Efficacy, Safety and Cost-Effectiveness of Thermotherapy in the Treatment of Leishmania donovani–Induced Cutaneous Leishmaniasis: A Randomized Controlled Clinical Trial
| Autor: | Nayani P. Madarasingha, Abhay R. Satoskar, Amala De Silva, Buthsiri Sumanasena, Nadira D. Karunaweera, Wardha F. Refai, Rohini Fernandopulle, Sudath Weerasingha |
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| Rok vydání: | 2017 |
| Předmět: |
Adult
Male medicine.medical_specialty Adolescent Sodium stibogluconate Cost effectiveness medicine.medical_treatment 030231 tropical medicine Leishmaniasis Cutaneous law.invention Young Adult 03 medical and health sciences 0302 clinical medicine Cutaneous leishmaniasis Randomized controlled trial law Virology Internal medicine medicine Humans 030212 general & internal medicine Child Adverse effect business.industry Standard treatment Articles Hyperthermia Induced Middle Aged medicine.disease Heat therapy Surgery Clinical trial Infectious Diseases Antimony Sodium Gluconate Leishmaniasis Visceral Female Parasitology business Leishmania donovani medicine.drug |
| Zdroj: | The American Journal of Tropical Medicine and Hygiene. 97:1120-1126 |
| ISSN: | 1476-1645 0002-9637 |
| DOI: | 10.4269/ajtmh.16-0879 |
| Popis: | 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. |
| Databáze: | OpenAIRE |
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