Intervention Review

Short-term low-dose corticosteroids vs placebo and nonsteroidal antiinflammatory drugs in rheumatoid arthritis

  1. Peter C Gøtzsche1,*,
  2. Helle Krogh Johansen2

Editorial Group: Cochrane Musculoskeletal Group

Published Online: 24 JAN 2005

Assessed as up-to-date: 4 NOV 2007

DOI: 10.1002/14651858.CD000189.pub2


How to Cite

Gøtzsche PC, Johansen HK. Short-term low-dose corticosteroids vs placebo and nonsteroidal antiinflammatory drugs in rheumatoid arthritis. Cochrane Database of Systematic Reviews 2005, Issue 1. Art. No.: CD000189. DOI: 10.1002/14651858.CD000189.pub2.

Author Information

  1. 1

    Rigshospitalet, The Nordic Cochrane Centre, Copenhagen, Denmark

  2. 2

    Rigshospitalet, Dept. 3343, The Nordic Cochrane Centre, Copenhagen Ø, Denmark

*Peter C Gøtzsche, The Nordic Cochrane Centre, Rigshospitalet, Blegdamsvej 9, 3343, Copenhagen, 2100, Denmark. pcg@cochrane.dk.

Publication History

  1. Publication Status: Edited (no change to conclusions)
  2. Published Online: 24 JAN 2005

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Abstract

  1. Top of page
  2. Abstract
  3. Plain language summary
  4. 摘要

Background

The effect of low dose corticosteroids, equivalent to 15 mg prednisolone daily or less, in patients with rheumatoid arthritis has been questioned. We reviewed the trials that compared corticosteroids with placebo or non-steroidal, anti-inflammatory drugs.

Objectives

To determine whether short-term (i.e. as recorded within the first month of therapy), oral low-dose corticosteroids (corresponding to a maximum of 15 mg prednisolone daily) is superior to placebo and non-steroidal, anti-inflammatory drugs in patients with rheumatoid arthritis.

Search methods

PubMed, the Cochrane Central Register of Controlled Trials, reference lists and a personal archive. Date of last search Nov 2007.

Selection criteria

All randomised trials comparing an oral corticosteroid (not exceeding an equivalent of 15 mg prednisolone daily) with placebo or a non-steroidal, anti-inflammatory drug were eligible if they reported clinical outcomes within one month after start of therapy. For adverse effects, long-term trials were also selected.

Data collection and analysis

Decisions on which trials to include were made independently by two observers based on the methods sections of the trials. Standardised mean difference (random effects model) was used for the statistical analyses.

Main results

Eleven trials, involving 462 patients, were included. Two placebo-controlled trials had adequate allocation concealment. For joint tenderness, the standardised mean difference was -0.52, 95% confidence interval (CI) -1.01 to -0.03, for pain it was -0.67, 95% CI -1.58 to 0.23, and for grip strength, 0.22, 95% CI -0.40 to 0.84. The estimates for the other trials were considerably larger.

Prednisolone also had a greater effect than non-steroidal, anti-inflammatory drugs on joint tenderness (-0.63, 95% CI -1.16 to -0.11) and pain (-1.25, 95% CI -2.24 to -0.26), whereas the difference in grip strength was not significant (0.31, 95% CI -0.02 to 0.64). The main harms in long-term treatment were vertebral fractures and infections.

Authors' conclusions

Prednisolone in low doses (not exceeding 15 mg daily) may be used intermittently in patients with rheumatoid arthritis, particularly if the disease cannot be controlled by other means. The risk of harms needs to be considered, however, especially the risk of fractures and infections. Since prednisolone is highly effective, short-term placebo controlled trials studying the clinical effect of low-dose prednisolone or other oral corticosteroids are no longer necessary.

 

Plain language summary

  1. Top of page
  2. Abstract
  3. Plain language summary
  4. 摘要

Corticosteroids versus placebo and NSAIDs for rheumatoid arthritis

Short-term low-dose corticosteroids compared with placebo and nonsteroidal antiinflammatory drugs in patients with rheumatoid arthritis

Corticosteroid drugs can relieve inflammation, and in high doses they have a dramatic effect on the symptoms of rheumatoid arthritis. They are used only temporarily, however, because of serious adverse effects during long-term use. The review found that corticosteroids in low doses are very effective. They are more effective than usual anti-arthritis medications (non-steroidal anti-inflammatory drugs, or NSAIDs). The risk of harms needs to be considered, however, especially the risk of fractures and infections.

 

摘要

  1. Top of page
  2. Abstract
  3. Plain language summary
  4. 摘要

背景

短期低劑量類固醇比安慰劑及非類固醇消炎止痛劑用於治療類風濕性關節炎

低劑量類固醇﹝每日15毫克或更低prednisolone相當劑量﹞用於治療類風濕性關節炎效果曾被存疑。本文回顧比較類固醇與安慰劑或非類固醇消炎止痛劑之臨床試驗。

目標

比較短期口服低劑量類固醇﹝每日15毫克或更低prednisolone相當劑量﹞用於治療類風濕性關節炎效果是否優於安慰劑或非類固醇消炎止痛劑。

搜尋策略

搜尋包括Medline, Cochrane Controlled Trials Register (CENTRAL),同時搜尋所選文章之參考文獻 (直到2004年2月)。

選擇標準

所有比較短期口服低劑量類固醇﹝每日15 毫克或更低prednisolone相當劑量﹞與安慰劑或非類固醇消炎止痛劑用於類風濕性關節炎病人,並有報告使用後一個月內臨床果之隨機研究。副作用方面,長期研究及配對之世代研究亦選入。

資料收集與分析

兩位作者獨立進行收錄文章之資料摘錄。使用標準化平均差異,使用隨機效應模式分析。

主要結論

10個研究包含320例病患於分析中。類固醇比安慰劑組之疼痛及腫脹關節數目統計上顯著減少。壓痛(標準化平均差異 1.30, 95% CI 0.78 to 1.83), 疼痛 (1.75, 95% CI 0.87 to 2.64),握力 (0.41, 95% CI 0.13 to 0.69)。若依原始測量單位,則差異為12 (6 to 18)個疼痛關節及握力差異為22 mm Hg (5 to 40)。類固醇比非類固醇消炎止痛劑之壓痛 (0.63, 95% CI 0.11 to 1.16), 疼痛 (1.25, 95% CI 0.26 to 2.24)減少,但握力未有顯著差異 (0.31, 95% CI −0.02 to 0.64)。若依原始測量單位,則差異為9 (5 to 12)個疼痛關節及握力差異為12 mm Hg (−6 to 31)。中長期使用的副作用風險似乎可以接受。

作者結論

低劑量類固醇﹝每日15毫克或更低prednisolone相當劑量﹞可間歇用於治療類風濕性關節炎病人,尤其無法以其他方法控制者。因類固醇高度有效,因此不再需要短期安慰劑之對照研究。

翻譯人

本摘要由林口長庚醫院余光輝翻譯。

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

總結

低劑量類固醇緩解類風濕性關節炎病人疼痛,並有低度副作用風險。類固醇通常短期使用,本回顧發現低劑量類固醇非常有效。類固醇比非類固醇消炎止痛劑有效,即使長期使用,其副作用亦相對低。