Clobazam monotherapy for focal or generalized seizures

Ravindra Arya; Nisha Giridharan; Vidhu Anand; Sushil K Garg

doi:10.1002/14651858.CD009258.pub3

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Figure 1

Study flow diagram (results from updated searches)

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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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Figure 4

Forest plot of comparison: 2 clobazam vs carbamazepine, outcome: 2.1 retention at 12 months

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Figure 5

Forest plot of comparison: 1 clobazam versus phenytoin, outcome: 1.1 retention at 6 months

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Figure 6

Forest plot of comparison: 1 clobazam versus carbamazepine, outcome: 1.4 terminal remission at 9 months (seizure free for last 9 months)

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Analysis 1.1

Comparison 1 Clobazam versus carbamazepine, Outcome 1 Retention at 12 months.

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Analysis 1.2

Comparison 1 Clobazam versus carbamazepine, Outcome 2 Seizure freedom at 4 weeks.

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Analysis 1.3

Comparison 1 Clobazam versus carbamazepine, Outcome 3 Seizure freedom between weeks 4 and 40.

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Analysis 1.4

Comparison 1 Clobazam versus carbamazepine, Outcome 4 Terminal remission at 9 months (seizure free for last 9 months).

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Analysis 1.5

Comparison 1 Clobazam versus carbamazepine, Outcome 5 50% responder rate at 4 weeks.

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Analysis 1.6

Comparison 1 Clobazam versus carbamazepine, Outcome 6 Reported adverse effects (number of participants).

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Analysis 1.7

Comparison 1 Clobazam versus carbamazepine, Outcome 7 Discontinued study medication due to adverse effects (number of participants).

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Analysis 2.1

Comparison 2 Clobazam versus phenytoin, Outcome 1 Retention at 6 months.

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Analysis 2.2

Comparison 2 Clobazam versus phenytoin, Outcome 2 Breakthrough seizure(s) during study period.

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Analysis 2.3

Comparison 2 Clobazam versus phenytoin, Outcome 3 Discontinued study medication due to adverse effects.

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Analysis 2.4

Comparison 2 Clobazam versus phenytoin, Outcome 4 Reported adverse effects.

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Summary of findings for the main comparison. Clobazam versus carbamazepine for focal or generalized seizures

Clobazam versus carbamazepine for focal or generalized seizures
Patient or population: people with focal or generalized seizures Settings: 15 Canadian pediatric epilepsy centers (Canadian Study Group 1998); single center, outpatient clinic from Cuba (Andrade 2009) Intervention: clobazam versus carbamazepine
Outcomes	*Illustrative comparative risks (95% CI)**		Relative effect (95% CI)	No of participants (studies)	Quality of the evidence (GRADE)	Comments
	Assumed risk	Corresponding risk
	Carbamazepine	Clobazam
Time on allocated treatment (retention time)	Outcome not reported	Outcome not reported	Outcome not reported	Outcome not reported	Outcome not reported
Retention at 12 months Follow‐up: mean 12 months	Study population		RR 0.83 (0.61 to 1.12)	115 (1 study)	⊕⊕⊝⊝ low^1,2,3
	654 per 1000	543 per 1000 (399 to 732)


Seizure freedom at 4 weeks	720 per 1000	611 per 1000 (396 to 950)	RR 0.85 (0.55 to 1.32)	43 (1 study)	low^2,3,4
Seizure freedom 4‐40 weeks	760 per 1000	722 per 1000 (502 to 1034)	RR 0.95 (0.66 to 1.36)	43 (1 study)	low^2,3,4
50% responder rate	800 per 1000	944 per 1000 (752 to 1184)	RR 1.18 (0.94 to 1.48)	43 (1 study)	low^2,3,4
Adverse effects requiring withdrawal/discontinuation of study medication	Outcome not reported	Outcome not reported	Outcome not reported	Outcome not reported	Outcome 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: we are very confident that the true effect lies close to that of the estimate of the effect Moderate quality: we are moderately confident in the effect estimate; the true effect is likely to be close to the estimate of effect, but there is a possibility that it is substantially different Low quality: our confidence in the effect estimate is limited; the true effect may be substantially different from the estimate of the effect Very low quality: we have very little confidence in the effect estimate; the true effect is likely to be substantially different from the estimate of effect
¹Blinding of participants and personnel was not done in this open‐label study. This can potentially affect assessment of this outcome. Downgraded by 1. ²Only 1 study, hence no 'inconsistency' and no 'publication bias'. ³Wide CI, downgraded by 1. ⁴Allocation concealment not stated, which could potentially introduce selection bias. Blinding of participants and personnel was not done in this open‐label study.

