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Steroid prophylaxis for prevention of nerve function impairment in leprosy: randomised placebo controlled trial (TRIPOD 1)

BMJ 2004; 328 doi: https://doi.org/10.1136/bmj.38107.645926.AE (Published 17 June 2004) Cite this as: BMJ 2004;328:1459
  1. W Cairns S Smith, professor of public health (w.c.s.smith{at}abdn.ac.uk)1,
  2. Alison M Anderson, bio statistician2,
  3. Stephen G Withington, country director3,
  4. Wim H van Brakel, senior advisor public health4,
  5. Richard P Croft, general practitioner5,
  6. Peter G Nicholls, research fellow1,
  7. Jan Hendrik Richardus, senior researcher6
  1. 1Department of Public Health, University of Aberdeen, Aberdeen AB25 2ZD
  2. 2International Nepal Fellowship, RELEASE, PO Box 28, Pokhara, Nepal
  3. 3Leprosy Mission Bangladesh, House 17A, Road 3, Banani (Old), Dhaka 1206, Bangladesh
  4. 4Royal Tropical Institute (KIT), Leprosy Unit, Wibautstraat 137J, 1097DN Amsterdam, Netherlands
  5. 556a St Peters Road, Earley, Reading RG6 1PH
  6. 6Department of Public Health, Erasmus MC, University Medical Centre, Rotterdam, PO Box 1738, 3000 DR Rotterdam, Netherlands
  1. Correspondence to: W C S Smith
  • Accepted 1 April 2004

Abstract

Objective To determine whether addition of low dose prednisolone to multidrug treatment can prevent reaction and nerve function impairment in leprosy.

Design Multicentre, double blind, randomised, placebo controlled, parallel group trial.

Setting Six centres in Bangladesh and Nepal.

Participants 636 people with newly diagnosed multibacillary leprosy.

Intervention Prednisolone 20 mg/day for three months, with tapering dose in month 4, plus multidrug treatment, compared with multidrug treatment alone.

Main outcome measures Signs of reaction, impairment of sensory and motor nerve function, and nerve tenderness needing full dose prednisolone at four months and one year.

Results Prednisolone had a significant effect in the prevention of reaction and nerve function impairment at four months (relative risk 3.9, 95% confidence interval 2.1 to 7.3), but this was not maintained at one year (relative risk 1.3, 0.9 to 1.8). Fewer events occurred in the prednisolone group at all time points up to 12 months, but the difference at 12 months was small. Subgroup analysis showed a difference in response between people with and without impairment of nerve function at diagnosis.

Conclusions The use of low dose prophylactic prednisolone during the first four months of multidrug treatment for leprosy reduces the incidence of new reactions and nerve function impairment in the short term, but the effect is not sustained at one year. The presence of nerve function impairment at diagnosis may influence the response to low dose prednisolone.

Footnotes

  • Contributors WCSS was responsible for the study conception, contributed to the interpretation and writing the paper, and is the guarantor. AMA contributed to the study design, interpretation, and writing the paper and was responsible for the execution and analysis. SGW contributed to the execution and interpretation. WHvB contributed to the study design, execution, and interpretation. RPC contributed to the study design and execution. PGN contributed to the study design, execution, and analysis and was responsible for the database design. JHR contributed to the study design and interpretation.

  • Funding The study was sponsored by LEPRA UK, the Leprosy Mission International, the American Leprosy Missions, the University of Aberdeen, and the International Nepal Fellowship.

  • Competing interests None declared.

  • Ethical approval The study design was reviewed by the medical advisory board of LEPRA and the technical and ethical standards committee of the International Nepal Fellowship. The Nepal Health Research Council and the Bangladesh Medical Research Council gave ethical approval.

  • Accepted 1 April 2004
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