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Design Details
Arms
Arm Details
Sample Characteristics
Outcomes
Outcome Details
Risk of Bias Assessment
Results
Print Data

Extraction form for project: Management of Infantile Epilepsies

Design Details

1. Study Design


	RCT Nonrandomized comparative study Pre/post observational study

2. Country


	South Korea

3. Total sample size


	146

4. Intervention Type


	Pharmacological Dietary Surgery

5. Funding source


	NR

Arms

Arm Name	Arm Description
Topiramate	Initial 0.5-1 mg/kg/day and increased weekly in increments of 1/mg/kg/day to a maximum of 3-9.
Carbamazepine	Initial 5-10 mg/kg/day and increased weekly in increments of 5-10/mg/kg/day to a maximum of 30.

Arm Details

1. Sample size for arm

Topiramate


	41

Carbamazepine


	105

2. Inclusion Criteria

Topiramate


	Under age 2 and initially prescribed either TPM or CBZ at the pediatric neurology clinic, Kyungpook National University Hospital, Daegu, South Korea from January 1, 2000 to December 31, 2003

Carbamazepine


	Under age 2 and initially prescribed either TPM or CBZ at the pediatric neurology clinic, Kyungpook National University Hospital, Daegu, South Korea from January 1, 2000 to December 31, 2003

3. Exclusion Criteria

Topiramate


	NR

Carbamazepine


	NR

4. Treatment details

Topiramate


	Initial 0.5-1 mg/kg/day and increased weekely in increments of 1/mg/kg/day to a maximum of 3-9.

Carbamazepine


	Initial 5-10 mg/kg/day and increased weekely in increments of 5-10/mg/kg/day to a maximum of 30.

Sample Characteristics

1. Gender, number of male

Topiramate


	19

Carbamazepine


	57

Total


	76

2. Gender, percentage of male

Topiramate


	46

Carbamazepine


	54

Total


	52

3. Age at intervention (mean)

Topiramate


	10 months

Carbamazepine


	8.4 months

Total


	9.2

4. Age at intervention (SD)

Topiramate


	SD 6.4

Carbamazepine


	SD 5.6

Total

5. Age at intervention (range)

Topiramate


	NR

Carbamazepine


	NR

Total


	NR

6. Age at intervention (median)

Topiramate


	NR

Carbamazepine


	NR

Total


	NR

7. Seizure types and/or etiology

Topiramate


	46% had presence of underlying pathology

Carbamazepine


	32% had presence of underlying pathology

Total

8. Prior treatment

Topiramate


	No prior treatments permitted. Did not report whether patients received concomitant treatments

Carbamazepine


	No prior treatments permitted. Did not report whether patients received concomitant treatments

Total

9. Comments

Topiramate

Carbamazepine

Total


	Kyungpook National University Hospital, Daegu, South Korea

Outcomes

Type	Domain	Specific measurement (i.e., tool/definition/specific outcome)	Populations	Timepoints
Categorical	Seizure freedom		All Participants	6 months
Categorical	Seizure reduction/effective (>50% reduction)		All Participants	Baseline
Categorical	Adverse Event	Anhidrosis	All Participants	6 months
Categorical	Adverse Event	Diarrhea	All Participants	6 months
Categorical	Adverse Event	Hair loss	All Participants	6 months
Categorical	Adverse Event	Hyperactivity	All Participants	6 months
Categorical	Adverse Event	Liver enzyme	All Participants	6 months
Categorical	Adverse Event	Nausea/vomiting	All Participants	6 months
Categorical	Adverse Event	Poor oral intake	All Participants	6 months
Categorical	Adverse Event	Psychomotor retardation	All Participants	6 months
Categorical	Adverse Event	Skin rash	All Participants	6 months
Categorical	Adverse Event	Sleepiness	All Participants	6 months
Categorical	Adverse Event	Withdrawal due to AE	All Participants	6 months
Categorical	Adverse Event	Hypohydrosis	All Participants	6 months

Outcome Details

1. For RCTs: Generation of randomization sequence

Seizure freedom

Seizure reduction/effective (>50% reduction)

Adverse Event

Adverse Event

Adverse Event

Adverse Event

Adverse Event

Adverse Event

Adverse Event

Adverse Event

Adverse Event

Adverse Event

Adverse Event

Adverse Event

2. For RCTs: Allocation concealment

Seizure freedom

Seizure reduction/effective (>50% reduction)

