Background and aim: Cutaneous leishmaniasis (CL) is endemic in Iran and many other countries. The use of pentavalent antimony compounds for the treatment of this disease is associated with serious side effects. There have been reports of the effect of the extract of Berberis vulgaris root on leishmania major, both in vitro and in vivo. The goal of the present study was to investigate the effect of an alcoholic extract of this plant on experimental L. major ulcers in BALB/c mice. The experiment was conducted in 2006 by the Department of Parasitology, Kashan University of Medical sciences.

Materials and Methods: We used different concentrations of an alcoholic extract of Berberis vulgaris in the form of an ointment. Ninety BALB/c mice received a subcutaneous inoculation of 0.1 ml liquid-phase culture of infective L. major (MRHO/IR/75/ER standard variety) in the base of their tail. Ulcers appeared after 30-35 days and these were divided into 5 groups: 3 groups received treatment with 20%, 40%, and 80% concentrations and the remaining 2 groups served as controls. The extract was used applied topically, three times a day for 30 days. Each weak we measured the diameter of the lesions and the animals' weight. After preparation and staining, we determined the number of parasites in lesions through microscopic examinations. Results were recorded on paper and analyzed with the use of Student's t and Fisher's exact tests as well as analysis of variance and Tokey's post-hoc tests.

Results: With the 20% preparation: By the end of the treatment period, the mean diameter of the lesions had decreased, with complete healing in 5 mice (27.7%), (p< 0.001). By the time of the decrease in diameter, the mean weight of the animals had increased and the number of parasites in the lesions had declined (80%). Total elimination of the parasites was observed in 12 animals (p<0.001).
At a concentration of 40%: Mean ulcer diameter decreased, with complete healing in 2 mice (11.1%, p<0.001). By the time of the decrease in diameter, the mean weight of the mice had increased (p<0.05). The mean number of parasites in lesions decreased (64.3%), with total elimination in 9 animals (p< 0.05).

Conclusion: We showed that the extract of Berberis vulgaris is most effective at a concentration of 20%, causing greater reductions in both ulcer diameter and the number of parasites in the lesions compared to other preparations. Therefore, we suggest the use of a 20% extract for the treatment of human cases.