Mukerji 2015.
Study characteristics | ||
Methods | Study design: randomised, double‐blind, parallel‐group, placebo‐controlled trial Number of study centres and location: single centre; Palmerston North Hospital, New Zealand Study setting: emergency department (ED) Withdrawals: stated Date of study: July and October 2013 |
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Participants | Number screened: 37
Number randomised: 33 Numbers in treatment group: 14 Number in placebo group: 19 Numbers of withdrawals: 1 (magnesium), 2 (placebo) Numbers completing trial: 13 (magnesium), 17 (placebo) Number included in analysis: 30 Mean age SD (years): 76.1 (SD 12.47) (magnesium), 72.9 (SD 9.39) (placebo) Gender (male/female): 11/2 (magnesium), 10/7 (placebo) Diagnostic criteria: clinically by the attending physician who was not one of the investigators Baseline lung function Mean FEV1 at presentation: 0.637 L (magnesium); 0.691 L (placebo) Number of participants with FEV1 at presentation < 50% of predicted: 13 (magnesium); 17 (placebo) Smoking history Mean amount of smoking (pack‐years): 40.0 (magnesium); 38.8 (placebo) Current smokers: 4 (magnesium); 5 (placebo) Never smokers: 1 (magnesium); 1 (placebo) Serum magnesium level (mmol/L) mean/SD: 0.79/0.1 (magnesium); 0.78/0.1 (placebo) Inclusion criteria: non‐infective and infective cases of AECOPD in people above the age of 35 years, who had a previously documented diagnosis of COPD by either their general practitioner or in‐hospital respiratory specialists Exclusion criteria:
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Interventions | Intervention: 2 g IV magnesium sulphate made up to 20 mL in 0.9% sodium chloride solution (saline) + standard therapy Comparator: 20 ml of IV saline as placebo + standard therapy Concomitant medications 5 mg of nebulised salbutamol Standard therapy 5 mg salbutamol and 500 mcg ipratropium Bromide by jet nebulisation • 60 mg of oral prednisone or 100 mg of IV hydrocortisone • Oxygen: 2 L per min via nasal prongs if the patient’s pulse oximetry revealed saturations of < 90% |
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Outcomes | Primary outcomes percentage change in FEV1 and FVC at 0, 60 and 120 minutes Secondary outcomes:
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Notes | Funding for studies: Midcentral District Health Board, Palmerston North, New Zealand. Conflicts of interest of trial authors: declared "nil" The trial was registered with Australian New Zealand Clinical Trials Registry: (ANZCTR) (ACTRN12613000837729). |
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Risk of bias | ||
Bias | Authors' judgement | Support for judgement |
Random sequence generation (selection bias) | Low risk | Quote: "The senior ED pharmacist performed block randomisation. A block size of 20 was used with a 1:1 allocation ratio" |
Allocation concealment (selection bias) | Low risk | Quote: "The senior ED pharmacist provided identical numbered pre‐made syringes with either trial drug or placebo" |
Blinding of participants and personnel (performance bias) All outcomes | Low risk | Quote: "The senior ED pharmacist provided identical pre‐made syringes with either trial drug or placebo, as per randomisation, to maintain investigator and patient masking" |
Blinding of outcome assessment (detection bias) All outcomes | Low risk | Comment: participants, investigators, outcome assessors were all masked. |
Incomplete outcome data (attrition bias) All outcomes | Low risk | Comment: attrition rates were similar in both groups (7.1% vs 5.2%). |
Selective reporting (reporting bias) | Low risk | Comment: trial was registered on website, all outcome measures were reported as planned. |
Other bias | Low risk | Comments: no other apparent biases identified. |