Homeopathic prophylaxis of headaches and migraine? A systematic review. The methodological quality of randomized controlled trials of homeopathy, herbal medicines and acupuncture. World Federation of Societies of Biological Psychiatry (WFSBP) Guidelines for Biological Treatment of Unipolar Depressive Disorders, Part 1: Update 2013 on the acute and continuation treatment of unipolar depressive disorders A systematic review of anxiety interventions in stroke and acquired brain injury: Efficacy and trial design The feasibility of a randomised, placebo-controlled clinical trial of homeopathic treatment of depression in general practice. Valerian for insomnia: a systematic review of randomized clinical trials. Homeopathy and conventional medicine: an outcomes study comparing effectiveness in a primary care setting. Guidelines for randomized clinical trial protocol content: a systematic review Yoga on Our Minds: A Systematic Review of Yoga for Neuropsychiatric Disorders Acupuncture for the Treatment of Opiate Addiction The clinical effectiveness of different parenting programmes for children with conduct problems: a systematic review of randomised controlled trials A systematic review of online interventions for mental health in low and middle income countries: a neglected field Assessing the evidence for the use of chiropractic manipulation in paediatric health conditions: A systematic review. A Systematic Review of the Effect of Expectancy on Treatment Responses to Acupuncture Cost-effectiveness of interventions to control cardiovascular diseases and type 2 diabetes mellitus in South Asia: protocol for a systematic review A Double-Blind Randomized Placebo-Controlled Pilot Study of Neuropsychiatric Adverse Events in Abstinent Smokers Treated with Varenicline or Placebo
Homeopathy is often advocated as a prophylaxis of  migraine and headaches .  The aim of this systematic review was to evaluate the clinical trials , testing the efficacy of homeopathy for these indications . Independent computerized literature search es were carried out in 4 data bases . Only r and omized , placebo-controlled trials were included . Four such studies were found . Their method ological quality was variable but , on average , satisfactory . One study suggested that homeopathic remedies were effective . The other , method ologically stronger trials did not support this notion . It is concluded that the trial data available to date do not suggest that homeopathy is effective in the prophylaxis of  migraine or headache  beyond a placebo effect BACKGROUND To investigate the method ological quality of r and omized controlled trials in three areas of complementary medicine . METHODS The method ological quality of 207 r and omized trials collected for five previously published systematic review s on homeopathy , herbal medicine  ( Hypericum for depression , Echinacea for common cold ) , and acupuncture ( for asthma and chronic headache ) was assessed using a vali date d scale ( the Jadad scale ) and single quality items . RESULTS While the method ological quality of the trials was highly variable , the majority had important shortcomings in reporting and /or methodology . Major problems in most trials were the description of allocation concealment and the reporting of drop-outs and withdrawals . There were relevant differences in single quality components between the different complementary therapies : For example , acupuncture trials reported adequate allocation concealment less often ( 6 % versus 32 % of homeopathy and 26 % of herb trials ) , and trials on herbal extracts had better summary scores ( mean score 3.12 versus 2.33 for homeopathy and 2.19 for acupuncture trials ) . Larger trials published more recently in journals listed in Medline and in English language scored significantly higher than trials not meeting these criteria . CONCLUSION Trials of complementary therapies often have relevant method ological weaknesses . The type of weaknesses varies considerably across interventions Abstract Objectives . This 2013 up date of the practice guidelines for the biological treatment of unipolar depressive disorders was developed by an international Task Force of the World Federation of Societies of Biological Psychiatry ( WFSBP ) . The goal has been to systematic ally review all available evidence pertaining to the treatment of unipolar depressive disorders , and to produce a series of practice recommendations that are clinical ly and scientifically meaningful based on the available evidence . The guidelines are intended for use by all physicians seeing and treating patients with these conditions . Methods . The 2013 up date was conducted by a systematic up date literature search and appraisal . All recommendations were approved by the Guidelines Task Force . Results . This first part of the guidelines ( Part 1 ) covers disease definition , classification , epidemiology , and course of unipolar depressive disorders , as well as the management of the acute and continuation phase treatment . It is