Pharmacotherapy of anxiety. The diagnosis and treatment of generalized anxiety disorder. World Federation of Societies of Biological Psychiatry (WFSBP) Guidelines for the Pharmacological Treatment of Anxiety, Obsessive-Compulsive and Post-Traumatic Stress Disorders – First Revision Treatment of endogenous anxiety with phobic, hysterical, and hypochondriacal symptoms. Pharmacotherapy of impaired affect in recovering schizophrenic patients. Ginkgo biloba special extract EGb 761 in generalized anxiety disorder and adjustment disorder with anxious mood: a randomized, double-blind, placebo-controlled trial. Selective anxiolysis produced by ocinaplon, a GABA(A) receptor modulator. Guidelines for the pharmacological treatment of anxiety disorders, obsessive–compulsive disorder and posttraumatic stress disorder in primary care Results of a naturalistic longitudinal study of benzodiazepine and SSRI use in the treatment of generalized anxiety disorder and social phobia. Protocol for a randomised controlled trial investigating the effectiveness of an online e-health application compared to attention placebo or sertraline in the treatment of generalised anxiety disorder Glycemic control improvement through treatment of depression using antidepressant drugs in patients with diabetes mellitus type 1. Kava for the treatment of generalised anxiety disorder (K-GAD): study protocol for a randomised controlled trial Cannabidiol Reduces the Anxiety Induced by Simulated Public Speaking in Treatment-Naïve Social Phobia Patients A randomized, double-blind, placebo-controlled study of ziprasidone monotherapy in bipolar disorder with co-occurring lifetime panic or generalized anxiety disorder. Cognitive-behavioural, pharmacological and psychosocial predictors of outcome during tapered discontinuation of benzodiazepine. n-3 Polyunsaturated Fatty Acids Decrease Anxiety Feelings in a Population of Substance Abusers Naturopathic Care for Anxiety: A Randomized Controlled Trial ISRCTN78958974
The pharmacological treatment of anxiety has a long and chequered history , and recent years have seen a rich development in the options available to prescribers . Most of the currently used anxiolytic agents act via monoaminergic ( chiefly serotonin ) or amino acid ( GABA or glutamate ) neurotransmitters , and this chapter describes the pharmacology of the major drug groups . Clinical applications are discussed with respect to the five major anxiety disorders , as well as simple phobia and depression with concomitant anxiety . Prospect i ve future developments in the field are considered BACKGROUND Generalized anxiety disorder  ( GAD ) is a common and serious disease with a lifetime prevalence of 4.3 % to 5.9 % . It is underdiagnosed in primary care . METHODS Recommendations on the treatment of GAD are given on the basis of all available findings from pertinent r and omized trials , retrieved by a selective search of the literature . RESULTS Among psychotherapeutic techniques , various kinds of cognitive behavioral therapy ( CBT ) have been found useful in controlled trials . The drugs of first choice include selective serotonin reuptake inhibitors ( SSRIs ) , serotonin-norepinephine reuptake inhibitors ( SNRIs ) , and the calcium-channel modulator pregabalin . Tricyclic antidepressants are also effective but have more adverse effects than SSRIs . Although benzodiazepines are effective anxiolytic agents for short-term use , they should not be given over the long term because of the danger of addiction . Buspirone , an azapirone , was found to be effective in a small number of trials , but the findings across trials are inconsistent . The response rate of GAD to CBT in published studies lies between 47 % and 75 % , while its response rate to drug treatment lies between 44 % and 81 % . CONCLUSION The treatment of GAD with CBT and drugs is evidence -based and has a good chance of improving the manifestations of the disorder In this report , which is an up date of a guideline published in 2002 ( B and elow et al. 2002 , World J Biol Psychiatry 3:171 ) , recommendations for the pharmacological treatment of anxiety disorder , obsessive-compulsive disorder ( OCD ) and post-traumatic stress disorder ( PTSD ) are presented . Since the publication of the first version of this guideline , a substantial number of new r and omized controlled studies of anxiolytics have been published . In particular , more relapse prevention studies are now available that show sustained efficacy of anxiolytic drugs . The recommendations , developed by the World Federation of Societies of Biological Psychiatry ( WFSBP ) Task Force for the Pharmacological Treatment of Anxiety , Obsessive-Compulsive and Post-traumatic Stress