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Study flow diagram.
Figuras y tablas -
Figure 1

Study flow diagram.

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Risk of bias graph: review authors' judgments about each risk of bias item presented as percentages across all included studies.
Figuras y tablas -
Figure 2

Risk of bias graph: review authors' judgments about each risk of bias item presented as percentages across all included studies.

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Risk of bias summary: review authors' judgments about each risk of bias item for each included study.
Figuras y tablas -
Figure 3

Risk of bias summary: review authors' judgments about each risk of bias item for each included study.

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Comparison 1 Sulfasalazine versus placebo, Outcome 1 Spondylitis function index (Score 0 to 40, 0 to 44, 0 = the best).
Figuras y tablas -
Analysis 1.1

Comparison 1 Sulfasalazine versus placebo, Outcome 1 Spondylitis function index (Score 0 to 40, 0 to 44, 0 = the best).

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Comparison 1 Sulfasalazine versus placebo, Outcome 2 Spondylitis function index (2nd analysis) (score 0 to 40, 0 to 44, 0 = the best).
Figuras y tablas -
Analysis 1.2

Comparison 1 Sulfasalazine versus placebo, Outcome 2 Spondylitis function index (2nd analysis) (score 0 to 40, 0 to 44, 0 = the best).

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Comparison 1 Sulfasalazine versus placebo, Outcome 3 Improvement in back pain.
Figuras y tablas -
Analysis 1.3

Comparison 1 Sulfasalazine versus placebo, Outcome 3 Improvement in back pain.

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Comparison 1 Sulfasalazine versus placebo, Outcome 4 Back pain (VAS 100 mm, 0 = no pain, 100 = severe pain).
Figuras y tablas -
Analysis 1.4

Comparison 1 Sulfasalazine versus placebo, Outcome 4 Back pain (VAS 100 mm, 0 = no pain, 100 = severe pain).

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Comparison 1 Sulfasalazine versus placebo, Outcome 5 Back pain (2nd analysis) (VAS 100 mm, 0 = no pain, 100 = severe pain).
Figuras y tablas -
Analysis 1.5

Comparison 1 Sulfasalazine versus placebo, Outcome 5 Back pain (2nd analysis) (VAS 100 mm, 0 = no pain, 100 = severe pain).

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Comparison 1 Sulfasalazine versus placebo, Outcome 6 Night pain (% no pain).
Figuras y tablas -
Analysis 1.6

Comparison 1 Sulfasalazine versus placebo, Outcome 6 Night pain (% no pain).

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Comparison 1 Sulfasalazine versus placebo, Outcome 7 Score of sleep disturbance (end point) (0 to 4, 0 = no disturbance, 4 = severe disturbance).
Figuras y tablas -
Analysis 1.7

Comparison 1 Sulfasalazine versus placebo, Outcome 7 Score of sleep disturbance (end point) (0 to 4, 0 = no disturbance, 4 = severe disturbance).

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Comparison 1 Sulfasalazine versus placebo, Outcome 8 Frequency of nocturnal awakening (change from baseline).
Figuras y tablas -
Analysis 1.8

Comparison 1 Sulfasalazine versus placebo, Outcome 8 Frequency of nocturnal awakening (change from baseline).

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Comparison 1 Sulfasalazine versus placebo, Outcome 9 Score of daily NSAIDs (change from baseline, usual dosage as 10).
Figuras y tablas -
Analysis 1.9

Comparison 1 Sulfasalazine versus placebo, Outcome 9 Score of daily NSAIDs (change from baseline, usual dosage as 10).

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Comparison 1 Sulfasalazine versus placebo, Outcome 10 Reducing or stopping NSAIDs.
Figuras y tablas -
Analysis 1.10

Comparison 1 Sulfasalazine versus placebo, Outcome 10 Reducing or stopping NSAIDs.

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Comparison 1 Sulfasalazine versus placebo, Outcome 11 Chest expansion (cm).
Figuras y tablas -
Analysis 1.11

Comparison 1 Sulfasalazine versus placebo, Outcome 11 Chest expansion (cm).

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Comparison 1 Sulfasalazine versus placebo, Outcome 12 Chest expansion (2nd analysis) (cm).
Figuras y tablas -
Analysis 1.12

Comparison 1 Sulfasalazine versus placebo, Outcome 12 Chest expansion (2nd analysis) (cm).

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Comparison 1 Sulfasalazine versus placebo, Outcome 13 Forced vital volume (change from baseline) (L/min).
Figuras y tablas -
Analysis 1.13

Comparison 1 Sulfasalazine versus placebo, Outcome 13 Forced vital volume (change from baseline) (L/min).

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Comparison 1 Sulfasalazine versus placebo, Outcome 14 (Modified) Schober's test (cm).
Figuras y tablas -
Analysis 1.14

Comparison 1 Sulfasalazine versus placebo, Outcome 14 (Modified) Schober's test (cm).

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Comparison 1 Sulfasalazine versus placebo, Outcome 15 (Modified) Schober's test (2nd analysis) (cm).
Figuras y tablas -
Analysis 1.15

Comparison 1 Sulfasalazine versus placebo, Outcome 15 (Modified) Schober's test (2nd analysis) (cm).

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Comparison 1 Sulfasalazine versus placebo, Outcome 16 Occiput‐to‐wall test (cm).
Figuras y tablas -
Analysis 1.16

Comparison 1 Sulfasalazine versus placebo, Outcome 16 Occiput‐to‐wall test (cm).

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Comparison 1 Sulfasalazine versus placebo, Outcome 17 Occiput‐to‐wall test (2nd analysis) (cm).
Figuras y tablas -
Analysis 1.17

Comparison 1 Sulfasalazine versus placebo, Outcome 17 Occiput‐to‐wall test (2nd analysis) (cm).

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Comparison 1 Sulfasalazine versus placebo, Outcome 18 Fingers‐to‐floor test (cm).
Figuras y tablas -
Analysis 1.18

Comparison 1 Sulfasalazine versus placebo, Outcome 18 Fingers‐to‐floor test (cm).

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Comparison 1 Sulfasalazine versus placebo, Outcome 19 Fingers‐to‐floor test (2nd analysis) (cm).
Figuras y tablas -
Analysis 1.19

Comparison 1 Sulfasalazine versus placebo, Outcome 19 Fingers‐to‐floor test (2nd analysis) (cm).

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Comparison 1 Sulfasalazine versus placebo, Outcome 20 Chin sternum distance (change from baseline) (cm).
Figuras y tablas -
Analysis 1.20

Comparison 1 Sulfasalazine versus placebo, Outcome 20 Chin sternum distance (change from baseline) (cm).

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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.
Figuras y tablas -
Analysis 1.21

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.

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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).
Figuras y tablas -
Analysis 1.22

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).

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Comparison 1 Sulfasalazine versus placebo, Outcome 23 Joint swelling score (0 to 198, the higher score the more severe the disease) or number.
Figuras y tablas -
Analysis 1.23

Comparison 1 Sulfasalazine versus placebo, Outcome 23 Joint swelling score (0 to 198, the higher score the more severe the disease) or number.

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Comparison 1 Sulfasalazine versus placebo, Outcome 24 Joint swelling score (2nd analysis) (0 to 198, the higher the score the more severe the disease).
Figuras y tablas -
Analysis 1.24

Comparison 1 Sulfasalazine versus placebo, Outcome 24 Joint swelling score (2nd analysis) (0 to 198, the higher the score the more severe the disease).

