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


CONCLUSIONS
Ecabet sodium significantly augmented gastric ulcer healing and symptom relief by cimetidine, especially in the elderly.
Murata
Hiroaki
H
Department of Internal Medicine and Therapeutics, Osaka University Graduate School of Medicine, 1-7 Yamada-Oka, Suita-City, Osaka 565-0871, Japan.
Kawano
Sunao
S
Tsuji
Shingo
S
Kamada
Takenobu
T
Matsuzawa
Yuuji
Y
Katsu
Kenichi
K
Inoue
Kyouichi
K
Kobayashi
Kenichi
K
Mitsufuji
Syouji
S
Bamba
Tadao
T
Kawasaki
Hironaka
H
Kajiyama
Gorou
G
Umegaki
Eiji
E
Inoue
Msasnori
M
Saito
Ichimonji
I
D045784:Abietanes / Q000627:therapeutic use*; D000328:Adult; D000897:Anti-Ulcer Agents / Q000627:therapeutic use*; D002927:Cimetidine / Q000627:therapeutic use*; D004359:Drug Therapy, Combination; D005260:Female; D006801:Humans; D008297:Male; D008875:Middle Aged; D011446:Prospective Studies; D013276:Stomach Ulcer / Q000188:drug therapy*; D013997:Time Factors
D045784:Abietanes; D000897:Anti-Ulcer Agents; C061681:ecabet; D002927:Cimetidine