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Treatment with corticosteroids of long-standing nerve function impairment in leprosy: a randomized controlled trial (TRIPOD 3).
Lepr Rev. 2003 Dec; 74(4):311-8.LR

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+Show Affiliations

Department of Public Health, Erasmus MC, University Medical Center Rotterdam, PO Box 1738, 3000 DR Rotterdam, The Netherlands. j.richardus@erasmusmc.nlNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info available

Pub Type(s)

Clinical Trial
Comparative Study
Journal Article
Multicenter Study
Randomized Controlled Trial
Research Support, Non-U.S. Gov't

Language

eng

PubMed ID

14750576

Citation

Richardus, Jan H., et al. "Treatment With Corticosteroids of Long-standing Nerve Function Impairment in Leprosy: a Randomized Controlled Trial (TRIPOD 3)." Leprosy Review, vol. 74, no. 4, 2003, pp. 311-8.
Richardus JH, Withington SG, Anderson AM, et al. Treatment with corticosteroids of long-standing nerve function impairment in leprosy: a randomized controlled trial (TRIPOD 3). Lepr Rev. 2003;74(4):311-8.
Richardus, J. H., Withington, S. G., Anderson, A. M., Croft, R. P., Nicholls, P. G., Van Brakel, W. H., & Smith, W. C. (2003). Treatment with corticosteroids of long-standing nerve function impairment in leprosy: a randomized controlled trial (TRIPOD 3). Leprosy Review, 74(4), 311-8.
Richardus JH, et al. Treatment With Corticosteroids of Long-standing Nerve Function Impairment in Leprosy: a Randomized Controlled Trial (TRIPOD 3). Lepr Rev. 2003;74(4):311-8. PubMed PMID: 14750576.
* Article titles in AMA citation format should be in sentence-case
TY - JOUR T1 - Treatment with corticosteroids of long-standing nerve function impairment in leprosy: a randomized controlled trial (TRIPOD 3). AU - Richardus,Jan H, AU - Withington,Stephen G, AU - Anderson,Alison M, AU - Croft,Richard P, AU - Nicholls,Peter G, AU - Van Brakel,Wim H, AU - Smith,W Cairns S, PY - 2004/1/31/pubmed PY - 2004/2/20/medline PY - 2004/1/31/entrez SP - 311 EP - 8 JF - Leprosy review JO - Lepr Rev VL - 74 IS - 4 N2 - 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. SN - 0305-7518 UR - https://www.unboundmedicine.com/medline/citation/14750576/Treatment_with_corticosteroids_of_long_standing_nerve_function_impairment_in_leprosy:_a_randomized_controlled_trial__TRIPOD_3__ DB - PRIME DP - Unbound Medicine ER -