Objective: To establish Caco-2 (a human colon adenocarcinoma cell line) cell monolayer model and the standard operation procedure for studying and assessing intestinal absorption of chemical components of traditional Chinese medicine.Methods: Caco-2 cell monolayer model was established and evaluated by morphology feature using scanning electron microscope, inverted microscope and transepithelial electrical resistance (TEER) assay. Additionally, the model was further tested for the activity of alkaline phosphatase and the apparent permeability (P_app) of standard compounds, i.e. propranolol and atenolol, which were the control substances for high and poor transcellular transport marker, respectively.Results: The integrality of cell monolayer, cell differentiation (reflected by expression of alkaline phosphatase and cell monolayer morphology), and the P_app value of standard compounds in the established Caco-2 cell model were satisfactory. All parameters tested were in good agreement with those reported in the literature.Conclusion: The established Caco-2 cell model can be used to study the intestinal absorption of orally administrated chemical components of traditional Chinese medicine and their absorption mechanism.

The field of gene therapy has been increasingly studied in the last four decades, and its clinical application has become a reality in the last 15 years. Traditional Chinese medicine (TCM), an important component of complementary and alternative medicine, has evolved over thousands of years with its own unique system of theories, diagnostics and therapies. TCM is well-known for its various roles in preventing and treating infectious and chronic diseases, and its usage in other modern clinical practice. However, whether TCM can be applied alongside gene therapy is a topic that has not been systematically examined. Here we provide an overview of TCM theories in relation to gene therapy. We believe that TCM theories are congruent with some principles of gene therapy. TCM-derived drugs may also act as gene therapy vehicles, therapeutic genes, synergistic therapeutic treatments, and as co-administrated drugs to reduce side effects. We also discuss in this review some possible approaches to combine TCM and gene therapy.

Progressive loss of retinal ganglion cells (RGCs) and their axons is the main pathogenesis of glaucoma. The cause of glaucoma is not fully understood, but the neurodegeneration of glaucoma involves many mechanisms such as oxidative stress, glutamate toxicity and ischemia/reperfusion insult. In order to target these mechanisms, multiple neuroprotective interventions have been investigated to prevent the death of RGCs. Of note are some tonic herbs from the traditional Chinese medicine (TCM) pharmacopeia that have shown neuroprotective effects in glaucoma. TCM differs from Western medicine in that TCM exhibits complicated bioactive components, triggering many signaling pathways and extensive actions on vital organs. Modern scientific approaches have demonstrated some of their underlying mechanisms. In this review, we used Lycium barbarum and Ginkgo biloba as examples to elaborate the characteristics of TCM and their potential applications in neuroprotection in glaucoma.

Biological, psychological and sociological model of medicine substantializes the old model lacking the social humane attributes. The new medical model makes people take medical anthropology into research and highly evaluate traditional medical system. Cultural anthropology of traditional Chinese medicine (TCM) is part of medical anthropology with three major characteristics: wide research scope, specificity, and integration. It has developed its own research methods, such as field investigation, comprehensive inspection and comparison study. Cultural anthropology provides an efficient research method for TCM, and its application would further develop TCM theory and form comprehensive evaluation on TCM effects.

Objective

Traditional Chinese medicine (TCM) is regarded as an important treatment for gastric cancer patients, especially for those in advanced stage. To evaluate the effects of TCM treatment on gastric cancer patients, the authors performed a retrospective study to report the result of the integrated treatment of TCM with chemotherapy for stage IV non-surgical gastric cancer.

Methods

In this study, 182 patients with stage IV and non-surgical gastric cancer were retrospectively analyzed to evaluate the effects of TCM integrated with chemotherapy. Among the 182 cases, 88 cases received integrated therapy consisting of TCM and chemotherapy, while 94 cases received chemotherapy alone. The overall survival and Karnofsky performance status (KPS) score were measured as the main outcome.