primarily concerned with the biological treatment ( including antidepressants , other psychopharmacological medications , electroconvulsive therapy , light therapy , adjunctive and novel therapeutic strategies ) of adults . Conclusions . To date , there is a variety of evidence -based antidepressant treatment options available . Nevertheless there is still a substantial proportion of patients not achieving full remission . In addition , somatic and psychiatric comorbidities and other special circumstances need to be more thoroughly investigated . Therefore , further high- quality informative r and omized controlled trials are urgently needed Objective There is little r and omized controlled trial ( RCT ) evidence to guide treatment for anxiety after stroke . We systematic ally review ed RCTs of anxiety interventions in acquired brain injury ( ABI ) conditions including stroke and traumatic brain injury ( TBI ) in order to summarize efficacy and key aspects of trial design to help guide future RCTs . Methods We search ed the Cochrane trial register , Medline , Embase , PsychInfo and CINAHL systematic ally up to August 2017 . Two independent review ers systematic ally selected studies and extracted data . We summarized the effect size , key study characteristics and sources of potential bias in trial design . Results 14 studies ( 12 stroke ; one stroke & TBI ; one TBI ) with 928 participants were included . Meta- analysis of five psychotherapy comparisons favoured intervention over control ( st and ardized mean difference ( SMD ) : − 0.41 [ − 0.79 , − 0.03 ] , I2 = 28 % ) ; Overall effect size of pharmacotherapy comparisons favoured intervention over control ( SMD : − 2.12 [ − 3.05 , − 1.18 ] , I2 = 89 % ) . One comparison of mixed pharmacotherapy and psychotherapy favoured intervention over usual care ( SMD : − 4.79 [ − 5.87 , − 3.71 ] ) . One comparison favoured  forest therapy versus urban control ( SMD : − 2.00 [ − 2.59 , − 1.41 ] ) . All positive studies carried high or unclear risk of bias . Sample sizes were small in all included studies . Conclusions There is low quality evidence to suggest that psychotherapy and pharmacotherapy may be effective interventions in the treatment of anxiety after stroke based on underpowered studies that carried high risk of bias . Large-scale well- design ed definitive trials are needed to establish whether pharmacological or psychotherapy works . Our review highlighted key considerations for investigators wishing to design high quality trials to evaluate treatments for anxiety after stroke UNLABELLED Depression is common in general practice and lack of concordance is an important problem in its treatment . Homeopathy has few side effects and is generally associated with good compliance . We report a study investigating the feasibility of a trial to compare the effectiveness of homeopathy with a conventional antidepressant and placebo . OBJECTIVES To assess the feasibility of a general practice -based clinical trial comparing the effectiveness of individualised homeopathic treatment vs Fluoxetine ( Prozac ) vs placebo in the treatment of major depressive episodes of moderate severity . DESIGN R and omised , double-dummy , double-blind parallel group clinical trial . SETTING Lower Clapton Group Practice , East London . METHOD Patients were recruited through their general practitioners as they presented during a 9 month period . Recruitment target was 30 patients . Eligibility was confirmed by a consultant psychiatrist using st and ard criteria ( DSM-IV ) and instruments Hamilton Depression Scale ( HAMD ) . Suicidal and psychotic patients were excluded , additional pre caution s against suicide were incorporated . There was a 1 week run-in period and patients showing spontaneous improvement were excluded . Homeopathic treatment was prescribed by a GP qualified in homeopathy , from a ' limited list ' of 30 homeopathic medicines , with the help of decision support software . Patients were r and omised to receive verum Fluoxetine and placebo homeopathy , or verum homeopathy and placebo Fluoxetine , or placebo homeopathy and placebo Fluoxetine . Treatment duration was 12 weeks . The outcomes were : adverse drug reactions , clinical global impression ( CGI ) ; HAMD ; mini international psychiatric Interview ; Pittsburgh sleep quality index ; Side-effects checklist ; Short Form 12 ; treatment credibility question naire ; work and social disability scale . The primary outcome measures were HAMD and CGI . RESULTS A recruitment calculation indicated that over 230 suitable patients would be expected to attend the practice during the recruitment phase . Thirty one patients were referred for possible inclusion in the trial by their GPs . Twenty three met the entry criteria , 11 were r and omised and 6 completed the study . Of the completers , one received homeopathy , 2 placebo and 3 Fluoxetine . CONCLUSIONS A trial of this design in general practice is not feasible , because of recruitment difficulties , many of them linked to patient preference . Different approaches are required to recruit adequate patient numbers to trials of this sort Objective : To systematic ally review the evidence for the effects of the herb valerian ( Valeriana officinalis ) on  insomnia  , based on r and omized , placebo-controlled , double-blind trials . Background : Valerian has long been advocated and used for promoting sleep but until quite recently evidence was solely anecdotal . However , during the last two decades a number of clinical trials have been conducted . Material s and methods : Systematic literature search es were performed to locate r and omized , placebo-controlled , double-blind trials measuring the effect of  valerian monopreparations on sleep in human participants . Data were extracted in a st and ardized manner and method ological quality was assessed by the Jadad score . Results : Nine trials were located meeting the selection criteria . The findings of the studies were contradictory and there was great inconsistency between trials in terms of patients , experimental design and procedures and method ological quality . Conclusion : The evidence for valerian as a treatment for  insomnia  is inconclusive . There is a need for rigorous trials to determine its efficacy BACKGROUND Recent meta-analyses of r and omized controlled trials in homeopathy have suggested that homeopathy is more than a placebo response . OBJECTIVE Comparison of the effectiveness of homeopathy in primary care with conventional medicine in primary care for three commonly encountered clinical conditions . DESIGN An international multicenter , prospect i ve , observational study in a real world medical setting comparing the effectiveness of homeopathy with conventional medicine . PARTICIPANTS Thirty ( 30 ) investigators with conventional medical licenses at six clinical sites in four countries enrolled 500 consecutive patients with at least one of the following three complaints : ( 1 ) upper respiratory tract complaints including allergies ; ( 2 ) lower respiratory tract complaints including allergies ; or ( 3 ) ear complaints . MAIN OUTCOME MEASURES The primary outcomes criterion was the response to treatment , defined as cured or major improvement after 14 days of treatment . Secondary outcomes criteria were : ( 1 ) rate of recovery ; ( 2 ) occurrence of adverse events ; ( 3 ) patient satisfaction ; and ( 4 ) length of consultation . RESULTS Four hundred and fifty-six ( 456 ) patient visits were compared : 281 received homeopathy  , 175 received conventional medicine .  The response to treatment as measured by the primary outcomes criterion for patients receiving homeopathy was 82.6 % , for conventional medicine it was 68 % . Improvement in less than 1 day and in 1 to 3 days was noted in 67.3 % of the group receiving homeopathy and in 56.6 % of those receiving conventional medicine . The adverse events for those treated with conventional medicine was 22.3 % versus 7.8 % for those treated with homeopathy . Seventy-nine percent ( 79.0 % ) of patients treated with homeopathy were very satisfied and 65.1 % of patients treated with conventional , medicine were very satisfied . In both treatment groups 60 % of cases had consultations lasting between 5 and 15 minutes . CONCLUSIONS Homeopathy appeared to be at least as effective as conventional medical care in the treatment of patients with the three conditions studied Background All r and omized clinical trials ( RCTs ) require a protocol ; however , numerous studies have highlighted protocol deficiencies . Reporting guidelines may improve the content of research reports and , if developed using robust methods , may increase the utility of reports to stakeholders . The objective of this study was to systematic ally identify and review RCT protocol guidelines , to assess their characteristics and methods of development , and to compare recommendations . Methods We conducted a systematic review of indexed literature ( MEDLINE , EMBASE and the Cochrane Methodology Register from inception to September 2010 ; reference lists ; related article features ; forward citation search ing ) and a targeted search of supplementary sources , including a survey of major trial funding agencies in six countries . Records were eligible if they described a content guideline in English or French relevant to RCT protocol s. Guidelines were excluded if they specified content for protocol s for trials of specific procedures or conditions or were intended to assess trial quality . We extracted guideline characteristics and methods . Content was mapped for a subset of guidelines that described development methods or had institutional endorsement . Results Forty guidelines published in journals , books and institutional reports were included in the review ; seven were specific to RCT protocol s. Only eight ( 20 % ) described development methods which included informal consensus methods , pilot testing and formal validation ; no guideline described all of these methods . No guideline described formal consensus methods or a