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Meta-Analysis
. 2014 Nov 27;2014(11):CD004800.
doi: 10.1002/14651858.CD004800.pub3.

Sulfasalazine for ankylosing spondylitis

Junmin Chen  1 , Shaopeng Lin, Chao Liu
Affiliations
Meta-Analysis

Sulfasalazine for ankylosing spondylitis

Junmin Chen et al. Cochrane Database Syst Rev. .

Abstract

Background: Ankylosing spondylitis (AS) is a chronic inflammatory disease of unknown cause and affects mainly the spine, but can also affect other joints. Disease progression may result in loss of mobility and function. Sulfasalazine is a disease-modifying antirheumatic drug used in the treatment of AS. However, its efficacy remains unclear. This is an update of a Cochrane review first published in 2005.

Objectives: To evaluate the benefits and harms of sulfasalazine for the treatment of ankylosing spondylitis (AS).

Search methods: We searched for relevant randomized and quasi-randomized trials in any language, using the following sources: the Cochrane Central Register of Controlled Trials (CENTRAL) (The Cochrane Library 2013, Issue 11); MEDLINE (2003 to 28 November 2013); EMBASE (2003 to 27 November 2013); CINAHL (2003 to 28 November 2013); Ovid MEDLINE data, World Health Organization International Clinical Trials Registry Platform (28 November 2013); and the reference sections of retrieved articles.

Selection criteria: We evaluated randomized and quasi-randomized trials examining the benefits and harms of sulfasalazine on AS.

Data collection and analysis: Two review authors independently reviewed unblinded trial reports according to the selection criteria. Disagreements on the inclusion of the studies were resolved, when necessary, by recourse to a third review author. The same authors independently assessed the risk of bias of included trials and entered the data extracted from the included trials. We combined results using mean difference (MD) or standardised mean difference (SMD) for continuous data, and risk ratio (RR) for dichotomous data.We restructured outcome measures for this update based on recommendations from the editorial group. Major outcomes included: pain, Bath ankylosing spondylitis disease activity index (BASDAI), Bath ankylosing spondylitis function index (BASFI), Bath ankylosing spondylitis metrology index (BASMI), radiographic progression, total number of withdrawals due to adverse events, and serious adverse events.

Main results: We did not add any new studies to this review following the updated search. In the original review, we included 11 studies in the analysis, involving 895 participants in total. All included studies compared sulfasalazine with placebo. We judged most of the studies as low risk of bias or unclear risk of bias in five domains (random sequence generation, allocation concealment, blinding of outcome assessment, selective reporting, and other sources of bias). However, for incomplete outcome data, we only judged one trial at low risk of bias.None of the included trials assessed BASDAI, BASFI, BASMI or radiographic progression. Different parameters were used to assess pain. The pooled MD for back pain measured on a 0 to 100 mm visual analogue scale was -2.96 (95% confidence interval (CI) -6.33 to 0.41; absolute risk difference 3%, 95% CI 1% to 6%; 6 trials). Compared to placebo, a significantly higher rate of withdrawals due to adverse effects (RR 1.50, 95% CI 1.04 to 2.15; absolute risk difference 4%, 95% CI 0.4% to 8.8%; 11 trials) was found in the sulfasalazine group. A serious adverse reaction was reported in one patient taking sulfasalazine (Peto odds ratio 7.50, 95% CI 0.15 to 378.16).

Authors' conclusions: There is not enough evidence to support any benefit of sulfasalazine in reducing pain, disease activity, radiographic progression, or improving physical function and spinal mobility in the treatment of AS. A statistically significant benefit in reducing the erythrocyte sedimentation rate and easing spinal stiffness was mentioned in the previous version. However, the effect size was very small and not clinically meaningful. More withdrawals because of side effects occurred with sulfasalazine. Further studies, with larger sample sizes, longer duration, and using validated outcome measures are needed to verify the uncertainty of sulfasalazine in AS.

