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Metilfenidato para el trastorno de déficit de atención e hiperactividad (TDAH) en niños y adolescentes: evaluación de los eventos adversos en estudios no aleatorios
Ole Jakob Storebø, Nadia Pedersen, Erica Ramstad, Maja Lærke Kielsholm, Signe Sofie Nielsen, Helle B Krogh, Carlos R Moreira‐Maia, Frederik L Magnusson, Mathilde Holmskov, Trine Gerner, Maria Skoog, Susanne Rosendal, Camilla Groth, Donna Gillies, Kirsten Buch Rasmussen, Dorothy Gauci, Morris Zwi, Richard Kirubakaran, Sasja J Håkonsen, Lise Aagaard, Erik Simonsen, Christian Gluud | 10 mayo 2018

Topics

Temas

Comparison 1 Valproate/divalproex versus placebo, Outcome 1 Overall clinical response: numbers classed as 'responders', at endpoint (8 weeks).
Figuras y tablas -
Analysis 1.1

Comparison 1 Valproate/divalproex versus placebo, Outcome 1 Overall clinical response: numbers classed as 'responders', at endpoint (8 weeks).

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Comparison 1 Valproate/divalproex versus placebo, Outcome 2 Adverse events, any.
Figuras y tablas -
Analysis 1.2

Comparison 1 Valproate/divalproex versus placebo, Outcome 2 Adverse events, any.

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Comparison 1 Valproate/divalproex versus placebo, Outcome 3 Adverse events, rash.
Figuras y tablas -
Analysis 1.3

Comparison 1 Valproate/divalproex versus placebo, Outcome 3 Adverse events, rash.

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Comparison 1 Valproate/divalproex versus placebo, Outcome 4 Adverse events, headache.
Figuras y tablas -
Analysis 1.4

Comparison 1 Valproate/divalproex versus placebo, Outcome 4 Adverse events, headache.

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Comparison 1 Valproate/divalproex versus placebo, Outcome 5 Adverse events, weight gain.
Figuras y tablas -
Analysis 1.5

Comparison 1 Valproate/divalproex versus placebo, Outcome 5 Adverse events, weight gain.

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Comparison 1 Valproate/divalproex versus placebo, Outcome 6 Adverse events, increased appetite.
Figuras y tablas -
Analysis 1.6

Comparison 1 Valproate/divalproex versus placebo, Outcome 6 Adverse events, increased appetite.

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Comparison 1 Valproate/divalproex versus placebo, Outcome 7 Non‐compliance: leaving the study early, any reason.
Figuras y tablas -
Analysis 1.7

Comparison 1 Valproate/divalproex versus placebo, Outcome 7 Non‐compliance: leaving the study early, any reason.

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Comparison 1 Valproate/divalproex versus placebo, Outcome 8 Aggression: number improved as > 69% reduction on MOAS + SCL‐90 'irritability', at 6 wks.
Figuras y tablas -
Analysis 1.8

Comparison 1 Valproate/divalproex versus placebo, Outcome 8 Aggression: number improved as > 69% reduction on MOAS + SCL‐90 'irritability', at 6 wks.

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Comparison 1 Valproate/divalproex versus placebo, Outcome 9 Adverse events, nausea.
Figuras y tablas -
Analysis 1.9

Comparison 1 Valproate/divalproex versus placebo, Outcome 9 Adverse events, nausea.

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Comparison 1 Valproate/divalproex versus placebo, Outcome 10 Adverse events, somnolence.
Figuras y tablas -
Analysis 1.10

Comparison 1 Valproate/divalproex versus placebo, Outcome 10 Adverse events, somnolence.

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Comparison 1 Valproate/divalproex versus placebo, Outcome 11 Non‐compliance: leaving the study early, any reason; Cluster B PD subgroup.
Figuras y tablas -
Analysis 1.11

Comparison 1 Valproate/divalproex versus placebo, Outcome 11 Non‐compliance: leaving the study early, any reason; Cluster B PD subgroup.

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Comparison 2 Carbamazepine versus placebo, Outcome 1 Adverse events, any.
Figuras y tablas -
Analysis 2.1

Comparison 2 Carbamazepine versus placebo, Outcome 1 Adverse events, any.

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Comparison 2 Carbamazepine versus placebo, Outcome 2 Adverse events, rash/dermatitis.
Figuras y tablas -
Analysis 2.2

Comparison 2 Carbamazepine versus placebo, Outcome 2 Adverse events, rash/dermatitis.

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Comparison 2 Carbamazepine versus placebo, Outcome 3 Adverse events, headache.
Figuras y tablas -
Analysis 2.3

Comparison 2 Carbamazepine versus placebo, Outcome 3 Adverse events, headache.

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Comparison 2 Carbamazepine versus placebo, Outcome 4 Adverse events, dizziness.
Figuras y tablas -
Analysis 2.4

Comparison 2 Carbamazepine versus placebo, Outcome 4 Adverse events, dizziness.

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Comparison 2 Carbamazepine versus placebo, Outcome 5 Adverse events, stomach ache.
Figuras y tablas -
Analysis 2.5

Comparison 2 Carbamazepine versus placebo, Outcome 5 Adverse events, stomach ache.

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Comparison 2 Carbamazepine versus placebo, Outcome 6 Adverse events, weight loss.
Figuras y tablas -
Analysis 2.6

Comparison 2 Carbamazepine versus placebo, Outcome 6 Adverse events, weight loss.

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Comparison 2 Carbamazepine versus placebo, Outcome 7 Adverse events, weight gain.
Figuras y tablas -
Analysis 2.7

Comparison 2 Carbamazepine versus placebo, Outcome 7 Adverse events, weight gain.

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Comparison 2 Carbamazepine versus placebo, Outcome 8 Non‐compliance: leaving the study early, any reason.
Figuras y tablas -
Analysis 2.8

Comparison 2 Carbamazepine versus placebo, Outcome 8 Non‐compliance: leaving the study early, any reason.

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Comparison 2 Carbamazepine versus placebo, Outcome 9 Aggression (self‐reported): number with any aggression to others/objects, over last 3 wks of intervention.
Figuras y tablas -
Analysis 2.9

Comparison 2 Carbamazepine versus placebo, Outcome 9 Aggression (self‐reported): number with any aggression to others/objects, over last 3 wks of intervention.

