Effectiveness of strengthened stimulation during acupuncture for the treatment of allergic rhinitis: study protocol for a randomized controlled trial.
Effectiveness of strengthened stimulation during acupuncture for the treatment of allergic rhinitis: study protocol for a randomized controlled trial.
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针灸强化刺激治疗过敏性鼻炎的有效性：随机对照试验研究方案
DOI：
10.1186/1745-6215-15-301
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发表时间：
2014-07-24
期刊：
影响因子：
2.5
通讯作者：
Li M
中科院分区：
文献类型：
--
作者：
Chen Q;Zhang Q;Jiang L;Li X;Liu Y;Xie Y;Mu S;Liu Y;Wang X;Yu Y;Li M
中国传统的针灸理论强调，针灸的强度必须达到一个阈值才能产生气（针灸时的一种特定的复合感觉），这是达到最佳治疗效果所必需的。然而，为获得最大利益必须达到最低限度的观念尚未得到现代科学证据的证实。本研究旨在比较强刺激（旨在激发气）和弱刺激对变应性鼻炎患者的疗效。方法/设计本研究比较了140例有持续性变应性鼻炎（PER）或间歇性变应性鼻炎（IAR）病史且皮肤点刺试验（SPT）阳性的患者的真针和假针治疗。试验将在成都中医药大学附属医院进行。在研究中，患者将通过计算机随机化随机分为两组，并在治疗前进行评估。然后，他们将接受连续4周的12次治疗，并进行持续12周的随访。主要评价指标包括一级指标和二级指标。主要指标是主观症状评分，通过视觉模拟量表（VAS）、鼻结膜炎生活质量问卷（RQLQ）和改良的马萨诸塞州总医院针灸感觉量表（C-MMASS）进行评估。次要指标是实验室检查结果，如血清过敏原特异性免疫球蛋白E （sIgE）、鼻炎症细胞计数（肥大细胞、嗜酸性粒细胞和T细胞）和鼻排泄物中的一氧化氮浓度。抗过敏药物的使用也将作为次要指标之一进行记录。此外，不良事件将被记录和分析。将进行意向治疗分析（ITT）和每个方案分析（PP）来测试和验证该试验的结果。本试验的结果将证明针灸治疗变应性鼻炎的疗效，并验证针灸的疗效是否与针感气有关。中国临床试验注册：ChiCTR-TRC-13003594（于2013年8月16日注册，第一例患者于2013年9月27日随机分配）。
BackgroundThe traditional Chinese theory of acupuncture emphasizes that the intensity of acupuncture must reach a threshold to generatede qi(a specific and compound sensation during the acupuncture), which is necessary to achieve the best therapeutic effect. However, the notion thatde qimust 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 elicitde qi) or weak stimulation among patients with allergic rhinitis.Methods/DesignThis 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.DiscussionThe 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 sensationde qi.Trial registrationChinese Clinical Trial Registry: ChiCTR-TRC-13003594 (registered on 16 August 2013, and the first patient was randomized on 27 September 2013).
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影响因子：
5.7
作者：
Xue, CCL;English, R;Li, CG
通讯作者：
Li, CG
影响因子：
6.1
作者：
JUNIPER, EF;GUYATT, GH
通讯作者：
GUYATT, GH
影响因子：
2.6
作者：
Kong, Jian;Gollub, Randy;Kaptchuk, Ted J.
通讯作者：
Kaptchuk, Ted J.
影响因子：
12.4
作者：
Choi, S. M.;Park, J. -E.;Baoyan, L.
通讯作者：
Baoyan, L.
DOI：
10.1093/ecam/nep006
发表时间：
2010-06
期刊：
Evidence-based complementary and alternative medicine : eCAM
影响因子：
--
作者：
Lim S
通讯作者：
Lim S