PubMed Disclaimer

Conflict of interest statement

JC ‐ none SL ‐ none CL ‐ none

Figures

1
1
Study flow diagram.
2
2
Risk of bias graph: review authors' judgments about each risk of bias item presented as percentages across all included studies.
3
3
Risk of bias summary: review authors' judgments about each risk of bias item for each included study.
1.1
1.1. Analysis
Comparison 1 Sulfasalazine versus placebo, Outcome 1 Spondylitis function index (Score 0 to 40, 0 to 44, 0 = the best).
1.2
1.2. Analysis
Comparison 1 Sulfasalazine versus placebo, Outcome 2 Spondylitis function index (2nd analysis) (score 0 to 40, 0 to 44, 0 = the best).
1.3
1.3. Analysis
Comparison 1 Sulfasalazine versus placebo, Outcome 3 Improvement in back pain.
1.4
1.4. Analysis
Comparison 1 Sulfasalazine versus placebo, Outcome 4 Back pain (VAS 100 mm, 0 = no pain, 100 = severe pain).
1.5
1.5. Analysis
Comparison 1 Sulfasalazine versus placebo, Outcome 5 Back pain (2nd analysis) (VAS 100 mm, 0 = no pain, 100 = severe pain).
1.6
1.6. Analysis
Comparison 1 Sulfasalazine versus placebo, Outcome 6 Night pain (% no pain).
1.7
1.7. Analysis
Comparison 1 Sulfasalazine versus placebo, Outcome 7 Score of sleep disturbance (end point) (0 to 4, 0 = no disturbance, 4 = severe disturbance).
1.8
1.8. Analysis
Comparison 1 Sulfasalazine versus placebo, Outcome 8 Frequency of nocturnal awakening (change from baseline).
1.9
1.9. Analysis
Comparison 1 Sulfasalazine versus placebo, Outcome 9 Score of daily NSAIDs (change from baseline, usual dosage as 10).
1.10
1.10. Analysis
Comparison 1 Sulfasalazine versus placebo, Outcome 10 Reducing or stopping NSAIDs.
1.11
1.11. Analysis
Comparison 1 Sulfasalazine versus placebo, Outcome 11 Chest expansion (cm).
1.12
1.12. Analysis
Comparison 1 Sulfasalazine versus placebo, Outcome 12 Chest expansion (2nd analysis) (cm).
1.13
1.13. Analysis
Comparison 1 Sulfasalazine versus placebo, Outcome 13 Forced vital volume (change from baseline) (L/min).
1.14
1.14. Analysis
Comparison 1 Sulfasalazine versus placebo, Outcome 14 (Modified) Schober's test (cm).
1.15
1.15. Analysis
Comparison 1 Sulfasalazine versus placebo, Outcome 15 (Modified) Schober's test (2nd analysis) (cm).
1.16
1.16. Analysis
Comparison 1 Sulfasalazine versus placebo, Outcome 16 Occiput‐to‐wall test (cm).
1.17
1.17. Analysis
Comparison 1 Sulfasalazine versus placebo, Outcome 17 Occiput‐to‐wall test (2nd analysis) (cm).
1.18
1.18. Analysis
Comparison 1 Sulfasalazine versus placebo, Outcome 18 Fingers‐to‐floor test (cm).
1.19
1.19. Analysis
Comparison 1 Sulfasalazine versus placebo, Outcome 19 Fingers‐to‐floor test (2nd analysis) (cm).
1.20
1.20. Analysis
Comparison 1 Sulfasalazine versus placebo, Outcome 20 Chin sternum distance (change from baseline) (cm).
1.21
1.21. Analysis
Comparison 1 Sulfasalazine versus placebo, Outcome 21 Joint pain/tenderness score (0 to 198, the higher the score the more severe the disease) or number.
1.22
1.22. Analysis
Comparison 1 Sulfasalazine versus placebo, Outcome 22 Joint pain/tenderness score (2nd analysis) (0 to 198, the higher the score the more severe the disease).
1.23
1.23. Analysis
Comparison 1 Sulfasalazine versus placebo, Outcome 23 Joint swelling score (0 to 198, the higher score the more severe the disease) or number.
1.24
1.24. Analysis
