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. 2014 May 7;2014(5):CD005062. doi: 10.1002/14651858.CD005062.pub4

Mao 2011.

Methods Randomised controlled trial, parallel groups
Study period: March 2004 to March 2009
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
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