Summary of findings for the main comparison. Psychological therapy compared with usual care or waiting list for somatoform disorders and medically unexplained physical symptoms.
Psychological therapy compared with usual care for somatoform disorders and medically unexplained physical symptoms | ||||||
Patient or population: people with somatoform disorders and medically unexplained physical symptoms Settings: all settings Intervention: psychological therapy Comparison: usual care | ||||||
Outcomes | Illustrative comparative risks* (95% CI) | Relative effect (95% CI) | No of participants (studies) | Quality of the evidence (GRADE) | Comments | |
Assumed risk | Corresponding risk | |||||
Usual care | Psychological therapy | |||||
Severity of somatic symptoms at end of treatment Various instruments | The mean severity of somatic symptoms at end of treatment ranged across control groups from 0.5 to 48.71 using varying scales1 | The mean severity of somatic symptoms at end of treatment in the intervention groups was 0.34 standard deviations lower (0.53 to 0.16 lower) | ‐ | 1081 (10 studies2) | ⊕⊕⊝⊝ low3,4,5 | A difference of 0.34 SMD was considered to be 'small to medium' |
Acceptability 1 ‐ proportion of participants withdrawing during treatment | 896 per 1000 | 833 per 1000 (788 to 887) | RR 0.93 (0.88 to 0.99) | 1644 (14 studies6) | ⊕⊕⊕⊝ moderate7,8 | Excluding the outlier (see footnote) (70 participants) reduced I2 statistic from 70% to 33% |
Dysfunctional cognitions, emotions, or behaviours (participant rated) at end of treatment Whitely Index | The mean dysfunctional cognitions, emotions, or behaviours (participant rated) at end of treatment in the control groups was 7.3 on the Whitely Index | The mean dysfunctional cognitions, emotions, or behaviours (participant rated) at end of treatment in the intervention groups was 0.11 standard deviations lower (0.37 lower to 0.16 higher) | ‐ | 440 (3 studies9) | ⊕⊕⊕⊝ moderate10 | A difference of 0.11 SMD was considered to be 'small' |
Treatment response at end of treatment CGI‐improvement/Global impression of change | 157 per 1000 | 517 per 1000 (326 to 816) | RR 3.30 (2.08 to 5.21) | 391 (4 studies11) | ⊕⊕⊝⊝ low12,13 | ‐ |
Functional disability/quality of life at end of treatment Various instruments | ‐ | The mean functional disability/quality of life at end of treatment in the intervention groups was 0.17 standard deviations higher (0.03 to 0.32 higher) | ‐ | 730 (7 studies14) | ⊕⊕⊝⊝ low3,13 | A difference of 0.17 SMD was considered to be small |
Healthcare use Various measures, participant or physician assessed < 1 year after end of treatment Follow‐up: 6‐11 months | ‐ | The mean healthcare use in the intervention groups was 0.09 standard deviations lower (0.31 lower to 0.12 higher) | ‐ | 532 (4 studies15) | ⊕⊕⊕⊝ moderate12 | Difference small and 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% confidence interval) is based on the assumed risk in the comparison group and the relative effect of the intervention (and its 95% CI). CGI: Clinical Global Impression; CI: confidence interval; RR: risk ratio; SMD: standardised mean difference | ||||||
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 Measured with different instruments using different scales. 2 Analysis 1.1. 3 Quality of evidence downgraded one point for each of the following study limitations (present in most studies): lack of blinding and incomplete outcome data (loss to follow up) 4 I2 = 49%. 5 95% CI crossed effect size of 0.5. 6 Analysis 1.4. 7 Quality downgraded by one point as studies not blinded. As acceptability and loss to follow‐up are interrelated, we decided not to downgrade the evidence for loss to follow‐up. 8 I2 = 70%. One outlier explained most of the heterogeneity (Kashner 1995). 9 Analysis 1.15. 10 Due to lack of blinding in all studies and loss to follow‐up in one study. 11 Analysis 1.18. 12 Due to lack of blinding in all studies and loss to follow‐up > 20% in 2 studies. 13 < 300 events. 14 Analysis 1.21. 15 Analysis 1.25.