Roy 2014.
Methods | Randomised, single‐blind, placebo‐controlled, parallel, single‐centre. PP analysis. Duration 6 months Followed up every month |
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Participants | 80 outpatients age > 40, stable mild to moderate COPD, smoking history at least 10 pack‐years. Exclusions: those with asthma, lung cancer, cardiomyopathy, LVRS or transplant, or on LTOT or corticosteroids. Mean age 61; 89% male. Total 20 dropouts, evenly matched between groups | |
Interventions | NAC 600 mg twice daily or placebo. Both groups received a bronchodilator Deriphylline Retard 150 mg in addition | |
Outcomes | Symptoms (cough, dyspnoea, sputum), spirometry, Hb, adverse events | |
Notes | Indian Funding source not reported |
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Risk of bias | ||
Bias | Authors' judgement | Support for judgement |
Random sequence generation (selection bias) | High risk | No details on this, except it was a "simple method" |
Allocation concealment (selection bias) | High risk | Single‐blind study; few details on allocation or concealment of sequence given |
Blinding of participants and personnel (performance bias) All outcomes | High risk | No details on match between placebo and NAC, or on who performed measurements; sIngle‐blind |
Blinding of outcome assessment (detection bias) All outcomes | High risk | SIngle‐blind study |
Incomplete outcome data (attrition bias) All outcomes | High risk | 25% dropout rate (20/80); numbers and reasons per arm not given |
Selective reporting (reporting bias) | Unclear risk | Spirometric data reported in units that read "total count" |