Placebo response rate in patients with chronic constipation: A protocol for systematic review

Area of Science:

• Gastroenterology
• Clinical Trials
• Evidence Synthesis

Background:

• Chronic constipation (CC) affects a significant patient population.
• Accurate assessment of treatment efficacy requires understanding the placebo response rate in clinical trials.
• Variability in placebo response can impact the interpretation of randomized controlled trials (RCTs) for CC.

Purpose of the Study:

• To systematically review and meta-analyze randomized controlled trials (RCTs) to determine the pooled placebo response rate in patients with chronic constipation (CC).
• To identify factors that may influence the placebo response rate in CC patients within RCTs.

Main Methods:

• A systematic review and meta-analysis adhering to Cochrane Handbook guidelines.
• Comprehensive literature search of PubMed, Cochrane Library, and Embase databases.
• Independent data extraction and risk of bias assessment by two reviewers, followed by pooled analysis using R 3.6.0.

Main Results:

• The pooled placebo response rate and its 95% confidence interval (95%CI) will be calculated.
• Heterogeneity, publication bias, and subgroup analyses will be performed to explore variability.
• Results will be published in a peer-reviewed journal.

Conclusions:

• The findings will provide a quantitative estimate of the placebo response in CC RCTs.
• This information is essential for designing future clinical trials and interpreting treatment effects in CC.
• Understanding placebo response variability can refine the evaluation of novel therapeutic interventions for chronic constipation.