Omeprazole 20 mg = 40 mg for primary care acid related dyspepsia

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

Synopsis A common primary care strategy for patients with dyspepsia and no alarm symptoms is to prescribe a proton pump inhibitor. This pragmatic randomised controlled trial 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 randomised to omeprazole 40 mg per day, omeprazole 20 mg per day, or placebo. Alarm symptoms were defined as rectal bleeding or haematemesis, 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 two 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 relapse of symptoms 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 two 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 three groups had a relapse of symptoms during the year following their initial treatment.

Bottom line Omeprazole (Prilosec) 20 mg is highly effective for treating acid related dyspepsia. There was no advantage to higher doses, and relapse following the initial two week treatment period was common.

Level of evidence 1b (see www.infopoems.com/levels.html). Individual randomised controlled trials (with narrow confidence interval).