title: Tian Jiu therapy for allergic rhinitis: study protocol for a randomized controlled trial.
abstract: BACKGROUND
  Allergic rhinitis (AR) is one of the most common allergic diseases. The conventional treatments of allergic rhinitis are oral anti-histamines, the use of intranasal corticosteroids, and immunotherapy. Dissatisfied with the ineffectiveness and side effects of these treatments, substantial numbers of patients are turning to alternative treatments like Chinese herbal medicine, particularly Tian Jiu (TJ). TJ is a form of moxibustion in which herbal patches are applied to specific acupoints on the skin. This study aims to investigate the efficacy and safety of TJ in the treatment of allergic rhinitis.
  
  
  METHODS
  This will be a prospective, randomized, single-blinded, controlled trial in patients with AR. After a 1-week run-in period, eligible subjects will be randomly assigned to the TJ group, placebo-control group or waitlist-control group. The TJ and placebo-control groups will undergo a 4-week treatment with one session per week and one 4-week post-treatment follow-up. Participants in the waitlist-control group will not receive any treatment during the first 4 weeks but will be required to be assessed. The primary outcome will be the change in the weekly average of the Total Nasal Symptom Score recorded from baseline to the end of treatment. The secondary outcomes will be change in symptoms and change in need for medication between baseline and the end of treatment by using the Rhinitis Quality of Life Questionnaire. Rescue medication (RM) needs will be measured using an RM score, comprising the weekly sum of daily assessments and any form of systemic steroids for allergic rhinitis.
  
  
  CONCLUSIONS
  This study will be the first study to compare TJ treatment for allergic rhinitis with a placebo-control group, and a waitlist-control group. The investigation of TJ for allergic rhinitis will also suggest recommendations for clinical practice. The results of this study are expected to provide consolidated evidence for the effectiveness and safety of TJ for the treatment of patients with allergic rhinitis.
  
  
  BACKGROUND
  NCT02470845 (17 May 2015).
authors.affiliation: School of Chinese Medicine, Hong Kong Baptist University, 7 Baptist University Road, Kowloon Tong, Hong Kong, China.|Hong Kong Chinese Medicine Clinical study Center, Hong Kong Baptist University, 205, Jockey Club School of Chinese Medicine Building, 7 Baptist University Road, Kowloon Tong, Kowloon, Hong Kong.
authors.forename: Wai
authors.initials: W
authors.lastname: Kun
authors.affiliation: School of Chinese Medicine, Hong Kong Baptist University, 7 Baptist University Road, Kowloon Tong, Hong Kong, China.|Hong Kong Chinese Medicine Clinical study Center, Hong Kong Baptist University, 205, Jockey Club School of Chinese Medicine Building, 7 Baptist University Road, Kowloon Tong, Kowloon, Hong Kong.
authors.forename: Linda L D
authors.initials: LL
authors.lastname: Zhong
authors.affiliation: School of Chinese Medicine, Hong Kong Baptist University, 7 Baptist University Road, Kowloon Tong, Hong Kong, China.|Hong Kong Chinese Medicine Clinical study Center, Hong Kong Baptist University, 205, Jockey Club School of Chinese Medicine Building, 7 Baptist University Road, Kowloon Tong, Kowloon, Hong Kong.
authors.forename: Liang
authors.initials: L
authors.lastname: Dai
authors.affiliation: School of Chinese Medicine, Hong Kong Baptist University, 7 Baptist University Road, Kowloon Tong, Hong Kong, China.|Hong Kong Chinese Medicine Clinical study Center, Hong Kong Baptist University, 205, Jockey Club School of Chinese Medicine Building, 7 Baptist University Road, Kowloon Tong, Kowloon, Hong Kong.
authors.forename: Chung-Wah
authors.initials: CW
authors.lastname: Cheng
authors.affiliation: School of Chinese Medicine, Hong Kong Baptist University, 7 Baptist University Road, Kowloon Tong, Hong Kong, China.|Hong Kong Chinese Medicine Clinical study Center, Hong Kong Baptist University, 205, Jockey Club School of Chinese Medicine Building, 7 Baptist University Road, Kowloon Tong, Kowloon, Hong Kong.
authors.forename: Ai-Ping
authors.initials: AP
authors.lastname: Lu
authors.affiliation: School of Chinese Medicine, Hong Kong Baptist University, 7 Baptist University Road, Kowloon Tong, Hong Kong, China. bzxiang@hkbu.edu.hk.|Hong Kong Chinese Medicine Clinical study Center, Hong Kong Baptist University, 205, Jockey Club School of Chinese Medicine Building, 7 Baptist University Road, Kowloon Tong, Kowloon, Hong Kong. bzxiang@hkbu.edu.hk.
authors.forename: Zhao-Xiang
authors.initials: ZX
authors.lastname: Bian
mesh_terms: D002985:Clinical Protocols; D006723:Hong Kong; D006801:Humans; D009071:Moxibustion / Q000009:adverse effects; D011446:Prospective Studies; D011788:Quality of Life; D012107:Research Design; D065631:Rhinitis, Allergic / Q000175:diagnosis / Q000523:psychology / Q000628:therapy*; D016037:Single-Blind Method; D011795:Surveys and Questionnaires; D013997:Time Factors; D016896:Treatment Outcome
keywords: Allergic rhinitis; Chinese herbal medicine; Randomized controlled trial; Tian Jiu