for the main comparison.
| Cognitive behavioural therapies compared to controls for fibromyalgia | ||||||
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Patient or population: Patients with fibromyalgia Settings: In‐ and outpatient Intervention: Cognitive behavioural therapies Comparison: Controls (attention control, treatment as usual, waiting list, other active therapy) | ||||||
| Outcomes | Illustrative comparative risks* (95% CI) | Relative effect (95% CI) | No of Participants (studies) | Quality of the evidence (GRADE) | Comments | |
| Assumed risk | Corresponding risk | |||||
| controls | Cognitive behavioural therapies | |||||
|
Pain end of treatment (0‐10 scale) Higher scores indicate higher pain levels |
Mean pain baseline 7.37 (SD 2.10) 3 |
The mean pain in the intervention groups was 0.29 standard deviations lower (0.49 to 0.11 lower) | 1382 (20) | ⊕⊕⊝⊝ low1,2 | SMD ‐0.29 (95% CI ‐0.47 to ‐0.11) 8.5% (95% CI 3.1% to 14.0%) relative improvement 6.3 % (95% 2.3% to 10.3%) CI) fewer points on the scale (absolute change) NNTB 7 (95% CI 5 to19) |
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|
Pain
follow‐up median 6 months (0‐10 scale) Higher scores indicate higher pain levels |
Mean pain baseline 64.72 (SD 10.44) 4 |
The mean pain in the intervention groups was 0.40 standard deviations lower (0.64 to 0.16 lower) | 822 (14) | ⊕⊕⊝⊝ low1,2 | SMD ‐0.40 (95% CI ‐0.62 to ‐0.17) 6.4% (95% CI 2.7% to 9.9%) relative improvement 4.2% (95% CI 1.8% to 6.5%) fewer points on the scale (absolute change) NNTB 10 (95% CI 6 to 24) |
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Negative mood end of treatment (0‐10 scale) Higher scores indicate higher negative mood levels |
Mean depression baseline 6.82 (SD 3.11) 5 |
The mean negative mood in the intervention groups was 0.33 standard deviations lower (0.49 to 0.17 lower) | 1578 (18) | ⊕⊕⊝⊝ low1,2 | SMD ‐0.33 (95% CI ‐0.49 to ‐0.17) 15.0% (95% CI 7.7% to 22.3%) relative improvement 10.2% (95% CI 5.2% to 15.2%) fewer points on the scale (absolute change) NNTB 6 (95% CI 4 to12) |
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Negative mood
follow‐up median 6 months (0‐50 scale) Higher scores indicate higher negative mood levels |
Mean depression baseline 14.94 (SD 3.11) 6 |
The mean negative mood in the intervention groups was 0.43 standard deviations lower (0.75 to 0.11 lower) | 721 (11) | ⊕⊕⊝⊝ low1,2 | SMD ‐0.43 (95% CI ‐0.75 to ‐0.11) 8.9% (95% CI 2.3% to 15.8%) relative improvement 2.7% (95% CI 0.1% to 4.7%) fewer points on the scale (absolute change) NNTB 11 (95% CI 6 to 43) |
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Disability end of treatment (0‐10 scale) Higher scores indicate disability levels |
Mean physical impairment baseline 2.80 (SD 2.40) 7 | The mean disability in the intervention groups was 0.30 standard deviations lower (0.51 to 0.08 lower) | 1163 (15) | ⊕⊕⊝⊝ low1,2 | SMD ‐0.30 (95% CI ‐0.51 to ‐0.08) 25.8 % (95% CI 6.9% to 43.7% relative improvement 7.2% (95% CI 1.9% to 12.2%) fewer points on the scale (absolute change) NNTB 7 (95% CI 4 to 26) |
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Disability
follow‐up median 6 months (0‐10 scale) Higher scores indicate disability levels |
Mean physical impairment baseline 3.24 (SD 2.26) 8 | The mean disability in the intervention groups was 0.52 standard deviations lower (0.86 to 0.18 lower) | 664 (9) | ⊕⊕⊝⊝ low1,2 | SMD ‐0.52 (95% CI ‐0.86 to ‐0.18) 36.4% (95% CI 1.3% to 60.2%) relative improvement 11.7% (95% CI 4.1% to 19.4%) fewer points on the scale (absolute change) NNTB 4 (95% CI 3 to12) |
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Acceptability end of treatment (dropouts from study due to any reasons) |
136 (94 to 195) per 1000 | 127 (88 to 182) | RR 0.94 (0.65 to 1.35) | 1914 (21) | ⊕⊕⊝⊝ low1 | Absolute risk difference
0% (95% CI ‐1 to 0) Relative per cent change 6% (95% CI 15% improvement to 35% worsening) Not statistically significant |
| *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% CI) is based on the assumed risk in the comparison group and the relative effect of the intervention (and its 95% CI). CI: confidence interval | ||||||
| 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 Some studies with lack of reported allocation concealment, without intention‐to‐treat analysis and with selective outcome reporting
2 High heterogeneity of treatment effect
3 Luciano 2011: N=216 patients; Pain VAS 0‐10 scale
4 Alda 2011: N=113 patients; Pain VAS 0‐100 scale
5 Luciano 2011: N=216 patients; Depression VAS 0‐10 scale
6 Alda 2011; N=113 patients; Hamilton Rating Scale for Depression (0‐50)
7 Luciano 2011: N=216 patients; Physical impairment VAS 0‐10 scale
8 Alda 2011; N=113 patients; Physical impairment VAS 0‐10 scale