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Comparison 2 Carbamazepine versus placebo, Outcome 10 Aggression (self‐reported): number with any aggression to others/objects/self, over last 3 wks of intervention.
Figuras y tablas -
Analysis 2.10

Comparison 2 Carbamazepine versus placebo, Outcome 10 Aggression (self‐reported): number with any aggression to others/objects/self, over last 3 wks of intervention.

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Comparison 2 Carbamazepine versus placebo, Outcome 11 Adverse events, leucopenia.
Figuras y tablas -
Analysis 2.11

Comparison 2 Carbamazepine versus placebo, Outcome 11 Adverse events, leucopenia.

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Comparison 2 Carbamazepine versus placebo, Outcome 12 Anger: more than one angry outburst, over 6 weeks.
Figuras y tablas -
Analysis 2.12

Comparison 2 Carbamazepine versus placebo, Outcome 12 Anger: more than one angry outburst, over 6 weeks.

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Comparison 2 Carbamazepine versus placebo, Outcome 13 Anger: any angry outburst, over 6 weeks.
Figuras y tablas -
Analysis 2.13

Comparison 2 Carbamazepine versus placebo, Outcome 13 Anger: any angry outburst, over 6 weeks.

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Comparison 3 Phenytoin/diphenylhydantoin versus placebo, Outcome 1 Non‐compliance: leaving the study early, any reason.
Figuras y tablas -
Analysis 3.1

Comparison 3 Phenytoin/diphenylhydantoin versus placebo, Outcome 1 Non‐compliance: leaving the study early, any reason.

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Comparison 3 Phenytoin/diphenylhydantoin versus placebo, Outcome 2 Adverse events, nausea.
Figuras y tablas -
Analysis 3.2

Comparison 3 Phenytoin/diphenylhydantoin versus placebo, Outcome 2 Adverse events, nausea.

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Comparison 4 Levetiracetam versus placebo, Outcome 1 Non‐compliance: leaving the study early (before 4 weeks), any reason.
Figuras y tablas -
Analysis 4.1

Comparison 4 Levetiracetam versus placebo, Outcome 1 Non‐compliance: leaving the study early (before 4 weeks), any reason.

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Comparison 4 Levetiracetam versus placebo, Outcome 2 Adverse events, sedation.
Figuras y tablas -
Analysis 4.2

Comparison 4 Levetiracetam versus placebo, Outcome 2 Adverse events, sedation.

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Comparison 4 Levetiracetam versus placebo, Outcome 3 Adverse events, dizziness.
Figuras y tablas -
Analysis 4.3

Comparison 4 Levetiracetam versus placebo, Outcome 3 Adverse events, dizziness.

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Comparison 4 Levetiracetam versus placebo, Outcome 4 Adverse events, headache.
Figuras y tablas -
Analysis 4.4

Comparison 4 Levetiracetam versus placebo, Outcome 4 Adverse events, headache.

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Comparison 5 Oxcarbazepine versus placebo, Outcome 1 Aggression (self‐reported): OAS‐M‐revised, number of responders as > 49% reduction in Global Overt Aggression score, at 10 wks.
Figuras y tablas -
Analysis 5.1

Comparison 5 Oxcarbazepine versus placebo, Outcome 1 Aggression (self‐reported): OAS‐M‐revised, number of responders as > 49% reduction in Global Overt Aggression score, at 10 wks.

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Comparison 5 Oxcarbazepine versus placebo, Outcome 2 Non‐compliance: leaving the study early, any reason.
Figuras y tablas -
Analysis 5.2

Comparison 5 Oxcarbazepine versus placebo, Outcome 2 Non‐compliance: leaving the study early, any reason.

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Comparison 5 Oxcarbazepine versus placebo, Outcome 3 Non‐compliance: leaving the study early, due to adverse events.
Figuras y tablas -
Analysis 5.3

Comparison 5 Oxcarbazepine versus placebo, Outcome 3 Non‐compliance: leaving the study early, due to adverse events.

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Comparison 5 Oxcarbazepine versus placebo, Outcome 4 Non‐compliance: leaving the study early, due to ineffectiveness.
Figuras y tablas -
Analysis 5.4

Comparison 5 Oxcarbazepine versus placebo, Outcome 4 Non‐compliance: leaving the study early, due to ineffectiveness.

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Comparison 6 Any epileptic drug versus placebo, Outcome 1 Non‐compliance: leaving the study early, any reason.
Figuras y tablas -
Analysis 6.1

Comparison 6 Any epileptic drug versus placebo, Outcome 1 Non‐compliance: leaving the study early, any reason.

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Comparison 6 Any epileptic drug versus placebo, Outcome 2 Adverse events, any.
Figuras y tablas -
Analysis 6.2

Comparison 6 Any epileptic drug versus placebo, Outcome 2 Adverse events, any.

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Antiepileptic medication compared with placebo for individuals with recurrent aggression

Patient or population: Any individual experiencing recurrent aggressive outbursts or episodes

Settings: Any (including hospital inpatient, outpatient, community and custodial settings)

Intervention: Any antiepileptic drug1

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

With placebo

With antiepileptic medication

Aggression

OAS, OAS‐M, MOAS, self‐reported incidents, CPRS subscale

(endpoints fall between 2 weeks and 6 months)

Unclear2

See comment

Not estimable

606

(12 studies; 14 comparisons)

+++O
moderate

Quantitative synthesis not possible since 11 of the 14 comparisons met criteria for skewed data

Descriptively, 8 of the 14 comparisons demonstrated significantly lower aggression scores in the intervention condition

Impulsivity

Q‐sort, Porteus Maze Test

(endpoints fall between 2 weeks and 6 months)

Unclear2

See comment

Not estimable

43

(2 studies; 2 comparisons)

+OOO
very low

Quantitative synthesis not possible since both comparisons met criteria for skewed data

Descriptively, neither of the 2 comparisons demonstrated significantly lower impulsivity scores in the intervention or control conditions

Hostility

BPRS hostility sub scale, CPRS hostility subscale, Q‐sort, speech content analysis

(endpoints fall between 1 and 6 months)

Unclear2

See comment

Not estimable

143

(4 studies; 4 comparisons)

++OO
low

Quantitative synthesis not possible since all 4 comparisons met criteria for skewed data

Descriptively, one of the 4 comparisons demonstrated significantly lower hostility scores in the intervention condition

