Magnesium sulphate for treating acute bronchiolitis in children up to two years of age

Sudha Chandelia; Dinesh Kumar; Neelima Chadha; Nishant Jaiswal

doi:10.1002/14651858.CD012965.pub2

Cochrane Database of Systematic Reviews

Sulfato de magnesio para el tratamiento de la bronquiolitis aguda en niños de hasta dos años de edad

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DOI:

https://doi.org/10.1002/14651858.CD012965.pub2 Copiar DOI

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Cochrane Database of Systematic Reviews

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14 diciembre 2020see what's new

Tipo:

Intervention

Etapa:

Review

Grupo Editorial Cochrane:

Grupo Cochrane de Infecciones respiratorias agudas

Copyright:

Copyright © 2020 The Cochrane Collaboration. Published by John Wiley & Sons, Ltd.

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Autores

Sudha Chandelia

Correspondencia a: Pediatric Emergency and Critical Care, PGIMER and Dr. RML Hospital, New Delhi, India

[email protected]
Dinesh Kumar

Division of Pediatric Cardiology, Department of Pediatrics, PGIMER, Delhi, India
Neelima Chadha

PGIMER Library, PGIMER, Chandigarh, India
Nishant Jaiswal

ICMR Advanced Centre for Evidence-Based Child Health, Postgraduate Institute of Medical Education and Research, Chandigarh, India

Contributions of authors

Dr Sudha Chandelia (SC): conceptualised, designed the search strategy, performed the literature search, screened search results, screened and retrieved papers against eligibility criteria, collected and extracted data, obtained and screened data on unpublished studies, entered data into RevMan 5, conducted data analysis and interpretation, assessed certainty of evidence, co‐ordinated the review, wrote and drafted the review.

Dr Dinesh Kumar (DK): provided intellectual input for the background, screened search results, retrieved and screened papers against eligibility criteria, conducted data extraction, and assessed certainty of evidence.

Ms Neelima Chadha (NC): provided intellectual input into the development of the search strategy, literature search; and provided full‐text articles.

Nishant Jaiswal (NJ): provided intellectual input for 'Risk of bias' assessment, reported and wrote revised drafts of the review, provided intellectual input and guidance for GRADE application.

All authors reviewed and approved the review.

Sources of support

Internal sources

PGIMER and Dr RML Hospital, New Delhi and PGIMER, Chandigarh, India

Library and Internet facility

External sources

No sources of support supplied

Declarations of interest

SC: None known
DK: None known
NC: None known
NJ: None known

Acknowledgements

We thank Khalid Ansari and Mehmat Kose for their gracious assistance in providing additional data and responding to our questions (Alansari 2019; Kose 2019). We thank Arun K Yadav for his support and help in this review. We thank Dr Kalpana Kumari and Dr Rahul Teotia for their help with analyses.

The Methods section of the protocol for this review was based on a standard template developed by Cochrane Airways, and adapted by the Cochrane Acute Respiratory Infections Group.

We would also like to acknowledge the reviewers, Professor David Isaacs, University of Sydney, Australia and Linjie Zhang, Faculty of Medicine, Federal University of Rio Grande, Brazil for giving us valuable suggestions and comments. We acknowledge Anne Lyddiatt and Dee Schneiderman, the consumer reviewers, for providing valuable suggestions during the course of peer review. We also acknowledge the contact editor, Lubna Al‐Ansary, and statistical editor, Conor Teljeur, for giving their valuable time to this review.

Version history

Published

Title

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Authors

Version

2020 Dec 14

Magnesium sulphate for treating acute bronchiolitis in children up to two years of age

