Efficacy of Weitan Waifu patch on the postsurgical gastroparesis syndrome of gastrointestinal cancer: a multi-center trial
10.3760/cma.j.issn.0253-3766.2017.12.008
- VernacularTitle: 胃瘫外敷方穴位贴敷治疗消化系统肿瘤患者术后胃瘫的多中心临床研究
- Author:
Qin ZHOU
1
;
Minghuan ZUO
1
;
Quanwang LI
1
;
Yantao TIAN
2
;
Yibin XIE
2
;
Yanbin WANG
3
;
Guangyun YANG
3
;
Yingjiang YE
4
;
Peng GUO
4
;
Jianping LIU
5
;
Zhaolan LIU
5
;
Chao AN
1
;
Tian ZHOU
1
;
Zhen TIAN
1
;
Chuanbo LIU
1
;
Ye HU
1
;
Xiaoyi CHI
1
;
Yang SHEN
1
;
Yun XIA
1
;
Kaiwen HU
1
Author Information
1. Department of Oncology, Dongfang Hospital, Beijing University of Chinese Medicine, Beijing 100078, China
2. Department of Pancreatic and Gastric Surgery, National Cancer Center/Cancer Hospital, Chinese Academy of Medical Sciences and Peking Union Medical College, Beijing 100021, China
3. Department of Hepatobiliary Surgery, Chinese PLA General Hospital, Beijing 100853, China
4. Department of General Surgery, Peking University People′s Hospital, Beijing 100044, China
5. Evidence-Based Medicine Center, Beijing University of Chinese Medicine, Beijing 100029, Chinak
- Publication Type:Clinical Trail
- Keywords:
Gastroenterological carcinoma;
Postsurgical gastroparesis syndrome;
Traditional Chinese medicine;
External treatment
- From:
Chinese Journal of Oncology
2017;39(12):919-925
- CountryChina
- Language:Chinese
-
Abstract:
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 (P=0.003). The medium time of effective therapy in the treatment group was 8 days, significantly shorter than 10 days in the control group (P=0.017). In the FAS, 3 adverse events occurred in the treatment group, including mild to moderate decrustation, pruritus and nausea. The incidence rate of adverse events was 5.0% (3/60) and these symptoms were spontaneously remitted after drug withdrawal. No severe adverse events were observed in the control group. There was no significant difference between these two groups (P=0.244).
Conclusion:Weitan Waifu patch is a safely and effectively therapeutic method for patients with PGS (cold syndrome) of gastroenterological cancer.
Trial registration:International Standard Randomized Controlled Trial Number Register, ISRCTN18291857
