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

Moradi 2021.

Study characteristics
Methods Study design: randomised double‐blind placebo‐controlled trial
Number of study centres and location: single centre; Emam Reza hospital in north‐east of Iran, affiliated with Mashhad University of Medical Sciences
Study setting: emergency department (ED)
Withdrawals: stated
Date of study: October 2017 to March 2018
Participants Number screened: 167
Number randomised: 77
Number in treatment group: 39
Number in placebo group: 38
Mean age (years): 71.9 (SD 7) (magnesium); 69.8 (SD 8.2) (placebo)
Gender (male/female): 20/19 (magnesium); 22/16 (placebo)
Diagnostic criteria: physician diagnosed
Baseline lung function:
Mean PEFR at presentation (% of predicted): 27.3 (magnesium); 28.1 (placebo)
Smoking history
Current smokers: 5 (magnesium); 7 (placebo)
Ex smokers: 19 (magnesium); 20 (placebo)
Non‐smokers: 15 (magnesium); 11 (placebo)
Inclusion criteria: adults with the initial diagnosis of AECOPD
Exclusion criteria: people who:
  • need immediate endotracheal intubation or mechanical ventilation;

  • were haemodynamically unstable;

  • were uncooperative or unable to perform peak flow meter;

  • were pregnant;

  • had other conditions or complications contributing to dyspnoea, such as pneumonia, pleural or pericardial effusion, pneumothorax, heart failure, renal failure, sepsis, or a past history suggestive of asthma.

Interventions Intervention: intravenous infusion of 2.5 g of MgSO4 (5 mL of 50% solution) in 50 mL of normal saline over 15 minutes
Comparator: intravenous infusion of 5 mL sterile water in 50 mL of normal saline over 15 minutes as placebo
Concomitant medications: standard treatment with supplemental oxygen to maintain SpO2 > 90%, nebulized salbutamol, nebulized ipratropium, IV hydrocortisone, IV ceftriaxone and oral azithromycin
Outcomes Primary outcomes
  • changes in PEFR

  • DSS

  • RR


Secondary outcomes
  • need for endotracheal intubation after randomisation

  • ED discharge rate

Notes Funding for studies: Mashhad University of Medical Sciences
Conflicts of interest of trial authors: declared none
Clinical Trials Registry: IRCT2014111519962N1
Risk of bias
Bias Authors' judgement Support for judgement
Random sequence generation (selection bias) Low risk Quote: "Randomisation was performed by block randomisation (blocks of 4) by a third party."
Allocation concealment (selection bias) Low risk Quote: "patients were randomly allocated to either group A (MgSO4) or group B (placebo) by a third party process so that patients and researchers were unaware of allocation."
Blinding of participants and personnel (performance bias)
All outcomes Low risk Quote: "Patients, treating physician, and investigators were blinded to the treatment. A nurse who was not involved in patients’ care prepared the MgSO4/placebo vials by filling similarly appearing vials with 5 mL of MgSO4 (50% solution) or sterile water daily and kept the codes for content of each bottle in a log not accessible by the investigators until the completion of the study"
Blinding of outcome assessment (detection bias)
All outcomes Low risk Comment: "Participant, care provider, investigator and outcome assessor" were masked.
Incomplete outcome data (attrition bias)
All outcomes Unclear risk Comments: 4 participants lost to follow‐up (5.2 %), reasons not provided.
Selective reporting (reporting bias) Low risk Comment: trial was registered on website, all outcomes were reported as planned.
Other bias Low risk Comment: no other apparent biases identified.