systematic retrieval of empirical evidence to inform its development . The guidelines included a median of 23 concepts per guideline ( interquartile range ( IQR ) = 14 to 34 ; range = 7 to 109 ) . Among the subset of guidelines ( n = 23 ) for which content was mapped , approximately 380 concepts were explicitly addressed ( median concepts per guideline IQR = 31 ( 24,80 ) ; range = 16 to 150 ) ; most concepts were addressed in a minority of guidelines . Conclusions Existing guidelines for RCT protocol content varied substantially in their recommendations . Few reports described the methods of guideline development , limiting comparisons of guideline validity . Given the importance of protocol s to diverse stakeholders , we believe a systematic ally developed , evidence -informed guideline for clinical trial protocol s is needed Background : The dem and for clinical ly efficacious , safe , patient acceptable , and cost-effective forms of treatment for mental illness is growing . Several studies have demonstrated benefit from yoga in specific psychiatric symptoms and a general sense of well-being . Objective : To systematic ally examine the evidence for efficacy of yoga in the treatment of selected major psychiatric disorders . Methods : Electronic search es of The Cochrane Central Register of Controlled Trials and the st and ard bibliographic data bases , MEDLINE , EMBASE , and PsycINFO , were performed through April 2011 and an up date d in June 2011 using the keywords yoga AND psychiatry OR depression OR anxiety OR schizophrenia OR cognition OR memory OR attention AND r and omized controlled trial ( RCT ) . Studies with yoga as the independent variable and one of the above mentioned terms as the dependent variable were included and exclusion criteria were applied . Results : The search yielded a total of 124 trials , of which 16 met rigorous criteria for the final review . Grade B evidence supporting a potential acute benefit for yoga exists in depression ( four RCTs ) , as an adjunct to pharmacotherapy in schizophrenia ( three RCTs ) , in children with ADHD ( two RCTs ) , and Grade C evidence in sleep complaints ( three RCTs ) . RCTs in cognitive disorders and eating disorders yielded conflicting results . No studies looked at primary prevention , relapse prevention , or comparative effectiveness versus pharmacotherapy . Conclusion : There is emerging evidence from r and omized trials to support popular beliefs about yoga for depression , sleep disorders , and as an augmentation therapy . Limitations of literature include inability to do double-blind studies , multiplicity of comparisons within small studies , and lack of replication . Biomarker and neuroimaging studies , those comparing yoga with st and ard pharmaco- and psychotherapies , and studies of long-term efficacy are needed to fully translate the promise of yoga for enhancing mental health Acupuncture is an accepted treatment worldwide for various clinical conditions , and the effects of acupuncture on opiate addiction have been investigated in many clinical trials . The present review systematic ally analyzed data from r and omized clinical trials published in Chinese and English since 1970 . We found that the majority agreed on the efficacy of acupuncture as a strategy for the treatment of opiate addiction . However , some of the methods in several included trials have been criticized for their poor quality . This review summarizes the quality of the study design , the types of acupuncture applied , the commonly selected acupoints or sites of the body , the effectiveness of the treatment , and the possible mechanism underlying the effectiveness of acupuncture  in these trials Background Conduct problems are common , disabling and costly . The prognosis for children with conduct problems is poor , with outcomes in adulthood including criminal behaviour , alcoholism , drug abuse , domestic violence , child abuse and a range of psychiatric disorders . There has been a rapid expansion of group based parent-training programmes for the treatment of children with conduct problems  in a number of countries over the past 10 years . Existing review s of parent training have method ological limitations such as inclusion of non-r and omised studies , the absence of investigation for heterogeneity prior to meta- analysis or failure to report confidence intervals . The objective of the current study was to systematic ally review r and omised controlled trials of parenting programmes for the treatment of children with conduct problems .  