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Comparison 1 Sulfasalazine versus placebo, Outcome 25 Dactylitis score (0 to 3, 0 = normal, 3 = severe).
Figuras y tablas -
Analysis 1.25

Comparison 1 Sulfasalazine versus placebo, Outcome 25 Dactylitis score (0 to 3, 0 = normal, 3 = severe).

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Comparison 1 Sulfasalazine versus placebo, Outcome 26 Dactylitis score (2nd analysis) (0 to 3, 0 = normal, 3 = severe).
Figuras y tablas -
Analysis 1.26

Comparison 1 Sulfasalazine versus placebo, Outcome 26 Dactylitis score (2nd analysis) (0 to 3, 0 = normal, 3 = severe).

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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).
Figuras y tablas -
Analysis 1.27

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).

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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).
Figuras y tablas -
Analysis 1.28

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).

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Comparison 1 Sulfasalazine versus placebo, Outcome 29 Spondylitis articular index (0 to 90, the higher score the more severe the disease).
Figuras y tablas -
Analysis 1.29

Comparison 1 Sulfasalazine versus placebo, Outcome 29 Spondylitis articular index (0 to 90, the higher score the more severe the disease).

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Comparison 1 Sulfasalazine versus placebo, Outcome 30 Spondylitis articular index (2nd analysis) (0 to 90, the higher score the more severe the disease).
Figuras y tablas -
Analysis 1.30

Comparison 1 Sulfasalazine versus placebo, Outcome 30 Spondylitis articular index (2nd analysis) (0 to 90, the higher score the more severe the disease).

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Comparison 1 Sulfasalazine versus placebo, Outcome 31 Improvement in patient global assessment.
Figuras y tablas -
Analysis 1.31

Comparison 1 Sulfasalazine versus placebo, Outcome 31 Improvement in patient global assessment.

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Comparison 1 Sulfasalazine versus placebo, Outcome 32 Patient assessment of disease severity (end point) (VAS 100 mm, 0 = very good, 100 = very poor).
Figuras y tablas -
Analysis 1.32

Comparison 1 Sulfasalazine versus placebo, Outcome 32 Patient assessment of disease severity (end point) (VAS 100 mm, 0 = very good, 100 = very poor).

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Comparison 1 Sulfasalazine versus placebo, Outcome 33 General well‐being (end point) (VAS 100 mm, 0 = very good, 100 = very poor).
Figuras y tablas -
Analysis 1.33

Comparison 1 Sulfasalazine versus placebo, Outcome 33 General well‐being (end point) (VAS 100 mm, 0 = very good, 100 = very poor).

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Comparison 1 Sulfasalazine versus placebo, Outcome 34 Improvement in physician global assessment.
Figuras y tablas -
Analysis 1.34

Comparison 1 Sulfasalazine versus placebo, Outcome 34 Improvement in physician global assessment.

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Comparison 1 Sulfasalazine versus placebo, Outcome 35 Response to treatment (based on both patient and physician assessment).
Figuras y tablas -
Analysis 1.35

Comparison 1 Sulfasalazine versus placebo, Outcome 35 Response to treatment (based on both patient and physician assessment).

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Comparison 1 Sulfasalazine versus placebo, Outcome 36 Duration of morning stiffness (hr).
Figuras y tablas -
Analysis 1.36

Comparison 1 Sulfasalazine versus placebo, Outcome 36 Duration of morning stiffness (hr).

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Comparison 1 Sulfasalazine versus placebo, Outcome 37 Duration of morning stiffness (2nd analysis) (hr).
Figuras y tablas -
Analysis 1.37

Comparison 1 Sulfasalazine versus placebo, Outcome 37 Duration of morning stiffness (2nd analysis) (hr).

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Comparison 1 Sulfasalazine versus placebo, Outcome 38 Morning stiffness (end point) (VAS 100 mm, 0 = no stiffness, 100 = severe stiffness).
Figuras y tablas -
Analysis 1.38

Comparison 1 Sulfasalazine versus placebo, Outcome 38 Morning stiffness (end point) (VAS 100 mm, 0 = no stiffness, 100 = severe stiffness).

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Comparison 1 Sulfasalazine versus placebo, Outcome 39 Improvement in morning stiffness.
Figuras y tablas -
Analysis 1.39

Comparison 1 Sulfasalazine versus placebo, Outcome 39 Improvement in morning stiffness.

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Comparison 1 Sulfasalazine versus placebo, Outcome 40 Erythrocyte sedimentation rate (mm/hr).
Figuras y tablas -
Analysis 1.40

Comparison 1 Sulfasalazine versus placebo, Outcome 40 Erythrocyte sedimentation rate (mm/hr).

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Comparison 1 Sulfasalazine versus placebo, Outcome 41 Erythrocyte sedimentation rate (2nd analysis) (mm/hr).
Figuras y tablas -
Analysis 1.41

Comparison 1 Sulfasalazine versus placebo, Outcome 41 Erythrocyte sedimentation rate (2nd analysis) (mm/hr).

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Comparison 1 Sulfasalazine versus placebo, Outcome 42 C‐reactive protein (ug/ml).
Figuras y tablas -
Analysis 1.42

Comparison 1 Sulfasalazine versus placebo, Outcome 42 C‐reactive protein (ug/ml).

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Comparison 1 Sulfasalazine versus placebo, Outcome 43 C‐reactive protein (2nd analysis) (ug/ml).
Figuras y tablas -
Analysis 1.43

Comparison 1 Sulfasalazine versus placebo, Outcome 43 C‐reactive protein (2nd analysis) (ug/ml).

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Comparison 1 Sulfasalazine versus placebo, Outcome 44 Withdrawal due to side effect.
Figuras y tablas -
Analysis 1.44

Comparison 1 Sulfasalazine versus placebo, Outcome 44 Withdrawal due to side effect.

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Comparison 1 Sulfasalazine versus placebo, Outcome 45 Withdrawal due to ineffectiveness.
Figuras y tablas -
Analysis 1.45

Comparison 1 Sulfasalazine versus placebo, Outcome 45 Withdrawal due to ineffectiveness.

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Comparison 1 Sulfasalazine versus placebo, Outcome 46 Drop‐out for any reason.
Figuras y tablas -
Analysis 1.46

Comparison 1 Sulfasalazine versus placebo, Outcome 46 Drop‐out for any reason.

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Comparison 1 Sulfasalazine versus placebo, Outcome 47 Serious adverse events.
Figuras y tablas -
Analysis 1.47

Comparison 1 Sulfasalazine versus placebo, Outcome 47 Serious adverse events.

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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).
Figuras y tablas -
Analysis 2.1

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).

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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).
Figuras y tablas -
Analysis 2.2

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).

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Comparison 2 Sulfasalazine versus placebo (ankylosing spondylitis with peripheral arthritis, end point values), Outcome 3 Chest expansion (cm).
Figuras y tablas -
Analysis 2.3

Comparison 2 Sulfasalazine versus placebo (ankylosing spondylitis with peripheral arthritis, end point values), Outcome 3 Chest expansion (cm).

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Comparison 2 Sulfasalazine versus placebo (ankylosing spondylitis with peripheral arthritis, end point values), Outcome 4 Schober's test (cm).
Figuras y tablas -
Analysis 2.4

Comparison 2 Sulfasalazine versus placebo (ankylosing spondylitis with peripheral arthritis, end point values), Outcome 4 Schober's test (cm).

