title: Effectiveness of strengthened stimulation during acupuncture for the treatment of allergic rhinitis: study protocol for a randomized controlled trial.
abstract: BACKGROUND
  The traditional Chinese theory of acupuncture emphasizes that the intensity of acupuncture must reach a threshold to generate de qi (a specific and compound sensation during the acupuncture), which is necessary to achieve the best therapeutic effect. However, the notion that de qi must be achieved for maximum benefit has not been confirmed by modern scientific evidence. This study aims to compare the efficacy of acupuncture with either strong (intended to elicit de qi) or weak stimulation among patients with allergic rhinitis.
  
  
  METHODS
  This study compares real versus sham acupuncture in 140 patients with a history of persistent allergic rhinitis (PER) or intermittent allergic rhinitis (IAR) and with a positive skin prick test (SPT). The trial will be conducted in the Teaching Hospital of Chengdu University of Traditional Chinese Medicine (China). In the study, patients will be randomly assigned into two groups by computer-generated randomization and assessed prior to treatment. They will then receive 12 sessions of treatments for 4 consecutive weeks and have a follow-up phase lasting 12 weeks. The main outcome measures include the primary and secondary indicators. Primary indicators are subjective symptoms scores as evaluated by visual analogue scales (VAS), rhinoconjunctivitis quality of life questionnaires (RQLQ), and the Modified Massachusetts General Hospital acupuncture sensation scale, Chinese version (C-MMASS). The secondary indicators are the results of laboratory examinations, such as serum allergen-specific immunoglobulin E (sIgE) nasal inflammatory cells counts (mast cells, eosinophils, and T cells), and nitric oxide concentration in nasal excretion. The use of anti-allergic medication will also be recorded as one of the secondary indicators. Furthermore, adverse events will be recorded and analyzed. Intention-to-treat analysis (ITT) and per-protocol (PP) analysis will be performed to test and verify the results in this trial.
  
  
  CONCLUSIONS
  The results of this trial will demonstrate the efficacy of using acupuncture to treat allergic rhinitis and verify whether the effectiveness of acupuncture is related to the needle sensation de qi.
  
  
  BACKGROUND
  Chinese Clinical Trial Registry: ChiCTR-TRC-13003594 (registered on 16 August 2013, and the first patient was randomized on 27 September 2013).
authors: Qing
authors: Q
authors: Chen
authors: Department of Otorhinolaryngology, Head and Neck Surgery of the Teaching Hospital of Chengdu University of Traditional Chinese Medicine, No,39 Twelve Bridge Road, Chengdu, Sichuan Province 610072, China. zhqinxiu@163.com.
authors: Qinxiu
authors: Q
authors: Zhang
authors: Luyun
authors: L
authors: Jiang
authors: Xinrong
authors: X
authors: Li
authors: Yang
authors: Y
authors: Liu
authors: Yan
authors: Y
authors: Xie
authors: Shan
authors: S
authors: Mu
authors: Ying
authors: Y
authors: Liu
authors: Xiaopei
authors: X
authors: Wang
authors: Yunzhi
authors: Y
authors: Yu
authors: Min
authors: M
authors: Li
mesh_terms: D015670:Acupuncture Therapy / Q000009:adverse effects; D002985:Clinical Protocols; D004311:Double-Blind Method; D006801:Humans; D017063:Outcome Assessment, Health Care; D011788:Quality of Life; D065631:Rhinitis, Allergic / Q000523:psychology / Q000628:therapy*