Lee Boram, Leem Jungtae, Kim Hyunho, Jo Hee-Geun, Kwon Chan-Young
Clinical Medicine Division, Korea Institute of Oriental Medicine, Daejeon, South Korea.
Research and Development Institute, CY Pharma Co., Seoul, South Korea.
Front Neurol. 2020 Sep 18;11:772. doi: 10.3389/fneur.2020.00772. eCollection 2020.
This systematic review aimed to evaluate the effectiveness (functional outcomes and clinical symptoms) and safety (incidence of adverse events) of herbal medicine (HM) as monotherapy or adjunctive therapy to conventional treatment (CT) for traumatic brain injury (TBI). We comprehensively searched 14 databases from their inception until July 2019. Randomized controlled trials (RCTs) using HM as monotherapy or adjunctive therapy to treat TBI patients were included. The primary outcome was functional outcomes, consciousness state, morbidity, and mortality. Meta-analysis was performed to calculate a risk ratio (RR) or mean difference (MD) with 95% confidence intervals (CIs), when appropriate data were available. Methodological quality of RCTs and the strength of evidence were also assessed. Thirty-seven RCTs with 3,374 participants were included. According to meta-analysis, HM as a monotherapy (RR 1.29, 95% CI: 1.21-1.37) or an adjunctive therapy to CT (RR 1.21, 95% CI: 1.16-1.27) showed significantly better total effective rate based on clinical symptoms, compared to CT alone. Subgroup analysis showed that HM had significantly improved post-concussion syndrome, dizziness, headache, epilepsy, and mild TBI, but not traumatic brain edema, compared to CT. Moreover, HM combined with CT had significantly improved post-concussion syndrome, mental disorder, headache, epilepsy, and mild TBI-like symptoms, but not cognitive dysfunction and posttraumatic hydrocephalus, compared to CT alone. When HM was combined with CT, functional outcomes such as activities of daily living and neurological function were significantly better than in patients treated using CT alone. In terms of the incidence of adverse events, HM did not differ from either CT (RR 0.88, 95% CI: 0.33-2.30) or placebo (RR 2.29, 95% CI: 0.83-6.32). However, HM combined with CT showed better safety profile than CT alone (RR 0.64, 95% CI: 0.44-0.93). Most studies had a high risk of performance bias, and the quality of evidence was mostly rated "very low" to "moderate," mostly because the included studies had a high risk of bias and imprecise quantitative synthesis results. The current evidence suggests that there is insufficient evidence for recommending HM for TBI in clinical practice. Therefore, further larger, high-quality, rigorous RCTs should be conducted.
本系统评价旨在评估草药（HM）作为单一疗法或辅助常规治疗（CT）用于治疗创伤性脑损伤（TBI）的有效性（功能结局和临床症状）及安全性（不良事件发生率）。我们全面检索了14个数据库，检索时间从建库至2019年7月。纳入使用HM作为单一疗法或辅助疗法治疗TBI患者的随机对照试验（RCT）。主要结局为功能结局、意识状态、发病率和死亡率。当有合适数据时，进行荟萃分析以计算风险比（RR）或均值差（MD）及95%置信区间（CI）。还评估了RCT的方法学质量和证据强度。共纳入37项RCT，涉及3374名参与者。根据荟萃分析，与单纯CT相比，HM作为单一疗法（RR 1.29，95%CI：1.21 - 1.37）或CT的辅助疗法（RR 1.21，95%CI：1.16 - 1.27）基于临床症状显示出显著更高的总有效率。亚组分析表明，与CT相比，HM显著改善了脑震荡后综合征、头晕、头痛、癫痫和轻度TBI，但未改善创伤性脑水肿。此外，与单纯CT相比，HM联合CT显著改善了脑震荡后综合征、精神障碍、头痛、癫痫和轻度TBI样症状，但未改善认知功能障碍和创伤后脑积水。当HM与CT联合使用时，日常生活活动和神经功能等功能结局显著优于单纯使用CT治疗的患者。在不良事件发生率方面，HM与CT（RR 0.88，95%CI：0.33 - 2.30）或安慰剂（RR 2.29，95%CI：0.83 - 6.32）相比无差异。然而，HM联合CT显示出比单纯CT更好的安全性（RR 0.64，95%CI：0.44 - 0.93）。大多数研究存在较高的执行偏倚风险，证据质量大多评为“非常低”至“中等”，主要是因为纳入研究存在较高的偏倚风险且定量综合结果不精确。目前的证据表明，在临床实践中推荐HM用于TBI的证据不足。因此，应开展进一步更大规模、高质量、严谨的RCT。
