Ancient and modern medication laws of aromatic Chinese medicines in treating angina pectoris based on data mining / 数字中医药（英文）

@#Objective To explore ancient and modern medication laws of aromatic Chinese medicines in treating angina pectoris, and to provide new ideas for the clinical treatment. Methods With “angina pectoris” as the key word, ancient books prescriptions and Chinese patent medicines related to angina pectoris were collected from China National Knowledge Infrastructure (CNKI), Traditional Chinese Medicine Database System, Chinese Medicine Prescription Database, New National Proprietary Chinese Medicine (2nd edition), and Chinese Pharmacopoeia (2020 edition) from January 1, 2015 to December 31, 2021. Core high-frequency aromatic Chinese medicines were defined, and their potential medication rules were analyzed and summarized. Microsoft Access 2010 was used for data management. Data analysis software, including Excel and IBM SPSS Modeler 18.0 were used for drug association rule analysis, and Cytoscape 3.7.2 for visual display. Results There were 67 ancient books prescriptions and 258 Chinese patent medicines containing aromatic Chinese medicines treating angina pectoris collected from relevant databases. In ancient books prescriptions, there were nine aromatic Chinese medicines with the frequency ≥10, and the most commonly used medicine was Danggui (Angelicae Sinensis Radix), followed by Chenpi (Citri Reticulatae Pericarpium). There were 33 aromatic Chinese medicines with the frequency ≥10 in Chinese patent medicines, and the most commonly used medicine was Danshen (Salviae Miltiorrhizae Radix et Rhizoma), followed by Chuanxiong (Chuanxiong Rhizoma) and Sanqi (Notoginseng Radix et Rhizoma). In ancient books prescriptions, the medicines mainly belonged to intenal-warming medicines, Qi-regulating medicines, and blood circulation promoting and blood stasis removing medicines. There were eight medicine pairs with confidence equal to 100% in ancient books prescriptions, the most frequently used pairs were Chuanxiong (Chuanxiong Rhizoma) + Danggui (Angelicae Sinensis Radix), and Xiangfu (Cyperi Rhizoma) + Chenpi (Citri Reticulatae Pericarpium). In Chinese patent medicines, the aromatic Chinese medicine Chuanxiong (Chuanxiong Rhizoma) could be combined with many other Chinese medicines, among which the Confidence and Support of Chuanxiong (Chuanxiong Rhizoma) + Danshen (Salviae Miltiorrhizae Radix et Rhizoma) were at a high level. Conclusion Aromatic Chinese medicines for the treatment of angina pectoris of coronary heart disease are mainly warm, and the flavors are mainly pungent, sweet, and bitter. They mainly access to the liver, gallbladder, and pericardium meridians. The treatment of angina pectoris of coronary heart disease mainly focuses on warming heart pulse, and promoting blood circulation and removing blood stasis.

Discovery of markers for discriminating the age of cultivated ginseng by using UHPLC-QTOF/MS coupled with OPLS-DA.

BACKGROUND: Ginseng (Ginseng Radix et Rhizoma, Panax ginseng C.A. Meyer) is gaining more publicity in modern society due to its health benefit and huge value in market. In the practice of grading and pricing of ginseng, the age is one of the major factor influencing the price and grade of ginseng. Therefore, the age discrimination is an important task for the quality control of ginseng. However, the traditional morphological methods are too subjective to be reproductive in discrimination. PURPOSE: To establish a method that can discriminate the ginseng samples with different cultivation years. STUDY DESIGN: To analyze the correlation between chemical compositions and cultivation years of cultivated ginseng samples of different age and thus discover potential quality marker (Q-marker) for discriminating the age of cultivated ginseng. METHODS: In the present study, the ultra-high performance liquid chromatography coupled with the quadrupole-time of flight mass spectrometry (UHPLC-QTOF/MS) were utilized for the age discrimination and marker discovery. A statistical data processing procedure was established to screen markers and reduce the false positive rate. RESULTS: The results showed that the ginseng samples from 2- to 6-year-old could be well separated in the orthogonal projections on the latent structure - discrimination analysis (OPLS-DA) using the markers screened by the established statistical procedure, which could reduce approximately 20% of the insignificant markers and false positive discoveries. Ultimately, more than 50 compounds contributing to the age discrimination were identified including one new compound (malonylginsenoside). One negative marker (1038.4825@8.98) was discovered for the 2-year-old ginseng, and an equation was established to effectively predict the age of 3- to 6-year-old of ginseng. CONCLUSION: The constructed method can discriminate the ginseng samples with different cultivation years and is a complement to the traditional discrimination method of ginseng age.

