Randomized, Double‐Blind Study of Stibogluconate Plus Human Granulocyte Macrophage Colony‐Stimulating Factor versus Stibogluconate Alone in the Treatment of Cutaneous Leishmaniasis

Abstract

The response to recombinant human granulocyte macrophage colony-stimulating factor (GM-CSF) in the treatment of cutaneous leishmaniasis was evaluated. Twenty patients with cutaneous leishmaniasis who had lesions for 60 days were enrolled in a double-blind placebo trial of GM-CSF with standard parenteral sodium stibogluconate (20 mg/kg⁻/day⁻) for 20 days. Ten patients were randomized to receive intralesionally injected GM-CSF (200 µg) at enrollment and 1 week after, and 10 patients received saline as placebo. GM-CSF— and antimony-treated patients healed faster than patients who received antimony alone (49 ± 32.8 vs. 110 ± 61.6 days, P < .05). Seven of 10 patients were healed of their lesions before 40 days after therapy in the GM-CSF group, compared with only 1 of 10 patients in the placebo group (relative risk, 7; 95% confidence interval, 1.04–47.00). Thus, GM-CSF plus antimony significantly increased the chance of lesion healing in 40 days.