Omeprazole 20 mg equal to 40 mg for primary care acid-related dyspepsia

Journal of Family Practice, Nov, 2004 by V. Meineche-Schmidt

* CLINICAL QUESTION

Is 40 mg omeprazole more effective than 20 mg for primary care patients with dyspepsia?

* BOTTOM LINE

Omeprazole (Prilosec) 20 mg is highly effective for the treatment of acid-related dyspepsia. There was no advantage to higher doses, and relapse following the initial 2-week treatment period was common. (LOE: 1b)

* STUDY DESIGN

Randomized controlled trial (double-blinded)

* ALLOCATION

Concealed

* SETTING

Outpatient (primary care)

* SYNOPSIS

A common primary care strategy for patients with dyspepsia and no alarm symptoms is to prescribe a proton-pump inhibitor. This pragmatic study took place in a Danish primary care research network with 103 participating physicians and 829 patients. Adults presenting with dyspepsia (that their physician thought was acid-related) and no alarm symptoms were randomized to omeprazole 40 mg/d, omeprazole 20 mg/d, or placebo. Alarm symptoms were defined as rectal bleeding or hematemesis, unintended weight loss, vomiting, dysphagia, jaundice, or other signs of serious disease.

Groups were similar at baseline, with a mean age of 50 years; 58% were women. Allocation was concealed and outcomes were blindly assessed, with analysis by intention to treat. Patients were treated for 2 weeks, and then medications were discontinued. During the remaining year of observation, in which 92% of the patients participated, the author tracked the time until symptom relapse and the consumption of healthcare resources.

The most common symptoms in both groups were epigastric pain, regurgitation, heartburn, bloating, and pain at night. Symptoms were rated as moderate by 63% of patients and severe by 15%. At 2 weeks, sufficient relief was reported more often in the 40 mg and 20 mg groups than in the placebo group (71%, 69.6%, and 43%, respectively), as was complete relief (66.4%, 63%, and 34.9%). The number needed to treat was between 3 and 4 for both outcomes. Results were similar for Helicobacter pylori-positive and H pylori-negative patients. Most patients in all 3 groups had a relapse of symptoms during the year following their initial treatment.

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Meineche-Schmidt V. Empiric treatment with high and standard dose of omeprazole in general practice: 2-week randomized placebo-controlled trial and 12-month follow-up of healthcare consumption. Am J Gastroenterol 2004; 99:1050-1058.