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

Zhang 2006b.

Methods Randomised controlled trial, parallel groups
Participants Setting: hospital inpatients and outpatients
Treatment group 1 (catgut implantation at acupoints) (males): 50 (27)
 Treatment group 2 (needle acupuncture) (males): 50 (25)
 Control group (males): 50 (24)
 Age: Treatment group 1: 15 to 30 years (28), 30 to 45 years (19), 45 to 60 years (3); Treatment roup 2: 15 to 30 years (30), 30 to 45 years (13), 45 to 60 years (7); Control group: 15 to 30 years (26), 30 to 45 years (20), 45 to 60 years (4)
 Inclusion: aged 15 to 60 years, generalized tonic‐clonic epilepsy, informed consent signed
 Exclusion: no seizure within past 6 months, received treatment that may affect current study, concomitant diseases of heart, liver, spleen, lung, or kidney, or brain tumour or psychiatric diseases, or bleeding disorders, cannot comply with study treatment
 Seizure type: generalized tonic‐clonic epilepsy
 Duration of epilepsy Treatment group 1: < 5years (24), 5 to 10 years (20), > 10 years (6); Treatment group 2: < 5years (28), 5 to 10 years (13), > 10 years (9) Control group: < 5years (25), 5 to 10 years (19), > 10 years (6)
Aetiology of epilepsy: not available
 Baseline seizure frequency: not available
 Number of AEDs taken: not available
Interventions Treatment group 1: catgut implantation in 9 acupoints (9 points were divided into 3 groups, each group was used in alternate cycle), plus 1 additional acupoints according to Traditional Chinese Medicine diagnosis. Implantation once every 15 days
 Treatment group 2: needle acupuncture at same acupoints, needle left in place for 20 minutes. Treatment applied once daily on alternate days
 Control group: Sodium valproate 200 mg tds
 Duration of treatment: 3 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
70% or greater reduction in epilepsy score
 40% or greater reduction in epilepsy score
 20% or greater reduction in epilepsy score
 Post‐treatment epilepsy score
Post‐treatment quality of life score (QOLIE‐31 score)
Post‐treatment EEG abnormality: severe, moderate, mild
Frequency of adverse effects: dizziness, malaise, nausea, anorexia, impaired concentration, sleepiness
Notes Duration of follow‐up: 3 months
Risk of bias
Bias Authors' judgement Support for judgement
Random sequence generation (selection bias) Low risk Randomization was done by computer‐generated random number
Allocation concealment (selection bias) Low risk Allocation was concealed by sealed opaque envelopes
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 The comparability of the groups at baseline was questionable 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