Results

The median overall survival of the integrated therapy group and chemotherapy group were 16.9 and 10.5 months, respectively. The 1-, 3- and 5-year survival rates of integrated therapy group vs. chemotherapy group were 70% vs. 32%, 18% vs. 4%, and 11% vs. 0%, respectively. There was a significant difference between the two groups (χ² = 42.244, P < 0.001). After six-month treatment, KPS scores of the integrated therapy group and the chemotherapy group were 75.00 ± 14.78 and 60.64 ± 21.39, respectively (P < 0.001). The Cox regression analysis showed that TCM treatment is a protective factor for patients' overall survival.

Conclusion

This study demonstrated that TCM integrated with chemotherapy may prolong overall survival and improve survival rate and life quality of patients with stage IV non-surgical gastric cancer.

Objective

To explore and identify the therapeutic components of traditional Chinese medicine (TCM) as a complex intervention through grounded theory, and the correlation and interaction within this model and the possible effects that they may have on the therapeutic effects of TCM.
Methods

Data were collected through 41 half-day participant observations and 7 in-depth interviews, and the study design and data analysis were based on the grounded theory.
Results

The components of TCM practice that emerged were: prescribed Chinese medicinal herbs, doctor’s medical advice, psychological intervention, doctor-patient relationship, and patient adherence. There were some overlaps in the TCM diagnosis and treatment process, and there were underlying therapeutic effects associated with diagnosis. TCM herbal intervention was considered as a main therapeutic component which might dominate patients’ outcome. We summarized this process as a process of problem finding and solving from macroscopic and microcosmic perspectives, which embodies the concept of a holistic approach and highly individualized pattern through syndrome differentiation and treatment.
Conclusion

TCM is a complex whole system, and all therapeutic components of TCM may contribute to global treatment effect. In the future, we need more participants to test and improve the model of grounded theory through qualitative and quantitative methods such as randomized controlled trials so as to identify and explore the relevance of each therapeutic component of TCM with the treatment effect.

Some conclusions drawn from explanatory randomized controlled trial (ERCT) lack practical value in application under real-world clinical settings, and there are also some limitations on the generalization of pragmatic randomized controlled trial (PRCT) results. In some countries, real-world studies (RWSs) have been conducted to explore the effectiveness and safety of clinical interventions or postmarketing drugs, which is a new tendency in clinical researches. By reviewing some RWSs carried out in Western countries, we sum up the basic characteristics of the research design, and discuss the differences and connections between PRCT and RWS. The design ideas of RWS are different from PRCT. Researchers in RWS tend to perform long-term evaluation based on large quantities of subjects and quite large sample and focus on outcome measures which are clinically meaningful. Strict control on data collection, management and analysis are very important to RWS and PRCT. Owing to the complexity of clinical interventions and evaluation, PRCT is not completely suitable for clinical researches in traditional Chinese medicine (TCM). It is an inevitable tendency to apply RWS in clinical trials of TCM. We can explore the efficacy of TCM interventions through PRCT, and better understand the effectiveness through RWS. RWS will become a powerful approach to TCM clinical trials and postmarketing evaluation of Chinese medicines.

Background: Coronary artery disease (CAD), a common disease with high incidence and mortality rate, has seriously threatened the health and life of the public. Traditional Chinese medicine (TCM) has an important role in the prevention and treatment of this disease. Through clinical epidemiological survey, a deeper understanding of TCM etiology and syndrome characteristics in CAD would further improve clinical efficacy in the treatment of this disease.
Methods/design: The preliminary clinical questionnaire for TCM etiology and syndrome differentiation in CAD was designed after literature reviews and analysis. Through a series of clinical pre-surveys, expert consultation and demonstration, the formal TCM clinical epidemiology questionnaire on the etiology and syndrome differentiation in CAD was finalized, after which, the study protocol, inclusive and exclusive criteria and related quality control measures were prepared. The multiregional clinical epidemiological survey with more than 5 000 participants with CAD will be carried out in 41 TCM hospitals of China for investigating the TCM etiology and syndrome differentiation of CAD.
Discussion: Multiregion large sample size clinical epidemiology survey on TCM etiology and syndrome differentiation in CAD will provide further evidence in preventing CAD and improving the standardization process of syndrome research.

