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Background Non-alcoholic fatty liver disease (NAFLD) is a common chronic liver disease characterized by excessive fat accumulation in the liver. One of the underlying pathophysiological mechanisms is insulin resistance (IR). Traditional Chinese medicine (TCM) has showed potential benefits in the management of NAFLD. Lingguizhugan decoction (LGZG) is a representative Chinese herbal formula; however, there is still no rigorous clinical trial supporting its application. Methods/design This study will be a three-arm, dose-optimization, randomized, double-blinded, placebo-controlled clinical trial. A total of 243 patients with NAFLD will be recruited and randomly assigned to the standard dose LGZG (SLGD) group, low dose LGZG (LLGD) group, or the placebo group based on a ratio of 1:1:1. The treatment period will be 12 weeks and the follow-up period will last 4 weeks. The primary outcome will be the proportions of participants with at least a 1-unit decrease of HOMA-IR from baseline to 12 weeks. Secondary outcomes will include the changes of body weight, body mass index, liver function, blood lipid metabolism, blood glucose metabolism, inflammatory responses, liver-kidney echo ratio by ultrasound, and various scales. Biological samples will also be collected for future researches on mechanism exploration. Discussion This study will provide initial evidence regarding the efficacy and safety of LGZG in the treatment of NAFLD with spleen-yang deficiency pattern and promote its application in community healthcare centers. In addition, potential mechanisms will be explored based on studies of oral and gut microbiota. Trial registration Chinese Clinical Trial Registry, ChiCTR1800014364. Registered on 1 January 2018. The final protocol version was V3.0.

Ethnopharmacological relevanceEucommia ulmoides Oliv., a valuable Chinese herb, has shown a variety of health benefits. Despite the widespread clinical use of this herb to treat rheumatoid arthritis (RA) in Traditional Chinese Medicine (TCM), very few studies have described its anti-pathological effects or mechanism in RA. The present study investigated the mechanism of Eucommia ulmoides Oliv. in an experimental collagen-induced arthritis (CIA) rat model.Materials and methodsThe effects of four different Eucommia ulmoides Oliv. extracts on the proliferation of rheumatoid arthritis fibroblast-like synoviocytes (RA-FLS) were screened in an MTT assay, and apoptotic effects were detected by flow cytometry. Among the extracts, the 70% ethanol extract (EU70) presented the best inhibition and was further investigated for its curative effect in CIA rats. Foot swelling was detected, and the arthritis index (AI) was scored. Pathological improvement was assessed by haematoxylin and eosin (H&E) staining of joint tissues. The mechanistic effects of EU70 were investigated as follows: anti-inflammatory effects in Th17-positive cells by flow cytometry; serum levels of inflammatory cytokines by ELISA; TNFα and IL-1β expression by immunohistochemistry (IHC); and anti-osteoclastogenesis by QPCR detection of RANKL and OPG mRNA.ResultsCompared with vehicle treatment in CIA model rats, EU70 significantly ameliorated foot swelling, decreased AI in vivo and reduced inflammatory cell infiltration and synoviocyte proliferation. EU70 decreased the number of Th17-positive cells in the spleen and the serum levels of cytokines, including IL-17, IL-1β and TNFα, and upregulated the serum levels of IL-10; these results indicated the anti-inflammatory effect of EU70. Moreover, EU70 effectively suppressed TNFα and IL-1β expression in the joint tissues and resulted in the downregulation of RANKL mRNA and the upregulation of OPG mRNA. These results revealed the possible preventive role of EU70 against bone destruction.ConclusionFor the first time, these mechanisms and pathological improvements support the clinical use of Eucommia ulmoides Oliv. in treating RA. The findings indicated that the 70% ethanol extract of Eucommia ulmoides Oliv. could relieve RA symptoms by (1) suppressing the proliferation of synoviocytes, (2) reducing the number of Th17-positive cells and downregulating serum IL-17 expression, (3) increasing the anti-inflammatory effects of IL-10, (4) inhibiting the serum and tissue levels of key pro-inflammatory cytokines, TNFα and IL-1β, and (5) reducing the degradation of cartilage and bone.

To develop an improved version of the Quality-of-Life Assessment instrument for Lung Cancer Patients Based on Traditional Chinese Medicine (QLASTCM-Lu) and to evaluate its psychometric property. The structured group method and the theory in developing rating scale were employed to revise the preliminary scale. The psychometric property (reliability, validity, and responsiveness) of the established QLASTCM-Lu (modified) were evaluated by quality of life data measured in 100 lung cancer patients. Statistical analyses were made accordingly by way of correlation analysis, factor analysis and paired t-test. The internal consistency reliability of the overall scale and all domains was from 0.80 to 0.94. Correlation and factor analyses demonstrated that the scale was good in construct validity. The criterion validity was formed with European Organization for Research and Treatment of Cancer-Quality of Life Questionnaire-Lung Cancer (EORTC QLQ-LC43) as the criterion. Statistically significant changes were found apart from such domain as "mental condition" and "social function", with the standardized response means being close to those of QLQ-LC43. QLASTCM-Lu (modified) could be used to measure the quality of life of lung cancer patients with good reliability, validity and a certain degree of responsiveness.