Comparison 1 Sulfasalazine versus placebo, Outcome 24 Joint swelling score (2nd analysis) (0 to 198, the higher the score the more severe the disease).
1.25
1.25. Analysis
Comparison 1 Sulfasalazine versus placebo, Outcome 25 Dactylitis score (0 to 3, 0 = normal, 3 = severe).
1.26
1.26. Analysis
Comparison 1 Sulfasalazine versus placebo, Outcome 26 Dactylitis score (2nd analysis) (0 to 3, 0 = normal, 3 = severe).
1.27
1.27. Analysis
Comparison 1 Sulfasalazine versus placebo, Outcome 27 Enthesopathy index (0 to 90, 0 to 66, 0 to 90, the higher the score the more severe the disease).
1.28
1.28. Analysis
Comparison 1 Sulfasalazine versus placebo, Outcome 28 Enthesopathy index (2nd analysis) (0 to 90, 0 to 66, 0 to 90, the higher score the more severe the disease).
1.29
1.29. Analysis
Comparison 1 Sulfasalazine versus placebo, Outcome 29 Spondylitis articular index (0 to 90, the higher score the more severe the disease).
1.30
1.30. Analysis
Comparison 1 Sulfasalazine versus placebo, Outcome 30 Spondylitis articular index (2nd analysis) (0 to 90, the higher score the more severe the disease).
1.31
1.31. Analysis
Comparison 1 Sulfasalazine versus placebo, Outcome 31 Improvement in patient global assessment.
1.32
1.32. Analysis
Comparison 1 Sulfasalazine versus placebo, Outcome 32 Patient assessment of disease severity (end point) (VAS 100 mm, 0 = very good, 100 = very poor).
1.33
1.33. Analysis
Comparison 1 Sulfasalazine versus placebo, Outcome 33 General well‐being (end point) (VAS 100 mm, 0 = very good, 100 = very poor).
1.34
1.34. Analysis
Comparison 1 Sulfasalazine versus placebo, Outcome 34 Improvement in physician global assessment.
1.35
1.35. Analysis
Comparison 1 Sulfasalazine versus placebo, Outcome 35 Response to treatment (based on both patient and physician assessment).
1.36
1.36. Analysis
Comparison 1 Sulfasalazine versus placebo, Outcome 36 Duration of morning stiffness (hr).
1.37
1.37. Analysis
Comparison 1 Sulfasalazine versus placebo, Outcome 37 Duration of morning stiffness (2nd analysis) (hr).
1.38
1.38. Analysis
Comparison 1 Sulfasalazine versus placebo, Outcome 38 Morning stiffness (end point) (VAS 100 mm, 0 = no stiffness, 100 = severe stiffness).
1.39
1.39. Analysis
Comparison 1 Sulfasalazine versus placebo, Outcome 39 Improvement in morning stiffness.
1.40
1.40. Analysis
Comparison 1 Sulfasalazine versus placebo, Outcome 40 Erythrocyte sedimentation rate (mm/hr).
1.41
1.41. Analysis
Comparison 1 Sulfasalazine versus placebo, Outcome 41 Erythrocyte sedimentation rate (2nd analysis) (mm/hr).
1.42
1.42. Analysis
Comparison 1 Sulfasalazine versus placebo, Outcome 42 C‐reactive protein (ug/ml).
1.43
1.43. Analysis
Comparison 1 Sulfasalazine versus placebo, Outcome 43 C‐reactive protein (2nd analysis) (ug/ml).
1.44
1.44. Analysis
Comparison 1 Sulfasalazine versus placebo, Outcome 44 Withdrawal due to side effect.
1.45
1.45. Analysis
Comparison 1 Sulfasalazine versus placebo, Outcome 45 Withdrawal due to ineffectiveness.
1.46
1.46. Analysis
Comparison 1 Sulfasalazine versus placebo, Outcome 46 Drop‐out for any reason.
1.47
1.47. Analysis
Comparison 1 Sulfasalazine versus placebo, Outcome 47 Serious adverse events.
2.1
2.1. Analysis
Comparison 2 Sulfasalazine versus placebo (ankylosing spondylitis with peripheral arthritis, end point values), Outcome 1 Back pain (VAS 100 mm, 0 = no pain, 100 = severe pain).
