The Affiliated Hospital of Jiangxi University of TCM, Nanchang, PR China.
Trials. 2010 Dec 15;11:121. doi: 10.1186/1745-6215-11-121.
Asthma is a major health problem and has significant mortality around the world. Although the symptoms can be controlled by drug treatment in most patients, effective low-risk, non-drug strategies could constitute a significant advance in asthma management. An increasing number of patients with asthma are attracted by acupuncture and moxibustion. Therefore, it is of importance that scientific evidence about the efficacy of this type of therapy is regarded. Our past researches suggested heat-sensitive moxibustion might be effective in treatment of asthma. Our objective is to investigate the effectiveness of heat-sensitive moxibustion compared with conventional drug treatment.
METHODS/DESIGN: This study is comprised of a multi-centre (12 centers in China), randomized, controlled trial with two parallel arms (A: heat-sensitive moxibustion; B: conventional drug). Group A selects heat- sensitive acupoints from the rectangle region which consist of two outer lateral lines of dorsal Bladder Meridian of Foot-Taiyang, and two horizontal lines of BL13(Fei Shu) and BL17 (Ge Shu);6 inch outer the first and second rib gap of anterior chest. Group B treats with fluticasone/salmeterol (seretide). The outcome measures will be assessed over a 3-month period before each clinic visit at days 15, 30, 60, and 90. Follow-up visit will be at 3, 6 months after the last treatment session. Adverse event information will be collected at each clinic visit.
This trial will utilize high quality trial methodologies in accordance with CONSORT guidelines. It may provide evidence for the effectiveness of heat-sensitive moxibustion as a treatment for chronic moderate persistent asthma. Moreover, the result may propose a new type moxibustion to control asthma.
The trial is registered at Chinese Clinical Trials Registry: ChiCTR-TRC-09000599.
哮喘是一个主要的健康问题，在全球范围内有很高的死亡率。尽管大多数患者可以通过药物治疗控制症状，但有效的低风险、非药物策略可能是哮喘管理的重大进展。越来越多的哮喘患者被针灸所吸引。因此，重视这种治疗类型的疗效的科学证据是很重要的。我们过去的研究表明热敏灸可能对哮喘的治疗有效。我们的目的是研究热敏灸与常规药物治疗相比的疗效。
方法/设计：这是一项多中心（中国 12 个中心）、随机、对照试验，分为两个平行组（A：热敏灸；B：常规药物）。A 组选择从足太阳膀胱经外侧两条线和 BL13（肺俞）、BL17（膈俞）两条水平线，以及前胸部第一、二肋间隙外 6 英寸的矩形区域的热敏穴位。B 组使用氟替卡松/沙美特罗（舒利迭）治疗。在每次就诊前 3 个月进行评估，在第 15、30、60 和 90 天进行评估。最后一次治疗后 3 个月和 6 个月进行随访。每次就诊时收集不良事件信息。
本试验将按照 CONSORT 指南采用高质量的试验方法。它可能为热敏灸作为慢性中度持续性哮喘的治疗提供证据。此外，结果可能提出一种新的艾灸控制哮喘的方法。
该试验在中国临床试验注册中心注册：ChiCTR-TRC-09000599。
