1. Efficacy of Weitan Waifu patch on the postsurgical gastroparesis syndrome of gastrointestinal cancer: a multi-center trial
Qin ZHOU ; Minghuan ZUO ; Quanwang LI ; Yantao TIAN ; Yibin XIE ; Yanbin WANG ; Guangyun YANG ; Yingjiang YE ; Peng GUO ; Jianping LIU ; Zhaolan LIU ; Chao AN ; Tian ZHOU ; Zhen TIAN ; Chuanbo LIU ; Ye HU ; Xiaoyi CHI ; Yang SHEN ; Yun XIA ; Kaiwen HU
Chinese Journal of Oncology 2017;39(12):919-925
Objective:
To investigate the safety and efficacy of the Weitan Waifu patch on the postsurgical gastroparesis syndrome (PGS) of gastrointestinal cancer.
Methods:
The multi-center, double-blind, randomized controlled trial was conducted with superiority design. Patients with PGS of gastrointestinal cancer diagnosed in 4 AAA hospitals and the abdominal symptom manifested as cold syndrome by Chinese local syndrome differentiation were recruited. These patients were randomly divided into two groups according to 1∶1 proportion. Placebo or Weitan Waifu patch was applied in control group or intervention group, respectively, based on the basic treatments, including nutrition support, gastrointestinal decompression, promoting gastric dynamics medicine.Two acupuncture points (Zhongwan and Shenque) were stuck with placebo in control group or patch in treatment group. The intervention course was 14 days or reached the effective standard.
Results:
From July 15, 2013 to Jun 3, 2015, 128 participants were recruited and 120 eligible cases were included in the full analysis set (FAS), and 60 cases in each group. 88 cases were included in the per-protocol set (PPS), including 45 cases in the treatment group and 43 cases in the control group. In the FAS, the clinical effective rate in the treatment group was 68.3%, significantly superior than 41.7% of the control group (
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