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
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.
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.
Inclusion Criteria:

 -  Patient should be diagnosed as gastric cancer by pathology and have received radical
 gastrectomy. They should finish the following radiotherapy and chemotherapy and the
 treatment for surgical complications (such as leak, stricture, and marginal ulcer).

 -  Patient should be constitution of spleen qi deficiency, that is, meet two primary
 symptoms of spleen deficiency + two primary symptoms of qi deficiency, or meet two
 primary symptoms of spleen deficiency + one primary symptoms of qi deficiency + one
 auxiliary symptoms, or meet one primary symptoms of spleen deficiency + one primary
 symptoms of qi deficiency + two secondary symptoms + one auxiliary symptoms as follow:

 1. Main symptoms of spleen deficiency: a) poor appetite; b) abnormal stool (loose,
 diarrhea); c) abdominal distention after meal or afternoon

 2. Main symptoms of qi deficiency: a) fatigue; b) tired mind and taciturnity

 3. Secondary symptoms: a) tastelessness, hypodipsia, like hot drink, polysialia; b)
 abdominal pain, as a result either patients like warm or press, or remit after
 meal, or occur when work; c) nausea and vomiting; d) fullness in stomach; e)
 abnormal bowel sounds; f) lean or puffiness; g) sallow complexion; h) powerless
 defecation weakness; i) edema

 4. Auxiliary symptoms: pale or swollen or teeth-printed tongue with thin and white
 fur

 -  Age ranges from 18 to 70 years; both male and female

 -  Patient should be in fair performance status, indicated by a score of Eastern
 Cooperative Oncology Group (ECOG) Performance Status ≤ 1

 -  Sign the informed consent

 Exclusion Criteria:

 -  Stage IV gastric cancer according to the Japanese classification criteria [16]

 -  Impaired liver function (total bilirubin > 2 × upper limit of normal (ULN), alanine
 transaminase > 2 × ULN, or aspartate aminotransferase > 2 × ULN), kidney function
 (serum creatinine > 2 × ULN), or hematopoiesis (neutrophil counts < 0.5×109/L or,
 thrombocyte counts < 20×109/L or, absolute reticulocyte counts < 15×109/L)

 -  Obviously abnormal electrocardiogram

 -  Severe mental disorders

 -  Other severe diseases (e.g. multiple organ failure, HIV infection)

 -  Pregnant or breast-feeding women

 -  Allergic to the test sample

 -  Unwilling to provider personal information and sign the informed consent