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. 2018 Dec 19;2018(12):CD012346. doi: 10.1002/14651858.CD012346.pub2

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
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
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
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.
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.
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).