title: Efficacy and safety of using a warming needle for persistent allergic rhinitis: study protocol for a randomized controlled trial.
abstract: Many previous studies have shown the potential therapeutic effect of acupuncture for allergic rhinitis. Most of these studies, however, were limited by the short duration of observations and lack of sham acupuncture as the control group. Our preliminary experiments showed that the use of a warm needling achieved a much more persistent effect in the treatment of allergic rhinitis (AR) compared with simple acupuncture therapy. Hence, we have designed a multicenter, randomized controlled trial (RCT) in which the first-line medication loratadine will be used as the control group, and the effect of warm needling therapy will be evaluated through long-term observation.
  
  
  
  The trial is designed as a multicenter, parallel-group, randomized, single-blinded (outcome assessors), non-inferiority trial. A total of 98 patients with persistent AR will be randomly assigned into two groups. Patients in the treatment group will be treated with warm needling at GV14 and acupuncture at EX-HN3, ST2, LI20, EX-HN8, GV23, LU7, LU5 and LI4 three times a week, for a total of 4 weeks. Patients in the control group will be treated with oral loratadine 10 mg/day for 4 weeks. The primary outcome will be the change in the Total Nasal Symptom Score (TNSS) from baseline to that at 6 months after treatment during the follow-up period. The secondary outcomes will include the Total Non-nasal Symptom Score and the Rhinoconjunctivitis Quality of Life Questionnaire, changes in the TNSS from baseline to that at 2 and 4 weeks during treatment, and 3 months after treatment during the follow-up period. Outcomes will be measured at 2 and 4 weeks, and 3 and 6 months after treatment. Any side effects of treatment will be observed and recorded.
  
  
  
  We expect that the study results will provide evidence to determine the effects of warm needling compared with loratadine. Our final goal of the study is to evaluate the difference in the short-term and long-term effects between the two therapeutic methods, especially the long-term effect of warm needling.
  
  
  
  ClinicalTrials.gov NCT02339714 . Registered on 14 January 2015.
authors.affiliation: Guang'anmen Hospital, China Academy of Chinese Medical Sciences, Beijing, 100053, China.|Hubei University of Chinese Medicine, Wuhan, 430061, China.
authors.forename: Yuxiu
authors.initials: Y
authors.lastname: Sun
authors.affiliation: Institute of Acupuncture and Moxibustion, China Academy of Chinese Medical Sciences, Beijing, 100700, China. hongzhao2005@aliyun.com.
authors.forename: Hong
authors.initials: H
authors.lastname: Zhao
authors.affiliation: Guang'anmen Hospital, China Academy of Chinese Medical Sciences, Beijing, 100053, China.
authors.forename: Yongming
authors.initials: Y
authors.lastname: Ye
authors.affiliation: Mentougou Hospital of TCM, Beijing, 102300, China.
authors.forename: Wenbin
authors.initials: W
authors.lastname: Nie
authors.affiliation: China Academy of Chinese Medical Sciences, Beijing, 100700, China.
authors.forename: Wenjing
authors.initials: W
authors.lastname: Bai
authors.affiliation: China Academy of Chinese Medical Sciences, Beijing, 100700, China.
authors.forename: Jia
authors.initials: J
authors.lastname: Liu
authors.affiliation: Guang'anmen Hospital, China Academy of Chinese Medical Sciences, Beijing, 100053, China.
authors.forename: Sinuo
authors.initials: S
authors.lastname: Li
authors.affiliation: Institute of Acupuncture and Moxibustion, China Academy of Chinese Medical Sciences, Beijing, 100700, China.
authors.forename: Fang
authors.initials: F
authors.lastname: Wang
authors.affiliation: Institute of Acupuncture and Moxibustion, China Academy of Chinese Medical Sciences, Beijing, 100700, China.
authors.forename: Mingjuan
authors.initials: M
authors.lastname: Han
authors.affiliation: China Academy of Chinese Medical Sciences, Beijing, 100700, China.
authors.forename: Liyun
authors.initials: L
authors.lastname: He
mesh_terms: D015670:Acupuncture Therapy / Q000009:adverse effects / Q000295:instrumentation*; D000293:Adolescent; D000328:Adult; D018926:Anti-Allergic Agents / Q000009:adverse effects / Q000627:therapeutic use*; D002681:China; D002985:Clinical Protocols; D005260:Female; D006358:Hot Temperature; D006801:Humans; D017336:Loratadine / Q000009:adverse effects / Q000627:therapeutic use*; D008297:Male; D008875:Middle Aged; D009339:Needles; 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; D055815:Young Adult
chemical_list: D018926:Anti-Allergic Agents; D017336:Loratadine
keywords: Acupuncture; Persistent allergic rhinitis; RCT; Study protocol; Warm needling