PMID- 32963565
OWN - NLM
STAT- PubMed-not-MEDLINE
LR  - 20220417
IS  - 1741-427X (Print)
IS  - 1741-4288 (Electronic)
IS  - 1741-427X (Linking)
VI  - 2020
DP  - 2020
TI  - Chinese Herbal Formula Xuefu Zhuyu for Tension-Type Headache with Qi-Stagnation 
      and Blood-Stasis Pattern (CheruXTH): Study Protocol for a Randomized Controlled 
      Trial.
PG  - 5653169
LID - 10.1155/2020/5653169 [doi]
LID - 5653169
AB  - BACKGROUND: Tension-type headache (TTH) is the most common headache disorder. 
      Current treatments for TTH have been reported to be associated with insufficient 
      long-term benefits and unwanted adverse events (AEs). The Chinese herbal formula 
      Xuefu Zhuyu (XFZY) has been utilized in TTH treatment, but the evidence 
      supporting its efficacy remains unclear. This study will evaluate the efficacy 
      and safety of XFZY for TTH. METHODS: This multicenter, double-blind, randomized, 
      placebo-controlled trial will be undertaken in China. A total of 174 eligible 
      participants will be randomly assigned to either an XFZY group or a placebo group 
      (20 ml each dose, three times daily for 4 weeks) at a ratio of 1 : 1. The primary 
      outcome is the change in mean headache intensity measured by a 10 cm visual 
      analogue scale (VAS). Secondary outcomes include the area-under-the headache 
      curve (AUC), headache frequency, rescue medication use, qi-stagnation and 
      blood-stasis pattern measurement, quality of life measured by the 
      EuroQol-5-Dimensions-5-Level (EQ-5D-5L), global evaluation of medication, and 
      health economic indexes. Discussion. The results of the study are expected to 
      provide evidence of high methodological and reporting quality on the efficacy and 
      safety of XFZY for TTH. This trail is registered with ChiCTR1900026716 
      (registered on 19 October, 2019).
CI  - Copyright (c) 2020 Li Zhou et al.
FAU - Zhou, Li
AU  - Zhou L
AD  - Second Clinical Medical College, Guangzhou University of Chinese Medicine, 
      Guangzhou, Guangdong, China.
AD  - Second Affiliated Hospital of Guangzhou University of Chinese Medicine, 
      Guangzhou, Guangdong, China.
AD  - Key Unit of Methodology in Clinical Research, Guangdong Provincial Hospital of 
      Chinese Medicine, Guangzhou, Guangdong, China.
FAU - Zhang, Zhe
AU  - Zhang Z
AD  - Liaoning University of Traditional Chinese Medicine, Shenyang, Liaoning, China.
FAU - Li, Geng
AU  - Li G
AD  - Second Affiliated Hospital of Guangzhou University of Chinese Medicine, 
      Guangzhou, Guangdong, China.
AD  - Key Unit of Methodology in Clinical Research, Guangdong Provincial Hospital of 
      Chinese Medicine, Guangzhou, Guangdong, China.
FAU - Liao, Shaojun
AU  - Liao S
AD  - Second Clinical Medical College, Guangzhou University of Chinese Medicine, 
      Guangzhou, Guangdong, China.
FAU - Zhou, Hongfei
AU  - Zhou H
AD  - Department of Neurology, Affiliated Hospital of Liaoning University of 
      Traditional Chinese Medicine, Shenyang, Liaoning, China.
FAU - Wang, Pengqin
AU  - Wang P
AD  - Department of Neurology, Affiliated Hospital of Liaoning University of 
      Traditional Chinese Medicine, Shenyang, Liaoning, China.
FAU - Liu, Guanghui
AU  - Liu G
AD  - Department of Neurology, Affiliated Hospital of Liaoning University of 
      Traditional Chinese Medicine, Shenyang, Liaoning, China.
FAU - Bai, Li
AU  - Bai L
AUID- ORCID: 0000-0003-4391-2248
AD  - Department of Neurology, Affiliated Hospital of Liaoning University of 
      Traditional Chinese Medicine, Shenyang, Liaoning, China.
FAU - Wen, Zehuai
AU  - Wen Z
AUID- ORCID: 0000-0002-1797-2047
AD  - Second Affiliated Hospital of Guangzhou University of Chinese Medicine, 
      Guangzhou, Guangdong, China.
AD  - Key Unit of Methodology in Clinical Research, Guangdong Provincial Hospital of 
      Chinese Medicine, Guangzhou, Guangdong, China.
AD  - Guangdong Provincial Key Laboratory of Clinical Research on Traditional Chinese 
      Medicine Syndrome, Guangzhou, Guangdong, China.
AD  - State Key Laboratory of Dampness Syndrome of Chinese Medicine, Second Affiliated 
      Hospital of Guangzhou University of Chinese Medicine, Guangzhou, Guangdong, 
      China.
LA  - eng
PT  - Journal Article
DEP - 20200911
PL  - United States
TA  - Evid Based Complement Alternat Med
JT  - Evidence-based complementary and alternative medicine : eCAM
JID - 101215021
PMC - PMC7502128
COIS- The authors have no conflicts of interest to declare.
EDAT- 2020/09/24 06:00
MHDA- 2020/09/24 06:01
PMCR- 2020/09/11
CRDT- 2020/09/23 06:34
PHST- 2020/04/06 00:00 [received]
PHST- 2020/08/21 00:00 [revised]
PHST- 2020/08/25 00:00 [accepted]
PHST- 2020/09/23 06:34 [entrez]
PHST- 2020/09/24 06:00 [pubmed]
PHST- 2020/09/24 06:01 [medline]
PHST- 2020/09/11 00:00 [pmc-release]
AID - 10.1155/2020/5653169 [doi]
PST - epublish
SO  - Evid Based Complement Alternat Med. 2020 Sep 11;2020:5653169. doi: 
      10.1155/2020/5653169. eCollection 2020.