Mao 2011.
Methods | Randomised controlled trial, parallel groups Study period: March 2004 to March 2009 |
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Participants | Setting: hospital outpatients Treatment group (males): 30 (16) Control group (males): 22 (12) Age: Treatment group : mean 29.93.56 (SD 14.31) years; Control group: mean 33.62 (SD 16.17) years Inclusion: generalized tonic‐clonic epilepsy Exclusion: partial epilepsy, pseudoseizure, syncope, migraine, transient ischemic attack, hyperventilation, hepatic or renal dysfunction Seizure type: generalized tonic‐clonic epilepsy Duration of epilepsy: Treatment group: mean 16.45 (SD 11.05) years; Control group: mean 15.89 (SD 9.62) years Aetiology of epilepsy: not available Baseline seizure frequency: Treatment group: mean 5.17 (SD 1.91) times/year; Control group: mean 5.27 (SD 1.96) times/year Number of AEDs taken: not available |
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Interventions | Treatment group: catgut implantation in 4 acupoints, plus 1‐3 additional acupoints according to Traditional Chinese Medicine diagnosis. Implantation once every month for 6 months. Valproate 2 g/day divided into 2 doses for adults, 50mg/kg/day divided into 3 doses for children, for 1 year Control group: Valproate 2 g/day divided into 2 doses for adults, 50mg/kg/day divided into 3 doses for children, for 1 year Duration of treatment: 12 months | |
Outcomes | Seizure freedom 75% or greater reduction in seizure frequency 50% or greater reduction in seizure frequency 25% or greater reduction in seizure frequency Post‐treatment seizure frequency (times/year) | |
Notes | Duration of follow‐up: 12 months | |
Risk of bias | ||
Bias | Authors' judgement | Support for judgement |
Random sequence generation (selection bias) | Low risk | Allocation to treatment groups according to 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 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 groups at baseline was uncertain since there were no data on aetiology of epilepsy and current AED treatments. 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 |