Zheng 2011.
| Methods | Design: parallel RCT Duration: not reported Setting: not reported |
|
| Participants | Number screened: not reported Number randomised: 153 Number completed: not reported Number withdrawals: not reported Baseline details: not reported Gender: not reported Age: not reported Diagnosis COPD: not reported AE criteria: not reported Inclusion criteria: not reported Exclusion criteria: not reported |
|
| Interventions | Group 1 (n = 53): 2 mg/4 mL nebulised budesonide, every 6 hours and normal saline 10 mL IV 4 times daily Group 2 (n = 54): methylprednisolone 40 mg, IV and nebulised normal saline 4 mL every 6 hours Group 3 (n = 46): nebulised normal saline 4 mL every 6 hours and normal saline 10 mL IV 4 times daily Treatment period: 7 days Follow‐up period: not reported |
|
| Outcomes | Treatment failure, FEV1, dyspnoea score, use of rescue medication and systemic glucocorticoids, length of hospital stay, adverse events |
|
| Notes | Likelihood of COPD: age limit for inclusion unknown, unknown pack‐ years' smoking, unknown if asthma an exclusion, fixed airflow obstruction criteria for COPD unknown. Funding: no sources disclosed Protocol: not available (abstract only). No trial registration located Emailed data request to authors ‐ 9 August 2013, 30 September 2013 (Zheng). No response received |
|
| Risk of bias | ||
| Bias | Authors' judgement | Support for judgement |
| Random sequence generation (selection bias) | Unclear risk | Described as randomised, method for randomisation not known |
| Allocation concealment (selection bias) | Unclear risk | Allocation method not known |
| Blinding of participants and personnel (performance bias) All outcomes | Low risk | Described as double‐blind, double‐dummy and parallel controlled trial. Each group used nebulised medication (active or placebo) and had IV medication (active or saline) over same period and frequency |
| Blinding of outcome assessment (detection bias) All outcomes | Unclear risk | Assessor blinding not described |
| Incomplete outcome data (attrition bias) All outcomes | High risk | Results data incomplete in abstract |
| Selective reporting (reporting bias) | Unclear risk | Protocol not available |
| Free of other potential confounders? | Unclear risk | No data on baseline characteristics |
ABG: arterial blood gas; ACCP: American College of Chest Physicians; AE: acute exacerbation; ATS: American Thoracic Society; CCQ: Clinical COPD Questionnaire; CI: confidence interval; COPD: chronic obstructive pulmonary disease; ED: emergency department; F: female; FEV1 : forced expiratory volume in 1 second; FVC: forced vital capacity; GOLD: Global Initiative for Chronic Obstructive Lung Disease; ICU: intensive care unit; IQR: interquartile range; IV: intravenous; LTOT: long‐term oxygen therapy; LVF: left ventricular failure; M: male; MDI: metered‐dose inhaler; NIV: non‐invasive ventilation; PaCO2: partial pressure of carbon dioxide dissolved in arterial blood; PaO2 : partial pressure of oxygen dissolved in arterial blood; PEF: peak expiratory flow; QoL: quality of life; SD: standard deviation; SGRQ: St. George Respiratory Questionnaire.