Disorders , a consensus panel of 30 international experts , are now based on 510 published r and omized , placebo- or comparator-controlled clinical studies ( RCTs ) and 130 open studies and case reports . First-line treatments for these disorders are selective serotonin reuptake inhibitors ( SSRIs ) , serotonin-noradrenaline reuptake inhibitors ( SNRIs ) and the calcium channel modulator pregabalin . Tricyclic antidepressants ( TCAs ) are equally effective for some disorders , but many are less well tolerated than the SSRIs/SNRIs . In treatment-resistant cases , benzodiazepines may be used when the patient does not have a history of substance abuse disorders . Potential treatment options for patients unresponsive to st and ard treatments are described in this overview . Although these guidelines focus on medications , non-pharmacological were also considered . Cognitive behavioural therapy ( CBT ) and other variants of behaviour therapy have been sufficiently investigated in controlled studies in patients with anxiety disorders , OCD , and PTSD to support them being recommended either alone or in combination with the above medicines Endogenous anxiety ( anxiety hysteria , agoraphobia with panic attacks ) is characterized by sudden , spontaneous panic attacks accompanied by multiple autonomic symptoms , overwhelming fear , a flight response , and polyphobic behavior . Psychotherapy , behavior therapy , and tranquillizers have been of limited success in treating this syndrome . Fifty-seven patients severely disabled by the syndrome for a mean period of 13 years completed the three-month study . R and omly assigned in a double-blind , placebo-controlled design to imipramine hydrochloride , pheneizine sulfate , or placebo , they were seen in supportive group therapy every two weeks . Patients in the pheneizine and imipramine cells showed significant improvement ovehe persistent trend for pheneizine to be superior to imipramine achieved significance only on the Work and Social Disability Scale and the Sympton Severity and Phobic Avoidance Scale . The implication s for classification and theory are discussed BACKGROUND Prominent and persistent anxiety , depression , and /or negative features characterize a substantial minority of recovered or residually psychotic schizophrenic out patients and contribute to poor outcome . Because extrapyramidal side effects of typical neuroleptic medications often resemble such features , we first systematic ally studied the contribution of extrapyramidal side effects to these problems and their treatment . For patients who remained distressed , controlled trials of supplemental thymoleptics were undertaken . METHODS In trial 1 , 92 distressed ( depressed and /or anxious ) patients and 36 patients in a defect state ( patients with negative symptoms ) participated in a double-blind , intramuscular challenge that compared central ly acting benztropine mesylate with peripherally acting glycopyrrolate . In trial 2 , 57 distressed patients and 22 patients in a defect state were r and omly assigned to a double-blind , neuroleptic medication dose-reduction group . In trial 3 , 57 chronically distressed patients who were maintained on a low dose of fluphenazine decanoate  were r and omly assigned to a supplemental desipramine hydrochloride , lithium carbonate , or placebo group under double-blind conditions for 12 weeks . RESULTS For patients who were already maintained on antiparkinsonian medication , impaired affect was not resolved by additional benztropine . Only distressed patients with a family history of severe mental disorder ( often affective ) showed improvement with neuroleptic medication dose reduction . Patients in the defect-state group reported less dysphoria on a reduced neuroleptic medication dose , but negative symptoms persisted . Desipramine improved diverse aspects of mood and residual psychoticism , possibly as a prophylaxis against minor affective exacerbations . Depression improved in women only . Lithium positively affected multiple indexes of anxiety and anxious depression . CONCLUSION Most often , persistent affective impairments are neither resistant extrapyramidal side effects nor characterological traits . Thymoleptics improve the nonphasic , chronic types of anxiety and depression in contrast to the acute , episodic forms , for which little support can be found in the literature Ginkgo biloba special extract EGb 761 , an anti-dementia drug , enhances cognitive functioning and stabilizes mood in cognitively impaired elderly subjects . Moreover , EGb 761 had been found to alleviate symptoms of anxiety in people with mental decline , therefore it was now tested for clinical efficacy in younger patients