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

Solooki 2014.

Study characteristics
Methods Study design: double‐blind randomised controlled trial
Number of study centres and location: single centre; Imam Hussein Hospital affiliated to Shahid Beheshti University of Medical Sciences in Eastern Tehran, Iran
Study setting: emergency department (ED)
Withdrawals: not stated
Date of study: not stated
Participants Number randomised: 30
Numbers in treatment group: 15
Number in placebo group: 15
Mean age (years): 67 (SD 10) (magnesium), 70 (SD 8) (placebo)
Gender (male/female): 11/4 (magnesium), 10/5 (placebo)
Diagnostic criteria: not stated
Baseline lung function:
Baseline mean FEV1 (% of predicted): 26 (magnesium); 35 (placebo)
Baseline mean PEFR (L/min): 126 (magnesium); 142 (placebo)
Smoking history:
Mean amount of smoking (pack‐years): 23 (magnesium); 22 (placebo)
History of admission, n (%): 9 (60) (magnesium); 10 (67) (placebo)
Serum magnesium level (mEq/L) mean/SD: 2.11/0.28 (magnesium); 2.05/0.40 (placebo)
Inclusion criteria: 40 years or older with COPD exacerbation
Exclusion criteria:

  • patients with contraindications for use of IV magnesium sulfate;

  • patients unable to perform spirometry;

  • presence of pneumonia;

  • oral temperatures of 38 °C or more;

  • systolic blood pressure < 100 mmHg.
Interventions Intervention: 2 g of magnesium sulfate diluted in 100 ml normal saline, infused over 20 min, concurrent with standard treatment
Comparator: placebo of 100 mL normal saline with standard treatment
Concomitant medications:

  • standard treatment

  • oxygen for appropriate SpO2

  • salbutamol 2 puffs every 6 hours

  • ipratropium bromide 2 puffs every 6 hours

  • IV methylprednisolone 60 mg every 12 hours

  • azithromycin 500 mg first day then 250 mg/day for 4 days
Outcomes PEFR, FEV1, SaO2, duration of hospital stay
Notes Funding: not mentioned
Conflicts of interest of trial authors: not explicitly described, but the proposal was approved by the research ethic board
Risk of bias
Bias Authors' judgement Support for judgement
Random sequence generation (selection bias) Unclear risk Comment: stated as "patients were randomly divided" with no further details.
Allocation concealment (selection bias) Unclear risk Comment: stated as "randomised‐control double blind study" with no further details.
Blinding of participants and personnel (performance bias)
All outcomes Unclear risk Comment: stated to be a double‐blind study, but no further details provided.
Blinding of outcome assessment (detection bias)
All outcomes Unclear risk Comment: stated to be a double‐blind study, but no further details provided.
Incomplete outcome data (attrition bias)
All outcomes Low risk Comment: there were no dropouts form the study arms.
Selective reporting (reporting bias) Unclear risk Comment: study protocol was not available; unclear if all outcomes were reported as planned.
Other bias Low risk Comment: no other apparent biases identified.

ABG: arterial blood gas; AECOPD: acute exacerbations of COPD; ATS: American Thoracic Society; BP: blood pressure; bpm: beats per minute; COPD: chronic obstructive pulmonary disease; CXR: chest X‐ray; DSS: Dyspnea Severity Score; ED: emergency department; ECG: electrocardiogram; FEV1: forced expiratory volume in one second; FVC: forced vital capacity; HR: heart rate; ICU: intensive care unit; MIP: maximal inspiratory pressure; MEP: maximal expiratory pressure; mmHg: millimetre of mercury; NIMV: noninvasive mechanical ventilation; NIV: non‐invasive ventilation; PaO2: partial pressure of arterial oxygen; PaCO2: partial pressure of arterial carbon dioxide; PEFR: peak expiratory flow rate; PO: per oral; PR: pulse rate; RR: respiratory rate; SaO2: arterial oxygen saturation; SD: standard deviation; VAS: visual analogue scale.