Randomized, double-blind study on intralesional metronidazole versus intralesional sodium stibogluconate in Leishmania donovani cutaneous leishmaniasis

Abstract

Objectives: The aim of our study was to assess the efficacy of intralesional metronidazole on Leishmania donovani cutaneous leishmaniasis (CL).

Material and methods: A total of 188 patients with CL were randomly allocated to intralesional sodium stibogluconate (SSG) and intralesional metronidazole. Cure was assessed after 1–10 injections. Cure rates were assessed for statistical significance using chi-square test at p = .05 level (SLCTR/2014/028).

Results: When the treatment cutoff was taken at 100%, the rate of cure for SSG (n = 64, 65.6%) was higher than that of metronidazole (n = 45, 48.9%): statistically significant at p < .05 level (Yates corrected chi-square 5.37, df = 1, p < .5). When the treatment cutoff was taken at >80%, the rate of cure for SSG (n = 75, 77.1%) was also higher than that of metronidazole (n = 58, 63.0%): statistically significant at p < .05 level (Yates corrected chi-square 4.46, df = 1, p < .5). Since it is based on a smaller sample, we estimated the statistical power of the test at a cutoff of 100% [above 80%] results identified a risk ratio of 1.4 [1.3], and a statistical power based on normal approximation at 74.8% [70.0%], respectively.

Conclusion: This study showed that intralesional SSG has the best response against CL, while intralesional metronidazole was an effective alternative treatment.

Keywords:

• Cutaneous leishmaniasis
• Leishmania donovani
• metronidazole
• sodium stibogluconate

Acknowledgements

We thank FAIRMED FOUNDATION Sri Lanka and Sri Lanka Medical Association for funding this research.

Disclosure statement

The authors report no conflicts of interest.

Additional information

Funding

This study was funded by the Sri Lanka Medical Association/FAIRMED FOUNDATION Research grants 2015.