He 2016.
| Methods |
Study design: Randomised, placebo‐controlled, double‐blind trial Country: China |
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| Participants |
Sample size: N = 120 randomised (N = 120 included in analysis, although N = 112 completed the study) Mean age: Intervention 69.8 years (SD ± 7.2), control 70.2 years (SD ± 6.8) Gender: N = 67 male, N = 53 female Inclusion criteria: Stable COPD according to GOLD ‐ stage I or higher; total score on the 17‐item Hamilton Depression Rating Scale (HAM‐D‐17) of 17 or higher Exclusion criteria: Presence of cancer, severe physical disability, mental disorders including those requiring concomitant use of medications that would impact on mental status, refusing participants, patients with poor compliance |
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| Interventions |
Intervention: Selective serotonin reuptake inhibitor (sertraline hydrochloride) Control: Placebo Duration: 6 weeks Dose: 50 mg daily Number of participants randomised to intervention: N = 60; participants who completed the trial: N= 55 Number of participants randomised to the control group: N = 60; participants who completed the trial: N = 57 |
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| Outcomes |
Primary outcomes reported: Quality of life assessed with COPD Assessment Test (CAT) Secondary outcomes reported: Exercise capacity assessed with 6‐minute walk test HAM‐D‐17 Other: Parameters of spirometry tests (FVC, FEV1, FEV1/FVC) and adverse events were observed and reported. |
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| Notes | ||
| Risk of bias | ||
| Bias | Authors' judgement | Support for judgement |
| Random sequence generation (selection bias) | Low risk | Assessment via random number tables and sequentially numbered envelopes |
| Allocation concealment (selection bias) | Unclear risk | No information provided. |
| Blinding of participants and personnel (performance bias) All outcomes | Low risk | Double‐blind randomised controlled trial. No further details reported. |
| Blinding of outcome assessment (detection bias) All outcomes | Low risk | 1 of the investigators who had not participated in the trial recorded relevant data from participants' medical records and hospital’s mainframe computer for laboratory data. |
| Incomplete outcome data (attrition bias) All outcomes | Low risk | Attrition reported. |
| Selective reporting (reporting bias) | Unclear risk | No information on whether a protocol has been published or the trial registered |
| Other bias | Low risk | No other bias identified. |