Loperamide oxide for the treatment of chronic diarrhoea in Crohn's disease.
Loperamide oxide was compared with placebo for the treatment of chronic diarrhoea in patients with Crohn's disease. After initially receiving 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-blind investigation. Patients who responded to this treatment by passing less than three unformed stools per 24 h continued to receive the drug, twice daily, for a further week. At the end of the initial 1-week treatment phase both the investigator's and the patients' global evaluations of efficacy were significantly in favour of the active treatment (P = 0.025 and P = 0.020, respectively). The investigator's assessment of the change in abdominal pain was significant for loperamide oxide (P = 0.020) but not for placebo. Improvements in patient-rated severity of diarrhoea were significantly greater for loperamide oxide than for 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. Adverse events were rare. The results suggest that loperamide oxide (3 mg/per day) provides a safe and effective treatment for the chronic diarrhoea associated with Crohn's disease.
van Outryve
M
M
Department of Gastroenterology, University Hospital of Antwerp, Belgium.
Toussaint
J
J
D000293:Adolescent; D000328:Adult; D000368:Aged; D000930:Antidiarrheals / Q000009:adverse effects / Q000627:therapeutic use*; D001835:Body Weight; D002648:Child; D003424:Crohn Disease / Q000503:physiopathology*; D003967:Diarrhea / Q000188:drug therapy* / Q000209:etiology; D004311:Double-Blind Method; D005260:Female; D006801:Humans; D008139:Loperamide / Q000009:adverse effects / Q000031:analogs & derivatives* / Q000627:therapeutic use; D008297:Male; D008875:Middle Aged; D010146:Pain; D010147:Pain Measurement; D010919:Placebos
D000930:Antidiarrheals; D010919:Placebos; D008139:Loperamide; C066043:loperamide oxide