Efficacy, safety and cost-effectiveness of thermotherapy in the treatment of leishmania donovani-induced cutaneous leishmaniasis: A randomized controlled clinical trial

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Abstract

Leishmania donovani causes cutaneous leishmaniasis (CL) in Sri Lanka. Standard treatment is multiple, painful doses of intralesional sodium stibogluconate (IL-SSG). Treatment failures are increasingly reported, hence the need to investigate alternatives. Efficacy, safety, and cost-effectiveness of thermotherapy were assessed for the first time for L. donovani CL. A single blinded noninferiority randomized controlled trial was conducted on new laboratoryconfirmed CL patients with single lesions (N = 213). Selected patients were randomly assigned to 1) test group (N = 98; single session of radiofrequency-induced heat therapy (RFHT) given at 50-Cfor 30 seconds) and 2) control group (N= 115; 1-3 mL IL-SSG given weekly, until cure/10 doses). Patients were followed-up fortnightly for 12 weeks to assess clinical cure. Cost of treatment was assessed using scenario building technique. Cure rates by 8, 10, and 12 weeks in RFHT group were 46.5%, 56.5%, and 65.9% as opposed to 28%, 40.8%, and 59.4% in IL-SSG group, with no major adverse events. Cure rate by RFHT was significantly higher at 8 weeks (P = 0.009, odds ratio [OR]: 2.236, confidence interval [CI]: 1.217-4.108) and 10 weeks (P = 0.035, OR: 1.881, CI: 1.044-3.388), but comparable thereafter. Cost of RFHT was 7 times less (USD = 1.54/patient) than IL-SSG (USD = 11.09/patient). A single application of RFHT is safe, cost-effective, and convenient, compared with multiple doses of IL-SSG in the treatment of L. donovani CL. Therefore, RFHT would be considered noninferior as per trial outcome when compared with standard IL-SSG therapy with multiple benefits for the patient and the national health care system.

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Refai, W. F., Madarasingha, N. P., Sumanasena, B., Weerasingha, S., De Silva, A., Fernandopulle, R., … Karunaweera, N. D. (2017). Efficacy, safety and cost-effectiveness of thermotherapy in the treatment of leishmania donovani-induced cutaneous leishmaniasis: A randomized controlled clinical trial. American Journal of Tropical Medicine and Hygiene, 97(4), 1120–1126. https://doi.org/10.4269/ajtmh.16-0879

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