Evaluating the efficacy of allopurinol for the treatment of cutaneous leishmaniasis

Abstract

This study was performed in Corte de Pedra, an area of L. braziliensis braziliensis transmission located 240 km southeast of Salvador, the capital of the state of Bahia in Brazil. This open controlled trial included 34 patients, aged 12 to 45 years, with leishmania-positive skin test and a maximum of three ulcerated lesions (with a minimum lesion diameter of 10 mm and a maximum diameter of 50 mm) who had received no previous treatment. Exclusion criteria included chronic disease, use of other drugs, history of allergy to allopurinol, pregnancy, breast feeding, or forms of leishmaniasis other than cutaneous. Informed consent was obtained from all subjects after the nature of the procedures had been fully explained to them. Randomly selected patients received 20 mg/kg of allopurinol orally, three times a day, or 10 mg/kg of intravenous antimoniate of meglumine, once a day. Both patient groups used the drugs for a period of 20 days. A clinical history was collected and a physical examination was performed on all patients before initiating the treatment. Lesions were photographed and biopsied, and the tissue was used for histopathologic study and inoculation in hamsters and appropriate culture media. Patients were re-examined on days 10 and 20 and at monthly intervals for 1 year following the beginning of treatment. Blood samples for serologic and biochemical analysis (measurements of serum uric acid, urea, crsatinine, and transaminases) were collected at days 0, 10, and 22 following the beginning of treatment. The definition of therapeutic failure included incompletion of the treatment protocol, use of a treatment different from the protocol, lesions not healed 3 months after the beginning of treatment, or relapse or development of new cutaneous or mucosal lesions caused by leishmaniasis within 1 year of treatment. The exact Fischer test was used to compare the treatment results between the two patient groups. Student's t-test was used to compare the age of the patients and the duration of the illness. The Mann-Whitney test was used to compare the diameter of the lesions at day 0 and 3 months after treatment completion in the two groups, and the Kruskal-Wallis test was used to compare the number of lesions per patient and their localization.