Comparing intramuscular meglumine antimoniate with oral chloroquine in the treatment of cutaneous leishmaniasis: A randomized controlled trail
Keywords:
Cutaneous leishmaniasis, Efficacy, meglumine antimoniate, intralesional chloroquineAbstract
Background Cutaneous leishmaniasis (CL) is highly prevalent in developing countries, including Pakistan. The conventional treatment for CL, meglumine antimoniate (MA), is unfortunately associated with considerable toxicity. Studies of alternative treatment options have reported inconsistent results. This study aimed to quantitatively compare the effectiveness of intramuscular MA with oral chloroquine in the treatment of CL. Methods Patients of both genders between the ages of 06-60 years, presenting with CL lesions of less than 03 months duration were enrolled in this randomized controlled trial (RCT), carried out from August 2021 to February 2022 at the Department of Dermatology, Lady Reading Hospital, Peshawar. CL patients with a history of prior treatment and/or those with comorbidities were excluded. Eligible patients were allocated randomly into two groups, where patients in Group I were given intramuscular MA (20 mg/Kg body weight once daily for 4 weeks) while patients in Group II were given oral chloroquine (250 mg, twice daily over 4 weeks). The treatment response was assessed at 4-week follow-up after completion of the treatment. Results The enrolled CL patients (n=82) were equally divided in two groups. The age and gender was evenly distributed between the two groups. The mean patient’s age in Group I and II was 36.49±13.22 years and 37.34±13.19 years, whilst the male to female ratio was 1.28 and 1.16, respectively. Results showed a significantly higher rate of complete treatment response in Group I compared to Group II (78% vs. 48.8%, p=0.006). Treatment responses in both groups were also stratified on the basis of gender and socioeconomic status. Conclusion This study indicated significantly higher efficacy of intramuscular MA compared to oral chloroquine for CL treatment.References
Alvar J, Vélez ID, Bern C, Herrero M, Desjeux P, Cano J, et al. Leishmaniasis worldwide and global estimates of its incidence. PLoS One. 2012;7(5):e35671.
Ashford RW, Bern C, Boelaert M, Bryceson A, Chappuis F, Croft S, et al. Control of the leishmaniases. In: World Health Organization - Technical Report Series. 2008.
Burza S, Croft SL, Boelaert M. Leishmaniasis. Lancet. 2018;392(10151): 951-70.
Markle WH, Makhoul K. Cutaneous leishmaniasis: Recognition and treatment. Am Fam Physician. 2004;69(6):1455–60.
Vega-López F. Diagnosis of cutaneous leishmaniasis. Curr Opin Infect Dis. 2003;16(2):97–101.
Elmahallawy EK, Sampedro Martínez A, Rodriguez-Granger J, Hoyos-Mallecot Y, Agil A, Navarro Mari JM, et al. Diagnosis of leishmaniasis. J Infect Dev Ctries. 2014;8(8):961–71.
Rogers ME, Ilg T, Nikolaev A V, Ferguson MAJ, Bates PA. Transmission of cutaneous leishmaniasis by sand flies is enhanced by regurgitation of fPPG. Nature. 2004; 430(6998):463–7.
Georgiadou SP, Makaritsis KP, Dalekos GN. Leishmaniasis revisited: Current aspects on epidemiology, diagnosis and treatment. J Transl Intern Med. 2015;3(2):43–50.
Yesilova Y, Surucu HA, Ardic N, Aksoy M, Yesilova A, Oghumu S, et al. Meglumine antimoniate is more effective than sodium stibogluconate in the treatment of cutaneous leishmaniasis. J Dermatal Treat. 2016; 27(1):83–7.
Minodier P, Parola P. Cutaneous leishmaniasis treatment. Travel Med Infect Dis. 2007;5(3):150–8.
Croft SL, Seifert K, Yardley V. Current scenario of drug development for leishmaniasis. Indian J Med Res. 2006;123(3):399-410.
Nieto J, Alvar J, Mullen AB, Carter KC, Rodríguez C, Andre MIS, et al. Pharmacokinetics, toxicities, and efficacies of sodium stibogluconate formulations after intravenous administration in animals. Antimicrob Agents Chemother. 2003; 47(9):2781–7.
Khan K, Khan AU, Ghufran, Khan A, Khan M, Ahmad I. Fractionated illumination improves the treatment outcomes of photodynamic therapy for high grade cutaneous leishmaniasis. Photodiagnosis Photodyn Ther. 2020;29:101622.
Khan K, Khan AU, Gul B, Ullah A, Khan M, Ahmad I. Photodynamic therapy for the treatment of cutaneous: a case series from Pakistan. Eur J Med Case Reports. 2021; 5(7):203–8.
Khan K, Khan AU, Ghufran, Ullah A, Khan M, Ahmad I. Low‐level laser therapy for the treatment of early stage cutaneous leishmaniasis: A pilot study. Dermatol Ther. 2020;33(6):e14232.
Al-Natour SH. Update in the treatment of cutaneous leishmaniasis. J Fam Community Med. 1994;16(2):41–7.