Methods St and ard systematic review methods were followed including duplicate inclusion decisions , data extraction and quality assessment . Twenty electronic data bases from the fields of medicine , psychology , social science and education were comprehensively search ed for RCTs and systematic review s to February 2006 . Inclusion criteria were : r and omised controlled trial ; of structured , repeatable parenting programmes ; for parents/carers of children up to the age of 18 with a conduct problem ; and at least one measure of child behaviour . Meta- analysis and qualitative synthesis were used to summarise included studies . Results 57 RCTs were included . Studies were small with an average group size of 21 . Meta-analyses using both parent ( SMD -0.67 ; 95 % CI : -0.91 , -0.42 ) and independent ( SMD -0.44 ; 95 % CI : -0.66 , -0.23 ) reports of outcome showed significant differences favouring the intervention group . There was insufficient evidence to determine the relative effectiveness of different approaches to delivering parenting programmes . Conclusion Parenting programmes are an effective treatment for children with conduct problems . The relative effectiveness of different parenting programmes requires further research Background . Low and middle income countries ( LMICs ) are facing an increase of the impact of mental health problems while confronted with limited re sources and limited access to mental health care , known as the ‘ mental health gap ’ . One strategy to reduce the mental health gap would be to utilize the internet to provide more widely-distributed and low cost mental health care . We undertook this systematic review to investigate the effectiveness and efficacy of online interventions in LMICs . Methods . We systematic ally search ed the data -bases PubMed , PsycINFO , JMIR , and additional sources . MeSH terms , Thesaurus , and free text keywords were used . We included all r and omized controlled trials ( RCTs ) of online interventions in LMICs . Results . We found only three articles reported results of RCTs on  online interventions for mental health conditions in LMICs , but none of these interventions was compared with an active control condition . Also , the mental health conditions were diverse across the three studies . Conclusions . There is a dearth of studies examining the effect of online interventions  in LMICs , so we can not draw a firm conclusion on its effectiveness . However , given the effectiveness of  online interventions in high income countries and sharp increase of internet access in LMICs , online interventions may offer a potential to help reduce the ‘ mental health gap ’ . More studies are urgently needed in LMICs OBJECTIVE To review the biomedical literature up to and including 2003 , and determine the extent of the evidence related to the therapeutic application of chiropractic manipulation for paediatric health conditions . No critical appraisal of the evidence is undertaken . DATA SOURCES The indexed manual therapy sector including medical , chiropractic , physiotherapy , naturopathic and osteopathic literature was search ed . This included PubMed ; the Manual , Alternative , and Natural Therapy Index System ; the Cumulative Index to Nursing and Allied Health Literature ; the Index to Chiropractic Literature ; the Paediatric Economic Data base Evaluation Project ; the Cochrane Library ; the Canadian Coordinating Office for Health Technology Assessment data base ; and the Agency for Healthcare Research and Quality data base . Other re sources included research conference and symposium proceedings , and the references of identified studies . RESULT The search identified 1731 articles , of which 166 met the eligibility criteria . Two review ers determined by consensus each citation 's appropriate level on the strength of evidence scale . There was one systematic review , nine r and omized controlled trials , one observational study , 141 descriptive case studies and 14 conference abstract s. SUMMARY Health cl aims made by practitioners regarding the application of chiropractic manipulation as a health care intervention for paediatric health conditions are , for the most part , supported by low levels of scientific evidence . Chiropractors , in particular , employ manipulation for the treatment of a wide variety of paediatric health conditions . The evidence rests primarily with clinical experience , descriptive case studies and a few r and omized controlled trials . There is a need for more rigorous scientific inquiry to examine the value of manipulative therapy in the treatment of paediatric conditions . To advance the health interests of paediatric patients , health care decisions made on the basis of expert opinion or clinical experience must integrate the best research evidence available from high- quality , scientific studies R and omised controlled trials ( RCTs ) of acupuncture often find equivalent responses to real and placebo acupuncture despite both appearing superior to no treatment . This raises questions regarding the mechanisms of acupuncture , especially the contribution of patient expectancies . We systematic ally review ed previous research assessing the relationship between expectancy and treatment responses following acupuncture , whether real or placebo . To be included , studies needed to assess and /or manipulate expectancies about acupuncture and relate these to at least one health-relevant outcome . Nine such independent studies were identified through systematic search