Systematic review and meta-analysis of the placebo effect in panic disorder: Implications for research and clinical practice

2022 ◽  
pp. 000486742110687
Author(s):  
Masoud Ahmadzad-Asl ◽  
Farnoush Davoudi ◽  
Safoura Mohamadi ◽  
Fatemeh Hadi ◽  
Seyed Aria Nejadghaderi ◽  
...  

Objective: This review aimed to measure the degree of placebo response in panic disorder. Data Sources: We searched major databases up to 31 January 2021, for randomized pharmacotherapy trials published in English. Study Selection: A total of 43 studies met inclusion criteria to be in the analysis (with 174 separate outcome measurements). Data Extraction: Changes in outcome measures from baseline in the placebo group were used to estimate modified Cohen’s d effect size. Results: A total of 43 trials (2392 subjects, 174 outcomes using 27 rating scales) were included in the meta-analysis. Overall placebo effect size was 0.57 (95% confidence interval = [0.50, 0.64]), heterogeneity ( I2: 96.3%). Higher placebo effect size was observed among clinician-rated scales compared to patient reports (0.75 vs 0.35) and among general symptom and anxiety scales compared to panic symptoms and depression scales (0.92 and 0.64 vs 0.56 and 0.54, respectively). There was an upward trend in effect size over the publication period ( r = 0.02, p = 0.002) that was only significant among clinician-rated scales ( r = 0.02, p = 0.011). There was no significant publication bias, Egger’s test ( p = 0.08). Conclusion: We observed a substantial placebo effect size in panic disorder. This effect was more prominent for some aspects of panic disorder psychopathology than for others and was correlated with the source of the assessment and publication year. This finding has implications both for research design, to address the heterogeneity and diversity in placebo responses, and for clinical practice to ensure optimal quality of care. Systematic review registration number: PROSPERO, CRD42019125979.

BJPsych Open ◽  
2021 ◽  
Vol 7 (S1) ◽  
pp. S261-S262
Author(s):  
Brett D M Jones ◽  
Cory R. Weissman ◽  
Jewel Karbi ◽  
Tya Vine ◽  
Louise S. Mulsant ◽  
...  

AimsThe placebo response in depression clinical trials is a major contributing factor for failure to establish the efficacy of novel and repurposed treatments. However, it is not clear as to what the placebo response in treatment-resistant depression (TRD) patients is or whether it differs across treatment modalities. Our objective was to conduct a systematic review and meta-analysis of the magnitude of the placebo response in TRD patients across different treatment modalities and its possible moderators.MethodSearches were conducted on MEDLINE and PsychInfo from inception to January 24, 2020. Only studies that recruited TRD patients and randomization to a placebo (or sham) arm in a pharmacotherapy, brain stimulation, or psychotherapy study were included (PROSPERO 2020 CRD42020190465). The primary outcome was the Hedges’ g for the reported depression scale using a random-effects model. Secondary outcomes included moderators assessed via meta-regression and response and remission rate. Heterogeneity was evaluated using the Egger's Test and a funnel plot. Cochrane Risk of Bias Tool was used to estimate risks.Result46 studies met our inclusion criteria involving a total of 3083 participants (mean (SD) age: 45.7 (6.2); female: 52.4%). The pooled placebo effect for all modalities was large (N = 3083, g = 1.08 ,95% CI [0.95-1.20)I 2 = 0.1). The placebo effect in studies of specific treatment modalities did not significantly differ: oral medications g = 1.14 (95%CI:0.99-1.29); parenteral medications g = 1.32 (95%CI:0.59-2.04); ayahuasca g = 0.47 (95%CI:-0.28-1.17); rTMS g = 0.93 (95%CI:0.63-1.23); tDCS g = 1.32 (95%CI:0.52-2.11); invasive brain stimulation g = 1.06 (95%CI:0.64-1.47). There were no psychotherapy trials that met our eligibility criteria. Similarly, response and remission rates were comparable across modalities. Heterogeneity was large. Two variables predicted a lager placebo effect: open-label prospective design (B:0.32, 95%CI: 0.05-0.58; p:0.02) and sponsoring by a pharmaceutical or medical device company (B:0.39, 95%CI:0.13-0.65, p:0.004)). No risk of publication bias was found.ConclusionThe overall placebo effect in TRD studies was large (g = 1.08) and did not differ among treatment modalities. A better understanding of the placebo response in TRD will require: standardizing the definition of TRD, head-to-head comparisons of treatment modalities, an assessment of patient expectations and experiences, and standardized reporting of outcomes.


