Anti-inflammatory effects of rebamipide according to Helicobacter pylori status in patients with chronic erosive gastritis: a randomized sucralfate-controlled multicenter trial in China-STARS study.
The aim of the study was to investigate the effects of rebamipide on symptom, histology, endogenous prostaglandin, and mucosal oxygen free radicals in chronic erosive gastritis (CEG) patients by using sucralfate as a control. The trial also examined whether Helicobacter pylori infection would affect rebamipide-induced protection. A total of 453 endoscopy-confirmed CEG patients from 11 hospitals in China were enrolled in the study. They randomly received either rebamipide (100 mg t.i.d) or sucralfate (1.0 t.i.d) for 8 weeks with a ratio of 3:1. Per-protocol analysis (n = 415) showed the accumulated symptom score in the rebamipide group dropped from 5.54 +/- 0.97 to 0.80 +/- 0.47 after 8 weeks (P < 0.001 versus control). The endoscopic inflammation score in rebamipide group also decreased from 2.65 +/- 0.09 to 0.60 +/- 0.10, which showed better effects than sucralfate. It was shown a significant improvement (P < 0.01) in prostaglandin E2 (PGE(2)) contents in rebamipide-treated subjects mucosa (225.4 +/- 18.3 pg/g versus 266.7 +/- 14.7 pg/g) compared with that in sucralfate group after 8 weeks of treatment. Malondialdehyde (MDA) contents were significantly depressed both in the trial and control group. When Helicobacter pylori infection was considered, no statistically difference was found in the effect of rebamipide on either symptom or inflammation scores. In conclusion, Rebamipide demonstrated a stronger suppressive effect on the mucosal inflammation in chronic erosive gastritis than sucralfate. The gastroprotection induced by rebamipide is not influenced by H. pylori infection, which indicates its usage in the treatment of H. pylori-associated CEG.
Du
Yiqi
Y
Department of Gastroenterology, Changhai Hospital, Second Military Medical University, Shanghai, 200433, China.
Li
Zhaoshen
Z
Zhan
Xianbao
X
Chen
Jie
J
Gao
Jun
J
Gong
Yanfang
Y
Ren
Jianlin
J
He
Liping
L
Zhang
Zhijian
Z
Guo
Xiaozhong
X
Wu
Jianshen
J
Tian
Zibin
Z
Shi
Ruihua
R
Jiang
Bo
B
Fang
Dianchun
D
Li
Youming
Y
D000328:Adult; D000409:Alanine / Q000031:analogs & derivatives* / Q000627:therapeutic use; D000893:Anti-Inflammatory Agents / Q000627:therapeutic use*; D000897:Anti-Ulcer Agents / Q000627:therapeutic use*; D002681:China; D015232:Dinoprostone / Q000378:metabolism; D005260:Female; D005753:Gastric Mucosa / Q000378:metabolism / Q000382:microbiology; D005756:Gastritis / Q000188:drug therapy* / Q000208:ethnology / Q000382:microbiology*; D016481:Helicobacter Infections / Q000150:complications*; D016480:Helicobacter pylori / Q000472:pathogenicity; D006801:Humans; D008297:Male; D008315:Malondialdehyde / Q000378:metabolism; D008875:Middle Aged; D015363:Quinolones / Q000627:therapeutic use*; D013392:Sucralfate / Q000627:therapeutic use*
D000893:Anti-Inflammatory Agents; D000897:Anti-Ulcer Agents; D015363:Quinolones; D008315:Malondialdehyde; D013392:Sucralfate; D015232:Dinoprostone; C052785:rebamipide; D000409:Alanine