Ma 2001.
Methods | Randomised controlled trial, parallel groups | |
Participants | Setting: hospital inpatients and outpatients Treatment group: (boys): 30 (23) Control group (boys): 30 (18) Age: Treatment group: < 5 years (4), 5 to 10 years (6), 10 to 16 years (20); Control group: < 5 years (2), 5 to 10 years (9), 10 to 16 years (19) Inclusion: generalized epilepsy, < 16 years Seizure type: generalized epilepsy Duration of epilepsy: Treatment group: < 1 year (10), 1 to 5 years (12), 5 to 10 years (5), 10 to 15 years (3); Control group: < 1 year (13), 1 to 5 (10), 5 to 10 years (5), 10 to 15 years (2) Aetiology of epilepsy: Treatment group: antenatal problems (2), caesarian section (5), forceps delivery (2), birth asphyxia (4), history of febrile convulsion (8), history of trauma (6), history of brain disorder (4), mental retardation (2), history of intoxication (2), history of phobia (2), family history of epilepsy (1); Control group: antenatal problems (5), caesarian section (5), forceps delivery (2), birth asphyxia (5), history of febrile convulsion (7), history of trauma (5), history of brain disorder (5), mental retardation (1), history of intoxication (6), history of phobia (2), family history of epilepsy (1), prematurity (1), history of hypocalcaemic seizure (1) Baseline seizure frequency: Treatment group: > 1/day (12), 1 to 6/week (7), 1 to 3/month (6), 1/1 to 2 months (2), 1/2 to 4 months (1), 1/4 to 6 months (2); Control group: > 1/day (5), 1 to 6/week (3), 1 to 3/month (9), 1/1 to 2 months (4), 1/2 to 4 months (6), 1/4 to 6 months (3) Number of AEDs taken: not available |
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Interventions | Treatment group: acupuncture + mixed Chinese herbal capsule (Xi Feng capsule). Acupuncture at 6 points for 30 minutes, daily for 8 days then rest for 2 days then begin another course. Additional acupuncture at 1or 2 acupoints depending on Traditional Chinese Medicine diagnosis. Xi Feng capsule to be taken 3 times at age‐dependent dosage: < 1 year (1 tab), 1 to 3 years (2 tabs), 4 to 16 years (age‐1 tabs, max 8 tabs) Control group: Xi Feng capsule alone Duration of treatment: 6 months | |
Outcomes | 75% or greater reduction in seizure frequency
50% or greater reduction in seizure frequency
25% or greater reduction in seizure frequency 75% or greater reduction in seizure duration 50% or greater reduction in seizure duration 4 points or greater improvement in EEG 2 points or greater improvement in EEG Post‐treatment EEG abnormality: severe, moderate, mild, borderline |
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Notes | Duration of follow‐up: 6 months | |
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 treatment and the control groups were not comparable at baseline since the treatment group had more frequent seizures. 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 |