Therapeutic Response to Thermotherapy in Cutaneous Leishmaniasis Treatment Failures for Sodium Stibogluconate: A Randomized Controlled Proof of Principle Clinical Trial

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  • 1 Department of Parasitology, Faculty of Medicine, University of Colombo, Colombo, Sri Lanka;
  • 2 Base Hospital Tangalle, Galle, Sri Lanka;
  • 3 District General Hospital Hambantota, Hambantota, Sri Lanka;
  • 4 Teaching Hospital Anuradhapura, Anuradhapura, Sri Lanka;
  • 5 General Sir John Kotelawala Defence University, Dehiwala-Mount Lavinia, Sri Lanka

Treatment failure to intralesional sodium stibogluconate (IL-SSG) is a health challenge for cutaneous leishmaniasis (CL) in Sri Lanka. A randomized controlled proof of principle clinical trial, with two arms (viz., radio frequency–induced heat therapy [RFHT] by a ThermoMed™ device and thermotherapy by a handheld exothermic crystallization thermotherapy for CL [HECT-CL] device) was conducted on 40 CL treatment failures to IL-SSG, from three hospitals in Tangalle, Hambantota, and Anuradhapura, from January 2017 to January 2018, followed up for 180 days post-thermotherapy with a final follow-up in February 2020. Intention-to-treat cure rates were calculated at day 90 (initial cure rate) and at day 180 (final cure rate) posttreatment. Radio frequency–induced heat therapy group: the initial cure rate was 100% (20/20) and the final cure rate was 95% (19/20), with one patient relapsing. The HECT-CL group: both the initial and final cure rates were 80% (16/20), with no relapses and one excluded from the trial. In February 2020 (1.6–3 years posttreatment), 27 traceable patients (RFHT = 16, HECT-CL = 11) remained healed. Second-degree burns were observed with RFHT in 65% (13/20), with HECT-CL in 15% (3/20), which completely resolved subsequently. The cure rates between the two treatment groups were comparable (P = 0.15). Radio frequency–induced heat therapy consumed less time and required only a single hospital visit. Handheld exothermic crystallization thermotherapy for CL is potentially usable at community settings with both being less costly than IL-SSG. This study is the first proof that thermotherapy is an efficacious and safe treatment for CL patients in Sri Lanka, complicated by treatment failure to IL-SSG.

Author Notes

Address correspondence to Nadira Karunaweera, Department of Parasitology, Faculty of Medicine, University of Colombo, Colombo, Sri Lanka. E-mail: nadira@parasit.cmb.ac.lk

Disclaimer: The content is solely the responsibility of the authors and does not necessarily represent the official views of the NIAID, NIH, or the University of Colombo.

Financial support: This study was supported by the University of Colombo research grant (AP/3/2/2016/SG/13) to Hermali Silva and the National Institute of Allergy and Infectious Diseases (NIAID) of the NIH, USA, under award number R01AI099602 and U01AI136033 to Nadira Karunaweera.

Authors’ addresses: Hermali Silva, Sudath Weerasingha, and Nadira Karunaweera, Department of Parasitology, Faculty of Medicine, University of Colombo, Colombo, Sri Lanka, E-mails: hermali@parasit.cmb.ac.lk or hermalisilva@gmail.com, sudathws@yahoo.com, and nadira@parasit.cmb.ac. Achala Liyanage, Department of Community Medicine, Faculty of Medicine, University of Ruhuna, Galle, Sri Lanka, E-mail: achalaliyanage@yahoo.com. Theja Deerasinghe, District General Hospital Embilipitiya, Embilipitiya, Sri Lanka, E-mail: athdeerasinghe@yahoo.com. Buthsiri Sumanasena and Deepani Munidasa, Teaching Hospital Anuradhapura, Anuradhapura, Sri Lanka, E-mails: jam.buth@yahoo.com and deepanimunidasa@yahoo.com. Hiromel de Silva, District General Hospital Matara, Matara, Sri Lanka, E-mail: virajine@gmail.com. Rohini Fernandopulle, General Sir John Kotelawala Defence University, Rathmalana, Sri Lanka, E-mail: rohinifernandopulle@gmail.com.

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