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 tookplacebo. 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.
RCT Entities:
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.
Authors: R W Van der Hulst; E A Rauws; B Köycü; J J Keller; M J Bruno; J G Tijssen; G N Tytgat Journal: Gastroenterology Date: 1997-10 Impact factor: 22.682
Authors: M Asaka; K Satoh; K Sugano; T Sugiyama; S Takahashi; Y Fukuda; H Ota; K Murakami; K Kimura; T Shimoyama Journal: Helicobacter Date: 2001-09 Impact factor: 5.753
Authors: K Higuchi; Y Fujiwara; K Tominaga; T Watanabe; M Shiba; S Nakamura; N Oshitani; T Matsumoto; T Arakawa Journal: Aliment Pharmacol Ther Date: 2003-01 Impact factor: 8.171
Authors: K Higuchi; T Arakawa; H Nebiki; T Uchida; Y Fujiwara; K Ando; K Yamasaki; O Takaishi; T Fukuda; K Kobayashi; T Kuroki Journal: Dig Dis Sci Date: 1998-09 Impact factor: 3.199