2.2
2.2. Analysis
Comparison 2 Sulfasalazine versus placebo (ankylosing spondylitis with peripheral arthritis, end point values), Outcome 2 Score of sleep disturbance (0 to 4, 0 = no disturbance, 4 = severe disturbance).
2.3
2.3. Analysis
Comparison 2 Sulfasalazine versus placebo (ankylosing spondylitis with peripheral arthritis, end point values), Outcome 3 Chest expansion (cm).
2.4
2.4. Analysis
Comparison 2 Sulfasalazine versus placebo (ankylosing spondylitis with peripheral arthritis, end point values), Outcome 4 Schober's test (cm).
2.5
2.5. Analysis
Comparison 2 Sulfasalazine versus placebo (ankylosing spondylitis with peripheral arthritis, end point values), Outcome 5 Fingers‐to‐floor test (cm).
2.6
2.6. Analysis
Comparison 2 Sulfasalazine versus placebo (ankylosing spondylitis with peripheral arthritis, end point values), Outcome 6 Articular index (0 to 66, the higher the score the more severe the disease).
2.7
2.7. Analysis
Comparison 2 Sulfasalazine versus placebo (ankylosing spondylitis with peripheral arthritis, end point values), Outcome 7 Degree of joint swelling (0 to 66, the higher the score the more severe the disease).
2.8
2.8. Analysis
Comparison 2 Sulfasalazine versus placebo (ankylosing spondylitis with peripheral arthritis, end point values), Outcome 8 Patient assessment of disease severity (VAS 100 mm, 0 = very good, 100 = very poor).
2.9
2.9. Analysis
Comparison 2 Sulfasalazine versus placebo (ankylosing spondylitis with peripheral arthritis, end point values), Outcome 9 Duration of morning stiffness (hr).
2.10
2.10. Analysis
Comparison 2 Sulfasalazine versus placebo (ankylosing spondylitis with peripheral arthritis, end point values), Outcome 10 Erythrocyte sedimentation rate (mm/hr).
3.1
3.1. Analysis
Comparison 3 Sulfasalazine versus placebo (axial form ankylosing spondylitis, end point values), Outcome 1 Back pain (VAS 100 mm, 0 = no pain, 100 = severe pain).
3.2
3.2. Analysis
Comparison 3 Sulfasalazine versus placebo (axial form ankylosing spondylitis, end point values), Outcome 2 Score of sleep disturbance (0 to 4, 0 = no disturbance, 4 = severe disturbance).
3.3
3.3. Analysis
Comparison 3 Sulfasalazine versus placebo (axial form ankylosing spondylitis, end point values), Outcome 3 Chest expansion (cm).
3.4
3.4. Analysis
Comparison 3 Sulfasalazine versus placebo (axial form ankylosing spondylitis, end point values), Outcome 4 Schober's test (cm).
3.5
3.5. Analysis
Comparison 3 Sulfasalazine versus placebo (axial form ankylosing spondylitis, end point values), Outcome 5 Fingers‐to‐floor test (cm).
3.6
3.6. Analysis
Comparison 3 Sulfasalazine versus placebo (axial form ankylosing spondylitis, end point values), Outcome 6 Patient assessment of disease severity (VAS 100 mm, 0 = very good, 100 = very poor).
3.7
3.7. Analysis
Comparison 3 Sulfasalazine versus placebo (axial form ankylosing spondylitis, end point values), Outcome 7 Duration of morning stiffness (hr).
3.8
3.8. Analysis
Comparison 3 Sulfasalazine versus placebo (axial form ankylosing spondylitis, end point values), Outcome 8 Erythrocyte sedimentation rate (mm/hr).
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Update of

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