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

Background: The efficacy of Hz-receptor antagonists in functional dyspepsia is equivocal and the therapeutic place of proton pump inhibitors in functi onal dyspepsia is unknown, Aim: To evaluate the efficacy of proton pump inhibitor therapy in functiona l dyspepsia. Methods: Patients (n = 1262) with a clinical diagnosis of functional dyspep sia (persistent or recurrent epigastric pain or discomfort for at least 1 m onth and a normal upper gastrointestinal endoscopy) were randomized to rece ive omeprazole 20 mg, 10 mg or identical placebo, for 4 weeks. Symptoms wer e assessed using validated measures, Helicobacter pylori status was determi ned pre-entry by a C-13-urea breath test. Results: On an intention-to-treat analysis (n=1248), complete symptom relie f 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 wi th ulcer-like and reflux-like dyspepsia, complete symptom relief was achiev ed in 40% and 54% on omeprazole 20 mg, and 35% and 45% on omeprazole 10 mg, respectively, compared with 27% and 23% on placebo tall P< 0.05, except om eprazole 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 dyspe psia at standard (20 mg) and low doses (10 mg) but not in patients with dys motility-like dyspepsia.