Background

Pulse wave analysis (PWA) quantifies the phenomenon of pulse waveform propagation in patients with cardiovascular diseases, whereas pulse image analysis (PIA) is a subjective examination in traditional Chinese medicine.

Objective

 This study evaluated the association of PIA with PWA and hemodynamics in patients with hypertension.Design, setting, participants and interventions This observational, cross-sectional study enrolled 45 patients (26 men, (55.2 ± 10.3) years, systolic blood pressure (155 ± 28) mmHg, diastolic blood pressure (93 ± 17) mmHg) for assessment of clinical and laboratorial data.

Main outcome measures

Primary outcomes comprised: pattern differentiation based on an automated method; PIA at the radial artery using the ‘simultaneous pressing’ method for identification of factors such as strength (strong/weak), depth (superficial/deep), and speed (fast/moderate/slow); and PWA at the same artery using a noninvasive system.

Results

Significant multivariate main effects were observed for depth (λ=0.648, F5,29 =3.149, P=0.022, η2 =0.352), strength (λ=0.608, F5,29 =3.736, P=0.010, η2 =0.392), and speed (λ=0.535, F5,29 =5.302, P=0.002, η2 =0.465). General effects comprised high values of PWA and blood pressure for superficial, strong, and fast pulse images. A strong pulse was found for pulse pressure ≥ 62.5 mmHg and systolic blood pressure ≥ 149.5 mmHg, whereas a superficial pulse was found for heart rate ≥ 58.25 beats/min; a fast pulse was found for heart rate ≥ 69.6 beats/min and pulse wave velocity ≥ 9.185 m/s.

Conclusion

Associations were explained by LaPlace's law, arterial remodeling in hypertension, alongside the traditional criterion for classifying speed in pulse images. PIA is associated with PWA and hemodynamics in patients with hypertension. Systolic and pulse pressures, heart rate, and pulse wave velocity are quantitative variables that have information to describe the qualitative pulse images such as strength, depth and speed.

Objective: To study the effect of Feiyanning Decoction (FYN), a compound traditional Chinese medicine, on expressions of inducible nitric oxide synthase (iNOS) and cyclooxygenase-2 (COX-2) activated by tumor necrosis factor-α (TNF-α) in human lung adenocarcinoma epithelial cell line (A549).
Methods: A549 cells were incubated with rat serum containing FYN for 24 h. Gene expressions of iNOS and COX-2 were determined by quantitative real-time polymerase chain reaction and Western blot. The iNOS-dependent luciferase reporter was transfected for 24 h and the cells were treated with the reagents for 24 h, then the transcriptional activity of iNOS promoter was detected by luciferase assay. The production of NO was determined by diaminofluorescein-2.
Results: FYN significantly inhibited TNF-α-induced expression of iNOS and COX-2 compared with the control group in A549 cells (P<0.01, P<0.01). Also, FYN inhibited the transcriptional activity of the iNOS promoter and reduced NO production compared with the control group (P<0.01, P<0.01).
Conclusion: These results suggest that FYN inhibits iNOS and COX-2 activation induced by TNF-α, therefore, it is expected to develop a new strategy to treat lung cancer.

Background

Polycystic ovary syndrome (PCOS) is an endocrine disease that affects gynecological health. Treatment of PCOS remains a big challenge for clinicians.

Objective

This meta-analysis was developed to compare the efficacy of co-treatment with traditional Chinese medicine (TCM) and letrozole against letrozole monotherapy in the treatment of PCOS.

Search strategy

Randomized controlled trials (RCTs) were electronically retrieved from PubMed, Cochrane Library, China Biomedical Literature Database, China National Knowledge Infrastructure and Wanfang Data; related papers that were not available electronically were manually checked. All papers were assessed according to the Cochrane Handbook for Systematic Reviews of Interventions and the valid data were analyzed using Revman software (The Cochrane Collaboration, Copenhagen, Denmark).

