LOPERAMIDE OXIDE FOR THE TREATMENT OF CHRONIC DIARRHEA IN CROHNS-DISEASE

Loperamide oxide was compared with placebo for the treatment of chroni c diarrhoea in patients with Crohn's disease. After initially receivin g 2 mg loperamide oxide or placebo, hospital out-patients with Crohn's disease were instructed to take one tablet of loperamide oxide (1 mg) or placebo after passage of each unformed stool in a 1-week double-bl ind investigation. Patients who responded to this treatment by passing less than three unformed stools per 24 h continued to receive the dru g, twice daily, for a further week. At the end of the initial 1-week t reatment phase both the investigator's and the patients' global evalua tions of efficacy were significantly in favour of the active treatment (P = 0.025 and P = 0.020, respectively). The investigator's assessmen t of the change in abdominal pain was significant for loperamide oxide (P = 0.020) but not for placebo. Improvements in patient-rated severi ty of diarrhoea were significantly greater for loperamide oxide than f or placebo (P = 0.046). The mean daily dose of loperamide oxide was 2. 7 mg. During the second week, both the investigator's and the patients ' assessments of global efficacy and symptom improvement continued to favour loperamide oxide though the differences were not significant. A dverse events were rare. The results suggest that loperamide oxide (3 mg/per day) provides a safe and effective treatment for the chronic di arrhoea associated with Crohn's disease.