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Efficacy and safety of different drug monotherapies for tension-type headache in adults: study protocol for a Bayesian network meta-analysis
  1. Runsheng Xie1,2,
  2. Jinhui Tian3,4,
  3. Yangyang Wang1,2,
  4. Yefeng Cai5,
  5. Hui Li1,2
  1. 1 Department of Standardization of Chinese Medicine, The Second Affiliated Hospital of Guangzhou University of Chinese Medicine (Guangdong Provincial Hospital of Chinese Medicine; Guangdong Provincial Academy of Chinese Medical Sciences), Guangzhou, China
  2. 2 Engineering and Technology Research Center of Standardization of Traditional Chinese Medicine, Guangzhou, China
  3. 3 Evidence-Based Medicine Center, Lanzhou University, Lanzhou, China
  4. 4 Key Laboratory of Evidence-Based Medicine and Knowledge Translation of Gansu Province, Lanzhou, China
  5. 5 Department of Internal Neurology, The Second Affiliated Hospital of Guangzhou University of Chinese Medicine (Guangdong Provincial Hospital of Chinese Medicine; Guangdong Provincial Academy of Chinese Medical Sciences), Guangzhou, China
  1. Correspondence to Dr Hui Li; lihuitcm{at}126.com

Abstract

Introduction Tension-type headache (TTH) is the most prevalent neurological disease, with an estimated 1.5 billion cases worldwide. Pharmacotherapy should be considered by patients with TTH who have a limited response to non-pharmacological treatment. However, recommendations for the vast array of therapeutic drugs for TTH partially overlap, with conflicting recommendations for strength in different guidelines; these may confuse the decision-making process of clinicians. Hence, the aims of this study are to analyse the available direct and indirect evidence on different drug monotherapies for TTH in adults, and to generate a treatment ranking according to their efficacy and safety outcomes by using a Bayesian network meta-analysis (NMA).

Methods and analysis We will systematically search the Cochrane Library, PubMed, Web of Science, Embase, China Biomedical Literature Database, International Clinical Trials Registry Platform and other resources for eligible studies. Randomised controlled trials on different drug monotherapies for TTH will be included. Two review authors (RX and YW) will independently search and select the studies, extract the data and assess the risk of bias. A Bayesian NMA will afterwards be conducted to pool the effect measures across all types of monotherapy drugs. The ranking probabilities of the efficacy and safety of different drug monotherapies will be estimated. Heterogeneity will be quantified using the Q statistic and the I² index. Inconsistency between direct and indirect evidence will be assessed by the node-splitting model. In addition, the overall quality of evidence will be assessed using the Grading of Recommendations Assessment, Development and Evaluation approach.

Ethics and dissemination No ethical issues are foreseen. The results will be published in a peer-reviewed journal, which will be disseminated electronically and in print.

PROSPERO registration number CRD42018090554.

  • tension-type headache
  • monotherapies
  • efficacy
  • network meta-analysis

This is an open access article distributed in accordance with the Creative Commons Attribution Non Commercial (CC BY-NC 4.0) license, which permits others to distribute, remix, adapt, build upon this work non-commercially, and license their derivative works on different terms, provided the original work is properly cited, appropriate credit is given, any changes made indicated, and the use is non-commercial. See: http://creativecommons.org/licenses/by-nc/4.0/.

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Footnotes

  • Patient consent for publication Not required.

  • RX and JT contributed equally.

  • Contributors RX, JT and HL conceived the study and drafted the manuscript. JT and YW provided search strategies and professional advice. RX and YW implemented a preliminary search. JT and HL provided guidance on the NMA methodology. YC and HL provided expertise on treatments, outcomes and related knowledge on TTH. All authors read, critically reviewed and approved the final manuscript as submitted.

  • Funding This work was supported by Special Research Fund for Traditional Chinese Medicine Science and Technology of the Guangdong Provincial Hospital of Chinese Medicine (grant number YN2015MS22).

  • Competing interests None declared.

  • Provenance and peer review Not commissioned; externally peer reviewed.

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