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Meta-Analysis: Placebo Response and Its Determinants in Functional Dyspepsia
Xinyi Huang1, Tadayuki Oshima, Toshihiko Tomita
1Division of Gastroenterology and Hepatology, Department of Internal Medicine, Hyogo College of Medicine, Nishinomiya, Japan.
The American Journal of Gastroenterology
|August 17, 2021
Summary
Placebo response rates in functional dyspepsia (FD) clinical trials vary by how improvement is measured. Assessing complete symptom relief, rather than general improvement, leads to lower placebo response in drug development for FD.
Area of Science:
- Gastroenterology
- Clinical Trials
- Psychosomatic Medicine
Background:
- Placebo response rates are notably high in clinical trials for brain-gut interaction disorders.
- Understanding and minimizing placebo response is crucial for effective drug development in functional dyspepsia (FD).
Purpose of the Study:
- To conduct a meta-analysis to quantify placebo response rates in randomized controlled trials (RCTs) for FD.
- To identify specific factors, such as efficacy criteria, that influence placebo response magnitude in FD trials.
Main Methods:
- Systematic search of PubMed, EMBASE, and Cochrane Central Register for double-blinded RCTs in FD.
- Analysis of pooled placebo response rates for both symptom improvement and complete relief as primary endpoints.
- Evaluation of trial characteristics, including assessment duration and endpoint definition, on placebo response.
Main Results:
- Analysis of 58 RCTs involving 6,732 participants revealed pooled placebo response rates of 44.3% for symptom improvement and 15.6% for complete relief.
- Placebo response rates were significantly lower in trials assessing symptom improvement for eight weeks or longer.
- Trials focusing on complete symptom relief demonstrated consistently lower placebo response rates, even in shorter trial durations.
Conclusions:
- Pooled placebo response rates in FD trials are contingent upon the defined efficacy criteria.
- Utilizing complete symptom relief as an endpoint in short-term trials can lead to more stable and lower placebo response rates, aiding drug development.
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