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...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.展开更多
基金Supported by research project of "Innovation Engineering" of The First Affiliated Hospital of Tianjin University of TCM:Academy 0804
文摘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.