Adverse Event

Adverse Event

Adverse Event

Adverse Event

Adverse Event

Adverse Event

Adverse Event

Adverse Event

Adverse Event

Adverse Event

Adverse Event

Adverse Event

3. For RCTs: Baseline imbalance

Seizure freedom

Seizure reduction/effective (>50% reduction)

Adverse Event

Adverse Event

Adverse Event

Adverse Event

Adverse Event

Adverse Event

Adverse Event

Adverse Event

Adverse Event

Adverse Event

Adverse Event

Adverse Event

4. For RCTs: Patient blinded

Seizure freedom

Seizure reduction/effective (>50% reduction)

Adverse Event

Adverse Event

Adverse Event

Adverse Event

Adverse Event

Adverse Event

Adverse Event

Adverse Event

Adverse Event

Adverse Event

Adverse Event

Adverse Event

5. For RCTs: Staff blinded

Seizure freedom

Seizure reduction/effective (>50% reduction)

Adverse Event

Adverse Event

Adverse Event

Adverse Event

Adverse Event

Adverse Event

Adverse Event

Adverse Event

Adverse Event

Adverse Event

Adverse Event

Adverse Event

6. For RCTs: Differential ancillary treatments

Seizure freedom

Seizure reduction/effective (>50% reduction)

Adverse Event

Adverse Event

Adverse Event

Adverse Event

Adverse Event

Adverse Event

Adverse Event

Adverse Event

Adverse Event

Adverse Event

Adverse Event

Adverse Event

7. For RCTs: Adherence

Seizure freedom

Seizure reduction/effective (>50% reduction)

Adverse Event

Adverse Event

Adverse Event

Adverse Event

Adverse Event

Adverse Event

Adverse Event

Adverse Event

Adverse Event

Adverse Event

Adverse Event

Adverse Event

8. For RCTs: Analytic approach to address departures from intended intervention

Seizure freedom

Seizure reduction/effective (>50% reduction)

Adverse Event

Adverse Event

Adverse Event

Adverse Event

Adverse Event

Adverse Event

Adverse Event

Adverse Event

Adverse Event

Adverse Event

Adverse Event

Adverse Event

9. For RCTs: Data on at least 80% of those enrolled

Seizure freedom

Seizure reduction/effective (>50% reduction)

Adverse Event

Adverse Event

Adverse Event

Adverse Event

Adverse Event

Adverse Event

Adverse Event

Adverse Event

Adverse Event

Adverse Event

Adverse Event

Adverse Event

10. For RCTs: Differential dropout <=15%

Seizure freedom

Seizure reduction/effective (>50% reduction)

Adverse Event

Adverse Event

Adverse Event

Adverse Event

Adverse Event

Adverse Event

Adverse Event

Adverse Event

Adverse Event

Adverse Event

Adverse Event

Adverse Event

11. For RCTs: Standard way to measure the outcome

Seizure freedom

Seizure reduction/effective (>50% reduction)

Adverse Event

Adverse Event

Adverse Event

Adverse Event

Adverse Event

Adverse Event

Adverse Event

Adverse Event

Adverse Event

Adverse Event

Adverse Event

Adverse Event

12. For RCTs: Blinded outcome assessor

Seizure freedom

Seizure reduction/effective (>50% reduction)

Adverse Event

Adverse Event

Adverse Event

Adverse Event

Adverse Event

Adverse Event

Adverse Event

Adverse Event

Adverse Event

Adverse Event

Adverse Event

Adverse Event

13. For RCTs: Bias in selection of reported results

Seizure freedom

Seizure reduction/effective (>50% reduction)

Adverse Event

Adverse Event

Adverse Event

Adverse Event

Adverse Event

Adverse Event

Adverse Event

Adverse Event

Adverse Event

Adverse Event

Adverse Event

Adverse Event

14. For nonrandomized comparative studies: Confounding

Seizure freedom


	High

Seizure reduction/effective (>50% reduction)

Adverse Event


	High

Adverse Event


	High

Adverse Event


	High

Adverse Event


	High

Adverse Event


	High

Adverse Event


	High

Adverse Event


	High

Adverse Event


	High

Adverse Event


	High

Adverse Event


	High

Adverse Event


	High

Adverse Event


	High

15. For nonrandomized comparative studies: Selection into study

Seizure freedom


	Some concerns

Seizure reduction/effective (>50% reduction)