suffering from anxiety . One hundred and seven patients with generalized anxiety disorder ( GAD , n=82 ) or adjustment disorder with anxious mood ( ADWAM , n=25 ) according to the diagnostic and statistical manual of mental disorders , third edition - revised ( DSM-III-R ) were r and omized to daily doses of 480 mg EGb 761 , 240 mg EGb 761 or placebo for 4 weeks . Intention-to-treat ( ITT ) analyses were performed on the primary outcome measure , the Hamilton rating scale for anxiety ( HAMA ) , and the secondary variables , the clinical global impression of change ( CGI-C ) , the Erlangen anxiety tension and aggression scale ( EAAS ) , the list of complaints ( B-L ' ) , and the patient 's global rating of change . The HAMA total scores decreased by -14.3 ( + /-8.1 ) , -12.1 ( + /-9.0 ) and -7.8 ( + /-9.2 ) in the high-dose EGb 761 , the low-dose EGb 761 and the placebo group , respectively . Changes were significantly different from placebo for both treatment groups with p=0.0003 ( high-dose group ) and p=0.01 ( low-dose ) . Regression analyses revealed a dose-response trend ( p=0.003 ) . EGb 761 was significantly superior to placebo on all secondary outcome measures . It was safe and well tolerated and may thus be of particular value in elderly patients with anxiety related to cognitive decline Benzodiazepines remain widely used for the treatment of anxiety disorders despite prominent , often limiting side effects including sedation , muscle relaxation , and ataxia . A compound producing a robust anxiolytic action comparable to benzodiazepines , but lacking these limiting side effects at therapeutic doses ( an anxioselective agent ) , would represent an important advance in the treatment of generalized anxiety disorder , and perhaps other anxiety disorders . Here we report that the pyrazolo[1,5-a]-pyrimidine , ocinaplon , exhibits an anxioselective profile in both pre clinical procedures and in patients with generalized anxiety disorder , the most common of the anxiety disorders . In rats , ocinaplon produces significant muscle relaxation , ataxia , and sedation only at doses > 25-fold higher than the minimum effective dose ( 3.1 mg/kg ) in the Vogel " conflict " test . This anticonflict effect is blocked by flumazenil ( Ro 15 - 1788 ) , indicating that like benzodiazepines , ocinaplon produces an anxiolytic action through allosteric modulation of GABA(A ) receptors . Nonetheless , in eight recombinant GABA(A ) receptor isoforms expressed in Xenopus oocytes , the potency and efficacy of ocinaplon to potentiate GABA responses varied with subunit composition not only in an absolute sense , but also relative to the prototypical benzodiazepine , diazepam . In a double blind , placebo controlled clinical trial , a 2-week regimen of ocinaplon ( total daily dose of 180 - 240 mg ) produced statistically significant reductions in the Hamilton rating scale for anxiety scores . In this study , the incidence of benzodiazepine-like side effects ( e.g. , sedation , dizziness ) in ocinaplon-treated patients did not differ from placebo . These findings indicate that ocinaplon represents a unique approach both for the treatment and underst and ing of anxiety disorders Abstract Objective . Anxiety disorders are frequently under-diagnosed conditions in primary care , although they can be managed effectively by general practitioners . Methods . This paper is a short and practical summary of the World Federation of Biological Psychiatry ( WFSBP ) guidelines for the pharmacological treatment of anxiety disorders , obsessive – compulsive disorder ( OCD ) and posttraumatic stress disorder ( PTSD ) for the treatment in primary care . The recommendations were developed by a task force of 30 international experts in the field and are based on r and omized controlled studies . Results . First-line pharmacological treatments for these disorders are  selective serotonin reuptake inhibitors  ( for all disorders ) ,  serotonin-norepinephrine reuptake inhibitors  ( for some ) and  pregabalin  ( for generalized anxiety disorder only ) . A combination of  medication and cognitive behavior/exposure therapy  was shown to be a clinical ly desired treatment strategy . Conclusions . This short version of an evidence -based guideline may improve treatment of anxiety disorders , OCD , and PTSD in primary care The past decade has brought major new developments in the psychopharmacologic management of generalized anxiety disorder and social phobia . We examined medication-prescribing patterns for the treatment of these anxiety disorders for 12 years to assess changes in patients ' anti-anxiety psychotropic medication usage during that period of evolving practice guidelines . We examined psychotropic medication use in 305 patients with generalized anxiety disorder and 232 with social phobia enrolled in the Harvard/Brown Anxiety Disorders Research Project ( HARP ) , a prospect i ve , longitudinal study of anxiety disorders .  