Chemotherapy of African AIDS diarrhoea: a preliminary study.

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.