Gut Liver.
2011 Dec;5(4):468-471.
Failure of a Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Efficacy of H. pylori Eradication in H. pylori-Infected Patients with Functional Dyspepsia
- Affiliations
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- 1Department of Internal Medicine, Soonchunhyang University College of Medicine, Bucheon, Korea.
- 2Department of Internal Medicine, Konkuk University School of Medicine, Seoul, Korea.
- 3Department of Internal Medicine, Chung-Ang University College of Medicine, Seoul, Korea.
- 4Department of Internal Medicine, Korea University College of Medicine, Seoul, Korea.
- 5Department of Internal Medicine, Wonkwang University School of Medicine, Iksan, Korea.
- 6Department of Internal Medicine, Dongguk University College of Medicine, Gyeongju, Korea.
- 7Department of Internal Medicine, Yonsei University College of Medicine, Seoul, Korea.
- 8Department of Internal Medicine, Seoul National University College of Medicine, Seongnam, Korea.
- 9Department of Internal Medicine, Pusan National University School of Medicine, Busan, Korea.
- 10Department of Internal Medicine, Kyungpook National University School of Medicine, Daegu, Korea.
- 11Department of Internal Medicine, Kosin University College of Medicine, Busan, Korea.
- 12Department of Preventive Medicine, Seoul National University College of Medicine, and Medical Research Collaboration Center, Seoul National University Hospital, Seoul, Korea.
- 13Cancer Research Institute, Seoul National University, Seoul, Korea.
- 14Department of Internal Medicine, Inje University College of Medicine, Busan, Korea. seolsymd@hanmail.net
Abstract
- 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 3 of 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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