‘high impact’ clinical practice recommendations in general practice Randomized, placebo‐controlled, double‐blind trial of Boswellia serrata in maintaining remission of Crohn's disease: Good safety profile but lack of efficacy Topical Boswellic acids for treatment of photoaged skin. Evaluation of the clinical efficacy and safety of grapeseed extract in the treatment of fall seasonal allergic rhinitis: a pilot study. Reporting Randomized, Controlled Trials of Herbal Interventions: An Elaborated CONSORT Statement A comparative study of the safety and efficacy of 75% mulberry (Morus alba) extract oil versus placebo as a topical treatment for melasma: a randomized, single-blind, placebo-controlled trial. A Placebo-Controlled Double-Blind Study Demonstrates the Clinical Efficacy of a Novel Herbal Formulation for Relieving Joint Discomfort in Human Subjects with Osteoarthritis of Knee. A commercialized dietary supplement alleviates joint pain in community adults: a double-blind, placebo-controlled community trial The effect of herbal extracts in an experimental mouthrinse on established plaque and gingivitis. Development and testing of a new measure of health status for clinical trials in rhinoconjunctivitis
Osteoarthritis is a common , chronic , progressive , skeletal , degenerative disorder , which commonly affects the knee joint . Boswellia serrata tree is commonly found in India . The therapeutic value of its gum ( guggulu ) has been known . It posses good anti-inflammatory , anti-arthritic and analgesic activity . A r and omized double blind placebo controlled crossover study was conducted to assess the efficacy , safety and tolerability of Boswellia serrata Extract ( BSE ) in 30 patients of osteoarthritis of knee , 15 each receiving active drug or placebo for eight weeks . After the first intervention , washout was given and then the groups were crossed over to receive the opposite intervention for eight weeks . All patients receiving drug treatment reported decrease in knee pain , increased knee flexion and increased walking distance . The frequency of swelling in the knee joint was decreased . Radiologically there was no change . The observed differences between drug treated and placebo being statistically significant , are clinical ly relevant . BSE was well tolerated by the subjects except for minor gastrointestinal ADRs . BSE is recommended in the patients of osteoarthritis of the knee with possible therapeutic use in other arthritis The gum resin of Boswellia serrata , known in Indian Ayurvedic system of medicine as Salai guggal , contains boswellic acids , which have been shown to inhibit leukotriene bio synthesis . In a double-blind , placebo-controlled study forty patients , 23 males and 17 females in the age range of 18 - 75 years having mean duration of illness , bronchial asthma , of 9.58 + /- 6.07 years were treated with a preparation of gum resin of 300 mg thrice daily for a period of 6 weeks . 70 % of patients showed improvement of disease as evident by disappearance of physical symptoms and signs such as dyspnoea , rhonchi , number of attacks , increase in FEV subset1 , FVC and PEFR as well as decrease in eosinophilic count and ESR . In the control group of 40 patients 16 males and 24 females in the age range of 14 - 58 years with mean of 32.95 + /- 12.68 were treated with lactose 300 mg thrice daily for 6 weeks . Only 27 % of patients in the control group showed improvement . The data show a definite role of gum resin of Boswellia serrata in the treatment of bronchial asthma Background and aims The objective of this study was to investigate the effect of Boswellia serrata extract ( BSE ) on symptoms , quality of life , and histology in patients with collagenous colitis . Material s and methods Patients with chronic diarrhea and histologically proven collagenous colitis were r and omized to receive either oral BSE 400 mg three times daily for 6 weeks or placebo . Complete colonoscopy and histology were performed before and after treatment . Clinical symptoms and quality of life were assessed by st and ardized question naires and SF-36 . The primary endpoint was the percentage of patients with clinical remission after 6 weeks ( stool frequency ≤3 soft /solid stools per day on average during the last week ) . Patients of the placebo group with persistent diarrhea received open-label BSE therapy for a further 6 weeks . Results Thirty-one patients were r and