Short-term low-dose corticosteroids vs placebo and nonsteroidal antiinflammatory drugs in rheumatoid arthritis
Editorial Group: Cochrane Musculoskeletal Group
Published Online: 24 JAN 2005
Assessed as up-to-date: 4 NOV 2007
Copyright © 2009 The Cochrane Collaboration. Published by John Wiley & Sons, Ltd.
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.
- Publication Status: Edited (no change to conclusions)
- Published Online: 24 JAN 2005
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.
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.
PubMed, the Cochrane Central Register of Controlled Trials, reference lists and a personal archive. Date of last search Nov 2007.
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.
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.
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
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.
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)。
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。
此翻譯計畫由臺灣國家衛生研究院(National Health Research Institutes, Taiwan)統籌。