Anger

Self‐reported outbursts, Rosenweig Picture Frustration Test

(endpoints fall between 2 weeks and 6 months)

Unclear2

See comment

Not estimable

46

(2 studies; 2 comparisons)

++OO
low

Quantitative synthesis not possible since 1 of the 2 comparisons met criteria for skewed data

Descriptively, neither of the 2 comparisons demonstrated significantly lower impulsivity scores in the intervention or control conditions

Anger‐Hostility

POMS anger‐hostility subscale

(endpoints fall between 1 and 6 months)

Unclear2

See comment

Not estimable

125

(3 studies; 3 comparisons)

++OO
low

Quantitative synthesis not possible since all 3 comparisons met criteria for skewed data

Descriptively, 1 of the 3 comparisons demonstrated significantly lower hostility scores in the intervention condition

Non‐compliance

leaving the study early

(endpoints fall between 1 and 6 months)

Low‐risk population

Not estimable

411

(6 studies; 8 comparisons)

+++O
moderate

None of the 8 comparisons demonstrated any significant difference between experimental and control conditions

Meta‐analysis of all 8 comparisons: OR 1.14; 95%CI 0.77 to 1.70, P = 0.52, Analysis 6.1

See comment

See comment

Medium‐risk population

See comment

See comment

High‐risk population

See comment

See comment

Adverse events, any

(endpoints fall between 1 6 six months)

Low‐risk population

Not estimable

300

(3 studies; 3 comparisons)

+++O
moderate

Two of the 3 comparisons found a significantly higher proportion of participants having any adverse effect in the intervention compared to the control condition

Meta‐analysis of 3 comparisons: OR 3.48; 95% CI 1.68 to 7.21, P < 0.001, Analysis 6.2

See comment

See comment

Medium‐risk population

See comment

See comment

High‐risk population

See comment

See comment

*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; CPRS: Children's Psychiatric Rating Scale; BPRS: British Psychiatric Rating Scale; OAS: Overt Aggression Scale; MOAS: Modified Overt Aggression Scale; OAS‐M: Overt Aggression Scale ‐ Modified; POMS: Profile of Moods Scale

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.

1Table summarises findings for antiepileptic drugs as a class.

2Unclear, since (a) this outcome is measured as a continuous (scale) variable using several instruments that are not directly equivalent, and (b) we have been unable to find normative data for individuals with recurrent aggression in the general population. We have not used baseline or control group data from the included studies to estimate risk or cut‐off scores on scale measures because of the diversity of the sample populations.

Figuras y tablas -
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Table 1. Comparison 1: valproate versus placebo: aggression, observer‐reported (skewed data)

Study   

Outcome

n(Exp)

Mean(Exp)

SD(Exp)

n(Cntrl)

Mean(Cntrl) 

SD(Cntrl)

Statistic

Notes

Hellings 2005

20 mg/kg/day

OAS total score, at 8 wks (mean of wks 6, 7 & 8)

16

5.86

3.84

14

5.72

4.62

P = 0.96 (2‐sided Wilcoxon rank sum test)

Favours neither condition

Stanford 2005

750 mg/day

OAS aggression score, at 2 wks

7

2.02

1.95

8

4.38

1.86

F1,13 = 16.92 (repeated measures ANOVA; P = 0.001; partial eta2 = 0.57; power = 0.97); treatment OAS aggression score significantly lower compared with the placebo group.

Significant main effect by time (3 interventions of which valproate was one; baseline, 2, 4, 6 wks); F3,75 = 3.41;P = 0.02; partial eta2 = 0.12; power = 0.78).

Favours valproate

Completer analysis

(see note 1)

Stanford 2005

750 mg/day

OAS aggression score, at 4 wks

7

2.80

2.30

8

4.49

2.14

F1,13 = 16.92 (repeated measures ANOVA; P = 0.001; partial eta2 = 0.57; power = 0.97); treatment OAS aggression score significantly lower compared with the placebo group

Significant main effect by time (3 interventions of which valproate was one; baseline, 2, 4, 6 wks); F3,75 = 3.41;P = 0.02; partial eta2 = 0.12; power = 0.78)

Favours valproate

Completer analysis

(see note 1)

Stanford 2005

750 mg/day

OAS aggression score, at 6 wks

7

0.62

1.99

8

5.40

1.86

F1,13 = 16.92 (repeated measures ANOVA; P = 0.001; partial eta2 = 0.57; power = 0.97); treatment OAS aggression score significantly lower compared with the placebo group

Significant main effect by time (three interventions of which valproate was one; baseline, 2, 4, 6 wks); F3,75 = 3.41; P = 0.02; partial eta2 = 0.12; power = 0.78).

Favours valproate

Completer analysis

(see note 1)

1. Data extracted from graph provided in study paper and confirmed by inspection of original Excel file supplied by lead author (email to J. Dennis 22 January 2009)

OAS = Overt Aggression Scale; wks = weeks
Figuras y tablas -
Table 1. Comparison 1: valproate versus placebo: aggression, observer‐reported (skewed data)
Ir a la tabla de la revisión
Table 2. Comparison 1: divalproex versus placebo: aggression, self‐reported (skewed data)

Study   

Outcome

n(Exp)

Mean(Exp)

SD(Exp)

n(Cntrl)

Mean(Cntrl) 

SD(Cntrl)

Statistic

Notes

Hollander 2003

max 30 mg/kg/day

OAS‐M aggression score, all participants, mean over last 4 wks

116

34.5

median 10.6

71.3

117

32.1

median 12.3

57.2

Z = 0.000 (Wilcoxon rank‐sum test, van Elteren analyses; P = 0.989)

Favours neither condition

Hollander 2003

max 30 mg/kg/day

OAS‐M aggression score, IED subgroup, mean over last 4 wks

55

28.9

median 13.0

39.1

54

28.9

median 9.0

59.9

Z = 2.580 (Wilcoxon rank‐sum test, van Elteren analyses; P = 0.108)

Favours neither condition

Hollander 2003

max 30 mg/kg/day

OAS‐M aggression score, PTSD subgroup, mean over last 4 wks

18

64.2

median 14.9)

13.6

15

22.9

median 14.3

27.1

Z = 0.173 (Wilcoxon rank‐sum test, van Elteren analyses; P = 0.679)