Psychotropic treatment patterns seem to have remained relatively stable over 12 years with benzodiazepines the medications most commonly used for both generalized anxiety disorder and social phobia . Comparatively , selective serotonin reuptake inhibitor ( SSRI ) and venlafaxine usage as st and -alone medications for these disorders remained low throughout the follow-up period . At the 12-year follow-up , 24 % of patients with generalized anxiety disorder and 30 % of patients with social phobia were utilizing neither an  SSRI/selective norepinephrine reuptake inhibitor ( SNRI ) nor a benzodiazepine . Treatment recommendations for use of SSRIs and venlafaxine in the management of generalized anxiety disorder and social phobia initially promulgated in 1998 had a modest impact on changes in psychopharmacologic practice 4 - 5 years later . Difficulties in the implementation of treatment guidelines are discussed Background Generalised anxiety disorder ( GAD ) is a high prevalence , chronic psychiatric disorder which commonly presents early in the lifespan . Internet e-health applications have been found to be successful in reducing symptoms of anxiety and stress for post traumatic stress disorder ( PTSD ) , panic disorder , social phobia and depression . However , to date , there is little evidence for the effectiveness of e-health applications in adult GAD . There are no studies which have directly compared e-health applications with recognised evidence -based medication . This study aims to determine the effectiveness of a  web-based program for treating GAD relative to sertraline and attention placebo . Methods / Design 120 community-dwelling participants , aged 18 - 30 years with a clinical diagnosis of GAD will be recruited from the Australian Electoral Roll . They will be r and omly allocated to one of three conditions : ( i ) an online treatment program for GAD , E-couch ( ii ) pharmacological treatment with a selective serotonin re-uptake inhibitor ( SSRI ) , sertraline ( a fixed-flexible dose of 25 - 100 mg/day ) or ( iii ) an attention control placebo , HealthWatch . The treatment program will be completed over a 10 week period with a 12 month follow-up . Discussion As of February 2010 , there were no registered trials evaluating the effectiveness of an e-health application for GAD for young adults . Similarly to date , this will be the first trial to compare an e-health intervention with a pharmacological treatment . Trial Registration Current Controlled Trials IS RCT OBJECTIVE Depression is a common disorder among diabetic patients and affects negatively the treatment of their basic disease . The aim of the study was to assess , whether antidepressant medication could positively influence glycemic control of diabetes type 1 in depressive or anxious patients . METHODS A six-month , double-blinded , r and omized , placebo-controlled study was performed to investigate the reaction of type 1diabetic patients ( n=21 ) to treatment of depression and anxiety symptoms using antidepressant drug sertraline . The patients were given sertraline ( 100 mg/day ) or placebo . The evolution of mental change was assessed using Zung Self-Rating Depression Scale ( SDS ) , Hamilton Anxiety Rating Scale ( HAMA ) and Hamilton Depression Rating Scale ( HAMD ) along with development of somatic parameters commonly assessed in diabetic patients , especially glycosylated hemoglobin , insulin dose and body weight . The level of active substance in serum of the patients was also measured . RESULTS Mental state improved at the level of statistical significance of p<0.001 in both patients using antidepressant and placebo . From somatic parameters , body weight and systolic blood pressure increased statistically significantly also in both groups of patients . CONCLUSIONS The mental state of most patients who successfully completed the study improved regardless of the fact if they were using antidepressant or placebo . No statistically significant connections between the mental and somatic changes were found . This finding points out to the placebo effect of the medication , to the importance of a contact with patients , but also to the need to concentrate on their mental state Background Generalised anxiety disorder ( GAD ) is a chronic and pervasive condition that generates high levels of psychological stress , and it is difficult to treat in the long term . Current pharmacotherapeutic options for GAD are in some cases only modestly effective , and may