Abstract
BackgroundPentavalent antimonials (Sb5) and miltefosine are the first-line drugs for treating cutaneous leishmaniasis in Colombia; however, toxicity and treatment duration negatively impact compliance and cost, justifying an active search for better therapeutic options. We compared the efficacy and safety of thermotherapy and meglumine antimoniate for the treatment of cutaneous leishmaniasis in Colombia.MethodAn open randomized Phase III clinical trial was performed in five military health centres. located in northwestern, central and southern Colombia. Volunteers with parasitological positive diagnosis (Giemsa-stained smears) of cutaneous leishmaniasis were included. A single thermotherapy session involving the application of 50°C at the center and active edge of each lesion. Meglumine antimoniate was administered intramuscularly at a dose of 20 mg Sb5/kg weight/day for 20 days.ResultsBoth groups were comparable. The efficacy of thermotherapy was 64% (86/134 patients) by protocol and 58% (86/149) by intention-to-treat. For the meglumine antimoniate group, efficacy by protocol was 85% (103/121 patients) and 72% (103/143) by intention-to-treat, The efficacy between the treatments was statistically significant (p 0.01 and <0.001) for analysis by intention to treat and by protocol, respectively. There was no difference between the therapeutic response with either treatment regardless of the Leishmania species responsible for infection. The side effects of meglumine antimoniate included myalgia, arthralgia, headache and fever. Regarding thermotherapy, the only side effect was pain at the lesion area four days after the initiation of treatment.ConclusionAlthough the efficacy rate of meglumine antimoniate was greater than that of thermotherapy for the treatment of cutaneous leishmaniasis, the side effects were also greater. Those factors, added to the increased costs, the treatment adherence problems and the progressive lack of therapeutic response, make us consider thermotherapy as a first line treatment for cutaneous leishmaniasis. Registered ClinicalTrials.gov NCT00471705
Highlights
Pentavalent antimonials (Sb5) and miltefosine are the first-line drugs for treating cutaneous leishmaniasis in Colombia; toxicity and treatment duration negatively impact compliance and cost, justifying an active search for better therapeutic options
Inclusion Criteria Patients included in this study met the following criteria: a) positive parasitologic diagnosis of leishmaniasis, b) no previous treatment for this parasitic infection, c) laboratory exams including renal, hepatic and hematologic testing and d) voluntary agreement to participate in the study
Recurrences Recurrence was reported in 6 (4.1%) and 4 (3%) patients for the thermotherapy and Meglumine antimoniate groups, respectively. All of these patients received Meglumine antimoniate as a rescue treatment, and only one patient, who was assigned to the Meglumine antimoniate group, required a third treatment with amphotericine B
Summary
Pentavalent antimonials (Sb5) and miltefosine are the first-line drugs for treating cutaneous leishmaniasis in Colombia; toxicity and treatment duration negatively impact compliance and cost, justifying an active search for better therapeutic options. Leishmaniasis is a group of diseases caused by parasites from the Leishmania genus. It is transmitted by female insects from the Lutzomyia genus in America and Phlebotomus in the Old World, affecting humans and domestic and wild mammals [1,2]. It is endemic in more than 98 countries. There are 2 million new cases per year, of which 1.5 million present in the cutaneous form [3]. During the years of 2005–2008, 61,120 new cases were diagnosed. 34,262 (56.1%) occurred in National Army soldiers Statistical data (Dirección de Sanidad del Ejército (DISAN))
Sign-in/Register to view highlights & summary Sign-in/Register to access full text options 
Free) 
Talk to us
Join us for a 30 min session where you can share your feedback and ask us any queries you have
Schedule a call
