Effects of rebamipide, a gastro-protective drug on the Helicobacter pylori status and inflammation in the gastric mucosa of patients with gastric ulcer: a randomized double-blind placebo-controlled multicentre trial.
OBJECTIVE
To investigate the effects of rebamipide on the Helicobacter pylori eradication rate with amoxicillin and omeprazole. The trial also examined its histological effects on gastro-mucosal inflammation after eradication.


METHODS
Two hundred and six H. pylori-positive patients with active gastric ulcer underwent 8-week based therapy (OA) consisting of 2-week amoxicillin with omeprazole and subsequent 6-week omeprazole. They randomly received either rebamipide (OA-R) or placebo (OA-P) for 16 weeks: combined with the OA based therapy, and subsequently for another 8 weeks. Besides eradication rate, inflammatory findings of gastric mucosa after eradication were evaluated histologically.


RESULTS
Per Protocol Set analysis showed no significant difference in eradication rate between OA-R (64.6%; 95% confidence interval, 54.3-75.0%) and OA-P (67.9%; 95% CI, 57.6-78.3%). Histological findings in the gastric mucosa of the ulcer region, however, indicated a significant improvement (P = 0.017) in inflammation scores in OA-R (1.84 +/- 0.41) compared with that in OA-P (2.02 +/- 0.39) after 16-weeks of treatment. This suppressive effect on inflammation was observed even in the OA-R patients unsuccessfully eradicated.


CONCLUSIONS
Rebamipide demonstrated a suppressive effect on the persistent and possibly chronic inflammation in the gastric mucosa of the ulcer region after eradication, but the drug did not improve the eradication rate.
Fujioka
T
T
Department of General Medicine, Oita Medical University, Oita, Japan. FUJIOKA@oita-med.ac.jp
Arakawa
T
T
Shimoyama
T
T
Yoshikawa
T
T
Itoh
M
M
Asaka
M
M
Ishii
H
H
Kuwayama
H
H
Sato
R
R
Kawai
S
S
Takemoto
T
T
Kobayashi
K
K
D000328:Adult; D000368:Aged; D000409:Alanine / Q000031:analogs & derivatives* / Q000627:therapeutic use*; D000897:Anti-Ulcer Agents / Q000627:therapeutic use*; D004311:Double-Blind Method; D005260:Female; D005753:Gastric Mucosa / Q000382:microbiology; D005756:Gastritis / Q000188:drug therapy*; D016481:Helicobacter Infections / Q000188:drug therapy*; D016480:Helicobacter pylori; D006801:Humans; D008297:Male; D008875:Middle Aged; D015363:Quinolones / Q000627:therapeutic use*; D013276:Stomach Ulcer / Q000188:drug therapy*
D000897:Anti-Ulcer Agents; D015363:Quinolones; C052785:rebamipide; D000409:Alanine