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A comparative study on the efficacy of combination therapy with omeprazole and low dose systemic meglumine antimoniate (Glucantime)and the full dose systemic meglumine antimoniate in the treatment of cutaneous leishmaniasis

Background and Objective : Pentavalent antimony compounds are the first line treatment of cutaneous leishmaniasis. However, because of their potential toxic effects attempts to find more effective and safer drugs still is in function. The objective of this study was to compare the efficacy of oral omeprazole and low dose systemic meglumine antimoniate (MA) and full dose systemic MA in the treatment of cutaneous leishmaniasis. Materials and Methods: A double blind clinical trial was performed on 150 patients with cutaneous leishmaniasis. The patients were randomly divided to three groups: 1)intramuscular injections of MA (60 mg/kg/day) and oral placebo for three weeks; 2) intramuscular injections of MA (30 mg/kg/day) and oral omeprazole (40 mg/day) for three weeks; 3) intramuscular injections of MA (30 mg/kg/day) and oral placebo for three weeks. All patients were visited every two weeks from the beginning of the trial up to 6 weeks and then at 8 and 12 weeks. The effectiveness of the treatment was classified in three levels as complete response, partial response and failure. Data were analyzed by SPSS software version 10 by using X2 , Mann-Whitney, Kaplan-Mayer and ANOVA t tests. Results: Three months after the treatment, complete response and partial response in group one (43 patients) were 93% and 0%, respectively, which were significantly higher than other two groups (P<0.05). Complete response and partial response were 88.9% and 2.8% in group two (36 patients), and 80% and 2.2% in group three (45 patients), respectively. Efficacy of the treatment in group two was significantly higher than group three (P<0.05). Conclusion: Although oral omeprazole and low dose of systemic MA showed less efficacy in comparison to standard dose of systemic MA in treatment of cutaneous leishmaniasis, it can be considered as an alternative therapy in high risk patients (such as patients with heart, kidney and/or liver disease) under close supervision of specialized physician.