Zhao Baixiao, Wang Xinjuan, Lin Zhixiu, Liu Renquan, Lao Lixing
School of Acupuncture, Beijing University of Chinese Medicine.
Complement Ther Med. 2006 Mar;14(1):53-60; discussion 61. doi: 10.1016/j.ctim.2005.06.003. Epub 2005 Nov 16.
(1) Develop a sham moxibustion device; (2) determine whether volunteer participants and practitioners can distinguish the sham procedure from real moxibustion during treatment for prevention of the common cold; and (3) assess the feasibility of conducting a larger clinical trial of the device.
Double-blinded, randomized, placebo-controlled clinical trial.
A community outpatient health station in Chaoyang district, Beijing, China, from early November through late December 2003.
Sham and real moxibustion pillars were made by affixing moxa cones onto special collar bases. These pillars resemble each other in appearance, burning procedure and residue, but the base of the sham pillar isolates the moxa-produced heat and smoke and prevents them from radiating to the skin. These devices were tested in a pilot clinical trial in which patients received moxibustion at Zusanli (ST 36) for prevention of the common cold. Volunteers (n = 71) aged 55-75 years were given pre-treatment questionnaires to assess their knowledge of moxibustion and their expectations and motives for participating in the trial, randomized into treatment (n = 36) and placebo-controlled (n = 35) groups, and treated once every 2 days for 1 month. Questionnaires assessing the effectiveness of the blinding were given to the volunteers at the end of the trial and to practitioners after each treatment session.
There were no significant differences between the two groups of patients in past moxibustion experience, knowledge of moxibustion, expectations and motivation. The number of volunteers in the treatment group and the placebo group who believed they received: (1) real moxibustion; (2) sham moxibustion; and (3) were uncertain as to which they received is 30, 0, 5; 29, 0, 4, respectively. The results show no significant statistical differences (P = 1.000). The number of volunteers in the treatment group and the placebo group who were believed, by the two practitioners who provided the treatments, to have received: (1) real moxibustion; (2) sham moxibustion; and (3) and an undisclosed treatment were 10, 6, 19; 9, 4, 20 and 11, 7, 17; 12, 5, 16, respectively. There were no statistically significant differences between the practitioners (P = 0.811 and 0.840).
The sham moxibustion device was successfully validated in the present study. The results demonstrate that these specially designed real and sham moxibustion pillars can be used together to provide an effective placebo-control in moxibustion research and can successfully fulfill the double blinding protocol in moxibustion clinical trials.
（1）研发一种假艾灸装置；（2）确定志愿者参与者和从业者在预防普通感冒的治疗过程中能否区分假操作和真正的艾灸；（3）评估开展该装置更大规模临床试验的可行性。
双盲、随机、安慰剂对照临床试验。
中国北京朝阳区的一个社区门诊健康站，时间为2003年11月初至12月底。
通过将艾绒锥体粘贴到特殊的颈圈底座上制作假艾灸柱和真正的艾灸柱。这些柱子在外观、燃烧过程和残余物方面相似，但假艾灸柱的底座隔绝了艾绒产生的热量和烟雾，防止它们辐射到皮肤上。这些装置在一项试点临床试验中进行测试，患者在足三里（ST 36）接受艾灸以预防普通感冒。年龄在55 - 75岁的志愿者（n = 71）在治疗前填写问卷，以评估他们对艾灸的了解以及参与试验的期望和动机，随机分为治疗组（n = 36）和安慰剂对照组（n = 35），每2天治疗一次，持续1个月。试验结束时向志愿者以及每次治疗后向从业者发放评估盲法效果的问卷。
两组患者在过去的艾灸经历、对艾灸的了解、期望和动机方面无显著差异。治疗组和安慰剂组中认为自己接受了：（1）真正艾灸；（2）假艾灸；（3）不确定接受了哪种的志愿者人数分别为30、0、5；29、0、4。结果显示无显著统计学差异（P = 1.000）。提供治疗的两位从业者认为治疗组和安慰剂组中接受了：（1）真正艾灸；（2）假艾灸；（3）未公开治疗的志愿者人数分别为10、6、19；9、4、20以及11、7、17；12、5、16。从业者之间无统计学显著差异（P = 0.811和0.840）。
本研究中假艾灸装置成功得到验证。结果表明，这些专门设计的真正艾灸柱和假艾灸柱可共同用于在艾灸研究中提供有效的安慰剂对照，并能在艾灸临床试验中成功完成双盲方案。
