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

Comert 2016.

Study characteristics
Methods Study design: randomised placebo‐controlled trial of parallel design
Number of study centres: single centre
Study location: Turkey University hospital
Study setting: ambulatory care unit, Department of Pulmonology, School of Medicine, Istanbul University
Date of study: December 2004 to September 2005
Withdrawals: none
Participants Number randomised: 20
Numbers in treatment group: 10
Number in placebo group: 10
Numbers of withdrawals: 0
Numbers completing trial: 20
Mean age (years): 62.1 (SD 12) (magnesium); 71.3 (SD 5) (placebo)
Gender (male/female): 8/2 (magnesium); 10/0 (placebo)
Diagnostic criteria: clinical diagnosis
Mean duration of COPD (years): 11.4 (magnesium); 13.5 (placebo)
History of hospitalisation in recent year, n (%): 3(30) (magnesium); 4(40) (placebo)
History of ICU in recent year, n (%): 0 (magnesium); 0 (placebo)
Long‐term oxygen use, n (%): 2 (20) (magnesium); 6 (60) (placebo)
Corticosteroid use in last 6 months, n (%): 3 (30) (magnesium); 4(40) (placebo)
Inclusion criteria
  • diagnosis of COPD (shortness of breath, chronic cough, sputum, exposure to known COPD risk factors, and FEV1/FVC < 70% measured after bronchodilator administration at a stable disease period)

  • symptoms compatible with infectious COPD exacerbation according to Anthonisen criteria (increase in 2 of the following: shortness of breath, sputum purulence and sputum amount) – hospitalisation criteria (RR > 25/min, HR > 110 bpm, cyanosis, use of accessory respiratory muscles, drowsiness, PEFR < 100 L/min, FEV1 < 1 L, in arterial blood gas analysis PaO2 < 60 mmHg, PaCO2 ≥ 45 mmHg, SaO2 < 90%)


Exclusion criteria
  • presence of ICU indication

  • presence of NIMV indication

  • suspicion of pneumonia, pulmonary embolism, or pneumothorax

  • known history of severe heart failure, renal, or hepatic disease

  • suspicion of a mass lesion on CXR

  • history of systemic corticosteroid use

  • uncooperative patients

  • severe loss of sight

  • did not consent to participate

Interventions Intervention: 2.5 mL isotonic magnesium sulfate (250 mmol/L, 151 mg/dose) by nebuliser + standard care
Comparator: 2.5 mL isotonic saline solution by nebuliser + standard care
Concomitant medications
  • Nasal oxygen to increase SO2 > 90%

  • Methyl prednisolone 32 mg PO

  • Sulbactam/ampicillin 4g/day IV or cefuroxime 1.5 g/day

  • 500 μg ipratropium bromide

Outcomes At 24 and 48 hours: FEV1, ABG (PaO2, PaCO2, pH, SaO2), VAS dyspnoea score (0 ‐ 100), serum magnesium level
10, 30, 60 and 120 mins after each nebule treatment: PEFR
10, 30, and 120 mins after each nebule treatment: BP and HR
Notes Funding: researcher
Full text article in Turkish; translation done by Cochrane Airways.
Risk of bias
Bias Authors' judgement Support for judgement
Random sequence generation (selection bias) Unclear risk Comment: "1:1 randomisation in two groups" with no further information.
Allocation concealment (selection bias) Unclear risk Comment: no details reported.
Blinding of participants and personnel (performance bias)
All outcomes Low risk Comment: authors stated that all measurements were made by a single researcher; participants and the researcher who made the measurements did not know in which group the participant was.
Blinding of outcome assessment (detection bias)
All outcomes Low risk Comment: blinding of participants and researcher who made the measurements.
Incomplete outcome data (attrition bias)
All outcomes Low risk Comment: all participants completed the study with no withdrawals.
Selective reporting (reporting bias) Unclear risk Comment: trial protocol was not available, unclear if outcomes were reported as planned.
Other bias Low risk Comment: no other apparent biases identified.