BMJ Open ◽  
2021 ◽  
Vol 11 (9) ◽  
pp. e050912
Author(s):  
Mia Bierbaum ◽  
Frances Rapport ◽  
Gaston Arnolda ◽  
Yvonne Tran ◽  
Bróna Nic Giolla Easpaig ◽  
...  

IntroductionClinical practice guidelines (CPGs) synthesise the latest evidence to support clinical and patient decision-making. CPG adherent care is associated with improved patient survival outcomes; however, adherence rates are low across some cancer streams in Australia. Greater understanding of specific barriers to cancer treatment CPG adherence is warranted to inform future implementation strategies.This paper presents the protocol for a systematic review that aims to determine cancer treatment CPG adherence rates in Australia across a variety of common cancers, and to identify any factors associated with adherence to those CPGs, as well as any associations between CPG adherence and patient outcomes.Methods and analysisFive databases will be searched, Ovid Medline, PsychInfo, Embase, Scopus and Web of Science, for eligible studies evaluating adherence rates to cancer treatment CPGs in Australia. A team of reviewers will screen the abstracts in pairs according to predetermined inclusion criteria and then review the full text of eligible studies. All included studies will be assessed for quality and risk of bias. Data will be extracted using a predefined data extraction template. The frequency or rate of adherence to CPGs, factors associated with adherence to those CPGs and any reported patient outcome rates (eg, relative risk ratios or 5-year survival rates) associated with adherence to CPGs will be described. If applicable, a pooled estimate of the rate of adherence will be calculated by conducting a random-effects meta-analysis. The systematic review will adhere to the Preferred Reporting Items for Systematic Reviews and Meta-Analyses guidelines.Ethics and disseminationEthics approval will not be required, as this review will present anonymised data from other published studies. Results from this study will form part of a doctoral dissertation (MB), will be published in a journal, presented at conferences, and other academic presentations.PROSPERO registration numberCRD42020222962.


2020 ◽  
Author(s):  
Aikaterini Grimani ◽  
Louis Goffe ◽  
Mei Yee Tang ◽  
Fiona Beyer ◽  
Falko F. Sniehotta ◽  
...  

Abstract Background: Letters are regularly sent by healthcare organisations to healthcare professionals to encourage them to take action, change practice or implement guidance. However, whether letters are an effective tool in delivering a change in clinical practice behaviour is currently uncertain. In addition, there are currently no evidence-based guidelines to support providers and health authorities with advice on how to formulate the communication, what information and behaviour change techniques to include in order to optimise the potential effect on the behaviour of the receivers. To address this research gap, we aim to inform such guidance through this systematic review.Methods/ Design: A systematic literature search of published and unpublished studies (the grey literature) in electronic databases will be conducted to identify studies that meet our inclusion criteria. The search will be conducted in five electronic databases: MEDLINE, EMBASE, PsycINFO, the Cochrane Library and CINAHL. We will also conduct supplementary searches in Google Scholar, hand search relevant journals, and conduct backward and forward citation searching for included studies and relevant reviews. A systematic approach to searching, screening, reviewing and data extraction will be applied based on Preferred Reporting Items for Systematic reviews and Meta-Analysis. Titles, abstracts, full-texts for eligibility will be examined independently by researchers. The quality of the included studies will be assessed using quality assessment tool for studies with diverse design and Cochrane risk of bias tool. Disagreements will be resolved by a consensus procedure.Discussion: This review aims to provide comprehensive evidence of the effectiveness of personal letters to healthcare professionals in changing clinical practice behaviours. Health policy makers across government will benefit from being able to increase compliance in clinical settings by applying theories of behaviour to design of policy communications. The synthesized findings will be disseminated through peer-reviewed publication.Systematic review registration: PROSPERO CRD42020167674


2019 ◽  
Vol 77 (8) ◽  
pp. 557-571 ◽  
Author(s):  
Wolfgang Marx ◽  
Melissa Lane ◽  
Tetyana Rocks ◽  
Anu Ruusunen ◽  
Amy Loughman ◽  
...  

