Rebamipide, a gastro-protective and anti-inflammatory drug, promotes gastric ulcer healing following eradication therapy for Helicobacter pylori in a Japanese population: a randomized, double-blind, placebo-controlled trial.
BACKGROUND
One week of Helicobacter pylori eradication therapy is insufficient for healing of gastric ulcers. We examined the efficacy of rebamipide in gastric ulcer healing following 1 week of eradication therapy in a randomized, double-blind, placebo-controlled trial.


METHODS
Patients with H. pylori-positive gastric ulcer were enrolled and received 1 week of eradication therapy, followed by 100 mg of rebamipide or placebo for 7 weeks. The primary end point was the gastric ulcer healing rate.


RESULTS
Of the 309 patients entered in the trial, 301 completed H. pylori eradication therapy; 154 patients took rebamipide, and 147 took placebo. The healing rate in the rebamipide group was higher than that in the placebo group in the per-protocol analysis-80.0% (104/130) versus 66.1% (82/124) [95% confidence interval (CI), 3.1-24.7; P = 0.013)-and in a full analysis-70.1% (108/154) versus 60.5% (89/147) (95% CI, -1.1 to 20.3; P = 0.080).


CONCLUSIONS
Compared with placebo, rebamipide significantly promoted gastric ulcer healing following 1 week of eradication therapy.
Terano
Akira
A
Department of Gastroenterology, Dokkyo University School of Medicine, Tochigi, Japan.
Arakawa
Tetsuo
T
Sugiyama
Toshiro
T
Suzuki
Hidekazu
H
Joh
Takashi
T
Yoshikawa
Toshikazu
T
Higuchi
Kazuhide
K
Haruma
Ken
K
Murakami
Kazunari
K
Kobayashi
Kenzo
K
D053799:2-Pyridinylmethylsulfinylbenzimidazoles / Q000627:therapeutic use; D000328:Adult; D000409:Alanine / Q000031:analogs & derivatives* / Q000627:therapeutic use; D000658:Amoxicillin / Q000627:therapeutic use; D000900:Anti-Bacterial Agents / Q000627:therapeutic use*; D000897:Anti-Ulcer Agents / Q000627:therapeutic use*; D017291:Clarithromycin / Q000627:therapeutic use; D004311:Double-Blind Method; D016099:Endoscopy, Gastrointestinal; D004791:Enzyme Inhibitors / Q000627:therapeutic use*; D005260:Female; D005500:Follow-Up Studies; D005753:Gastric Mucosa / Q000382:microbiology / Q000473:pathology; D016481:Helicobacter Infections / Q000188:drug therapy* / Q000453:epidemiology / Q000473:pathology; D016480:Helicobacter pylori / Q000302:isolation & purification; D006801:Humans; D007564:Japan / Q000453:epidemiology; D064747:Lansoprazole; D008297:Male; D008875:Middle Aged; D015995:Prevalence; D054328:Proton Pump Inhibitors; D015363:Quinolones / Q000627:therapeutic use*; D012189:Retrospective Studies; D013276:Stomach Ulcer / Q000188:drug therapy* / Q000453:epidemiology / Q000473:pathology; D016896:Treatment Outcome
D053799:2-Pyridinylmethylsulfinylbenzimidazoles; D000900:Anti-Bacterial Agents; D000897:Anti-Ulcer Agents; D004791:Enzyme Inhibitors; D054328:Proton Pump Inhibitors; D015363:Quinolones; D064747:Lansoprazole; D000658:Amoxicillin; D017291:Clarithromycin; C052785:rebamipide; D000409:Alanine
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