Details of Chinese herbal medicine (n = 10).

ObjectiveTo evaluate the efficacy and safety of herbal medicine and acupuncture combination for pediatric epilepsy treatment.MethodsDatabases were searched from their interception until October 2023 to identify randomized controlled trials focusing on the therapeutic efficacy of herbal medicine-acupuncture combination (intervention group) for pediatric epilepsy. The primary outcome was the risk of treatment failure, whereas the secondary outcomes included the risk of post-treatment electroencephalogram (EEG) abnormalities and adverse events. Subgroup analyses were conducted based on the type of herbal compound formulas. Meta-regression analysis was conducted to examine the influence of patient demographics and clinical history on the therapeutic efficacy of herbal medicine-acupuncture combination for pediatric epilepsy. To assess the cumulative evidence, trial sequential analysis (TSA) was performed.ResultsThe analysis included 10 trials involving a total of 882 pediatric patients. Meta-analysis revealed that the intervention group had a lower risk of treatment failure than the control group (risk ratio [RR] = 0.3, 95% confidence interval [CI]: 0.19–0.47, PI2 = 0%, 10 trials). Subgroup analyses showed that therapeutic efficacy was consistent among the different herbal compound formulas. Meta-regression analysis revealed that the efficacy of the treatments did not significantly vary with patient age, male sex, and duration of seizure history. TSA suggested that herbal medicine-acupuncture combination exerted a robust and conclusive effect on seizure treatment. Although the combined used of herbal medicine and acupuncture was not associated with a lower risk of post-treatment EEG abnormalities (RR = 0.82, 95%CI:0.6–1.11, P = 0.2, 3 trials), the risk of adverse events was reduced (RR = 0.27, 95%CI:0.18–0.41, PConclusionThe meta-analysis suggested that combined use of herbal medicine and acupuncture is a promising and safe clinical approach for pediatric epilepsy treatment. Further large-scale studies are necessary to conclusively determine the efficacy and safety of herbal medicine and acupuncture in pediatric epilepsy treatment.

研究目的：本研究旨在评估中药联合针灸治疗小儿癫痫的有效性与安全性。
研究方法：检索各数据库自建库起始至2023年10月的文献，筛选以中药-针灸联合疗法为干预措施、针对小儿癫痫治疗有效性的随机对照试验（randomized controlled trial）。本研究的主要结局指标为治疗失败风险，次要结局指标包括治疗后脑电图（electroencephalogram, EEG）异常风险与不良事件发生风险。根据中药复方的类型开展亚组分析，采用Meta回归分析探究患者人口学特征与临床病史对中药-针灸联合疗法治疗小儿癫痫疗效的影响。为评估累积证据质量，采用试验序贯分析（trial sequential analysis, TSA）。
研究结果：本分析共纳入10项随机对照试验，共计882名儿科患者。Meta分析结果显示，干预组的治疗失败风险显著低于对照组（风险比[RR]=0.30，95%置信区间[CI]：0.19~0.47，I²=0%，共10项试验）。亚组分析结果表明，不同中药复方类型的治疗疗效具有一致性。Meta回归分析显示，患者年龄、男性占比与癫痫发作病程对该联合疗法的疗效无显著影响。试验序贯分析结果提示，中药联合针灸对癫痫发作的治疗效果确切且稳健。尽管中药与针灸联合使用未显著降低治疗后脑电图异常风险（RR=0.82，95%CI：0.60~1.11，P=0.20，共3项试验），但可显著降低不良事件发生风险（RR=0.27，95%CI：0.18~0.41，P[原文未完整标注]）。
研究结论：本Meta分析表明，中药联合针灸是一种颇具前景且安全的小儿癫痫临床治疗方案。未来仍需开展大规模研究，以确切明确中药联合针灸治疗小儿癫痫的有效性与安全性。