Document 0773
 DOCN  M9550773
 TI    Octreotide therapy of large-volume refractory AIDS-associated diarrhea:
       a randomized controlled trial.
 DT    9505
 AU    Garcia Compean D; Ramos Jimenez J; Guzman de la Garza F; Saenz C;
       Maldonado H; Barragan RF; Michel H; Department of Internal Medicine,
       University Hospital, Faculty of; Medicine, Autonomous University of
       Nuevo Leon, Monterrey, Mexico.
 SO    AIDS. 1994 Nov;8(11):1563-7. Unique Identifier : AIDSLINE MED/95151233
 AB    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 micrograms 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.
 DE    Acquired Immunodeficiency Syndrome/*COMPLICATIONS  Adult  Age of Onset
       Comparative Study  Diarrhea/*DRUG THERAPY/ETIOLOGY
       Diphenoxylate/THERAPEUTIC USE  Dose-Response Relationship, Drug  Drug
       Therapy, Combination  Human  Loperamide/THERAPEUTIC USE  Male  Middle
       Age  Octreotide/ADVERSE EFFECTS/*THERAPEUTIC USE  Placebos  Time Factors
       CLINICAL TRIAL  JOURNAL ARTICLE  RANDOMIZED CONTROLLED TRIAL

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