Efficacy of Gastrosis No.1 Compound on Functional Dyspepsia of Spleen and Stomach Deficiency-Cold Syndrome:A Multi-Center,Double-Blind,Placebo-Controlled Clinical Trial  

作　　者：张声生 赵鲁卿 汪红兵 吴兵 王垂杰 黄穗平 沈洪 魏玮 来要良 

机构地区：[1]Beijing Hospital of Traditional Chinese Medicine Affiliated to Capital Medical University [2]The Affiliated Hospital of Liaoning University of Traditional Chinese Medicine [3]The Second Affiliated Hospital of Guangdong University of Traditional Chinese Medicine [4]The Affiliated Hospital of Nanjing University of Traditional Chinese Medicine [5]Wangjing Hospital,China Academy of Chinese Medical Sciences [6]Beijing Xuanwu Hospital of Traditional Chinese Medicine

出　　处：《Chinese Journal of Integrative Medicine》2013年第7期498-504,共7页中国结合医学杂志（英文版）

基　　金：Supported by the Eleventh Five-Year National Key Technology R&D Program(No.2007BAI20B092)

摘　　要：To assess the efficacy and safety of Gastrosis No.1 compound in the treatment of functional dyspepsia with Spleen （Pi） and Stomach （Wei） deficiency-cold syndrome. Methods： A randomized, double-blind, placebo-controlled trial was performed in 5 centers. Patients with functional dyspepsia （FD） of Spleen-deficiency and qi-stagnation syndrome （162 cases） were randomly assigned to groups given Chinese herbal medicine （CHM） Gastrosis No.1 compound or placebo in a 2：1 ratio. This trial included a 4-week treatment period and a 4-week follow-up period. The outcomes were the dyspepsia symptom scores （measured by total dyspepsia symptom scale and single dyspepsia symptom scale） and syndromes of traditional Chinese medicine score （measured by traditional Chinese medicine syndrome scale）. The outcomes were noted at weeks 0, 4 and 8. Results： Compared with patients in the placebo group, patients in the CHM group showed significant improvement in the dyspepsia symptom scores as rated by patients and investigators （P〈0.01）, and also showed improvement in syndromes of traditional Chinese medicine score （P〈0.01）. No serious adverse event was reported. Safety tests obtained after 4 weeks of treatment showed no abnormal values. Conclusion： CHM Gastrosis No.1 compound was effective and safe in the treatment of functional dyspepsia with Spleen and Stomach deficiency-cold syndrome.To assess the efficacy and safety of Gastrosis No.1 compound in the treatment of functional dyspepsia with Spleen （Pi） and Stomach （Wei） deficiency-cold syndrome. Methods： A randomized, double-blind, placebo-controlled trial was performed in 5 centers. Patients with functional dyspepsia （FD） of Spleen-deficiency and qi-stagnation syndrome （162 cases） were randomly assigned to groups given Chinese herbal medicine （CHM） Gastrosis No.1 compound or placebo in a 2：1 ratio. This trial included a 4-week treatment period and a 4-week follow-up period. The outcomes were the dyspepsia symptom scores （measured by total dyspepsia symptom scale and single dyspepsia symptom scale） and syndromes of traditional Chinese medicine score （measured by traditional Chinese medicine syndrome scale）. The outcomes were noted at weeks 0, 4 and 8. Results： Compared with patients in the placebo group, patients in the CHM group showed significant improvement in the dyspepsia symptom scores as rated by patients and investigators （P〈0.01）, and also showed improvement in syndromes of traditional Chinese medicine score （P〈0.01）. No serious adverse event was reported. Safety tests obtained after 4 weeks of treatment showed no abnormal values. Conclusion： CHM Gastrosis No.1 compound was effective and safe in the treatment of functional dyspepsia with Spleen and Stomach deficiency-cold syndrome.

关 键 词：functional dyspepsia Spleen and Stomach deficiency-cold syndrome randomized controlled trial 

分 类 号：R57[医药卫生—消化系统]