Adverse Event


	Some concerns

Adverse Event


	Some concerns

Adverse Event


	Some concerns

Adverse Event


	Some concerns

Adverse Event


	Some concerns

Adverse Event


	Some concerns

Adverse Event


	Some concerns

Adverse Event


	Some concerns

Adverse Event


	Some concerns

Adverse Event


	Some concerns

Adverse Event


	Some concerns

Adverse Event


	Some concerns

16. For nonrandomized comparative studies: Classification of interventions

Seizure freedom


	Low

Seizure reduction/effective (>50% reduction)

Adverse Event


	Low

Adverse Event


	Low

Adverse Event


	Low

Adverse Event


	Low

Adverse Event


	Low

Adverse Event


	Low

Adverse Event


	Low

Adverse Event


	Low

Adverse Event


	Low

Adverse Event


	Low

Adverse Event


	Low

Adverse Event


	Low

17. For nonrandomized comparative studies: Differential ancillary treatments

Seizure freedom


	Some concerns

Seizure reduction/effective (>50% reduction)

Adverse Event


	Some concerns

Adverse Event


	Some concerns

Adverse Event


	Some concerns

Adverse Event


	Some concerns

Adverse Event


	Some concerns

Adverse Event


	Some concerns

Adverse Event


	Some concerns

Adverse Event


	Some concerns

Adverse Event


	Some concerns

Adverse Event


	Some concerns

Adverse Event


	Some concerns

Adverse Event


	Some concerns

18. For nonrandomized comparative studies: Adherence

Seizure freedom


	Some concerns

Seizure reduction/effective (>50% reduction)

Adverse Event


	Some concerns

Adverse Event


	Some concerns

Adverse Event


	Some concerns

Adverse Event


	Some concerns

Adverse Event


	Some concerns

Adverse Event


	Some concerns

Adverse Event


	Some concerns

Adverse Event


	Some concerns

Adverse Event


	Some concerns

Adverse Event


	Some concerns

Adverse Event


	Some concerns

Adverse Event


	Some concerns

19. For nonrandomized comparative studies: Data on at least 80% of those enrolled

Seizure freedom


	Low

Seizure reduction/effective (>50% reduction)

Adverse Event


	Low

Adverse Event


	Low

Adverse Event


	Low

Adverse Event


	Low

Adverse Event


	Low

Adverse Event


	Low

Adverse Event


	Low

Adverse Event


	Low

Adverse Event


	Low

Adverse Event


	Low

Adverse Event


	Low

Adverse Event


	Low

20. For nonrandomized comparative studies: Differential dropout <=15%

Seizure freedom


	Low

Seizure reduction/effective (>50% reduction)

Adverse Event


	Low

Adverse Event


	Low

Adverse Event


	Low

Adverse Event


	Low

Adverse Event


	Low

Adverse Event


	Low

Adverse Event


	Low

Adverse Event


	Low

Adverse Event


	Low

Adverse Event


	Low

Adverse Event


	Low

Adverse Event


	Low

21. For nonrandomized comparative studies: Standard way to measure the outcome

Seizure freedom


	Low

Seizure reduction/effective (>50% reduction)

Adverse Event


	Low

Adverse Event


	Low

Adverse Event


	Low

Adverse Event


	Low

Adverse Event


	Low

Adverse Event


	Low

Adverse Event


	Low

Adverse Event


	Low

Adverse Event


	Low

Adverse Event


	Low

Adverse Event


	Low

Adverse Event


	Low

22. For nonrandomized comparative studies: Blinded outcome assessor

Seizure freedom


	Some concerns

Seizure reduction/effective (>50% reduction)

Adverse Event


	Some concerns

Adverse Event


	Some concerns

Adverse Event


	Some concerns

Adverse Event


	Some concerns

Adverse Event


	Some concerns

Adverse Event


	Some concerns

Adverse Event


	Some concerns

Adverse Event


	Some concerns

Adverse Event


	Some concerns

Adverse Event


	Some concerns

Adverse Event


	Some concerns

Adverse Event


	Some concerns

23. For nonrandomized comparative studies: Bias in selection of reported result

Seizure freedom


	Low

Seizure reduction/effective (>50% reduction)

Adverse Event


	Low

Adverse Event


	Low

Adverse Event


	Low

Adverse Event


	Low

Adverse Event


	Low

Adverse Event


	Low

Adverse Event


	Low

Adverse Event


	Low

Adverse Event


	Low

Adverse Event


	Low

Adverse Event


	Low

Adverse Event


	Low

24. For single arm studies: Does the design or analysis control account for important confounding and modifying variables through matching, stratification, multivariable analysis, or other approaches?

