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The efficacy of fluconazole in the treatment of cutaneous leishmaniasis

Despite the fact that there is confirmed evidence that some oral antifungal azoles are active against leishmania, information on the efficacy of fluconazole in the treatment of leishmaniasis is very limited. In this regard, scientists from Harvard School of Public Health (Brigham) and Women's Hospital (Boston) conducted a double-blind, randomized, placebo-controlled study in Saudi Arabia on the efficacy of fluconazole in confirmed cutaneous leishmaniasis parasitologically caused by Leishmania major.

106 patients received oral fluconazole 200 mg daily for six weeks, 103 patients received a placebo. The main criterion for the outcome of therapy was considered to be complete healing of the skin.

Follow-up data were available for 80 and 65 patients in the two groups, respectively. Over three months, complete recovery occurred in 63 of 80 patients receiving fluconazole (79%) and in 22 of 65 patients receiving placebo (34%). When using the analysis in accordance with the intention to apply the intervention, the data were 59% for patients receiving fluconazole and 22% in the placebo group.

In 11 patients receiving fluconazole (14%) and 33 patients (51%) receiving placebo, treatment was considered to be ineffective and offered treatment with sodium stibogluconate.

Kaplan-Mayer's analysis showed that the healing time was shorter in the fluconazole group (on average 8.5 weeks compared to 11.2 weeks in the placebo group, p less than 0.001). Adverse events were similar, moderately expressed and did not differ in frequency of occurrence in the two groups.

The study suggests that a six-week oral treatment with fluconazole is a safe and effective treatment for cutaneous leishmaniasis caused by L. major.