Comparison of heat-sensitive moxibustion versus fluticasone/salmeterol (seretide) combination in the treatment of chronic persistent asthma: design of a multicenter randomized controlled trial.
Author(s): Chen R, Chen M, Xiong J, Yi F, Chi Z, Zhang B
Affiliation(s): The Affiliated Hospital of Jiangxi University of TCM, Nanchang, PR China. email@example.com
Publication date & source: 2010-12-15, Trials., 11:121.
Publication type: Comparative Study; Multicenter Study; Randomized Controlled Trial; Research Support, Non-U.S. Gov't
BACKGROUND: 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. DISCUSSION: 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. TRIAL REGISTRATION: The trial is registered at Chinese Clinical Trials Registry: ChiCTR-TRC-09000599.