Topiramate monotherapy for juvenile myoclonic epilepsy

Jia Liu; Lu‐Ning Wang; Yu‐Ping Wang

doi:10.1002/14651858.CD010008.pub2

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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 Topiramate versus placebo, Outcome 1 Proportion of responders (at least 50% seizure frequency reduction in PGTCS).

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Analysis 1.2

Comparison 1 Topiramate versus placebo, Outcome 2 Nausea.

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Analysis 1.3

Comparison 1 Topiramate versus placebo, Outcome 3 Upper respiratory tract infection.

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Analysis 1.4

Comparison 1 Topiramate versus placebo, Outcome 4 Abnormal vision.

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Analysis 1.5

Comparison 1 Topiramate versus placebo, Outcome 5 Diarrhoea.

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Analysis 2.1

Comparison 2 Topiramate versus valproate, Outcome 1 Proportion of responders (at least 50% seizure frequency reduction in myoclonic seizures).

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Analysis 2.2

Comparison 2 Topiramate versus valproate, Outcome 2 Proportion of responders (at least 50% seizure frequency reduction in PGTCS).

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Analysis 2.3

Comparison 2 Topiramate versus valproate, Outcome 3 Number of participants with seizure‐free.

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Analysis 2.4

Comparison 2 Topiramate versus valproate, Outcome 4 Paraesthesia.

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Analysis 2.5

Comparison 2 Topiramate versus valproate, Outcome 5 Weight gain.

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Analysis 2.6

Comparison 2 Topiramate versus valproate, Outcome 6 Tremor.

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Analysis 2.7

Comparison 2 Topiramate versus valproate, Outcome 7 Headache.

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Analysis 2.8

Comparison 2 Topiramate versus valproate, Outcome 8 Concentration difficulty.

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Analysis 2.9

Comparison 2 Topiramate versus valproate, Outcome 9 Fatigue.

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Analysis 2.10

Comparison 2 Topiramate versus valproate, Outcome 10 Alopecia.

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Analysis 2.11

Comparison 2 Topiramate versus valproate, Outcome 11 Dizziness.

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Analysis 2.12

Comparison 2 Topiramate versus valproate, Outcome 12 Weight loss.

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Analysis 2.13

Comparison 2 Topiramate versus valproate, Outcome 13 Psychomotor slowing.

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Analysis 2.14

Comparison 2 Topiramate versus valproate, Outcome 14 Somnolence.

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Analysis 2.15

Comparison 2 Topiramate versus valproate, Outcome 15 Nausea.

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Analysis 2.16

Comparison 2 Topiramate versus valproate, Outcome 16 Appetite increase.

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Analysis 2.17

Comparison 2 Topiramate versus valproate, Outcome 17 Insomnia.

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Analysis 2.18

Comparison 2 Topiramate versus valproate, Outcome 18 Abnormal vision.

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Analysis 2.19

Comparison 2 Topiramate versus valproate, Outcome 19 Rash.

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Analysis 2.20

Comparison 2 Topiramate versus valproate, Outcome 20 Anorexia.

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Analysis 2.21

Comparison 2 Topiramate versus valproate, Outcome 21 Hallucination.

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Analysis 2.22

Comparison 2 Topiramate versus valproate, Outcome 22 Diarrhoea.

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Topiramate compared with placebo for juvenile myoclonic epilepsy
Patient or population: people with juvenile myoclonic epilepsy Settings: 18 centers in the United States; 10 centers in Europe; 1 center in Costa Rica Intervention: topiramate 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	Topiramate
Proportion of responders (at least 50% seizure frequency reduction in PGTCS)	182 per 1000	727 per 1000 (197 to 1000)	RR 4.00 (1.08 to 14.75)	22 (1 study)	⊕⊝⊝⊝ very low^1,2	More participants taking topiramate responded with a 50% or more reduction in PGTCS compared with placebo (P = 0.03)
Proportion of participants who experienced at least one AE and individual AEs	See comment	See comment	NA	22 (1 study)	⊕⊝⊝⊝ very low^1,2	Number of participants experiencing at least one AE was not reported. Individual AEs: no significant differences were found in nausea, upper respiratory tract infection, abnormal vision, or diarrhoea between topiramate versus placebo
Number of participants who were seizure‐free	Not reported	Not reported	NA
The basis for the assumed risk* was the event rate in the control group. 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). AE: Adverse event;CI: Confidence interval; RR: Risk Ratio; URTI: Upper respiratory tract infection
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.
¹ The included trials were reported as randomized, double‐blind trials with insufficient methodological information ² A relatively small number of patients

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Topiramate compared with valproate for juvenile myoclonic epilepsy
Patient or population: people with juvenile myoclonic epilepsy Settings: Cincinnati Children’s Hospital Medical Center, Cincinnati, USA; Haeundae Paik Hospital, Busan, Republic of Korea Intervention: topiramate Comparison: valproate
Outcomes	*Illustrative comparative risks (95% CI)**		Relative effect (95% CI)	No of Participants (studies)	Quality of the evidence (GRADE)	Comments
	Assumed risk	Corresponding risk
	Valproate	Topiramate
Proportion of responders (at least 50% seizure frequency reduction in myoclonic seizures)	1000 per 1000	857 per 1000 (670 to 1000)	RR 0.88 (0.67 to 1.15)	28 (1 study)	⊕⊝⊝⊝ very low^1,2	No significant difference was found
Proportion of responders (at least 50% seizure frequency reduction in PGTCS)	750 per 1000	917 per 1000 (510 to 1000)	RR 1.22 (0.68 to 2.21)	28 (1 study)	⊕⊝⊝⊝ very low^1,2	No significant difference was found
Proportion of participants who experienced at least one AE and individual AEs	See comment	See comment	NA	61 (2 studies)	⊕⊝⊝⊝ very low^1,2	Number of participants experiencing at least one AE was not reported. In Levisohn 2007 and Park 2013, we found significant differences in the AEs of paraesthesia, weight gain and tremor. Moreover, no significant difference was found in headache, concentration difficulty, fatigue, alopecia, dizziness, weight loss, psychomotor slowing, somnolence, nausea, appetite increase, insomnia, abnormal vision, rash, anorexia, hallucination or diarrhoea.
Number of participants who were seizure‐free	563 per 1000	636 per 1000 (343 to 1188)	RR 1.13 (0.61 to 2.11)	33 (1 study)	⊕⊝⊝⊝ very low^1,2	No significant difference was found (P = 0.08)
The basis for the assumed risk* was the event rate in the control group. 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). AE: Adverse event; 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.
¹ The included trials were reported as randomized, double‐blind trials with insufficient methodological information ² A relatively small number of patients

