医学
随机化
安慰剂
餐后
临床终点
内科学
苦恼
随机对照试验
意向治疗分析
临床试验
替代医学
临床心理学
病理
胰岛素
作者
Yinglian Xiao,Yuwen Li,Jian-chang Shu,Yan Li,Jianming Xu,Jianlin Ren,Deliang Liu,Jiangbin Wang,Liya Zhou,Yanqing Li,Guodou Tang,Dean Tian,Shutian Zhang,Xiaohua Hou,Huahong Wang,Zhaoshen Li,Nonghua Lv,Minhu Chen
摘要
The treatment of patients with functional dyspepsia (FD) remains unsatisfactory. We assessed the efficacy of Zhizhu Kuanzhong (ZZKZ) capsule, a traditional Chinese medicine formula, in patients with postprandial distress syndrome (PDS) of FD.The study was designed as a multicenter, randomized, double-blinded, controlled clinical trial. Three-hundred ninety-two patients with PDS defined by Rome III criteria from 16 centers in China were randomly assigned to receive either ZZKZ or placebo. The proportion of the responders at 4 weeks after randomization was considered primary endpoint. Secondary endpoint was the symptom score reduction of each dyspeptic symptom relative to the baseline at 4 weeks after randomization in all subjects.In terms of the primary endpoint, the proportion of the responders concerning the composite PDS symptom score was 38.8% and 54.7% in placebo group and ZZKZ group, respectively (P = 0.003), in per protocol analysis at 4 weeks after randomization. Concerning the individual evaluated upper gastrointestinal symptoms, only postprandial fullness and early satiety showed significant difference in symptom score reduction at 4 weeks after randomization between placebo and ZZKZ groups.Zhizhu Kuanzhong is superior to placebo in the treatment of PDS with FD. The exact mechanisms by which ZZKZ improves symptoms remain to be established (http://www.chictr.org.cn/ChinCTR-TRC-14004714).
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