Sofalcone, a gastroprotective drug, promotes gastric ulcer healing following eradication therapy for Helicobacter pylori: a randomized controlled comparative trial with cimetidine, an H2-receptor antagonist.
OBJECTIVE
According to reports in Japanese patients, 1 week of Helicobacter pylori eradication therapy alone is not adequate for healing of gastric ulcers; 7-8 weeks of anti-ulcer therapy are subsequently required. We compared a gastroprotective drug, sofalcone, and an H(2)-receptor antagonist, cimetidine, in terms of promoting ulcer healing after 7 weeks of administration following 1 week of eradication therapy.


METHODS
Eradication therapy was administered to 64 patients with H. pylori-positive active gastric ulcer at least 10 mm in diameter, after which 32 patients each received 7 weeks of ulcer treatment with sofalcone (300 mg/day) or cimetidine (800 mg/day).


RESULTS
The H. pylori eradication rate was 81.3% (intention-to-treat: ITT) and 81.3% (per protocol: PP) in the sofalcone group, and 62.5% (ITT) and 64.5% (PP) in the cimetidine group. The ulcer healing rate after 8 weeks was 71.9% (ITT) and 71.9% (PP) in the sofalcone group, and 71.9% (ITT) and 71.0% (PP) in the cimetidine group. The rate of a flat pattern of scarred mucosa was 43.5% (ITT) and 43.5% (PP) in the sofalcone group, and 47.8% (ITT) and 50.0% (PP) in the cimetidine group. No significant differences were seen between the two groups in terms of H. pylori eradication rate, ulcer healing rate and flat pattern rate.


CONCLUSIONS
Sofalcone promoted gastric ulcer healing during 7 weeks of treatment following 1 week of eradication therapy, and the healing rate was equivalent to that of cimetidine. Symptom disappearance rates were significantly better in the sofalcone group than in the cimetidine group. This may be a useful way of using a gastroprotective drug in the H. pylori era.
Higuchi
Kazuhide
K
Second Department of Internal Medicine, Osaka Medical College, Takatsuki, Osaka, Japan. higuchi@poh.osaka-med.ac.jp
Watanabe
Toshio
T
Tanigawa
Tetsuya
T
Tominaga
Kazunari
K
Fujiwara
Yasuhiro
Y
Arakawa
Tetsuo
T
D000328:Adult; D000368:Aged; D000900:Anti-Bacterial Agents / Q000627:therapeutic use*; D000897:Anti-Ulcer Agents / Q000627:therapeutic use*; D047188:Chalcones / Q000627:therapeutic use*; D016009:Chi-Square Distribution; D002927:Cimetidine / Q000627:therapeutic use*; D016145:Endoscopy, Digestive System; D005260:Female; D005753:Gastric Mucosa / Q000187:drug effects* / Q000382:microbiology / Q000473:pathology; D016481:Helicobacter Infections / Q000188:drug therapy* / Q000382:microbiology / Q000473:pathology; D016480:Helicobacter pylori / Q000187:drug effects*; D006635:Histamine H2 Antagonists / Q000627:therapeutic use*; D006801:Humans; D007564:Japan; D008297:Male; D008875:Middle Aged; D013276:Stomach Ulcer / Q000188:drug therapy* / Q000382:microbiology / Q000473:pathology; D013997:Time Factors; D016896:Treatment Outcome; D014945:Wound Healing / Q000187:drug effects*
D000900:Anti-Bacterial Agents; D000897:Anti-Ulcer Agents; D047188:Chalcones; D006635:Histamine H2 Antagonists; C035032:sofalcone; D002927:Cimetidine