A national survey of Chinese medicine doctors and clinical practice guidelines in China.

BACKGROUND: Clinical practice guidelines (CPGs) for Chinese medicine (CM) are being developed to assist doctors with appropriate decisions concerning CM care. To date, there has been little investigation on the perspectives of those to whom the guidelines are directed. METHODS: A self-administered questionnaire was sent to 4503 doctors in 28 provinces of China in the latter half of 2012. Questions were organized around the topics of knowledge, application, practice changes, beliefs and outcomes of implementation. Basic classificatory data on specialties and years of qualification were also collected. RESULTS: Replies were received from 4495 CM doctors (99.82%). Of these, 85.56% of CM doctors reported being familiar with CPG recommendations, but the overall adherence rate was only 50.39%. The length of time practicing CM may influence the rate of adherence, since 709 doctors (51.90%) with less than 5 years of experience reported never having followed CPGs. Doctors in nine specialties showed a modest degree of homogeneity in their attitudes towards CM diagnosis and treatment, which were generally positive. Most doctors regarded CPG-recommended therapies as safe (92%), economic (84%), and effective (76%). Approximately four-fifths of those questioned selected 'acceptable' (60.84%) and 'acceptable after revision' (19.23%) regarding their comprehensive assessment of the CPGs. CONCLUSIONS: An encouraging result from this survey is that the majority of CM doctors support the concept of CPGs for the practice of CM. However, the results of this survey also suggest that improving the adherence of CM doctors to the guidelines remains a major challenge to improving the practice standards for CM.

Predicting and verifying outcome of Tripterygium wilfordii Hook F. based therapy in rheumatoid arthritis: from open to double-blinded randomized trial.

Tripterygium wilfordii Hook F. (TwHF) based therapy has been proved as effective in treating rheumatoid arthritis (RA), yet the predictors to its response remains unclear. A two-stage trial was designed to identify and verify the baseline symptomatic predictors of this therapy. 167 patients with active RA were enrolled with a 24-week TwHF based therapy treatment and the symptomatic predictors were identified in an open trial; then in a randomized clinical trial (RCT) for verification, 218 RA patients were enrolled and classified into predictor positive (P+) and predictor negative (P-) group, and were randomly assigned to accept the TwHF based therapy and Methotrexate and Sulfasalazine combination therapy (M) for 24 weeks, respectively. Five predictors were identified (diuresis, excessive sweating, night sweats for positive; and yellow tongue-coating, thermalgia in the joints for negative). In the RCT, The ACR 20 responses were 82.61% in TwHF/P+ group, significantly higher than that in TwHF/P- group (P = 0.0001) and in M&S/P+ group (P < 0.05), but not higher than in M&S/P- group. Similar results were yielded in ACR 50 yet not in ACR 70 response. No significant differences were detected in safety profiles among groups. The identified predictors enable the TwHF based therapy more efficiently in treating RA subpopulations.

Study on essential oils from four species of Zhishi with gas chromatography-mass spectrometry.

BACKGROUND: Citrus fruits are widely used as food and or for medicinal purposes, and they contain a host of active substances that contribute to health. The immature fruits of Citrus sinensis Osbeck and its cultivars (CS), C. junos Sieb. ex Tanaka (CJ), C. aurantium L. and its cultivars (CA) and Poncirus trifoliate Raf. (PT) are the most commonly used medicinal herbs in Traditional Chinese Medicine, called Zhishi. And their mature fruits can be used as food. RESULTS: In this study, the essential oils of four different Zhishi species were extracted by steam distillation and detected using gas chromatography- mass spectrometry (GC-MS). A total of 39 volatiles from the four species were tentatively identified. The limonene was the most abundant amongst the four species. Principal component analysis (PCA) of essential oils showed a clear separation of volatiles among CS, CJ and PT. However, CA could not be separated from these three species. Additionally, the volatiles accounting for the variations among the widely separated species were characterized through their corresponding loading weight. CONCLUSION: Sesquiterpenes were identified as characteristic markers for PT. The content of some monoterpenes could be as taxonomic markers between CS and CJ. This work is of great importance for the evaluation and authentication of Zhishi samples through essential oils.

