Hyperbaric oxygen therapy for acute ischaemic stroke

Michael H Bennett; Stephanie Weibel; Jason Wasiak; Alexander Schnabel; Christopher French; Peter Kranke

doi:10.1002/14651858.CD004954.pub3

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Figure 1

Study flow diagram.

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Figure 2

Methodological quality summary: review authors' judgements about each methodological quality item for each included study.

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Figure 3

Methodological quality graph: review authors' judgements about each methodological quality item presented as percentages across all included studies.

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Analysis 1.1

Comparison 1 Mortality, Outcome 1 Death at 3 to 6 months.

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Analysis 2.1

Comparison 2 Severe functional disability, Outcome 1 No effect of therapy—participants unable to care for themselves.

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Analysis 3.1

Comparison 3 Functional scales, Outcome 1 Mean neurological score at day 5.

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Analysis 3.2

Comparison 3 Functional scales, Outcome 2 Mean neurological score at week 6.

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Analysis 3.3

Comparison 3 Functional scales, Outcome 3 Mean neurological score at 1 year.

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Analysis 3.4

Comparison 3 Functional scales, Outcome 4 Mean Orgogozo score at 6 months.

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Analysis 3.5

Comparison 3 Functional scales, Outcome 5 Mean Orgogozo score at 1 year.

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Analysis 3.6

Comparison 3 Functional scales, Outcome 6 Mean Trouillas score at 6 months.

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Analysis 3.7

Comparison 3 Functional scales, Outcome 7 Mean Trouillas score at 1 year.

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Analysis 3.8

Comparison 3 Functional scales, Outcome 8 Mean Rankin score at 6 months.

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Analysis 3.9

Comparison 3 Functional scales, Outcome 9 Mean Rankin score at 1 year.

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Analysis 3.10

Comparison 3 Functional scales, Outcome 10 Mean neurological recovery score at 12 months.

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Analysis 3.11

Comparison 3 Functional scales, Outcome 11 Neurological function deficit score at 3 weeks.

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Analysis 4.1

Comparison 4 Deemed to have a good outcome, Outcome 1 NIHSS 0 or improved by 4 points at 24 hours.

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Analysis 4.2

Comparison 4 Deemed to have a good outcome, Outcome 2 Modified Rankin score less than 2 at 90 days.

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Analysis 4.3

Comparison 4 Deemed to have a good outcome, Outcome 3 Glasgow Outcome Score of 5.

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Analysis 4.4

Comparison 4 Deemed to have a good outcome, Outcome 4 NIHSS less than 2.

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Analysis 4.5

Comparison 4 Deemed to have a good outcome, Outcome 5 Deemed cured and self‐caring.

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Analysis 5.1

Comparison 5 Activities of daily living, Outcome 1 Barthel Index 95 or 100 at 90 days.

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Analysis 5.2

Comparison 5 Activities of daily living, Outcome 2 Mean Barthel Index at 3 weeks.

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Analysis 6.1

Comparison 6 Mean volume of infarct on CT, Outcome 1 Mean volume of infarct at 4 months.

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Analysis 7.1

Comparison 7 Adverse effects of therapy, Outcome 1 Ear pain.

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Summary of findings for the main comparison. Should hyperbaric oxygen therapy be used as an adjuvant therapy to routine therapy and rehabilitation for acute ischaemic stroke?

Should hyperbaric oxygen therapy be used as an adjuvant therapy to routine therapy and rehabilitation for acute ischaemic stroke?
Patient or population: people with acute ischaemic stroke Settings: hospital inpatients Intervention: hyperbaric oxygen therapy used as adjuvant therapy to Comparison: routine therapy and rehabilitation
Outcomes	*Illustrative comparative risks (95% CI)**		Relative effect (95% CI)	Number of participants (studies)	Quality of the evidence (GRADE)	Comments
	Assumed risk	Corresponding risk
	Routine therapy and rehabilitation	Hyperbaric oxygen therapy used as adjuvant therapy
Death Follow‐up: 3 to 6 months	Low‐risk population		RR 0.97 (0.34 to 2.75)	144 (4 studies)	⊕⊕⊕⊝ moderate^a
	20 per 1000	19 per 1000 (7 to 55)
	Medium‐risk population
	80 per 1000	78 per 1000 (27 to 220)
	High‐risk population
	120 per 1000	116 per 1000 (41 to 330)
The basis for the assumed risk* (e.g. 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.
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.
^a Small trials, with most not blinded to allocation.

Summary of findings for the main comparison. Should hyperbaric oxygen therapy be used as an adjuvant therapy to routine therapy and rehabilitation for acute ischaemic stroke?