Inclusion criteria

We included RCTs that compared co-treatment with TCM and letrozole against letrozole monotherapy in women with PCOS, which was defined by anovulation, biochemical or clinical hyperandrogenemia and polycystic ovaries. We included trials from all sources.

Data extraction and analysis

Two independent reviewers extracted data, and evaluated study quality according to the Cochrane Handbook for Systematic Reviews of Interventions criteria for RCT, including issues of patient randomization, blinding and bias.

Results

Eight RCTs, involving a total of 537 patients, were included in the present study. The meta-analysis showed that the cycle ovulation rate, the pregnancy rate and the total effective rate of symptom treatment were higher in treatments combining TCM with letrozole, compared with letrozole monotherapy. Although the rate of luteinizing hormone (LH)/follicle-stimulating hormone (FSH) and the body mass index of the group receiving combined therapy were lower than in letrozole monotherapy, no statistical difference was found in the LH and FSH level between the two groups.

Conclusion

Available evidence showed that co-treatment with TCM and letrozole was more effective than letrozole monotherapy in the treatment of PCOS.

Objective: To establish diagnostic criteria for common traditional Chinese medicine (TCM) syndromes in osteoporosis.
Methods: Based on the collection and analysis of related medical literature, clinical investigation, and expert discussion, a draft of preliminary diagnostic criteria for the basic syndromes of TCM in patients with osteoporosis was formulated. Then it was used in clinic for verification and revised repeatedly until a formal version of diagnostic criteria was satisfactorily achieved.
Results: The basic syndromes listed in the diagnostic criteria for patients with osteoporosis consisted of two parts: qualitative diagnosis and localization diagnosis. Results of qualitative diagnosis showed that the qualitative syndromes included damage of essence, deficiency of vital energy, deficiency of yin, deficiency of yang and blood stasis. The localization diagnosis showed that location of osteoporosis is bone and corresponds to the kidney, and also involves liver, lung, spleen (stomach) and heart. The diagnostic content has established the specific symptoms and the non-specific symptoms during various stages. Each of the above syndromes could be diagnosed according to a specific combination of its corresponding symptoms or signs. The clinical verification results showed that the total matching ratio of qualitative diagnosis was 80.56% between the diagnoses made according to the criteria and the diagnoses acquired from the experts' experience, and the total matching ratio of localization diagnosis was 85.56%.
Conclusion: The TCM syndrome diagnostic criteria for osteoporosis is generally consistent with TCM clinical practice, worthy of further popularization and application in clinical practice.

Background

Chinese and contemporary Western medical practices evolved on different cultures and historical contexts and, therefore, their medical knowledge represents this cultural divergence. Computerization of traditional Chinese medicine (TCM) is being used to promote the integrative medicine to manage, process and integrate the knowledge related to TCM anatomy, physiology, semiology, pathophysiology, and therapy.

Methods

We proposed the development of the SuiteTCM software, a collection of integrated computational models mainly derived from epidemiology and statistical sciences for computerization of Chinese medicine scientific research and clinical practice in all levels of prevention. The software includes components for data management (DataTCM), simulation of cases (SimTCM), analyses and validation of datasets (SciTCM), clinical examination and pattern differentiation (DiagTCM, TongueTCM, and PulseTCM), intervention selection (AcuTCM, HerbsTCM, and DietTCM), management of medical records (ProntTCM), epidemiologic investigation of sampled data (ResearchTCM), and medical education, training, and assessment (StudentTCM).

Discussion

The SuiteTCM project is expected to contribute to the ongoing development of integrative medicine and the applicability of TCM in worldwide scientific research and health care. The SuiteTCM 1.0 runs on Windows XP or later and is freely available for download as an executable application.