omized ; 26 patients were available for per- protocol - analysis . After 6 weeks , the proportion of patients in clinical remission was higher in the BSE group than in the placebo group ( per protocol 63.6 % ; 95%CI , 30.8–89.1 vs 26.7 % , 95%CI , 7.7–55.1 ; p = 0.04 ; intention-to-treat 43.8 % vs 26.7 % , p = 0.25 ) . Compared to placebo , BSE treatment had no effect on histology and quality of life . Five patients discontinued BSE treatment prematurely . Discontinuation was due to adverse events ( n = 1 ) , unwillingness to continue ( n = 3 ) , or loss to follow-up for unknown reasons ( n = 1 ) . Seven patients received open-label BSE therapy , five of whom achieved complete remission . Conclusions Our study suggests that BSE might be clinical ly effective in patients with collagenous colitis . Larger trials are clearly necessary to establish the clinical efficacy of BSE BACKGROUND The purpose of this clinical trial was to compare efficacy and safety of the Boswellia serrata extract H15 with mesalazine for the treatment of active Crohn 's disease . PATIENTS AND METHODS R and omised , double-blind , verum-controlled , parallel group comparison for which 102 Patients were r and omised . The per protocol population included 44 patients treated with H15 and 39 patients treated with mesalazine .  As primary outcome measure the change of the Crohn Disease Activity Index ( CDAI ) between the status of enrolment and end of therapy was chosen . H 15 was tested on non-inferiority compared to st and ard treatment with mesalazine . RESULTS The CDAI between the status of enrolment and end of therapy after treatment with H15 was reduced by 90 and after therapy with mesalazine by 53 scores in the mean . In this non-inferiority-trial the test hypothesis was confirmed by the statistical analysis . The difference between both treatments could not be proven to be statistically significant in favor to H15 for the primary outcome measure . The secondary efficacy endpoints confirm the assessment of the comparison of H15 and mesalazine . The proven tolerability of H15 completes the results of the shown clinical efficacy . CONCLUSIONS The study confirms that therapy with H15 is not inferior to mesalazine . This can be interpreted as evidence for the efficacy of H15 according to the state of art in the treatment of active Crohn 's disease with Boswellia serrata extract , since the efficacy of mesalazine for this indication has been approved by the health authorities . Considering both safety and efficacy of Boswellia serrata extract H15 it appears to be superior over mesalazine in terms of a benefit-risk-evaluation Ulcerative colitis is a chronic inflammatory disease of the colon where leukotrienes are suggested to play an important role for keeping inflammation active . Boswellic acids , the biologically active ingredients of the gum resin of Boswellia serrata ( Sallai guggal ) , have been shown to be specific , nonredox and noncompetitive inhibitors of 5-lipoxygenase , the key enzyme of leukotriene bio synthesis . In patients suffering from ulcerative colitis grade II and III the effect of Boswellia serrata gum resin preparation ( 350 mg thrice daily for 6 weeks ) on stool properties , histolopathology and scan microscopy of rectal biopsies , blood parameters including Hb , serum iron , calcium , phosphorus , proteins , total leukocytes and eosinophils was studied . Patients receiving sulfasalazine ( 1 g thrice daily ) served as controls . All parameters tested improved after treatment with Boswellia serrata gum resin , the results being similar compared to controls : 82 % out of treated patients went into remission ; in case of sulfasalazine remission rate was 75 % Boswellic acids ( BAs ) are pentacyclic triterpenes with strong anti-inflammatory activity ; their most important source is the extract of the gum resin of Boswellia serrata , a tropical tree that grows in India and Africa . In the present r and omized , double-blind , split-face , comparative study we have assessed efficacy , tolerability , and safety of a base cream containing 0.5 % BAs as compared to the same cream without these active ingredients in the treatment of clinical manifestations of photoaging of facial skin . Fifteen female volunteers were enrolled ; they applied creams once daily for 30 days . At baseline , at the end of the treatment , and after a 2-month follow-up , clinical findings were assessed according