Empiric treatment with high and standard dose of omeprazole in general practice: two-week randomized placebo-controlled trial and 12-month follow-up of health-care consumption.

Abstract

Patients with acid-related symptoms in general practice are often treated empirically with a standard dose of proton pump inhibitors (PPIs). The effect of higher doses is not known. The study compared the immediate symptom relieving as well as the long-term effect of standard and double dose of omeprazole in such patients. Consecutive patients with dyspeptic symptoms, normally treated by the general practitioner with PPIs or H2-blockers were randomized to treatment with omeprazole 40 mg, 20 mg, or placebo in the morning for 2 wk. Patients with alarm symptoms, IBS, and PPI-treated patients were excluded. Dyspeptic symptoms and Helicobacter pylori status were recorded. The study endpoint was complete relief of the dyspeptic symptoms, which initiated the consultation. Relapse rates and health-care consumption were recorded during 12-month observation. Eight hundred and twenty-nine patients were randomized. Complete relief of the predominant symptom was obtained by 66%, 63%, and 35% in patients treated with omeprazole 40 mg, 20 mg, and placebo, respectively. No difference was found comparing H. pylori-positive and -negative patients. Relapse rates were high and health-care consumption during 12 months was related to the treatment outcome, but not to the omeprazole dose or the H. pylori status. Compared to placebo, omeprazole 40 mg and 20 mg were equally and significantly better in relieving acid-related symptoms; the numbers needed-to-treat (NNT) were 3.2 (40 mg) and 3.7 (20 mg). Relief of the dyspeptic complaint was followed by significantly reduced health-care consumption during 12-month observation.