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

Skorodin 1995.

Study characteristics
Methods Study design: double‐blind randomised controlled trial
Number of study centres and location: 2; Edward Hines Jr. Veterans Affairs Hospital, Hines, Illinois and Augusta (GA) Veterans Affairs Medical Center
Study setting: emergency department (ED)
Withdrawals: not stated
Date of study: not stated
Participants Number randomised: 72
Numbers in treatment group: 36
Number in placebo group: 36
Mean age (years): 62.8 (SD 9.0) (magnesium); 66.5 (SD 7.3) (placebo)
Gender (male/female): 35/1 (magnesium); 35/1 (placebo)
Diagnostic criteria: ATS
Mean duration of COPD (years): 11 (SD 10.6) (magnesium); 11 (SD 13) (placebo)
Baseline lung function:
Mean PEFR at presentation (L/min): 122.8 (magnesium); 119.7 (placebo)
Smoking history:
Mean duration of smoking (years): 39.7 (magnesium); 39.5 (placebo)
Serum magnesium level (mmol/L) mean: 0.94 (SD 0.16) (magnesium); 0.98 (SD 0.16) (placebo)
Inclusion criteria: people aged 35 years or older who presented with acute exacerbation of COPD
Exclusion criteria:
  • temperature > 37.9º C;

  • systolic blood pressure < 100 mmHg;

  • history of kidney disease;

  • clinical evidence of pneumonia;

  • initial PEFR > 250 L/min.

Interventions Intervention: IV 1.2 g of magnesium sulfate in 150 mL of normal saline over 20 minutes
Comparator: IV 2.5 mL of saline in 150 mL of normal saline over 20 minutes as placebo
Concomitant medications:
  • nebulised albuterol 2.5 mg in 3 mL of normal saline;

  • supplemental oxygen 2L/min via nasal cannula if SpO2 less than 88%;

  • standard treatment.

Outcomes Dyspnoea score, PEFR, hospital admission, emergency department visit in next two weeks, MIP and MEP
Notes Funding for studies: Veterans Affair Health Services Research & Development grant 90‐091; magnesium sulfate was donated by Abbot Lab
Conflicts of interest of trial authors: not declared
Risk of bias
Bias Authors' judgement Support for judgement
Random sequence generation (selection bias) Unclear risk Comment: stated as "coded from a randomised list", with no elaboration on how sequence generation was performed.
Allocation concealment (selection bias) Low risk Quote: "placebo and magnesium sulfate solutions were prepackaged and coded from a randomised list"
Blinding of participants and personnel (performance bias)
All outcomes Low risk Quote: "randomised in a double‐blind fashion"
Quote: "placebo and magnesium sulfate solutions were prepackaged in identical vials in the pharmacy and added to the normal saline in the pharmacy before delivery to the emergency department"
Blinding of outcome assessment (detection bias)
All outcomes Unclear risk Comment: no details provided for outcome assessment.
Incomplete outcome data (attrition bias)
All outcomes Low risk Comment: there were no dropouts from the study arms.
Selective reporting (reporting bias) Unclear risk Comment: unclear if all outcomes were reported as planned since trial protocol was not available.
Other bias Low risk Comment: no other apparent biases identified.