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Double blind, randomised, placebo controlled study of four weeks of lansoprazole for the treatment of functional dyspepsia in Chinese patients.

AbstractBACKGROUND:
The use of proton pump inhibitors for the treatment of functional dyspepsia is controversial and the role of Helicobacter pylori infection in functional dyspepsia is uncertain.
AIM:
To evaluate the efficacy of different doses of lansoprazole for the treatment of functional dyspepsia in Chinese patients.
METHOD:
Patients with a clinical diagnosis of functional dyspepsia according to the Rome II criteria and normal upper gastrointestinal endoscopy were recruited and randomised to receive: (1) lansoprazole 30 mg, (2) lansoprazole 15 mg, or (3) placebo, all given daily for four weeks. Dyspepsia symptom scores and quality of life (SF-36 score) were evaluated before and four weeks after treatment.
RESULTS:
A total of 453 patients were randomised. There was no difference in the proportion of patients with complete symptom relief in the lansoprazole 30 mg (23%) and lansoprazole 15 mg (23%) groups compared with the placebo group (30%). The proportion of H pylori positive patients with a complete response was similar with lansoprazole 30 mg (34%) and lansoprazole 15 mg (20%) versus placebo (22%). All symptom subgroups (ulcer-like, dysmotility-like, reflux-like, and unspecified dyspepsia) had similar proportions of patients with complete symptom relief after treatment.
CONCLUSION:
Proton pump inhibitor treatment is not superior to placebo for the management of functional dyspepsia in Chinese patients.
AuthorsW M Wong, B C Y Wong, W K Hung, Y K Yee, A W C Yip, M L Szeto, F M Y Fung, T S M Tong, K C Lai, W H C Hu, M F Yuen, S K Lam
JournalGut (Gut) Vol. 51 Issue 4 Pg. 502-6 (Oct 2002) ISSN: 0017-5749 [Print] England
PMID12235071 (Publication Type: Clinical Trial, Journal Article, Randomized Controlled Trial, Research Support, Non-U.S. Gov't)
Chemical References
  • 2-Pyridinylmethylsulfinylbenzimidazoles
  • Anti-Bacterial Agents
  • Anti-Ulcer Agents
  • Lansoprazole
  • Omeprazole
Topics
  • 2-Pyridinylmethylsulfinylbenzimidazoles
  • Adolescent
  • Adult
  • Aged
  • Anti-Bacterial Agents (adverse effects, therapeutic use)
  • Anti-Ulcer Agents (therapeutic use)
  • China
  • Double-Blind Method
  • Drug Administration Schedule
  • Dyspepsia (complications, drug therapy, microbiology)
  • Female
  • Helicobacter Infections (complications)
  • Helicobacter pylori
  • Humans
  • Lansoprazole
  • Male
  • Middle Aged
  • Omeprazole (adverse effects, analogs & derivatives, therapeutic use)
  • Quality of Life

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