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The lessons learned from randomized clinical trials of GERD
F Pace1, A Sonnenberg, G Bianchi Porro
1Department and Chair of Gastroenterology, L. Sacco University Hospital, Milan, Italy.
Summary
Randomized controlled trials for gastro-oesophageal reflux disease offer limited clinical applicability. Future research should focus on large databases to understand the natural history of this common upper GI disorder.
Area of Science:
- Gastroenterology
- Clinical Trials
- Evidence-Based Medicine
Background:
- Gastro-oesophageal reflux disease (GERD) is a prevalent upper gastrointestinal disorder.
- Despite numerous clinical trials, translating findings into clinical practice remains a challenge.
Purpose of the Study:
- To summarize pivotal randomized controlled trials (RCTs) and reviews on GERD.
- To evaluate the applicability of RCT results to current clinical practice.
Main Methods:
- Systematic review of relevant RCTs and review articles on GERD since 1978.
- Exploration of six key areas: diagnostic criteria, efficacy parameters, therapy duration, antisecretory effect, placebo effect, and follow-up data.
Main Results:
- Information from RCTs has shown limited applicability in routine clinical practice.
- There is a significant lack of data regarding the natural history of GERD.
Conclusions:
- Current RCTs provide insufficient insights for direct clinical application in GERD management.
- Development of large cooperative databases is crucial for understanding GERD's natural history.
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