Abstract
BACKGROUND: Refractory epilepsy (RE) remains a significant topic in neurology. With the advantages of multi-target mechanisms and higher compliance in traditional Chinese medicine (TCM), RE patients shift their focus to this therapy. However, contradictions exist between reported efficacy and safety. The purpose of this meta-analysis was to evaluate the efficacy and safety of integrated traditional Chinese and Western medicine in RE. METHODS: Seven databases (CNKI, Wanfang, VIP, PubMed, Web of Science, Cochrane Library, Embase) were searched from inception to March 2023 in English or Chinese. The primary outcomes were epilepsy frequency, clinical efficacy (total effective rate). The secondary outcomes were quality of life score, TCM symptom score, electroencephalogram abnormality rates, epilepsy duration, and incidence of adverse reactions. We performed meta-analysis with fixed- or random-effects model based on heterogeneity (I2 > 50% or P < .10). Heterogeneity was detected by subgroup analysis and sensitivity analysis. The risk of bias tool was used to quality assessment. Trial sequential analysis (TSA) was performed with primary outcome. We conducted a Grading of Recommendations Assessment, Development, and Evaluation assessment for all outcomes in this meta-analysis. RESULTS: Twenty randomized controlled trials (RCTs) with 1521 RE patients were included, with 760 cases in the treatment group and 761 cases in the control group. Meta-analysis showed that the treatment group for RE reduced epilepsy frequency [MD = -2.37, 95% Cl = (-3.17, -1.57), P < .00001]; alleviated clinical symptoms [MD = -2.32, 95% Cl = (-4.13, -0.51), P = .01]; shortened the duration of epilepsy [MD = -1.20, 95% Cl = (-1.71, -0.68), P < .00001]; improved clinical outcome [RR = 1.27, 95% Cl = (1.19, 1.35), P < .00001]; and improved quality of life [MD = 4.45, 95% Cl = (1.60, 7.30), P = .002]. However, there was no statistically significant difference between the treatment and control groups in the improvement of electroencephalogram abnormalities [RR = 0.87, 95% Cl = (0.70, 1.10), P = .25] and the incidence of adverse effects [RR = 0.75, 95% Cl = (0.48, 1.16), P = .19]. TSA analysis confirmed the clinical efficacy of the primary outcome measure. CONCLUSION: The combination of traditional Chinese and Western medicine may be an effective treatment option for RE, but further studies are needed to be assessed.