Schröder Sven, Wang Mingzhe, Sima Dandan, Schröder Joana, Zhu Xuying, Zheng Xuanlu, Liu Lin, Li Tingying, Wang Qiudong, Friedemann Thomas, Liu Te, Pan Weidong
HanseMerkur Center for Traditional Chinese Medicine, University Medical Center Hamburg-Eppendorf, Hamburg, Germany.
Department of Neurology, Shuguang Hospital Affiliated to Shanghai University of Traditional Chinese Medicine, Shanghai, China.
Front Neurol. 2022 Oct 17;13:990802. doi: 10.3389/fneur.2022.990802. eCollection 2022.
Amyotrophic lateral sclerosis (ALS) is a chronic neurodegenerative disease characterized by gradually increasing damage to the upper and lower motor neurons. However, definitive and efficacious treatment for ALS is not available, and oral intake in ALS patients with bulbar involvement is complicated due to swallowing difficulties.
HYPOTHESIS/PURPOSE: This study investigated whether the external plaster application of the herbal composition Ji-Wu-Li efficiently slows ALS progression because prior studies obtained promising evidence with oral herbal applications.
The randomized, triple-blinded study compared the efficacy, safety, and tolerability of the application of Ji-Wu-Li plaster (JWLP) with placebo plaster (PLAP).
In total, 120 patients with definite ALS, clinically probable ALS, or clinically probable laboratory-supported ALS were randomized in a 1:1 ratio to receive JWLP or PLAP. Patients were treated and observed for 20 weeks. The primary outcome was the ALSFRS-R score, while the secondary outcomes were the ALS-SSIT score and weight loss.
The mean±SD decrease in the ALSFRS-R over 20 weeks differed by 0.84 points in a group comparison (JWLP, -4.44 ± 1.15; PLAP, -5.28 ± 1.98; = 0.005). The mean increase in the ALS-SSIT over 20 weeks differed by 2.7 points in a group comparison (JWLP, 5.361.15; PLAP, 8.06 ± 1.72; < 0.001). The mean weight loss over 20 weeks differed by 1.65 kg in a group comparison (JWLP, -3.98 ± 2.61; PLAP, -5.63 ± 3.17; = 0.002). Local allergic dermatitis suspected as causal to the intervention occurred in 10 of 60 participants in the JWLP group and 9 of 60 participants in the PLAP group. Systemic adverse events were mild, temporary, and considered unrelated to the intervention.
The JWLP showed clinical efficacy in the progression of ALS, as measured by the ALSFRS-R, ALS-SSIT, and weight loss in a randomized, placebo-controlled trial. Because skin reactions occurred in both groups, the covering material needs improvement. All of the herbal ingredients regulate multiple mechanisms of neurodegeneration in ALS. Hence, JWLP may offer a promising and safe add-on therapy for ALS, particularly in patients with bulbar involvement, but a confirmative long-term multicentre study is required.
肌萎缩侧索硬化症（ALS）是一种慢性神经退行性疾病，其特征是上下运动神经元逐渐受到损害。然而，目前尚无针对ALS的确切有效治疗方法，并且球部受累的ALS患者由于吞咽困难，经口摄入存在困难。
假设/目的：本研究调查了中药制剂芨蜈沥外用是否能有效减缓ALS的进展，因为先前的研究通过口服中药制剂获得了有前景的证据。
这项随机、三盲研究比较了芨蜈沥膏剂（JWLP）与安慰剂膏剂（PLAP）的疗效、安全性和耐受性。
总共120例确诊的ALS、临床可能的ALS或临床可能实验室支持的ALS患者按1:1比例随机分组，接受JWLP或PLAP治疗。对患者进行20周的治疗和观察。主要结局是ALS功能评定量表修订版（ALSFRS-R）评分，次要结局是ALS功能独立性测量（ALS-SSIT）评分和体重减轻。
在组间比较中，20周内ALSFRS-R的平均±标准差下降差异为0.84分（JWLP组，-4.44±1.15；PLAP组，-5.28±1.98；P = 0.005）。20周内ALS-SSIT的平均增加差异在组间比较中为2.7分（JWLP组，5.36±1.15；PLAP组，8.06±1.72；P<0.001）。20周内平均体重减轻差异在组间比较中为1.65 kg（JWLP组，-3.98±2.61；PLAP组，-5.63±3.17；P = 0.002）。JWLP组60名参与者中有10名、PLAP组60名参与者中有9名出现疑似与干预有关的局部过敏性皮炎。全身性不良事件轻微、短暂，且被认为与干预无关。
在一项随机、安慰剂对照试验中，通过ALSFRS-R、ALS-SSIT和体重减轻评估，JWLP在ALS进展方面显示出临床疗效。由于两组均出现皮肤反应，覆盖材料需要改进。所有草药成分均调节ALS中神经退行性变的多种机制。因此，JWLP可能为ALS提供一种有前景且安全的辅助治疗方法，特别是对于球部受累的患者，但需要进行一项确证性的长期多中心研究。
