Yishenyangsui granule for degenerative cervical myelopathy: a randomized, double-blind, placebo-controlled trial with long-term follow-up
ObjectiveThis randomized controlled trial aims to evaluate the efficacy and safety of Yishenyangsui granule for treating Degenerative Cervical Myelopathy.Materials and methodsA randomized, double-blind, placebo-controlled clinical trial was conducted with 152 participants recruited from three center...
Saved in:
| Main Authors: | , , , , , , , , , , , , |
|---|---|
| Format: | Article |
| Language: | English |
| Published: |
Frontiers Media S.A.
2025-01-01
|
| Series: | Frontiers in Pharmacology |
| Subjects: | |
| Online Access: | https://www.frontiersin.org/articles/10.3389/fphar.2025.1542231/full |
| Tags: |
Add Tag
No Tags, Be the first to tag this record!
|
| _version_ | 1832576323048964096 |
|---|---|
| author | He Yin Xin Chen Zhiwei Liu Zhiwei Liu Bo Xu Zhefeng Jin Yan Liu Baoyu Qi Bin Tang Ping Wang Fanping Xu Xu Wei Jie Yu Liguo Zhu Liguo Zhu |
| author_facet | He Yin Xin Chen Zhiwei Liu Zhiwei Liu Bo Xu Zhefeng Jin Yan Liu Baoyu Qi Bin Tang Ping Wang Fanping Xu Xu Wei Jie Yu Liguo Zhu Liguo Zhu |
| author_sort | He Yin |
| collection | DOAJ |
| description | ObjectiveThis randomized controlled trial aims to evaluate the efficacy and safety of Yishenyangsui granule for treating Degenerative Cervical Myelopathy.Materials and methodsA 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).ResultsThe 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.ConclusionYishenyangsui granule was effective in treating mild to moderate Degenerative Cervical Myelopathy. The participants have improved long-term outcomes.Clinical Trials Registrationhttps://www.chictr.org.cn/indexEN.html, identifier ChiCTR-INR-16009723. |
| format | Article |
| id | doaj-art-2aab799c77cb4fd2a36cac8b411cfa77 |
| institution | Kabale University |
| issn | 1663-9812 |
| language | English |
| publishDate | 2025-01-01 |
| publisher | Frontiers Media S.A. |
| record_format | Article |
| series | Frontiers in Pharmacology |
| spelling | doaj-art-2aab799c77cb4fd2a36cac8b411cfa772025-01-31T06:39:54ZengFrontiers Media S.A.Frontiers in Pharmacology1663-98122025-01-011610.3389/fphar.2025.15422311542231Yishenyangsui granule for degenerative cervical myelopathy: a randomized, double-blind, placebo-controlled trial with long-term follow-upHe Yin0Xin Chen1Zhiwei Liu2Zhiwei Liu3Bo Xu4Zhefeng Jin5Yan Liu6Baoyu Qi7Bin Tang8Ping Wang9Fanping Xu10Xu Wei11Jie Yu12Liguo Zhu13Liguo Zhu14Wangjing Hospital, China Academy of Chinese Medical Sciences, Beijing, ChinaWangjing Hospital, China Academy of Chinese Medical Sciences, Beijing, ChinaWangjing Hospital, China Academy of Chinese Medical Sciences, Beijing, ChinaSpine Department, Zhangjiakou Hospital of Traditional Chinese Medicine, Zhangjiakou City, Hebei, ChinaWangjing Hospital, China Academy of Chinese Medical Sciences, Beijing, ChinaWangjing Hospital, China Academy of Chinese Medical Sciences, Beijing, ChinaKey Laboratory of Chinese Internal Medicine of Ministry of Education, Beijing University of Chinese Medicine Affiliated Dongzhimen Hospital, Beijing, ChinaWangjing Hospital, China Academy of Chinese Medical Sciences, Beijing, ChinaWangjing Hospital, China Academy of Chinese Medical Sciences, Beijing, ChinaFirst Teaching Hospital of Tianjin University of Traditional Chinese Medicine, Tianjin, ChinaSpine Department, Beijing Hospital of Traditional Chinese Medicine, Beijing, ChinaWangjing Hospital, China Academy of Chinese Medical Sciences, Beijing, ChinaWangjing Hospital, China Academy of Chinese Medical Sciences, Beijing, ChinaWangjing Hospital, China Academy of Chinese Medical Sciences, Beijing, ChinaBeijing Key Laboratory of Manipulative Technique, Beijing, ChinaObjectiveThis randomized controlled trial aims to evaluate the efficacy and safety of Yishenyangsui granule for treating Degenerative Cervical Myelopathy.Materials and methodsA 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).ResultsThe 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.ConclusionYishenyangsui granule was effective in treating mild to moderate Degenerative Cervical Myelopathy. The participants have improved long-term outcomes.Clinical Trials Registrationhttps://www.chictr.org.cn/indexEN.html, identifier ChiCTR-INR-16009723.https://www.frontiersin.org/articles/10.3389/fphar.2025.1542231/fulldegenerative cervical myelopathynon-surgical treatmentChinese botanical drugslong-term follow-upcervical spondylotic myelopathy |
