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

Su Jin Hong, In Kyung Sung, Jae Gyu Kim, Sang Woo Lee, Suck Chei Choi, Chang Hun Yang, Sang In Lee, Dong Ho Lee, Gwang Ha Kim, Seong Woo Jeon, Moo In Park, Sue K. Park, Byung Joo Park, Sang Young Seol

Research output: Contribution to journalArticle

6 Citations (Scopus)

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.

Original languageEnglish
Pages (from-to)468-471
Number of pages4
JournalGut and liver
Volume5
Issue number4
DOIs
Publication statusPublished - 2011 Dec

Keywords

  • Dyspepsia
  • Helicobacter pylori
  • Symptom

ASJC Scopus subject areas

  • Hepatology
  • Gastroenterology

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    Hong, S. J., Sung, I. K., Kim, J. G., Lee, S. W., Choi, S. C., Yang, C. H., Lee, S. I., Lee, D. H., Kim, G. H., Jeon, S. W., Park, M. I., Park, S. K., Park, B. J., & Seol, S. Y. (2011). 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. Gut and liver, 5(4), 468-471. https://doi.org/10.5009/gnl.2011.5.4.468