Objective: Due to the differences between Chinese and Western cultures, Chinese version of foreign research instruments may not be totally applicable for use in evaluating the therapeutic effect of traditional Chinese medicine (TCM). Great efforts have been made by Chinese researchers to develop scales for evaluation of the therapeutic effects of TCM. This study aims to understand the current situation of research in the development of evaluation instrument in TCM.
Methods: Database searches of Chinese Biomedical Literature Database, China Academic Journal Network Publishing Database and Chinese Scientific Journals Database were undertaken to identify published studies with the purpose of developing instruments in assessing the effectiveness of TCM, including papers regarding the construction of conceptual framework of instrument, item generation and selection and the evaluation of measurement properties.
Results: A total of 60 pieces of literature involving 36 instruments were included. The first article on the development of each of the instruments was published between 2005 and 2011 and the instruments were used in many kinds of medical conditions, including cardiocerebrovascular, respiratory, digestive and infectious diseases. The number of items ranged from 10 to 52. Of the 36 instruments, 13 (36.1%) defined the hypothesized concepts measured by the instrument, 30 (83.3%) reported the domains of the questionnaires before measurement property testing and all of them were multidomain. Of 32 studies regarding item selection and the instrument’s property evaluation, 14 (43.8%) articles reported the administration mode, 24 (75%) reported response option types, and 10 (31.5%) provided scoring algorithm for the scale, but none of these 32 studies specified the recall period. In 29 studies aiming at testing instrument’s measurement property, 28 articles tested the Cronbach’s α coefficient of the full scale and/or subscales, and retest reliability was also detected in 15 studies. Twenty-seven studies evaluated the construct validity by exploratory factor analysis and among them there were two studies applying confirmatory factor analysis. Content validity, responsiveness and feasibility of instruments were assessed in 11, 16 and 16 studies, respectively.
Conclusion: This study shows that in recent years many instruments have been developed in an attempt to evaluate the therapeutic effects of TCM, but some problems still exist in their practical implementation, including negligence in outlining the hypothesized concepts of the TCM instruments and in the reporting of instrument’s content validity such as administration mode, scoring and recall period. Some instrument attributes and testing methods were misunderstood and/or misused. Revision of instruments is rarely carried out, though the development of an instrument is an iterative process. Researchers should have a thorough understanding of the general procedure and steps before starting to develop an instrument.

The paper aims to explore basic steps, regulation and data analysis methods of semi-structured and in-depth interview studies of clinical research in traditional Chinese medicine (TCM), and to provide some helpful information obtained from the examples for decision making in TCM research field. A pilot study was made with eight interviewees and, based on which, a formal one with twelve interviewees was done in this study. All the recordings were transcribed into verbal manuscripts, categorized into different archives and labeled by letter from A to T. Grounded theory for analyzing qualitative data was used in this study, and cross-case analysis was also made on the basis of case-by-case analysis results. Nine theories with central categories were constructed by three coding procedures from grounded theory. Three kinds of relationships, three types of optimized attitude, and three concerns were obtained from the example study. Nine analyzing conceptual graphs and nine theories related to optimization of TCM clinical research program were established finally. The researchers of large national studies were included as interviewees in the study. A comprehensive and critical data analysis from twelve interviewees for in-depth interview was conducted in accordance with current international qualitative research, and a response theory model focused on optimization of TCM clinical research program was established. The study laid the foundation for using semi-structured and in-depth interview for TCM clinical research.

The central nervous system (CNS) plays a key regulatory role in glucose homeostasis. In particular, the brain is important in initiating and coordinating protective counterregulatory responses when blood glucose levels fall. This may due to the metabolic dependency of the CNS on glucose, and protection of food supply to the brain. In healthy subjects, blood glucose is normally maintained within a relatively narrow range. Hypoglycemia in diabetic patients can increase the risk of complications, such as heart disease and diabetic peripheral neuropathy. The clinical research finds that the use of traditional Chinese medicine (TCM) has a positive effect on the treatment of hypoglycemia. Here the authors reviewed the current understanding of sensing and counterregulatory responses to hypoglycemia, and discuss combining traditional Chinese and Western medicine and the theory of iatrogenic hypoglycemia in diabetes treatment. Furthermore, the authors clarify the feasibility of treating hypoglycemia on the basis of TCM theory and CNS and have an insight on its clinical practice.

