A Multicenter， Randomized， Double-blind， and Placebo-parallel Controlled Trial of Tibetan Medicine Ruyi Zhenbaowan in Treatment of Knee Osteoarthritis
10.13422/j.cnki.syfjx.20241693
- VernacularTitle:藏族药如意珍宝丸治疗膝骨关节炎的多中心、随机、双盲、安慰剂、平行对照临床试验
- Author:
Chunquan SUN
1
;
Yanming XIE
1
;
Jinghua GAO
2
;
Weiheng CHEN
3
;
Lianxin WANG
1
;
Shangquan WANG
2
;
Xiangdong TIAN
3
;
Zujian XU
4
;
Yuxin ZHENG
5
;
Mingwang ZHOU
6
;
Chungen LI
7
;
Zhanwang XU
8
;
Jiayi GUO
9
;
Shuangqing DU
10
;
Qigang CHEN
11
;
Quan JI
12
;
Zhiqiang BAI
13
;
Jing XIAO
14
;
Wanli QI
15
;
Weiyi YANG
16
;
Jingxiao ZHANG
17
Author Information
1. Institute of Basic Research in Clinical Medicine，China Academy of Chinese Medical Sciences，Beijing 100700，China
2. Wangjing Hospital，China Academy of Chinese Medical Sciences，Beijing 100102，China
3. Beijing University of Chinese Medicine Third Affiliated Hospital，Beijing 100029，China
4. The Affiliated Traditional Chinese Medicine Hospital of Southwest Medical University，Luzhou，646099，China
5. Shuguang Hospital Affiliated to Shanghai University of Traditional Chinese Medicine（TCM）， Shanghai 201203，China
6. Gansu Provincial Hospital of TCM，Lanzhou 730050，China
7. Beijing Hospital of TCM，Capital Medical University，Beijing 100010，China
8. The Affiliated Hospital of Shandong University of TCM，Jinan 250011，China
9. Luoyang Orthopedic-Traumatological Hospital of Henan Province，Luoyang 471002，China
10. Hebei Provincial Hospital of TCM，Shijiazhuang 050013，China
11. Kunming Municipal Hospital of Chinese Medicine，Kunming 650599，China
12. Beijing Hospital，Beijing 100005，China
13. Beijing First Hospital of Integrated Chinese and Western medicine，Beijing 100026，China
14. Xiyuan Hospital，China Academy of Chinese Medical Sciences，Beijing 100091，China
15. Affiliated Hospital of Changchun University of TCM，Changchun 130021，China
16. Guangdong Provincial Hospital of Chinese Medicine，Guangzhou 510120，China
17. School of Statistics，Renmin University of China，Beijing 100044，China
- Publication Type:Journal Article
- Keywords:
Tibetan medicine;
Ruyi Zhenbaowan;
clinical trials;
knee osteoarthritis
- From:
Chinese Journal of Experimental Traditional Medical Formulae
2024;30(24):57-67
- CountryChina
- Language:Chinese
-
Abstract:
ObjectiveThis study aimed to evaluate the clinical efficacy of Ruyi Zhenbaowan（RYZBW）in the treatment of initial and early knee osteoarthritis （KOA） through a prospective multicenter，randomized，double-blind，and placebo-parallel controlled trial. MethodFrom October 13th， 2021 to December 25th， 2021， 240 KOA subjects meeting the acceptance criteria were enrolled in 15 sub-centers including Wangjing Hospital， Chinese Academy of Chinese Medical Sciences， and they were randomly divided into observation group and control group， with 120 cases in each group. The intervention measures for the observation group were RYZBW + health education， and the intervention measures for the control group were RYZBW placebo + health education. The intervention period in both groups was four weeks， and they were followed up for four weeks after the intervention. The primary outcome measure was the total score of Western Ontario and McMaster University Osteoarthritis Index score （WOMAC score）， and the secondary outcome measures were the response rate of visual scale （VAS） pain score， WOMAC sub item scores （joint pain， joint stiffness， and joint function）， quality of life （SF-12） score， and traditional Chinese medicine （TCM） syndrome score. Result（1） Efficacy evaluation. The marginal model results showed that the observation group was better than the control group in improving the WOMAC total score and WOMAC pain score in the treatment of KOA with RYZBW， and the difference was statistically significant （P<0.05）. There was no significant difference between the two groups in improving VAS score response rate， WOMAC function score， WOMAC stiffness score， SF12-PCS （quality of life-physical health） score， SF12-MCS （quality of life-mental health） score， and TCM syndrome score. （2） Subgroup analysis. ① In terms of VAS score response rate， the response rate of the observation group was higher than that of the control group for subjects with baseline VAS score of （4， 5］， and the difference was statistically significant （P<0.05）. ② In terms of TCM syndrome score， for subjects aged ［56， 60］ and ［61， 65］， the decrease in total TCM syndrome score in the observation group was better than that in the control group， and the difference was statistically significant （P<0.05）. ConclusionTibetan medicine RYZBW has good clinical efficacy in improving WOMAC total score， VAS score response rate， WOMAC pain score， WOMAC function score， and TCM syndrome score for patients with initial and early KOA， which can fill the lack of Tibetan medicine RYZBW in the treatment of KOA and make a demonstration study for the inheritance and development of ethnic medicine.
