Scolaris Content Display Scolaris Content Display

Study flow diagram. The results shown in this figure refer both to the searches conducted in the present version of the review and in its previous versions (Brigo 2014; Brigo 2015).
Figures and Tables -
Figure 1

Study flow diagram. The results shown in this figure refer both to the searches conducted in the present version of the review and in its previous versions (Brigo 2014; Brigo 2015).

Comparison 1 Add‐on stiripentol versus placebo, Outcome 1 ≥ 50% seizure reduction.
Figures and Tables -
Analysis 1.1

Comparison 1 Add‐on stiripentol versus placebo, Outcome 1 ≥ 50% seizure reduction.

Comparison 1 Add‐on stiripentol versus placebo, Outcome 2 Seizure freedom.
Figures and Tables -
Analysis 1.2

Comparison 1 Add‐on stiripentol versus placebo, Outcome 2 Seizure freedom.

Comparison 1 Add‐on stiripentol versus placebo, Outcome 3 ≥ 1 adverse effect.
Figures and Tables -
Analysis 1.3

Comparison 1 Add‐on stiripentol versus placebo, Outcome 3 ≥ 1 adverse effect.

Comparison 1 Add‐on stiripentol versus placebo, Outcome 4 Neurological adverse effects.
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Analysis 1.4

Comparison 1 Add‐on stiripentol versus placebo, Outcome 4 Neurological adverse effects.

Comparison 1 Add‐on stiripentol versus placebo, Outcome 5 Gastrointestinal adverse effects.
Figures and Tables -
Analysis 1.5

Comparison 1 Add‐on stiripentol versus placebo, Outcome 5 Gastrointestinal adverse effects.

Comparison 1 Add‐on stiripentol versus placebo, Outcome 6 Dropouts.
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Analysis 1.6

Comparison 1 Add‐on stiripentol versus placebo, Outcome 6 Dropouts.

Summary of findings for the main comparison. Stiripentol compared with placebo for focal refractory epilepsy

Stiripentol compared with placebo for focal refractory epilepsy

Patient or population: people with focal refractory epilepsy

Settings: community

Intervention: stiripentol

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

Stiripentol

≥ 50% seizure reduction

467 per 1000

705 per 1000
(378 to 1000)

RR 1.51 (0.81 to 2.82)

32
(1)

⊕⊕⊖⊖

lowa,b

Seizure freedom

200 per 1000

236 per 1000
(62 to 886)

RR 1.18 (0.31 to 4.43)

32
(1)

⊕⊕⊖⊖

lowa,b

≥ 1 adverse effect

267 per 1000

707 per 1000
(288 to 1000)

RR 2.65 (1.08 to 6.47)

32
(1)

⊕⊕⊖⊖
lowa,b

Neurological adverse effects

200 per 1000

530 per 1000
(176 to 1000)

RR 2.65 (0.88 to 8.01)

32
(1)

⊕⊕⊖⊖
lowa,b

Gastrointestinal adverse effects

0 events occurred in the placebo group

0 events occurred in the stiripentol group
(0 to 0)

RR 11.56 (0.71 to 189.36)

32
(1)

⊕⊕⊖⊖
lowa,b

Dropouts

533 per 1000

352 per 1000
(160 to 784)

RR 0.66 (0.30 to 1.47)

32
(1)

⊕⊕⊖⊖
lowa,b

* Quality of life was not assessed in this study.

**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% CI) is based on the assumed risk in the comparison group and the relative effect of the intervention (and its 95% CI) and is calculated according to the following formula: corresponding intervention risk, per 1000 = 1000 X ACR X RR.
ACR: assumed control risk; 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: 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 .
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.

aDowngraded once for risk of bias and once for imprecision (small sample size which is made even smaller with dropouts).
bInformation is from only one small paediatric study. The main issues with this study are imprecision (small sample size which is made even smaller with dropouts) and applicability (due to the high risk of carry‐over effect).

Figures and Tables -
Summary of findings for the main comparison. Stiripentol compared with placebo for focal refractory epilepsy
Comparison 1. Add‐on stiripentol versus placebo

Outcome or subgroup title

No. of studies

No. of participants

Statistical method

Effect size

1 ≥ 50% seizure reduction Show forest plot

1

32

Risk Ratio (M‐H, Fixed, 95% CI)

1.51 [0.81, 2.82]

2 Seizure freedom Show forest plot

1

32

Risk Ratio (M‐H, Fixed, 95% CI)

1.18 [0.31, 4.43]

3 ≥ 1 adverse effect Show forest plot

1

32

Risk Ratio (M‐H, Fixed, 95% CI)

2.65 [1.08, 6.47]

4 Neurological adverse effects Show forest plot

1

32

Risk Ratio (M‐H, Fixed, 95% CI)

2.65 [0.88, 8.01]

5 Gastrointestinal adverse effects Show forest plot

1

32

Risk Ratio (M‐H, Fixed, 95% CI)

11.56 [0.71, 189.36]

6 Dropouts Show forest plot

1

32

Risk Ratio (M‐H, Fixed, 95% CI)

0.66 [0.30, 1.47]

Figures and Tables -
Comparison 1. Add‐on stiripentol versus placebo