Objective: To evaluate the efficacy and safety of Danning Tablet (DNT) in patients with non-alcoholic fatty liver disease (NAFLD) of damp-heat syndrome type. Methods: A multicenter, randomized, double-blinded and positive drug parallel controlled trial was performed. One hundred and thirty-five patients were enrolled into the study and divided into two groups: DNT-treated group (n=102) and ursodeoxycholic acid (UDCA)-treated group (n=33). Body mass index (BMI), principal symptoms, liver function, blood lipids, iconographic, and compositional parameters were measured before and after treatment, respectively. Results: In the two groups, BMI, distress in hepatic region, fatigue. anorexia, liver function, blood lipids and iconographic parameters were significantly improved and the improvements of BMI, distress in hepatic region were better in DNT-treated group than in UDCA-treated group. The histological study also showed that DNT had positive effect in treatment of NAFLD. Conclusion: DNT is an effective drug to treat patients with NAFLD of damp-heat syndrome type and is more effective than UDCA.

Objective: To evaluate the growth-inhibiting and anti-metastasis effects of Weichang'an Decoction (WCAD) on orthotopic transplant nude mouse model of human gastric cancer. Methods: Forty-one nude mice were implanted with SGC-7901 cells at orthotopic site, whereas 25 were implanted with SGC-7901 cells subcutaneously. Then the nude mice in each transplantation model were divided into the same three groups which were WCAD-treated group with WCAD 0.5 ml/ d taken orally. 5-FU-treated group with 5-FU 50 mg/kg intraperitoneally injected weekly and untreated control group with physiological saline 0. 5 ml/d taken orally. The growth-inhibiting rates of transplant tumors were detected and the metastatic lesions were examined in the orthotopic transplant mouse model while PCNA-positive rate and apoptotic index (AI) were observed in the subcutaneous transplant mouse model. Results: The growth-inhibiting rates in the WCAD-treated and 5-FU-treated groups of orthotopic transplant mouse model were 40. 82% and 37. 92% respectively whereas those of subcutaneous transplant mouse model were 48.70% and 60.10% . The incidence rates of metastasis in perigastric lymph notes, lymph nodes in the porta hepatis, liver, diaphragm and peritoneum in the WCAD-treated and 5-FU-treated groups were lower than those in the untreated control group, and the total metastasis rates in the WCAD-treated, 5-FU-treated and the untreated control groups were 30. 77%, 28. 57% and 71.43% respectively with significant differences (P0.05). The total PCNA-positive rates in the WCAD-treated and 5-FU-treated groups were obviously lower than that in the untreated control group (P0.05 or P0.01) while the Al was higher than that in the untreated control group (P0.01). The growth-inhibiting rate, total PCNA-positive rate and total metastasis rate in the WCAD-treated group had no significant differences as compared with those in the 5-FU-treated group, but the Al in the WCAD-treated group was significantly higher than that in the 5-FU-treated group (P0. 05). Conclusion: WCAD has the inhibiting effects on tumor growth and metastasis of gastric cancer which is orthotopic implanted onto nude mice. This effect may be obtained by proliferation suppression and apoptosis induction in cancer.

To establish questionnaire scaling and reliability and examine the clinical and psychometric validity of the quality of life assessment based on Traditional Chinese Medicine for advanced gastric cancer (QLASTCM-Ga).The QLASTCM-Ga was developed based on programmed decision procedures with multiple nominal and focus group discussions, in-depth interview, pretesting and quantitative statistical procedures. The questionnaire was administered to 240 patients diagnosed with advanced gastric cancer before and after treatment. Structured group methods were employed to establish a general and a specifific module respectively. The psychometric properties of the scale were evaluated with respect to validity, reliability and responsiveness.The three identified scales of the QLASTCM-Ga and the total score demonstrated good psychometric properties. Test-retest reliability of the total scale and all domains ranged from 0.90 to 0.94, and internal consistency ranged from 0.86 to 0.93. Correlation and factor analysis demonstrated good construct validity. Signifificant difference in the subscales and the total score were found among groups differing in traditional Chinese medicine syndrome, supporting the clinical sensitivity of the QLASTCM-Ga. Statistically signifificant changes were found for each scale and the total score. Responsiveness was also good.The QLASTCM-Ga demonstrates good psychometric and clinical validity to assess quality of life in patients with advanced gastric cancer undergoing traditional Chinese medicine therapy. This study is an important fifirst step for future research in this area.

