Corticosteroids for treating nerve damage in leprosy

 

Abstract

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 methods

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.

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.

 

Plain language summary

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.

 

摘要

背景

皮質類固醇用於治療痲瘋造成的神經損傷

痲瘋所造成的神經損傷會導致神經功能缺失和失能。皮質類固醇常被用來治療神經損傷，不過長期的治療效果仍然不明。

目標

評估皮質類固醇對痲瘋造成的神經損傷是否有效。

搜尋策略

我們在2006年1月搜尋了以下的資料庫： Cochrane Neuromuscular Disease Group Register, the Cochrane Central Register of Controlled Trials (Issue 4), MEDLINE (自1966年起), EMBASE (自1980年起), CINAHL (自1980年起), LILACS (自 1982年起)。我們翻閱了這些研究所參考的書目，也查詢了 Current Controlled Trials Register (www.controlledtrials.com) 尋找正在進行中的試驗並連絡這些試驗的作者。

選擇標準

使用皮質類固醇治療痲瘋造成的神經損傷的隨機試驗或準隨機試驗。

資料收集與分析

主要療效是指1年後感覺和運動神經功能的改善。主要療效是指兩年後神經功能的改善、神經痛或觸痛的變化、不良反應。資料的翠取和評估試驗的品質是由兩位獨立作業的作者進行。我們會連絡這些試驗的作者以取得額外的資料。除了這些試驗的資料，我們還從一些非隨機的試驗收集有關不良反應的資訊。

主要結論

我們找到3個共包含513人的隨機分組試驗。其中2個試驗使用prednisolone和安慰劑進行比較。這兩個試驗中的一個僅治療輕微的感覺缺失，且治療時間少於6個月；另一個試驗則治療神經功能缺失6到24個月。這兩個試驗皆有檢查開始治療後12個月時的效果。在使用prednisolone和安慰劑的這兩群人身上，神經功能的改善並沒有顯著的差別。我們找到的第三個試驗，是比較在嚴重的第一型反應時，3種不同皮質類固醇處方的效果；這個試驗並沒有提到我們選定的療效；但是治療後12個月，只接受3個月prednisolone的病人，比起使用高劑量或低劑量治療5個月的病人，有更高的比例需要投與額外的皮質類固醇。糖尿病、消化道潰瘍、和皮膚潰瘍感染是有時會出現的嚴重副作用；但是這些分組對照的試驗顯示，這類副作用並沒有顯著地較常出現在皮質類固醇組。

作者結論

皮質類固醇被用來治療痲瘋造成的神經損傷，但是就隨機分組試驗的資料所見，並沒有顯著地長期療效。需要隨機對照試驗來進一步驗證療效、最佳療程、和找尋新的治療方法。

翻譯人

本摘要由新光醫院黃心樂翻譯。

此翻譯計畫由臺灣國家衛生研究院(National Health Research Institutes, Taiwan)統籌。

總結

皮質類固醇被用來治療痲瘋造成的神經損傷 痲瘋分支桿菌會造成皮膚及神經的損害，導致神經功能的缺失及失能。皮質類固醇，尤其是prednisolone，常被用在治療神經損害，不過長期的療效目前仍無法確定。本評論收集了三個隨機分組試驗。其中兩個拿prednislone和安慰劑進行比較；這兩個中的一個試驗是治療輕微的感覺缺失，僅治療不到6個月；另一個則是治療神經功能缺失6至24個月。治療開始後12個月的時候，服用prenisolone的人和服用安慰劑的人，在神經功能的改善方面，並沒有顯著的差別。第三個試驗則是比較三種不同的類固醇給法用於治療嚴重的痲瘋第一型反應；僅接受三個月 prednisolone 療程的人，比起接受5個月高劑量或低劑量療程的人，在開始治療後12個月的時候，有更高的比例要追加額外的皮質類固醇進行治療。糖尿病、消化道潰瘍、和皮膚潰瘍感染是有時會出現的嚴重副作用，但是這類副作用並沒有顯著地在皮質類固醇組較常發生。