elicit undesirable side effects . Through targeted actions on the gamma-aminobutyric acid ( GABA ) pathway , the South Pacific medicinal plant kava ( Piper methysticum ) is a non-addictive , non-hypnotic anxiolytic with the potential to treat GAD . The evidence for the efficacy of kava for treating anxiety has been affirmed through clinical trials and meta-analyses . Recent research has also served to lessen safety concerns regarding the use of kava due to hepatotoxic risk , which is reflected in a recent German court overturning the previous kava ban in that country ( which may in turn influence a reinstatement by the European Union ) . The aim of current research is to assess the efficacy of an ‘ aqueous noble cultivar rootstock extract ’ of kava in GAD in a larger longer term study . In addition , we plan to investigate the pharmacogenomic influence of GABA transporters on response , effects of kava on gene expression , and for the first time , the neurobiological correlates of treatment response via functional and metabolic imaging . Methods / Design This clinical trial is funded by the Australian National Health and Medical Research Council ( APP1063383 ) and co-funded by MediHerb ( Integria Healthcare ( Australia ) Pty . Ltd ) . The study is a phase III , multi-site , two-arm , 18-week , r and omised , double-blind , placebo-controlled study using an aqueous extract of noble kava cultivar ( st and ardised to 240 mg of kavalactones per day ) versus matching placebo in 210 currently anxious participants with diagnosed GAD who are non-medicated . The study takes place at two sites : the Centre for Human Psychopharmacology ( Swinburne University of Technology ) , Hawthorn , Melbourne , Australia ; and the Academic Discipline of Psychiatry ( The University of Queensl and ) based at the Royal Brisbane and Women ’s Hospital , Herston , Brisbane , Australia . Written informed consent will be obtained from each participant prior to commencement in the study . The primary outcome is the Structured Interview Guide for the Hamilton Anxiety Rating Scale ( SIGH-A ) . The secondary outcomes involve a range of scales that assess affective disorder symptoms and quality of life outcomes , in addition to the study of mediating biomarkers of response ( assessed via genomics and neuroimaging ) . Discussion If this study demonstrates positive findings in support of the superiority of kava over placebo in the treatment of GAD , and also is shown to be safe , then this plant-medicine can be considered a ’ first-line ‘ therapy for GAD . Genomic and neuroimaging data may reveal clinical response patterns and provide more evidence of the neurobiological activity of the plant extract . Trial Registration Information Clinical Trials.gov : NCT02219880 Date : 13 August 2014 Generalized Social Anxiety Disorder ( SAD ) is one of the most common anxiety conditions with impairment in social life . Cannabidiol ( CBD ) , one major non-psychotomimetic compound of the cannabis sativa plant , has shown anxiolytic effects both in humans and in animals . This preliminary study aim ed to compare the effects of a simulation public speaking test ( SPST ) on healthy control ( HC ) patients and treatment-naïve SAD patients who received a single dose of CBD or placebo .  A total of 24 never-treated patients with SAD were allocated to receive either CBD ( 600 mg ; n=12 ) or placebo ( placebo ; n=12 ) in a double-blind r and omized design 1 h and a half before the test . The same number of HC ( n=12 ) performed the SPST without receiving any medication . Each volunteer participated in only one experimental session in a double-blind procedure . Subjective ratings on the Visual Analogue Mood Scale ( VAMS ) and Negative Self-Statement scale ( SSPS-N ) and physiological measures ( blood pressure , heart rate , and skin conductance ) were measured at six different time points during the SPST . The results were su bmi tted to a repeated- measures analysis of variance . Pretreatment with CBD significantly reduced anxiety , cognitive impairment and discomfort in their speech performance , and significantly decreased alert in their anticipatory speech . The placebo group presented higher anxiety , cognitive impairment , discomfort , and alert levels when compared with the control group as assessed with the VAMS . The SSPS-N scores evidence d significant increases during the testing of placebo group that was almost abolished in the CBD group . No significant differences were observed between CBD and HC in SSPS-N scores or in the cognitive impairment , discomfort , and alert factors of VAMS . The increase in anxiety induced by the SPST on subjects with SAD was reduced with the use of CBD , result ing in a