Double blind, randomised, placebo controlled study of four weeks of lansoprazole for the treatment of functional dyspepsia in Chinese patients
- W M Wong1,†,
- B C Y Wong1,†,
- W K Hung2,
- Y K Yee3,
- A W C Yip2,
- M L Szeto3,
- F M Y Fung1,
- T S M Tong1,
- K C Lai1,
- W H C Hu1,
- M F Yuen1,
- S K Lam1
- 1Department of Medicine, University of Hong Kong, Queen Mary Hospital, Hong Kong
- 2Department of Surgery, Kwong Wah Hospital, Hong Kong
- 3Department of Medicine, Tuen Mun Hospital, Hong Kong
- Correspondence to:
Dr B C Y Wong, Department of Medicine, University of Hong Kong, Queen Mary Hospital, Hong Kong;
bcywong{at}hku.hk
- Accepted 28 January 2002
Abstract
Background: 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.
Footnotes
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↵† W M Wong and B C Y Wong contributed equally to this work.
