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Published in: Trials 1/2016

Open Access 01-12-2016 | Study protocol

Efficacy and safety of using a warming needle for persistent allergic rhinitis: study protocol for a randomized controlled trial

Authors: Yuxiu Sun, Hong Zhao, Yongming Ye, Wenbin Nie, Wenjing Bai, Jia Liu, Sinuo Li, Fang Wang, Mingjuan Han, Liyun He

Published in: Trials | Issue 1/2016

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Abstract

Background

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.

Methods/design

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.

Discussion

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.

Trial registration

ClinicalTrials.gov NCT02339714. Registered on 14 January 2015.
Appendix
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Metadata
Title
Efficacy and safety of using a warming needle for persistent allergic rhinitis: study protocol for a randomized controlled trial
Authors
Yuxiu Sun
Hong Zhao
Yongming Ye
Wenbin Nie
Wenjing Bai
Jia Liu
Sinuo Li
Fang Wang
Mingjuan Han
Liyun He
Publication date
01-12-2016
Publisher
BioMed Central
Published in
Trials / Issue 1/2016
Electronic ISSN: 1745-6215
DOI
https://doi.org/10.1186/s13063-016-1432-z

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