Characterization changes and research waste in randomized controlled trials of global gastroesophageal reflux disease and hiatus hernia over the past 20 years
Abstract
Background: The results of many large randomized clinical trials (RCTs) have transformed clinical practice in gastroesophageal reflux disease (GERD) and esophageal hiatal hernia (HH). However, research waste (i.e., unpublished data, inadequate reporting, or avoidable design limitations) remains a major challenge to evidence-based medicine. Method: A cross-sectional analysis was conducted to comprehensively review and evaluate RCTs related to GERD and esophageal HH, registered in the ClinicalTrials.gov database between 2003 and 2023. A sample of eligible RCTs was identified by excluding early-stage trials, pediatric studies, and duplicate studies. Publication status was tracked using PubMed and Scopus databases, reporting adequacy was assessed according to the CONSORT guidelines, and design flaws were checked with the help of Cochrane tools. Shortcomings of RCT studies in different regions and intervention types were identified by quantifying RCT conduct, recruitment, reporting adequacy, risk of bias, and guideline citations. Results: From 2003 to 2023, a total of 182 RCTs were included in the analysis, of which 69.8% (127 trials) were drug-related, and 71.4% of the principal investigators were located in North America and Asia (65 trials [35.7%] in both). Among them, the country with the most RCTs is the United States. RCTs in Asia were under-conducted in “procedure” and “other” types and fewer RCTs were conducted in Europe in “drug” type. RCTs in Oceania and South America…
How strong is the evidence?
Evidence Hub reads this as a randomized trial, done in people. Its evidence level is 2 of 5 (High · randomized trial). Randomized trials of a reasonable size are the strongest single-study design.
Read the paper
Related studies
- Advantages and Disadvantages of Long-term Proton Pump Inhibitor Use
- Ivth brazilian consensus conference on helicobacter pylori infection
- A pSMAD/CDX2 complex is essential for the intestinalization of epithelial metaplasia
- S2k-Leitlinie Gastroösophageale Refluxkrankheit und eosinophile Ösophagitis der Deutschen Gesellschaft für Gastroenterologie, Verdauungs- und Stoffwechselkrankheiten (DGVS) – März 2023 – AWMF-Registernummer: 021–013
- Step-by-step management of refractory gastresophageal reflux disease
- Insights into Effects/Risks of Chronic Hypergastrinemia and Lifelong PPI Treatment in Man Based on Studies of Patients with Zollinger–Ellison Syndrome
Go deeper in Evidence Hub
Evidence Hub adds a study data sheet (design, sample size, evidence level, key numbers), an AI summary and a chat grounded in the paper's text.