Han 2008.
Methods | Randomised controlled trial, parallel groups | |
Participants | Setting: hospital patients Treatment group (males): 85 (45) Control group (males): 85 (53) Age: Treatment group: mean 33.4 (SD 20.15) years; Control group: mean 34.9 (SD 15.57) years Inclusion: generalized epilepsy Exclusion: none Seizure type: generalized epilepsy Duration of epilepsy: not available Aetiology of epilepsy: not available Baseline seizure frequency: not available Number of AEDs taken: not available |
|
Interventions | Treatment group: catgut implantation at 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, applied every 15 days Control group: sodium valproate 200 mg tds Duration of treatment: 90 days | |
Outcomes | 30% or greater reduction in epilepsy score Post‐treatment epilepsy score |
|
Notes | Duration of follow‐up: 3 months | |
Risk of bias | ||
Bias | Authors' judgement | Support for judgement |
Random sequence generation (selection bias) | High risk | Allocation to treatment groups according to sequence of attendance (quasi‐random) |
Allocation concealment (selection bias) | High risk | Allocation to treatment groups was done according to sequence of attendance and hence allocation was considered not concealed |
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 | Comparability of the groups at baseline was uncertain since there were no data on aetiology and duration 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 |