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Comparison 2 Sulfasalazine versus placebo (ankylosing spondylitis with peripheral arthritis, end point values), Outcome 5 Fingers‐to‐floor test (cm).
Figuras y tablas -
Analysis 2.5

Comparison 2 Sulfasalazine versus placebo (ankylosing spondylitis with peripheral arthritis, end point values), Outcome 5 Fingers‐to‐floor test (cm).

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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).
Figuras y tablas -
Analysis 2.6

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).

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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).
Figuras y tablas -
Analysis 2.7

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).

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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).
Figuras y tablas -
Analysis 2.8

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).

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Comparison 2 Sulfasalazine versus placebo (ankylosing spondylitis with peripheral arthritis, end point values), Outcome 9 Duration of morning stiffness (hr).
Figuras y tablas -
Analysis 2.9

Comparison 2 Sulfasalazine versus placebo (ankylosing spondylitis with peripheral arthritis, end point values), Outcome 9 Duration of morning stiffness (hr).

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Comparison 2 Sulfasalazine versus placebo (ankylosing spondylitis with peripheral arthritis, end point values), Outcome 10 Erythrocyte sedimentation rate (mm/hr).
Figuras y tablas -
Analysis 2.10

Comparison 2 Sulfasalazine versus placebo (ankylosing spondylitis with peripheral arthritis, end point values), Outcome 10 Erythrocyte sedimentation rate (mm/hr).

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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).
Figuras y tablas -
Analysis 3.1

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).

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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).
Figuras y tablas -
Analysis 3.2

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).

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Comparison 3 Sulfasalazine versus placebo (axial form ankylosing spondylitis, end point values), Outcome 3 Chest expansion (cm).
Figuras y tablas -
Analysis 3.3

Comparison 3 Sulfasalazine versus placebo (axial form ankylosing spondylitis, end point values), Outcome 3 Chest expansion (cm).

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Comparison 3 Sulfasalazine versus placebo (axial form ankylosing spondylitis, end point values), Outcome 4 Schober's test (cm).
Figuras y tablas -
Analysis 3.4

Comparison 3 Sulfasalazine versus placebo (axial form ankylosing spondylitis, end point values), Outcome 4 Schober's test (cm).

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Comparison 3 Sulfasalazine versus placebo (axial form ankylosing spondylitis, end point values), Outcome 5 Fingers‐to‐floor test (cm).
Figuras y tablas -
Analysis 3.5

Comparison 3 Sulfasalazine versus placebo (axial form ankylosing spondylitis, end point values), Outcome 5 Fingers‐to‐floor test (cm).

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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).
Figuras y tablas -
Analysis 3.6

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).

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Comparison 3 Sulfasalazine versus placebo (axial form ankylosing spondylitis, end point values), Outcome 7 Duration of morning stiffness (hr).
Figuras y tablas -
Analysis 3.7

Comparison 3 Sulfasalazine versus placebo (axial form ankylosing spondylitis, end point values), Outcome 7 Duration of morning stiffness (hr).

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Comparison 3 Sulfasalazine versus placebo (axial form ankylosing spondylitis, end point values), Outcome 8 Erythrocyte sedimentation rate (mm/hr).
Figuras y tablas -
Analysis 3.8

Comparison 3 Sulfasalazine versus placebo (axial form ankylosing spondylitis, end point values), Outcome 8 Erythrocyte sedimentation rate (mm/hr).

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Summary of findings for the main comparison. Sulfasalazine compared to placebo for ankylosing spondylitis

Sulfasalazine compared to placebo for ankylosing spondylitis

Patient or population: Patients with ankylosing spondylitis
Settings: Outpatients and inpatients
Intervention: Sulfasalazine
Comparison: Placebo

Outcomes

Illustrative comparative risks* (95% CI)

Relative effect
(95% CI)

No of Participants
(studies)

Quality of the evidence
(GRADE)

Comments

Assumed risk

Corresponding risk

Placebo

Sulfasalazine

Back pain (pooled data)
100 mm visual analogue scale, 0 = no pain, 100 = severe
Follow‐up: median 26 weeks

The mean back pain (pooled data) in the control groups was
49.5 mm1

The mean back pain (pooled data) in the intervention groups was
2.96 lower
(6.33 lower to 0.41 higher)

454
(6 studies)

⊕⊕⊕⊝
Moderate2

Absolute risk difference 3% lower (95% CI 1% to 6%); Relative percent change = 6% (95% CI 2% to 12%); NNT4 = n/a5

Mean improvement in Bath ankylosing spondylitis disease activity index (BASDAI) ‐ not reported

See comment

See comment

Not estimable

No data

See comment

Not measured

Mean improvement in Bath ankylosing spondylitis function index (BASFI) ‐ not reported

See comment

See comment

Not estimable

No data

See comment

Not measured

Mean improvement in Bath ankylosing spondylitis metrology index (BASMI) ‐ not reported

See comment

See comment

Not estimable

No data

See comment

Not measured

Radiographic progress ‐ not reported

See comment

See comment

Not estimable

No data

See comment

Not measured

Total number of withdrawals due to adverse events
Follow‐up: median 26 weeks

94 per 1000

134 per 1000
(98 to 182)

RR 1.43
(1.04 to 1.94)

895
(11 studies)

⊕⊕⊕⊝
Moderate2

Absolute risk difference 4% (95% CI 0.4% to 8.8%); NNTH6 = 25 (95% CI 266 to 12)

Serious adverse events
Follow‐up: mean 36 weeks

0 per 1000

1 per 1000
(0 to 0)

OR 7.5
(0.15 to 378.16)

264
(1 study)

⊕⊕⊕⊝
Moderate3

Absolute risk difference 750% (95% CI 15% to 37816%) (W); Relative percent change = 205% (95% CI ‐87% to 7309%); NNTH = n/a

*The basis for the assumed risk (e.g. the median control group risk across studies) is provided in footnotes. The corresponding risk (and its 95% confidence interval) is based on the assumed risk in the comparison group and the relative effect of the intervention (and its 95% CI).
CI: Confidence interval; RR: Risk ratio; OR: Odds ratio;

GRADE Working Group grades of evidence
High quality: Further research is very unlikely to change our confidence in the estimate of effect.
Moderate quality: Further research is likely to have an important impact on our confidence in the estimate of effect and may change the estimate.
Low quality: Further research is very likely to have an important impact on our confidence in the estimate of effect and is likely to change the estimate.
Very low quality: We are very uncertain about the estimate.

1 From Clegg 1996, mean back pain at baseline in placebo = 48.9 (95% CI 3.0 to 94.8).
2 Different baseline value (3 as endpoint value and 3 as change from baseline value).
3 Wide confidence interval.

4 NNT (Number needed to treat). NNT for dichotomous outcomes calculated using Cates NNT calculator (http://www.nntonline.net/visualrx/).

5 n/a means result is not statistically significant.

6NNTH (Number needed to treat to harm).

