He 2010.
Study characteristics | ||
Methods |
Design: randomised, double‐blind, placebo‐controlled, parallel‐group design Duration: 26 weeks Location: Affiliated Hospital of Guangxi Medical University, China |
|
Participants |
Population: 36 adults with COPD (severity not reported) were randomly assigned to erythromycin (n = 18) or placebo (n = 18) Baseline characteristics: age (mean years): 69 (SD 7.6); % male (mean): 86; % FEV₁ predicted (mean): 43.2 (SD 18.2); pack‐years (mean): 41.7 (SD 18.8); exacerbation history: not reported Inclusion criteria: % FEV₁ predicted between 30 and 70; mean FEV₁ (L): 1.12 (erythromycin) vs 1.02 (placebo); ≥ 10 pack‐year smoking history; no acute exacerbations during the previous 1 month Exclusion criteria: patients with significant other respiratory disorders other than COPD; history of unstable cardiovascular disease; hypersensitivity to macrolides |
|
Interventions |
Allowed co‐medications: present treatment included: inhaled corticosteroid (41%), theophylline (58%), inhaled anticholinergic (52%), inhaled β‐adrenergic (75%) |
|
Outcomes | Analysis of sputum samples (total and differential inflammatory cell counts, sputum bacterial culture), quality of life (SGRQ, SF‐36), number of people with exacerbations, time to first exacerbation, spirometry, adverse events | |
Notes |
Funding: not reported Identifier: ChiCTR‐TRC‐0000036 |
|
Risk of bias | ||
Bias | Authors' judgement | Support for judgement |
Random sequence generation (selection bias) | Unclear risk | Randomisation was done but was not clearly explained |
Allocation concealment (selection bias) | Unclear risk | Allocation concealment was not well explained |
Blinding of participants and personnel (performance bias) All outcomes | Low risk | This was a double‐blind trial |
Blinding of outcome assessment (detection bias) All outcomes | Unclear risk | This is unknown |
Incomplete outcome data (attrition bias) All outcomes | Low risk | All outcome data were described using a CONSORT diagram |
Selective reporting (reporting bias) | Low risk | All pre‐specified outcomes were reported |
Other bias | Low risk | No other bias was identified |