to the Dover classification scale for photoaging and by biophysical and ecographic measurements . We registered a significant improvement of tactile roughness and fine lines in the half side of the face treated with BAs ; noninvasive instrumental diagnostic investigations showed an improvement of elasticity , a decrease of sebum excretion , and a change of echographic parameters suggesting a reshaping of dermal tissue . The treatment was always well tolerated without adverse effects . The present findings seem to indicate that the topical application of BAs may represent a suitable treatment option for selected features of skin photoaging Patients studied here suffered from chronic colitis characterized by vague lower abdominal pain , bleeding per rectum with diarrhoea and palpable tender descending and sigmoid colon . The inflammatory process in colitis is associated with increased formation of leukotrienes causing chemotaxis , chemokinesis , synthesis of superoxide radicals and release of lysosomal enzymes by phagocytes . The key enzyme for leukotriene bio synthesis is 5-lipoxygenase . Boswellic acids were found to be non-redox , non-competitive specific inhibitors of the enzyme 5-lipoxygenase . We studied the gum resin of Boswellia serrata for the treatment of this disease . Thirty patients , 17 males and 13 females in the age range of 18 to 48 years with chronic colitis were included in this study . Twenty patients were given a preparation of the gum resin of Boswellia serrata ( 900 mg daily divided in three doses for 6 weeks ) and ten patients were given sulfasalazine ( 3 gm daily divided in three doses for 6 weeks ) and served as controls . Out of 20 patients treated with Boswellia gum resin 18 patients showed an improvement in one or more of the parameters : including stool properties , histopathology as well as scanning electron microscopy , besides haemoglobin , serum iron , calcium , phosphorus , proteins , total leukocytes and eosinophils . In the control group 6 out of 10 patients showed similar results with the same parameters . Out of 20 patients treated with Boswellia gum resin 14 went into remission while in case of sulfasalazine  remission rate was 4 out of 10 . In conclusion , this study shows that a gum resin preparation from Boswellia serrata could be effective in the treatment of chronic colitis with minimal side effects Background There are recognised gaps between evidence and practice in general practice , a setting which provides particular challenges for implementation . We earlier screened clinical guideline recommendations to derive a set of ‘ high impact ’ indicators based upon criteria including potential for significant patient benefit , scope for improved practice and amenability to measurement using routinely collected data . We aim to evaluate the effectiveness and cost-effectiveness of a multifaceted , adaptable intervention package to implement four targeted , high impact recommendations in general practice . Methods / design The research programme Action to Support Practice Implement Research Evidence ( ASPIRE ) includes a pair of pragmatic cluster-r and omised trials which use a balanced incomplete block design . Clusters are general practice s in West Yorkshire , United Kingdom ( UK ) , recruited using an ‘ opt-out ’ recruitment process . The intervention package adapted to each recommendation includes combinations of audit and feedback , educational outreach visits and computerised prompts with embedded behaviour change techniques selected on the basis of identified needs and barriers to change . In trial 1 , practice s are r and omised to adapted interventions targeting either diabetes control or risky prescribing and those in trial 2 to adapted interventions targeting either blood pressure control in patients at risk of cardiovascular events or anticoagulation in atrial fibrillation . The respective primary endpoints comprise achievement of all recommended target levels of haemoglobin A1c ( HbA1c ) , blood pressure and cholesterol in patients with type 2 diabetes , a composite indicator of risky prescribing , achievement of recommended blood pressure targets for specific patient groups and anticoagulation prescribing in patients with atrial fibrillation . We are also r and omising practice s to a fifth , non-intervention control group to further assess Hawthorne effects . Outcomes will be assessed using routinely collected data