Figuras y tablas -
Summary of findings for the main comparison. Sulfasalazine compared to placebo for ankylosing spondylitis
Ir a la tabla de la revisión
Table 1. Concise comparison of included trials

Study

Methodological quality

Duration/sample size

Disease duration

Peripheral arthritis

Baseline ESR

Intervention

Main results

Drop‐out

Clegg 1996

Mutlicenter RCT

Concealment: unclear risk

Assessment: blind

36 weeks/264

18.5+/‐11.6

29%

SSZ: 24.6+/‐18.0

Placebo: 25.2+/‐22.0

SSZ (or placebo) 2.0 g/d

ESR declined more with SSZ than with placebo (P < 0.0001). When comparing SSZ responders with non‐responders, the former had a greater decrease in ESR (P < 0.04)

Patients with peripheral arthritis showed improvement that favored SSZ (P < 0.02)

No significant difference in other parameters. One patient taking SSZ had severe adverse drug reaction

19.3%

Corkill 1990

RCT

Concealment: unclear risk

Assessment: blind

48 weeks/62

SSZ: 12.3+/‐8.2

Placebo: 16.1+/‐11.4

19%

SSZ: 15+/‐16

Placebo: 24+/‐26

SSZ (or placebo) 2.0 g/d

No significant difference between intervention groups

No data

Davis 1989

RCT

Concealment: unclear

Risk assessment: blind

3 months/30

Median SSZ: 8.6

Placebo: 8.4

23%

SSZ: 24+/‐7.8(95% confidence limits)

Placebo: 26.4+/‐8.6

SSZ (or placebo) 2.0 g/d

Claimed effective on the basis of before‐after comparison

6.7%

Dougados 1986

RCT

Concealment: low risk

Assessment: blind

6 months/60

Median 10

0%

SSZ: 13.5(median)

Placebo: 11.0

SSZ (or placebo) 2.0 g/d

Success in patient assessment was more in SSZ than in placebo group. Function index and NSAIDs dosage were significantly improved in SSZ compared with placebo group. No difference was found in other parameters

21.7%

Feltelius 1986

RCT

Concealment: unclear risk

Assessment: blind

12 weeks/37

Median SSZ: 12.1

Placebo: 10.4

5%

SSZ: 24.3+/‐17.4

Placebo: 28.5+/‐19.5

SSZ (or placebo) up to 3.0 g/d

Only graphs (no figures) were presented. Compared with placebo group, morning stiffness and sleep disturbance were significantly improved in SSZ group

Analysis of SSZ group showed that the greatest improvement were those with ESR > 20 mm/hr or haptoglobin > 3.8 g/L

21.6%

Kirwan 1993

RCT

Concealment: low risk

Assessment: blind

3 years/89

SSZ: 19+/‐12

Placebo: 21.9+/‐11.7

28%

No data

SSZ (or placebo) 2.0 g/d

Occurence of peripheral joint symptoms was lower in SSZ group:

SSZ: 0.298 episodes/yr

Placebo: 0.392 episodes/yr, P < 0.05

No difference was found in Schober test, chest expansion and cervical spine lateral flexion. More drop‐outs in SSZ group

30.3%

Krajnc 1990

RCT

Concealment: unclear risk

Assessment: blind

24 weeks/95

SSZ = 71

Placebo = 24

No data

66%

SSZ: 41+/‐19

Placebo: 43+/‐18

SSZ (or placebo) up to 3.0 g/d

On the basis of before‐after treatment comparison, duration of morning stiffness, number of painful and swollen joints, and ESR, there was significant improvement in SSZ group

Duration of morning stiffness and ESR value were given in the paper and we found no significant difference between the intervention groups

14.3%

Nissila 1988

RCT

Concealment: unclear risk

Assessment: blind

26 weeks/85

SSZ: 5.4+/‐7.3

Placebo: 3.8+/‐4.3

68%

SSZ: 42+/‐20

Placebo: 46+/‐19

SSZ (or placebo) up to 3.0 g/d

Significant differences between intervention groups were observed in severity of morning stiffness, chest expansion and ESR. We also found severity of pain significantly improved in SSZ, compared with placebo group

12.2%

Schmidt 2002

RCT

Concealment: unclear risk

Assessment: blind?

26 weeks/70

SSZ: 16.7+/‐7.2

Placebo: 16.3+/‐7.8

36%

SSZ: 23.1+/‐3.2

Placebo 20.4+/‐2.4

SSZ (or placebo) 3.0 g/d

No significant difference was found between intervention groups except IgA. There were more drop‐outs in SSZ than in placebo group (18/34 versus 7/36)

32.9%

Taylor 1991

RCT

Concealment: low risk

Assessment: blind

1 year/40

SSZ: 11+/‐1.6

Placebo: 10.7+/‐1.6

15%

SSZ: 27

Placebo: 25

SSZ (or placebo) 2.0 g/d

No significant difference was found between intervention groups in all parameters except pain (measured with visual analogue scale). However, the pooled result showed no statistically significant, too

17.5%

Winkler 1989

RCT

Concealment: unclear risk

Assessment: blind?

24 weeks/63

Median SSZ: 10.8

Placebo: 11.2

33%

SSZ: 33.4+/‐20.4

Placebo: 26.9+/‐16.4

SSZ (or placebo) 2.0 g/d

The advantage of SSZ over placebo were significant only in the duration of morning stiffness and disturbance of sleep. The same results were found in the patients with axial form (N = 34). In patients with peripheral arthritis (N = 15), articular index showed significant improvement in SSZ over placebo

22.2%

ESR ‐ erythrocyte sedimentation rate
g/d ‐ grams per day
Ig A ‐ immunoglobulin A
NSAIDs ‐ non‐steroidal anti‐inflammatory drugs
RCT ‐ randomized controlled trials
SSZ ‐ sulfasalazine

Figuras y tablas -
Table 1. Concise comparison of included trials
Ir a la tabla de la revisión
Table 2. Randomized controlled trials comparing sulphasalazine with placebo

Study and Duration

Participants

Outcomes assessed

Results reported

Present analysis

ESR results

Spinal stiffness

Clegg 1996, 36 weeks

264

(SSZ: 31)

(Placebo: 133)

29% with PA

DD (year):

18.5±11.6

ESR (mm/h): 26.4±18.0 (SSZ)

25.2±22.0 (placebo)

Primary outcomes included response to treatment, improvement in PhGA, PGA, back pain and morning stiffness. Secondary outcomes included night pain (event), duration of morning stiffness, back pain VAS, spondylitis function index, joint/tenderness score, joint swelling score, dactylitis score, enthesopathy index, spondylitis articular index, chest expansion, Schober's test, occiput‐to‐wall test, fingers‐to‐floor test, ESR and CRP

Drop‐out: 19.3%. Both end point value and change from baseline were presented for all continuous outcomes. No difference was found between treatment groups in all outcomes except ESR, which declined more with SSZ than placebo group (P < 0.0001). When comparing SSZ responders with non‐responders, the former had a greater decrease in ESR (P < 0.04). Subgroup analysis showed that in patients with PA, 55.9% of SSZ group and 30.2% of placebo group got peripheral response (P = 0.023)

All the results reported have been confirmed except subgroup analysis where no information about treatment allocation was available for analysis. MD for ESR (change from baseline) was ‐3.10 mm/h, 95% CI ‐4.85 to ‐1.35 mm/h, favoring SSZ group

Absolute benefit from SSZ: ‐3.6 mm/h

Relative difference in change from baseline: ‐14%

Did not report

Corkill 1990, 48 weeks

62

(SSZ: 32)

(Placebo: 30)

19% with PA

DD (year):

12.3±8.2 (SSZ) 16.1±11.4 (placebo)

ESR (mm/h):

15±16 (SSZ)

24±26 (placebo)

