Objective To study the feasibility of the crossover trial design and the minimal imbalance index random distribution method in the clinical small-sample-size randomized controlled trial（RCT） research of thalamic pain treated with acupuncture under the guidance of evidence-based medicine（EBM）.Methods The crossover trial design was adopted.Eleven cases with the definite diagnosis were randomized into a program-I group（6 cases,treated with acupuncture before western medicine） and a program-II group（5 cases,treated with western medicine before acupuncture） according to the minimal imbalance index method.In the statistical analysis,the groups were named as an acupuncture group and a western medicine group separately,11 cases in each one.Acupuncture was applied to Xìmén（郄门 PC 4）,Yīnxì（阴郄 HT 6）,Xuèhǎi（血海 SP 10）,etc.In the control treatment,Carbamazepine was prescribed for oral administration.Either the duration of treatment or the wash-out period was 10 days.The visual analogue scale（VAS） was adopted for the efficacy assessment.Results The total effective was 100.0%（11/11） after treatment in either group.The remarkably effective rates were 63.6%（7/11） and 36.4%（4/11） in the acupuncture group and the western medicine group separately,without statistically significant difference in comparison.Conclusion The crossover trial design and the minimal imbalance index distribution method can accomplish RCT of the clinical acupuncture and moxibustion research with the small sample size involved.They can provide the high-quality evidences for clinical acupuncture research.Acupuncture therapy can achieve the same therapeutic effect as Carbamazepine,the common western medicine,and the efficacy of it is potentially superior to that of western medicine.
目的:比较调神活血止痛针刺法与西药卡马西平治疗丘脑痛的疗效差异。方法:采用交叉试验设计,将11例确诊患者按照最小不平衡指数法随机分为Ⅰ组(先针刺治疗后西药治疗,6例)和Ⅱ组(先西药治疗后针刺治疗,5例)。进行统计分析时将组别命名为针刺组、西药组,均为11例。针刺治疗采用"清心调神,活血止痛"法,穴取郄门、阴郄、血海、照海。西药治疗采用口服卡马西平,疗程和治疗洗脱期均为10天。分别应用视觉模拟评分法(VAS)和美国Anderson Cancer Center疼痛评估表(MD疼痛评估值)进行疗效评定。结果:治疗后,两组患者VAS值和MD疼痛值均较治疗前明显下降(均P<0.05),但两组之间比较差异无统计学意义;针刺组疼痛降低显效率为63.6%(7/11),高于西药组的36.4%(4/11),但组间差异无统计学意义。结论:调神活血止痛针刺法治疗丘脑痛可以达到西医常用药物卡马西平的治疗效果。