Favours neither condition

Hollander 2003

max 30 mg/kg/day

OAS‐M aggression score, Cluster B PD subgroup, mean over last 4 wks

43

29.2

median 8.3

66.1

48

38.6

median 16.3

61.1

Z = 3.952 (Wilcoxon rank‐sum test, van Elteren analyses; P = 0.047)

Favours divalproex

IED = intermittent explosive disorder; OAS = Overt Aggression Scale; PTSD = post‐traumatic stress disorder; wks = weeks; PD = personality disorder

Figuras y tablas -
Table 2. Comparison 1: divalproex versus placebo: aggression, self‐reported (skewed data)
Ir a la tabla de la revisión
Table 3. Comparison 2: carbamazepine versus placebo: aggression, observer‐reported (skewed data)

Study   

Outcome

n(Exp)  

Mean(Exp)

SD(Exp)

n(Cntrl)

Mean(Cntrl) 

SD(Cntrl)

Statistic

Notes

Cueva 1996

Mean 683 mg/day

CPRS aggression subscale, at 4 wks

See note 1

3.42

1.73

See note 1

3.20

1.46

No significant difference between groups (ANCOVA)

Favours neither condition

Completer analysis

(see note 1)

Cueva 1996

Mean 683 mg/day

CPRS aggression subscale, at 6 wks

See note 1

3.08

1.60

See note 1

3.18

1.34

No significant difference between groups (ANCOVA)

Favours neither condition

Completer analysis

(see note 2)

Cueva 1996

Mean 683 mg/day

OAS total score; via regression model, at 4 wks

13

No data

 

11

No data

 

No significant difference between groups (fitted slopes analysis)

Favours neither condition

Cueva 1996

Mean 683 mg/day

OAS total score; via regression model, at 6 wks

13

No data

 

11

No data

 

No significant difference between groups (fitted slopes analysis)

Favours neither condition

Stanford 2005

450 mg/day

OAS aggression score, at 2 wks

7

3.62

1.95

8

4.38

1.86

Treatment mean OAS aggression scores not significantly lower compared with the placebo group (repeated measures ANOVA; P = 0.083).

Favours neither condition

Completer analysis

(see note 2)

Stanford 2005

450 mg/day

OAS aggression score, at 4 wks

7

4.21

2.30

8

4.49

2.14

Treatment mean OAS aggression scores not significantly lower compared with the placebo group (repeated measures ANOVA; P = 0.083).

Favours neither condition

Completer analysis

(see note 2)

Stanford 2005

450 mg/day

OAS aggression score, at 6 wks

7

1.86

1.99

8

5.40

1.86

Treatment mean OAS aggression scores not significantly lower compared with the placebo group (repeated measures ANOVA; P = 0.083).

Favours neither condition

Completer analysis

(see note 2)

1. 22 of 24 completed, but trial investigators do not report the distribution of dropouts between conditions

2. Data extracted from graph provided in study paper and confirmed by inspection of original Excel file supplied by lead author (email to J. Dennis 22 January 2009)

CPRS = Children's Psychiatric Rating Scale; OAS = Overt Aggression Scale; wks = weeks
Figuras y tablas -
Table 3. Comparison 2: carbamazepine versus placebo: aggression, observer‐reported (skewed data)
Ir a la tabla de la revisión
Table 4. Comparison 2: carbamazepine versus placebo: hostility (skewed data)

Study   

Outcome

n(Exp)

Mean(Exp)

SD(Exp)

n(Cntrl)

Mean(Cntrl) 

SD(Cntrl)

Statistic

Notes

Cueva 1996

Mean 683 mg/day

CPRS hostility subscale, at 4 wks

see note 1

1.58

0.74

see note 1

1.78

1.05

No significant difference between groups (ANCOVA)

Favours neither condition

Completer analysis

(see note 1)

Cueva 1996

Mean 683 mg/day

CPRS hostility subscale, at 6 wks

see note 1

1.81

1.20

see note 1

1.73

0.68

No significant difference between groups (ANCOVA)

Favours neither condition

Completer analysis

(see note 1)

1. 22 of 24 completed, but trial investigators do not report the distribution of dropouts between conditions.

CPRS = Children's Psychiatric Rating Scale; wks = weeks
Figuras y tablas -
Table 4. Comparison 2: carbamazepine versus placebo: hostility (skewed data)
Ir a la tabla de la revisión
Table 5. Comparison 3: phenytoin/diphenylhydantoin versus placebo: aggression, observer‐reported (skewed data)

Study   

Outcome

n(Exp)

Mean(Exp)

SD(Exp)

n(Cntrl)

Mean(Cntrl) 

SD(Cntrl)

Statistic

Notes

Stanford 2005

300 mg/day

OAS aggression score, at 2 wks

7

2.17

1.95

8

4.38

1.86

F1,13 = 19.84 (repeated measures ANOVA; P = 0.001; partial eta2 = 0.60; power = 0.98); treatment OAS aggression score significantly lower compared with the placebo group

Significant main effect by time (3 interventions of which phenytoin was one; baseline, 2, 4, 6 wks); F3,75 = 3.41; P = 0.02; partial eta2 = 0.12; power = 0.78)

Favours phenytoin

Completer analysis

(see note 1)

Stanford 2005

300 mg/day

OAS aggression score, at 4 wks

7

1.28

2.30

8

4.49

2.14

F1,13 = 19.84 (repeated measures ANOVA; P = 0.001; partial eta2 = 0.60; power = 0.98); treatment OAS aggression score significantly lower compared with the placebo group

Significant main effect by time (3 interventions of which phenytoin was one; baseline, 2, 4, 6 wks); F3,75 = 3.41; P = 0.02; partial eta2 = 0.12; power = 0.78).

