An Investigation of Factors Contributing to Higher Levels of Placebo Response in Clinical Trials in Neuropathic Pain: A Systematic Review and Meta-Analysis

We performed a systematic review and meta-analysis of randomised controlled trials (RCTs) conducted from January 2005 to June 2021 to update the evidence of Botulinum toxin A (BoNT-A) in neuropathic pain (NP) in addition to quality of life (QOL), mental health, and sleep outcomes. We conducted a Cochrane Grading of Recommendations Assessment, Development, and Evaluation (GRADE) criteria analysis of RCTs from the following data sources: EMBASE, CINAHL, WHO International Clinical Trial Registry Platform, ClinicalTrials.gov, Cochrane database, Cochrane Clinical Trial Register, Australia New Zealand Clinical Trials Registry, and EU Clinical Trials Register. Meta-analysis of 17 studies showed a mean final VAS reduction in pain in the intervention group of 2.59 units (95% confidence interval: 1.79, 3.38) greater than the mean for the placebo group. The overall mean difference for sleep, Hospital Anxiety and Depression Scale (HADS) anxiety, HADS depression, and QOL mental and physical sub-scales were, respectively, 1.10 (95% CI: −1.71, 3.90), 1.41 (95% CI: −0.61, 3.43), −0.16 (95% CI: −1.95, 1.63), 0.85 (95% CI: −1.85, 3.56), and −0.71 (95% CI: −3.39, 1.97), indicating no significance. BoNT-A is effective for NP; however, small-scale RCTs to date have been limited in evidence. The reasons for this are discussed, and methods for future RCTs are developed to establish BoNT-A as the first-line agent.

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P236. Placebo response and remission rates in Ulcerative Colitis clinical trials: Systematic review and meta-analysis

Journal of Crohn s and Colitis ◽

10.1093/ecco-jcc/jju027.353 ◽

2015 ◽

Vol 9 (suppl 1) ◽

pp. S193-S194

Keyword(s):

Systematic Review ◽

Ulcerative Colitis ◽

Clinical Trials ◽

Meta Analysis ◽

Placebo Response ◽

Remission Rates

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EFFECTIVENESS OF ACAMPROSATE FOR TINNITUS: A SYSTEMATIC REVIEW AND META-ANALYSIS OF CLINICAL TRIALS

10.1101/2021.06.09.21258585 ◽

2021 ◽

Author(s):

Osmar Clayton Person ◽

Fernando Veiga Angelico Junior ◽

Rodrigo Lima de Godoy Santos ◽

William Marasini de Rezende ◽

Maria Fernanda Giusti ◽

...

Keyword(s):

Systematic Review ◽

Clinical Trials ◽

Randomized Clinical Trials ◽

Meta Analysis ◽

Medical Science ◽

Placebo Response ◽

Cochrane Central Register ◽

Significant Difference ◽

Tinnitus Treatment

Introduction: The effectiveness of tinnitus treatment represents a huge gap in the medical science. Acamprosate is a glutamatergic antagonist drug and GABA-agonist that could be used to control tinnitus due to its action on peripheral and central neurotransmission. Purpose: To assess the effectiveness of acamprosate in the treatment of tinnitus. Material and Methods: This is a systematic review and we searched for randomized clinical trials linking acamprosate to tinnitus in six databases: Cochrane - Central Register of Controlled Trials - CENTRAL (2021), PUBMED (1966-2021), EMBASE (1974-2021), IBECS (1982-2021), QINSIGHT (2021) and SCOPUS (2021). Two researchers independently extracted the data and assessed the quality of the studies. Results: Two trials involving 121 patients were included. The methodological quality of these studies was low. Both studies evaluated as primary outcome the efficacy of acamprosate in improving tinnitus. The meta-analysis by random model resulted in no significant difference between the groups treated with acamprosate and placebo (RR = 3,69, 95% CI 0,87-15,62; p=0,08), considering tinnitus improvement. Conclusions: There is no evidence that acamprosate is effective for tinnitus treatment. We recommend new trials using rigorous methodology. Randomization and blinding should be of the highest quality, given the subjective nature of tinnitus and the strong likelihood of a placebo response. The CONSORT statement should be used in the design and reporting of future studies.

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