Dataset Information

Efficacy and safety of the Chaixiong Qiwei granule for tension-type headache: study protocol for a randomised controlled trial.

ABSTRACT:

Introduction

Tension-type headache (TTH) is the most prevalent headache disorder worldwide. Although current treatments for TTH are beneficial, they are not without adverse effects. Chaixiong Qiwei granule (CXQW) is an experienced prescription medicine for TTH management. This study will evaluate the efficacy and safety of CXQW for the treatment of TTH.

Methods and analysis

This study will be a multicentre, randomised, double-blind, placebo-controlled trial. A total of 148 eligible participants will be divided into the intervention (CXQW treatment) and control (placebo treatment) groups. The primary outcome will be the reduction in the number of headache days (headache-days reduction) within 9-12 weeks after randomisation, while secondary outcomes will include the number of headache days, headache intensity, responder rate, drug consumption for acute treatment, quality of life and symptoms related to traditional Chinese medicine use based on a symptom-observation table. This protocol describes the design of the randomised controlled trial.

Ethics and dissemination

The study design was approved by the Institutional Review Board of Human Research at Xiyuan Hospital, China Academy of Chinese Medical Sciences (No. 2020XLA030-2).

Trial registration number

ChiCTR2100042514.

SUBMITTER: Shen W

PROVIDER: S-EPMC10689380 | biostudies-literature | 2023 Nov

REPOSITORIES: biostudies-literature

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Publications

Efficacy and safety of the Chaixiong Qiwei granule for tension-type headache: study protocol for a randomised controlled trial.

Shen Wei W Fan Xueming X Fu Guojing G Liu Hongxi H Liang Xiao X Wei Jingjing J Sun Linjuan L Zhang Lu L Chi Xiansu X Zhang Yunling Y

BMJ open 20231130 11

<h4>Introduction</h4>Tension-type headache (TTH) is the most prevalent headache disorder worldwide. Although current treatments for TTH are beneficial, they are not without adverse effects. Chaixiong Qiwei granule (CXQW) is an experienced prescription medicine for TTH management. This study will evaluate the efficacy and safety of CXQW for the treatment of TTH.<h4>Methods and analysis</h4>This study will be a multicentre, randomised, double-blind, placebo-controlled trial. A total of 148 eligibl ...[more]

PMID: 38035742

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Project description:ObjectiveThe high incidence of Tension-type headache (TTH) has led to significant social and economic challenges. Given the widespread use of Chinese patent medicines (CPM) for TTH patients, this study aim to evaluate the efficacy of different CPMs in treating TTH by network meta-analysis.MethodsEight databases were conducted to identify CPMs-related randomized controlled trials (RCTs) from database inception date to August 2023. The primary outcome was clinical efficiency rate. The secondary outcomes were numerical rating scale (NRS), frequency of headache, duration of headache, hamilton anxiety scale (HAMA), hamilton depression Scale (HAMD) and adverse reactions. ROB 2.0 were used for quality evaluation. Stata 15.1 and R 3.5.3 software were used for Bayesian network meta-analysis.ResultsA total of forty-one RCTs were included, involving 3,996 patients and 8 CPMs. The network meta-analysis revealed that Shugan Jieyu capsule plus western medicine (WM) was the best choice of CPM for improving clinical efficiency rate [vs. WM: relative risk (RR) = 7.31, 95 % confidence interval (CI): (1.65, 56.71)]. Yangxue Qingnao granule plus WM was superior to other therapeutic combinations in reducing duration of headache [vs. WM: MD = 1.05, 95%CI(0.74, 1.40)]. Jieyu pill plus WM might have best effect in reducing HAMD [vs. WM: MD = 7.15, 95%CI(-3.77, 18.14)], HAMA scores [vs. WM: MD = -7.41, 95%CI(-13.39, -1.42)], and NRS scores [vs. WM: mean difference (MD) = 2.01, 95%CI(1.47, 2.55)]. In terms of the frequency of headache, although Yangxue Qingnao granule plus WM and Toutong-ning capsule plus WM performed best, the optimal CPMs in reducing the frequency of headache remain to be further explored. Furthermore, due to the limited safety evidence available, reliable safety conclusions could not be drawn.ConclusionCPM can effectively improve headache symptoms, clinical efficiency, and quality of life in patients with TTH. However, research with high quality and large sample sizes is needed for further investigation due to the limitations of this study.

Project description:BackgroundTension-type headache (TTH) is the most common neurologic disease worldwide. Acupuncture is commonly applied to treat TTH, but evidence of acupuncture for TTH is contradictory based on previous meta-analyses. Therefore, we conducted this systematic review and meta-analysis to update the evidence of acupuncture for TTH and aimed to provide a valuable reference for clinical application.MethodsWe searched 9 electronic databases from their inceptions to July 1, 2022 for randomized controlled trials (RCTs) of acupuncture for TTH. We also manually searched reference lists and relevant websites, and the experts in this field were consulted for possible eligible studies. Two independent reviewers conducted literature screening, data extraction, and risk of bias assessment. The revised Cochrane risk-of-bias tool (ROB 2) was used to assess the risk of bias of included studies. Subgroup analyses were carried out based on frequency of acupuncture, total sessions, treatment duration, needle retention, types of acupuncture and categories of medication. Data synthesis was performed using Review Manager 5.3 and Stata 16. The Grading of Recommendations Assessment, Development and Evaluation Approach (GRADE) was used to evaluate the certainty of evidence of each outcome. Meanwhile, the Standards for Reporting Interventions in Clinical Trials of Acupuncture (STRICTA) was used to assess the reporting quality of interventions in clinical trials of acupuncture.Results30 RCTs involving 2,742 participants were included. According to ROB 2, 4 studies were considered as low risk, and the rest studies were some concerns. After treatment, compared with sham acupuncture, acupuncture had greater effect in improvement of responder rate [3 RCTs, RR = 1.30, 95%CI (1.13, 1.50), I2 = 2%, moderate certainty] and headache frequency [5 RCTs, SMD = -0.85, 95%CI (-1.58, -0.12), I2 = 94%, very low certainty]. In contrast to medication, acupuncture was more effective to reduce pain intensity [9 RCTs, SMD = -0.62, 95%CI (-0.86, -0.38), I2 = 63%, low certainty]. Adverse events were evaluated in 16 trials, and no serious event associated with acupuncture occurred.ConclusionsAcupuncture may be an effective and safe treatment for TTH patients. Due to low or very low certainty of evidence and high heterogeneity, more rigorous RCTs are needed to verify the effect and safety of acupuncture in the management of TTH.

Dataset Information

Efficacy and safety of the Chaixiong Qiwei granule for tension-type headache: study protocol for a randomised controlled trial.

Introduction

Methods and analysis

Ethics and dissemination

Trial registration number

Publications

Efficacy and safety of the Chaixiong Qiwei granule for tension-type headache: study protocol for a randomised controlled trial.

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