Summary of findings for the main comparison. Tricylic antidepressant compared to placebo for the treatment of depression in chronic obstructive pulmonary disease.
| Tricylic antidepressant compared to placebo for the treatment of depression in chronic obstructive pulmonary disease (COPD) | ||||||
| Patient or population: COPD with depression Setting: clinical Intervention: tricyclic antidepressant: nortriptyline Comparison: placebo | ||||||
| Outcomes | Anticipated absolute effects* (95% CI) | Relative effect (95% CI) | № of participants (studies) | Quality of evidence (GRADE) | Comments | |
| Risk with placebo | Risk with tricyclic antidepressant | |||||
| Change in depressive symptoms assessed with Hamilton Depression Rating Scale; scale from 0 to 61 (higher scores = worse symptoms); follow‐up: range 1 to 12 weeks | The mean depressive symptom score post‐placebo was 22.8 (SD 11.3). | The mean difference in depressive symptoms was 10.2 lower (16.75 lower to 3.65 lower). | ‐ | 30 (1 RCT) | ⊕⊝⊝⊝ VERY LOW 1 2 | |
| Adverse events (disease‐related: all physical symptoms); follow‐up: range 1 to 12 weeks | The mean score post‐placebo was 21.6 (SD 12.4). | The mean difference in disease‐related adverse events was 6.20 lower (12.38 lower to 0.02 lower). | ‐ | 30 (1 RCT) |
⊕⊝⊝⊝ VERY LOW 1 2 | Adverse events related to the intervention were not more significant in the treatment group than in the placebo group. |
|
Change in quality of life assessed with Sickness Impact Profile; scale from 0 to 100 (higher scores = greater dysfunction); follow‐up: range 1 to 12 weeks |
The mean quality of life score post‐placebo was 18.5 (SD 10.8). | The mean difference in quality of life was 2.80 lower (11.02 lower to 5.42 higher). | ‐ | 30 (1 RCT) | ⊕⊝⊝⊝ VERY LOW 1 2 | |
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Change in dyspnoea assessed with Pulmonary Functional Status Instrument; follow‐up: range 1 to 12 weeks |
The mean dyspnoea score post‐placebo was 52.7 (SD 21.0). | The mean difference in dyspnoea was 9.8 higher (6.2 lower to 25.8 higher). | ‐ | 30 (1 RCT) | ⊕⊝⊝⊝ VERY LOW1 2 3 | |
| Change in FEV1 (l) | The authors indicate that there was no significant group difference for FEV1, but report no data for this outcome. | ‐ | 30 (1 RCT) | ⊕⊝⊝⊝ VERY LOW 1 2 4 | ||
| Change in exercise tolerance ‐ not reported | The authors indicate that there was no significant group difference for change in exercise tolerance, but report no data for this outcome. | ‐ | 30 (1 RCT) |
⊕⊝⊝⊝ VERY LOW 1 2 4 | ||
| Change in hospital utilisation ‐ not measured | ‐ | ‐ | ‐ | ‐ | ‐ | |
| *The risk in the intervention group (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; FEV1: forced expiratory volume in 1 second; RCT: randomised controlled trial; SD: standard deviation | ||||||
| GRADE Working Group grades of evidence High certainty: We are very confident that the true effect lies close to that of the estimate of the effect. Moderate certainty: We are moderately confident in the effect estimate: the true effect is likely to be close to the estimate of the effect, but there is a possibility that it is substantially different. Low certainty: Our confidence in the effect estimate is limited: the true effect may be substantially different from the estimate of the effect. Very low certainty: We have very little confidence in the effect estimate: the true effect is likely to be substantially different from the estimate of effect. | ||||||
1Downgraded one level: no information provided on allocation concealment and imbalanced dropout. 2Downgraded two levels: low observation number: single small study with 30 participants (Borson 1992). 3Downgraded one level: imprecise estimate, large confidence interval. 4Downgraded one level: limited data provided to verify reported non‐significant difference.