Huoling Shengji granule in amyotrophic lateral sclerosis: A multicenter, randomized, double-blind, riluzole-controlled trial.

Authors

Xiaolu Liu, Wencheng Fu, Xuanye Cui, Yi Feng, Bin Wen, Lei Shan, Xin Xu, Jian Yang, Jiquan Zhang, Lizhu He, Yingjun Zang, Shengchao Zhao, Xiaoli Yao, Yaling Liu, Mingming Ma, Baoxin Du, Jingxia Dang, Zhangyu Zou, Honglin Feng, Zuneng Lu, Yong Zhang, Zhiying Wu, Huifang Shang, Ping Yin, Dongsheng Fan

Published in

Neurotherapeutics : the journal of the American Society for Experimental NeuroTherapeutics. Volume 23. Issue 5. Pages e00953. Jul 27, 2026. Epub Jul 27, 2026.

Abstract

Currently, no curative therapies exist for Amyotrophic Lateral Sclerosis (ALS). This study aimed to evaluate the efficacy and safety of Huoling Shengji granules (HLSJ), a traditional Chinese medicine (TCM), compared to the standard treatment riluzole. A multicenter, randomized, double-blind, double-dummy, active-controlled Phase II clinical trial was conducted across 11 centers in China. A total of 140 ALS patients were randomly assigned (1:1) to receive either HLSJ or riluzole for 48 weeks. The primary endpoint, analyzed in the full analysis set (FAS), was the change in the ALS Functional Rating Scale-Revised (ALSFRS-R) score from baseline to Week 48. Safety profiles were comparable between groups, with no significant difference in adverse events (80.28% vs. 80.56%, P = 0.9671). Analysis using the pre-specified Last Observation Carried Forward (LOCF) method showed a numerical advantage for HLSJ (1.07 points) but lacked statistical superiority. However, a more scientific analysis using the Mixed Model for Repeated Measures (MMRM), recommended for progressive diseases, indicated that HLSJ was significantly superior to riluzole in slowing ALSFRS-R score decline (Least Squares Mean Difference [LSMD]: 2.29 points; 95% confidence interval [CI]: 0.52 to 4.06; P = 0.0114). While the LOCF model showed no statistical difference, the MMRM analysis confirmed that HLSJ demonstrated significant efficacy superior to riluzole with a favorable safety profile. These findings provide a critical basis for conducting pivotal Phase III confirmatory trials of HLSJ for ALS treatment.

PMID:
42508294
Bibliographic data and abstract were imported from PubMed on 28 Jul 2026.

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