Spinal pain VAS, spinal stiffness VAS, peripheral joint pain VAS, Schober's test, chest expansion, cervical flexion, cervical rotation, and ESR

Drop‐out: 1.6%. No significant difference was found between treatment groups

Because SDs were not given for all outcomes, these results could not be analyzed

Absolute benefit from SSZ: ‐0.1 mm/h

Relative difference in change from baseline: ‐1%

Absolute benefit from SSZ: ‐9.8 mm on 100 mm VAS

Relative difference in change from baseline: ‐25%

Davis 1989, 3 months

30

(SSZ: 15)

(Placebo: 15)

23% with PA

DD (year):

8.6 (SSZ)

8.4 (placebo)

ESR (mm/h):

24±7.8 (SSZ) 26.4±8.6 (placebo)

Pain VAS, spinal stiffness VAS, sleep disturbance (event), occiput‐to‐wall test, fingers‐to‐floor test, ESR and CRP

Drop‐out: 6.7%. In SSZ group, all clinical outcomes showed significantly improved when initial and 3 months results are compared

Pain VAS, spinal stiffness VAS and CRP could not be analyzed because means and SDs were not given. No significant difference was found in any other outcome

Absolute benefit from SSZ: ‐5.4 mm/h

Relatiive difference in change from baseline: ‐20%

Absolute benefit from SSZ: ‐20 mm on 100 mm VAS

Relative difference in change from baseline: ‐40%

Dougados 1986, 6 months

60

(SSZ: 30)

(Placebo: 30)

None with PA

DD (year, median): 10

ESR (mm/h, median): 13.5 (SSZ)

11.0 (placebo)

PGA, score of daily NSAIDs, pain VAS, joint index, frequency of nocturnal awakening, function index, Schober's test, fingers‐to‐floor test, chest expansion and ESR

Drop‐out: 21.7%. Success in PGA was more in SSZ than in placebo group (15/30 vs 6/30, P < 0.05). SSZ resulted in a significant reduction in score of daily NSAIDs (P < 0.05) and significant improvement of function index (P was not given) compared with placebo. No significant difference was found in other outcomes

All continuous outcomes were presented as median and 95% CI. For RevMan analysis, we assumed that mean is equal to median for each outcome and calculated SD from 95% CI and sample size. Success in PGA was more in SSZ than in placebo group (RR 2.5, 95% CI 1.12 to 5.56). No significant difference was found between treatment groups in other outcomes

Absolute benefit from SSZ: 0 mm/h

Did not report

Feltelius 1986, 12 weeks

37

(SSZ:18)

(Placebo: 19)

5% with PA

DD (year, median): 12.1 (SSZ)

10.4 (placebo)

ESR (mm/h): 24.3±17.4 (SSZ) 28.5±19.5 (placebo)

Duration of morning stiffness, spinal stiffness VAS, pain VAS, general wellbeing VAS, chest expansion, Schober's test, sleep disturbance (event), sacroiliac pain VAS, ESR

Drop‐out: 21.6%. Spinal stiffness VAS, chest expansion and sleep disturbance were significantly improved in SSZ compared with placebo group

All outcomes were presented as graphs and no data were available for analysis except ESR that showed no significant difference between treatment groups

Absolute benefit from SSZ: 1.3 mm/h

Relative difference in change from baseline: 5%

Did not report

Kirwan 1993, 3 years

89

(SSZ: 44)

(Placebo: 45)

28% with PA

DD (year): 19±12 (SSZ)

21.9±11.7 (placebo)

ESR not given

Primary outcomes included Schober's test, chest expansion, and lateral cervical flexion. Secondary outcomes included function (HAQ), back pain VAS, consumption of anti‐inflammatory drugs, sleep disturbance VAS, PGA, episodes of peripheral arthritis, episodes of heel pain, flares in general AS symptoms, episodes of arthritis

Drop‐out: 30.3%. No significant difference was found between treatment groups in all outcomes except occurrence of peripheral joint symptoms. The episodes of PA were 0.289 episodes/year in SSZ and 0.392 episodes/year in placebo group, respectively (P < 0.05)

There were significantly more drop‐outs for any reason in SSZ than in placebo group. RR was 2.43 (95% CI 1.19 to 4.96). No data were available for analysis in any other outcome

Did not report

Did not report

Krajnc 1990, 24 weeks

95

(SSZ: 71)

(Placebo: 24)

66% with PA

DD not given

ESR (mm/h): 41±19 (SSZ) 43±18 (placebo)

Duration of morning stiffness, Schober's test, chest expansion, fingers‐to‐floor test, number of painful/swollen joints and ESR

Drop‐out: 14.3%. In SSZ group, duration of morning stiffness, chest expansion, number of painful/swollen joints and ESR showed significantly improved when initial and 24 weeks results are compared

No significant difference was found between treatment groups in all outcomes except ESR (MD ‐17.00 mm/h, 95% CI ‐26.99 to ‐7.01mm/h, favoring SSZ)

Absolute benefit from SSZ: 15 mm/h

Relatiive difference in change from baseline: ‐35%

Absoluete benefit from SSZ: ‐4 mm on 100 mm VAS

Relative difference in change from baseline: ‐8%

Nissila 1988, 26 weeks

85

(SSZ: 43

(Placebo: 42)

68% with PA

DD (year): 5.4±7.3 (SSZ)

3.8±4.3 (placebo)

ESR (mm/h): 42±20 (SSZ) 46±19 (placebo)

Duration of morning stiffness, spinal stiffness VAS, chest expansion, Schober's test, fingers‐to‐floor test, occiput‐to‐wall test, number of painful joints, number of swollen joints, general wellbeing VAS, ESR and CRP

Drop‐out: 12.2%. Significant differences between treatment groups were found in morning stiffness VAS (P = 0.02), chest expansion (P = 0.03) and ESR (P = 0.02), favoring SSZ. No significant difference was found in other outcomes.

Note: we suspected that results of chest expansion were errors because they were impossible to be about 40 to 50 cm. So we divided them by 10 for analysis

Significant differences were found in morning stiffness VAS 100 mm (0 = no stiffness, 100 = severe, MD ‐14.00, 95% CI ‐23.78 to ‐4.22), chest expansion (MD 1.00 cm, 95% CI 0.10 to 1.90 cm), occiput‐to‐wall test (MD ‐0.80 cm, 95% CI ‐1.55 to 0.05 cm), ESR (MD ‐19.00 mm/h, 95% CI ‐29.65 to ‐8.35 mm/h), and general wellbeing VAS 100 mm (0 = the best, 100 = the worst, MD ‐11.00, 95% CI ‐19.84 to ‐2.16), favoring SSZ. No significant difference was found in other outcomes

Absolute benefit from SSZ: ‐15 mm/h

Relatiive difference in change from baseline: ‐33%

Absolute benefit from SSZ: ‐6 mm on 100 mm VAS

Relative difference in change from baseline: ‐15%

Schmidt 2002, 26 weeks

70

(SSZ: 34)

(Placebo: 36)

36% with PA

DD (year): 16.7±7.2 (SSZ)

16.3±7.8 (placebo)

ESR (mm/h): 23.1±3.2 (SSZ) 20.4±2.4 (placebo)

Back pain VAS, nocturnal awakening (event), pain/tenderness score, duration of morning stiffness, number of painful joints, number of swollen joints, spondylitis function index, PGA, PhGA, Schober's test, fingers‐to‐floor test, chin sternum distance, chest expansion, ESR and CRP