Favours phenytoin

Completer analysis

(see note 1)

Stanford 2005

300 mg/day

OAS aggression score, at 6 wks

7

2.38

1.99

8

5.40

1.86

F1,13 = 19.84 (repeated measures ANOVA; P = 0.001; partial eta2 = 0.60; power = 0.98); treatment OAS aggression score significantly lower compared with the placebo group

Significant main effect by time (3 interventions of which phenytoin was one; baseline, 2, 4, 6 wks); F3,75 = 3.41; P = 0.02; partial eta2 = 0.12; power = 0.78)

Favours phenytoin

Completer analysis

(see note 1)

Barratt 1991

100 mg/day

Frequency of aggressive acts, change from baseline, at 4 wks

13

 

No data

 

13

 

No data

 

Frequency of aggressive acts not  significantly reduced from baseline during either treatment or placebo conditions (Wilcoxon’s signed ranks test)

Favours neither condition

Completer analysis

(no data available)

Barratt 1991

 

300 mg/day

Frequency of aggressive acts, change from baseline, at 4 wks

13

 

No data

 

13

 

No data

 

Frequency of aggressive acts significantly reduced from baseline (Wilcoxon’s signed ranks test; P < 0.001) during treatment but not placebo condition

Favours phenytoin

Completer analysis

(no data available)

Barratt 1997

300 mg/day

Frequency of aggressive acts per wk, mean, at 6 wks

60

0.33

No data

60

0.51

No data

F1,58  = 9.64 (repeated measure ANOVA, Geissner‐Greenhouse adjusted; P < 0.001)

Favours phenytoin

(see below for subgroup analysis)

Barratt 1997

 

300 mg/day

Intensity of aggressive acts, mean, at 6 wks

60

2.61

No data

60

3.96

No data

F1,58  = 8.23 (repeated measure ANOVA, Geissner‐Greenhouse adjusted; P < 0.01)

Favours phenytoin

(see below for subgroup analysis)

Barratt 1997

 

300 mg/day

Frequency of aggressive acts per wk, mean, impulsive subgroup, at 6 wks

30

0.20

0.19

30

0.52

0.46

Subgroup effect (impulsive vs. non‐impulsive) F1,58 = 9.21 (repeated measure ANOVA, Geissner‐Greenhouse adjusted; P < 0.01)

Subgroup by drug‐placebo effect F1,58 = 9.50 (repeated measure ANOVA, Geissner‐Greenhouse adjusted; P < 0.01)

Favours phenytoin

(impulsive aggression subgroup)

Barratt 1997

300 mg/day

Intensity of aggressive acts, mean, impulsive subgroup, at 6 wks

30

2.11

1.20

30

4.16

1.92

Subgroup effect (impulsive vs. non‐impulsive) F1,58 = 4.78 (repeated measure ANOVA, Geissner‐Greenhouse adjusted; P < 0.05)

Subgroup by drug‐placebo effect F1,58 = 9.74 (repeated measure ANOVA, Geissner‐Greenhouse adjusted; p<0.01).

Favours phenytoin

(impulsive aggression subgroup)

Barratt 1997

300 mg/day

Frequency of aggressive acts per week, mean, non‐impulsive subgroup, at 6 wks

30

0.42

0.24

30

0.51

0.48

Subgroup effect (impulsive vs. non‐impulsive) F1,58 = 9.21 (repeated measure ANOVA, Geissner‐Greenhouse adjusted; P < 0.01)

Subgroup by drug‐placebo effect F1,58 = 9.50 (repeated measure ANOVA, Geissner‐Greenhouse adjusted; P < 0.01)

Favours neither condition

(non‐impulsive aggression subgroup)

Barratt 1997

300 mg/day

Intensity of aggressive acts, mean, non‐impulsive subgroup, at 6 wks

30

3.40

1.29

30

3.76

1.59

Subgroup effect (impulsive vs. non‐impulsive) F1,58 = 4.78 (repeated measure ANOVA, Geissner‐Greenhouse adjusted; P < 0.05)

Subgroup by drug‐placebo effect F1,58 = 9.74 (repeated measure ANOVA, Geissner‐Greenhouse adjusted; P < 0.01)

Favours neither condition

(non‐impulsive aggression subgroup)

Stanford 2001

300 mg/day

Frequency of impulsive‐aggressive outbursts, from OAS, mean no outbursts/week, over 6 wks

23

0.60

0.41

23

0.97

0.68

F1,21 = 8.44 (repeated measures ANOVA; P = 0.008)

Frequency of impulsive‐aggressive outbursts significantly reduced from baseline for phenytoin (F1,21 = 9.37; P = 0.006)

Favours phenytoin

Completer analysis

(see note 2)

1. Data presented here extracted from graph provided as figure 1 in study paper and confirmed by inspection of original Excel file supplied by lead author (email to J. Dennis 22 January 2009); statistics from study paper.

2. Data presented here extracted from graph provided as figure 1 in study paper; statistics from study paper.

OAS = Overt Aggression Scale; wks = weeks
Figuras y tablas -
Table 5. Comparison 3: phenytoin/diphenylhydantoin versus placebo: aggression, observer‐reported (skewed data)
Ir a la tabla de la revisión
Table 6. Comparison 3: phenytoin/diphenylhydantoin versus placebo: impulsivity (skewed data)

Study   

Outcome

n(Exp)

Mean(Exp)

SD(Exp)

n(Cntrl)

Mean(Cntrl) 

SD(Cntrl)

Statistic

Notes

Conners 1971

200 mg/day

Porteus Maze test quotient, at 2 wks

15

112.90

22.60

15

101.60

26.20

No significant differences between conditions (one‐way ANOVA)

Favours neither condition

Conners 1971

200 mg/day

Porteus Maze qualitative score, at 2 wks

15

36.90

26.40

15

28.10

14.18

No significant differences between conditions (one‐way ANOVA)

Favours neither condition

Rosenblatt 1976

400 mg/day

Q‐sort 'A' aggressive impulsiveness subscale, mean % change from baseline, at end of trial

 5

 ‐31%

No data

 3

 ‐31%

No data

No significant differences between conditions (Mann Whitney U test)

Favours neither condition

wks = weeks
Figuras y tablas -
Table 6. Comparison 3: phenytoin/diphenylhydantoin versus placebo: impulsivity (skewed data)
Ir a la tabla de la revisión
Table 7. Comparison 3: phenytoin/diphenylhydantoin versus placebo: hostility (skewed data)

Study   

Outcome

n(Exp)

Mean(Exp)

SD(Exp)

n(Cntrl)

Mean(Cntrl) 

SD(Cntrl)

Statistic

Notes

Gottschalk 1973

300 mg/day

Speech content analysis, hostility‐out, fitted slope at 24 wks

24

0.093

0.433

18

‐0.038

0.162

t = 1.21 (no significant differences between conditions; fitted slopes analysis)