The chemotaxonomic classification of Rhodiola plants and its correlation with morphological characteristics and genetic taxonomy.

BACKGROUND: Rhodiola plants are used as a natural remedy in the western world and as a traditional herbal medicine in China, and are valued for their ability to enhance human resistance to stress or fatigue and to promote longevity. Due to the morphological similarities among different species, the identification of the genus remains somewhat controversial, which may affect their safety and effectiveness in clinical use. RESULTS: In this paper, 47 Rhodiola samples of seven species were collected from thirteen local provinces of China. They were identified by their morphological characteristics and genetic and phytochemical taxonomies. Eight bioactive chemotaxonomic markers from four chemical classes (phenylpropanoids, phenylethanol derivatives, flavonoids and phenolic acids) were determined to evaluate and distinguish the chemotaxonomy of Rhodiola samples using an HPLC-DAD/UV method. Hierarchical cluster analysis (HCA) and principal component analysis (PCA) were applied to compare the two classification methods between genetic and phytochemical taxonomy. CONCLUSIONS: The established chemotaxonomic classification could be effectively used for Rhodiola species identification.

Semen Astragali Complanati- and Rhizoma Cibotii-enhanced bone formation in osteoporosis rats.

BACKGROUND: Growing evidence shows that herb medicines have some anti-osteoporotic effects, the mechanism underlying is unknown. This study aims to investigate the therapeutic effect of Chinese herb supplements on rats that had osteoporosis-like symptom induced by ovariectomy (OVX). METHODS: OVX or sham operations were performed on virgin Wistar rats at three-month old, which were randomly divided into eight groups: sham (sham); OVX control group (OVX); OVX rats with treatments [either diethylstilbestrol (DES) or Semen Astragali Complanati decoction (SACD) or Rhizoma Cibotii decoction (RCD) or Herba Cistanches decoction (HCD) or Semen Allii Tuberosi decoction (SATD)]. Non-surgical rats were served as a normal control (NC). The treatments began 4 weeks after surgery, and lasted for 12 weeks. Bone mass and its turnover were analyzed by histomorphometry. Levels of protein and mRNA of osteoprotegerin (OPG) and receptor activator of nuclear factor κB ligand (RANKL) in osteoblasts (OB) and bone marrow stromal cells (bMSC) were evaluated by immunohistochemistry and in situ hybridization. RESULTS: Compared to OVX control, TBV% in both SACD and RCD groups was increased significantly, while TRS%, TFS%, MAR, and mAR were decreased remarkably in the SACD group, only TRS% decreased dramatically in the RCD group. No significant changes in bone formation were observed in either HCD or SATD groups. OPG levels in both protein and mRNA were reduced consistantly in OB and bMSC from OVX control rats, in contrast, RANKL levels in both protein and mRNA were increased significantly. These effects were substantially reversed by treatments with either DES or SACD or RCD. No significant changes in both OPG and RANKL expression were observed in OB and bMSC from OVX rats treated with SATD and HCD. CONCLUSIONS: Our study showed that SACD and RCD increased bone formation by stimulating OPG expression and downregulating RANKL expression in OB and bMSC. This suggests that SACD and RCD may be developed as alternative anti-osteoporotic agents for therapy of postmenopausal osteoporosis.

Xiaoqinglong granules as add-on therapy for asthma: latent class analysis of symptom predictors of response.