extracted 1 year after r and omisation . Economic modelling will estimate intervention cost-effectiveness . A process evaluation involving eight non-trial practice s will examine intervention delivery , mechanisms of action and unintended consequences . Discussion ASPIRE will provide ‘ real-world ’ evidence about the effects , cost-effectiveness and delivery of adapted intervention packages targeting high impact recommendations . By implementing our adaptable intervention package across four distinct clinical topics , and using ‘ opt-out ’ recruitment , our findings will provide evidence of wider generalisability . Trial registration IS RCT Background : Complementary therapies are frequently used by patients with inflammatory bowel disease ( IBD ) . The aim of this study was to evaluate the efficacy and safety of long‐term therapy with a new Boswellia serrata extract ( Boswelan , PS0201Bo ) in maintaining remission in patients with Crohn 's disease ( CD ) . Methods : In 22 German centers a double‐blind , placebo‐controlled , r and omized , parallel study was performed . In all , 108 out patients with CD in clinical remission were included . Patients were r and omized to Boswelan ( 3 × 2 capsules/day ; 400 mg each ) or placebo for 52 weeks . The primary endpoint was the proportion of patients in whom remission was maintained throughout the 52 weeks . Secondary endpoints were time to relapse , changes of Crohn 's Disease Activity Index ( CDAI ) , and IBD Question naire ( IBDQ ) scores . Results : The trial was prematurely terminated due to insufficient discrimination of drug and placebo with regard to the primary efficacy endpoint . A total of 82 patients were r and omized to Boswelan ( n = 42 ) or placebo ( n = 40 ) . Sixty‐six patients could be analyzed for efficacy . 59.9 % of the actively treated patients and 55.3 % of the placebo group stayed in remission ( P = 0.85 ) . The mean time to diagnosis of relapse was 171 days for the active group and 185 days for the placebo group ( P = 0.69 ) . With respect to CDAI , IBDQ , and laboratory measurements of inflammation , no advantages in favor of active treatment were detected . Regarding safety concerns , no disadvantages of taking the drug compared to placebo were observed . Conclusions : The trial confirmed good tolerability of a new Boswellia serrata extract , Boswelan , in long‐term treatment of CD . However , superiority versus placebo in maintenance therapy of remission could not be demonstrated . ( Inflamm Bowel Dis 2011 Boswellic acids ( BAs ) are pentacyclic triterpenes extracted from the gum resins of the tropical tree Boswellia serrata . They are orally administered in traditional Indian medicine for the treatment of several inflammatory disease and cancer because of their anti-inflammatory and immunomodulatory activities as well as stimulatory effects on fibroblasts . The present authors have investigated efficacy , tolerability , and safety of a base cream containing 0.5 % BAs in the treatment of clinical manifestations of photoaging of facial skin with a r and omized , double-blind , placebo-controlled , split-face study . Fifteen female volunteers applied the creams with or without BAs on the half sides of the face once daily for 30 days . Significant improvements of the Dover 's global score for photoaging , tactile roughness , and fine lines , as well as , with noninvasive diagnostic techniques , an increase of elasticity , a decrease of sebum excretion , and a change of echographic parameters were observed with topical BAs in comparison with placebo . The treatment was always well tolerated without adverse effects . The present findings seem to indicate that topical application of BAs may represent a suitable treatment option for selected features of skin photoaging BACKGROUND Herbal products are widely used by consumers as alternatives to prescription drugs in treating symptoms of allergic rhinitis . However , there have been few placebo-controlled clinical trials that have examined the efficacy or safety of these products . Although grapeseed extract ( GSE ) is an herbal that is marketed for treating allergic rhinitis , its efficacy is unproven . OBJECTIVE The aim of this study was to compare the efficacy and safety of GSE with placebo in the treatment of seasonal allergic rhinitis ( SAR ) . METHODS This was a r and omized , double-blind , placebo-controlled study of GSE 100 mg , twice daily , versus placebo .  