Background: Cutaneous leishmaniasis (CL) is a major world health problem, which is increasing in incidence. It is highly endemic in the north and east Mediterranean regions in the Syrian Arab Republic, with more than 75.9% of all (CL) cases recorded from these regions. Pentavalent antimonials have been considered as standard treatment for leishmaniasis. Use of pentavalent antimonials to treat leishmaniasis is associated with a range of clinical, laboratory and electrocardiographic adverse effects. The aim of this study was to compare the effect of oral Cimetidine and low dose of systemic Meglumine Antimoniate (MA) with standard dose of systemic (MA) in the treatment of Syrian cutaneous leishmaniasis patients. This study was, to our knowledge, the first to show the effect of combination therapy oral Cimetidine and (MA) in the treatment of cutaneous leishmaniasis all over the world.
Methods: In this randomized double-blinded placebo-controlled clinical trial, Of 120 suspected (CL) patients referred to the Aleppo University Hospital Clinic, 90 patients with the clinical and parasitological diagnosis of (CL) were recruited and were randomly divided into three treatment groups of 30 subjects each. Group (A) was treated with (MA) 60 mg/kg/day/IM and oral placebo. Groups (B) and (C) received (MA) 30 mg/kg/day/IM and oral Cimetidine 1200 mg/day, (MA) 30 mg/kg/day/IM and oral placebo, respectively. The duration of treatment was 3 weeks for all groups. Informed consent was obtained from all the cases. All the patients were visited every two weeks from the beginning of the trial up to six weeks and then at 8 and 12 weeks. The effectiveness of the treatment was classified in three levels as complete response, partial response and no response. Data were analyzed by SPSS 19 using KI square, Mann-Whitney, Kaplan-Mayer and ANOVA tests.