Double-blind placebo-controlled multicentre studies of rebamipide, a gastroprotective drug, in the treatment of functional dyspepsia with or without Helicobacter pylori infection.

BACKGROUND

Functional dyspepsia is a problem that is difficult to treat in clinical practice.

AIM: To evaluate the efficacy and safety of rebamipide (a cytoprotective drug) in functional dyspepsia.

METHODS

Patients with functional dyspepsia (n=557) were divided a priori into two studies by Helicobacter pylori status, and enrolled in a 2-week baseline evaluation period. Ninety-nine patients with Helicobacter pylori and 173 patients without Helicobacter pylori, continuing to have at least moderate upper abdominal pain or discomfort, were randomly assigned to rebamipide 100 mg, rebamipide 200 mg or placebo, three times a day, in a double-blind design for 8 weeks.

RESULTS

There was significant improvement of individual symptom scores from baseline in all the treatment arms. No significant improvement of individual symptom scores was observed in either rebamipide group at the end of the studies compared to placebo, although the belching score was significantly reduced in the rebamipide 100 mg and 200 mg groups at week 2 (P=0.017 and P=0.012, respectively) in the Helicobacter pylori-positive patients. The ratio of patients who requested usage of the study medication again was greater in the rebamipide 100 mg (85%) and 200 mg (96%, P=0.020) groups compared with the placebo group (72%) among Helicobacter pylori-positive patients. There were no serious study medication related adverse events.

CONCLUSIONS

Rebamipide was not superior to placebo in terms of individual symptoms at the end of treatment.