Comparison of low-dose meglumine antimoniate/ allopurinol combination therapy with full dose meglumine antimoniate alone in the treatment of cutaneous leishmaniasis – A randomized controlled trial
Keywords:
Cutaneous leishmaniasis, meglumine antimoniate, allopurinol, randomized controlled trialAbstract
Objective To compare the efficacy and safety of meglumine antimoniate 20 mg/kg/day with combination of meglumine antimoniate 10 mg/kg/day and allopurinol 20 mg/kg/day. Methods A multi-center single blind randomized controlled trial was conducted. Soldiers over 18 years of age having parasitologically proven cutaneous leishmaniasis requiring systemic therapy, willing for admission to hospital for the study and regular follow up visits in outdoor, and consenting not to use any other treatment for cutaneous leishmaniasis while in study were included. On entry into the study patients were randomly assigned to either group A or group B using a random number table. Group A patients were given meglumine antimoniate 20 mg/kg/day/intramuscular till clinical resolution or for 28 days maximum. Group B patients were given intramuscular meglumine antimoniate 10mg/kg/day along with allopurinol 20 mg/kg/day/per oral till clinical resolution or for a maximum of 28 days. The ulcer and induration areas were recorded separately for each patient. Time to healing was recorded and compared among the two groups. Results A total of 324 patients were included in the study. Group A had 151 (46.6%) patients while 173 (53.4%) were in group B. Three hundred and six patients completed the study and 18 dropped out due to various complications, 9 belonging to each group. Lesion size at baseline in group A was 29.7+16.4 mm, while in group B it was 28+15.8 mm (p=0.35). Lesion size at the end of treatment period was 1.5+3.4 mm in group A and 0.9+2.6 mm in group B (p=0.07). Lesion size at the end of follow-up period was 0.1+0.9 mm in group A and 0.03+0.4 mm in group B (p=0.40). A total of 109 adverse effects were seen, 60 in group A and 49 in group B (p=0.05). Conclusion Low-dose meglumine antimoniate/allopurinol combination is equally effective and safe as compared to full dose meglumine antimoniate treatment.ÂReferences
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