similar response as the HC OBJECTIVE Bipolar disorder often co-occurs with anxiety disorders . Evidence suggests that second-generation antipsychotics ( SGAs ) may be useful in treating both conditions . This study examined the efficacy of ziprasidone in the treatment of these disorders . METHOD This 3-site , r and omized , double-blind , placebo-controlled , parallel group , 8-week trial of ziprasidone monotherapy examined 49 subjects with bipolar disorder and lifetime panic disorder ( with or without agoraphobia ) or generalized anxiety disorder ( GAD ) experiencing moderately severe anxiety symptoms at entrance into the study . Both bipolar disorder and anxiety diagnoses were based on DSM-IV-TR criteria . Patients were screened and r and omized from June 25 , 2010 , through August 23 , 2011 . Primary outcome measures were the Clinical Global Impressions-21 Anxiety Scale ( CGI-21 Anxiety ) and the Sheehan Disability Scale ( SDS ) , with secondary measures monitoring anxiety and mood symptoms . RESULTS Last-observation-carried-forward analyses demonstrated that patients in the ziprasidone group did not improve significantly more than those in the placebo group on the CGI-21 Anxiety ( F1 = 0.34 ; P = .564 ) or SDS ( F1 = 0.26 ; P = .611 ) . Secondary analysis using hierarchical linear modeling found similar results ( CGI-21 Anxiety : F1 = 1.82 ; P = .178 ; and SDS : F1 = 0.70 ; P = .408 ) . Regardless of group , time in the study was associated with significant decrease in anxiety ( F1 = 11.08 ; P = .001 ) and total disability ( F1 = 26.16 ; P < .001 ) . Patients in the ziprasidone group showed a greater increase in abnormal involuntary movement , and 81.8 % ( n = 9 ) of the subjects who withdrew from the study due to adverse events , serious adverse events , or side effects were in the ziprasidone group . CONCLUSIONS Results suggest that ziprasidone monotherapy was not associated with a clinical ly significant improvement in anxiety symptoms or improved function for patients with bipolar disorder , lifetime panic disorder or GAD , and concurrent moderately severe anxiety symptoms , and it was associated with a more negative side-effect profile relative to placebo . TRIAL REGISTRATION Clinical Trials.gov identifier : NCT01172652 Eighty-six participants wishing to stop benzodiazepine and who met DSM-IV ( Diagnostic and Statistical Manual of Mental Disorders , 4th ed . American Psychological Association , 1994 ) criteria for anxiety disorder or insomnia were assessed pre- and post-taper on clinical , pharmacological and psychosocial measures . An initial cohort of 41 participants received treatment as usual ( taper only ) plus physician counselling in the same clinic setting . A second cohort of 45 participants were r and omly allocated to group cognitive-behavioural therapy ( CBT ) plus taper , or group support ( GS ) plus taper . At 3 months follow-up , the outcomes in both the CBT and the GS subgroups were equivalent . Intention to treat analysis revealed a slight advantage to the CBT over the GS group and the CBT group showed higher self-efficacy post-taper . Over all 86 participants , a high-baseline level of psychological distress , anxiety and dosage predicted a poor outcome , but increase in self-efficacy contributed to a successful outcome particularly in those with initially poor baseline predictors . Although there was a decrease in positive affect during preliminary stages of tapered discontinuation compared to baseline , there was no significant overall increase in negative affect There is mounting evidence that low levels of n-3 polyunsaturated fatty acids ( PUFAs ) play a role in the pathophysiology of a number of psychiatric disorders . Pre clinical studies have shown that n-3 PUFAs decrease anxietylike behaviors , but there is a paucity of information about their effects on anxiety in humans . In light of our observation that substance abusers have poor dietary habits and the strong association between anxiety disorders and substance use disorders , the possibility that the administration of supplements of n-3 PUFAs would decrease the anxiety level of a group of substance abusers was explored . Thirteen patients were given on a daily basis capsules containing 3 g of n-3 PUFAS ( eicosapentaenoic acid + docosahexaenoic acid ) . Eleven patients received similarly looking placebo capsules containing vegetable oil . The trial was double-blind , r and omized , and lasted 3 months . A scale assessing anxiety feelings was administered at baseline and on a monthly basis thereafter . Six PUFA group patients and 8 placebo group patients were followed for an additional 3 months after treatment discontinuation and administered the same question naire