Review

Sudha Chandelia, Dinesh Kumar, Neelima Chadha, Nishant Jaiswal

https://doi.org/10.1002/14651858.CD012965.pub2

2018 Feb 20

Magnesium sulphate for acute bronchiolitis in children under two years of age

Protocol

Sudha Chandelia, Arun K Yadav, Dinesh Kumar, Neelima Chadha

https://doi.org/10.1002/14651858.CD012965

Differences between protocol and review

In the protocol, we planned to include non‐randomised controlled trials (non‐RCTs), as we were expecting to identify few studies. In the review, we only included RCTs, as we did not identify any non‐RCTs.
We added the primary outcome, time to recovery, as it is a person‐centred, and clinically important outcome, likely to be modified by the treatment.
In the protocol, the primary outcome, clinical severity score, had four components: clinical severity score measured using any validated scoring system, duration of mechanical ventilation, duration of hospital stay, or duration of intensive care unit stay. These could not be described under one outcome. Therefore, we separated these into four outcomes. We moved 'clinical severity score' to the secondary outcomes.
We did not specify time points of clinical severity score in the protocol. Clinical severity scoring was conducted at multiple time points amongst the studies. Therefore, we specified the time points of clinical severity score at 0 to 24 hours, and 25 to 48 hours after treatment for the review.
There was a change in authorship: Arun K Yadav, an author on the protocol, did not co‐author the review.
We planned to meta‐analyse using the random‐effects model, as we anticipated the studies would differ. We used the fixed‐effect model to calculate effect size and 95% confidence intervals (CIs) when we could not pool results, and included only one study for comparison.
We planned to conduct sensitivity and subgroup analyses. However, there were insufficient data.

Keywords

MeSH

Medical Subject Headings (MeSH) Keywords

Medical Subject Headings Check Words

Humans; Infant; Infant, Newborn;

PICO

Population

Intervention

Comparison

Outcome

El uso y la enseñanza del modelo PICO están muy extendidos en el ámbito de la atención sanitaria basada en la evidencia para formular preguntas y estrategias de búsqueda y para caracterizar estudios o metanálisis clínicos. PICO son las siglas en inglés de cuatro posibles componentes de una pregunta de investigación: paciente, población o problema; intervención; comparación; desenlace (outcome).

Para saber más sobre el uso del modelo PICO, puede consultar el Manual Cochrane.

Figure 1

Study flow diagram

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Figure 2

'Risk of bias' summary: review authors' judgements about each 'Risk of bias' item for each included study

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Figure 3

'Risk of bias' graph: review authors' judgements about each 'Risk of bias' item, presented as percentages across all included studies

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Analysis 1.1

Comparison 1: Magnesium sulphate compared with placebo for acute bronchiolitis in children, Outcome 1: Clinical severity score at 0 to 24 hours after treatment

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Analysis 1.2

Comparison 1: Magnesium sulphate compared with placebo for acute bronchiolitis in children, Outcome 2: Clinical severity score at 25 to 48 hours after treatment

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Analysis 1.3

Comparison 1: Magnesium sulphate compared with placebo for acute bronchiolitis in children, Outcome 3: Hospital readmission rate within 30 days of discharge

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Analysis 2.1

Comparison 2: Magnesium sulphate compared with hypertonic saline for acute bronchiolitis in children, Outcome 1: Duration of hospital stay

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Analysis 2.2

Comparison 2: Magnesium sulphate compared with hypertonic saline for acute bronchiolitis in children, Outcome 2: Clinical severity score at 25 to 48 hours after treatment

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Analysis 3.1

Comparison 3: Magnesium sulphate + epinephrine compared with no treatment or normal saline + epinephrine for acute bronchiolitis in children, Outcome 1: Duration of hospital stay

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Analysis 3.2

Comparison 3: Magnesium sulphate + epinephrine compared with no treatment or normal saline + epinephrine for acute bronchiolitis in children, Outcome 2: Clinical severity score at 0 to 24 hour after treatment

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Analysis 3.3

Comparison 3: Magnesium sulphate + epinephrine compared with no treatment or normal saline + epinephrine for acute bronchiolitis in children, Outcome 3: Clinical severity score at 25 to 48 hour after treatment

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Summary of findings 1. Magnesium sulphate compared with placebo for acute bronchiolitis in children

