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

Author(s): Wong WM, Wong BC, Hung WK, Yee YK, Yip AW, Szeto ML, Fung FM, Tong TS, Lai KC, Hu WH, Yuen MF, Lam SK

Affiliation(s): Department of Medicine, University of Hong Kong, Queen Mary Hospital, Hong Kong.

Publication date & source: 2002-10, Gut., 51(4):502-6.

Publication type: Clinical Trial; Randomized Controlled Trial

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.