Favours neither condition

Gottschalk 1973

300 mg/day

Speech content analysis, hostility‐in, fitted slope at 24 wks

24

‐0.037

0.128

18

‐0.007

0.124

t = ‐0.76 (no significant differences between conditions; fitted slopes analysis)

Favours neither condition

Gottschalk 1973

300 mg/day

Speech content analysis, amb. hostility, fitted slope at 24 wks

24

‐0.045

0.203

18

‐0.038

0.162

t = ‐1.77 (no significant differences between conditions; fitted slopes analysis)

Favours neither condition

Rosenblatt 1976

400 mg/day

Q‐sort 'A' hostility subscales, mean % change from baseline, at end of trial

 5

 ‐37%

No data

 3

 ‐6%

No data

No significant differences between conditions (Mann Whitney U test)

Favours neither condition

Rosenblatt 1976

400 mg/day

Q‐sort 'B' hostility subscales, mean % change from baseline, at end of trial

 5

 ‐5%

No data

 3

 ‐53%

No data

No significant differences between conditions (Mann Whitney U test)

Favours neither condition

wks = weeks
Figuras y tablas -
Table 7. Comparison 3: phenytoin/diphenylhydantoin versus placebo: hostility (skewed data)
Ir a la tabla de la revisión
Table 8. Comparison 3: phenytoin/diphenylhydantoin versus placebo: anger (skewed data)

Study   

Outcome

n(Exp)

Mean(Exp)

SD(Exp)

n(Cntrl)

Mean(Cntrl) 

SD(Cntrl)

Statistic

Notes

Conners 1971

200 mg/day

Rosenzweig Picture Frustration Test Categories, at 2 wks

15

Positive 4.4

Neutral 4.8

Negative 4.2

No data

15

Positive 4.4

Neutral 4.5

Negative 4.2

No data

No significant differences between conditions for the 3 categories (one‐way Kurskal‐Wallis ANOVA)

Favours neither condition
Figuras y tablas -
Table 8. Comparison 3: phenytoin/diphenylhydantoin versus placebo: anger (skewed data)
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Table 9. Comparison 3: phenytoin/diphenylhydantoin versus placebo: anger‐hostility (skewed data)

Study   

Outcome

n(Exp)

Mean(Exp)

SD(Exp)

n(Cntrl)

Mean(Cntrl) 

SD(Cntrl)

Statistic

Notes

Barratt 1991

 

300 mg/day

POMS anger‐hostility subscale, change from baseline, at 4 wks

13

 

No data

 

13

 

No data

 

Scores not significantly reduced from baseline (ANOVA, Geissner‐Greenhouse adjusted; no further details given)

Favours neither condition

Completer analysis

(no data available)

Barratt 1991

 

100 mg/day

POMS anger‐hostility subscale, change from baseline, at 4 wks

13

 

No data

 

13

 

No data

 

Scores not significantly reduced from baseline (ANOVA, Geissner‐Greenhouse adjusted; no further details given)

Favours neither condition

Completer analysis

(no data available)

Barratt 1997

300 mg/day

POMS anger‐hostility subscale, impulsive subgroup, at 6 wks

30

20.4

No data

30

22.3

No data

Scores not significantly reduced from baseline (ANOVA, Geissner‐Greenhouse adjusted; no further details given)

Favours neither condition

(impulsive aggression subgroup)

Barratt 1997

300 mg/day

POMS anger‐hostility subscale, non‐impulsive subgroup, at 6 wks

30

11.2

No data

30

12.5

No data

Scores not significantly reduced from baseline (ANOVA, Geissner‐Greenhouse adjusted; no further details given)

Favours neither condition

(non‐impulsive aggression subgroup)

Stanford 2001

300 mg/day

POMS anger‐hostility subscale, at 6 wks

23

8.44

1.32

23

13.39

2.21

F2,42 = 5.78 (repeated measures ANOVA; P = 0.011; significant main effect for condition)

Scores significantly reduced from baseline for phenytoin (F1,21 = 22.80; P < 0.001) but not for placebo condition

Favours phenytoin

POMS = Profile of Mood States; wks = weeks
Figuras y tablas -
Table 9. Comparison 3: phenytoin/diphenylhydantoin versus placebo: anger‐hostility (skewed data)
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Table 10. Comparison 4: levetiracetam versus placebo: aggression, self‐reported (skewed data)

Study   

Outcome

n(Exp)

Mean(Exp)

SD(Exp)

n(Cntrl)

Mean(Cntrl) 

SD(Cntrl)

Statistic

Notes

Mattes 2008

mean 1738 mg/day

OAS‐M‐revised, change in Global Overt Aggression score, at 10 wks

19

‐0.84

0.94

20

‐0.93

0.98

t = 0.74 (ANCOVA; P = 0.47)

(see note 1)

Favours neither condition

Mattes 2008

mean 1738 mg/day

OAS‐M‐revised, change in total aggression, at 10 wks

19

‐4.68

5.54

20

‐4.48

4.70

t = 0.67 (ANCOVA; P = 0.51)

(see note 1)

Favours neither condition

Mattes 2008

mean 1738 mg/day

OAS‐M‐revised, change in subjective irritability, at 10 wks

19

‐0.66

0.80

20

‐0.68

0.95

t = 0.11 (ANCOVA; P = 0.92)

(see note 1)

Favours neither condition

Mattes 2008

mean 1738 mg/day

Mean change in relative rating of aggression, at 10 wks

11

‐7.63

11.75

14

‐7.14

7.75

t = ‐0.39 (ANCOVA; P = 0.70)

(see note 1)

Favours neither condition

Mattes 2008

mean 1738 mg/day

Patient‐rated global improvement, at 10 wks

19

1.74

1.45

20

1.60

1.39

t = 0.39 (ANCOVA; P = 0.71)

(see note 1)

Favours neither condition

Mattes 2008

mean 1738 mg/day

OAS‐M‐revised, change in verbal aggression, at 10 wks

19

‐3.00

3.30

20

‐2.75

2.69

t = ‐0.08 (ANCOVA; P = 0.94)

(see note 1)

Favours neither condition

Mattes 2008

mean 1738 mg/day

OAS‐M‐revised, change in aggression against objects, at 10 wks

19

‐1.42

2.22

20

‐1.28

1.23

t = 0.95 (ANCOVA; P = 0.35)

(see note 1)

Favours neither condition

Mattes 2008

mean 1738 mg/day

OAS‐M‐revised, change in assault against others, at 10 wks

19

‐0.13

0.64

20

‐0.43

1.05

t = 1.04 (ANCOVA; P = 0.30)

(see note 1)

Favours neither condition

1. Covariance analysis comparing levetiracetam versus placebo on change scores (final ‐ initial), covarying out the relationship between initial scores and change scores.