Seizure freedom

Seizure reduction/effective (>50% reduction)

Adverse Event

Adverse Event

Adverse Event

Adverse Event

Adverse Event

Adverse Event

Adverse Event

Adverse Event

Adverse Event

Adverse Event

Adverse Event

Adverse Event

25. For single arm studies: Did researchers rule out any impact from a concurrent intervention or an unintended exposure that might bias results?

Seizure freedom

Seizure reduction/effective (>50% reduction)

Adverse Event

Adverse Event

Adverse Event

Adverse Event

Adverse Event

Adverse Event

Adverse Event

Adverse Event

Adverse Event

Adverse Event

Adverse Event

Adverse Event

26. For single arm studies: Did the study maintain fidelity to the intervention protocol?

Seizure freedom

Seizure reduction/effective (>50% reduction)

Adverse Event

Adverse Event

Adverse Event

Adverse Event

Adverse Event

Adverse Event

Adverse Event

Adverse Event

Adverse Event

Adverse Event

Adverse Event

Adverse Event

27. For single arm studies: If attrition (overall or differential nonresponse, dropout, loss to follow-up, or exclusion of participants) was a concern, were missing data handled appropriately (e.g., intention-to-treat analysis and imputation)?

Seizure freedom

Seizure reduction/effective (>50% reduction)

Adverse Event

Adverse Event

Adverse Event

Adverse Event

Adverse Event

Adverse Event

Adverse Event

Adverse Event

Adverse Event

Adverse Event

Adverse Event

Adverse Event

28. For single arm studies: Were the outcome assessors blinded to the intervention or exposure status of participants?

Seizure freedom

Seizure reduction/effective (>50% reduction)

Adverse Event

Adverse Event

Adverse Event

Adverse Event

Adverse Event

Adverse Event

Adverse Event

Adverse Event

Adverse Event

Adverse Event

Adverse Event

Adverse Event

29. For single arm studies: Were interventions/exposures assessed/defined using valid and reliable measures, implemented consistently across all study participants?

Seizure freedom

Seizure reduction/effective (>50% reduction)

Adverse Event

Adverse Event

Adverse Event

Adverse Event

Adverse Event

Adverse Event

Adverse Event

Adverse Event

Adverse Event

Adverse Event

Adverse Event

Adverse Event

30. For single arm studies: Were outcomes assessed/defined using valid and reliable measures, implemented consistently across all study participants?

Seizure freedom

Seizure reduction/effective (>50% reduction)

Adverse Event

Adverse Event

Adverse Event

Adverse Event

Adverse Event

Adverse Event

Adverse Event

Adverse Event

Adverse Event

Adverse Event

Adverse Event

Adverse Event

31. For single arm studies: Were confounding variables assessed using valid and reliable measures, implemented consistently across all study participants?

Seizure freedom

Seizure reduction/effective (>50% reduction)

Adverse Event

Adverse Event

Adverse Event

Adverse Event

Adverse Event

Adverse Event

Adverse Event

Adverse Event

Adverse Event

Adverse Event

Adverse Event

Adverse Event

32. For single arm studies: Were the potential outcomes prespecified by the researchers? Are all prespecified outcomes reported?

Seizure freedom

Seizure reduction/effective (>50% reduction)

Adverse Event

Adverse Event

Adverse Event

Adverse Event

Adverse Event

Adverse Event

Adverse Event

Adverse Event

Adverse Event

Adverse Event

Adverse Event

Adverse Event

Risk of Bias Assessment

1. For Risk of Bias Assessment results, see Outcome Details section.

Results

Categorical

Seizure freedom

All Participants
		Descriptive Statistics			Between Arm Comparisons
		Topiramate	Carbamazepine
6 months
	Total (N analyzed)			Odds Ratio (OR)
	Events			95% CI low (OR)
	Percentage			95% CI high (OR)
				p value
		Within Arm Comparisons			Net Comparisons
		Topiramate	Carbamazepine

Seizure reduction/effective (>50% reduction)

All Participants
		Descriptive Statistics			Between Arm Comparisons
		Topiramate	Carbamazepine
Baseline
	Total (N analyzed)			Odds Ratio (OR)
	Events			95% CI low (OR)
	Percentage			95% CI high (OR)
				p value
		Within Arm Comparisons			Net Comparisons
		Topiramate	Carbamazepine

Adverse Event (Anhidrosis)

