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Chinese Herbal Formula Xuefu Zhuyu for Tension-Type Headache with Qi-Stagnation and Blood-Stasis Pattern (CheruXTH): Study Protocol for a Randomized Controlled Trial
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 t...
Autores principales: | , , , , , , , , |
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Formato: | Online Artículo Texto |
Lenguaje: | English |
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Hindawi
2020
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Materias: | |
Acceso en línea: | https://www.ncbi.nlm.nih.gov/pmc/articles/PMC7502128/ https://www.ncbi.nlm.nih.gov/pubmed/32963565 http://dx.doi.org/10.1155/2020/5653169 |
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author | Zhou, Li Zhang, Zhe Li, Geng Liao, Shaojun Zhou, Hongfei Wang, Pengqin Liu, Guanghui Bai, Li Wen, Zehuai |
author_facet | Zhou, Li Zhang, Zhe Li, Geng Liao, Shaojun Zhou, Hongfei Wang, Pengqin Liu, Guanghui Bai, Li Wen, Zehuai |
author_sort | Zhou, Li |
collection | PubMed |
description | 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). |
format | Online Article Text |
id | pubmed-7502128 |
institution | National Center for Biotechnology Information |
language | English |
publishDate | 2020 |
publisher | Hindawi |
record_format | MEDLINE/PubMed |
spelling | pubmed-75021282020-09-21 Chinese Herbal Formula Xuefu Zhuyu for Tension-Type Headache with Qi-Stagnation and Blood-Stasis Pattern (CheruXTH): Study Protocol for a Randomized Controlled Trial Zhou, Li Zhang, Zhe Li, Geng Liao, Shaojun Zhou, Hongfei Wang, Pengqin Liu, Guanghui Bai, Li Wen, Zehuai Evid Based Complement Alternat Med Research Article 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). Hindawi 2020-09-11 /pmc/articles/PMC7502128/ /pubmed/32963565 http://dx.doi.org/10.1155/2020/5653169 Text en Copyright © 2020 Li Zhou et al. https://creativecommons.org/licenses/by/4.0/ This is an open access article distributed under the Creative Commons Attribution License, which permits unrestricted use, distribution, and reproduction in any medium, provided the original work is properly cited. |
spellingShingle | Research Article Zhou, Li Zhang, Zhe Li, Geng Liao, Shaojun Zhou, Hongfei Wang, Pengqin Liu, Guanghui Bai, Li Wen, Zehuai Chinese Herbal Formula Xuefu Zhuyu for Tension-Type Headache with Qi-Stagnation and Blood-Stasis Pattern (CheruXTH): Study Protocol for a Randomized Controlled Trial |
title | Chinese Herbal Formula Xuefu Zhuyu for Tension-Type Headache with Qi-Stagnation and Blood-Stasis Pattern (CheruXTH): Study Protocol for a Randomized Controlled Trial |
title_full | Chinese Herbal Formula Xuefu Zhuyu for Tension-Type Headache with Qi-Stagnation and Blood-Stasis Pattern (CheruXTH): Study Protocol for a Randomized Controlled Trial |
title_fullStr | Chinese Herbal Formula Xuefu Zhuyu for Tension-Type Headache with Qi-Stagnation and Blood-Stasis Pattern (CheruXTH): Study Protocol for a Randomized Controlled Trial |
title_full_unstemmed | Chinese Herbal Formula Xuefu Zhuyu for Tension-Type Headache with Qi-Stagnation and Blood-Stasis Pattern (CheruXTH): Study Protocol for a Randomized Controlled Trial |
title_short | Chinese Herbal Formula Xuefu Zhuyu for Tension-Type Headache with Qi-Stagnation and Blood-Stasis Pattern (CheruXTH): Study Protocol for a Randomized Controlled Trial |
title_sort | chinese herbal formula xuefu zhuyu for tension-type headache with qi-stagnation and blood-stasis pattern (cheruxth): study protocol for a randomized controlled trial |
topic | Research Article |
url | https://www.ncbi.nlm.nih.gov/pmc/articles/PMC7502128/ https://www.ncbi.nlm.nih.gov/pubmed/32963565 http://dx.doi.org/10.1155/2020/5653169 |
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