Yishenyangsui granule for degenerative cervical myelopathy: a randomized, double-blind, placebo-controlled trial with long-term follow-up.

IF 4.8 2区医学 Q1 PHARMACOLOGY & PHARMACY Frontiers in Pharmacology Pub Date : 2025-01-31 eCollection Date: 2025-01-01 DOI:10.3389/fphar.2025.1542231

He Yin, Xin Chen, Zhiwei Liu, Bo Xu, Zhefeng Jin, Yan Liu, Baoyu Qi, Bin Tang, Ping Wang, Fanping Xu, Xu Wei, Jie Yu, Liguo Zhu

{"title":"Yishenyangsui granule for degenerative cervical myelopathy: a randomized, double-blind, placebo-controlled trial with long-term follow-up.","authors":"He Yin, Xin Chen, Zhiwei Liu, Bo Xu, Zhefeng Jin, Yan Liu, Baoyu Qi, Bin Tang, Ping Wang, Fanping Xu, Xu Wei, Jie Yu, Liguo Zhu","doi":"10.3389/fphar.2025.1542231","DOIUrl":null,"url":null,"abstract":"Objective: This randomized controlled trial aims to evaluate the efficacy and safety of Yishenyangsui granule for treating Degenerative Cervical Myelopathy.Materials and methods: A randomized, double-blind, placebo-controlled clinical trial was conducted with 152 participants recruited from three centers and randomly assigned to receive either Yishenyangsui granule or placebo. The Japanese Orthopaedic Association (JOA) score and Neck Disability Index (NDI) score were evaluated for 32 weeks. Patient-reported outcomes including surgical treatment data, re-treatment data, and patient-reported condition were collected for long-term follow-up. This trial was approved by the ethics committee of WangJing Hospital of China Academy of Chinese Medical Sciences (WJEC-KT-2016-004-P001) and was registered at the Chinese Clinical Trials Registry (ChiCTR-INR-16009723) on 03 November 2016 (Check out at https://www.chictr.org.cn/indexEN.html for a more comprehensive overview).Results: The results showed that the improvement in JOA score at week 8 was significantly better in the Yishenyangsui granule group than in the placebo group (1.47 vs. 0.43; P < 0.001). Furthermore, improvements in motor function of upper/lower extremities, sensory function of upper extremities, reading ability, and recreation domain scores were also significantly superior in the Yishenyangsui granule group compared to the placebo group (P < 0.05). Long-term follow-up outcomes revealed no statistical differences between groups regarding surgical treatment data or patient-reported condition (P > 0.05). However, there was a significant difference detected in re-treatment data between groups with a lower rate observed among those receiving Yishenyangsui granule compared to those receiving placebo [25 (43.10%) vs. 40 (68.97%); P = 0.033], indicating its effectiveness for treating mild-to-moderate Degenerative Cervical Myelopathy.Conclusion: Yishenyangsui granule was effective in treating mild to moderate Degenerative Cervical Myelopathy. The participants have improved long-term outcomes.Clinical trials registration: https://www.chictr.org.cn/indexEN.html, identifier ChiCTR-INR-16009723.","PeriodicalId":12491,"journal":{"name":"Frontiers in Pharmacology","volume":"16 ","pages":"1542231"},"PeriodicalIF":4.8000,"publicationDate":"2025-01-31","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC11825510/pdf/","citationCount":"0","resultStr":null,"platform":"Semanticscholar","paperid":null,"PeriodicalName":"Frontiers in Pharmacology","FirstCategoryId":"3","ListUrlMain":"https://doi.org/10.3389/fphar.2025.1542231","RegionNum":2,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":null,"EPubDate":"2025/1/1 0:00:00","PubModel":"eCollection","JCR":"Q1","JCRName":"PHARMACOLOGY & PHARMACY","Score":null,"Total":0}

引用次数: 0

Abstract

Objective: This randomized controlled trial aims to evaluate the efficacy and safety of Yishenyangsui granule for treating Degenerative Cervical Myelopathy.

