Eiser 2005.
Methods |
Study design: Randomised, placebo‐controlled, double‐blind trial. Due to ethical reasons, after 6 weeks of active drug versus placebo intervention, all participants were placed on active‐drug treatment for 3 months. This was an unblinded treatment trial without a placebo control group. Only data from the randomised, double‐blinded trial were included in this review. Country: UK |
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Participants |
Sample size: N = 28 randomised, N = 28 included in analysis Mean age: 66 years (SD ± 8); range 49 to 79 years Gender: N = 14 male, N = 14 female Inclusion criteria: Well‐documented, stable, poorly reversible COPD with a change in FEV1 after bronchodilators of < 15% of predicted normal, current or ex‐smokers, exercise tolerance limited by dyspnoea, clinical depression (confirmed by standard psychiatric interview using ICD‐10 criteria) Exclusion criteria: Previously diagnosed with depression, use of psychotropic drugs within 3 months of study, significant comorbidity limiting mobility |
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Interventions |
Intervention: Selective serotonin reuptake inhibitor (paroxetine) Control: Placebo Duration: 6 weeks Dose: 20 mg daily Number of participants randomised to intervention: N = 14; participants who completed the trial: N = 14 (N = 4 participants in the intervention group were offered 140 mg of lofepramine (every night) due to side effects of the SSRI treatment) Number of participants randomised to the control group: N = 14; participants who completed the trial: N = 14 |
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Outcomes |
Primary outcomes reported: HADS, BDI, MADRS Quality of life: measured by SGRQ Exercise tolerance: 6‐minute walking test Secondary outcomes reported: Lung function: residual volume, FEV1, FVC and slow vital capacity, peak expiratory flow Other: bronchodilator use, nocturnal walking due to dyspnoea, dyspnoea, effect of dyspnoea on quality of life. All measured by 5‐point scales. |
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Notes | Only data from the randomised, double‐blind, placebo‐controlled trial were included in the review. The second phase of the intervention was an open‐label intervention without a placebo. Also, N = 4 participants in the intervention group were offered 140 mg of tricyclic antidepressant (lofepramine) every night due to side effects of the SSRI treatment. |
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Risk of bias | ||
Bias | Authors' judgement | Support for judgement |
Random sequence generation (selection bias) | Unclear risk | Insufficient information on methods of randomisation: "patients received either paroxetine 20mg daily for 6 weeks or matched placebo in a randomised and double‐blind fashion" |
Allocation concealment (selection bias) | Unclear risk | Not described |
Blinding of participants and personnel (performance bias) All outcomes | Low risk | Blinding of participants and personnel only kept until 6 weeks, after which the study became an open‐label trial. |
Blinding of outcome assessment (detection bias) All outcomes | Unclear risk | Not reported |
Incomplete outcome data (attrition bias) All outcomes | Low risk | No dropout during double‐blind phase of the trial |
Selective reporting (reporting bias) | Unclear risk | No information on whether a protocol has been published or the trial registered |
Other bias | High risk | Due to paroxetine‐related side effects, 4 participants were given lofepramine (TCA). |