Efficacy, Safety and Cost-Effectiveness of Thermotherapy in the Treatment of Leishmania donovani–Induced Cutaneous Leishmaniasis: A Randomized Controlled Clinical Trial

Wardha F. Refai Postgraduate Institute of Medicine, Colombo, Sri Lanka;

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Nayani P. Madarasingha Teaching Hospital Anuradhapura, Anuradhapura, Sri Lanka;

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Buthsiri Sumanasena Teaching Hospital Anuradhapura, Anuradhapura, Sri Lanka;

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Sudath Weerasingha Department of Parasitology, Faculty of Medicine, University of Colombo, Colombo, Sri Lanka;

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Amala De Silva Department of Economics, University of Colombo, Colombo, Sri Lanka;

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Rohini Fernandopulle Department of Pharmacolology, Kotelawala Defense University, Ratmalana, Sri Lanka;

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Abhay R. Satoskar Department of Microbiology, The Ohio State University, Ohio

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Nadira D. Karunaweera Department of Parasitology, Faculty of Medicine, University of Colombo, Colombo, Sri Lanka;

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DOI:
https://doi.org/10.4269/ajtmh.16-0879
Volume/Issue:
Volume 97: Issue 4
Page(s):
1120–1126
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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 laboratory-confirmed 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°C for 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.

Author Notes

Address correspondence to Nadira D. Karunaweera, Department of Parasitology, Faculty of Medicine, University of Colombo, 25, Kynsey Road, Colombo 8, Sri Lanka. E-mails: nadira@parasit.cmb.ac.lk or nkarunaw@hsph.harvard.edu

Financial support: This study was supported by University of Colombo research grants. NDK is supported by the National Institute of Allergy and Infectious Diseases of the National Institutes of Health under Award Number R01AI099602. The content is solely the responsibility of the authors and does not necessarily represent the official views of the National Institutes of Health.

Authors’ addresses: Wardha F. Refai, Postgraduate Institute of Medicine, Colombo, Sri Lanka, E-mail: wardharefai@yahoo.com. Nayani P. Madarasingha and Buthsiri Sumanasena, Consultant Dermatologist, Teaching Hospital Anuradhapura, Anuradhapura, Sri Lanka, E-mails: nayanimadara@yahoo.com and jam.buth@yahoo.com. Nadira D. Karunaweera and Sudath Weerasingha, Department of Parasitology, Faculty of Medicine, University of Colombo, Sri Lanka, E-mails: nadira@parasit.cmb.ac.lk or nkarunaw@hsph.harvard.edu, and sudathws@yahoo.com. Amala De Silva, Department of Economics, University of Colombo, Sri Lanka, E-mail: amalades@sltnet.lk. Rohini Fernandopulle, Department of Pharmacolology, Kotelawala Defense University, Ratmalana, Sri Lanka, E-mail: rohinifernandopulle@hotmail.com. Abhay R. Satoskar, Department of Microbiology, Ohio State University, Columbus, OH, E-mail: abhay.satoskar@osumc.edu.

Copyright:
© The American Society of Tropical Medicine and Hygiene 2017
Received:
08 Nov 2016
|
Accepted:
02 Jul 2017
|
Published Online:
14 Aug 2017
Cover The American Journal of Tropical Medicine and Hygiene
The American Journal of Tropical Medicine and Hygiene
Print ISSN:
0002-9637
Online ISSN:
1476-1645
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