Summary of findings 2. Summary of findings: needle acupuncture plus valproate versus valproate alone.
| Needle acupuncture plus valproate compared with valproate alone for epilepsy | ||||||
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Patient or population: participants with generalised epilepsy Settings: hospital outpatients (one included study recruited outpatients only, the other included study did not specify the patient settings) Intervention: Needle acupuncture plus valproate Comparison: Valproate alone | ||||||
| Outcomes | Illustrative comparative risks* (95% CI) | Relative effect (95% CI) | No of Participants (studies) | Quality of the evidence (GRADE) | Comments | |
| Assumed risk | Corresponding risk | |||||
| valproate alone | Needle acupuncture plus valproate | |||||
|
Seizure freedom (follow‐up: 3‐6 months) |
136 per 1000 | 132 per 1000 (97 to 177) | RR 0.97 (0.72 to 1.30) | 150 (2) | ⊕⊕⊕⊝ moderatea | |
|
50% or greater reduction in seizure frequency (follow‐up: 3‐6 months) |
556 per 1000 | 745 per 1000 (289 to 1000) | RR 1.34 (0.52 to 3.48) | 150 (2) | ⊕⊕⊝⊝ lowb | |
|
Post‐treatment quality of life (QOLIE‐31 score, which has a range of 0‐200, with higher score indicates better quality of life) (follow‐up: 6 months) |
The mean post‐treatment quality of life across control groups ranged from 170.22 to 172.6 points. | The mean post‐treatment quality of life in the intervention group was 10.1 points higher (2.51 points higher to 17.69 points higher). | 90 (1) |
⊕⊕⊝⊝ lowb | ||
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Frequency of adverse effects ‐ dizziness (follow‐up: 6 months) |
160 per 1000 | 107 per 1000 (19 to 608) | RR 0.67 (0.12 to 3.80) | 90 (1) | ⊕⊕⊝⊝ lowb | |
|
Frequency of adverse effects ‐ malaise (follow‐up: 6 months) |
233 per 1000 | 193 per 1000 (62 to 592) | RR 0.83 (0.27 to 2.54) | 90 (1) | ⊕⊕⊝⊝ lowb | |
|
Frequency of adverse effects ‐ nausea (follow‐up: 6 months) |
140 per 1000 | 96 per 1000 (21 to 331) | RR 0.60 (0.15 to 2.36) | 90 (1) | ⊕⊕⊝⊝ lowb | |
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Frequency of adverse effects ‐ sleepiness (follow‐up: 6 months) |
119 per 1000 | 84 per 1000 (28 to 248) | RR 0.71 (0.24 to 2.08) | 90 (1) | ⊕⊕⊝⊝ lowb | |
| *The basis for the assumed risk (e.g. the median control group risk across studies) is provided in footnotes. The corresponding risk (and its 95% confidence interval) is based on the assumed risk in the comparison group and the relative effect of the intervention (and its 95% CI). CI: Confidence interval; RR: Risk Ratio. | ||||||
| GRADE Working Group grades of evidence High quality: Further research is very unlikely to change our confidence in the estimate of effect. Moderate quality: Further research is likely to have an important impact on our confidence in the estimate of effect and may change the estimate. Low quality: Further research is very likely to have an important impact on our confidence in the estimate of effect and is likely to change the estimate. Very low quality: We are very uncertain about the estimate. | ||||||
a. Evidence from RCT downgraded by one level because of high risk of bias in study design.
b. Evidence from RCT downgraded by two levels because of high risk of bias in study design and imprecise result.