J Brun1, H Sörngård. 1. Södra Hälsocentralen, S-824 81 Hudiksvall, Sweden.
Abstract
BACKGROUND: The diagnosis of gastro-oesophageal reflux disease (GERD) in primary care rests primarily on symptoms. Oesophageal acid exposure is the most important pathogenic factor and it is likely that symptom response to acid inhibition also identifies patients with GERD. OBJECTIVE: The aim of this study was to evaluate the outcome of a symptom-based strategy in the management of GERD patients in primary care. METHODS:Patients in general practice with main symptoms of at least moderate heartburn or regurgitation were givenomeprazole 20 mg b.i.d. openly for 7 days (first phase). Responders with later relapse were randomized to double-blind treatment with omeprazole 20 mg o.m. or placebo for 2 weeks (second phase). A response in both phases was defined as a decrease by at least three grades on a seven-grade Likert scale and no more than mild intensity of the main symptom. RESULTS: Of the 362/371 recruited patients who were evaluated in the first phase, 73% were responders. A total of 174/179 patients with a relapse were assessed in the second phase, and 74 and 28% in the omeprazole and placebo group, respectively, were defined as responders (P: < 0.001, 95% confidence interval 33-59). CONCLUSIONS:GERD patients are highly responsive to omeprazole 20 mg b.i.d. They are equally responsive to omeprazole 20 mg o.m. at symptomatic relapse, but have a low response rate to placebo. Omeprazole is a valuable therapeutic instrument to detect and treat patients with GERD in general practice.
RCT Entities:
BACKGROUND: The diagnosis of gastro-oesophageal reflux disease (GERD) in primary care rests primarily on symptoms. Oesophageal acid exposure is the most important pathogenic factor and it is likely that symptom response to acid inhibition also identifies patients with GERD. OBJECTIVE: The aim of this study was to evaluate the outcome of a symptom-based strategy in the management of GERDpatients in primary care. METHODS:Patients in general practice with main symptoms of at least moderate heartburn or regurgitation were given omeprazole 20 mg b.i.d. openly for 7 days (first phase). Responders with later relapse were randomized to double-blind treatment with omeprazole 20 mg o.m. or placebo for 2 weeks (second phase). A response in both phases was defined as a decrease by at least three grades on a seven-grade Likert scale and no more than mild intensity of the main symptom. RESULTS: Of the 362/371 recruited patients who were evaluated in the first phase, 73% were responders. A total of 174/179 patients with a relapse were assessed in the second phase, and 74 and 28% in the omeprazole and placebo group, respectively, were defined as responders (P: < 0.001, 95% confidence interval 33-59). CONCLUSIONS:GERDpatients are highly responsive to omeprazole 20 mg b.i.d. They are equally responsive to omeprazole 20 mg o.m. at symptomatic relapse, but have a low response rate to placebo. Omeprazole is a valuable therapeutic instrument to detect and treat patients with GERD in general practice.