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Combination of enprostil and cimetidine is more effective than cimetidine alone in treating gastric ulcer: prospective multicenter randomized controlled trial.

AbstractBACKGROUND/AIMS:
Little is known about the clinical efficacy of co-therapy of enprostil, a prostaglandin E2 analogue, with a histamine H2-receptor antagonist. We aimed to assess the additive benefit of enprostil in combination with cimetidine for treating gastric ulcer in a prospective multicenter randomized controlled trial.
METHODOLOGY:
In 43 hospitals 171 intention-to-treat (ITT) patients, diagnosed as having gastric ulcer by endoscopy, were randomly allocated to receive either enprostil 25microg b.i.d. and cimetidine 400mg b.i.d. (Group E=85), or cimetidine 400mg b.i.d. alone (Group C=86) for 8 weeks. Healing was examined by endoscopy at 4 and 8 weeks.
RESULTS:
Per protocol (PP) analysis comprised 166 patients (E=82, C=84). Despite no significant advantage at 4 weeks (E=55.3%, C=42.2%), the combination yielded higher healing rates at 8 weeks by ITT (E=89.4%, C=68.6%; p<0.001) and PP analysis (E=92.7%, C=70.2%; p<0.001). Symptom relief rates [E, C] at 2, 4, and 8 weeks were [80.2%, 68.3%] (not significant), [97.4%, 88.3%] (p<0.05), and [95.6%, 87.0%] (p<0.05), respectively. Significant advantage was observed in the patients aged 40 or older, with solitary ulcer (>5mm in diameter), and without smoking or drinking habits. No adverse effects were critical.
CONCLUSIONS:
Enprostil safely and significantly augmented gastric ulcer healing and symptom relief by cimetidine.
AuthorsHiroaki Murata, Sunao Kawano, Shingo Tsuji, Masahiko Tsujii, Masatsugu Hori, Takenobu Kamada, Yuuji Matsuzawa, Kenichi Katsu, Kyouichi Inoue, Kenichi Kobayashi, Syouji Mitsufuji, Tadao Bamba, Hironaka Kawasaki, Goro Kajiyama, Euji Umegaki, Masanori Inoue, Ichimonji Saito
JournalHepato-gastroenterology (Hepatogastroenterology) 2005 Nov-Dec Vol. 52 Issue 66 Pg. 1925-9 ISSN: 0172-6390 [Print] Greece
PMID16334808 (Publication Type: Comparative Study, Journal Article, Multicenter Study, Randomized Controlled Trial, Research Support, Non-U.S. Gov't)
Chemical References
  • Cimetidine
  • Enprostil
Topics
  • Adult
  • Aged
  • Cimetidine (administration & dosage)
  • Dose-Response Relationship, Drug
  • Drug Administration Schedule
  • Drug Therapy, Combination
  • Enprostil (administration & dosage)
  • Female
  • Follow-Up Studies
  • Gastric Mucosa (pathology)
  • Gastroscopy
  • Humans
  • Japan
  • Male
  • Middle Aged
  • Probability
  • Prospective Studies
  • Recurrence
  • Risk Assessment
  • Severity of Illness Index
  • Statistics, Nonparametric
  • Stomach Ulcer (drug therapy, pathology)
  • Treatment Outcome

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