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. 2022 May 26;2022(5):CD013506. doi: 10.1002/14651858.CD013506.pub2

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
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:
  • people requiring mechanical ventilation or NIV at presentation;

  • anyone who was unable to do spirometry or had evidence of pneumothorax or hypotension or any other serious medical condition that would prevent their participation;

  • responders or ‘asthma‐type’ COPD patients;

  • those with a history of asthma.

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%
Outcomes Primary outcomes
percentage change in FEV1 and FVC at 0, 60 and 120 minutes
Secondary outcomes:
  • hospital admission;

  • episodes of NIV/mechanical ventilation;

  • length of stay.

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).
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.