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Comparison 1. Topiramate versus placebo

Outcome or subgroup title	No. of studies	No. of participants	Statistical method	Effect size
1 Proportion of responders (at least 50% seizure frequency reduction in PGTCS) Show forest plot	1	22	Risk Ratio (M‐H, Fixed, 95% CI)	4.0 [1.08, 14.75]

2 Nausea Show forest plot	1	22	Risk Ratio (M‐H, Fixed, 95% CI)	1.67 [0.52, 5.33]

3 Upper respiratory tract infection Show forest plot	1	22	Risk Ratio (M‐H, Fixed, 95% CI)	1.5 [0.31, 7.30]

4 Abnormal vision Show forest plot	1	22	Risk Ratio (M‐H, Fixed, 95% CI)	2.0 [0.21, 18.98]

5 Diarrhoea Show forest plot	1	22	Risk Ratio (M‐H, Fixed, 95% CI)	2.0 [0.21, 18.98]

Comparison 1. Topiramate versus placebo

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Comparison 2. Topiramate versus valproate

Outcome or subgroup title	No. of studies	No. of participants	Statistical method	Effect size
1 Proportion of responders (at least 50% seizure frequency reduction in myoclonic seizures) Show forest plot	1	23	Risk Ratio (M‐H, Fixed, 95% CI)	0.88 [0.67, 1.15]

2 Proportion of responders (at least 50% seizure frequency reduction in PGTCS) Show forest plot	1	16	Risk Ratio (M‐H, Fixed, 95% CI)	1.22 [0.68, 2.21]

3 Number of participants with seizure‐free Show forest plot	1	27	Risk Ratio (M‐H, Fixed, 95% CI)	1.13 [0.61, 2.11]

4 Paraesthesia Show forest plot	2	61	Risk Difference (M‐H, Fixed, 95% CI)	0.19 [0.02, 0.35]

5 Weight gain Show forest plot	2	61	Risk Difference (M‐H, Fixed, 95% CI)	‐0.30 [‐0.49, ‐0.10]

6 Tremor Show forest plot	1	33	Risk Difference (M‐H, Fixed, 95% CI)	‐0.24 [‐0.45, ‐0.02]

7 Headache Show forest plot	1	28	Risk Ratio (M‐H, Fixed, 95% CI)	2.37 [0.32, 17.42]

8 Concentration difficulty Show forest plot	1	28	Risk Ratio (M‐H, Fixed, 95% CI)	1.42 [0.17, 11.83]

9 Fatigue Show forest plot	2	61	Risk Ratio (M‐H, Fixed, 95% CI)	0.62 [0.17, 2.21]

10 Alopecia Show forest plot	2	61	Risk Ratio (M‐H, Fixed, 95% CI)	0.24 [0.06, 1.02]

11 Dizziness Show forest plot	1	28	Risk Ratio (M‐H, Fixed, 95% CI)	0.95 [0.10, 9.13]

12 Weight loss Show forest plot	1	28	Risk Difference (M‐H, Fixed, 95% CI)	0.11 [‐0.09, 0.30]

13 Psychomotor slowing Show forest plot	1	28	Risk Difference (M‐H, Fixed, 95% CI)	0.11 [‐0.09, 0.30]

14 Somnolence Show forest plot	2	61	Risk Difference (M‐H, Fixed, 95% CI)	0.08 [‐0.05, 0.21]

15 Nausea Show forest plot	2	61	Risk Ratio (M‐H, Fixed, 95% CI)	0.21 [0.04, 1.18]

16 Appetite increase Show forest plot	1	28	Risk Difference (M‐H, Fixed, 95% CI)	‐0.22 [‐0.50, 0.05]

17 Insomnia Show forest plot	1	28	Risk Difference (M‐H, Fixed, 95% CI)	‐0.22 [‐0.50, 0.05]

18 Abnormal vision Show forest plot	1	28	Risk Difference (M‐H, Fixed, 95% CI)	‐0.22 [‐0.50, 0.05]

19 Rash Show forest plot	1	28	Risk Difference (M‐H, Fixed, 95% CI)	‐0.22 [‐0.50, 0.05]

20 Anorexia Show forest plot	1	33	Risk Ratio (M‐H, Fixed, 95% CI)	3.19 [0.37, 27.58]

21 Hallucination Show forest plot	1	33	Risk Difference (M‐H, Fixed, 95% CI)	0.06 [‐0.09, 0.22]

22 Diarrhoea Show forest plot	1	33	Risk Difference (M‐H, Fixed, 95% CI)	‐0.12 [‐0.30, 0.06]

Comparison 2. Topiramate versus valproate

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