Thermoterapy effective and safer than miltefosine in the treatment of cutaneous leishmaniasis in Colombia

Abstract

SUMMARYIn Colombia, pentavalent antimonials and miltefosine are the drugs of choice for the treatment of cutaneous leishmaniasis; however, their toxicity, treatment duration, (treatment adherence problems), cost, and decreased parasite sensitivity make the search for alternative treatments of American cutaneous leishmaniasis necessary. Based on the results found in a controlled, open, randomized, phase III clinical trial, the efficacy and safety of miltefosine was compared to that of thermotherapy for the treatment of cutaneous leishmaniasis in Colombia. Adult patients from the Colombian army participated in the study; they received either 50 mg of miltefosine three times per day for 28 days by the oral route (n = 145) or a thermotherapy (Thermomed ® ) application of 50 ºC for 30 seconds over the lesion and surrounding area (n = 149). Both groups were comparable with respect to their sociodemographic, clinical, and parasitological characteristics. The efficacy of miltefosine by protocol and by intention to treat was 70% (85/122 patients) and 69% (85/145 patients), respectively. The adverse effects were primarily gastrointestinal for miltefosine and pain at the lesion site after treatment for thermotherapy. No statistically significant difference was found in the efficacy analysis (intention to treat and protocol) between the two treatments. ClinicalTrials.gov: NCT00471705.

Risk factors for therapeutic failure to meglumine antimoniate and miltefosine in adults and children with cutaneous leishmaniasis in Colombia: A cohort study

“…Estimates of treatment failure with meglumine antimoniate (22.03%, 95%CI: 14.48–29.58) are similar to previous reports from Colombian studies [6, 17], although they are lower than reported in other regions of Latin America [11, 12]. In this cohort, the proportion of treatment failure with miltefosine (8.92%, 95%CI: 3.59–14.26) was lower than reported in other studies conducted in children and adults [6, 7], although it was similar to the proportion reported by Soto et al in patients with L . panamensis infection in other regions of Colombia [8].…”

Cost‐effectiveness analysis of thermotherapy versus pentavalent antimonials for the treatment of cutaneous leishmaniasis

“…Both studies concluded that this therapy could be applied to patients with cutaneous leishmaniasis, which is consistent with studies that have shown favorable results of the use of heat or caustic treatments in Latin American rural and indigenous populations . Furthermore, thermotherapy effectiveness gains greater relevance in the treatment of the cutaneous form of the disease, as the following advantages are given: shorter duration; greater adherence; does not require paraclinical examinations; and can be used in patients with kidney, liver, or heart problems, in pregnant women, children, and other groups in which pentavalent antimonials or miltefosine are contraindicated . Moreover, in the systemic therapy, effectiveness can be reduced, and resistance based on incomplete administration or poor adherence can grow day by day …”

Eligibility criteria and outcome measures adopted in clinical trials of treatments of cutaneous leishmaniasis: systematic literature review covering the period 1991–2015

“…Sex was considered an inclusion criterion in 94.3% ( n = 100) of studies enrolling 11 081 patients; 87.7% ( n = 93) enrolled participants of both sexes , seven studies (6.6%) enrolled only men ; in five studies (4.7%), although sex was not specified in the inclusion criteria, inclusions can be derived from the results , and one study did not refer to the sex of the participants (Table ). For pregnancy and lactation, see Exclusion criteria below (Table ).…”