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Comparison 1. Mortality

Outcome or subgroup title	No. of studies	No. of participants	Statistical method	Effect size
1 Death at 3 to 6 months Show forest plot	4	144	Risk Ratio (M‐H, Fixed, 95% CI)	0.97 [0.34, 2.75]

1.1 HBO alone	3	106	Risk Ratio (M‐H, Fixed, 95% CI)	0.61 [0.17, 2.20]
1.2 HBO and edaravone	1	38	Risk Ratio (M‐H, Fixed, 95% CI)	3.0 [0.34, 26.33]

Comparison 1. Mortality

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Comparison 2. Severe functional disability

Outcome or subgroup title	No. of studies	No. of participants	Statistical method	Effect size
1 No effect of therapy—participants unable to care for themselves Show forest plot	1	70	Risk Ratio (M‐H, Fixed, 95% CI)	0.36 [0.10, 1.28]

Comparison 2. Severe functional disability

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Comparison 3. Functional scales

Outcome or subgroup title	No. of studies	No. of participants	Statistical method	Effect size
1 Mean neurological score at day 5 Show forest plot	1	38	Mean Difference (IV, Fixed, 95% CI)	5.30 [‐7.47, 18.07]

2 Mean neurological score at week 6 Show forest plot	1	32	Mean Difference (IV, Fixed, 95% CI)	10.2 [‐8.48, 28.88]

3 Mean neurological score at 1 year Show forest plot	1	25	Mean Difference (IV, Fixed, 95% CI)	5.60 [‐15.02, 26.22]

4 Mean Orgogozo score at 6 months Show forest plot	1	27	Mean Difference (IV, Fixed, 95% CI)	‐18.20 [‐41.62, 5.22]

5 Mean Orgogozo score at 1 year Show forest plot	1	27	Mean Difference (IV, Fixed, 95% CI)	‐27.90 [‐51.79, ‐4.01]

6 Mean Trouillas score at 6 months Show forest plot	1	20	Mean Difference (IV, Fixed, 95% CI)	‐1.5 [‐4.16, 1.16]

7 Mean Trouillas score at 1 year Show forest plot	1	27	Mean Difference (IV, Fixed, 95% CI)	‐2.2 [‐4.25, ‐0.15]

8 Mean Rankin score at 6 months Show forest plot	1	27	Mean Difference (IV, Fixed, 95% CI)	‐0.60 [‐1.38, 0.18]

9 Mean Rankin score at 1 year Show forest plot	1	27	Mean Difference (IV, Fixed, 95% CI)	‐0.60 [‐1.38, 0.18]

10 Mean neurological recovery score at 12 months Show forest plot	1	17	Mean Difference (IV, Fixed, 95% CI)	‐2.2 [‐2.82, ‐1.58]

11 Neurological function deficit score at 3 weeks Show forest plot	1	80	Mean Difference (IV, Fixed, 95% CI)	‐3.0 [‐5.63, ‐0.37]

Comparison 3. Functional scales

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Comparison 4. Deemed to have a good outcome

Outcome or subgroup title	No. of studies	No. of participants	Statistical method	Effect size
1 NIHSS 0 or improved by 4 points at 24 hours Show forest plot	1	33	Risk Ratio (M‐H, Fixed, 95% CI)	0.56 [0.16, 1.99]

2 Modified Rankin score less than 2 at 90 days Show forest plot	2		Risk Ratio (M‐H, Fixed, 95% CI)	Subtotals only

2.1 HBO alone	1	33	Risk Ratio (M‐H, Fixed, 95% CI)	0.52 [0.22, 1.23]
2.2 HBO and edaravone	1	38	Risk Ratio (M‐H, Fixed, 95% CI)	6.0 [0.80, 45.20]
3 Glasgow Outcome Score of 5 Show forest plot	1	33	Risk Ratio (M‐H, Fixed, 95% CI)	0.56 [0.27, 1.19]

4 NIHSS less than 2 Show forest plot	1	33	Risk Ratio (M‐H, Fixed, 95% CI)	0.59 [0.24, 1.42]

5 Deemed cured and self‐caring Show forest plot	1	70	Risk Ratio (M‐H, Fixed, 95% CI)	1.89 [0.64, 5.58]

Comparison 4. Deemed to have a good outcome

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Comparison 5. Activities of daily living

Outcome or subgroup title	No. of studies	No. of participants	Statistical method	Effect size
1 Barthel Index 95 or 100 at 90 days Show forest plot	1	33	Risk Ratio (M‐H, Fixed, 95% CI)	1.20 [0.62, 2.32]

2 Mean Barthel Index at 3 weeks Show forest plot	1	80	Mean Difference (IV, Fixed, 95% CI)	‐20.0 [‐26.30, ‐13.70]

Comparison 5. Activities of daily living

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Comparison 6. Mean volume of infarct on CT

Outcome or subgroup title	No. of studies	No. of participants	Statistical method	Effect size
1 Mean volume of infarct at 4 months Show forest plot	1	27	Mean Difference (IV, Fixed, 95% CI)	20.20 [‐13.37, 53.77]

Comparison 6. Mean volume of infarct on CT

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Comparison 7. Adverse effects of therapy

Outcome or subgroup title	No. of studies	No. of participants	Statistical method	Effect size
1 Ear pain Show forest plot	2	71	Risk Ratio (M‐H, Fixed, 95% CI)	4.89 [0.60, 39.66]

Comparison 7. Adverse effects of therapy

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