Tan 2016.
| Methods | Prospective, randomised controlled trial. Blinding not stated in main trial report. Treatment duration 52 weeks | |
| Participants | N = 54. Age range: 49 to 70 years. Mean age (years): 68.8 (erythromycin, 12 months), 67.3 (erythromycin, 6 months) and 69.3 (control) Female: 16.7% (erythromycin, 12 months), 5.6% (erythromycin, 6 months) and 11.1% (control) Mean FEV1 % predicted: 44.8 (SD 13.9) (erythromycin, 12 months), 46.5 (SD 8.9) (erythromycin, 6 months), and 42.1 (SD 18.6) (control) Stable COPD outpatients (GOLD stages II–IV of 2006 guidelines: FEV 1 < 80% predicted and FEV1/FVC < 70% after bronchial relaxation); no acute exacerbation; no change in therapeutic schedule; and no treatment with any antibiotics or glucocorticoids in the previous 4 weeks Exclusions: patients with bronchial asthma, primary bronchiectasis, diffuse panbronchiolitis, active tuberculosis, lung cancer, pneumoconiosis, or other lung diseases with restrictive ventilatory impairment; patients with other serious systemic illnesses such as cardiovascular, nervous, or endocrine system illnesses, blood, hepatic, or kidney diseases, and malignant tumours; patients who were not cooperative or were completely unable to communicate; and patients who experienced serious adverse reactions to erythromycin |
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| Interventions | Prophylaxis: 1. Erythromycin 125 mg 3 times a day for 12 months 2. Erythromycin 125 mg 3 times a day for 6 months 3. Control group (no antibiotic treatment) |
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| Outcomes | 1. Concentrations of IL‐17 and IL‐23 in peripheral blood and induced sputum 2. Six‐minute walk distance (Primary and secondary outcomes not specified) |
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| Notes | Funding: funded by the National Nature Science Foundation of China (81460009) and the Guangxi Natural Science Foundation (2015GXNSFAA139189, Z2012077, and Z2012081). | |
| Risk of bias | ||
| Bias | Authors' judgement | Support for judgement |
| Random sequence generation (selection bias) | Unclear risk | Participants "randomly divided" but method of sequence generation not described |
| Allocation concealment (selection bias) | Unclear risk | Allocation concealment was not described |
| Blinding of participants and personnel (performance bias) All outcomes | High risk | No blinding of participants or personnel described. Assumed open‐label (although abstract stated double‐blind). Authors contacted but no response received to date |
| Blinding of outcome assessment (detection bias) All outcomes | High risk | No blinding of outcome assessors described. Assumed open‐label (although abstract stated double‐blind). Authors contacted but no response received to date |
| Incomplete outcome data (attrition bias) All outcomes | Unclear risk | Low and balanced dropout but details not given of how many people were analysed at each time point |
| Selective reporting (reporting bias) | Unclear risk | No prospective trial registration or protocol identified so not clear if outcomes of interest for this review may have been collected but not reported (e.g. serious adverse events, exacerbations, quality of life) |
| Other bias | Low risk | No additional bias identified |