Leng 2000.
Methods | Randomised controlled trial, parallel groups | |
Participants | Setting: hospital patients Treatment group (males): 86 (67) Control group (males): 32 (21) Age: Treatment group: mean 29.7 (range 3 to 43) years; Control group: mean 28 (range 17 to 45) years Inclusion: generalized epilepsy Exclusion: none Seizure type: generalized epilepsy Duration of epilepsy: Treatment group: 3 days to 4 years; Control group: 7 days to 3 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 9 acupoints monthlyControl group: Na valproate 100 mg bd Duration of treatment: 6 months | |
Outcomes | Seizure freedom 50% or greater reduction in seizure frequency | |
Notes | Duration of follow‐up: 1 year | |
Risk of bias | ||
Bias | Authors' judgement | Support for judgement |
Random sequence generation (selection bias) | Unclear risk | Random sequence generation was not described |
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 | 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 |