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
Exclusion criteria
|
|
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
|
|
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. |