Effect of Ecabet sodium enema on mildly to moderately active ulcerative proctosigmoiditis: An open-label study

OBJECTIVES: Ecabet sodium (ES), a nonabsorbable antigastric ulcer agent, ha s been shown to adhere to the region of an ulcer. It topically enhances gas tric mucosal defensive factors such as the endogenous prostaglandins, capsa icin-sensitive sensory nerves, nitric oxide, and mucin. All of these mucosa l defensive factors play an important role in maintaining the mucosal integ rity of the colon and rectum. Therefore, we investigated the effect of ES i n patients with mildly to moderately active ulcerative proctosigmoiditis. METHODS: In an open-label study, seven patients with mildly to moderately a ctive ulcerative colitis (UC) who had an inflamed mucosa in the rectum and/ or sigmoid and were resistant to 4-wk topical and systemic standard treatme nt were treated with an ES enema b.i.d. for 14 days. The enema consisted of ES (1 g) and tepid water (20 or 50 mi). These patients were assessed by th e Clinical Activity Index, colonoscopically, and histologically before and after the ES therapy. The ES therapy was started after obtaining informed c onsent from the patients. RESULTS: Six of the seven patients responded to therapy and achieved clinic al, endoscopic, and histological remissions. One patient was withdrawn beca use of increased stool frequency. All six patients who completed the study showed a significant change in the mean Clinical Activity Index score from 5.3 +/- 1.4(mean +/- SD) to 0.5 +/- 0.8 (p < 0.05), in the colonoscopic sco re from 3.0 <plus/minus> 0.9 to 0.8 +/- 0.4 (p < 0.05), and in the histolog ical score from 2.7 <plus/minus> 0.5 to 0.5 +/- 0.6 (p < 0.05), and achieve d remission at the end of the study. There were no side effects attributabl e to the ES therapy. Five of the six patients are still in clinical remissi on after a median follow-up period of 5 months. CONCLUSIONS: The ES enemas proved to be a safe and potentially useful adjuv ant therapy currently available for treating patients with mildly to modera tely active ulcerative proctosigmoiditis. A controlled study is necessary t o confirm our results. <(c)> 2001 by Am. Cell. of Gastroenterology.