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. 2021 Jan 15;2021(1):CD013198. doi: 10.1002/14651858.CD013198.pub2

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
  • Erythromycin (250 mg 3 times a day)

  • Placebo


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