Comparison of regimens of treatment with sodium stibogluconate in kala-azar.

One hundred and twenty six patients with kala-azar (visceral leishmaniasis) were allocated at random to one of two groups for treatment with sodium stibogluconate. One group was treated for 20 days; in the other group the patients were assessed after 20 days' treatment and treatment was continued if necessary. Both groups were followed up for six months. There was no significant difference in symptomatic outcome between the two groups at 20 days. At six months eight of the patients in the group treated for 20 days had relapsed and 54 were cured. Of the group given more than 20 days' treatment if necessary, 62 were cured and none had relapsed (12 required more than 20 days' treatment). This difference between the two groups was significant. One patient in each group did not respond to sodium stibogluconate, but both were were cured with pentamidine. Altogether 104 patients were cured after 20 days' treatment; 20, including the eight who relapsed, were cured after more than 20 days' treatment. There was no significant difference between the two groups in the side effects of the drug, which were minor. The longer courses of treatment (50 days in one patient) were well tolerated. It is suggested that the traditional six day course of treatment with sodium stibogluconate for kala-azar is grossly inadequate and that a longer course is required to prevent relapse.

RCT Entities:   Population Interventions Outcomes