Gamma aminobutyric acid (GABA) receptor agonists for acute stroke

Jia Liu; Lu‐Ning Wang; Xin Ma; Xunming Ji

doi:10.1002/14651858.CD009622.pub4

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Figure 1

Study flow diagram.

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Figure 2

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

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Figure 3

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

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Analysis 1.1

Comparison 1 Efficacy and safety for acute stroke, Outcome 1 Death or dependency.

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Analysis 1.2

Comparison 1 Efficacy and safety for acute stroke, Outcome 2 Somnolence.

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Analysis 1.3

Comparison 1 Efficacy and safety for acute stroke, Outcome 3 Rhinitis.

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Analysis 1.4

Comparison 1 Efficacy and safety for acute stroke, Outcome 4 Functional independence.

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Analysis 2.1

Comparison 2 Efficacy for acute ischemic stroke, Outcome 1 Death or dependency.

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Analysis 2.2

Comparison 2 Efficacy for acute ischemic stroke, Outcome 2 Functional independence.

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Analysis 3.1

Comparison 3 Efficacy for acute hemorrhagic stroke, Outcome 1 Death or dependency.

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Analysis 3.2

Comparison 3 Efficacy for acute hemorrhagic stroke, Outcome 2 Functional independence.

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Analysis 4.1

Comparison 4 Efficacy for TACS, Outcome 1 Functional independence.

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Analysis 5.1

Comparison 5 Efficacy for early‐treated acute stroke, Outcome 1 Functional independence.

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Summary of findings for the main comparison. Chlormethiazole compared with placebo for acute stroke

Chlormethiazole compared with placebo for acute stroke
Patient or population: people with acute stroke Settings: inpatients Intervention: chlormethiazole Comparison: placebo
Outcomes	*Illustrative comparative risks (95% CI)**		Relative effect (95% CI)	No of participants (studies)	Quality of the evidence (GRADE)	Comments
	Assumed risk	Corresponding risk
	Placebo	Chlormethiazole
Death or dependency	475 per 1000	487 per 1000	RR 1.03 (0.96 to 1.11)	2909 (4)	⊕⊕⊕⊝ Moderate¹	—
Adverse events	Somnolence 113 per 1000 Rhinitis 25 per 1000	Somnolence 517 per 1000 Rhinitis 130 per 1000	RR 4.56 (3.50 to 5.95) RR 4.75 (2.67 to 8.46)	2527 (2)	⊕⊕⊕⊝ Moderate¹	—
Functional independence	525 per 1000	513 per 1000	RR 0.98 (0.92 to 1.05)	2909 (4)	⊕⊕⊕⊝ Moderate¹	—
Other stroke scales	—	—	—	NIHSS 1367 (2) SSS 2727 (3)	⊕⊕⊕⊝ Moderate¹	In Lyden 2000, the mean change of the NIHSS score was ‐4.5 in the chlormethiazole group (N = 96) and ‐4.0 in the placebo group (N = 102; P = 0.36). In Lyden 2002, the change of NIHSS score (median (quartiles)) was ‐5.5 (‐11, 17) in the chlormethiazole group (N = 586) and ‐6.0 (‐10, 16) in the placebo group (N = 583; P = 0.68). In Wahlgren 1999, no significant difference was found between the placebo and chlormethiazole groups for the change in score in the SSS 48‐point (P = 0.56) and SSS motor power score (P = 0.96). In Lyden 2000 and Lyden 2002, the change in score in the SSS was not significant in the two groups (P = 0.06 and P = 0.23, respectively).
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; NIHSS: National Institutes of Health Stroke Scale; RR: Risk Ratio; SSS: Scandinavian Stroke Scale
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.
¹Downgraded one level due to unclear risk of selection bias Functional independence, defined as a BI score higher than 60 or a mRS score less than 3

Summary of findings for the main comparison. Chlormethiazole compared with placebo for acute stroke

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Summary of findings 2. Diazepam compared with placebo for acute stroke

Diazepam compared with placebo for acute stroke
Patient or population: people with acute stroke Settings: inpatients Intervention: diazepam Comparison: placebo
Outcomes	*Illustrative comparative risks (95% CI)**		Relative effect (95% CI)	No of participants (studies)	Quality of the evidence (GRADE)	Comments
	Assumed risk	Corresponding risk
	Placebo	Diazepam
Death or dependency	513 per 1000	481 per 1000	RR 0.94 (0.82 to 1.07)	849 (1)	⊕⊕⊕⊝ Moderate¹	—
Adverse events	357 per 1000	355 per 1000	RR 0.99 (0.75 to 1.31)	865 (1)	⊕⊕⊕⊝ Moderate¹	—
Functional independence	487 per 1000	519 per 1000	RR 1.07 (0.93 to 1.22)	849 (1)	⊕⊕⊕⊝ Moderate¹	—
Other stroke scales	Not reported	Not reported	—	—	—	—
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
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.
¹Downgraded one level: one study with small sample size Functional independence, defined as a BI score higher than 60 or a mRS score less than 3

