Corticosteroids for treating nerve damage in leprosy

Leprosy is a chronic infectious disease. Leprosy bacteria cause damage to skin and peripheral nerves which may result in nerve function impairment and disability. Corticosteroids, especially prednisolone, are commonly used for treating nerve damage although their long-term effect is uncertain. Three randomised controlled trials, involving 513 people, were included in the review. Risk of bias was generally low in the three trials. Two of the included trials compared prednisolone with placebo. One trial with 84 participants treated mild sensory impairment of less than six months duration and the other trial, which had 95 participants, treated nerve function impairment of 6 to 24 months duration. Twelve months after the start of treatment, there was no significant difference in nerve function improvement between people treated with prednisolone or with placebo. The third trial compared three corticosteroid regimens for severe type 1 reactions 12 months from the start of treatment in 334 participants. After 12 months, significantly more individuals on a three-month course of prednisolone required extra corticosteroids compared to the groups with a high-dose and low-dose regimen of five months duration. Diabetes and peptic or infected ulcer were sometimes reported as serious adverse events, but did not occur significantly more often in corticosteroid than placebo groups.

Authors' conclusions: 

Corticosteroids are used for treating acute nerve damage in leprosy, but evidence from two randomised controlled trials, treating either long-standing or mild nerve function impairment, did not show a significant long-term effect. A third trial showed significant benefit of a five-month steroid regimen over a three-month regimen. Standard corticosteroid regimens are not significantly more harmful than placebo treatment, despite known adverse effects of corticosteroids. Further randomised controlled trials are needed to establish the effectiveness of corticosteroids and the optimal regimens and to examine new therapies. Future trials should pay more attention to non-clinical aspects, such as costs and impact on quality of life, because these are highly relevant indicators for both policy makers and participants.

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Background: 

Leprosy causes nerve damage which can result in nerve function impairment and disability. Corticosteroids are commonly used for treating nerve damage, although the long-term effect is uncertain. This is an update of a review first published in 2007 and previously updated in 2009.

Objectives: 

To assess the effects of corticosteroids on nerve damage in leprosy.

Search strategy: 

We searched the Cochrane Neuromuscular Disease Group Specialized Register (January 2011), the Cochrane Central Register of Controlled Trials (Central) (Issue 4, 2010 in the Cochrane Library), MEDLINE (January 1966 to January 2011), EMBASE (January 1980 to January 2011), CINAHL Plus (January 1937 to January 2011), LILACS (1982 to December 2011). We checked reference lists of the studies identified, the Current Controlled Trials Register (www.controlled-trials.com), conference proceedings and contacted trial authors.

Selection criteria: 

Randomised and quasi-randomised controlled trials of corticosteroids for nerve damage in leprosy. The comparators were no treatment or placebo.

Data collection and analysis: 

The primary outcome was improvement in sensory and motor nerve function after one year. Secondary outcomes were improvement in nerve function after two years, change in nerve pain and tenderness, and adverse events. Two authors independently extracted data and assessed trial quality. We contacted trial authors for additional information. We collected adverse effects and cost effectiveness information from the trials and non-randomised studies.

Main results: 

We included three randomised controlled trials involving 513 people. Risk of bias was generally low in the three trials. Two trials compared prednisolone with placebo. One trial with 84 participants treated mild sensory impairment of less than six months duration and the other trial, which had 95 participants, treated nerve function impairment of 6 to 24 months duration. Both trials examined an effect 12 months from the start of treatment. There was no significant difference in nerve function improvement between people treated with prednisolone or with placebo. The third trial compared three corticosteroid regimens for severe type 1 reactions in 334 participants. This trial did not report the prespecified outcomes. However, after 12 months, a significantly higher proportion of individuals on a three-month course of prednisolone required extra corticosteroids compared to the groups with a high-dose and low-dose regimen of five months duration. Diabetes and peptic or infected ulcer were sometimes reported as serious adverse events in the placebo-controlled trials, but not significantly more often in the corticosteroid than placebo groups.