Combination therapy of ecabet sodium and cimetidine compared with cimetidine alone for gastric ulcer: prospective randomized multicenter study.

Abstract

BACKGROUND AND AIM:

Little is known about the clinical efficacy of co-therapy of ecabet sodium, a mucoprotective agent, and a histamine H2-receptor antagonist. The aim of the present study was to assess its additive benefit in combination with cimetidine for gastric ulcer.

METHODS:

In this prospective randomized study, after gastric ulcer was confirmed by endoscopy, 200 patients in 47 hospitals received either ecabet sodium 1 g b.i.d and cimetidine 400 mg b.i.d. (EC), or cimetidine 400 mg b.i.d. alone (C) for 8 weeks. Healing was examined by endoscopy at 4 and 8 weeks.

RESULTS:

Of the intention-to-treat (ITT) population (EC, 103; C, 97), 181 patients comprised the per protocol (PP) analysis (EC, 93; C, 88). At 4 weeks, healing rates were significantly higher in the EC group (60%) than in the C group (36%) ( p < 0.01). At 8 weeks, those by the ITT and PP analyses were 82% (EC) versus 58% (C), and 90% (EC) versus 64% (C), respectively ( p < 0.01 and p < 0.001). Symptom relief rates (EC vs C) at 2, 4 and 8 weeks were 73%versus 47% ( p < 0.01), 89%versus 66% ( p < 0.001), and 97%versus 73% ( p < 0.001), respectively. Significant additive effects of ecabet sodium were observed in patients aged 60 years or older, with solitary and medium to large ulcer, and without smoking or drinking habits. No adverse effects were critical.

CONCLUSION:

Ecabet sodium significantly augmented gastric ulcer healing and symptom relief by cimetidine, especially in the elderly.

• Authors: Hiroaki Murata, Sunao Kawano, Shingo Tsuji, Takenobu Kamada, Yuuji Matsuzawa, Kenichi Katsu, Kyouichi Inoue, Kenichi Kobayashi, Syouji Mitsufuji, Tadao Bamba, Hironaka Kawasaki, Gorou Kajiyama, Eiji Umegaki, Msasnori Inoue, Ichimonji Saito
• Journal: Journal of gastroenterology and hepatology (J Gastroenterol Hepatol) Vol. 18 Issue 9 Pg. 1029-33 (Sep 2003) ISSN: 0815-9319 [Print] Australia
• PMID: 12911658 (Publication Type: Clinical Trial, Comparative Study, Journal Article, Multicenter Study, Randomized Controlled Trial, Research Support, Non-U.S. Gov't)

Chemical References

• Abietanes
• Anti-Ulcer Agents
• ecabet
• Cimetidine

Topics

• Abietanes (therapeutic use)
• Adult
• Anti-Ulcer Agents (therapeutic use)
• Cimetidine (therapeutic use)
• Drug Therapy, Combination
• Female
• Humans
• Male
• Middle Aged
• Prospective Studies
• Stomach Ulcer (drug therapy)
• Time Factors