PMID- 36451389
OWN - NLM
STAT- MEDLINE
DCOM- 20221202
LR  - 20230103
IS  - 1536-5964 (Electronic)
IS  - 0025-7974 (Print)
IS  - 0025-7974 (Linking)
VI  - 101
IP  - 47
DP  - 2022 Nov 25
TI  - Efficacy and safety of Yaobitong capsule for acute lumbar disc herniation: A 
      protocol for a multi-center randomized controlled trial.
PG  - e31533
LID - 10.1097/MD.0000000000031533 [doi]
LID - e31533
AB  - BACKGROUND: There are few effective conservative therapies for acute lumbar disc 
      herniation (LDH), and the choice of nonsteroidal anti-inflammatory drugs is not 
      recommended for all patients. The purpose of this study was to compare the effect 
      of Yaobitong capsule with celecoxib capsule, and to further confirm the safety 
      and efficacy of Yaobitong capsule. METHODS: This study is a large sample 
      multicenter randomized controlled trial. Eight hospitals served as sub centers to 
      recruit patients. A total of 258 patients are divided into Yaobitong group and 
      celecoxib group according to the ratio of 1:1. Celecoxib or Yaobitong capsule was 
      taken orally for 14 days. Patients will complete the trial after 3 months of 
      follow-up, and independent statisticians who are blinded to random assignment 
      will analyze the data using SAS 9.3 software. The primary outcome was the visual 
      analogue scale (VAS) score after 14 days of treatment, and Japanese Orthopaedic 
      Association (JOA), Oswestry Disability Index (ODI), and SF-12 will be regarded as 
      secondary outcomes. Safety indexes will be recorded before and after treatment, 
      and adverse events (AEs) will be recorded throughout this trial. DISCUSSION: This 
      study will evaluate the efficacy and safety of Yaobitong capsule in treating LDH. 
      The experimental results will provide evidence support to treat LDH with 
      Yaobitong capsule.
CI  - Copyright (c) 2022 the Author(s). Published by Wolters Kluwer Health, Inc.
FAU - Zhang, Xianshuai
AU  - Zhang X
AD  - Changchun University of Chinese Medicine, Changchun City, China.
FAU - Yang, Kexin
AU  - Yang K
AD  - China Academy of Chinese Medical Sciences, Wangjing Hospital, Beijing, China.
FAU - Wang, Siyi
AU  - Wang S
AD  - Changchun University of Chinese Medicine, Changchun City, China.
FAU - Tang, Bin
AU  - Tang B
AD  - China Academy of Chinese Medical Sciences, Wangjing Hospital, Beijing, China.
FAU - Yin, He
AU  - Yin H
AD  - China Academy of Chinese Medical Sciences, Wangjing Hospital, Beijing, China.
FAU - Lei, Qunhui
AU  - Lei Q
AD  - Changchun University of Chinese Medicine, Changchun City, China.
FAU - Zhou, Guohui
AU  - Zhou G
AD  - Affiliated Hospital of Changchun University of Chinese Medicine, Changchun City, 
      Jilin Province, China.
FAU - Gu, Mingyu
AU  - Gu M
AD  - Changchun University of Chinese Medicine, Changchun City, China.
FAU - Shi, Mingpeng
AU  - Shi M
AD  - Changchun University of Chinese Medicine, Changchun City, China.
FAU - Zhao, Changwei
AU  - Zhao C
AD  - Affiliated Hospital of Changchun University of Chinese Medicine, Changchun City, 
      Jilin Province, China.
FAU - Li, Shaojun
AU  - Li S
AD  - Affiliated Hospital of Changchun University of Chinese Medicine, Changchun City, 
      Jilin Province, China.
FAU - Li, Zhenhua
AU  - Li Z
AUID- ORCID: 0000-0003-0117-7492
AD  - Affiliated Hospital of Changchun University of Chinese Medicine, Changchun City, 
      Jilin Province, China.
LA  - eng
PT  - Clinical Trial Protocol
PT  - Journal Article
PL  - United States
TA  - Medicine (Baltimore)
JT  - Medicine
JID - 2985248R
RN  - 0 (yaobitong capsule)
RN  - JCX84Q7J1L (Celecoxib)
RN  - 0 (Drugs, Chinese Herbal)
RN  - 0 (Anti-Inflammatory Agents, Non-Steroidal)
SB  - IM
MH  - Humans
MH  - *Intervertebral Disc Displacement/drug therapy
MH  - Celecoxib
MH  - *Drugs, Chinese Herbal/adverse effects
MH  - Anti-Inflammatory Agents, Non-Steroidal
MH  - Randomized Controlled Trials as Topic
MH  - Multicenter Studies as Topic
PMC - PMC9704913
COIS- The authors have no conflicts of interest to disclose.
EDAT- 2022/12/02 06:00
MHDA- 2022/12/03 06:00
PMCR- 2022/11/25
CRDT- 2022/12/01 01:05
PHST- 2022/12/01 01:05 [entrez]
PHST- 2022/12/02 06:00 [pubmed]
PHST- 2022/12/03 06:00 [medline]
PHST- 2022/11/25 00:00 [pmc-release]
AID - 00005792-202211250-00013 [pii]
AID - 10.1097/MD.0000000000031533 [doi]
PST - ppublish
SO  - Medicine (Baltimore). 2022 Nov 25;101(47):e31533. doi: 
      10.1097/MD.0000000000031533.