Drop‐out: 36%. No significant difference was reported between treatment groups. There were more drop‐outs in SSZ than in placebo (38% vs 11%)

All continuous outcomes were analyzed as change from baseline. Significant differences were found between treatment groups in back pain VAS 100 mm (0 = no pain, 100 = severe pain, MD ‐2.30, 95% CI ‐4.44 to ‐0.16), chest expansion (MD 0.30 cm, 95% CI 0.16 to 0.44 cm), Schober's test (MD 0.50 cm, 95 CI 0.44 to 0.56 cm), duration of morning stiffness (MD ‐0.39 h, 95% CI ‐0.48 to ‐0.30 h), ESR (MD ‐3.10 mm/h, 95% CI ‐4.85 to ‐1.35 mm/h) and CRP (MD ‐2.50 µg/ml, 95% CI ‐4.70 to ‐0.30 µg/ml), favoring SSZ group. But in occiput‐to‐wall test, the difference (MD 0.70 cm, 95% CI 0.32 to 1.08 cm) favored placebo over SSZ. No significant difference was found in other outcomes. There were significantly more withdrawals for side effects and drop‐outs for any reason in SSZ than in placebo group. RRs were 3.44 (95% CI 1.24 to 9.52) and 2.42 (95% CI 1.14 to 5.15), respectively

Absolute benefit from SSZ: ‐3.1 mm/h

Relatiive difference in change from baseline: ‐15%

Did not report

Taylor 1991, 1 year

40

(SSZ: 20) (Placebo: 20)

15% with PA

DD (year): 11±1.6 (SSZ) 10.7±1.6 (placebo)

ESR (mm/h, mean): 27 (SSZ)

25 (placebo)

Back pain VAS, fingers‐to‐floor test, chest expansion, sleep disturbance (event), forced vital volume, occiput‐to‐wall test, Schober's test, spinal stiffness VAS, reduction or stop of NSAIDs (event)

Drop‐out: 17.5%. No significant difference was found between treatment groups in all outcomes except pain VAS (P < 0.05, favoring SSZ)

No significant difference was found between treatment groups in all outcomes including pain VAS

Did not report

Absolute benefit from SSZ: ‐13.5 mm on 100 mm VAS

Relative difference in change from baseline: ‐42%

Winkler 1989, 24 weeks

63

(SSZ: 31) (Placebo: 32)

33% with PA

DD (year, median): 10.8 (SSZ)

11.2 (placebo)

ESR (mm/h): 33.4±20.4 (SSZ) 26.9±16.4 (placebo)

ESR, duration of morning stiffness, back pain VAS, score of sleep disturbance, chest expansion, Schober's test, fingers‐to‐floor test, disease severity in PGA

Drop‐out: 22.2%. The advantage of SSZ over placebo was significant only in the duration of morning stiffness (P < 0.05) and score of sleep disturbance (P< 0.05). In subgroup analysis, the same results were found in patients with axial form (N = 34). In patients with peripheral arthritis (N = 15), articular index showed significant improvement in SSZ over placebo (P < 0.05)

No significant difference was found between treatment groups in all outcomes. In subgroup analysis of patients with axial form, we found significant difference favoring SSZ over placebo in back pain VAS 100 mm (0 = no pain, 100 = severe pain). MD was ‐9.20 and 95% CI ‐17.81 to 0.59

Absolute benefit from SSZ: ‐2.7 mm/h

Relatiive difference in change from baseline: ‐10%

Did not report

CI ‐ confidence interval
CRP ‐ C‐reactive protein
DD ‐ duration of disease
ESR ‐ erythrocyte sedimentation rate
HAQ ‐ health assessment questionnaire
MD ‐ mean difference
mm/hr ‐ millimetre per hour
NSAIDs ‐ non‐steroidal anti‐inflammatory drugs
PA ‐ peripheral arthritis
PGA ‐ patient global assessment
PhGA ‐ physician global assessment
RR ‐ relative risk
SD ‐ standard deviation
SSZ ‐ sulphasalazine
VAS ‐ visual analogue scale

Figuras y tablas -
Table 2. Randomized controlled trials comparing sulphasalazine with placebo
Ir a la tabla de la revisión
Comparison 1. Sulfasalazine versus placebo

Outcome or subgroup title

No. of studies

No. of participants

Statistical method

Effect size

1 Spondylitis function index (Score 0 to 40, 0 to 44, 0 = the best) Show forest plot

3

297

Mean Difference (IV, Fixed, 95% CI)

0.14 [‐1.18, 1.46]

1.1 End point

1

203

Mean Difference (IV, Fixed, 95% CI)

‐1.0 [‐2.88, 0.88]

1.2 Change from baseline

2

94

Mean Difference (IV, Fixed, 95% CI)

1.27 [‐0.60, 3.13]

2 Spondylitis function index (2nd analysis) (score 0 to 40, 0 to 44, 0 = the best) Show forest plot

3

297

Mean Difference (IV, Fixed, 95% CI)

0.20 [‐0.77, 1.18]

2.1 Change from baseline

3

297

Mean Difference (IV, Fixed, 95% CI)

0.20 [‐0.77, 1.18]

3 Improvement in back pain Show forest plot

1

Risk Ratio (M‐H, Fixed, 95% CI)

Totals not selected

4 Back pain (VAS 100 mm, 0 = no pain, 100 = severe pain) Show forest plot

6

454

Mean Difference (IV, Random, 95% CI)

‐2.96 [‐6.33, 0.41]

4.1 End point

3

327

Mean Difference (IV, Random, 95% CI)

‐3.47 [‐10.17, 3.22]

4.2 Change from baseline

3

127

Mean Difference (IV, Random, 95% CI)

‐4.29 [‐12.15, 3.56]

5 Back pain (2nd analysis) (VAS 100 mm, 0 = no pain, 100 = severe pain) Show forest plot

6

454

Mean Difference (IV, Random, 95% CI)

‐2.38 [‐5.78, 1.03]

5.1 Change from baseline

4

330

Mean Difference (IV, Random, 95% CI)

‐1.24 [‐4.86, 2.37]

5.2 End point

2

124

Mean Difference (IV, Random, 95% CI)

‐6.59 [‐14.73, 1.55]

6 Night pain (% no pain) Show forest plot

4

404

Risk Ratio (M‐H, Fixed, 95% CI)

1.04 [0.75, 1.43]

7 Score of sleep disturbance (end point) (0 to 4, 0 = no disturbance, 4 = severe disturbance) Show forest plot

1

Mean Difference (IV, Random, 95% CI)

Totals not selected

8 Frequency of nocturnal awakening (change from baseline) Show forest plot

1

Mean Difference (IV, Random, 95% CI)

Totals not selected

9 Score of daily NSAIDs (change from baseline, usual dosage as 10) Show forest plot

1

Mean Difference (IV, Random, 95% CI)

Totals not selected

10 Reducing or stopping NSAIDs Show forest plot

1

Risk Ratio (M‐H, Fixed, 95% CI)

Totals not selected

11 Chest expansion (cm) Show forest plot

7

536

Mean Difference (IV, Random, 95% CI)

0.30 [0.17, 0.43]

11.1 End point

4

409

Mean Difference (IV, Random, 95% CI)

0.31 [‐0.03, 0.66]

11.2 Change from baseline

3

127

Mean Difference (IV, Random, 95% CI)

0.30 [0.16, 0.44]

