Li Ying, Liang Fanrong, Yu Shuguang, Liu Xuguang, Tang Yong, Yang Xuguang, Tian Xiaoping, Yan Jie, Sun Guojie, Chang Xiaorong, Zheng Hui, Zhang Hongxing, Ma Tingting
Chengdu University of Traditional Chinese Medicine, Chengdu, Sichuan, PR China.
Trials. 2008 Oct 20;9:57. doi: 10.1186/1745-6215-9-57.
The effectiveness of using acupuncture to treat migraine is rarely and even suspectedly reported in the literature. In this article, we report the design and the protocol of a randomized controlled large-scale trial to treat migraine using acupuncture, aiming at testifying it is effective to use acupuncture to treat migraine. We demonstrate also that the effectiveness of the treatment may vary due to using acupoints of different meridians or different acupoints of one meridian.
A multi-center randomized controlled trial is currently undergoing, with three acupoints treatment groups and one non-acupoints control group. The acupuncture treatment consists of 20 sessions per patient with a observation period of 20 weeks. In total, 480 patients with migraine are registered in this study within 8 hospitals in China from March 2008 to June 2009. These patients are randomly assigned to receive one of the following four acupoints treatment groups, i.e. 1) specific acupoints of Shaoyang meridians (120 patients), 2) non-specific acupoints of Shaoyang meridians (120 patients), 3) acupoints of other meridians (120 patients); or 4) non-acupoints control group (120 patients). The main outcome measurement in this trial is the effect comparison achieved among these four groups in terms of number of days with migraine and intensity of migraine during and after the baseline phase, i.e. the first 4 weeks before randomization and 4, 8 and 16 weeks after randomization. The intensity of headache including headache intensity grade (0-3) and visual analogue scale (VAS) score will also be used in this study. In addition, the differences of Migraine-Specific Quality-of-Life Questionnaire (MSQ) and Transcranial Doppler Sonography (TCD) before and after randomization are also used as the secondary outcome measurement.
The result of this trial (which will be available in 2009) will demonstrate the efficacy of using acupuncture to treat migraine, and verify whether the specific effect of acupoints exists and whether this specific effect of acupoints is related to meridian and a collection of meridian Qi.
Clinical Trials.gov NCT00599586.
针刺治疗偏头痛的有效性在文献中鲜有报道，甚至受到质疑。在本文中，我们报告一项使用针刺治疗偏头痛的随机对照大规模试验的设计与方案，旨在证实针刺治疗偏头痛的有效性。我们还证明，由于使用不同经络的穴位或同一经络的不同穴位，治疗效果可能会有所不同。
目前正在进行一项多中心随机对照试验，设有三个穴位治疗组和一个非穴位对照组。针刺治疗每位患者共20次，观察期为20周。2008年3月至2009年6月期间，中国8家医院共有480例偏头痛患者登记参加本研究。这些患者被随机分配到以下四个穴位治疗组之一，即1）少阳经特定穴位组（120例患者），2）少阳经非特定穴位组（120例患者），3）其他经络穴位组（120例患者）；或4）非穴位对照组（120例患者）。本试验的主要疗效指标是比较这四组在基线期（即随机分组前的前4周以及随机分组后的4、8和16周）期间及之后偏头痛发作天数和偏头痛强度方面所取得的疗效。本研究还将使用包括头痛强度分级（0 - 3级）和视觉模拟量表（VAS）评分在内的头痛强度指标。此外，随机分组前后偏头痛特异性生活质量问卷（MSQ）和经颅多普勒超声（TCD）的差异也用作次要疗效指标。
本试验结果（将于2009年公布）将证明针刺治疗偏头痛的疗效，并验证穴位的特定效应是否存在以及这种穴位的特定效应是否与经络及经气汇聚有关。
ClinicalTrials.gov NCT00599586
