title: 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.
abstract: OBJECTIVE
  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.
authors.affiliation: Department of Internal Medicine, Soonchunhyang University College of Medicine, Bucheon, Korea.
authors.forename: Su Jin
authors.initials: SJ
authors.lastname: Hong
authors.forename: In Kyung
authors.initials: IK
authors.lastname: Sung
authors.forename: Jae Gyu
authors.initials: JG
authors.lastname: Kim
authors.forename: Sang Woo
authors.initials: SW
authors.lastname: Lee
authors.forename: Suck Chei
authors.initials: SC
authors.lastname: Choi
authors.forename: Chang Hun
authors.initials: CH
authors.lastname: Yang
authors.forename: Sang In
authors.initials: SI
authors.lastname: Lee
authors.forename: Dong Ho
authors.initials: DH
authors.lastname: Lee
authors.forename: Gwang Ha
authors.initials: GH
authors.lastname: Kim
authors.forename: Seong Woo
authors.initials: SW
authors.lastname: Jeon
authors.forename: Moo In
authors.initials: MI
authors.lastname: Park
authors.forename: Sue K
authors.initials: SK
authors.lastname: Park
authors.forename: Byung Joo
authors.initials: BJ
authors.lastname: Park
authors.forename: Sang Young
authors.initials: SY
authors.lastname: Seol