ABSTRACT
Due to the differences of background, ways of thinking, visual angle and research tools between Chinese medicine and Western medicine,most Chinese medicine research based on western medicine are of low clinical value,although the combination of the Western and Traditional Chinese Medicine has gaining popularity.It is possible to change our perspective and use Chinese medicine theory to think and guide all modern treatment methods.This theory which is explained in the Tumor Green Therapeutics,has achieved remarkable clinical results and gained rapid development.Syndrome differentiation and treatment is the essence of TCM.Eight principles of syndrome differentiation of TCM are the general principles. The principles of cold and heat syndrome differentiation are the basis for the complex syndrome types.Therefore, this article will be a preliminary study for anti-cancer medicine from point of view of the principles of cold and heat syndrome differentiation, and will provide more clinical reference.
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