Xiaoqinglong granules (XQLG) has been shown to be an effective therapy in asthma animal models. We reviewed the literature and conducted this study to assess the impact of XQLG as an add-on therapy to treatment with fluticasone/salmeterol (seretide) in adult patients with mild-to-moderate, persistent asthma. A total of 178 patients were randomly assigned to receive XQLG and seretide or seretide plus placebo for 90 days. Asthma control was assessed by asthma control test (ACT), symptoms scores, FEV(1), and PEF. Baseline patient-reported Chinese medicine (CM)-specific symptoms were analyzed to determine whether the symptoms may be possible indicators of treatment response by conducting latent class analysis (LCA). There was no statistically significant difference in ACT score between two groups. In the subset of 70 patients with symptoms defined by CM criteria, XQLG add-on therapy was found to significantly increase the levels of asthma control according to global initiative for asthma (GINA) guidelines (P = 0.0329). There was no significant difference in another subset of 100 patients with relatively low levels of the above-mentioned symptoms (P = 0.1291). Results of LCA suggest that patients with the six typical symptoms defined in CM may benefit from XQLG.

Expert consensus on the treatment of rheumatoid arthritis with Chinese patent medicines.

BACKGROUND: Chinese patent medicines (CPMs) are widely used for the treatment of rheumatoid arthritis (RA) in China and especially by Western biomedical doctors who are not well trained in TCM. Thus, it is important to create a guideline or an expert consensus so that the CPMs are used correctly. METHODS: The Delphi technique was used to generate the expert consensus. Twenty-eight (28) integrative medicine rheumatologists joined the consensus. A questionnaire regarding the general therapeutic principles, the categories, and the indications for the specific CPMs used for RA treatment was devised for this study. RESULTS: More than 80% of the experts agreed on the following therapeutic principles: CPM could be used to treat all patients with RA (82.10%), CPM should be used under the guidance of Traditional Chinese Medicine (TCM) (100%), and CPM could be used for active RA treatment in combination with Western medicine (WM) (85.71%), but could be used alone (92.86%) for the treatment of inactive RA. In addition, CPM and WM should be taken separately (82.14%), although the CPM could reduce the side-effects of the WMs if used in combination with CPM (96.43%). For the treatment of active RA, the CPMs were recommended by more than 50% of the experts included the Leigongteng Duogan tablets (85.7%), Zhengqing Dengtongning tablets (64.3%), and Simiao pills (53.6%). Alternatively, for the treatment of inactive RA, Duhuo Jisheng mixture (71.4%), Yishen Juanbi pills (53.6%), and Wangbi electuary (50.0%) were recommended. Total paeonia glucoside capsules were recommended for the active (50.0%) and inactive RA (64.3%) treatment. The indications of each CPM were specified according to the symptoms related to the TCM pattern classification. CONCLUSIONS: This expert consensus regarding the treatment of RA with various CPMs was formed to aid WM doctors in the correct use of CPMs.

Understanding the molecular mechanism of interventions in treating rheumatoid arthritis patients with corresponding traditional chinese medicine patterns based on bioinformatics approach.

Better effectiveness would be achieved when interventions are used in treating patients with a specific traditional Chinese medicine (TCM) pattern. In this paper, the effectiveness in treating rheumatoid arthritis (RA) patients in a randomized clinical trial as reanalyzed after the patients were classified into different TCM patterns and the underlying mechanism of how the TCM pattern influences the clinical effectiveness of interventions (TCM and biomedicine therapy) was explored. The pharmacological networks of interventions were builtup with protein and protein interaction analyses based on all the related targeted proteins obtained from PubChem. The underlying mechanism was explored by merging the pharmacological networks with the molecular networks of TCM cold and hot patterns in RA. The results show that the TCM therapy is better in treating the RA patients with TCM hot pattern, and the biomedical therapy is better in the RA patients with cold pattern. The pharmacological network of TCM intervention is merged well with the molecular network of TCM hot pattern, and the pharmacological network of biomedical therapy is merged well with the network of cold pattern. The finding indicates that molecular network analysis could give insight into the full understanding of the underlying mechanism of how TCM pattern impacts the efficacy.

Duration of viral shedding of influenza A (H1N1) virus infection treated with oseltamivir and/or traditional Chinese medicine in China: a retrospective analysis.

