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.
PIP: One of the principal features of AIDS in Africa is the diarrhea wasting syndrome known as "slim disease." Although several researchers have tried to identify the pathogens implicated in diarrhea, none can be found in a large proportion of cases. Treatment regimens must be particularly effective in Africa, a region with many competing demands upon the drug budget. In this context, the authors compared the effects of a placebo against the effects of a drug regimen against diarrhea in 28 HIV-seropositive patients with chronic diarrhea. The regimen of combined chemotherapy with tinidazole, thiabendazole, and cotrimoxazole would be expected to eradicate or substantially many of the pathogens most frequently implicated in such cases. There were 38 diarrhea-free days out of 89 in the placebo group and 39 out of 72 in the chemotherapy group; a difference which was not statistically significant. The high level of spontaneous remission observed in this study most likely indicates a natural fluctuation in stool frequency and demonstrates the need for placebo-controlled studies in any assessment of therapy for AIDS diarrhea. The authors stress that the small number of patients involved in the study precludes them from ruling that the combined chemotherapy is ineffective.