Magnesium sulphate versus placebo for acute bronchiolitis in children
Patient or population: children up to 18 months old with acute bronchiolitis Settings: short stay unit, paediatric emergency department Intervention: magnesium sulphate Comparison: placebo
Outcomes	*Illustrative comparative risks (95% CI)**		Relative effect (95% CI)	No of Participants (studies)	Certainty of the evidence (GRADE)	Comments
	Assumed risk	Corresponding risk
	Placebo	Magnesium sulphate
Time to recovery	‐	‐	‐	‐	‐	Outcome not measured
Mortality	See comment	See comment	Not estimable	160 (1 RCT)	See comment	Trial authors confirmed there were no deaths in either group (personal communication)
Adverse events	See comment	See comment	Not estimable	160 (1 RCT)	See comment	Neither group reported adverse effects, such as apnoea, cyanosis, or haemodynamic instability
Duration of hospital stay	Geometric mean time to discharge was 25.3 hours in the placebo group.	Geometric mean time to discharge was 24.1 hours in the magnesium sulphate group.	Not estimable	160 (1 RCT)	See comment	Results were taken directly from the published report.
Clinical severity score (CSS) (Wang score; range 0 to 12; higher = poorer outcome) measured at 0 to 24 hours after treatment	The mean (SD) CSS at 24 hours in the placebo group was 4.55 points (1.62)	The mean CSS at 24 hours in the magnesium sulphate group was 0.13 points higher (0.28 lower to 0.54 higher)	MD 0.13, (‐0.28 to 0.54)	160 (1 RCT)	⊕⊝⊝⊝ very low^a
Clinical severity score (CSS) (Wang score; range 0 to 12; higher = poorer outcome) measured at 25 to 48 hours after treatment	The mean (SD) CSS at 48 hours in the placebo group was 4.84 points (1.57)	The mean CSS at 48 hours in the magnesium sulphate group was 0.42 points lower (0.84 lower to 0)	MD ‐0.42, (‐0.84 to ‐0.00)	160 (1 RCT)	⊕⊝⊝⊝ very low^a
Hospital re‐admission within 30 days of discharge (re‐admissions were reported at 14 days)	62 per 1000	195 per 1000	RR 3.16 (1.20 to 8.27)	158 (1 RCT)	⊕⊕⊝⊝ low^b
The basis for the assumed risk* (e.g. the median control group risk across studies) is provided in footnotes. The corresponding risk (and its 95% confidence interval) is based on the assumed risk in the comparison group and the relative effect of the intervention (and its 95% CI). CI: confidence interval; RR: risk ratio; MD: mean difference; SD: standard deviation; RCT: randomised controlled trial
GRADE Working Group grades of evidence High quality. Further research is very unlikely to change our confidence in the estimate of effect. Moderate quality. Further research is likely to have an important impact on our confidence in the estimate of effect and may change the estimate. Low quality. Further research is very likely to have an important impact on our confidence in the estimate of effect and is likely to change the estimate. Very low quality. We are very uncertain about the estimate.
^aWe downgraded the quality of the evidence to very low for indirectness and very serious imprecision (1 study, small sample size, wide confidence intervals). ^bWe downgraded the quality of the evidence to low for indirectness and serious imprecision (1 study, small sample size).

Summary of findings 1. Magnesium sulphate compared with placebo for acute bronchiolitis in children

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Summary of findings 2. Magnesium sulphate compared with hypertonic saline for acute bronchiolitis in children

Magnesium sulphate versus hypertonic saline for acute bronchiolitis in children
Patient or population: children up to 12 months old with acute bronchiolitis Settings: single‐centre, emergency department, paediatric intensive care unit and wards Intervention: magnesium sulphate Comparison: hypertonic saline
Outcomes	*Illustrative comparative risks (95% CI)**		Relative effect (95% CI)	No of Participants (studies)	Certainty of the evidence (GRADE)	Comments
	Assumed risk	Corresponding risk
	Hypertonic saline	Magnesium sulphate
Time to recovery	‐	‐	‐	‐	‐	Outcome not measured
Mortality	‐	‐	‐	‐	‐	Outcome not measured
Adverse events	‐	‐	‐	‐	‐	Outcome not measured
Duration of hospital stay	The mean (SD) duration of hospital stay in the hypertonic saline group was 3.2 days (1.0)	The mean duration of hospital stay in the magnesium sulphate group was 3.2 days (0.28 lower to 0.28 higher)	MD 0.00 (‐0.28 to 0.28)	220 (1 RCT)	⊕⊝⊝⊝ very low^a
Clinical severity score (CSS) (RDAI score; range 0 to 17; higher = poorer outcomes) measured at 0 to 24 hours after treatment	‐	‐	‐	‐	‐	Outcome not measured
Clinical severity score (CSS) (RDAI score; range 0 to 17; higher = poorer outcomes) measured at 25 to 48 hours after treatment	The mean (SD) CSS at 48 hours in the hypertonic saline group was 3.7 points (1.8)	The mean CSS at 48 hours in the magnesium sulphate group was 0.10 points higher (0.39 lower to 0.59 higher)	MD 0.10 (‐0.39 to 0.59)	220 (1 RCT)	⊕⊝⊝⊝ very low^a
Hospital re‐admission within 30 days of discharge	‐	‐	‐	‐	‐	Outcome not measured
The basis for the assumed risk* (e.g. the median control group risk across studies) is provided in footnotes. The corresponding risk (and its 95% confidence interval) is based on the assumed risk in the comparison group and the relative effect of the intervention (and its 95% CI). CI: confidence interval; MD: mean difference; SD: standard deviation; RCT: randomised controlled trial; RADI: respiratory distress assessment instrument
GRADE Working Group grades of evidence High quality. Further research is very unlikely to change our confidence in the estimate of effect. Moderate quality. Further research is likely to have an important impact on our confidence in the estimate of effect and may change the estimate. Low quality. Further research is very likely to have an important impact on our confidence in the estimate of effect and is likely to change the estimate. Very low quality. We are very uncertain about the estimate.
^aWe downgraded the quality of the evidence to very low for indirectness and very serious imprecision (1 study, small sample size).

