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

Authors: Wong, BCY; Hung, WK; Yee, YK; Yip, AWC; Szeto, ML; Fung, FMY; Tong, TSM; +5 Authors

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

Abstract

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.To evaluate the efficacy of different doses of lansoprazole for the treatment of functional dyspepsia in Chinese patients.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.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.Proton pump inhibitor treatment is not superior to placebo for the management of functional dyspepsia in Chinese patients.

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Keywords

Adult, Male, China, Helicobacter infections - complications, Adolescent, 610, 2-Pyridinylmethylsulfinylbenzimidazoles, Drug Administration Schedule, Helicobacter Infections, Dyspepsia - complications - drug therapy - microbiology, Double-Blind Method, Anti-bacterial agents - adverse effects - therapeutic use, Humans, Lansoprazole, Dyspepsia, Aged, Helicobacter pylori, Middle Aged, Anti-Ulcer Agents, Anti-Bacterial Agents, Omeprazole - adverse effects - analogs & derivatives - therapeutic use, Quality of Life, Female, Anti-ulcer agents - therapeutic use, Omeprazole

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    This is an alternative to the "Influence" indicator, which also reflects the overall/total impact of an article in the research community at large, based on the underlying citation network (diachronically).
    100
    popularity
    This indicator reflects the "current" impact/attention (the "hype") of an article in the research community at large, based on the underlying citation network.
    Top 10%
    influence
    This indicator reflects the overall/total impact of an article in the research community at large, based on the underlying citation network (diachronically).
    Top 10%
    impulse
    This indicator reflects the initial momentum of an article directly after its publication, based on the underlying citation network.
    Top 10%
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selected citations
These citations are derived from selected sources.
This is an alternative to the "Influence" indicator, which also reflects the overall/total impact of an article in the research community at large, based on the underlying citation network (diachronically).
BIP!Citations provided by BIP!
popularity
This indicator reflects the "current" impact/attention (the "hype") of an article in the research community at large, based on the underlying citation network.
BIP!Popularity provided by BIP!
influence
This indicator reflects the overall/total impact of an article in the research community at large, based on the underlying citation network (diachronically).
BIP!Influence provided by BIP!
impulse
This indicator reflects the initial momentum of an article directly after its publication, based on the underlying citation network.
BIP!Impulse provided by BIP!
100
Top 10%
Top 10%
Top 10%
Green
bronze