Department of Orthopaedic, Panzhihua Central Hospital, Panzhihua, Sichuan Province, China.
Medicine (Baltimore). 2024 Apr 19;103(16):e37865. doi: 10.1097/MD.0000000000037865.
There has been growing interest in using the traditional Chinese herb Buyang Huanwu Decoction (BHD) as a potential treatment for spinal cord injury (SCI), owing to its long-used treatment for SCI in China. However, the efficacy and safety of BHD treatment for SCI remain widely skeptical. This meta-analysis aims to assess the safety and efficacy of BHD in managing SCI.
A comprehensive literature search was conducted across several databases, including PubMed, EMBASE, Cochrane Library, CNKI, Wanfang, VIP, and Sinomed, up to January 1, 2024. Randomized controlled clinical trials evaluating the safety or efficacy of BHD in SCI treatment were included. The analysis focused on 8 critical endpoints: Patient-perceived total clinical effective rate, American Spinal Cord Injury Association (ASIA) sensory score, ASIA motor score, somatosensory evoked potential, motor evoked potential, visual analog scale pain score, Japanese Orthopaedic Association score, and adverse events.
Thirteen studies comprising 815 participants met the inclusion criteria. No significant heterogeneity or publication bias was observed across the trials. The findings revealed significant improvements in the patient-perceived total clinical effective rate (OR = 3.77; 95% confidence interval [CI] = [2.43, 5.86]; P < .001), ASIA sensory score (mean difference [MD] = 8.22; 95% CI = [5.87, 10.56]; P < .001), ASIA motor score (MD = 7.16; 95% CI = [5.15, 9.18]; P < .001), somatosensory evoked potential (MD = 0.25; 95% CI = [0.03, 0.48]; P = .02), motor evoked potential (MD = 0.30; 95% CI = [0.14, 0.46]; P = .0002), and Japanese Orthopaedic Association score (MD = 1.99; 95% CI = [0.39, 3.58]; P = .01) in the BHD combination group compared to the control group. Additionally, there was a significant reduction in visual analog scale pain scores (MD = -0.81; 95% CI = [-1.52, -0.11]; P = .02) with BHD combination treatment, without a significant increase in adverse effects (OR = 0.68; 95% CI = [0.33, 1.41]; P = .3).
The current evidence suggests that BHD is effective and safe in treating SCI, warranting consideration as a complementary and alternative therapy. However, given the low methodological quality of the included studies, further rigorous research is warranted to validate these findings.
由于在中国长期用于治疗脊髓损伤（SCI），因此人们对使用中药补阳还五汤（BHD）作为治疗 SCI 的潜在疗法越来越感兴趣。然而，BHD 治疗 SCI 的疗效和安全性仍然存在广泛的质疑。本荟萃分析旨在评估 BHD 治疗 SCI 的安全性和疗效。
对包括 PubMed、EMBASE、Cochrane 图书馆、CNKI、万方、VIP 和 Sinomed 在内的多个数据库进行了全面的文献检索，检索时间截至 2024 年 1 月 1 日。纳入评估 BHD 治疗 SCI 安全性或疗效的随机对照临床试验。分析集中在 8 个关键终点：患者感知的总临床有效率、美国脊髓损伤协会（ASIA）感觉评分、ASIA 运动评分、体感诱发电位、运动诱发电位、视觉模拟评分疼痛评分、日本矫形协会评分和不良事件。
符合纳入标准的 13 项研究共纳入 815 名参与者。各试验之间无显著异质性或发表偏倚。研究结果表明，患者感知的总临床有效率（OR=3.77；95%置信区间[CI]：[2.43, 5.86]；P<0.001）、ASIA 感觉评分（MD=8.22；95%CI：[5.87, 10.56]；P<0.001）、ASIA 运动评分（MD=7.16；95%CI：[5.15, 9.18]；P<0.001）、体感诱发电位（MD=0.25；95%CI：[0.03, 0.48]；P=0.02）、运动诱发电位（MD=0.30；95%CI：[0.14, 0.46]；P=0.0002）和日本矫形协会评分（MD=1.99；95%CI：[0.39, 3.58]；P=0.01）有显著改善在 BHD 联合组与对照组相比。此外，BHD 联合治疗可显著降低视觉模拟评分疼痛评分（MD=-0.81；95%CI：[-1.52, -0.11]；P=0.02），且不良事件发生率无显著增加（OR=0.68；95%CI：[0.33, 1.41]；P=0.3）。
目前的证据表明，BHD 治疗 SCI 有效且安全，值得作为一种补充和替代疗法考虑。然而，鉴于纳入研究的方法学质量较低，需要进一步进行严格的研究来验证这些发现。