12 Chest expansion (2nd analysis) (cm) Show forest plot

7

536

Mean Difference (IV, Fixed, 95% CI)

0.31 [0.17, 0.44]

12.1 Change from baseline

4

330

Mean Difference (IV, Fixed, 95% CI)

0.29 [0.15, 0.44]

12.2 End point

3

206

Mean Difference (IV, Fixed, 95% CI)

0.46 [0.01, 0.90]

13 Forced vital volume (change from baseline) (L/min) Show forest plot

1

Mean Difference (IV, Random, 95% CI)

Totals not selected

14 (Modified) Schober's test (cm) Show forest plot

7

536

Mean Difference (IV, Random, 95% CI)

0.18 [‐0.11, 0.46]

14.1 End point

4

409

Mean Difference (IV, Random, 95% CI)

0.07 [‐0.14, 0.29]

14.2 Change from baseline

3

127

Mean Difference (IV, Random, 95% CI)

0.50 [0.44, 0.56]

15 (Modified) Schober's test (2nd analysis) (cm) Show forest plot

7

536

Mean Difference (IV, Random, 95% CI)

0.12 [‐0.21, 0.45]

15.1 Change from baseline

4

330

Mean Difference (IV, Random, 95% CI)

0.19 [‐0.35, 0.74]

15.2 End point

3

206

Mean Difference (IV, Random, 95% CI)

0.10 [‐0.15, 0.35]

16 Occiput‐to‐wall test (cm) Show forest plot

5

386

Mean Difference (IV, Random, 95% CI)

0.08 [‐0.90, 1.06]

16.1 End point

3

306

Mean Difference (IV, Random, 95% CI)

‐0.63 [‐1.33, 0.07]

16.2 Change from baseline

2

80

Mean Difference (IV, Random, 95% CI)

0.68 [0.31, 1.05]

17 Occiput‐to‐wall test (2nd analysis) (cm) Show forest plot

5

386

Mean Difference (IV, Random, 95% CI)

‐0.03 [‐0.84, 0.79]

17.1 Change from baseline

3

283

Mean Difference (IV, Random, 95% CI)

0.30 [‐0.43, 1.03]

17.2 End point

2

103

Mean Difference (IV, Random, 95% CI)

‐0.75 [‐1.49, ‐0.02]

18 Fingers‐to‐floor test (cm) Show forest plot

7

517

Mean Difference (IV, Random, 95% CI)

‐1.03 [‐2.93, 0.87]

18.1 End point

5

437

Mean Difference (IV, Random, 95% CI)

‐0.64 [‐2.77, 1.49]

18.2 Change from baseline

2

80

Mean Difference (IV, Random, 95% CI)

‐2.54 [‐6.75, 1.67]

19 Fingers‐to‐floor test (2nd analysis) (cm) Show forest plot

7

517

Mean Difference (IV, Random, 95% CI)

‐0.71 [‐2.18, 0.75]

19.1 Change from baseline

3

283

Mean Difference (IV, Random, 95% CI)

‐0.96 [‐2.79, 0.88]

19.2 End point

4

234

Mean Difference (IV, Random, 95% CI)

‐0.28 [‐2.72, 2.15]

20 Chin sternum distance (change from baseline) (cm) Show forest plot

1

Mean Difference (IV, Fixed, 95% CI)

Totals not selected

21 Joint pain/tenderness score (0 to 198, the higher the score the more severe the disease) or number Show forest plot

2

278

Std. Mean Difference (IV, Random, 95% CI)

‐0.04 [‐0.37, 0.29]

21.1 End point

2

278

Std. Mean Difference (IV, Random, 95% CI)

‐0.04 [‐0.37, 0.29]

22 Joint pain/tenderness score (2nd analysis) (0 to 198, the higher the score the more severe the disease) Show forest plot

2

278

Std. Mean Difference (IV, Random, 95% CI)

‐0.15 [‐0.38, 0.09]

22.1 Change from baseline

1

203

Std. Mean Difference (IV, Random, 95% CI)

‐0.10 [‐0.38, 0.17]

22.2 End point

1

75

Std. Mean Difference (IV, Random, 95% CI)

‐0.26 [‐0.72, 0.19]

23 Joint swelling score (0 to 198, the higher score the more severe the disease) or number Show forest plot

2

278

Std. Mean Difference (IV, Random, 95% CI)

0.04 [‐0.20, 0.27]

23.1 End point

2

278

Std. Mean Difference (IV, Random, 95% CI)

0.04 [‐0.20, 0.27]

24 Joint swelling score (2nd analysis) (0 to 198, the higher the score the more severe the disease) Show forest plot

2

278

Mean Difference (IV, Random, 95% CI)

0.0 [‐0.29, 0.29]

24.1 Change from baseline

1

203

Mean Difference (IV, Random, 95% CI)

0.0 [‐0.97, 0.97]

24.2 End point

1

75

Mean Difference (IV, Random, 95% CI)

0.0 [‐0.30, 0.30]

25 Dactylitis score (0 to 3, 0 = normal, 3 = severe) Show forest plot

1

Mean Difference (IV, Random, 95% CI)

Totals not selected

26 Dactylitis score (2nd analysis) (0 to 3, 0 = normal, 3 = severe) Show forest plot

1

Mean Difference (IV, Random, 95% CI)

Totals not selected

27 Enthesopathy index (0 to 90, 0 to 66, 0 to 90, the higher the score the more severe the disease) Show forest plot

3

297

Std. Mean Difference (IV, Random, 95% CI)

0.10 [‐0.13, 0.33]

27.1 End point

1

203

Std. Mean Difference (IV, Random, 95% CI)

0.06 [‐0.22, 0.33]

27.2 Change from baseline

2

94

Std. Mean Difference (IV, Random, 95% CI)

0.19 [‐0.29, 0.68]

28 Enthesopathy index (2nd analysis) (0 to 90, 0 to 66, 0 to 90, the higher score the more severe the disease) Show forest plot

3

297

Std. Mean Difference (IV, Random, 95% CI)

0.11 [‐0.12, 0.34]

28.1 Change from baseline

3

297

Std. Mean Difference (IV, Random, 95% CI)

0.11 [‐0.12, 0.34]

29 Spondylitis articular index (0 to 90, the higher score the more severe the disease) Show forest plot

1

Mean Difference (IV, Random, 95% CI)

Totals not selected

30 Spondylitis articular index (2nd analysis) (0 to 90, the higher score the more severe the disease) Show forest plot

1

Mean Difference (IV, Random, 95% CI)

Totals not selected

31 Improvement in patient global assessment Show forest plot

3

394

Risk Ratio (IV, Random, 95% CI)

1.52 [0.78, 2.97]

32 Patient assessment of disease severity (end point) (VAS 100 mm, 0 = very good, 100 = very poor) Show forest plot

1

Mean Difference (IV, Fixed, 95% CI)

Totals not selected

33 General well‐being (end point) (VAS 100 mm, 0 = very good, 100 = very poor) Show forest plot

1

Mean Difference (IV, Random, 95% CI)

Totals not selected

34 Improvement in physician global assessment Show forest plot

2

334

Risk Ratio (IV, Random, 95% CI)

1.34 [0.59, 3.08]

35 Response to treatment (based on both patient and physician assessment) Show forest plot

1

Risk Ratio (M‐H, Random, 95% CI)

Totals not selected

36 Duration of morning stiffness (hr) Show forest plot

5

456

Mean Difference (IV, Random, 95% CI)

