Efficacy of omeprazole in functional dyspepsia: double-blind, randomized, placebo-controlled trials (the Bond and Opera studies).

Abstract

BACKGROUND:

The efficacy of H2-receptor antagonists in functional dyspepsia is equivocal and the therapeutic place of proton pump inhibitors in functional dyspepsia is unknown.

AIM:

To evaluate the efficacy of proton pump inhibitor therapy in functional dyspepsia.

METHODS:

Patients (n = 1262) with a clinical diagnosis of functional dyspepsia (persistent or recurrent epigastric pain or discomfort for at least 1 month and a normal upper gastrointestinal endoscopy) were randomized to receive omeprazole 20 mg, 10 mg or identical placebo, for 4 weeks. Symptoms were assessed using validated measures. Helicobacter pylori status was determined pre-entry by a 13C-urea breath test.

RESULTS:

On an intention-to-treat analysis (n=1248), complete symptom relief was observed in 38% on omeprazole 20 mg, compared with 36% on omeprazole 10 mg and 28% on placebo (P = 0.002 and 0.02, respectively). Among those with ulcer-like and reflux-like dyspepsia, complete symptom relief was achieved in 40% and 54% on omeprazole 20 mg, and 35% and 45% on omeprazole 10 mg, respectively, compared with 27% and 23% on placebo (all P < 0.05, except omeprazole 10 mg in ulcer-like dyspepsia, P = 0.08). There was no significant benefit of omeprazole over placebo in dysmotility-like dyspepsia. Symptom relief was similar in H. pylori-positive and negative cases.

CONCLUSIONS:

Omeprazole is modestly superior to placebo in functional dyspepsia at standard (20 mg) and low doses (10 mg) but not in patients with dysmotility-like dyspepsia.

• Authors: N J Talley, V Meineche-Schmidt, P Paré, M Duckworth, P Räisänen, A Pap, H Kordecki, V Schmid
• Journal: Alimentary pharmacology & therapeutics (Aliment Pharmacol Ther) Vol. 12 Issue 11 Pg. 1055-65 (Nov 1998) ISSN: 0269-2813 [Print] England
• PMID: 9845395 (Publication Type: Clinical Trial, Journal Article, Randomized Controlled Trial, Research Support, Non-U.S. Gov't)

Chemical References

• Anti-Ulcer Agents
• Adenosine Triphosphatases
• Omeprazole

Topics

• Adenosine Triphosphatases (antagonists & inhibitors)
• Adult
• Anti-Ulcer Agents (therapeutic use)
• Chi-Square Distribution
• Confidence Intervals
• Double-Blind Method
• Dyspepsia (complications, drug therapy, etiology)
• Female
• Helicobacter Infections (complications, diagnosis)
• Humans
• Male
• Omeprazole (therapeutic use)
• Quality of Life