All Participants
		Descriptive Statistics			Between Arm Comparisons
		Topiramate	Carbamazepine
6 months
	Total (N analyzed)			Odds Ratio (OR)
	Events			95% CI low (OR)
	Percentage			95% CI high (OR)
				p value
		Within Arm Comparisons			Net Comparisons
		Topiramate	Carbamazepine

Adverse Event (Diarrhea)

All Participants
		Descriptive Statistics			Between Arm Comparisons
		Topiramate	Carbamazepine
6 months
	Total (N analyzed)			Odds Ratio (OR)
	Events			95% CI low (OR)
	Percentage			95% CI high (OR)
				p value
		Within Arm Comparisons			Net Comparisons
		Topiramate	Carbamazepine

Adverse Event (Hair loss)

All Participants
		Descriptive Statistics			Between Arm Comparisons
		Topiramate	Carbamazepine
6 months
	Total (N analyzed)			Odds Ratio (OR)
	Events			95% CI low (OR)
	Percentage			95% CI high (OR)
				p value
		Within Arm Comparisons			Net Comparisons
		Topiramate	Carbamazepine

Adverse Event (Hyperactivity)

All Participants
		Descriptive Statistics			Between Arm Comparisons
		Topiramate	Carbamazepine
6 months
	Total (N analyzed)			Odds Ratio (OR)
	Events			95% CI low (OR)
	Percentage			95% CI high (OR)
				p value
		Within Arm Comparisons			Net Comparisons
		Topiramate	Carbamazepine

Adverse Event (Liver enzyme)

All Participants
		Descriptive Statistics			Between Arm Comparisons
		Topiramate	Carbamazepine
6 months
	Total (N analyzed)			Odds Ratio (OR)
	Events			95% CI low (OR)
	Percentage			95% CI high (OR)
				p value
		Within Arm Comparisons			Net Comparisons
		Topiramate	Carbamazepine

Adverse Event (Nausea/vomiting)

All Participants
		Descriptive Statistics			Between Arm Comparisons
		Topiramate	Carbamazepine
6 months
	Total (N analyzed)			Odds Ratio (OR)
	Events			95% CI low (OR)
	Percentage			95% CI high (OR)
				p value
		Within Arm Comparisons			Net Comparisons
		Topiramate	Carbamazepine

Adverse Event (Poor oral intake)

All Participants
		Descriptive Statistics			Between Arm Comparisons
		Topiramate	Carbamazepine
6 months
	Total (N analyzed)			Odds Ratio (OR)
	Events			95% CI low (OR)
	Percentage			95% CI high (OR)
				p value
		Within Arm Comparisons			Net Comparisons
		Topiramate	Carbamazepine

Adverse Event (Psychomotor retardation)

All Participants
		Descriptive Statistics			Between Arm Comparisons
		Topiramate	Carbamazepine
6 months
	Total (N analyzed)			Odds Ratio (OR)
	Events			95% CI low (OR)
	Percentage			95% CI high (OR)
				p value
		Within Arm Comparisons			Net Comparisons
		Topiramate	Carbamazepine

Adverse Event (Skin rash)

All Participants
		Descriptive Statistics			Between Arm Comparisons
		Topiramate	Carbamazepine
6 months
	Total (N analyzed)			Odds Ratio (OR)
	Events			95% CI low (OR)
	Percentage			95% CI high (OR)
				p value
		Within Arm Comparisons			Net Comparisons
		Topiramate	Carbamazepine

Adverse Event (Sleepiness)

All Participants
		Descriptive Statistics			Between Arm Comparisons
		Topiramate	Carbamazepine
6 months
	Total (N analyzed)			Odds Ratio (OR)
	Events			95% CI low (OR)
	Percentage			95% CI high (OR)
				p value
		Within Arm Comparisons			Net Comparisons
		Topiramate	Carbamazepine

Adverse Event (Withdrawal due to AE)

All Participants
		Descriptive Statistics			Between Arm Comparisons
		Topiramate	Carbamazepine
6 months
	Total (N analyzed)			Odds Ratio (OR)
	Events			95% CI low (OR)
	Percentage			95% CI high (OR)
				p value
		Within Arm Comparisons			Net Comparisons
		Topiramate	Carbamazepine

Adverse Event (Hypohydrosis)

All Participants
		Descriptive Statistics			Between Arm Comparisons
		Topiramate	Carbamazepine
6 months
	Total (N analyzed)			Odds Ratio (OR)
	Events			95% CI low (OR)
	Percentage			95% CI high (OR)
				p value
		Within Arm Comparisons			Net Comparisons
		Topiramate	Carbamazepine