title: Treatment with corticosteroids of long-standing nerve function impairment in leprosy: a randomized controlled trial (TRIPOD 3).
abstract: Some leprosy patients with long-standing nerve function impairment (NFI) appear to have responded favourably to treatment with corticosteroids. This study investigated whether patients with untreated NFI between 6 and 24 months duration and who are given standard regimen corticosteroid therapy, will have a better treatment outcome than a placebo group. A multicentre, randomized, double-blind placebo-controlled trial was conducted in Nepal and Bangladesh. Subjects were randomised to either prednisolone treatment starting at 40 mg/day, tapered by 5 mg every 2 weeks, and completed after 16 weeks, or placebo. Outcome assessments were at 4, 6, 9, and 12 months from the start of treatment. 92 MB patients on MDT were recruited, of whom 40 (45%) received prednisolone and 52 (55%) placebo treatment. No demonstrable additional improvement in nerve function, or in preventing further leprosy reaction events was seen in the prednisolone group. Overall, improvement of nerve function at 12 months was seen in about 50% of patients in both groups. Analysis of subgroups according to nerve (ulnar and posterior tibial), duration of NFI, and sensory and motor function, also did not reveal any differences between the treatment and placebo groups. There was however, indication of less deterioration of nerve function in the prednisolone group. Finally, there was no difference in the occurrence of adverse events between both groups. The trial confirms current practice not to treat long-standing NFI with prednisolone. Spontaneous recovery of nerve function appears to be a common phenomenon in leprosy. Leprosy reactions and new NFI occurred in a third of the study group, emphasizing the need to keep patients under regular surveillance during MDT, and, where possible, after completion of MDT.
authors.affiliation: Department of Public Health, Erasmus MC, University Medical Center Rotterdam, PO Box 1738, 3000 DR Rotterdam, The Netherlands. j.richardus@erasmusmc.nl
authors.forename: Jan H
authors.initials: JH
authors.lastname: Richardus
authors.forename: Stephen G
authors.initials: SG
authors.lastname: Withington
authors.forename: Alison M
authors.initials: AM
authors.lastname: Anderson
authors.forename: Richard P
authors.initials: RP
authors.lastname: Croft
authors.forename: Peter G
authors.initials: PG
authors.lastname: Nicholls
authors.forename: Wim H
authors.initials: WH
authors.lastname: Van Brakel
authors.forename: W Cairns S
authors.initials: WC
authors.lastname: Smith
mesh_terms: D000293:Adolescent; D000328:Adult; D016001:Confidence Intervals; D004305:Dose-Response Relationship, Drug; D004311:Double-Blind Method; D004334:Drug Administration Schedule; D005260:Female; D005500:Follow-Up Studies; D006801:Humans; D007918:Leprosy / Q000150:complications* / Q000175:diagnosis; D008297:Male; D008875:Middle Aged; D009390:Nepal; D009431:Neural Conduction; D016017:Odds Ratio; D010523:Peripheral Nervous System Diseases / Q000175:diagnosis / Q000188:drug therapy* / Q000209:etiology; D011239:Prednisolone / Q000008:administration & dosage*; D011336:Probability; D020127:Recovery of Function; D012016:Reference Values; D018570:Risk Assessment; D012678:Sensation Disorders / Q000175:diagnosis / Q000188:drug therapy* / Q000209:etiology; D012720:Severity of Illness Index; D016896:Treatment Outcome
chemical_list: D011239:Prednisolone