Summary of findings 2. Magnesium sulphate compared with hypertonic saline for acute bronchiolitis in children

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Summary of findings 3. Magnesium sulphate or magnesium sulphate + salbutamol compared with salbutamol for acute bronchiolitis in children

Magnesium sulphate or magnesium sulphate + salbutamol versus salbutamol for acute bronchiolitis in children
Patient or population: children from 1 month to 24 months old with acute bronchiolitis Settings: single‐centre, short‐stay unit, paediatric emergency department Intervention: magnesium sulphate or magnesium sulphate + salbutamol Comparison: salbutamol
Outcomes	*Illustrative comparative risks (95% CI)**		Relative effect (95% CI)	No of Participants (studies)	Certainty of the evidence (GRADE)	Comments
	Assumed risk	Corresponding risk
	Salbutamol	Magnesium sulphate or magnesium sulphate + salbutamol
Time to recovery	‐	‐	‐	‐	‐	Outcome not measured
Mortality	See comment	See comment	Not estimable	56 (1 RCT)^a	‐	No deaths occurred in any of the groups (personal communication)
Adverse events	See comment	See comment	Not estimable	56 (1 RCT)^a	‐	There were no instances of adverse effects, such as hypotension, arrhythmias, or loss of deep tendon reflexes reported in any of the groups.
Duration of hospital stay	The mean duration of hospital stay in the salbutamol group was 24 hours (95% CI 23.4 to 76.9).	The mean duration of hospital stay in the magnesium sulphate group was 24 hours (95% CI 25.8 to 47.4). The mean duration of hospital stay for the magnesium sulphate + salbutamol group was 20 hours (95% CI 15.3 to 39.0).	Not estimable	56 (1 RCT)^a	‐	Results were taken directly from the published report.
Clinical severity score (CSS) (Wang score; range 0 to 12; higher = poorer outcome) measured at 0 to 24 hours after treatment	‐	‐	‐	‐	‐	Outcome not measured
Clinical severity score (CSS) (Wang score; range 0 to 12; higher = poorer outcome) measured 25 to 48 hours after treatment	‐	‐	‐	‐	‐	Outcome not measured
Hospital re‐admission within 30 days of discharge	‐	‐	‐	‐	‐	Outcome not measured
The basis for the assumed risk* (e.g. the median control group risk across studies) is provided in footnotes. The corresponding risk (and its 95% confidence interval) is based on the assumed risk in the comparison group and the relative effect of the intervention (and its 95% CI). CI: Confidence interval; MD: mean difference; SD: standard deviation; RCT: randomised controlled trial
GRADE Working Group grades of evidence High quality. Further research is very unlikely to change our confidence in the estimate of effect. Moderate quality. Further research is likely to have an important impact on our confidence in the estimate of effect and may change the estimate. Low quality. Further research is very likely to have an important impact on our confidence in the estimate of effect and is likely to change the estimate. Very low quality. We are very uncertain about the estimate.
^a3‐arm trial: magnesium sulphate group (19 children), magnesium sulphate plus salbutamol (19 children), salbutamol (18 children)

