P Kelly1, A Buve. 1. Monze District Hospital, Zambia.
Abstract
OBJECTIVE: To determine whether combined chemotherapy with tinidazole, thiabendazole and cotrimoxazole is more effective than placebo in treatment of AIDS diarrhoea in Zambia. DESIGN: Single-blind prospective comparison in consecutive patients, randomized alternately to placebo or chemotherapy. SETTING:A district hospital in Zambia. PATIENTS: Sixty-four HIV-seropositive patients with chronic diarrhoea were considered for inclusion in the study. Of these, 25 patients were not eligible for randomization (in 13 cases because of spontaneous remission); 11 were randomized, but excluded from the analysis (seven failed to attend for a scheduled visit and four died), leaving 28 patients who completed the study. MAIN OUTCOME MEASURES: Proportion of diarrhoea-free days in the 7 days following treatment, as determined by daily stool counts. RESULTS: There were 38 diarrhoea-free days out of 89 (43%) in the placebo group, and 39 out of 72 (54%) in the chemotherapy group; this difference was not statistically significant. CONCLUSIONS: The high level of spontaneous remission probably indicates a natural fluctuation in stool frequency and demonstrates the need for placebo-controlled studies in any assessment of therapy for AIDS diarrhoea. Our findings do not allow us to conclude that the chemotherapy used is ineffective, since the number of patients was low, but will help in our understanding of the natural history of the disorder and the design of future studies.
RCT Entities:
OBJECTIVE: To determine whether combined chemotherapy with tinidazole, thiabendazole and cotrimoxazole is more effective than placebo in treatment of AIDS diarrhoea in Zambia. DESIGN: Single-blind prospective comparison in consecutive patients, randomized alternately to placebo or chemotherapy. SETTING: A district hospital in Zambia. PATIENTS: Sixty-four HIV-seropositivepatients with chronic diarrhoea were considered for inclusion in the study. Of these, 25 patients were not eligible for randomization (in 13 cases because of spontaneous remission); 11 were randomized, but excluded from the analysis (seven failed to attend for a scheduled visit and four died), leaving 28 patients who completed the study. MAIN OUTCOME MEASURES: Proportion of diarrhoea-free days in the 7 days following treatment, as determined by daily stool counts. RESULTS: There were 38 diarrhoea-free days out of 89 (43%) in the placebo group, and 39 out of 72 (54%) in the chemotherapy group; this difference was not statistically significant. CONCLUSIONS: The high level of spontaneous remission probably indicates a natural fluctuation in stool frequency and demonstrates the need for placebo-controlled studies in any assessment of therapy for AIDS diarrhoea. Our findings do not allow us to conclude that the chemotherapy used is ineffective, since the number of patients was low, but will help in our understanding of the natural history of the disorder and the design of future studies.
Entities:
Keywords:
Acquired Immunodeficiency Syndrome; Africa; Africa South Of The Sahara; Developing Countries; Diarrhea; Diseases; Drugs; Eastern Africa; English Speaking Africa; Hiv Infections; Prospective Studies; Research Methodology; Research Report; Studies; Treatment; Viral Diseases; Zambia