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.


METHODS
A randomized controlled trial.


METHODS
Referral-based clinic and hospital in a tertiary care center.


METHODS
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.


METHODS
Patients were randomly given either octreotide in doses of 100, 200 and 300 micrograms subcutaneously every 8 h, or high doses of loperamide and diphenoxylate orally plus placebo subcutaneously for 10 days.


METHODS
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.


CONCLUSIONS
Octreotide proved to be superior to conventional therapy in this short-term treatment of large-volume refractory AIDS-associated diarrhea.
Department of Internal Medicine, University Hospital, Faculty of Medicine, Autonomous University of Nuevo Leon, Monterrey, Mexico.
D
D
Garcia Compean
J
J
Ramos Jimenez
F
F
Guzman de la Garza
C
C
Saenz
H
H
Maldonado
R F
RF
Barragan
H
H
Michel
D000163:Acquired Immunodeficiency Syndrome / Q000150:complications*; D000328:Adult; D017668:Age of Onset; D003967:Diarrhea / Q000188:drug therapy* / Q000209:etiology; D004157:Diphenoxylate / Q000627:therapeutic use; D004305:Dose-Response Relationship, Drug; D004359:Drug Therapy, Combination; D006801:Humans; D008139:Loperamide / Q000627:therapeutic use; D008297:Male; D008875:Middle Aged; D015282:Octreotide / Q000009:adverse effects / Q000627:therapeutic use*; D010919:Placebos; D013997:Time Factors
D010919:Placebos; D008139:Loperamide; D004157:Diphenoxylate; D015282:Octreotide