| spellingShingle | He Yin Xin Chen Zhiwei Liu Zhiwei Liu Bo Xu Zhefeng Jin Yan Liu Baoyu Qi Bin Tang Ping Wang Fanping Xu Xu Wei Jie Yu Liguo Zhu Liguo Zhu Yishenyangsui granule for degenerative cervical myelopathy: a randomized, double-blind, placebo-controlled trial with long-term follow-up Frontiers in Pharmacology degenerative cervical myelopathy non-surgical treatment Chinese botanical drugs long-term follow-up cervical spondylotic myelopathy |
| title | Yishenyangsui granule for degenerative cervical myelopathy: a randomized, double-blind, placebo-controlled trial with long-term follow-up |
| title_full | Yishenyangsui granule for degenerative cervical myelopathy: a randomized, double-blind, placebo-controlled trial with long-term follow-up |
| title_fullStr | Yishenyangsui granule for degenerative cervical myelopathy: a randomized, double-blind, placebo-controlled trial with long-term follow-up |
| title_full_unstemmed | Yishenyangsui granule for degenerative cervical myelopathy: a randomized, double-blind, placebo-controlled trial with long-term follow-up |
| title_short | Yishenyangsui granule for degenerative cervical myelopathy: a randomized, double-blind, placebo-controlled trial with long-term follow-up |
| title_sort | yishenyangsui granule for degenerative cervical myelopathy a randomized double blind placebo controlled trial with long term follow up |
| topic | degenerative cervical myelopathy non-surgical treatment Chinese botanical drugs long-term follow-up cervical spondylotic myelopathy |
| url | https://www.frontiersin.org/articles/10.3389/fphar.2025.1542231/full |
| work_keys_str_mv | AT heyin yishenyangsuigranulefordegenerativecervicalmyelopathyarandomizeddoubleblindplacebocontrolledtrialwithlongtermfollowup AT xinchen yishenyangsuigranulefordegenerativecervicalmyelopathyarandomizeddoubleblindplacebocontrolledtrialwithlongtermfollowup AT zhiweiliu yishenyangsuigranulefordegenerativecervicalmyelopathyarandomizeddoubleblindplacebocontrolledtrialwithlongtermfollowup AT zhiweiliu yishenyangsuigranulefordegenerativecervicalmyelopathyarandomizeddoubleblindplacebocontrolledtrialwithlongtermfollowup AT boxu yishenyangsuigranulefordegenerativecervicalmyelopathyarandomizeddoubleblindplacebocontrolledtrialwithlongtermfollowup AT zhefengjin yishenyangsuigranulefordegenerativecervicalmyelopathyarandomizeddoubleblindplacebocontrolledtrialwithlongtermfollowup AT yanliu yishenyangsuigranulefordegenerativecervicalmyelopathyarandomizeddoubleblindplacebocontrolledtrialwithlongtermfollowup AT baoyuqi yishenyangsuigranulefordegenerativecervicalmyelopathyarandomizeddoubleblindplacebocontrolledtrialwithlongtermfollowup AT bintang yishenyangsuigranulefordegenerativecervicalmyelopathyarandomizeddoubleblindplacebocontrolledtrialwithlongtermfollowup AT pingwang yishenyangsuigranulefordegenerativecervicalmyelopathyarandomizeddoubleblindplacebocontrolledtrialwithlongtermfollowup AT fanpingxu yishenyangsuigranulefordegenerativecervicalmyelopathyarandomizeddoubleblindplacebocontrolledtrialwithlongtermfollowup AT xuwei yishenyangsuigranulefordegenerativecervicalmyelopathyarandomizeddoubleblindplacebocontrolledtrialwithlongtermfollowup AT jieyu yishenyangsuigranulefordegenerativecervicalmyelopathyarandomizeddoubleblindplacebocontrolledtrialwithlongtermfollowup AT liguozhu yishenyangsuigranulefordegenerativecervicalmyelopathyarandomizeddoubleblindplacebocontrolledtrialwithlongtermfollowup AT liguozhu yishenyangsuigranulefordegenerativecervicalmyelopathyarandomizeddoubleblindplacebocontrolledtrialwithlongtermfollowup |