Scolaris Content Display Scolaris Content Display

Study flow diagram.
Figures and Tables -
Figure 1

Study flow diagram.

Comparison 1 IVIg versus placebo, Outcome 1 50% or greater reduction in seizure frequency for refractory epilepsy, ITT analysis.
Figures and Tables -
Analysis 1.1

Comparison 1 IVIg versus placebo, Outcome 1 50% or greater reduction in seizure frequency for refractory epilepsy, ITT analysis.

Comparison 1 IVIg versus placebo, Outcome 2 50% or greater reduction in seizure frequency for refractory epilepsy, per‐protocol.
Figures and Tables -
Analysis 1.2

Comparison 1 IVIg versus placebo, Outcome 2 50% or greater reduction in seizure frequency for refractory epilepsy, per‐protocol.

Comparison 1 IVIg versus placebo, Outcome 3 50% or greater reduction in seizure frequency for refractory epilepsy, best‐case.
Figures and Tables -
Analysis 1.3

Comparison 1 IVIg versus placebo, Outcome 3 50% or greater reduction in seizure frequency for refractory epilepsy, best‐case.

Comparison 1 IVIg versus placebo, Outcome 4 50% or greater reduction in seizure frequency for refractory partial epilepsy, ITT analysis.
Figures and Tables -
Analysis 1.4

Comparison 1 IVIg versus placebo, Outcome 4 50% or greater reduction in seizure frequency for refractory partial epilepsy, ITT analysis.

Comparison 1 IVIg versus placebo, Outcome 5 50% or greater reduction in seizure frequency for refractory partial epilepsy, per‐protocol.
Figures and Tables -
Analysis 1.5

Comparison 1 IVIg versus placebo, Outcome 5 50% or greater reduction in seizure frequency for refractory partial epilepsy, per‐protocol.

Comparison 1 IVIg versus placebo, Outcome 6 50% or greater reduction in seizure frequency for refractory partial epilepsy, best‐case.
Figures and Tables -
Analysis 1.6

Comparison 1 IVIg versus placebo, Outcome 6 50% or greater reduction in seizure frequency for refractory partial epilepsy, best‐case.

Comparison 1 IVIg versus placebo, Outcome 7 Global assessment for refractory epilepsy, ITT analysis.
Figures and Tables -
Analysis 1.7

Comparison 1 IVIg versus placebo, Outcome 7 Global assessment for refractory epilepsy, ITT analysis.

Comparison 1 IVIg versus placebo, Outcome 8 Global assessment for refractory epilepsy, per‐protocol.
Figures and Tables -
Analysis 1.8

Comparison 1 IVIg versus placebo, Outcome 8 Global assessment for refractory epilepsy, per‐protocol.

Comparison 1 IVIg versus placebo, Outcome 9 Global assessment for refractory epilepsy, best‐case.
Figures and Tables -
Analysis 1.9

Comparison 1 IVIg versus placebo, Outcome 9 Global assessment for refractory epilepsy, best‐case.

Summary of findings for the main comparison. IVIg compared to placebo for refractory epilepsy

IVIg compared to placebo for refractory epilepsy

Patient or population: patients with refractory epilepsy
Settings: three participating hospitals‐Ottignies (Belgium), Zurich (Switzerland) and Kehl‐Kork (Germany)
Intervention: IVIg
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

IVIg

Seizure freedom

Not reported

Satisfactory seizure control
50% or greater reduction in seizure frequency for refractory epilepsy

278 per 1000

525 per 1000
(236 to 1000)

RR 1.89
(0.85 to 4.21)

58
(1 study)

⊕⊕⊝⊝
low1,2

Incidence of adverse or harmful effects

Not reported

Global assessment

167 per 1000

548 per 1000
(188 to 1000)

RR 3.29
(1.13 to 9.57)

60
(1 study)

⊕⊕⊝⊝
low1,2

*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.

1 Unclear risk of selection bias: no information was obtained on generation of the random sequence or concealment of allocation of the randomisation.
2 More trials and patients are needed to allow more precise estimation of the treatment effects of IVIg.

Figures and Tables -
Summary of findings for the main comparison. IVIg compared to placebo for refractory epilepsy
Comparison 1. IVIg versus placebo

Outcome or subgroup title

No. of studies

No. of participants

Statistical method

Effect size

1 50% or greater reduction in seizure frequency for refractory epilepsy, ITT analysis Show forest plot

1

61

Risk Ratio (M‐H, Fixed, 95% CI)

1.76 [0.79, 3.93]

2 50% or greater reduction in seizure frequency for refractory epilepsy, per‐protocol Show forest plot

1

58

Risk Ratio (M‐H, Fixed, 95% CI)

1.89 [0.85, 4.21]

3 50% or greater reduction in seizure frequency for refractory epilepsy, best‐case Show forest plot

1

61

Risk Ratio (M‐H, Fixed, 95% CI)

2.01 [0.91, 4.43]

4 50% or greater reduction in seizure frequency for refractory partial epilepsy, ITT analysis Show forest plot

1

49

Risk Ratio (M‐H, Fixed, 95% CI)

3.08 [0.84, 11.34]

5 50% or greater reduction in seizure frequency for refractory partial epilepsy, per‐protocol Show forest plot

1

46

Risk Ratio (M‐H, Fixed, 95% CI)

3.35 [0.91, 12.30]

6 50% or greater reduction in seizure frequency for refractory partial epilepsy, best‐case Show forest plot

1

49

Risk Ratio (M‐H, Fixed, 95% CI)

3.57 [0.98, 13.00]

7 Global assessment for refractory epilepsy, ITT analysis Show forest plot

1

61

Risk Ratio (M‐H, Fixed, 95% CI)

3.21 [1.10, 9.36]

8 Global assessment for refractory epilepsy, per‐protocol Show forest plot

1

60

Risk Ratio (M‐H, Fixed, 95% CI)

3.29 [1.13, 9.57]

9 Global assessment for refractory epilepsy, best‐case Show forest plot

1

61

Risk Ratio (M‐H, Fixed, 95% CI)

3.35 [1.15, 9.73]

Figures and Tables -
Comparison 1. IVIg versus placebo