Great progress has been made in the study of fatty liver with integrated traditional Chinese and western medicine in aspects of diagnosis, treatment and experimental study, etc. Most researches were designed to utilize diagnostic or model replicating method of western medicine to observe the effects or investigate the action mechanism of compound recipe, single Chinese herb or effective ingredients of Chinese herbs on fatty liver. According to the pathological mechanism of traditional Chinese medicine (TCM), fatty liver is characterized by deficiency in nature and repletion in appearance, which involves three Zang viscera such as liver, spleen and kidney and manifests as spleen Qi deficiency, liver and kidney deficiency, phlegm and dampness heaping internally, and Qi stagnation and blood stasis. This facilitates us to use specific recipe or modified recipe to treat fatty liver from the points of integrated traditional Chinese and western medicine and combining syndrome differentiation with disease differentiation. With gratifying achievement, this kind of approach has been the mainstream of the research on fatty liver and many researchers have reached an agreement on this point domestically. Spleen Fortifying and Blood Invigorating Recipe (SFBVER in brief, invented by our institute) can significantly improve the B ultrasound outcome of the liver in patients with fatty liver, with significant difference in B ultrasound scoring between pre-and post-treatment. It can alleviate the patients' symptoms, improve or regain liver function, decrease waist/buttocks ratio and the content of triglyceride and cholesterol in blood. SFBVER is superior to Dongbao Gantai Recipe in general effective rate. Experimental study also reveals that SFBVER can alleviate CCl₄ induced liver cell fatty degeneration and the inflammatory cell infiltration in rats, decrease the activities of ALT and AST, lower the content of triglyceride in liver, recover SOD activity in liver to normal level. The overall efficacy of SFBVER is superior to that of Dongbao Gantai Recipe. Further correlated study should be focused on inventing new preparation of traditional Chinese medicine and investigating its action mechanism with the guiding of the theory of TCM and referring to the latest discovery in fatty liver research in modern medicine.

Objective: To explore the analysis methods for composite traditional Chinese medicine (TCM) constitutions.

Methods: The epidemiological data of TCM constitutions were collected from 974 volunteers via a cross-sectional survey. The samples were classified into 9 constitution types according to the maximal standardized scores of imbalanced constitutions. The correlation matrix of 9 constitutions was computed. The standardized scores of 9 constitutions of all the volunteers were ranked respectively, and the composite status of every two constitutions was observed using cross tabulation. The constitution types of all the volunteers were transformed into ternary code of 9 digits, and the composite status of 3 or more than 3 kinds of constitution types was analyzed.

Results: According to the maximal standardized scores of imbalanced constitutions, of 974 volunteers, 227, 148, 218, 102, 31, 81, 44, 97 and 26 volunteers had balanced constitution, qi-deficiency constitution, yang-deficiency constitution, yin-deficiency constitution, phlegm-dampness constitution, heat-dampness constitution, blood stasis constitution, qi-stagnation constitution, and inherited special constitution, respectively. The standardized scores of balanced constitution were negatively correlated with those of imbalanced constitutions, while there was a positive correlation between the standardized scores of every two imbalanced constitutions. Among the 8 imbalanced constitutions, one kind of imbalanced constitutions was usually complicated with another kind of imbalanced constitutions. The number of qi-deficiency constitution complicated with yang-deficiency constitution, qi-deficiency constitution complicated with yin-deficiency constitution, and yin-deficiency constitution complicated with yang-deficiency constitution ranked the top three. The constitution types of 974 volunteers were transformed into a total of 465 ternary codes, showing a total of 465 kinds of constitution types; the simplex constitution, the approximately simplex constitution, and the composite constitution of two or more than two types were found in 259, 130, and 585 volunteers, respectively.

Conclusion: Cross tabulation can show the composite status of every two constitutions, while the ternary code can show the composite status of three or more than three constitutions.

