Background: This randomized, double-blind study compared the efficacy of Helicobacter pylori eradication against prokinetics in H. pylori-infected functional dyspepsia patients.
Methods: Patients with moderately severe or severe dyspepsia fulfilling the Rome II criteria were randomized to either H. pylori eradication for 1 week and 6 weeks of placebo prokinetics or 6 weeks of prokinetics and placebo H. pylori eradication in the first week. Symptoms were assessed at baseline and at 6 and 12 months using the Glasgow Dyspepsia Severity Score (GDSS). Global response to treatment was assessed at 12 months.
Results: Altogether 130 patients were enrolled (H. pylori eradication, 71; prokinetics, 59). The mean baseline GDSS was 9.3 for the H. pylori eradication group and 8.9 for the prokinetic group. At 6 months, the score was 3.6 and 4.1, respectively, and it remained at 3.5 and 3.8, respectively, at 12 months. With H. pylori eradication, 31.0% had complete symptom resolution (GDSS 0 or 1) at 12 months compared with 23.7% with prokinetics (a nonsignificant difference). At 12 months, global symptomatic improvement was seen in 62.0% of the H. pylori eradication group compared with 67.8% of the prokinetics group.
Conclusions: Both H. pylori eradication and prokinetic therapy resulted in symptom improvement in two-thirds of dyspeptic patients at 1 year. More patients tended to achieve complete symptom relief with H. pylori eradication.