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 pai...
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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 *** 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 *** the statistical analysis,the groups were named as an acupuncture group and a western medicine group separately,11 cases in each *** was applied to Xìmén（郄门 PC 4）,Yīnxì（阴郄 HT 6）,Xuèhǎi（血海 SP 10）,*** the control treatment,Carbamazepine was prescribed for oral *** the duration of treatment or the wash-out period was 10 *** visual analogue scale（VAS） was adopted for the efficacy *** The total effective was 100.0%（11/11） after treatment in either *** 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 *** 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 *** can provide the high-quality evidences for clinical 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.
目的观察调神活血止痛针刺法与卡马西平治疗丘脑痛的作用特点。方法采用交叉试验设计,将11例确诊患者按最小不平衡指数法随机分为1组(先针刺治疗后西药治疗6例)和2组(先西药治疗后针刺治疗5例)。每种疗法疗程10天,两种方法间有10天洗脱期,总疗程30天。进行统计分析时,针刺组和西药组均为11例。分别应用视觉模拟评分法(VAS)和美国安德森肿瘤中心(Anderson Cancer Center)疼痛评估表(MD疼痛值)进行疗效评定,记录两组患者每天VAS和MD疼痛值,得到变化曲线。结果治疗后,两组患者VAS和MD疼痛值均较治疗前明显下降(P<0.05);在治疗期间,两组疼痛曲线均表现出下降的趋势,针刺组变化趋势是一个平缓而稳定的下降过程;西药组则显示先有较大幅度下降,在经过一个平台期后又出现了相对大幅度的下降,呈梯形样走势。结论累计效应可能是针刺主要的镇痛作用;西药可能更主要是通过迅速起效而发挥作用的。
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