Randomized, double-blind, comparative clinical trial on the efficacy and safety of intralesional sodium stibogluconate and intralesional 7% hypertonic sodium chloride against cutaneous leishmaniasis caused by L. donovani

Abstract

Introduction: Since cutaneous leishmaniasis (CL) is a self healing disease, an ideal therapy should be rapidly effective, easily administered, cheap, available at all times at all centers and should have no side effects.

Objectives: To determine the efficacy and safety of intralesional 7% hypertonic saline in comparison to intralesional sodium stibogluconate against L. donovani CL.

Methods: Intralesional hypertonic saline (HS) and sodium stibogluconate (SSG) were randomly allocated to 154 patients (229 lesions); these were followed-up for 18 months.

Results: The M:F ratio was 1.8:1 (99:55). The average age of our population was 32 years. SSG was given to 87 patients (136 lesions); HS was given to 67 patients (93 lesions). SSG showed a 100% cure rate within one to six injections (average 3.24); HS showed a 92.2% cure rate within one to 10 injections (average 5.27). The average duration of treatment with SSG and HS was 5.11 and 8.78 weeks respectively. There was no difference in efficacy for both therapies with regard to ulcers or papules, and small or large, exposed or unexposed lesions. There was no association between the rapidity of clinical response and the duration and location of lesions. There were no local or systemic side effects except pain during injection. The lesions in the two groups showed post-inflammatory hyperpigmentation after treatment. During 18 months of follow-up there were no recurrences and no visceralization.

Conclusions: The most effective therapy for Leishmania donovani cutaneous leishmaniasis was intralesional SSG (average 3.24 injections). HS was effective, but needed an average of 5.27 injections in total per lesion. HS was cheap, with no risk of systemic side effects and was easily available at all centers.