‐0.20 [‐0.39, ‐0.01]

36.1 End point

4

409

Mean Difference (IV, Random, 95% CI)

‐0.10 [‐0.25, 0.05]

36.2 Change from baseline

1

47

Mean Difference (IV, Random, 95% CI)

‐0.39 [‐0.48, ‐0.30]

37 Duration of morning stiffness (2nd analysis) (hr) Show forest plot

5

456

Mean Difference (IV, Random, 95% CI)

‐0.20 [‐0.39, ‐0.00]

37.1 Change from base line

2

250

Mean Difference (IV, Random, 95% CI)

‐0.39 [‐0.48, ‐0.30]

37.2 End point

3

206

Mean Difference (IV, Random, 95% CI)

‐0.10 [‐0.25, 0.05]

38 Morning stiffness (end point) (VAS 100 mm, 0 = no stiffness, 100 = severe stiffness) Show forest plot

2

108

Mean Difference (IV, Random, 95% CI)

‐13.89 [‐22.54, ‐5.24]

38.1 End point

1

75

Mean Difference (IV, Random, 95% CI)

‐12.00 [‐23.78, ‐4.22]

38.2 Change from baseline

1

33

Mean Difference (IV, Random, 95% CI)

‐13.5 [‐30.00, 5.00]

39 Improvement in morning stiffness Show forest plot

1

Risk Ratio (M‐H, Random, 95% CI)

Totals not selected

40 Erythrocyte sedimentation rate (mm/hr) Show forest plot

8

560

Mean Difference (IV, Random, 95% CI)

‐5.66 [‐10.40, ‐0.93]

40.1 End point

6

466

Mean Difference (IV, Random, 95% CI)

‐7.07 [‐14.39, 0.25]

40.2 Change from baseline

2

94

Mean Difference (IV, Random, 95% CI)

‐3.09 [‐4.84, ‐1.35]

41 Erythrocyte sedimentation rate (2nd analysis) (mm/hr) Show forest plot

8

560

Mean Difference (IV, Random, 95% CI)

‐4.79 [‐8.80, ‐0.78]

41.1 Change from baseline

4

326

Mean Difference (IV, Random, 95% CI)

‐3.11 [‐4.62, ‐1.60]

41.2 End point

4

234

Mean Difference (IV, Random, 95% CI)

‐9.56 [‐22.03, 2.91]

42 C‐reactive protein (ug/ml) Show forest plot

3

325

Mean Difference (IV, Random, 95% CI)

‐1.42 [‐3.76, 0.92]

42.1 End pointSub‐category

2

278

Mean Difference (IV, Random, 95% CI)

‐1.76 [‐7.42, 3.90]

42.2 Change from baseline

1

47

Mean Difference (IV, Random, 95% CI)

‐2.5 [‐4.70, ‐0.30]

43 C‐reactive protein (2nd analysis) (ug/ml) Show forest plot

3

325

Mean Difference (IV, Random, 95% CI)

‐1.39 [‐3.85, 1.07]

43.1 Change from baseline

2

250

Mean Difference (IV, Random, 95% CI)

‐1.02 [‐3.37, 1.33]

43.2 End point

1

75

Mean Difference (IV, Random, 95% CI)

‐7.0 [‐16.80, 2.80]

44 Withdrawal due to side effect Show forest plot

11

895

Risk Ratio (M‐H, Fixed, 95% CI)

1.50 [1.04, 2.15]

45 Withdrawal due to ineffectiveness Show forest plot

10

833

Risk Ratio (M‐H, Fixed, 95% CI)

0.87 [0.53, 1.42]

46 Drop‐out for any reason Show forest plot

10

833

Risk Ratio (M‐H, Fixed, 95% CI)

1.33 [1.03, 1.73]

47 Serious adverse events Show forest plot

1

264

Peto Odds Ratio (Peto, Fixed, 95% CI)

7.50 [0.15, 378.16]
Figuras y tablas -
Comparison 1. Sulfasalazine versus placebo
Ir a la tabla de la revisión
Comparison 2. Sulfasalazine versus placebo (ankylosing spondylitis with peripheral arthritis, end point values)

Outcome or subgroup title

No. of studies

No. of participants

Statistical method

Effect size

1 Back pain (VAS 100 mm, 0 = no pain, 100 = severe pain) Show forest plot

1

Mean Difference (IV, Random, 95% CI)

Totals not selected

2 Score of sleep disturbance (0 to 4, 0 = no disturbance, 4 = severe disturbance) Show forest plot

1

Mean Difference (IV, Random, 95% CI)

Totals not selected

3 Chest expansion (cm) Show forest plot

1

Mean Difference (IV, Random, 95% CI)

Totals not selected

4 Schober's test (cm) Show forest plot

1

Mean Difference (IV, Random, 95% CI)

Totals not selected

5 Fingers‐to‐floor test (cm) Show forest plot

1

Mean Difference (IV, Random, 95% CI)

Totals not selected

6 Articular index (0 to 66, the higher the score the more severe the disease) Show forest plot

1

Mean Difference (IV, Random, 95% CI)

Totals not selected

7 Degree of joint swelling (0 to 66, the higher the score the more severe the disease) Show forest plot

1

Mean Difference (IV, Random, 95% CI)

Totals not selected

8 Patient assessment of disease severity (VAS 100 mm, 0 = very good, 100 = very poor) Show forest plot

1

Mean Difference (IV, Random, 95% CI)

Totals not selected

9 Duration of morning stiffness (hr) Show forest plot

1

Mean Difference (IV, Random, 95% CI)

Totals not selected

10 Erythrocyte sedimentation rate (mm/hr) Show forest plot

1

Mean Difference (IV, Random, 95% CI)

Totals not selected
Figuras y tablas -
Comparison 2. Sulfasalazine versus placebo (ankylosing spondylitis with peripheral arthritis, end point values)
Ir a la tabla de la revisión
Comparison 3. Sulfasalazine versus placebo (axial form ankylosing spondylitis, end point values)

Outcome or subgroup title

No. of studies

No. of participants

Statistical method

Effect size

1 Back pain (VAS 100 mm, 0 = no pain, 100 = severe pain) Show forest plot

1

Mean Difference (IV, Random, 95% CI)

Totals not selected

2 Score of sleep disturbance (0 to 4, 0 = no disturbance, 4 = severe disturbance) Show forest plot

1

Mean Difference (IV, Random, 95% CI)

Totals not selected

3 Chest expansion (cm) Show forest plot

1

Mean Difference (IV, Random, 95% CI)

Totals not selected

4 Schober's test (cm) Show forest plot

1

Mean Difference (IV, Random, 95% CI)

Totals not selected

5 Fingers‐to‐floor test (cm) Show forest plot

1

Mean Difference (IV, Random, 95% CI)

Totals not selected

6 Patient assessment of disease severity (VAS 100 mm, 0 = very good, 100 = very poor) Show forest plot

1

Mean Difference (IV, Random, 95% CI)

Totals not selected

7 Duration of morning stiffness (hr) Show forest plot

1

Mean Difference (IV, Random, 95% CI)

Totals not selected

8 Erythrocyte sedimentation rate (mm/hr) Show forest plot

1

Mean Difference (IV, Fixed, 95% CI)

Totals not selected
Figuras y tablas -
Comparison 3. Sulfasalazine versus placebo (axial form ankylosing spondylitis, end point values)
Ir a la tabla de la revisión