PMID- 36324375 OWN - NLM STAT- PubMed-not-MEDLINE LR - 20221104 IS - 1664-2295 (Print) IS - 1664-2295 (Electronic) IS - 1664-2295 (Linking) VI - 13 DP - 2022 TI - Slower progression of amyotrophic lateral sclerosis with external application of a Chinese herbal plaster-The randomized, placebo-controlled triple-blinded ALS-CHEPLA trial. PG - 990802 LID - 10.3389/fneur.2022.990802 [doi] LID - 990802 AB - BACKGROUND: 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. STUDY DESIGN: The randomized, triple-blinded study compared the efficacy, safety, and tolerability of the application of Ji-Wu-Li plaster (JWLP) with placebo plaster (PLAP). METHODS: 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. RESULTS: 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; p = 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; p < 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; p = 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. CONCLUSION: 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 Ji Wu Li 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. CI - Copyright (c) 2022 Schroder, Wang, Sima, Schroder, Zhu, Zheng, Liu, Li, Wang, Friedemann, Liu and Pan. FAU - Schroder, Sven AU - Schroder S AD - HanseMerkur Center for Traditional Chinese Medicine, University Medical Center Hamburg-Eppendorf, Hamburg, Germany. FAU - Wang, Mingzhe AU - Wang M AD - Department of Neurology, Shuguang Hospital Affiliated to Shanghai University of Traditional Chinese Medicine, Shanghai, China. FAU - Sima, Dandan AU - Sima D AD - Department of Neurology, Shuguang Hospital Affiliated to Shanghai University of Traditional Chinese Medicine, Shanghai, China. FAU - Schroder, Joana AU - Schroder J AD - HanseMerkur Center for Traditional Chinese Medicine, University Medical Center Hamburg-Eppendorf, Hamburg, Germany. AD - Department of Neurology, Shuguang Hospital Affiliated to Shanghai University of Traditional Chinese Medicine, Shanghai, China. FAU - Zhu, Xuying AU - Zhu X AD - Department of Neurology, Shuguang Hospital Affiliated to Shanghai University of Traditional Chinese Medicine, Shanghai, China. FAU - Zheng, Xuanlu AU - Zheng X AD - Department of Neurology, Shuguang Hospital Affiliated to Shanghai University of Traditional Chinese Medicine, Shanghai, China. FAU - Liu, Lin AU - Liu L AD - Department of Neurology, Shuguang Hospital Affiliated to Shanghai University of Traditional Chinese Medicine, Shanghai, China. AD - Department of Neurology, Qinghai Hospital of Traditional Chinese Medicine, Xining, Qinghai, China. FAU - Li, Tingying AU - Li T AD - Department of Neurology, Shuguang Hospital Affiliated to Shanghai University of Traditional Chinese Medicine, Shanghai, China. FAU - Wang, Qiudong AU - Wang Q AD - Department of Integrative Neurology, Pudong Traditional Chinese Medicine Hospital, Shanghai, China. FAU - Friedemann, Thomas AU - Friedemann T AD - HanseMerkur Center for Traditional Chinese Medicine, University Medical Center Hamburg-Eppendorf, Hamburg, Germany. FAU - Liu, Te AU - Liu T AD - Shanghai Geriatric Institute of Chinese Medicine, Shanghai University of Traditional Chinese Medicine, Shanghai, China. FAU - Pan, Weidong AU - Pan W AD - Department of Neurology, Shuguang Hospital Affiliated to Shanghai University of Traditional Chinese Medicine, Shanghai, China. LA - eng PT - Journal Article DEP - 20221017 PL - Switzerland TA - Front Neurol JT - Frontiers in neurology JID - 101546899 PMC - PMC9620479 OTO - NOTNLM OT - RTC OT - Traditional Chinese Medicine OT - dysphagia OT - herbal plaster OT - placebo control OT - sporadic amyotrophic lateral sclerosis EDAT- 2022/11/04 06:00 MHDA- 2022/11/04 06:01 PMCR- 2022/10/17 CRDT- 2022/11/03 02:25 PHST- 2022/07/10 00:00 [received] PHST- 2022/09/13 00:00 [accepted] PHST- 2022/11/03 02:25 [entrez] PHST- 2022/11/04 06:00 [pubmed] PHST- 2022/11/04 06:01 [medline] PHST- 2022/10/17 00:00 [pmc-release] AID - 10.3389/fneur.2022.990802 [doi] PST - epublish SO - Front Neurol. 2022 Oct 17;13:990802. doi: 10.3389/fneur.2022.990802. eCollection 2022.