Chengdu University of Traditional Chinese Medicine, Chengdu, Sichuan Province 610072, PR China.
Trials. 2013 Jan 10;14:12. doi: 10.1186/1745-6215-14-12.
Catgut implantation at acupoints has been used in China to treat allergic rhinitis (AR) for a long time. However, its efficacy and safety in the treatment of AR is controversial due to the poor quality of the clinical trial of this therapy. This study aims to identify whether catgut implantation at acupoints is indeed an effective and safe treatment for patients with persistent or intermittent allergic rhinitis (PER or IAR) by comparing with sham catgut implantation treatment.
This study compares real versus sham catgut implantation at acupoints in 242 patients with a history of PER or 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. In the study, patients will be randomly assigned by computer-generated randomization list into two groups and assessed prior to treatment. Then, they will receive two sessions of treatments (once per 2 weeks) for 4 consecutive weeks and have a follow-up phase of 12 weeks. The administration of catgut implantation (or sham-control) at acupoints follows the guidelines for clinical research on acupuncture (WHO Regional Publication, Western Pacific Series No.15, 1995), and is performed double-blindly by a well-trained physician in acupuncture. The main outcome measures include the primary and secondary indicators. Primary indicators are subjective symptoms scores evaluated by visual analogue scales (VAS) and Rhinoconjunctivitis Quality of Life Questionnaires (RQLQ). The secondary indicators are the results of laboratory examinations, such as serum allergen-specific IgE, 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. If any participants withdraw from the trial, intention-to-treat analysis (ITT) and per-protocol (PP) analysis will be performed.
The important features of this trial include the randomization procedures, large sample, and a standardized protocol of catgut implantation at acupoints. This trial will be the first study with a high evidence level in China in order to assess the efficacy and safety of catgut implantation at acupoints in treatment of AR following a randomized, double-blind sham-controlled method.
Chinese Clinical Trial Registry: ChiCTR-TRC-12002191.
穴位埋线疗法在中国已被用于治疗过敏性鼻炎（AR）很长时间。然而，由于这种疗法的临床试验质量较差，其治疗 AR 的疗效和安全性存在争议。本研究旨在通过与假埋线治疗比较，确定穴位埋线疗法是否确实对持续性或间歇性过敏性鼻炎（PER 或 IAR）患者有效且安全。
本研究比较了 242 例 PER 或 IAR 病史且皮肤点刺试验（SPT）阳性患者的真埋线与假埋线治疗。试验将在成都中医药大学附属医院进行。在研究中，患者将通过计算机生成的随机分组表随机分为两组，并在治疗前进行评估。然后，他们将接受两次治疗（每 2 周一次），连续 4 周，随访期为 12 周。穴位埋线（或假对照）的实施遵循世界卫生组织（WHO）西太平洋地区第 15 号出版物（1995 年）的针灸临床研究指南，并由一位经验丰富的针灸医师进行双盲操作。主要结局指标包括主要和次要指标。主要指标是通过视觉模拟量表（VAS）和鼻结膜炎生活质量问卷（RQLQ）评估的主观症状评分。次要指标是实验室检查结果，如血清过敏原特异性 IgE、鼻黏膜炎症细胞计数（肥大细胞、嗜酸性粒细胞和 T 细胞）和鼻分泌物中一氧化氮浓度。抗过敏性药物的使用也将作为次要指标之一记录。此外，还将记录并分析不良事件。如果任何参与者退出试验，将进行意向治疗分析（ITT）和符合方案分析（PP）。
本试验的重要特点包括随机分组程序、大样本量和标准化的穴位埋线方案。这将是中国首例采用随机、双盲假对照方法评估穴位埋线治疗 AR 的疗效和安全性的高质量研究。
中国临床试验注册中心：ChiCTR-TRC-12002191。
