• J Coll Physicians Surg Pak · Dec 2023

    Randomized Controlled Trial

    Comparison of Meglumine Antimoniate and Miltefosine in Cutaneous Leishmaniasis.

    • Atiya Rahman, Moizza Tahir, Tehseen Naveed, Mohammad Abdullah, Nida Qayyum, Danish Hafeez Malik, and Bushra Amin.
    • Department of Dermatology, PNS Shifa Hospital and Bahria University, Karachi, Pakistan.
    • J Coll Physicians Surg Pak. 2023 Dec 1; 33 (12): 136713711367-1371.

    ObjectiveTo compare the efficacy and safety of meglumine antimoniate and miltefosine in the treatment of cutaneous leishmaniasis in Pakistan.Study DesignRandomised-controlled trial. Place and Duration of the Study: Department of Dermatology, Combined Military Hospital, Lahore and Peshawar, from January to December 2021.MethodologySmear positive and/or skin biopsy-confirmed cases of cutaneous leishmaniasis in adult males aged between 18-60 years were enrolled after receiving informed consent. Patients were randomly divided into Group A and Group B by lottery method. Group A received intramuscular meglumine antimoniate 15-20mg/kg/day, and Group B received oral miltefosine 50 mg thrice a day for a duration of 28 days. Data were analysed by SPSS 22. Effectiveness and safety of therapeutic agents were calculated by Independent t-test and p-value of 0.05 or less was taken as significant.ResultsSixty-six patients, 33 in each group, participated in the study. Total number of cutaneous leishmaniasis lesions were 77 in Group A and 76 in Group B. The duration of lesions was 3.5 months in Group A and 3.2 months in Group B. Treatment response, in terms of complete or near complete resolution of lesions, was significantly higher in Group A as compared to Group B (p = 0.011). Both therapeutic agents had considerable side-effects with more patients withdrawn from Group A as compared to Group B (p = 0.010).ConclusionIntra-muscular meglumine antimoniate was more effective in comparison to oral miltefosine in the treatment of cutaneous leishmaniasis. However, efficacy of meglumine antimoniate is mired by its side-effect profile.Key WordsCutaneous leishmaniasis, Meglumine antimoniate, Miltefosine, Efficacy, Side-effects, Adverse effects, Safety, Treatment, Old world cutaneous leishmaniasis.

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