BACKGROUND Traditional Chinese medicine (TCM) is considered an important complementary therapy with beneficial effects for cancer patients. Elderly patients with non-small-cell lung cancer (NSCLC) are a complex patient group with increasing co-morbidity and shrinking physiological reserve, and may derive substantial benefit from the supportive aspects of TCM. Researchers from Shanghai Longhua Hospital found that qi and yin deficiency is a common syndrome in patients with stage III or IV lung cancer. This project was designed to study the combination of single-agent chemotherapy with TCM methods of benefiting qi and yin in elderly patients with advanced NSCLC. METHODS AND DESIGN This is a double-blind controlled, multi-center, and prospective study with randomly selected participants from elderly NSCLC patients in China. Seventy-six patients who meet the inclusion criteria will be allocated into two groups, which will receive treatments of 3-week single-agent chemotherapy with TCM or placebo for four cycles. Progression-free survival (PFS) is the primary end point, and the secondary end points are overall survival, objective response rate, time-to-progression, and quality of life (EORTC QLQ-LC43, and TCM syndrome score). Meanwhile, other end points such as toxicity, side effects and safety of the treatments will be assessed. DISCUSSION Results from this study may provide evidence on the effectiveness, and parameters for the usage of single-agent chemotherapy combined with or without TCM on PFS of elderly patients with NSCLC. TRIAL REGISTRATION ClinicalTrials.gov. (Identifier: NCT01780181).

Background Neck pain is a common symptom in most patients suffering from cervical radiculopathy. However, some conservative treatments are limited by their modest effectiveness. On the other hand, surgical intervention for cervical disc disorders is indicated when symptoms are refractory to conservative treatments and neurological symptoms are progressive. Many patients use complementary and alternative medicine, including traditional Chinese medicine, to address their symptoms. The purpose of the present study is to examine the efficacy and safety of Qishe Pill, a compound traditional Chinese herbal medicine, for neck pain in patients with cervical radiculopathy. Methods/design A multicenter, double-blind, randomized, placebo-controlled trial to evaluate the efficacy and safety of the Qishe Pill is proposed. The study will include 240 patients from five sites across China and diagnosed with cervical radiculopathy, according to the following inclusion criteria: age 18 to 65 with pain or stiffness in the neck for at least 2 weeks (neck disability index score 25 or more) and accompanying arm pain that radiates distally from the elbow. Qualified participants will be randomly allocated into two groups: Qishe Pill group and placebo group. The prescription of the trial medications (Qishe Pill/placebo) are 3.75 g each twice a day for 28 consecutive days. The primary outcome is pain severity. Secondary outcomes are functional status, patient satisfaction, and adverse events as reported in the trial. Discussion Qishe Pill is composed of processed Radix Astragali, Muscone, Szechuan Lovage Rhizome, Radix Stephaniae Tetrandrae, Ovientvine, and Calculus Bovis Artifactus. According to modern research and preparation standards, Qishe Pill is developed to improve on the various symptoms of cervical radiculopathy, especially for neck pain. As it has a potential benefit in treating patients with neck pain, we designed a double-blind, prospective, randomized-controlled trial and would like to publish the results and conclusions later. If Qishe Pill can alleviate neck pain without adverse effects, it may be a unique strategy for the treatment of cervical radiculopathy. Trial registration This study is registered at ClinicalTrials.gov, NCT01274936

Traditional Chinese Medicine (TCM) has many unique features. Thequality-of-life (QoL) instrument for lung cancer based on Traditional Chinese Medicine (QLASTCM-Lu) was the first self-reported instrument specifically developed to assess the quality of life from the perspective of TCM. Structured group methods and theory in developmental rating scale were employed to establish a general and a specific module, respectively. Quantitative and qualitative data from 240 lung cancer patients were collected to assess the psychometric properties. The three identified scales of the QLASTCM-Lu (correspondence between man and universe, unity of the body and spirit, and lung cancer specific module) and the total score demonstrated excellent psychometric properties. Test-retest reliability of all domains ranged from 0.93 to 0.96, and internal consistencyαranged from 0.86 to 0.93. Correlation and factor analysis demonstrated good construct validity. Significant differences in the QLASTCM-Lu scales and total score were found among groups differing in TCM syndrome, supporting the clinical sensitivity of the QLASTCM-Lu. Statistically significant changes were found for each scale and the total score. Responsiveness of the QLASTCM-Lu was greater than that of QLQ-LC43. The QLASTCM-Lu is a psychometrically sound and clinically sensitive measure of quality of life for lung cancer patients, which can be applied to both TCM therapy and Western medicine therapy.

