{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,1,13]],"date-time":"2026-01-13T06:29:06Z","timestamp":1768285746374,"version":"3.49.0"},"reference-count":23,"publisher":"American Society of Tropical Medicine and Hygiene","issue":"4","content-domain":{"domain":[],"crossmark-restriction":false},"short-container-title":[],"published-print":{"date-parts":[[2017,10,11]]},"abstract":"<jats:p><jats:italic>Leishmania donovani<\/jats:italic> 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 <jats:italic>L<\/jats:italic>. <jats:italic>donovani<\/jats:italic> CL. A single blinded noninferiority randomized controlled trial was conducted on new laboratory-confirmed CL patients with single lesions (<jats:italic>N<\/jats:italic> = 213). Selected patients were randomly assigned to 1) test group (<jats:italic>N<\/jats:italic> = 98; single session of radiofrequency-induced heat therapy (RFHT) given at 50\u00b0C for 30 seconds) and 2) control group (<jats:italic>N<\/jats:italic> = 115; 1\u20133 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 (<jats:italic>P<\/jats:italic> = 0.009, odds ratio [OR]: 2.236, confidence interval [CI]: 1.217\u20134.108) and 10 weeks (<jats:italic>P<\/jats:italic> = 0.035, OR: 1.881, CI: 1.044\u20133.388), 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 <jats:italic>L. donovani<\/jats:italic> 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.<\/jats:p>","DOI":"10.4269\/ajtmh.16-0879","type":"journal-article","created":{"date-parts":[[2017,8,15]],"date-time":"2017-08-15T07:00:38Z","timestamp":1502780438000},"page":"1120-1126","source":"Crossref","is-referenced-by-count":24,"title":["Efficacy, Safety and Cost-Effectiveness of Thermotherapy in the Treatment of Leishmania donovani\u2013Induced Cutaneous Leishmaniasis: A Randomized Controlled Clinical Trial"],"prefix":"10.4269","volume":"97","author":[{"given":"Wardha F.","family":"Refai","sequence":"first","affiliation":[{"name":"Postgraduate Institute of Medicine, Colombo, Sri Lanka;"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Nayani P.","family":"Madarasingha","sequence":"additional","affiliation":[{"name":"Teaching Hospital Anuradhapura, Anuradhapura, Sri Lanka;"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Buthsiri","family":"Sumanasena","sequence":"additional","affiliation":[{"name":"Teaching Hospital Anuradhapura, Anuradhapura, Sri Lanka;"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Sudath","family":"Weerasingha","sequence":"additional","affiliation":[{"name":"Department of Parasitology, Faculty of Medicine, University of Colombo, Colombo, Sri Lanka;"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Amala","family":"De Silva","sequence":"additional","affiliation":[{"name":"Department of Economics, University of Colombo, Colombo, Sri Lanka;"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Rohini","family":"Fernandopulle","sequence":"additional","affiliation":[{"name":"Department of Pharmacolology, Kotelawala Defense University, Ratmalana, Sri Lanka;"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Abhay R.","family":"Satoskar","sequence":"additional","affiliation":[{"name":"Department of Microbiology, The Ohio State University, Ohio"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Nadira D.","family":"Karunaweera","sequence":"additional","affiliation":[{"name":"Department of Parasitology, Faculty of Medicine, University of Colombo, Colombo, Sri Lanka;"}],"role":[{"role":"author","vocabulary":"crossref"}]}],"member":"2795","reference":[{"key":"b1","author":"Centers for Diease Control and Prevention, 2013"},{"key":"b2","series-title":"Trends Parasitol","first-page":"552","article-title":"Leishmaniasis and poverty","volume":"22","author":"Alvar","year":"2006"},{"key":"b3","first-page":"1","author":"WHO, Control of the leishmaniasis","year":"2010"},{"key":"b4","series-title":"PLoS Negl Trop Dis","first-page":"e259","article-title":"Marring leishmaniasis: the stigmatization and the impact of cutaneous leishmaniasis in Pakistan and 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