OBJECTIVE: H1N1 was a new and potentially serious infectious disease, in human, the severity of influenza can vary from mild to severe, thus to find an effective and safety way to control the influenza pandemic is of crucial importance. This retrospective study describes the duration of viral shedding in H1N1 patients that were hospitalized and treated in China. METHODS: Clinical data were collected from May to July, 2009 in China for 963 patients with influenza A (H1N1) virus infection. Patients were treated based on the guidelines issued by the Chinese Ministry of Health. The primary outcome was duration of viral shedding and statistical comparisons were performed. RESULTS: In the patients with body temperature greater than 38.0 degrees C, there were no differences in virus shedding duration among the patients taking oseltamivir within two days, patients undergoing Traditional Chinese Medicine (TCM) therapy or those receiving no drug therapy. In patients with body temperature > or =38.1 degrees C, TCM therapy reduced the viral shedding duration (P < 0.05, vs. oseltamivir therapy). Furthermore, taking oseltamivir two days after onset of symptoms might prolong the virus shedding duration (P < 0.05, vs. taking oseltamivir less than 2 days of onset). CONCLUSION: TCM therapy is effective for reducing the length of virus shedding in patients with body temperature > or =38.0 degrees C. Oseltamivir used for reducing virus shedding duration should be taken within two days of onset.

Therapeutic effects of radix dipsaci, pyrola herb, and Cynomorium songaricum on bone metabolism of ovariectomized rats.

BACKGROUND: The objective of this study was to evaluate the effects of herbal medicines, such as Radix Dipsaci (RDD), Pyrola Herb (PHD), and Cynomorium songaricum decoction (CSD), on osteoporotic rats induced by ovariectomy (OVX). METHODS: OVX or sham operations were performed on 69 virgin Wistar rats that were divided into six groups: sham (sham, n = 12), OVX control group (OVX, n = 12), and OVX rats with treatments (diethylstilbestrol, E2, n = 12; RDD, n = 11, PHD, n = 11, and CSD, n = 11). Non-surgical rats served as normal control (NC, n = 12). The treatments began four weeks after surgery and lasted for 12 weeks. Bone mass and bone turnover were analyzed by histomorphometry. Levels of protein expression and mRNA of OPG and RANKL in osteoblasts (OB) and bone marrow stromal cells (bMSC) were evaluated by immunohistochemistry and in situ hybridization. RESULTS: Compared to NC and sham rats, trabecular bone formation was significantly reduced in OVX rats, but restored in E2-treated rats. Treatment with either RDD or PHD enhanced trabecular bone formation remarkably. No significant change of bone formation was observed in CSD-treated rats. OPG expression of protein and mRNA was reduced significantly in OB and bMSC of OVX control rats. RANKL expression of protein and mRNA was increased significantly in OB and bMSC of OVX control rats. These effects were substantially reversed (increased in OPG and decreased in RANKL) by treatment with E2, RDD, or PHD in OB and bMSC of OVX rats. No significant changes in either OPG or RANKL expression were observed in OB and bMSC of OVX rats treated with CSD. CONCLUSIONS: Our study showed that RDD and PHD increased bone formation by stimulating overexpression of OPG and downregulation of RANKL in OB and bMSC. This suggests that RDD and PHD may be used as alternative therapeutic agents for postmenopausal osteoporosis.

Network-based gene expression biomarkers for cold and heat patterns of rheumatoid arthritis in traditional chinese medicine.

IN TRADITIONAL CHINESE MEDICINE (TCM), PATIENTS WITH RHEUMATOID ARTHRITIS (RA) CAN BE CLASSIFIED INTO TWO MAIN PATTERNS: cold-pattern and heat-pattern. This paper identified the network-based gene expression biomarkers for both cold- and heat-patterns of RA. Gene expression profilings of CD4+ T cells from cold-pattern RA patients, heat-pattern RA patients, and healthy volunteers were obtained using microarray. The differentially expressed genes and related networks were explored using DAVID, GeneSpring software, and the protein-protein interactions (PPI) method. EIF4A2, CCNT1, and IL7R, which were related to the up-regulation of cell proliferation and the Jak-STAT cascade, were significant gene biomarkers of the TCM cold pattern of RA. PRKAA1, HSPA8, and LSM6, which were related to fatty acid metabolism and the I-κB kinase/NF-κB cascade, were significant biomarkers of the TCM heat-pattern of RA. The network-based gene expression biomarkers for the TCM cold- and heat-patterns may be helpful for the further stratification of RA patients when deciding on interventions or clinical trials.