Abstract Context Saffron (Crocus sativus L.) has gained interest as a potential treatment in psychiatry. Objective This systematic review and meta-analysis sought to investigate the effect of saffron supplementation, as both an adjunctive therapy and monotherapy, on symptoms of depression and anxiety in clinical and general populations compared with pharmacotherapy or placebo. Data sources Using the PRISMA guidelines, a systematic literature review of randomized controlled trials was conducted. Data extraction A meta-analysis was conducted to determine treatment effect. Risk of bias was assessed using the Jadad scale. Results Twenty-three studies were included. Saffron had a large positive effect size when compared with placebo for depressive symptoms (g = 0.99, P < 0.001) and anxiety symptoms (g = 0.95, P < 0.006). Saffron also had a large positive effect size when used as an adjunct to antidepressants for depressive symptoms (g = 1.23, P = 0.028). Egger’s regression test found evidence of publication bias. Conclusions Saffron could be an effective intervention for symptoms of depression and anxiety; however, due to evidence of publication bias and lack of regional diversity, further trials are required. PROSPERO registration CRD42017070060.


2021 ◽  
Vol 11 (1) ◽  
Author(s):  
Bo Cao ◽  
Yang S. Liu ◽  
Alessandro Selvitella ◽  
Diego Librenza-Garcia ◽  
Ives Cavalcante Passos ◽  
...  

AbstractThe placebo effect across psychiatric disorders is still not well understood. In the present study, we conducted meta-analyses including meta-regression, and machine learning analyses to investigate whether the power of placebo effect depends on the types of psychiatric disorders. We included 108 clinical trials (32,035 participants) investigating pharmacological intervention effects on major depressive disorder (MDD), bipolar disorder (BD) and schizophrenia (SCZ). We developed measures based on clinical rating scales and Clinical Global Impression scores to compare placebo effects across these disorders. We performed meta-analysis including meta-regression using sample-size weighted bootstrapping techniques, and machine learning analysis to identify the disorder type included in a trial based on the placebo response. Consistently through multiple measures and analyses, we found differential placebo effects across the three disorders, and found lower placebo effect in SCZ compared to mood disorders. The differential placebo effects could also distinguish the condition involved in each trial between SCZ and mood disorders with machine learning. Our study indicates differential placebo effect across MDD, BD, and SCZ, which is important for future neurobiological studies of placebo effects across psychiatric disorders and may lead to potential therapeutic applications of placebo on disorders more responsive to placebo compared to other conditions.


2018 ◽  
Vol 2018 ◽  
pp. 1-16 ◽  
Author(s):  
Álvaro Murillo-García ◽  
Santos Villafaina ◽  
José C. Adsuar ◽  
Narcis Gusi ◽  
Daniel Collado-Mateo

Objective. The aim of this study was to perform a systematic review on the effectiveness of dance-based programs in patients with fibromyalgia, as well as calculate the overall effect size of the improvements, through a meta-analysis. Methods. The Cochrane Library, Physiotherapy Evidence Database (PEDro), PubMed, TRIP, and Web of Science (WOS) were selected to identify the articles included in this systematic review and meta-analysis. A total of seven articles fulfilled all inclusion and exclusion criteria. PRISMA guidelines were followed in the data extraction process. The level of evidence was established following guidelines from the Dutch Institute for Healthcare Improvement (CBO). Results. The studies were all randomized controlled trials, but not double-blind. Duration of dance programs ranged from 12 to 24 weeks. Sessions lasted between 60 and 120 minutes and were performed 1-2 times per week. The overall effect size for pain was -1.64 with a 95% CI from -2.69 to -0.59 which can be interpreted as large. In addition, significant improvements were observed in quality of life, depression, impact of the disease, anxiety, and physical function. Conclusion. Dance-based intervention programs can be an effective intervention for people suffering from fibromyalgia, leading to a significant reduction of the level of pain with an effect size that can be considered as large. However, findings and conclusions from this meta-analysis must be taken with caution due to the small number of articles and the large heterogeneity.