Summary of findings 2. Diazepam compared with placebo for acute stroke

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Comparison 1. Efficacy and safety for acute stroke

Outcome or subgroup title	No. of studies	No. of participants	Statistical method	Effect size
1 Death or dependency Show forest plot	5	3758	Risk Ratio (M‐H, Random, 95% CI)	1.01 [0.95, 1.08]

1.1 Chlormethiazole versus placebo	4	2909	Risk Ratio (M‐H, Random, 95% CI)	1.03 [0.96, 1.11]
1.2 Diazepam versus placebo	1	849	Risk Ratio (M‐H, Random, 95% CI)	0.94 [0.82, 1.07]
2 Somnolence Show forest plot	2	2527	Risk Ratio (M‐H, Random, 95% CI)	4.56 [3.50, 5.95]

2.1 Chlormethiazole versus placebo	2	2527	Risk Ratio (M‐H, Random, 95% CI)	4.56 [3.50, 5.95]
3 Rhinitis Show forest plot	2	2527	Risk Ratio (M‐H, Random, 95% CI)	4.75 [2.67, 8.46]

3.1 Chlormethiazole versus placebo	2	2527	Risk Ratio (M‐H, Random, 95% CI)	4.75 [2.67, 8.46]
4 Functional independence Show forest plot	5	3758	Risk Ratio (M‐H, Random, 95% CI)	1.00 [0.94, 1.06]

4.1 Chlormethiazole versus placebo	4	2909	Risk Ratio (M‐H, Random, 95% CI)	0.98 [0.92, 1.05]
4.2 Diazepam versus placebo	1	849	Risk Ratio (M‐H, Random, 95% CI)	1.07 [0.93, 1.22]

Comparison 1. Efficacy and safety for acute stroke

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Comparison 2. Efficacy for acute ischemic stroke

Outcome or subgroup title	No. of studies	No. of participants	Statistical method	Effect size
1 Death or dependency Show forest plot	3	2646	Risk Ratio (M‐H, Random, 95% CI)	1.04 [0.96, 1.12]

1.1 Chlormethiazole versus placebo	3	2646	Risk Ratio (M‐H, Random, 95% CI)	1.04 [0.96, 1.12]
2 Functional independence Show forest plot	4	3394	Risk Ratio (M‐H, Random, 95% CI)	1.00 [0.93, 1.08]

2.1 Chlormethiazole versus placebo	3	2646	Risk Ratio (M‐H, Random, 95% CI)	0.98 [0.91, 1.05]
2.2 Diazepam versus placebo	1	748	Risk Ratio (M‐H, Random, 95% CI)	1.10 [0.96, 1.27]

Comparison 2. Efficacy for acute ischemic stroke

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Comparison 3. Efficacy for acute hemorrhagic stroke

Outcome or subgroup title	No. of studies	No. of participants	Statistical method	Effect size
1 Death or dependency Show forest plot	2	292	Risk Ratio (M‐H, Random, 95% CI)	0.99 [0.75, 1.30]

1.1 Chlormethiazole versus placebo	2	292	Risk Ratio (M‐H, Random, 95% CI)	0.99 [0.75, 1.30]
2 Functional independence Show forest plot	3	387	Risk Ratio (M‐H, Random, 95% CI)	0.97 [0.81, 1.16]

2.1 Chlormethiazole versus placebo	2	292	Risk Ratio (M‐H, Random, 95% CI)	1.00 [0.83, 1.21]
2.2 Diazepam versus placebo	1	95	Risk Ratio (M‐H, Random, 95% CI)	0.80 [0.50, 1.27]

Comparison 3. Efficacy for acute hemorrhagic stroke

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Comparison 4. Efficacy for TACS

Outcome or subgroup title	No. of studies	No. of participants	Statistical method	Effect size
1 Functional independence Show forest plot	2	635	Risk Ratio (M‐H, Random, 95% CI)	1.33 [1.08, 1.63]

1.1 Chlormethiazole versus placebo	2	635	Risk Ratio (M‐H, Random, 95% CI)	1.33 [1.08, 1.63]

Comparison 4. Efficacy for TACS

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Comparison 5. Efficacy for early‐treated acute stroke

Outcome or subgroup title	No. of studies	No. of participants	Statistical method	Effect size
1 Functional independence Show forest plot	3	1314	Risk Ratio (M‐H, Random, 95% CI)	0.99 [0.80, 1.21]

1.1 Chlormethiazole versus placebo (< 6 hours)	2	1182	Risk Ratio (M‐H, Random, 95% CI)	0.93 [0.73, 1.19]
1.2 Diazepam versus placebo (< 3 hours)	1	132	Risk Ratio (M‐H, Random, 95% CI)	1.21 [0.85, 1.74]

Comparison 5. Efficacy for early‐treated acute stroke

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