Plasma metabonomics study of rheumatoid arthritis and its Chinese medicine subtypes by using liquid chromatography and gas chromatography coupled with mass spectrometry.

Rheumatoid arthritis (RA) is the most severe type of chronic inflammatory disease and has always been a research hotspot in different fields. In this study, a non-targeted metabonomics approach was carried out to profile metabolic characteristics of RA and its Chinese medicine subtypes by using liquid chromatography-mass spectrometry (LC-MS) and gas chromatography-mass spectrometry (GC-MS). Plasma samples of 57 RA patients and 23 healthy controls were collected. On the basis of the traditional Chinese medicine (TCM), RA patients were classified into two main patterns, the cold pattern and the heat pattern. By using univariate and multivariate data analysis, we found that the RA patients presented diverse dysfunctions in inositol phosphate metabolism, lipid metabolism, amino acid metabolism, glucose metabolism, ascorbate metabolism, glyoxylate and dicarboxylate metabolism. The metabolic phenotypes were different between the RA cold pattern and the RA heat pattern. Compared with the RA cold pattern, the RA heat pattern showed elevated plasma concentrations of glycochenodeoxycholate, proline, saturated and mono-unsaturated phosphatidylcholine (PC) but decreased levels of urea, free fatty acid (FFA) and polyunsaturated PC. Our data show that metabonomics is a valuable tool in disease and TCM subtype research.

A network-based analysis of traditional Chinese medicine cold and hot patterns in rheumatoid arthritis.

OBJECTIVE: Rheumatoid arthritis (RA) is a heterogeneous disease, and traditional Chinese medicine (TCM) can be used to classify RA into different patterns such as cold and hot based on its clinical manifestations. The aim of this study was to investigate potential network-based biomarkers for RA with either a cold or a hot pattern. METHOD: Microarray technology was used to reveal gene expression profiles in CD4(+) T cells from 21 RA patients with cold pattern and 12 with hot pattern. A T-test was used to identify significant differences in gene expression among RA patients with either cold or hot pattern. Cytoscape software was used to search the existing literature and databases for protein-protein interaction information for genes of interest that were identified from this analysis. The IPCA algorithm was used to detect highly connected regions for inferring significant complexes or pathways in this protein-protein interaction network. Significant pathways and functions were extracted from these subnetworks by the Biological Network Gene Ontology tool. RESULT: Four genes were expressed at higher levels in RA patients with cold pattern than in patients with hot pattern, and 21 genes had lower levels of expression. Protein-protein interaction network analysis for these genes showed that there were four highly connected regions. The most relevant functions and pathways extracted from these subnetwork regions were involved in small G protein signaling pathways, oxidation-reduction in fatty acid metabolism and T cell proliferation. CONCLUSION: Complicated network based pathways appear to play a role in the different pattern manifestations in patients with RA, and our results suggest that network-based pathways might be the scientific basis for TCM pattern classification.

Cold and heat pattern of rheumatoid arthritis in traditional Chinese medicine: distinct molecular signatures indentified by microarray expression profiles in CD4-positive T cell.

