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- Title
Drug Treatment of Functional Dyspepsia: A Systematic Analysis of Trial Methodology with Recommendations for Design of Future Trials.
- Authors
Van Zanten, Sander J. O. Veldhuyzen; Cleary, Cynthia; Talley, Nicolas J.; Peterson, Theresa C.; Nyrén, Olaf; Bradley, Lawrence A.; Verlinden, Marleen; Tytgat, Guido N. J.
- Abstract
Objectives: To evaluate drug treatment of functional dyspepsia (including <em>Helicobacter pylori</em>) and provide guidelines for future trials based on a critical systematic overview of published studies. Methods: Data sources were a Medline search for articles published in English going back to 1966 and a manual search of four GI journals going back to 1980. Original randomized, double-blind, placebo-controlled trials were selected that enrolled at least 20 patients. Using a standardized, pre-tested data extraction form, studies were evaluated independently by two observers for study design, outcome measures, and results. Results: Fifty two eligible studies were evaluated. Many studies suffered from important weaknesses in study design and execution. Only five studies used previously validated outcome measures. Conclusions: Because of suboptimal design and/or unclear presentation of the data, none of the trials provided unequivocal evidence that there is efficacious therapy for the treatment of functional dyspepsia.
- Publication
American Journal of Gastroenterology (Springer Nature), 1996, Vol 91, Issue 4, p660
- ISSN
0002-9270
- Publication type
Academic Journal