es of Medline , PsycInfo , PubMed , and Cochrane Clinical Trials Register . The methodology and reporting of these studies were quite heterogeneous , meaning that meta- analysis was not possible . A descriptive review revealed that five studies found statistically significant effects of expectancy on a least one outcome , with three also finding evidence suggestive of an interaction between expectancy and type of acupuncture ( real or placebo ) . While there were some trends in significant effects in terms of study characteristics , their generality is limited by the heterogeneity of study design s. The differences in design across studies highlight some important method ological considerations for future research in this area , particularly regarding whether to assess or manipulate expectancies and how best to assess expectancies Introduction While a number of strategies are being implemented to control cardiovascular diseases ( CVDs ) and type 2 diabetes mellitus ( T2DM ) , the cost-effectiveness of these in the South Asian context has not been systematic ally evaluated . We aim to systematic ally review the economic ( cost-effectiveness ) evidence available on the individual- , group- and population -level interventions for control of CVD and T2DM in South Asia . Methods and analysis This review will consider all relevant economic evaluations , either conducted alongside r and omised controlled trials or based on decision modelling estimates . These studies must include participants at risk of developing CVD/T2DM or with established disease in one or more of the South Asian countries ( India , Bangladesh , Pakistan , Sri Lanka , Nepal , Maldives , Bhutan and Afghanistan ) . We will identify relevant papers by systematic ally search ing all major data bases and registries . Selected articles will be screened by two independent research ers . Method ological quality of the studies will be assessed using a modified Drummond and a Phillips checklist . Cochrane guidelines will be followed for bias assessment in the effectiveness studies . Results Results will be presented in line with the PRISMA ( Preferred Reporting Items for Systematic review and Meta- analysis ) checklist , and overall quality of evidence will be presented as per the GRADE ( Grade s of Recommendation , Assessment , Development and Evaluation ) approach . Ethics and dissemination The study has received ethics approval from the All India Institute of Medical Sciences , New Delhi , India . The results of this review will provide policy-relevant recommendations for the uptake of cost-effectiveness evidence in prioritising decisions on essential chronic disease care packages for South Asia . Study registration number PROSPERO CRD42013006479 BACKGROUND Varenicline is an α4β2 partial nicotinic agonist approved for smoking cessation . There have been spontaneous postmarketing reports of neuropsychiatric adverse events ( NPAEs ) in smokers without a history of psychiatric illness quitting with varenicline . METHODS One hundred ten smokers without history of psychiatric illness ( screened by Structured Clinical Interview for DSM-IV ) were r and omized to 12 weeks of varenicline 1 mg twice daily ( n = 55 ) or placebo . Adverse events were solicited systematic ally . Depressive symptoms , anxiety , aggression , and irritability were measured at baseline and weekly using the Montgomery-Åsberg Depression Rating Scale ( MADRS ) , the Hamilton Anxiety Scale ( HAM-A ) , and the Overt Aggression Scale-Modified ( OAS-M ) . The Profile of Mood States ( POMS ) was administered daily . Mixed-model analysis of repeated measures was conducted to compare mean changes in scores between groups across study periods . RESULTS Participants ' mean baseline characteristics were 33 years of age , 22 cigarettes/day and Fagerström Test for Nicotine Dependence score > 7 . Reported NPAEs were similar between groups . No suicidal events were reported . There were no significant differences between groups for the MADRS ( treatment difference vs. placebo = .03 , 95 % confidence interval [ CI ] -.68-.73 ; NS ) , HAM-A ( treatment difference [ TD ] = .14 , 95 % CI -.62-.90 ; NS ) , OAS-M Aggression subscale ( TD = .5 , 95 % CI -1.18 - 2.18 ; NS ) , OAS-M Irritability subscale ( TD = .08 , 95 % CI -.17-.34 ; NS ) , and the POMS total scores ( TD = .5 , 95 % CI -.52 - 1.53 ; NS ) . CONCLUSIONS There were no significant differences between groups on measures of depressive symptoms , anxiety , or aggression/hostility . Systematic ally solicited NPAEs were similar between the varenicline and placebo groups
Efficacy was found for the functional somatic syndromes group ( fibromyalgia and chronic fatigue syndrome ) , but not for anxiety or stress .
For other disorders , homeopathy produced mixed effects .
Meaningful safety data were lacking in the reports , but the superficial findings suggested good tolerability of homeopathy .
OBJECTIVE To systematic ally review  placebo-controlled r and omized trials of  homeopathy for psychiatric conditions .