Placebo-Controlled Clinical Trial of Meglumine Antimonate (Glucantime) Vs. Localized Controlled Heat in the Treatment of Cutaneous Leishmaniasis in Guatemala

Navin, Thomas R.; Arana, Byron; Arana, Flora E.; Mérida, A M de; Castillo, Agustín Diez; Pozuelos, J L

doi:10.4269/ajtmh.1990.42.43

Cited by 123 publications

(100 citation statements)

References 0 publications

Supporting

Mentioning

Contrasting

Unclassified

Order By: Relevance

“…14 Only patients with positive cultures or clearly distinguishable amastigotes entered the study. As reported in previous studies, most of the patients (75%) we studied are infected with L. braziliensis, and the rest (25%) are infected with L. mexicana [15][16][17] ; therefore, no characterization of Leishmania parasites was performed. Surprisingly, despite the high incidence of L. braziliensis infections, very few cases of mucocutaneous leishmaniasis were found in the study area (Arana B, unpublished data).…”

Section: Patientsmentioning

confidence: 96%

Randomized, controlled, double-blind trial of topical treatment of cutaneous leishmaniasis with paromomycin plus methylbenzethonium chloride ointment in Guatemala.

Arana¹,

Mendoza²,

Rizzo³

et al. 2001

The American Journal of Tropical Medicine and Hygiene

114

View full text Add to dashboard Cite

Abstract. A double-blind, randomized trial was undertaken in Guatemala to determine the therapeutic efficacy of an ointment for the treatment of cutaneous leishmaniasis that contained 15% paromomycin and 12% methylbenzethonium chloride and that was applied twice a day for 20 days. The treatment group included 35 patients, and the placebo group included 33 patients. The initial clinical response rate (13 weeks after completing the treatment) was 91.4% in the treatment group and 39.4% in the placebo group. The final clinical response rate at the 12-month followup examination was 85.7% (31 of 35) in the treatment group and 39.4% (13 of 33) in the placebo group (P Յ 0.001). In general, the treatment was well tolerated and was never interrupted because of adverse effects. The number of adverse effects reported in the placebo group was lower than in the treatment group (16 events versus 30 events). All adverse effects reported by patients disappeared within 1 week of completing the treatment. Our findings show that the combination of paromomycin with methylbenzethonium chloride for 20 days is a good alternative for antimonial treatments of cutaneous leishmaniasis in Guatemala.

show abstract

Section: Patientsmentioning

confidence: 96%

Randomized, controlled, double-blind trial of topical treatment of cutaneous leishmaniasis with paromomycin plus methylbenzethonium chloride ointment in Guatemala.

Arana¹,

Mendoza²,

Rizzo³

et al. 2001

The American Journal of Tropical Medicine and Hygiene

114

View full text Add to dashboard Cite

show abstract

“…Thermotherapy has proven efficacious in the treatment of CL in adults in Old and New World settings, with cure rates from 58% to 75% for CL caused by L. braziliensis or L. panamensis and from 69% to 73% for L. tropica and L. major. [26][27][28][29][30] Tolerability of thermotherapy for young children, who can require multiple treatments to achieve clinical resolution, has not been evaluated. A recent study of intralesional treatment of CL in patients 12 years of age and older in Bolivia reported 70% efficacy and was considered an attractive therapeutic alternative for approximately 49% of patients having infections attributable to L. braziliensis who met the criteria of single lesions of less than 900 mm 2 .…”

Section: Discussionmentioning

confidence: 99%

Clinical and Epidemiologic Profile of Cutaneous Leishmaniasis in Colombian Children: Considerations for Local Treatment

Blanco¹,

Cossio²,

Martinez³

et al. 2013

The American Society of Tropical Medicine and Hygiene

View full text Add to dashboard Cite

Abstract. Treatment alternatives have seldom been evaluated in children with cutaneous leishmaniasis (CL). We examine the clinical/epidemiological profile of children with CL considering international guidelines for local treatment. Descriptive analyses were conducted using International Center for Medical Research and Training (CIDEIM) case reports of parasitologically diagnosed patients 14 years of age from 2004 to 2010. Eligibility for local treatment based on World Health Organization/Pan American Health Organization (WHO/PAHO) criteria was determined. Among 380 children, 90% presented lesions of 3 months duration, 54% presented single lesions 30 mm in diameter, and 45% were 5 years old. Lesions on the head and neck were more frequent among children 0-5 years, and lesions below the head/neck were more frequent among 11-to 14-year-old children (P = 0.004). Using PAHO and WHO criteria, 26% and 53% of children, respectively, were eligible for local treatment. Recommended local treatments for New World CL have potential but limited applicability in children. Individual risk-benefit assessment and effectiveness data in children may increase eligibility.

show abstract

“…The Thermomed ® is an operator, with special devices which achieve and maintain a temperature of 50 ºC. The electrodes are placed locally in the lesion for 30 seconds, the device produces heat waves through radio frequency technology, which extends them to deeper layers of the skin, causing destruction of the amastigotes 10,11,16,19,30 . In Colombia, there has only been one report of the use of thermotherapy in the treatment of CL in a study that focused on patients with an L. guyanensis from the Andean region; however, the elevated number of participant follow-up losses (81%) decreased the power of the study and did not allow for a conclusive efficacy result 29 .…”

Section: Introductionmentioning

confidence: 99%

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

López

Cruz

Godoy

et al. 2013

Rev. Inst. Med. trop. S. Paulo

View full text Add to dashboard Cite

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.

show abstract

Placebo-Controlled Clinical Trial of Meglumine Antimonate (Glucantime) Vs. Localized Controlled Heat in the Treatment of Cutaneous Leishmaniasis in Guatemala

Cited by 123 publications

References 0 publications

Randomized, controlled, double-blind trial of topical treatment of cutaneous leishmaniasis with paromomycin plus methylbenzethonium chloride ointment in Guatemala.

Randomized, controlled, double-blind trial of topical treatment of cutaneous leishmaniasis with paromomycin plus methylbenzethonium chloride ointment in Guatemala.

Clinical and Epidemiologic Profile of Cutaneous Leishmaniasis in Colombian Children: Considerations for Local Treatment

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

Contact Info

Product

Resources

About