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Missed Opportunities in the Trial on Proton-Pump Inhibitor Therapy in Bleeding Peptic Ulcers
- Joseph J.Y. Sung, MD, PhD;
- Alan Barkun, MD; and
- Ernst J. Kuipers, MD
- From Prince of Wales Hospital, Chinese University of Hong Kong, Hong Kong, China; McGill University Health Centre, Montreal, Quebec H3G 1A4, Canada; and Erasmus MC University Medical Center, Rotterdam 3015 GD, The Netherlands.
IN RESPONSE:
We thank all the correspondents for their considered comments. Ms. Yih and Dr. Tejani, Drs. Lin and Hsu, and Dr. Piscoya raised concerns about the use of placebo as a comparator in our study of patients with peptic ulcer bleeding. When this study was planned, the efficacy of intravenous PPI therapy for treatment of peptic ulcer bleeding was still in question, and no approved comparator treatment existed. After full discussion of the design with the U.S. Food and Drug Administration and the European Medicines Agency, it was agreed that the study should be placebo-controlled, which resulted in the first approval …
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