Patients with SAR and skin prick test sensitivity to ragweed were r and omized to 8 weeks of active treatment or placebo which was begun before the ragweed pollen season . Outcomes included : daily symptom diary scores recorded by patients , rhinitis quality of life scores at baseline and after 4 and 8 weeks of treatment ; and requirements for rescue chlorpheniramine . Safety was monitored with routine laboratory studies . RESULTS Over 8 weeks of treatment , no significant differences were observed between active and placebo groups in rhinitis quality of life assessment s , symptom diary scores , or requirements for rescue antihistamine . No significant laboratory abnormalities were detected . CONCLUSIONS This study did not show trends supporting the efficacy of GSE in the treatment of SAR R and omized , controlled trials ( RCTs ) of herbal interventions often inadequately describe important aspects of their methods ( 1 - 4 ) . Although the quality of reporting of these trials may be improving with time , many still lack important information , particularly about the composition of the herbal intervention ( 4 , 5 ) . Crude herbal drugs are natural products and their chemical composition varies depending on several factors , such as geographic source of the plant material , climate in which it was grown , and time of harvest . Commercially available herbal medicinal products also vary in their content and concentration of chemical constituents from batch to batch and when products containing the same herbal ingredient are compared among manufacturers ( 6 - 14 ) . Even when herbal products are st and ardized for content of known active or marker compounds to achieve more consistent pharmaceutical quality , there is variation in the concentrations of other constituents . These variations can result in differences in pharmacologic activity in vitro ( 15 ) and in bioavailability in humans ( 16 ) . Mindful of these issues , we elaborated on the 22-item checklist of the Consoli date d St and ards of Reporting Trials ( CONSORT ) statement ( 17 ) to help authors and editors improve reporting of RCTs of herbal interventions . Methods We developed these reporting recommendations in 3 phases that included premeeting item generation , a consensus meeting , and postmeeting feedback . The individuals who participated are listed in the Appendix . To generate items , 1 investigator conducted telephone interviews of 16 participants with expertise in the method and reporting of RCTs ( 5 participants ) , pharmacognosy ( 4 participants ) , herbal medicinal products ( 5 participants ) , medical statistics ( 1 participant ) , and herbal product manufacturing ( 1 participant ) . The investigator asked participants to suggest revisions to existing CONSORT checklist items and also to additional items required for reporting trials of herbal interventions . He asked participants to nominate revisions or new items on the basis of empirical evidence that not reporting the item would bias estimates of treatment effect . When no empirical evidence was available , commonsense reasoning was acceptable . After completing all telephone calls , the investigator thematically grouped items and circulated them by e-mail to each participant for review . Fourteen participants attended the consensus meeting . The meeting began with a review of the premeeting checklist item suggestions . We emphasized minimizing item elaborations and additions and basing elaborations on evidence whenever possible . Each item suggestion was presented and followed by debate for its inclusion , deletion , or modification . This process was repeated until all items were review ed and a consensus emerged . After the consensus meeting , we circulated a draft summary report to all participants to ensure that it accurately represented decisions made during the consensus meeting . We then circulated the report to the wider CONSORT Group for input and revised it on the basis of their suggestions . Ethical approval was obtained from The University of Toronto Health Sciences Ethics Review Committee on 23 January 2004 . Financial support for the consensus meeting was provided by the Canadian Institutes of Health Research . The funding body had no role in the design , conduct , or analysis of this study and did not influence the decision to su bmi t the manuscript for publication . All research ers are independent of the funders . Results The group did not recommend any new CONSORT checklist items or modifications in the CONSORT flow diagram . We did , however , elaborate on 9 of the 22 CONSORT checklist items to enhance their relevance to trials of herbal interventions ( Table , Figure ; Appendix Table ) , including minor recommendations for 8 items ( item 1 [ title and abstract ] , item 2 [ background ] , item 3 [ participants ] , item 6 [ outcomes ] , item 15 [ baseline data ] , item 20 [ interpretation ] , item 21 [ generalizability ] , and item 22 [ overall evidence ] ) and detailed recommendations for 1 item ( item 4 [ interventions ] ) . Table . Proposed Elaboration of CONSORT Checklist Item 4 for Reporting R and omized , Controlled Trials of Herbal Medicine Interventions Figure . The high-pressure liquid chromatography chemical fingerprint for the extract of Ginkgo biloba L Appendix Table . Proposed Elaborations of CONSORT Items for R and omized , Controlled Trials of Herbal Medicine Interventions The Table shows the detailed recommendations for item 4 and an example of good reporting related to each recommendation . These recommendations begin with the words where applicable to indicate that all information suggested may not be applicable to every type of herbal medicine intervention . For example , an herbal medicinal product comprising crude herbal material ( for example , leaves and stems ) simply prepared as a tea or decoction does not require description of the type and concentration of solvent used and the ratio of herbal drug to extract ( item 4B.3 ) . Also , not every herbal medicine intervention will have a finished product or extract name or manufacturer ( item 4A.2 ) , but instead may be made by the investigators specifically for the study . In such circumstances , all methods used in preparing and formulating the product must be reported . Similarly , item 4F is not required for herbal interventions when the practitioner is not a part of the intervention . With these exceptions , we recommend that all information shown in the Table be reported for all herbal interventions . Discussion We developed recommendations to be used in conjunction with the existing CONSORT checklist when reporting RCTs of herbal interventions . In particular , we thought it imperative that reports of RCTs provide clear and complete descriptions of the herbal intervention . We think that our recommendations might also be relevant for reporting herbal interventions in other research design s , whether pre clinical ( for example , in vivo or in vitro ) or clinical ( for example , N of 1 trials ) , and refer interested readers to a detailed explanatory document that further describes each of our recommendations and provides additional examples of good reporting ( 22 ) . We hope that authors find our recommendations instructive and that journals will endorse their use and modify their instructions to authors accordingly BACKGROUND Melasma is an aesthetically undesirable skin condition which remains difficult to treat . Mulberry is a whitening agent with antioxidant properties . OBJECTIVE To evaluate the safety and efficacy of 75 % mulberry extract oil as a treatment for melasma versus placebo . PATIENTS AND METHODS 50 patients were recruited and r and omly assigned into two groups , with 25 treated with 75 % mulberry extract oil and the other 25 treated with placebo .  All patients had a negative repeat open application test ( ROAT ) to both mulberry extract and placebo . Patients were followed up regularly at four-week intervals for a total of eight weeks . The severity of the melasma was assessed using the melasma area and severity score ( MASI ) , Mexameter reading , melasma quality of life score ( MelasQOL ) and any adverse events noted . RESULTS The mean MASI score significantly improved from 4.076 ( ± 0.24 ) at baseline to 2.884 ( ± 0.25 ) at week 8 for the 75 % mulberry extract oil group while the placebo group showed an improvement of a lesser magnitude . Mexameter readings for the mulberry group showed a significant drop from 355.56 ( ± 59.51 ) at baseline to 312.52 ( ± 57.03 ) at week 8 compared to the placebo group , whose Mexameter readings deteriorated from 368.24 ( ± 46.62 ) at baseline to 372.12 ( ± 44.47 ) at week 8 . The MelasQOL score also improved tremendously for the 75 % mulberry extract oil group , falling from 58.84 ( SD : ± 3.18 ) at baseline to 44.16 ( SD : ± 4.29 ) at week 8 , unlike the placebo group that showed a less dramatic improvement from 57.44 ( SD : ± 4.66 ) at baseline to 54.28 ( SD : ± 4.79 ) at week 8 . With regards to the adverse events , only mild itching was reported in four patients from the 75 % mulberry extract oil group while there were 12 cases of either itching or erythema reported from the placebo group LI73014F2 is a novel composition prepared from extracts of Terminalia chebula fruit , Curcuma longa rhizome , and Boswellia serrata gum resin with synergistic benefit in 5-Lipoxygenase ( 5-LOX ) inhibition . This herbal composition with strong anti-5-LOX activity exhibited significant pain relief as indicated through improvements in weight-bearing capacity in a monosodium iodoacetate-induced osteoarthritis ( OA ) model of Sprague-Dawley rats . A 90-day r and omized , placebo-controlled double-blind study evaluates the clinical efficacy and tolerability of LI73014F2 in the management of symptoms of OA of the knee ( Clinical Trial Registration No. CTRI/2014/01/004338 ) . Subjects , ( n = 105 ) , were r and omized into three groups : placebo ( n = 35 ) , 200 mg/day of LI73014F2 ( n = 35 ) , and 400 mg/day of LI73014F2 ( n = 35 ) . All study participants were evaluated for pain and physical function by using st and ard tools , that is , Visual Analog Scale , Lequesne 's Functional Index , and Western Ontario and McMaster Universities Osteoarthritis Index ( WOMAC ) at the baseline ( day 0 ) and on day 14 ± 3 , 30 ± 3 , 60 ± 3 , and at the end of the study ( day 90 ± 3 ) . In addition , routine examinations on biochemical parameters in serum , urine , and hematological parameters were conducted on each visit to assess the safety of the study material . At the end of the trial period , LI73014F2 conferred significant pain relief , improved physical function , and quality of life in OA patients . In conclusion , pre clinical and clinical data together strongly suggest that the herbal formulation LI73014F2 is a safe and effective intervention for management of joint discomfort , demonstrating efficacy as early as 14 days Background The purpose of this study was to assess the effect of 8-weeks ingestion of a commercialized joint pain dietary supplement ( InstaflexTM Joint Support , Direct Digital , Charlotte , NC ) compared to placebo on joint pain , stiffness , and function in adults with self-reported joint pain .  InstaflexTM is a joint pain supplement containing glucosamine sulfate , methylsufonlylmethane ( MSM ) , white willow bark extract ( 15 % salicin ) , ginger root concentrate , boswella serrata extract ( 65 % boswellic acid ) , turmeric root extract , cayenne , and hyaluronic acid . Methods Subjects included 100 men and women , ages 50 - 75 years , with a history ( > 3 months ) of joint pain , and were r and omized to Instaflex ™ or placebo ( 3 colored gel capsules per day for 8 weeks , double-blind administration ) . Subjects agreed to avoid the use of non-steroidal anti-inflammatory drugs ( NSAID ) and all other medications and supplements targeted for joint pain . Primary outcome measures were obtained pre- and post- study and included joint pain severity , stiffness , and function ( Western Ontario and McMaster Universities [ WOMAC ] ) , and secondary outcome measures included health-related quality of life ( Short Form 36 or SF-36 ) , systemic inflammation ( serum C-reactive protein and 9 plasma cytokines ) , and physical function ( 6-minute walk test ) . Joint pain symptom severity was assessed bi-weekly using a 12-point Likert visual scale ( 12-VS ) . Results Joint pain severity was significantly reduced in Instaflex ™ compared to placebo ( 8-week WOMAC , ↓37 % versus ↓16 % , respectively , interaction effect P = 0.025 ) , with group differences using the 12-VS emerging by week 4 of the study ( interaction effect , P = 0.0125 ) . Improvements in ability to perform daily activities and stiffness scores  in Instaflex ™ compared to placebo were most evident for the 74 % of subjects reporting knee pain ( 8-week WOMAC function score , ↓39 % versus ↓14 % , respectively , interaction effect P = 0.027 ; stiffness score , ↓30 % versus ↓12 % , respectively , interaction effect P = 0.081 ) . Patterns of change in SF-36 , systemic inflammation biomarkers , and the 6-minute walk test did not differ significantly between groups during the 8-week study Conclusions Results from this r and omized , double blind , placebo-controlled