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Figure 1

This diagram refers only to results of the updated searches for the current version of the review

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

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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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Comparison 1: Zonisamide versus placebo, Outcome 1: 50% responder rate ‐ whole treatment period

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Analysis 1.1

Comparison 1: Zonisamide versus placebo, Outcome 1: 50% responder rate ‐ whole treatment period

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Comparison 1: Zonisamide versus placebo, Outcome 2: 50% responder rate ‐ best‐case scenario

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Analysis 1.2

Comparison 1: Zonisamide versus placebo, Outcome 2: 50% responder rate ‐ best‐case scenario

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Comparison 1: Zonisamide versus placebo, Outcome 3: 50% responder rate ‐ worst‐case scenario

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Analysis 1.3

Comparison 1: Zonisamide versus placebo, Outcome 3: 50% responder rate ‐ worst‐case scenario

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Comparison 1: Zonisamide versus placebo, Outcome 4: 50% responder rate ‐ dose‐effect for Brodie 2005

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Analysis 1.4

Comparison 1: Zonisamide versus placebo, Outcome 4: 50% responder rate ‐ dose‐effect for Brodie 2005

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Comparison 1: Zonisamide versus placebo, Outcome 5: 50% responder rate ‐ dose effect for Faught 2001

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Analysis 1.5

Comparison 1: Zonisamide versus placebo, Outcome 5: 50% responder rate ‐ dose effect for Faught 2001

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Comparison 1: Zonisamide versus placebo, Outcome 6: Withdrawal rates

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Analysis 1.6

Comparison 1: Zonisamide versus placebo, Outcome 6: Withdrawal rates

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Comparison 1: Zonisamide versus placebo, Outcome 7: Adverse effects

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Analysis 1.7

Comparison 1: Zonisamide versus placebo, Outcome 7: Adverse effects

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Summary of findings 1. Zonisamide compared to placebo for focal epilepsy

Zonisamide compared to placebo for focal epilepsy

Patient or population: patients with focal epilepsy
Setting: hospital outpatients
Intervention: add‐on zonisamide
Comparison: placebo

Outcomes

Anticipated absolute effects* (95% CI)

Relative effect
(CI)

№ of participants
(studies)

Certainty of the evidence
(GRADE)

Comments

Risk with placebo

Risk with zonisamide

50% responder rate

(whole treatment period; any dose)

Study population

RR 1.86
(95% CI 1.60 to 2.17)

1429
(7 RCTs)

⊕⊕⊕⊝
Moderatea 

Zonisamide 300 mg to 500 mg/day (RR 1.90, 95% CI 1.63 to 2.22; moderate‐certainty evidence)

248 per 1000

461 per 1000
(396 to 537)

Withdrawal rates

(whole treatment period; any dose)

Study population

RR 1.44
(95% CI 1.08 to 1.93)

1156
(6 RCTs)

⊕⊕⊕⊝

Moderatea 

Zonisamide 300 mg to 500 mg/day (RR 1.59, 95% CI 1.18 to 2.13; moderate‐certainty evidence)

110 per 1000

159 per 1000
(119 to 213)

Adverse effects: ataxia

(whole treatment period; any dose)

Study population

RR 3.85
(99% CI 1.36 to 10.93)

734
(4 RCTs)

⊕⊕⊝⊝
Lowa,b

Note that for adverse events, we used a 99% CI.

17 per 1000

67 per 1000
(24 to 189)

Adverse effects: dizziness

(whole treatment period; any dose)

Study population

RR 1.40
(99% CI 0.90 to 2.18)

1429
(7 RCTs)

⊕⊕⊕⊝

Moderatea

75 per 1000

105 per 1000
(68 to 164)

Adverse effects: fatigue

(whole treatment period; any dose)

Study population

RR 1.41
(99% CI 0.79 to 2.53)

1045
(6 RCTs)

⊕⊕⊕⊝

Moderatea

54 per 1000

76 per 1000
(43 to 137)

Adverse effects: nausea

(whole treatment period; any dose)

Study population

RR 1.10
(99% CI 0.58 to 2.10)

805
(5 RCTs)

⊕⊕⊕⊝

Moderatea

66 per 1000

73 per 1000
(38 to 139)

Adverse effects: somnolence

(whole treatment period; any dose)

Study population

RR 1.52
(99% CI 1.00 to 2.31)

1636
(8 RCTs)

⊕⊕⊕⊝

Moderatea

72 per 1000

109 per 1000
(72 to 166)

*The assumed control risk (ACR) was calculated using median control group risk across the studies that provided data for that outcome.. The corresponding intervention risk in the zonisamide group (and its 95% CI) was based on the assumed risk in the comparison group (ACR) and the relative effect of the intervention (and its 95% CI) and is calculated according to following formula: corresponding intervention risk, per 100 = 100 * ACR * RR.

