Randomized, Double-blind, Controlled, Comparative Study on Intralesional 10% and 15% Hypertonic Saline Versus Intralesional Sodium Stibogluconate in Leishmania Donovani Cutaneous Leishmaniasis

Background: Intralesional 7% hypertonic saline (HS) has been shown to be effective and safe against Leishmania donovani and Leishmania major cutaneous leishmaniasis (CL), with cure rates of 92% and 96%, respectively. This study was designed to assess the efficacy and safety of 10% and 15% HS in CL.

Methods: A total of 444 patients (643 lesions) were randomly allocated to sodium stibogluconate (SSG), 10% HS and 15% HS at a ratio of 2 : 2 : 1, taking into consideration any unwanted side effects that might arise with 15% HS. The follow-up period was 18 months. Survival analysis using Cox proportional hazard regression was performed to assess the effectiveness of the three treatment modalities. The clinical trial was registered at the Sri Lanka Clinical Trial Registry (SLCTR/2013/024).

Results: Treatment with SSG resulted in a cure rate of 96.3% within one to seven injections (mean: 3.6 injections); the mean (median) duration of treatment was six weeks (6 weeks) per lesion. Treatment with 10% HS showed a cure rate of 93.0% within one to 10 injections (mean: 5.28 injections); the mean (median) duration of treatment was 9.3 weeks (9 weeks) per lesion. Treatment with 15% HS showed a cure rate of 93.6% within two to 10 injections (mean: 5.3 injections); the mean (median) duration of treatment was 11.3 weeks (10.0 weeks) per lesion. Treatment with 10% HS and 15% HS caused cutaneous necrosis in 3.1% and 30.6% of lesions, respectively. Despite continuous data collection for 14 months, we were unable to recruit a sample of sufficient size. Seventeen (3.8%) patients were lost to follow-up, and 24 (5.4%) were partial or non-responders.

Conclusions: This study found 10% HS to be an effective and safe alternative to SSG. Treatment with HS at concentrations of 15% or above was not safe as a result of cutaneous necrosis. Safety was not studied for concentrations of 11-14%, and these concentrations should be avoided pending further evidence. Hypertonic saline is very cheap (< US$1 per 100 ml, whereas SSG is priced at US$160 per 100 ml), is prepared locally and has no systemic side effects and minimal local side effects.