OAS = Overt Aggression Scale; wks = weeks
Figuras y tablas -
Table 10. Comparison 4: levetiracetam versus placebo: aggression, self‐reported (skewed data)
Ir a la tabla de la revisión
Table 11. Comparison 4: levetiracetam versus placebo: hostility (skewed data)

Study   

Outcome

n(Exp)

Mean(Exp)

SD(Exp)

n(Cntrl)

Mean(Cntrl) 

SD(Cntrl)

Statistic

Notes

Mattes 2008

mean 1738 mg/day

Change in BPRS hostility subscale, at 10 wks

19

‐1.00

0.94

20

‐0.85

0.95

t = ‐0.14 (ANCOVA; P = 0.89)

(see note 1)

Favours neither condition

1. Covariance analysis comparing levetiracetam versus placebo on change scores (final ‐ initial), covarying out the relationship between initial scores and change scores; negative change = good.

BPRS = British Psychiatric Rating scale; wks = weeks
Figuras y tablas -
Table 11. Comparison 4: levetiracetam versus placebo: hostility (skewed data)
Ir a la tabla de la revisión
Table 12. Comparison 5: oxcarbazepine versus placebo: aggression, self‐reported (skewed data)

Study   

Outcome

n(Exp)

Mean(Exp)

SD(Exp)

n(Cntrl)

Mean(Cntrl) 

SD(Cntrl)

Statistic

Notes

Mattes 2005

mean 1500 mg/day

OAS‐M‐revised, change in Global Overt Aggression score, at 10 wks

21

‐0.98

0.83

24

‐0.44

0.83

t = 2.18 (t‐test; P = 0.035)

Favours oxcarbazepine

Mattes 2005

mean 1500 mg/day

Patient‐rated global improvement, at 10 wks

21

2.24

1.18

23

1.22

1.35

t = 2.68 (t‐test; P = 0.010)

Favours oxcarbazepine

Mattes 2005

mean 1500 mg/day

OAS‐M‐revised, change in total aggression, at 10 wks

(see note 1)

21

‐5.93

4.81

24

‐4.08

7.65

t = 0.98 (t‐test; P = 0.33, but P = 0.011 with covariance analysis; see note 2)

Favours oxcarbazepine

Mattes 2005

mean 1500 mg/day

OAS‐M‐revised, change in subjective irritability, at 10 wks

21

‐0.86

0.73

24

‐0.44

0.65

t = 2.03 (t‐test; P = 0.049)

Favours oxcarbazepine

Mattes 2005

mean 1500 mg/day

OAS‐M‐revised, change in verbal aggression, at 10 wks

(see note 1)

21

‐3.79

3.00

24

‐2.42

4.91

t = 1.14 (t‐test; P = 0.26, but P = 0.005 with covariance analysis; see note 2)

Favours oxcarbazepine

Mattes 2005

mean 1500 mg/day

OAS‐M‐revised, change in aggression against objects, at 10 wks

(see note 1)

21

‐1.81

2.02

24

‐1.08

2.03

t = 1.20 (t‐test; P = 0.24, but P = 0.028 with covariance analysis; see note 2)

Favours oxcarbazepine

Mattes 2005

mean 1500 mg/day

OAS‐M‐revised, change in assault against others, at 10 wks

(see note 1)

21

‐0.12

0.22

24

‐0.29

1.00

t = 1.16 (t‐test; P = 0.251)

Favours neither condition

1. Calculated multiplying severity x frequency; in calculating total aggression, verbal aggression and aggression against objects weighted equally, but assault given extra weighting based on the severity of the assault.

2. ANCOVA, covarying out the relationship between initial scores and change.

OAS = Overt Aggression Scale; wks = weeks
Figuras y tablas -
Table 12. Comparison 5: oxcarbazepine versus placebo: aggression, self‐reported (skewed data)
Ir a la tabla de la revisión
Table 13. Comparison 5: oxcarbazepine versus placebo: hostility (skewed data)

Study   

Outcome

n(Exp)

Mean(Exp)

SD(Exp)

n(Cntrl)

Mean(Cntrl) 

SD(Cntrl)

Statistic

Notes

Mattes 2005

mean 1500 mg/day

Change in BPRS hostility subscale, at 10 wks

21

‐1.29

0.90

23

‐0.57

1.04

t = 2.46 (t‐test; P = 0.018)

Favours oxcarbazepine

BPRS = British Psychiatric Rating scale
Figuras y tablas -
Table 13. Comparison 5: oxcarbazepine versus placebo: hostility (skewed data)
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Comparison 1. Valproate/divalproex versus placebo

Outcome or subgroup title

No. of studies

No. of participants

Statistical method

Effect size

1 Overall clinical response: numbers classed as 'responders', at endpoint (8 weeks) Show forest plot

1

30

Odds Ratio (M‐H, Fixed, 95% CI)

2.25 [0.48, 10.60]

2 Adverse events, any Show forest plot

2

276

Odds Ratio (M‐H, Fixed, 95% CI)

3.07 [1.42, 6.65]

3 Adverse events, rash Show forest plot

1

30

Odds Ratio (M‐H, Fixed, 95% CI)

7.80 [0.80, 75.64]

4 Adverse events, headache Show forest plot

2

276

Odds Ratio (M‐H, Fixed, 95% CI)

0.76 [0.44, 1.32]

5 Adverse events, weight gain Show forest plot

2

276

Odds Ratio (M‐H, Fixed, 95% CI)

2.42 [1.10, 5.31]

6 Adverse events, increased appetite Show forest plot

1

30

Odds Ratio (M‐H, Fixed, 95% CI)

7.71 [1.28, 46.36]

7 Non‐compliance: leaving the study early, any reason Show forest plot

4

316

Odds Ratio (M‐H, Fixed, 95% CI)

1.23 [0.77, 1.96]

