Summary of findings 2. Cognitive behavioural therapies versus controls for fibromyalgia.
| Cognitive behavioural therapies versus controls for fibromyalgia | ||||||
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Patient or population: Patients with fibromyalgia Settings: In‐ and outpatients 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 | |||||
| Control | Cognitive behavioural therapies versus controls final treatment | |||||
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Fatigue end of treatment (0‐10 scale) Higher scores indicate higher fatigue levels |
Mean fatigue score 8.13 (SD 1.89) 3 | The mean fatigue in the intervention groups was 0.25 standard deviations lower (0.49 to 0.02 lower) | 910 (11 studies) | ⊕⊕⊝⊝ low1 | SMD ‐0.25 (95% CI ‐0.49 to ‐0.02) 5.8% (95% CI 0.05% to 11.3%) relative improvement 4.7% (95% CI 0.4% to 9.3%) fewer points on the scale (absolute change) NNTB 9 (95% CI 5 to109) |
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Sleep problems end of treatment (0‐50 scale) Higher scores indicate more sleep problems |
Mean sleep problems score 27.9 (SD 8.8) 4 | The mean sleep problems in the intervention groups was 0.4 standard deviations lower (0.85 lower to 0.05 higher) | 422 (8 studies) | ⊕⊕⊝⊝ low2 | SMD ‐0.40 (95% CI ‐0.85 to 0.05) 0.3% (95% CI ‐0.03% to 1.7%) relative improvement 7.0% (95% CI ‐0.90% to 15.0%) fewer points on the scale (absolute change) NNTB 5 (95% CI ‐45 to 3) |
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Health‐related quality of life end of treatment (0‐80 scale) Higher scores indicate lower health‐related quality of life |
Mean health‐related quality of life score 55.97 (SD 15.95) 5 | The mean health‐related quality of life in the intervention groups was 0.23 standard deviations lower (0.38 to 0.08 lower) | 1238 (13 studies) | ⊕⊕⊝⊝ low1,2 | SMD ‐0.23 (95% CI ‐0.38 to ‐0.08) 0.08% (95% CI 0.03% to 0.13%) relative improvement 4.6% (95% CI 1.6% to 7.6%) fewer points on the scale (absolute change) NNTB 9 (95% CI 6 to 27) |
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Fatigue Follow‐up median 6 months (0‐10 scale) Higher scores indicate higher fatigue levels |
Mean fatigue score Mean 8.32 (SD 2.17)6 |
The mean fatigue in the intervention groups was 0.46 standard deviations lower (0.77 to 0.15 lower) | 429 (6 studies) | ⊕⊕⊝⊝ low1,2 | SMD ‐0.46 (95% CI ‐0.77 to ‐0.15) 1.2% (95% CI 0.4% to 2.0%) relative improvement 10.0% (95% CI 3.2% to 16.7%) fewer points on the scale (absolute change) NNTB 5 (95% CI 3 to 14) |
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Sleep problems
Follow‐up median 6 months (0‐50 scale) Higher scores indicate more sleep problems |
Mean sleep problems score 27.9 (SD 8.8) 4 | The mean sleep problems in the intervention groups was 0.64 standard deviations lower (1.31 lower to 0.03 higher) | 378 (7 studies) | ⊕⊕⊝⊝ low1,2 | SMD ‐0.64 (95% CI ‐1.31 to 0.03) 0.4% (95% CI ‐0.02% to 0.8%) relative improvement 11.2% (95% CI ‐0.53% to 23.1%) fewer points on the scale (absolute change) NNTB 4 (95% CI ‐74 to 2) |
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Health‐related quality of life Follow‐up median 6 months (0‐80 scale) Higher scores indicate lower health‐related quality of life |
Mean health‐related quality if life score 64.48 (SD 10.50) 7 |
The mean health‐related quality of life in the intervention groups was 0.19 standard deviations lower (0.58 lower to 0.21 higher) | 425 (6 studies) | ⊕⊕⊝⊝ low1 | SMD ‐0.19 (95% CI ‐0.58 to 0.21) 0.03% (95% CI ‐0.03% to 0.15%) relative improvement 2.0% (95% CI ‐2.2% to 6.1%) fewer points on the scale (absolute change) NNTB 12 (95% CI ‐17 to 6) |
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| Acceptability Follow‐up: median 6 months | See comment | See comment | Not estimable | ‐ | See comment | Not assessed |
| *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; RR: Risk 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 Some studies with lack of reported allocation concealment, without intention‐to‐treat analysis and with selective reporting 2 High heterogeneity of treatment effect
3 Luciano 2011: N=216 patients; VAS 0‐10 scale
4 Castel 2012; N=60 patients; NRS 0‐50 scale
5 Luciano 2011: N=216 patients; VAS 0‐80 scale
6 Alda 2010; N= 113; VAS 0‐10 scale
7 Alda 2010; N= 113; VAS 0‐100 scale