community trial support the use of the Instaflex ™ dietary supplement in alleviating  joint pain severity in middle-aged and older adults , with mitigation of difficulty performing daily activities most apparent in subjects with knee pain . Trial registration Clinical Trials.gov Identifier : The purpose of the present study was to establish in vitro the inhibiting effect of a herbal extract mixture on a selected number of micro-organisms and to test in vivo the effect of a mouthwash containing 6.3 mg/ml herbal extract mixture on plaque and gingivitis as compared to a minus active control mouthrinse . The herbal extract was a mixture of : Juniperus communis ( juniper ) , Urtica dioca ( nettle ) , Achillaea millefolium ( yarrow ) ; 1:1:1 . In the study , in-vitro , the effect of pure herbal extract mixture on acid production of Streptococcus mutans was tested and the minimum inhibitory concentrations ( MIC ) of the following micro-organisms were tested : Streptococcus mutans , Streptococcus mitis , Actynomyces viscosus , Actynomyces naeslundii , Actinobacillus actinomycetemcomitans , Prevotella intermedia , Campylobacter rectus , Fusobacterium nucleatum , Veillonella parvula . The MIC-values for A. viscosus and P. gingivalis were 100 mg/ml . The MIC-values for A. naeslundii and A. actinomycetemcomitans were considerably lower ( 10 mg/ml ) . S. mitis was the most susceptible of the tested organisms to the extract with a MIC value of 1 mg/ml . S. mutans , C. rectus , V. parvula , and F. nucleatum were not influenced by the extracts . No inhibitory effect of the 6.3 mg/ml herbal extract mixture was observed on the acid production of S. mutans . For the study in-vivo , 45 volunteers were selected on the basis of having moderate gingival inflammation . As efficacy parameters the plaque index , modified gingival index and angulated bleeding index were assessed . The subjects were r and omly divided among 3 experimental groups ( 2x test and 1 ' minus active ' control ) . The participants were requested to rinse with 10 ml of mouthwash twice a day for a period of three months . After 6 weeks and 3 months , the same clinical indices as at baseline were recorded . The results show no difference between the two test groups and the control group . In conclusion , the results of the present study have shown that the mixture of the 3 herbal extracts , Juniperus communis , Urtica dioca and Achillaea millefolium when used in a mouthrinse has no effect on plaque growth and gingival health The objective of this study was to develop and test a health‐related quality of life question naire for clinical trials in rhinoconjunctivitis . The Rhinoconjunctivitis Quality of Life Question naire ( RQLQ ) was developed by asking patients to identify areas of their lives affected by rhinoconjunctivitis . The result ant RQLQ was tested for reproducibility , responsiveness and validity in a r and omized , double‐blind trial of regular versus ‘ as required ’ aqueous beclomethasone dipropionate ( BDP ) nasal spray in ragweed pollen‐induced rhinoconjunctivitis . Eighty‐five patients from previous rhinoconjunctivitis studies participated in the developmental survey . Sixty ragweed‐sensitive patients , from previous trials and media notices , were enrolled in the clinical trial . Aqueous BDP ( 800 μg ) nasal spray was administered regularly or ‘ as required ’ throughout the ragweed pollen season . The survey revealed that , in addition to local symptoms of rhinoconjunctivitis , patients experienced impairment of quality of life through systemic symptoms , sleep disturbance , practical problems , activity limitations and emotional problems . The RQLQ includes 28 questions related to these dimensions . Repeated administration of the RQLQ demonstrated good reproducibility . During the clinical trial , the RQLQ proved responsive in its ability to distinguish between regular and ‘ as required ’ medication use . Validity was shown by moderate to strong relations between changes in symptom diary scores and changes in RQLQ scores . In conclusion the RQLQ is likely to prove useful as a measure of health‐related quality of life in clinical trials in both rhinoconjunctivitis and rhinitis
The evidence for the effectiveness of B serrata extracts is encouraging but not compelling
OBJECTIVE To assess evidence from r and omised clinical trials about the effectiveness of  extracts of Boswellia serrata ( frankincense ) .