OCTREOTIDE THERAPY OF LARGE-VOLUME REFRACTORY AIDS-ASSOCIATED DIARRHEA - A RANDOMIZED CONTROLLED TRIAL

Objective: To compare the effect of octreotide (a long-acting somatostatin analog) to that of antidiarrheal therapy plus placebo on large-volume refractory AIDS-associated diarrhea. Design: A randomized controlled trial. Setting: Referral-based clinic and hospital in a tertiary care center. Patients: Twenty male patients with AIDS and refractory diarrhea, with stool volume >1000 ml/day who failed to improve after initial supportive management. All patients finished the study. Interventions: Patients were randomly given either octreotide in doses of 100, 200 and 300 mu g subcutaneously every 8 h, or high doses of loperamide and diphenoxylate orally plus placebo subcutaneously for 10 days. Main outcome measures: Bowel movements and stool volume were registered before and every day after treatment by the patients themselves and the nursing personnel. Results: Patients from both groups were similar for age, time of AIDS diagnosis, duration of diarrhea and etiology. Baseline mean bowel movements per day (9.4+/-2.8 in the octreotide group versus 10+/-3.1 in controls) and baseline mean stool volume (2753+/-840 versus 2630+/-630 ml/day, respectively) were similar in both groups before therapy (P<0.05). Mean bowel movements per day after 10 days of therapy was 2.1+/-1.6 in the octreotide group versus 7+/-3 in controls (P<0.05). Mean stool volume after 10 days of therapy was 485+/-480 in the octreotide group versus 1080+/-420 ml/day in controls (P<0.05). Complete response (stool volume <250 ml/day) was observed in two patients from the octreotide group and none from controls; partial response (decrease >50% in stool volume) in four and two; and no response (decrease <50% or no change) in four and eight (P<0.05), respectively. Side-effects occurred in eight out of 10 octreotide patients and three out of 10 controls (P<0.05), but none were significant to result in discontinuation of medication. Conclusion: Octreotide proved to be superior to conventional therapy in this short-term treatment of large-volume refractory AIDS-associated diarrhea.