M Camilleri1, R K Balm, A R Zinsmeister. 1. Gastroenterology Research Unit, Mayo Clinic and Foundation, Rochester, Minnesota 55905, USA.
Abstract
AIM: To assess the efficacy of a prokinetic agent in the long-term treatment of chronic intestinal dysmotility and the influence of extrinsic denervation. METHODS: We assessed symptoms, compliance and untoward effects in an open, 1-year trial of cisapride, 20 mg t.d.s., in 37 patients with neuropathic forms of chronic intestinal dysmotility. Patients' autonomic function had previously been characterized; effects of cisapride at 12 weeks in a placebo-controlled trial were previously reported. RESULTS:Seventeen patients had idiopathic dysmotility, 11 had diabetes mellitus with autonomic dysfunction, five had had previous gastric surgery and four had neurological syndromes. Median medication compliance was 98.9% for the study period completed by each individual. Median duration of follow-up was 9.5 months; 20 patients completed 1 year of treatment, and 27 of 37 at least 6 months of treatment; seven dropped out because of lack of benefit. Mean total symptom score was significantly reduced at the last observation relative to the entry into the trial; this was particularly the case in those patients without abdominal vagal dysfunction. One patient withdrew because of aggravation of abdominal pain. CONCLUSIONS: During an open, long-term trial, cisapride, 20 mg t.d.s., provided continued symptomatic relief to patients with chronic intestinal dysmotility, particularly those without vagal neuropathy.
RCT Entities:
AIM: To assess the efficacy of a prokinetic agent in the long-term treatment of chronic intestinal dysmotility and the influence of extrinsic denervation. METHODS: We assessed symptoms, compliance and untoward effects in an open, 1-year trial of cisapride, 20 mg t.d.s., in 37 patients with neuropathic forms of chronic intestinal dysmotility. Patients' autonomic function had previously been characterized; effects of cisapride at 12 weeks in a placebo-controlled trial were previously reported. RESULTS: Seventeen patients had idiopathic dysmotility, 11 had diabetes mellitus with autonomic dysfunction, five had had previous gastric surgery and four had neurological syndromes. Median medication compliance was 98.9% for the study period completed by each individual. Median duration of follow-up was 9.5 months; 20 patients completed 1 year of treatment, and 27 of 37 at least 6 months of treatment; seven dropped out because of lack of benefit. Mean total symptom score was significantly reduced at the last observation relative to the entry into the trial; this was particularly the case in those patients without abdominal vagal dysfunction. One patient withdrew because of aggravation of abdominal pain. CONCLUSIONS: During an open, long-term trial, cisapride, 20 mg t.d.s., provided continued symptomatic relief to patients with chronic intestinal dysmotility, particularly those without vagal neuropathy.