Corticosteroids versus placebo and NSAIDs for rheumatoid arthritis

Gøtzsche PC, Johansen HK

Published Online:

January 21, 2009

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.

Abstract (click to read)

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 strategy:

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.

This record should be cited as:

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

Assessed as up to date:

November 5, 2007

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Primary Review Group:

Musculoskeletal Group

Arthritis topics:

Rheumatoid Arthritis > Disease Modifying Anti-Rheumatic Drugs DMARDs and Slow-Acting Anti-Rheumatic Drugs SAARDs

Health topics:

Rheumatology > Rheumatoid arthritis > DMARDS & SAARDS

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Corticosteroids versus placebo and NSAIDs for rheumatoid arthritis

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