A comparative study between the efficacy of oral cimetidine and low-dose systemic
meglumine antimoniate (MA) with a standard dose of systemic MA in the treatment
of cutaneous leishmaniasis.
Author(s): Shanehsaz SM(1), Ishkhanian S(1).
Affiliation(s): Author information:
(1)Department of Dermatology and Venereology, Aleppo University Hospital, Aleppo,
Syria.
Publication date & source: 2015, Int J Dermatol. , 54(7):834-8
Cutaneous leishmaniasis (CL) is a major world health problem, which is increasing
in incidence. Pentavalent antimonials have been considered as standard treatment
for leishmaniasis. Many studies are performed to find an effective and safe
treatment for patients with CL. The aim of this study was to compare the effect
of oral cimetidine and low-dose systemic meglumine antimoniate (MA) with standard
dose of systemic MA in the treatment of CL. This study was, to our knowledge, the
first to show the effect of combination therapy oral cimetidine and MA in the
treatment of CL all over the world. In this randomized double-blind
placebo-controlled clinical trial, 120 patients with suspected CL were referred
to the Aleppo University Hospital Clinic; 90 of these 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/d IM and oral placebo. Groups B and C received MA 30 mg/kg/d IM and oral
cimetidine 1200 mg/d, MA 30 mg/kg/d IM and oral placebo, respectively. The
duration of treatment was three weeks for all groups. 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. At the end of the study (12 weeks), the rate of
complete response was 91.11% in the first group, and 84.66% and 78.33% in groups
B and C, respectively (P < 0.05). The highest response rate was for the group
treated with a standard dose of systemic MA and placebo. Our results showed that
although oral cimetidine and low-dose systemic MA had less efficacy in comparison
to a standard dose of systemic MA in the treatment of CL, it still can be
considered as a replacement therapy in high-risk patients (such as patients with
heart, kidney, and/or liver disease) under close supervision of physicians.
|