monthly . Patients who received n-3 PUFAs for 3 months showed a progressive decline in anxiety scores . This was not the case for patients who received placebos . A comparison of the 2 groups was significant ( P = 0.010 ) . Anxiety scores remained significantly decreased in the PUFA group for 3 months after treatment discontinuation . A comparison of the 2 groups followed for 6 months was also significant ( P = 0.042 ) . In conclusion , these preliminary data indicate that n-3 PUFA supplementation could be beneficial in the treatment of some patients with anxiety disorders Background Anxiety is a serious personal health condition and represents a substantial burden to overall quality of life . Additionally anxiety disorders represent a significant cost to the health care system as well as employers through benefits coverage and days missed due to incapacity . This study sought to explore the effectiveness of naturopathic care on anxiety symptoms using a r and omized trial . Methods Employees with moderate to severe anxiety of longer than 6 weeks duration were r and omized based on age and gender to receive naturopathic care ( NC ) ( n = 41 ) or st and ardized psychotherapy intervention ( PT ) ( n = 40 ) over a period of 12 weeks . Blinding of investigators and participants during r and omization and allocation was maintained . Participants in the NC group received dietary counseling , deep breathing relaxation techniques , a st and ard multi-vitamin , and the herbal medicine , ashwag and ha ( Withania somnifera ) ( 300 mg b.i.d . st and ardized to 1.5 % withanolides , prepared from root ) . The PT intervention received psychotherapy , and matched deep breathing relaxation techniques , and placebo . The primary outcome measure was the Beck Anxiety Inventory ( BAI ) and secondary outcome measures included the Short Form 36 ( SF-36 ) , Fatigue Symptom Inventory ( FSI ) , and Measure Yourself Medical Outcomes Profile ( MY-MOP ) to measure anxiety , mental health , and quality of life respectively . Participants were blinded to the placebo-controlled intervention . Results Seventy-five participants ( 93 % ) were followed for 8 or more weeks on the trial . Final BAI scores decreased by 56.5 % ( p<0.0001 ) in the NC group and 30.5 % ( p<0.0001 ) in the PT group . BAI group scores were significantly decreased in the NC group compared to PT group ( p = 0.003 ) . Significant differences between groups were also observed in mental health , concentration , fatigue , social functioning , vitality , and overall quality of life with the NC group exhibiting greater clinical benefit . No serious adverse reactions were observed in either group . Relevance Many patients seek alternatives and /or complementary care to conventional anxiety treatments . To date , no study has evaluated the potential of a naturopathic treatment protocol to effectively treat anxiety . Knowledge of the efficacy , safety or risk of natural health products , and naturopathic treatments is important for physicians and the public in order to make informed decisions . Interpretation Both NC and PT led to significant improvements in patients ' anxiety . Group comparison demonstrated a significant decrease in anxiety levels in the NC group over the PT group . Significant improvements in secondary quality of life measures were also observed in the NC group as compared to PT . The whole system of naturopathic care for anxiety needs to be investigated further including a closer examination of the individual components within the context of their additive effect . Trial Registration Controlled-Trials.com IS RCT
Collectively , the literature reveals pre clinical and clinical evidence for various phytomedicines modulating GABA-pathways , with comparative anxiolytic effect to the current array of pharmaceuticals , along with good safety and tolerability profiles
Anxiety disorders are chronic and functionally disabling conditions with high psychological stress , characterised by cognitive symptoms of excessive worry and focus difficulties and physiological symptoms such as muscle tension and insomnia .
Gamma-aminobutyric acid ( GABA ) is an inhibitory neurotransmitter within the central nervous system and is a key target of pharmacotherapies in the treatment of anxiety .
Although current pharmaceutical treatments are often efficacious , they may cause undesirable side effects including cognitive decrements and withdrawal symptoms .
Plant-based " phytomedicines " may provide novel treatment options , to act as an adjunctive or alternative to existing anxiolytic medications .
As such , we conducted a systematic review to assess the current body of literature on anxiolytic phytomedicines and /or phytoconstituents .