Sarhan 2016.
Methods | Double blind, randomised controlled trial. Chest and emergency departments at 1 hospital, Egypt. |
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Participants | Inclusion criteria: diagnosis of asthma. Exclusion criteria: fever, lower respiratory tract infection, cardiac/renal/hepatic dysfunction, needed NIV/intubation, near‐fatal asthma, pregnancy, lactation, failed to use PEF meter, inhaled/oral/intravenous bronchodilator use within past 6 h or steroid use within past 12 h. 30 randomised. Intervention 1 (magnesium): 10 randomised. Mean age (years): 33.5 (17.8). Men:women: 4:6. Mean % of predicted PEF at presentation: 33.9 (9.8). Intervention 2 (salbutamol and placebo) : 10 randomised. Mean age (years): 48.6 (9.9). Men:women: 3:7. Mean % of predicted PEF at presentation: 36.4 (10.5). Intervention 3 (salbutamol and magnesium): 10 randomised. Mean age (years): 51.3 (15.8). Men:women: 7:3. Mean % of predicted PEF at presentation: 34.1 (9.4). |
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Interventions | Intervention 1: 3 mL MgSO₄ (3.3% solution) nebulised. Intervention 2: 0.5 mL salbutamol (0.5% solution) in 2.5 mL isotonic saline nebulised. Intervention 3: 0.5 mL salbutamol (0.5% solution) in 2.5 mL MgSO₄ (4% solution) nebulised. 4 doses given at 20 minute intervals. Ultrasonic nebuliser. |
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Outcomes | PEF improvement, respiratory rate, heart rate, blood pressure, oxygen saturations, improvement in Fischl index of clinical severity, adverse event rate (all at "final" time point, assumed to be 2 h). Adverse events: no events "severe enough to warrant withdrawal" reported. |
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Notes | Funding: not reported. | |
Risk of bias | ||
Bias | Authors' judgement | Support for judgement |
Random sequence generation (selection bias) | Unclear risk | Reports patients were randomised into 3 groups but no details given. |
Allocation concealment (selection bias) | Unclear risk | Data not given. |
Blinding of participants and personnel (performance bias) All outcomes | Unclear risk | Described as "double blind" but no details given about who was blinded or how. |
Blinding of outcome assessment (detection bias) All outcomes | Unclear risk | Described as "double blind" but no details given about who was blinded or how. |
Incomplete outcome data (attrition bias) All outcomes | Unclear risk | The report does not specify how many randomised participants completed the trial. |
Selective reporting (reporting bias) | Unclear risk | No prospective trial registration identified. Primary and secondary outcomes not defined. No power calculation reported. |