Abstract

Cutaneous leishmaniasis (CL) is most common form of leishmaniasis and is characterized by ulcerative skin lesions. The objective of this study was to conduct a systematic review and meta-analysis of clinical trials that compared the efficacy of miltefosine and glucantime for the treatment of CL. We searched the following databases: Cochrane, PubMed, Embase, Scopus, Web of Science, ProQuest, Cochrane Central Register of Controlled Trials, International Clinical Trials Registry Platform search portal of World Health Organization, Sid, Irandoc, Magiran, and clinicaltrials.gov. We used keywords including “miltefosine,” “glucantime,” and “Leishmania.” The quality of studies was assessed using the Cochrane risk of bias tool. A random-effects model was employed for the analysis. We assessed heterogeneity by the chi-square test and the I2 index statistic. When heterogeneity was present, meta-regression analyses were performed. The Egger method was used to assess publication bias; when it was significant, the trim-and-fill method was used to test and adjust for publication bias. A total of 1,570 reports were identified, of which 10 studies were included in the meta-analysis. In the meta-analysis, there was no significant difference between the efficacy of miltefosine and glucantime; however, subgroup analysis showed that, regarding parasite species other than Leishmania braziliensis, miltefosine was significantly superior to glucantime (intention to treat; relative risk, 1.15; 95% confidence interval, 1.01 to 1.32). In the meta-regression, only the glucantime injection type was significant at the p=0.1 level. The Egger test found statistically significant publication bias; however, including the 3 missing studies in the trim-and-fill analysis did not change the results. This meta-analysis found that miltefosine seems to be more effective than glucantime, at least in species other than L. braziliensis, for treating CL.

Highlights

  • The objective of this paper is to present a systematic review and meta-analysis of clinical trials that com­ pared the efficacy of miltefosine and MA in the treatment of Cutaneous leishmaniasis (CL) in countries throughout the world

  • We presented summary estimates from efficacy analyses pri­ marily as relative risk (RR) to assess the strength of the effect; how­ ever, as an indicator of clinical significance, we reported the risk difference (RD)

  • A PRISMA-compliant systematic review and me­ ta-analysis was conducted based on clinical trials comparing miltefosine and MA in order to evaluate their efficacy in treating CL

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Summary

Introduction

Leishmaniasis is a protozoan parasitic infection that, depending on the infecting species of Leishmania, can manifest in different CL is widely distributed; 70% to 75% of the estimated global incidence is accounted for by 10 countries, including Brazil, Co­ lombia, North Sudan, Iran, Afghanistan, Algeria, Syria, Ethiopia, Costa Rica, and Peru [2].

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