Materials and methods: A randomized, double-blind, placebo-controlled clinical trial was conducted with 152 participants recruited from three centers and randomly assigned to receive either Yishenyangsui granule or placebo. The Japanese Orthopaedic Association (JOA) score and Neck Disability Index (NDI) score were evaluated for 32 weeks. Patient-reported outcomes including surgical treatment data, re-treatment data, and patient-reported condition were collected for long-term follow-up. This trial was approved by the ethics committee of WangJing Hospital of China Academy of Chinese Medical Sciences (WJEC-KT-2016-004-P001) and was registered at the Chinese Clinical Trials Registry (ChiCTR-INR-16009723) on 03 November 2016 (Check out at https://www.chictr.org.cn/indexEN.html for a more comprehensive overview).

Results: The results showed that the improvement in JOA score at week 8 was significantly better in the Yishenyangsui granule group than in the placebo group (1.47 vs. 0.43; P < 0.001). Furthermore, improvements in motor function of upper/lower extremities, sensory function of upper extremities, reading ability, and recreation domain scores were also significantly superior in the Yishenyangsui granule group compared to the placebo group (P < 0.05). Long-term follow-up outcomes revealed no statistical differences between groups regarding surgical treatment data or patient-reported condition (P > 0.05). However, there was a significant difference detected in re-treatment data between groups with a lower rate observed among those receiving Yishenyangsui granule compared to those receiving placebo [25 (43.10%) vs. 40 (68.97%); P = 0.033], indicating its effectiveness for treating mild-to-moderate Degenerative Cervical Myelopathy.

Conclusion: Yishenyangsui granule was effective in treating mild to moderate Degenerative Cervical Myelopathy. The participants have improved long-term outcomes.

Clinical trials registration: https://www.chictr.org.cn/indexEN.html, identifier ChiCTR-INR-16009723.

Abstract Image

查看原文

微信好友朋友圈 QQ好友复制链接

本刊更多论文

益肾养遂颗粒治疗退行性颈椎病：随机、双盲、长期随访的安慰剂对照试验

目的：本随机对照试验旨在评价益肾养髓颗粒治疗退行性颈椎病的疗效和安全性。材料与方法：随机、双盲、安慰剂对照临床试验，从三个中心招募152名受试者，随机分配服用益肾养肾颗粒组和安慰剂组。日本骨科协会（JOA）评分和颈部残疾指数（NDI）评分持续32周。收集患者报告的结果，包括手术治疗数据、再治疗数据和患者报告的病情，进行长期随访。该试验已获得中国中医科学院望京医院伦理委员会（wjec - tk -2016-004- p001）的批准，并于2016年11月3日在中国临床试验注册中心（ChiCTR-INR-16009723）注册（查看https://www.chictr.org.cn/indexEN.html了解更全面的概述）。结果：结果显示，益肾养遂颗粒组第8周JOA评分改善明显优于安慰剂组(1.47 vs 0.43；P < 0.001)。此外，益肾养肾颗粒组在上肢/下肢运动功能、上肢感觉功能、阅读能力和娱乐域评分方面的改善也显著优于安慰剂组（P < 0.05）。长期随访结果显示，两组间手术治疗资料和患者病情报告无统计学差异（P < 0.05）。然而，两组再治疗数据存在显著差异，接受益肾养遂颗粒组的再治疗率低于安慰剂组[25（43.10%）比40 (68.97%)；P = 0.033]，提示其治疗轻中度退行性脊髓型颈椎病有效。结论：益肾养遂颗粒治疗轻中度退行性脊髓型颈椎病疗效确切。参与者的长期结果有所改善。临床试验注册：https://www.chictr.org.cn/indexEN.html，标识符ChiCTR-INR-16009723。

本文章由计算机程序翻译，如有差异，请以英文原文为准。

求助全文

约1分钟内获得全文去求助

来源期刊

Frontiers in Pharmacology PHARMACOLOGY & PHARMACY-

CiteScore

7.80

自引率

8.90%

发文量

5163

审稿时长

14 weeks

期刊介绍： Frontiers in Pharmacology is a leading journal in its field, publishing rigorously peer-reviewed research across disciplines, including basic and clinical pharmacology, medicinal chemistry, pharmacy and toxicology. Field Chief Editor Heike Wulff at UC Davis is supported by an outstanding Editorial Board of international researchers. This multidisciplinary open-access journal is at the forefront of disseminating and communicating scientific knowledge and impactful discoveries to researchers, academics, clinicians and the public worldwide.