To investigate the expression of multiple genes in Chinese jianpi herbal recipe Wei Chang An (WCA) in human gastric cancer cell line SGC-7901.A human gastric adenocarcinoma cell line SGC-7901 grafted onto nude mice was used as the animal model. The mice were randomly divided into 3 groups, one control and the two representing experimental conditions. Animals in the two experimental groups received either WCA over a 34-d period or 5-fluorouracil (5-FU) over 6-d period starting at 8th d after grafting. Control animals received saline on an identical schedule. Animals were killed 41 d after being grafted. The expression profiles in paired WCA treated gastric cancer samples and the N.S. control samples were studied by using a cDNA array representing 14181 cDNA clusters. The alterations in gene expression levels were confirmed by Real-time Quantitative polymerase chain reaction (qPCR).When compared with controls, the average tumor inhibitory rate in WCA group was 44.32% +/- 5.67% and 5-FU 47.04% +/- 11.33% (P0.01, respectively). The average labeling index (LI) for PCNA in WCA group and 5-FU group was significantly decreased compared with the control group. Apoptotic index (AI) was significantly increased to 9.72% +/- 4.51% using the terminal deoxynucleotidyl transferase-mediated deoxyuridine triphosphate fluorescence nick end labeling (TUNEL) method in WCA group compared with the controls 2.45% +/- 1.37%. 5-FU group was also found to have a significantly increased AI compared with the controls. The expression of cleaved Caspase-3 in WCA group and 5-FU group was significantly increased compared with the control group respectively. There were 45 different expressed sequence tags (ESTs) among the control sample pool and WCA sample pool. There were 24 ESTs up-regulated in WCA samples and 21 ESTs down-regulated. By using qPCR, the expression level of Stat3, rap2 interacting protein x (RIPX), regulator of differentiation 1 (ROD1) and Bcl-2 was lower in WCA group than that in control group respectively. By using SP immunohistochemical method the expression of Phospho-Stat3 (Tyr705) and Bcl-2 in WCA group and 5-FU group was significantly decreased compared with the control group respectively.WCA could inhibit gastric cancer cell SGC-7901 growth in vivo. WCA could induce gastric cancer cell apoptosis and suppress proliferation. Its mechanisms might be involved in the down-regulation of Stat3, RIPX, ROD1 and Bcl-2 gene.

OBJECTIVE: To investigate the mechanism of Chinese herbal recipe Weichang'an (WCA) in inducing cell apoptosis of human gastric cancer grafted onto nude mice. METHODS: The high performance liquid chromatography was used for monitoring the stability of WCA. A human gastric cancer cell line SGC-7901 grafted in nude mouse was used as the animal model. The mice were divided into untreated group and two experimental groups. Animals in the two experimental groups received either WCA over a 34-day period or 5-fluorouracil (5-FU) over a 6-day period starting at the 8th day after grafting. Animals in the untreated group received normal saline on an identical schedule. Animals were killed 41 days after being grafted. To assess the effect of the treatment on tumor, the tumor weight was determined by the electron balance immediately after the animals were killed. SP immunohistochemical method was used to detect the expression of proliferating cell nuclear antigen (PCNA) in grafts. Apoptotic indices (AI) of the tumor cells were examined by terminal deoxynucleotidyl transferase-mediated deoxyuridine triphosphate fluorescence nick end labeling (TUNEL) method. SP method was also used to detect the expressions of cleaved caspase-3, caspase-8 and caspase-9. SYBR green dye I real-time quantitative polymerase chain reaction (real-time quantitative [corrected] PCR) was used to assess the related gene alterations in mRNA level. The expressions of phospho-Stat3 (Tyr705) and bcl-2 proteins were detected by using SP method. RESULTS: Compared with the untreated group, tumor growth was significantly inhibited by treatment of WCA or 5-FU (P

OBJECTIVE To observe the protective effects of Yanggan Lidan Granules (YGLDG) on carbon tetrachloride (CCl(4))-induced liver damage in mice and to find out its mechanism. METHODS A model of chronic liver damage was established in mice by intraperitoneal injection of CCl(4). After three weeks, those model mice were treated with low-, medium-, high-dose YGLDG, Danning Tablets and bifendate respectively for four weeks. Then the levels of serum alanine aminotransferase (ALT) and aspartate aminotransferase (AST), as well as the contents of superoxide dismutase (SOD) and malondialdehyde (MDA) in liver tissues were detected. RESULTS YGLDG could significantly reduce the levels of serum ALT and AST in model mice, and the content of MDA was obviously decreased while the content of SOD was increased in liver tissue. CONCLUSION The therapeutic effect of YGLDG on mice with CCl(4)-induced liver damage is to relieve the seriousness of liver damage, and its mechanism may relate to reducing peroxidation activity in liver tissue.