NCT03025152

Efficacy and Safety of Hou Gu Mi Xi in Patients With Spleen Qi Deficiency and Radical Gastrectomy for Gastric Cancer

Efficacy and Safety of Hou Gu Mi Xi in Patients With Spleen Qi Deficiency and Radical Gastrectomy for Gastric Cancer: A Multicenter, Randomized, Double-blinded, Parallel-group, Placebo-controlled Trial

• Status: Terminated
• Phase: N/A
• Study type: Interventional
• Enrollment: 130 (actual)
• Sponsor: Jiangxi University of Traditional Chinese Medicine · Academic / Other
• Sex: All
• Age: 18 Years – 70 Years
• Healthy volunteers: Not accepted

Summary

This trial aims to determine whether Hou Gu Mi Xi is an effective treatment for improving symptoms and indicators in patients with spleen qi deficiency and radical gastrectomy for gastric cancer.

Detailed description

The incidence of gastric cancer ranks high in many countries around the world. Although along with the development of economy and medical condition the incidence of gastric cancer appears a trend of decrease in developed countries, it is still one of most common cancers in Asia. There are more new gastric cancer cases in China compared with other countries every year. According to an epidemiological survey by World Health Organization, 5-year prevalence of gastric cancer was 53.7/10,000 in China - it is only lower than Japan. For the early gastric cancer, radical gastrectomy, is the most important treatment, which could significantly prolong disease-free survival and overall survival. However, the severe damage of surgery and following radiation and chemotherapy in intestinal tract usually leads patients to be a constitution of spleen qi deficiency, a concept of traditional Chinese medicine (TCM) that mainly involves digestive symptoms, such as poor appetite, abnormal stool (loose, diarrhea) and abdominal distention. Therefore, how to resolve and protect the function of intestinal tract, and change the constitution of spleen qi deficiency postoperatively is important for improving quality of life and reducing the recurrence rate of cancer. Shen Ling Bai Zhu San, a classic Chinese medicinal formulae originally described in Tai Ping Hui Min He Ji Ju Fang in the Song Dynasty (1102 AD), is composed of ginseng, tuckahoe, atractylodes, baked licorice, coixenolide, Chinese yam, lotus seed, shrinkage fructus amomi, platycodon grandiflorum, white hyacinth bean, and dried orange peel. It has effects of replenishing qi and invigorating spleen (spleen is a TCM conception that differs from western medicine), as well as penetrating wet and antidiarrheal. It is mainly used for treating the syndrome of spleen qi deficiency, including dyspepsia, chest and stomach distress, borborygmus and diarrhea, limb weakness, thin body, sallow complexion, pale tongue with white and greasy coating, and weak and slow pulse, etc. In the theory of TCM, spleen is the source for producing qi and blood and thus is the root of life. Shen Ling Bai Zhu San could invigorate spleen by supplying spleen and remove wet, and finally nourish the stomach and intestine. Previous pharmacologic studies also revealed that Shen Ling Bai Zhu San could adjust function of anaerobic and aerobic bacteria in gastrointestinal tract; specifically, it could improve the proliferation of probiotics (such as bifidobacterium) and inhibit the main resistance strains (such as enterococcus) and thus has an effect to improve gastrointestinal symptoms. According to the experience of TCM, the constitution of patients who are undergoing radiation and chemotherapy is usually yin deficiency, but changes to spleen qi deficiency due to digestive disorders after those treatment. Therefore, Shen Ling Bai Zhu San is expected to improve symptoms in patients who underwent gastrectomy and following radiation and chemotherapy. Hou Gu Mi Xi is a dietary therapy form of Shen Ling Bai Zhu San, which removes atractylodes and platycodon grandiflorum (two herbs that could not be used as food) from Shen Ling Bai Zhu San, and adds perilla leaf for adapting a dietary therapy for a long-term use. Hou Gu Mi Xi uses the main formula of Shen Ling Bai Zhu San, so that it could theoretically maintain the treatment effects. Although the reliable health effects of Shen Ling Bai Zhu San has been proved in previous studies, Hou Gu Mi Xi is optimized in formula and its preparations changed from electuary to rice paste, so that its functional mechanism and efficacy may be different. Therefore, the investigators plan to perform a hospital-based randomized controlled trial, enroll patients from three hospitals in Nanchang City of Jiangxi Province in China, for assessing efficacy and safety of Hou Gu Mi Xi on digestive symptoms in patients with spleen qi deficiency and radical gastrectomy for gastric cancer.

Conditions

• Gastric Cancer
• Gastrointestinal Disease

Interventions

Type	Name	Description
DIETARY_SUPPLEMENT	Hou Gu Mi Xi	Hou Gu Mi Xi is a dietary therapy form of Shen Ling Bai Zhu San, which removes atractylodes and platycodon grandiflorum, adds perilla leaf for adapting a dietary therapy.
OTHER	placebo	The placebo has same appearance, taste and smell as Hou Gu Mi Xi.

Timeline

• Start date: 2016-11-11
• Primary completion: 2019-07-20
• Completion: 2019-07-20
• First posted: 2017-01-19
• Last updated: 2021-04-26

Locations

1 site across 1 country: China