Q&A

Omeprazole and placebo have same long-term effect on dyspepsia

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  • BACKGROUND: Currently, approximately 80% of primary care physicians prescribe a course of antisecretory therapy for patients with uninvestigated dyspepsia, and reserve endoscopy for nonresponders. This strategy is based on a 1985 recommendation by the American College of Physicians.
  • POPULATION STUDIED: The investigators enrolled 140 patients referred by primary care physicians in a Veterans Administration outpatient clinic. To be eligible, patients had to have uninvestigated dyspepsia of at least 1 week’s duration, defined as epigastric or upper abdominal discomfort that was thought to arise from the upper gastrointestinal tract.
  • STUDY DESIGN AND VALIDITY: In this double-blind randomized study, participants with uninvestigated dyspepsia received a 6-week course of either omeprazole 20 mg twice daily or matching placebo. Patients were told to discontinue use of any nonsteroidal anti-inflammatory drugs but were allowed to continue taking aspirin (up to 325 mg daily). Patients were supplied with antacid tablets containing alumina, magnesia, and simethicone (Gelusil) for dyspepsia and acetaminophen for pain that was not related to dyspepsia. Patients were evaluated at regular intervals for 1 year.
  • OUTCOMES MEASURED: The primary outcome was “treatment failure” defined as a Severity of Dyspepsia Assessment (SODA) pain intensity score of 29 out of a possible 47 during any follow-up visit. SODA is a standardized reporting tool with 3 scales, which measure pain intensity, nonpain symptoms, and satisfaction with dyspepsia-related health. Secondary outcomes included SODA nonpain scores, SODA satisfaction scores, and endoscopy findings (patients classified as “treatment failures” were advised to undergo endoscopy).
  • RESULTS: During the 1 year of follow up, 55.7% of all patients failed treatment and were offered endoscopy. At 2 weeks, there were fewer treatment failures in the omeprazole group (17% vs. 35%, P=.037; number needed to treat=6), but at 6 weeks and 1 year this difference was no longer statistically significant.


 

PRACTICE RECOMMENDATIONS

Treatment with omeprazole relieved symptoms in the first 2 weeks in about half of patients with dyspepsia—a better response than in the patients treated with placebo. However, by 6 weeks a similar number of patients taking placebo also had symptoms relieved, and at 1 year treatment offered no benefit over placebo.

Additionally, treatment (vs placebo) did not reduce the number of patients who eventually would need endoscopy to investigate the cause of their dyspepsia. Interestingly, treating patients first with either placebo or omeprazole reduced the need for endoscopy by almost half.

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