The research is aimed to explore the distinct molecular signatures in discriminating the rheumatoid arthritis patients with traditional Chinese medicine (TCM) cold pattern and heat pattern. Twenty patients with typical TCM cold pattern and heat pattern were included. Microarray technology was used to reveal gene expression profiles in CD4+ T cells. The signal intensity of each expressed gene was globally normalized using the R statistics program. The ratio of cold pattern to heat pattern in patients with RA at more or less than 1:2 was taken as the differential gene expression criteria. Protein-protein interaction information for these genes from databases was searched, and the highly connected regions were detected by IPCA algorithm. The significant pathways were extracted from these subnetworks by Biological Network Gene Ontology tool. Twenty-nine genes differentially regulated between cold pattern and heat pattern were found. Among them, 7 genes were expressed significantly more in cold pattern. Biological network of protein-protein interaction information for these significant genes were searched and four highly connected regions were detected by IPCA algorithm to infer significant complexes or pathways in the biological network. Particularly, the cold pattern was related to Toll-like receptor signaling pathway. The following related pathways in heat pattern were included: Calcium signaling pathway; cell adhesion molecules; PPAR signaling pathway; fatty acid metabolism. These results suggest that better knowledge of the main biological processes involved at a given pattern in TCM might help to choose the most appropriate treatment.

Effect of combining therapy with traditional chinese medicine-based psychotherapy and herbal medicines in women with menopausal syndrome: a randomized controlled clinical trial.

This multicenter, randomized, controlled clinical study was designed to address the effectiveness of combined traditional-Chinese-medicine- (TCM-) based psychotherapy and Chinese herbal medicine (CHM) in the treatment of menopausal syndrome. Altogether 424 eligible women diagnosed as menopausal syndrome and categorized as Kidney-Yin/Kidney-Yang deficiency pattern in TCM were randomly assigned into 4 groups and accepted TCM-based psychotherapy (PSY), CHM, PSY + CHM, or placebo therapies, respectively, for 12 weeks, and another 12 weeks were taken as the followup. Kupperman Index (KI) and the Menopause-Specific Quality of Life (MENQOL) with its four subscales (vasomotor, physical, psychosocial, and sexual) were employed for efficacy assessment. Results showed that 400 participants completed 12-week treatment, of which 380 finished the record of KI and MENQOF at week 24. The average adjusted number of KI score decreased between baseline and 12 weeks in all groups. Statistically significant differences were detected in the average adjusted change between the PSY + CHM group and placebo at overall time points (P < 0.05). No severe adverse events occurred in each group and no significant differences were indicated between any of the three groups and placebo in adverse event proportion. We concluded that TCM psychotherapy combined with CHM has a favorable outcome in treating menopausal syndrome.

Risk factors of gastrointestinal and hepatic adverse drug reactions in the treatment of rheumatoid arthritis with biomedical combination therapy and Chinese medicine.

ETHNOPHARMACOLOGICAL RELEVANCE: The exploration of risk factors on the gastrointestinal adverse drug reactions (GI ADRs) and hepatic ADRs in the treatment of rheumatoid arthritis (RA) with traditional Chinese medicien (CM) and convertional Western Medicien (WM) therapy will benifit the clincial drug administration. METHODS: A multi-center, randomized-clinical trial was conducted on RA patients in China. After 12 and 24 weeks of treatment, the efficacy and safety of WM therapy and CM therapy were evaluated. The Chi-square and logistic regression were conducted to analyze the correlations between the biological parameters, CM symptoms and the ADRs. RESULTS: 505 patients were recruited from 9 centers and randomly assigned into WM therapy group (n=251) or CM group (n=254). 397 of them completed the 24 week treatment (194 in WM and 203 in CM group). Total ADRs incidence and withdrawal rates were similar in two groups. For the patients treated with WM, logistic regression analysis showed that CRP level was negatively related to GI ADRs (p<0.05), dizziness was positively related to GI ADRs (p<0.05); and IgG level and chills were positively related to hepatic ADRs (p<0.01, p<0.05). In the patients treated with CM, no laboratory measurements were found related with GI ADRs and hepatic ADRs, lassitude and nocturia were risk factors for GI ADRs, cold extremities for hepatic ADRs, respectively (p<0.05). CONCLUSION: CRP in normal scale and dizziness were the risk factors for GI ADRs, higher IgG level and chills were the risk factors for hepatic ADRs in the RA patients treated with conventional WM therapy. Lassitude and nocturia were the risk factors for GI ADRs, and cold extremities were the risk factors for hepatic ADRs in the RA patients treated with CM therapy.

Efficacy and safety of Fufangkushen colon-coated capsule in the treatment of ulcerative colitis compared with mesalazine: a double-blinded and randomized study.