Summary of findings 3. Magnesium sulphate or magnesium sulphate + salbutamol compared with salbutamol for acute bronchiolitis in children

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Summary of findings 4. Magnesium sulphate + epinephrine compared with no treatment or normal saline + epinephrine

Magnesium sulphate + epinephrine versus no treatment or normal saline + epinephrine
Patient or population: children up to 12 months old with acute bronchiolitis Settings: 3 paediatric departments of 3 hospitals Intervention: magnesium sulphate + epinephrine Comparison: no treatment or normal saline + epinephrine
Outcomes	*Illustrative comparative risks (95% CI)**		Relative effect (95% CI)	No of Participants (studies)	Certainty of the evidence (GRADE)	Comments
	Assumed risk	Corresponding risk
	no treatment or normal saline + epinephrine	Magnesium sulphate + epinephrine
Time to recovery	‐	‐	‐	‐	‐	Outcome not measured
Mortality	‐	‐	‐	‐	‐	Outcome not measured
Adverse events	‐	‐	‐	‐	‐	Outcome not measured
Duration of hospital stay	The mean (SD) duration of hospital stay in the epinephrine group was 84.7 hours (10.1)	The mean (SD) duration of hospital stay for the magnesium sulphate + epinephrine group was 0.40 hours less (3.94 lower to 3.14 higher)	MD ‐0.40 (‐3.94 to 3.14)	120 (1 RCT)	⊕⊝⊝⊝ very low^a
Clinical severity score (CSS) (RDAI score; range 0 to 17; higher = poorer outcomes) measured at 0 to 24 hours after treatment	The mean (SD) CSS at 24 hours in the epinephrine group was 6.6 points (2.2)	The mean CSS at 24 hours in the magnesium sulphate + epinephrine group was 0.20 points lower (1.06 lower to 0.66 higher)	MD ‐0.20 (‐1.06 to 0.66)	120 (1 RCT)	⊕⊝⊝⊝ very low^a
Clinical severity score (CSS) (RDAI score; range 0 to 17; higher = poorer outcomes) measured 25 to 48 hours after treatment	The mean (SD) CSS at 48 hours in the epinephrine group was 3.7 points (2.7)	The mean CSS at 48 hours in the magnesium sulphate + epinephrine group was 0.90 points lower (1.75 lower to 0.05 lower)	MD ‐0.90 (‐1.75 to ‐0.05)	120 (1 RCT)	⊕⊝⊝⊝ very low^a	Higher value indicates poor outcome
Hospital re‐admission within 30 days of discharge	‐	‐	‐	‐	‐	Outcome not measured
The basis for the assumed risk* (e.g. the median control group risk across studies) is provided in footnotes. The corresponding risk (and its 95% confidence interval) is based on the assumed risk in the comparison group and the relative effect of the intervention (and its 95% CI). CI: Confidence interval; MD: mean difference; SD: standard deviation; RCT: randomised controlled trial
GRADE Working Group grades of evidence High quality. Further research is very unlikely to change our confidence in the estimate of effect. Moderate quality. Further research is likely to have an important impact on our confidence in the estimate of effect and may change the estimate. Low quality. Further research is very likely to have an important impact on our confidence in the estimate of effect and is likely to change the estimate. Very low quality. We are very uncertain about the estimate.
^aWe downgraded the evidence to very low for indirectness and very serious imprecision (1 study, small sample size).

Summary of findings 4. Magnesium sulphate + epinephrine compared with no treatment or normal saline + epinephrine

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Table 1. Comparisons and outcomes for which analyses could not be conducted

