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:
|
|
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:
|
|
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. |