Farooq M, Farooq MS, Bari AU, Malik TM. Comparison of oral chloroquine with systemic meglumine antimoniate in treatment of cutaneous leishmaniasis. Pakistan Armed Forces Med J. 2021; 71(1):139–44.
Yasmin R, Khan I, Ahmad SA. Response to treatment of cutaneous leishmaniasis with intralesional chloroquine vs intralesional meglumine antimoniate. J Pakistan Assoc Dermatol. 2011;21(4):270–5.
Hanif MM, Akram K, Mustafa G. Intralesional versus oral chloroquine in cutaneous leishmaniasis: Comparison of outcome, duration of treatment and total dose of drug. J Coll Physicians Surg Pakistan. 2016;26(4):260–2.
Kip AE, Balasegaram M, Beijnen JH, Schellens JHM, Vries PJ De, Dorlo TPC. Systematic review of biomarkers to monitor therapeutic response in leishmaniasis. Antimicrob Agents Chemother. 2015; 59(1):1–14.
Gonzalez U, Pinart M, Reveiz L, Rengifo-pardo M, Tweed J, Macaya A, et al. Designing and reporting clinical trials on treatments for cutaneous leishmaniasis. Clin Infect Dis. 2010;51(4):409–19.
Yesilova Y, Surucu HA, Ardic N, Aksoy M, Yesilova A, Oghumu S, et al. Meglumine antimoniate is more effective than sodium stibogluconate in the treatment of cutaneous leishmaniasis. J Dermatolog Treat. 2016; 27:83–7.
Brito NC, Rabello A, Cota GF. Efficacy of pentavalent antimoniate intralesional infiltration therapy for cutaneous leishmaniasis: A systematic review. PLoS One. 2017;12(9):e0184777.
Bashir U, Tahir M, Anwar MI, Manzoor F. Comparison of intralesional meglumine antimonite along with oral itraconazole to intralesional meglumine antimonite in the treatment of cutaneous leishmaniasis. Pakistan J Med Sci. 2019;35(6):1669–73.
Banihashemi M, Yazdanpanah MJ, Amirsolymani H, Yousefzadeh H. Comparison of lesion improvement in lupoid leishmaniasis patients with two treatment approaches: Trichloroacetic acid and intralesional meglumine antimoniate. J Cutan Med Surg. 2015;19:35–9.
Nilforoushzadeh MA, Siadat AH, Ansari N, Haftbaradaran E, Ahmadi E. A comparison between the effects of glucantime, topical trichloroacetic acid 50% plus glucantime, and fractional laser plus glucantime on cutaneous leishmaniasis lesions. J Isfahan Med Sch. 2013;30(221):2450–9.
Gupta S, Jain VK, Aggarwal K. Comparison of topical paromomycin sulfate (twice/day) with intralesional meglumine antimoniate for the treatment of cutaneous leishmaniasis caused by L. major. Int J Dermatol. 2005;44:1064–5.
Uzun S, Durdu M, Culha G, Allahverdiyev AM, Memisoglu HR. Clinical features, epidemiology, and efficacy and safety of intralesional antimony treatment of cutaneous leishmaniasis: Recent experience in Turkey. J Parasitol. 2004;90(4):853–9.
Faghihi G, Tavakoli-kia R. Treatment of cutaneous leishmaniasis with either topical paromomycin or intralesional meglumine antimoniate. Clin Exp Dermatol. 2003; 28:13–6.
Asilian A, Sadeghinia A. of the efficacy of combined cryotherapy and intralesional meglumine antimoniate (Glucantime®) vs. cryotherapy and intralesional meglumine antimoniate (Glucantime®). Int J Dermatol. 2004;43:281–3.
Ferreira E Vasconcellos ÉDC, Fernandes Pimentel MI, De Oliveira Schubach A, Carvalhaes De Oliveira RDV, Azeredo-Coutinho RB, Da Conceição Silva F, et al. Short report: Intralesional meglumine antimoniate for treatment of cutaneous leishmaniasis patients with contraindication to systemic therapy from Rio de Janeiro (2000 to 2006). Am J Trop Med Hyg. 2012;87(2):257–60.
Sadeghian G, Nilfroushzadeh MA, Iraji F. Efficacy of local heat therapy by radiofrequency in the treatment of cutaneous leishmaniasis, compared with intralesional injection of meglumine antimoniate. Clin Exp Dermatol. 2007;32(4):371–4.
Asilian A, Sadeghinia A, Faghihi G, Momeni A, Amini Harandi A. The efficacy of treatment with intralesional meglumine antimoniate alone, compared with that of cryotherapy combined with the meglumine antimoniate or intralesional sodium stibogluconate, in the treatment of cutaneous leishmaniasis. Ann Trop Med Parasitol. 2003;97(5):493–8.
Alkhawajah AM, Larbi E, Al-Gindan Y, Abahussein A, Jain S. Treatment of cutaneous leishmaniasis with antimony: Intramuscular versus intralesional administration. Ann Trop Med Parasitol. 1997;91(8):899–905.