CI: confidence interval; RR: risk ratio

GRADE Working Group grades of evidence
High certainty. We are very confident that the true effect lies close to that of the estimate of the effect
Moderate certainty. We are moderately confident in the effect estimate; the true effect is likely to be close to the estimate of the effect, but there is a possibility that it is substantially different
Low certainty. Our confidence in the effect estimate is limited; the true effect may be substantially different from the estimate of the effect
Very low certainty. We have very little confidence in the effect estimate; the true effect is likely to be substantially different from the estimate of effect

aDowngraded once for methodological uncertainties in included studies (unclear risk of bias). Some studies were at high risk of attrition bias; they did not provide reasons for differences between the number of patients in ITT and in per protocol set (PPS). However, the conclusions were unchanged following best‐case (RR 2.22, 95% CI 1.92 to 2.57) and worst‐case (RR 1.44, 95% CI 1.26 to 1.64) scenario analysis. 
bDowngraded once for imprecision

Figuras y tablas -
Summary of findings 1. Zonisamide compared to placebo for focal epilepsy
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Comparison 1. Zonisamide versus placebo

Outcome or subgroup title

No. of studies

No. of participants

Statistical method

Effect size

1.1 50% responder rate ‐ whole treatment period Show forest plot

7

Risk Ratio (M‐H, Fixed, 95% CI)

Subtotals only

1.1.1 Any dose

7

1429

Risk Ratio (M‐H, Fixed, 95% CI)

1.86 [1.60, 2.17]

1.1.2 300 mg to 500 mg/day

7

1371

Risk Ratio (M‐H, Fixed, 95% CI)

1.90 [1.63, 2.22]

1.2 50% responder rate ‐ best‐case scenario Show forest plot

7

1429

Risk Ratio (M‐H, Fixed, 95% CI)

2.22 [1.92, 2.57]

1.3 50% responder rate ‐ worst‐case scenario Show forest plot

7

1429

Risk Ratio (M‐H, Fixed, 95% CI)

1.44 [1.26, 1.64]

1.4 50% responder rate ‐ dose‐effect for Brodie 2005 Show forest plot

1

Risk Ratio (M‐H, Fixed, 95% CI)

Totals not selected

1.4.1 100 mg/day

1

Risk Ratio (M‐H, Fixed, 95% CI)

Totals not selected

1.4.2 300 mg/day

1

Risk Ratio (M‐H, Fixed, 95% CI)

Totals not selected

1.4.3 500 mg/day

1

Risk Ratio (M‐H, Fixed, 95% CI)

Totals not selected

1.5 50% responder rate ‐ dose effect for Faught 2001 Show forest plot

1

Risk Ratio (M‐H, Fixed, 95% CI)

Totals not selected

1.5.1 100 mg/day

1

Risk Ratio (M‐H, Fixed, 95% CI)

Totals not selected

1.5.2 200 mg/day

1

Risk Ratio (M‐H, Fixed, 95% CI)

Totals not selected

1.5.3 400 mg/day

1

Risk Ratio (M‐H, Fixed, 95% CI)

Totals not selected

1.6 Withdrawal rates Show forest plot

6

Risk Ratio (M‐H, Fixed, 95% CI)

Subtotals only

1.6.1 Any dose

6

1156

Risk Ratio (M‐H, Fixed, 95% CI)

1.44 [1.08, 1.93]

1.6.2 300 mg to 500 mg/day

6

1099

Risk Ratio (M‐H, Fixed, 95% CI)

1.59 [1.18, 2.13]

1.7 Adverse effects Show forest plot

8

Risk Ratio (M‐H, Fixed, 99% CI)

Subtotals only

1.7.1 Ataxia

4

734

Risk Ratio (M‐H, Fixed, 99% CI)

3.85 [1.36, 10.93]

1.7.2 Dizziness

7

1429

Risk Ratio (M‐H, Fixed, 99% CI)

1.40 [0.90, 2.18]

1.7.3 Fatigue

6

1045

Risk Ratio (M‐H, Fixed, 99% CI)

1.41 [0.79, 2.53]

1.7.4 Nausea

5

805

Risk Ratio (M‐H, Fixed, 99% CI)

1.10 [0.58, 2.10]

1.7.5 Somnolence

8

1636

Risk Ratio (M‐H, Fixed, 99% CI)

1.52 [1.00, 2.31]

1.7.6 Agitation or irritability

4

598

Risk Ratio (M‐H, Fixed, 99% CI)

2.35 [1.05, 5.27]

1.7.7 Anorexia

6

1181

Risk Ratio (M‐H, Fixed, 99% CI)

2.74 [1.64, 4.60]
Figuras y tablas -
Comparison 1. Zonisamide versus placebo
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