Deng 2001a.
Methods | Randomised controlled trial, parallel groups | |
Participants | Setting: hospital patients Treatment group (males): 64 (30) Control group (males): 65 (28) Age: Treatment group: mean 21.75 (SD 12.03) years; Control group: mean 22.43 (SD 13.25) years Inclusion: generalized tonic‐clonic epilepsy Exclusion: none Seizure type: generalized tonic‐clonic epilepsy Duration of epilepsy: Treatment group: mean 7.36 ± 7.03 years; Control group: mean 7.85 ± 8.02 years Aetiology of epilepsy: not available Baseline seizure frequency: not available Number of AEDs taken: not available |
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Interventions | Treatment group: catgut implantation at 3 to 4 of 7 acupoints, every 25 to 30 days, for 4 to 5 times, plus carbamazepine or valproate at half doses + aminobutyric acid 500 mg 2 to 3 times/day + vitamin B6 20 to 30 mg 2 to 3 times/day + cinnarizine 25 to 50 mg 2 to 3 times/day Control group: carbamazepine 100 to 200 mg 2 to 3 times/day or valproate 200 mg 2 to 3 times/day +aminobutyric acid 500 mg 2 to 3 times/day + Vitamin B6 20 to 30 mg 2 to 3 times/day + cinnarizine 25‐50 mg 2 to 3 times/day Duration of treatment: 1 year | |
Outcomes | Seizure freedom: Treatment group 75% or greater reduction in seizure frequency 50% or greater reduction in seizure frequency 25% or greater reduction in seizure frequency Post‐treatment EEG abnormality: severe, moderate, mild |
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Notes | Duration of follow‐up: 1 year | |
Risk of bias | ||
Bias | Authors' judgement | Support for judgement |
Random sequence generation (selection bias) | Low risk | Randomisation was done by computer‐generated random number |
Allocation concealment (selection bias) | Unclear risk | Allocation concealment was not described |
Blinding (performance bias and detection bias) All outcomes | High risk | The participants and personnel and outcome assessors were not blinded |
Blinding of participants and personnel (performance bias) All outcomes | High risk | The participants and personnel and outcome assessors were not blinded |
Blinding of outcome assessment (detection bias) All outcomes | High risk | The outcome assessors were not blinded |
Incomplete outcome data (attrition bias) All outcomes | Low risk | There were no dropouts |
Selective reporting (reporting bias) | Low risk | All outcomes were reported |
Other bias | High risk | Comparability of the groups at baseline was uncertain since there were no data on aetiology of epilepsy, current AED treatments, and frequency of seizures at baseline. There was no sham or placebo control and hence there might be placebo effect which causes bias. Treatment was variable within the treatment group and might introduce bias |