ETHNOPHARMACOLOGICAL RELEVANCE: Fufangkushen colon-coated capsule (FCC) was a newly developed herbal drug for treating ulcerative colitis (UC) patients with traditional Chinese medicine (TCM) pattern of damp-heat accumulating in the interior. OBJECTIVE: To explore the efficacy and safety of FCC in the treatment of active UC compared with Huidi (HD, mesalazine enteric-coated tablets) were evaluated in a double-blinded and randomized clinical trial. MATERIALS AND METHODS: In the double-blind, double-dummy, multicenter, randomized and controlled study, 320 active UC patients with TCM pattern of damp-heat accumulating in the interior were assigned to two groups: 240 treated with FCC plus HD placebo treatment, 80 with HD plus FCC placebo. The drugs and their corresponding placebos were administrated at advised dosage for 8 weeks. The primary endpoint was a positive clinical response at week 8, and Mayo scoring system was employed for assessment of UC activity. RESULTS: At the 8th week, 72.50% of patients in FCC group (170 of 234) and 65.00% of patients in HD group (52 of 80) had achieved a clinical response. There was no statistically significance between the 2 groups (P>0.05). The proportions of patients who had a clinical remission was similar in 2 groups (41.50% in FCC group, 41.25% in HD group, P>0.05), mucosal healing rate at week 8 in the two groups were also without significant difference (55.13% in FCC group, 55.00% in HD group, P>0.05). Mayo scores at week 8 showed no statistically difference in the two groups. No significant differences were observed between the safety profiles of the 2 groups (P>0.05). No severe AEs were reported in either group. The latent class analysis indicated that FCC was superior applicable for the left hemicolon involved patients than HD. CONCLUSIONS: Compared with HD, a mesalamine enteric-coated tablet, FCC is similarly effective and safe in the treatment of active UC with TCM pattern of damp-heat accumulation interior pattern. In addition, FCC indicates superior effect in the treatment of UC with inflamed area of the left hemicolon than HD.

[Establishment of a rat model of rheumatoid arthritis with kidney deficiency syndrome].

OBJECTIVE: To establish a rat model of rheumatoid arthritis (RA) with kidney deficiency syndrome. METHODS: A total of 110 six-week-old specific pathogen-free male and female Sprague-Dawley rats were randomly divided into normal control group, sham-operated group, collagen-induced arthritis (CIA) control group, castration plus CIA group and hydroxyurea plus CIA group. Testiculus or ovary of rats in the castration plus CIA group was cut off, respectively. Rats in the hydroxyurea plus CIA group were given 375 mg/(kg·d) hydroxyurea by gavage administration for 17 d. Then rats in the CIA control group, castration plus CIA group and hydroxyurea plus CIA group were subcutaneously injected with mixture of type II collagen and incomplete Freund's adjuvant to induce rheumatoid arthritis. General state, arthritis index and joint swelling of the rats were observed to evaluate the onset of CIA. Contents of anti-type II collagen antibody, interleukin-6 (IL-6), IL-10, interferon-γ (IFN-γ) and corticosterone (CORT) in plasma were detected by enzyme-linked immunosorbent assay, and adrenal cyclic adenylic acid (cAMP) and cyclic guanylic acid (cGMP) levels were detected by radioimmunoassay. RESULTS: Compared with the CIA control group, the degrees of joint swelling and joint damage were significantly increased in the kidney-deficiency CIA rats (castration plus CIA group and hydroxyurea plus CIA group), with kidney deficiency syndrome similar to human clinical symptoms, such as depressed, bowed back, dullness, reduced diet and perianal contamination; the rats in those two groups were noted with a significantly decreased ratio of cAMP/cGMP; the content of CORT was increased in male rats while decreased in female rats, with an obvious increase in the content of anti-type II collagen antibody; the contents of IFN-γ, IL-6 and IL-10 were obviously increased in the castration plus CIA group. CONCLUSION: The rat model of RA with kidney deficiency syndrome has both obvious kidney deficiency syndrome and characteristics of RA and can reflect part of the patient's characteristics. However, castration is more suitable for inducing RA with kidney deficiency syndrome in rats.