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 |
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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 |
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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 |