Failure of a Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Effi cacy of H. pylori Eradication in H. pylori -Infected Patients with Functional Dyspepsia
Failure of a Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Effi cacy of H. pylori Eradication in H. pylori -Infected Patients with Functional Dyspepsia
- 주제(키워드) Helicobacter pylori , Dyspepsia , Symptom
- 발행기관 거트앤리버 소화기연관학회협의회
- 발행년도 2011
- 총서유형 Journal
- UCI G704-SER000001589.2011.5.4.009
- KCI ID ART001626883
- 본문언어 영어
초록/요약
Background/Aims: The role of Helicobacter pylori eradication in patients with functional dyspepsia (FD) is still uncertain. We originally planned a randomized clinical study to observe dyspeptic symptoms after H. pylori eradication therapy. However, we failed to complete the study; therefore,we analyzed the factors that affected the failure of the study. Methods: Interviews and questionnaire surveys were conducted to analyze the factors that induced early termination from the study. Results: Many patients were screened by gastroenterologists at 11 tertiary referral hospitals between July 2009 and August 2010; however, only 4 patients met the enrollment criteria. Most patients who visited our clinics had been experiencing FD symptoms for less than 6 months or were already taking medication. They also demanded to continue taking medications and using other drugs. Only 3of the 4 patients signed informed consent. Conclusions: The application of the current Rome III criteria to FD is difficult to evaluate in Korean patients with dyspeptic symptoms because of the early medical evaluation. Most Korean patients who were diagnosed with FD by the Rome III criteria did not overcome their fear of being unable to use rescue medications during the study period.
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