Outcome	Comparison	Reason for not conducting analysis
Time to recovery	All comparisons	No data available
Mortality	Magnesium sulphate compared with placebo	No deaths reported
	magnesium sulphate compared with conventional bronchodilator
	Magnesium sulphate + bronchodilator compared with no treatment or normal saline + the same bronchodilator
	Magnesium sulphate compared with hypertonic saline	No data available
	Magnesium sulphate + epinephrine compared with no treatment or normal saline + epinephrine	No data available
Adverse effects of magnesium sulphate treatment	Magnesium sulphate compared with placebo	No adverse effects reported
	Magnesium sulphate compared with conventional bronchodilator
	Magnesium sulphate + bronchodilator compared with no treatment or normal saline + the same bronchodilator
	Magnesium sulphate compared with hypertonic saline	No data available
	Magnesium sulphate + epinephrine compared with no treatment or normal saline + epinephrine	No data available
Duration of hospital stay	Magnesium sulphate compared with placebo	Reporting format was different. Study authors used geometric mean time^a. We did not transform data for analysis, as only single study was available for this comparison.
	Magnesium sulphate compared with conventional bronchodilator	Reporting format was different. Study authors used 95% confidence interval. We did not transform data for analysis, as only single study was available for this comparison.
	Magnesium sulphate + bronchodilator compared with no treatment or normal saline + the same bronchodilator
Clinical severity score at 0 to 24 hours after treatment	Magnesium sulphate compared with hypertonic saline	No data available
	Magnesium sulphate compared with conventional bronchodilator
	Magnesium sulphate + bronchodilator compared with no treatment or normal saline + the same bronchodilator
Clinical severity score at 25 to 48 hours after treatment	Magnesium sulphate compared with conventional bronchodilator	No data available
Clinical severity score at 25 to 48 hours after treatment	Magnesium sulphate + bronchodilator compared with no treatment or normal saline + the same bronchodilator	No data available
Pulmonary function test	All comparisons	No data available
Hospital readmission rate within 30 days of discharge	All comparisons except magnesium sulphate compared with placebo	No data available
Duration of mechanical ventilation	All comparisons	No data available
Duration of intensive care unit stay	All comparisons	No data available
Note: these analyses were planned in the protocol, but were not carried out due to limited or no available data. ^aGeometric mean is equal to the exponential of the mean of the log‐transformed values. The value of geometric mean is usually lesser than the arithmetic mean. Geometric mean is used as it is not much affected by the skewed distribution of data.

Table 1. Comparisons and outcomes for which analyses could not be conducted

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Comparison 1. Magnesium sulphate compared with placebo for acute bronchiolitis in children

Outcome or subgroup title	No. of studies	No. of participants	Statistical method	Effect size
1.1 Clinical severity score at 0 to 24 hours after treatment Show forest plot	1		Mean Difference (IV, Fixed, 95% CI)	Totals not selected

1.2 Clinical severity score at 25 to 48 hours after treatment Show forest plot	1		Mean Difference (IV, Fixed, 95% CI)	Totals not selected

1.3 Hospital readmission rate within 30 days of discharge Show forest plot	1		Risk Ratio (M‐H, Fixed, 95% CI)	Totals not selected

Comparison 1. Magnesium sulphate compared with placebo for acute bronchiolitis in children

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Comparison 2. Magnesium sulphate compared with hypertonic saline for acute bronchiolitis in children

Outcome or subgroup title	No. of studies	No. of participants	Statistical method	Effect size
2.1 Duration of hospital stay Show forest plot	1		Mean Difference (IV, Fixed, 95% CI)	Totals not selected

2.2 Clinical severity score at 25 to 48 hours after treatment Show forest plot	1		Mean Difference (IV, Fixed, 95% CI)	Totals not selected

Comparison 2. Magnesium sulphate compared with hypertonic saline for acute bronchiolitis in children

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Comparison 3. Magnesium sulphate + epinephrine compared with no treatment or normal saline + epinephrine for acute bronchiolitis in children

Outcome or subgroup title	No. of studies	No. of participants	Statistical method	Effect size
3.1 Duration of hospital stay Show forest plot	1		Mean Difference (IV, Fixed, 95% CI)	Totals not selected

3.2 Clinical severity score at 0 to 24 hour after treatment Show forest plot	1		Mean Difference (IV, Fixed, 95% CI)	Totals not selected

3.3 Clinical severity score at 25 to 48 hour after treatment Show forest plot	1		Mean Difference (IV, Fixed, 95% CI)	Totals not selected

Comparison 3. Magnesium sulphate + epinephrine compared with no treatment or normal saline + epinephrine for acute bronchiolitis in children

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Sulfato de magnesio para el tratamiento de la bronquiolitis aguda en niños de hasta dos años de edad

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