BMJ Open ◽  
2021 ◽  
Vol 11 (6) ◽  
pp. e047283
Author(s):  
Rosalind Gittins ◽  
Louise Missen ◽  
Ian Maidment

IntroductionThere is a growing concern about the misuse of over the counter (OTC) and prescription only medication (POM) because of the impact on physical and mental health, drug interactions, overdoses and drug-related deaths. These medicines include opioid analgesics, anxiolytics such as pregabalin and diazepam and antidepressants. This protocol outlines how a systematic review will be undertaken (during June 2021), which aims to examine the literature on the pattern of OTC and POM misuse among adults who are accessing substance misuse treatment services. It will include the types of medication being taken, prevalence and demographic characteristics of people who access treatment services.Methods and analysisAn electronic search will be conducted on the Cochrane, OVID Medline, Pubmed, Scopus and Web of Science databases as well as grey literature. Two independent reviewers will conduct the initial title and abstract screenings, using predetermined criteria for inclusion and exclusion. If selected for inclusion, full-text data extraction will be conducted using a pilot-tested data extraction form. A third reviewer will resolve disagreements if consensus cannot be reached. Quality and risk of bias assessment will be conducted for all included studies. A qualitative synthesis and summary of the data will be provided. If possible, a meta-analysis with heterogeneity calculation will be conducted; otherwise, Synthesis Without Meta-analysis will be undertaken for quantitative data. The reporting of this protocol follows the Preferred Reporting Items for Systematic Reviews and Meta-Analyses.Ethics and disseminationEthical approval is not required. Findings will be peer reviewed, published and shared verbally, electronically and in print, with interested clinicians and policymakers.PROSPERO registration numberCRD42020135216.


2021 ◽  
Vol 21 (1) ◽  
Author(s):  
Hyune June Lee ◽  
Sung Min Kim ◽  
Ji Yean Kwon

Abstract Background Peripartum depression is a common disorder with very high potential hazards for both the patients and their babies. The typical treatment options include antidepressants and electroconvulsive therapy. However, these treatments do not ensure the safety of the fetus. Recently, repetitive transcranial magnetic stimulation has emerged as a promising treatment for neuropathies as well as depression. Nevertheless, many studies excluded pregnant women. This systematic review was conducted to confirm whether repetitive transcranial magnetic stimulation was a suitable treatment option for peripartum depression. Methods We performed a systematic review that followed the PRISMA guidelines. We searched for studies in the MEDLINE, PsycINFO, EMBASE, and Cochrane library databases published until the end of September 2020. Eleven studies were selected for the systematic review, and five studies were selected for quantitative synthesis. Data analysis was conducted using Comprehensive Meta-Analysis 3 software. The effect size was analyzed using the standardized mean difference, and the 95% confidence interval (CI) was determined by the generic inverse variance estimation method. Results The therapeutic effect size of repetitive transcranial magnetic stimulation for peripartum depression was 1.394 (95% CI: 0.944–1.843), and the sensitivity analysis effect size was 1.074 (95% CI: 0.689–1.459), indicating a significant effect. The side effect size of repetitive transcranial magnetic stimulation for peripartum depression was 0.346 (95% CI: 0.214–0.506), a meaningful result. There were no severe side effects to the mothers or fetuses. Conclusions From various perspectives, repetitive transcranial magnetic stimulation can be considered an alternative treatment to treat peripartum depression to avoid exposure of fetuses to drugs and the severe side effects of electroconvulsive therapy. Further research is required to increase confidence in the results.


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