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 |
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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:
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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 |
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Outcomes | Primary outcomes
Secondary outcomes
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Notes | Funding for studies: Mashhad University of Medical Sciences Conflicts of interest of trial authors: declared none Clinical Trials Registry: IRCT2014111519962N1 |
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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. |