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.


OBJECTIVE
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.
Talley
N J
NJ
Department of Medicine, The University of Sydney, Nepean Hospital, Penrith 2747, Sydney, Australia. ntalley@med.usyd.edu.au
Riff
D S
DS
Schwartz
H
H
Marcuard
S P
SP
D015746:Abdominal Pain / Q000188:drug therapy; D000328:Adult; D000409:Alanine / Q000008:administration & dosage / Q000031:analogs & derivatives* / Q000627:therapeutic use*; D000863:Antacids / Q000627:therapeutic use; D000897:Anti-Ulcer Agents / Q000008:administration & dosage / Q000627:therapeutic use*; D004311:Double-Blind Method; D004415:Dyspepsia / Q000188:drug therapy* / Q000382:microbiology; D004884:Eructation / Q000188:drug therapy; D005260:Female; D016481:Helicobacter Infections / Q000150:complications* / Q000453:epidemiology; D016480:Helicobacter pylori / Q000302:isolation & purification; D006801:Humans; D008297:Male; D008875:Middle Aged; D015363:Quinolones / Q000008:administration & dosage / Q000627:therapeutic use*; D016896:Treatment Outcome
D000863:Antacids; D000897:Anti-Ulcer Agents; D015363:Quinolones; C052785:rebamipide; D000409:Alanine