Summary of findings for the main comparison. Clobazam versus carbamazepine for focal or generalized seizures

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Summary of findings 2. Clobazam versus phenytoin for focal or generalized seizures

Clobazam versus phenytoin for focal or generalized seizures
Patient or population: drug‐naïve people with focal or generalized seizures with solitary cysticercus granuloma Settings: single Indian teaching hospital Intervention: clobazam Comparison: phenytoin
Outcomes	*Illustrative comparative risks (95% CI)**		Relative effect (95% CI)	No of Participants (studies)	Quality of the evidence (GRADE)	Comments
	Assumed risk	Corresponding risk
	Control	Clobazam versus phenytoin
Time on allocated treatment (retention time)	Outcome not reported	Outcome not reported	Outcome not reported	Outcome not reported	Outcome not reported
Retention at 6 months (measured by the number of treatment failures in each group, which was defined as either breakthrough seizure or adverse effects requiring discontinuation or dose modification of study medication) Follow‐up: mean 6 months	Study population		RR 1.43 (1.08 to 1.9)	48 (1 study)	⊕⊕⊝⊝ low^1,2,3

	667 per 1000	953 per 1000 (720 to 1267)


Seizure freedom at 4 weeks	Outcome not reported	Outcome not reported	Outcome not reported	Outcome not reported	Outcome not reported
Seizure freedom 4‐40 weeks	Outcome not reported	Outcome not reported	Outcome not reported	Outcome not reported	Outcome not reported
50% responder rate	Outcome not reported	Outcome not reported	Outcome not reported	Outcome not reported	Outcome not reported
Adverse effects requiring withdrawal/discontinuation of study medication	Study population		RR 0.10 (0.01 to 1.65)	48 (1 study)	⊕⊕⊝⊝ low^1,2,3
	222 per 1000	22 per 1000 (2 to 367)


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: we are very confident that the true effect lies close to that of the estimate of the effect Moderate quality: we are moderately confident in the effect estimate; the true effect is likely to be close to the estimate of effect, but there is a possibility that it is substantially different Low quality: our confidence in the effect estimate is limited; the true effect may be substantially different from the estimate of the effect Very low quality: we have very little confidence in the effect estimate; the true effect is likely to be substantially different from the estimate of effect
¹Allocation concealment not stated, which could potentially introduce selection bias. Blinding of participants and personnel was not done in this open‐label study. This can potentially affect assessment of 'adverse effects requiring withdrawal' and hence 'retention time'. Downgraded by 1. ²Only 1 study, thus no 'inconsistency' and no 'publication bias'. ³Wide confidence interval and small sample size. Downgraded by 1.

Summary of findings 2. Clobazam versus phenytoin for focal or generalized seizures

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Comparison 1. Clobazam versus carbamazepine

Outcome or subgroup title	No. of studies	No. of participants	Statistical method	Effect size
1 Retention at 12 months Show forest plot	1	115	Risk Ratio (M‐H, Random, 95% CI)	0.83 [0.61, 1.12]

2 Seizure freedom at 4 weeks Show forest plot	1	43	Risk Ratio (M‐H, Random, 95% CI)	0.85 [0.55, 1.32]

3 Seizure freedom between weeks 4 and 40 Show forest plot	1	43	Risk Ratio (M‐H, Random, 95% CI)	0.95 [0.66, 1.36]

4 Terminal remission at 9 months (seizure free for last 9 months) Show forest plot	1	43	Risk Ratio (M‐H, Random, 95% CI)	1.23 [0.87, 1.72]

5 50% responder rate at 4 weeks Show forest plot	1	43	Risk Ratio (M‐H, Random, 95% CI)	1.18 [0.94, 1.48]

6 Reported adverse effects (number of participants) Show forest plot	1	43	Risk Ratio (M‐H, Random, 95% CI)	0.52 [0.16, 1.70]

7 Discontinued study medication due to adverse effects (number of participants) Show forest plot	1	43	Risk Ratio (M‐H, Random, 95% CI)	0.46 [0.02, 10.60]

Comparison 1. Clobazam versus carbamazepine

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Comparison 2. Clobazam versus phenytoin

Outcome or subgroup title	No. of studies	No. of participants	Statistical method	Effect size
1 Retention at 6 months Show forest plot	1	48	Risk Ratio (M‐H, Random, 95% CI)	1.43 [1.08, 1.90]

2 Breakthrough seizure(s) during study period Show forest plot	1	48	Risk Ratio (M‐H, Random, 95% CI)	0.43 [0.05, 3.83]

3 Discontinued study medication due to adverse effects Show forest plot	1	48	Risk Ratio (M‐H, Random, 95% CI)	0.10 [0.01, 1.65]

4 Reported adverse effects Show forest plot	1	288	Risk Ratio (M‐H, Random, 95% CI)	0.82 [0.32, 2.14]

4.1 Sedation	1	48	Risk Ratio (M‐H, Random, 95% CI)	0.96 [0.40, 2.35]
4.2 Skin problems including allergic rash	1	48	Risk Ratio (M‐H, Random, 95% CI)	0.18 [0.02, 1.38]
4.3 Tiredness	1	48	Risk Ratio (M‐H, Random, 95% CI)	0.43 [0.10, 1.91]
4.4 Oral or gingival problems	1	48	Risk Ratio (M‐H, Random, 95% CI)	0.21 [0.03, 1.65]
4.5 Headache	1	48	Risk Ratio (M‐H, Random, 95% CI)	2.57 [0.73, 9.09]
4.6 Weight gain	1	48	Risk Ratio (M‐H, Random, 95% CI)	11.45 [0.65, 201.60]

Comparison 2. Clobazam versus phenytoin

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