8 Aggression: number improved as > 69% reduction on MOAS + SCL‐90 'irritability', at 6 wks Show forest plot

1

15

Odds Ratio (M‐H, Fixed, 95% CI)

18.0 [1.27, 255.74]

9 Adverse events, nausea Show forest plot

1

246

Odds Ratio (M‐H, Fixed, 95% CI)

2.81 [1.44, 5.47]

10 Adverse events, somnolence Show forest plot

1

246

Odds Ratio (M‐H, Fixed, 95% CI)

1.64 [0.94, 2.87]

11 Non‐compliance: leaving the study early, any reason; Cluster B PD subgroup Show forest plot

1

96

Odds Ratio (M‐H, Fixed, 95% CI)

1.08 [0.48, 2.41]
Figuras y tablas -
Comparison 1. Valproate/divalproex versus placebo
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Comparison 2. Carbamazepine versus placebo

Outcome or subgroup title

No. of studies

No. of participants

Statistical method

Effect size

1 Adverse events, any Show forest plot

1

24

Odds Ratio (M‐H, Fixed, 95% CI)

10.0 [0.94, 105.92]

2 Adverse events, rash/dermatitis Show forest plot

1

24

Odds Ratio (M‐H, Fixed, 95% CI)

8.57 [0.84, 87.83]

3 Adverse events, headache Show forest plot

1

24

Odds Ratio (M‐H, Fixed, 95% CI)

19.93 [0.97, 408.44]

4 Adverse events, dizziness Show forest plot

1

24

Odds Ratio (M‐H, Fixed, 95% CI)

26.54 [1.30, 543.78]

5 Adverse events, stomach ache Show forest plot

1

24

Odds Ratio (M‐H, Fixed, 95% CI)

0.8 [0.13, 5.09]

6 Adverse events, weight loss Show forest plot

1

21

Odds Ratio (M‐H, Fixed, 95% CI)

0.4 [0.05, 3.12]

7 Adverse events, weight gain Show forest plot

1

21

Odds Ratio (M‐H, Fixed, 95% CI)

2.5 [0.32, 19.53]

8 Non‐compliance: leaving the study early, any reason Show forest plot

1

20

Odds Ratio (M‐H, Fixed, 95% CI)

0.76 [0.10, 5.96]

9 Aggression (self‐reported): number with any aggression to others/objects, over last 3 wks of intervention Show forest plot

1

22

Odds Ratio (M‐H, Fixed, 95% CI)

0.12 [0.01, 1.29]

10 Aggression (self‐reported): number with any aggression to others/objects/self, over last 3 wks of intervention Show forest plot

1

22

Odds Ratio (M‐H, Fixed, 95% CI)

0.06 [0.01, 0.63]

11 Adverse events, leucopenia Show forest plot

1

24

Odds Ratio (M‐H, Fixed, 95% CI)

8.57 [0.84, 87.83]

12 Anger: more than one angry outburst, over 6 weeks Show forest plot

1

22

Odds Ratio (M‐H, Fixed, 95% CI)

0.12 [0.01, 1.29]

13 Anger: any angry outburst, over 6 weeks Show forest plot

1

22

Odds Ratio (M‐H, Fixed, 95% CI)

0.18 [0.02, 1.92]
Figuras y tablas -
Comparison 2. Carbamazepine versus placebo
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Comparison 3. Phenytoin/diphenylhydantoin versus placebo

Outcome or subgroup title

No. of studies

No. of participants

Statistical method

Effect size

1 Non‐compliance: leaving the study early, any reason Show forest plot

1

20

Odds Ratio (M‐H, Fixed, 95% CI)

0.76 [0.10, 5.96]

2 Adverse events, nausea Show forest plot

1

60

Odds Ratio (M‐H, Fixed, 95% CI)

1.0 [0.06, 16.76]
Figuras y tablas -
Comparison 3. Phenytoin/diphenylhydantoin versus placebo
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Comparison 4. Levetiracetam versus placebo

Outcome or subgroup title

No. of studies

No. of participants

Statistical method

Effect size

1 Non‐compliance: leaving the study early (before 4 weeks), any reason Show forest plot

1

40

Odds Ratio (M‐H, Fixed, 95% CI)

6.33 [0.67, 60.16]

2 Adverse events, sedation Show forest plot

1

40

Odds Ratio (M‐H, Fixed, 95% CI)

1.52 [0.43, 5.43]

3 Adverse events, dizziness Show forest plot

1

40

Odds Ratio (M‐H, Fixed, 95% CI)

4.75 [0.48, 46.91]

4 Adverse events, headache Show forest plot

1

40

Odds Ratio (M‐H, Fixed, 95% CI)

3.0 [0.51, 17.74]
Figuras y tablas -
Comparison 4. Levetiracetam versus placebo
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Comparison 5. Oxcarbazepine versus placebo

Outcome or subgroup title

No. of studies

No. of participants

Statistical method

Effect size

1 Aggression (self‐reported): OAS‐M‐revised, number of responders as > 49% reduction in Global Overt Aggression score, at 10 wks Show forest plot

1

45

Odds Ratio (M‐H, Fixed, 95% CI)

4.88 [1.36, 17.47]

2 Non‐compliance: leaving the study early, any reason Show forest plot

1

48

Odds Ratio (M‐H, Fixed, 95% CI)

0.51 [0.16, 1.61]

3 Non‐compliance: leaving the study early, due to adverse events Show forest plot

1

48

Odds Ratio (M‐H, Fixed, 95% CI)

2.33 [0.51, 10.69]

4 Non‐compliance: leaving the study early, due to ineffectiveness Show forest plot

1

48

Odds Ratio (M‐H, Fixed, 95% CI)

0.24 [0.06, 0.90]
Figuras y tablas -
Comparison 5. Oxcarbazepine versus placebo
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Comparison 6. Any epileptic drug versus placebo

Outcome or subgroup title

No. of studies

No. of participants

Statistical method

Effect size

1 Non‐compliance: leaving the study early, any reason Show forest plot

6

444

Odds Ratio (M‐H, Fixed, 95% CI)

1.14 [0.77, 1.70]

2 Adverse events, any Show forest plot

3

300

Odds Ratio (M‐H, Fixed, 95% CI)

3.48 [1.68, 7.21]
Figuras y tablas -
Comparison 6. Any epileptic drug versus placebo
Ir a la tabla de la revisión