Yinglian Xiao1, Yuwen Li1, Jianchang Shu2, Yan Li3, Jianming Xu4, Jianlin Ren5, Deliang Liu6, Jiangbin Wang7, Liya Zhou8, Yanqing Li9, Guodou Tang10, De'an Tian11, Shutian Zhang12, Xiaohua Hou13, Huahong Wang14, Zhaoshen Li15, Nonghua Lv16, Minhu Chen1. 1. The First Affiliated Hospital, Sun Yat-Sen University, Guangzhou, Guangdong Province, China. 2. Guangzhou Red Cross Hospital Affiliated to Medical College of Jinan University, Guangzhou, Guangdong Province, China. 3. The Second Affiliated Hospital of Chinese Medical University, Shenyang, Liaoning Province, China. 4. The First Affiliated Hospital of Anhui University, Hefei, Anhui Province, China. 5. Zhongshan Hospital Affiliated to Xiamen University, Xiamen, Fujian Province, China. 6. The Second Xiangya Hospital of Central South University, Changsha, Hunan Province, China. 7. China-Japan Union Hospital of Jilin University, Changchun, Jilin Province, China. 8. The Third Hospital of Peking University, Beijing, China. 9. Qilu Hospital of Shandong University, Jinan, Shandong Province, China. 10. The First Affiliated Hospital of Guangxi Medical University, Nanning, Guangxi Province, China. 11. Tongji Hospital, Tongji Medical College, Huazhong University of Science and Technology, Wuhan, Hubei Province, China. 12. Beijing Friendship Hospital, Capital Medical University, Beijing, China. 13. Union Hospital, Tongji Medical College, Huazhong University of Science and Technology, Wuhan, Hubei Province, China. 14. The First Hospital of Peking University, Beijing, China. 15. Changhai Hospital of Shanghai, Second Military Medical University, Shanghai, China. 16. The First Affiliated Hospital of Nanchang University, Nanchang, Jiangxi Province, China.
Abstract
BACKGROUND AND AIM: 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. METHODS: 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. RESULTS: 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. CONCLUSIONS: 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).
RCT Entities:
BACKGROUND AND AIM: 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. METHODS: 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. RESULTS: 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. CONCLUSIONS: 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).