Objective: To study the mechanism of herbal application along meridians for treatment and prevention of asthma by using serum pharmacological test to observe the effects of serum containing herbs against the constriction of tracheal spiral strips induced by acetylcholine chloride (Ach).

Methods: Guinea pigs were randomly divided into normal control group, normal saline (NS) application group, aminophylline application group, aminophylline injection group, 1-day herb application group, 7-day herb application group and 14-day herb application group. Asthma was induced by Hutson's method in guinea pigs except the normal control group. Guinea pigs in herb application groups were treated by external application of a compound herbal medicine 60 min once every day. Guinea pigs in NS application group were treated by external application of NS. Guinea pigs in the two aminophylline-treated groups were treated by external application and intraperitoneal injection of aminophylline at a dose of 400 mg/kg, respectively. The guinea pigs were killed and the sera were obtained after 1-day, 7-day and 14-day treatment in the three herb application groups, 7-day treatment in the NS application group, the aminophylline application and injection groups, respectively. Serum pharmacological method was used to do the experiment, the effects of different sera on the constriction of tracheal strips were observed, and the constriction rates were calculated.

Result: The serum containing herbs had an effect in reducing the constriction of tracheal spiral strips induced by Ach, and the effect was similar to that of the serum obtained from the aminophylline injection group. The constriction rate of the tracheal spiral strips was decreased when herbal application treatment was prolonged within a period of time, and it became stable when herbal application treatment was between 7-14 days. The constriction of tracheal spiral strips induced by Ach could be reduced remarkably when it was previously treated by serum containing herbs. 

Conclusion: The anti-acetylcholine function with a time-dependent effect is one of the mechanisms of herbal application treatment along meridians for asthma, and furthermore, herbal application treatment along meridians might be useful for preventing asthma.

Objective: To study the traditional Chinese medicine (TCM) syndrome distribution in patients with hepatitis B virus (HBV) infection in Qidong region of Jiangsu Province, China.

Methods: A cross-sectional survey was performed. Subjects from Qidong of Jiangsu Province of China were screened among the locally enrolled residents by detecting hepatitis B surface antigen (HBsAg) from May 2007 to May 2011 and were assigned to HBsAg-negative cohort or HBsAg-positive cohort. Then, the subjects were diagnosed according to alanine aminotransferase, alpha-fetoprotein and B ultrasound. The syndrome of the subjects was determined using a TCM questionnaire consisting of signs and symptoms.

Results: A total of 5 908 subjects were enrolled in this survey, among whom, 4 718 were diagnosed with HbsAg infection (positive result of HbsAg detection) and 1 147 were negative. 143 subjects were excluded for not receiving the blood examination. The final diagnoses of the subjects were non-HBV infection (n=1 128), HBV carrier (n=4 019), chronic hepatitis B (n=225), posthepatitic cirrhosis (n=263) or liver cancer (n=111). The TCM syndrome differentiation results showed that there were differences in syndrome distribution between HBV-infected and non-HBV-infected patients. The main syndromes of the HBV-infected patients were qi deficiency, qi stagnation, blood stasis and dampness heat, related to the Zang of liver and spleen. The distribution principles of TCM syndrome among patients of HBV carrier, chronic hepatitis B and cirrhosis were similar. Moreover, with the progression of the patients’ condition, the scores of syndromes increased, and the number of accompanying syndromes increased as well. The main syndromes of patients with liver cancer were blood stasis and excess heat, which was slightly different from that of the other HBV-infected patients.

Conclusion: The TCM syndrome distribution in patients of HBV infection in Qidong region of Jiangsu Province shows regularity. The disorder is mainly due to qi stagnation and blood stasis and is also related to deficiency of healthy qi, especially deficiency of spleen qi

The incidence of breast cancer increased rapidly in recent years. Breast cancer has become the most frequent malignant tumor of female especially in the developed regions. Traditional Chinese medicine (TCM) is effective in treating breast cancer, but its theories appear hysteretic, restricting the progress in clinical practice, teaching and research of TCM in the treatment of breast cancer. This article described the significance and urgency to work out the standardization of syndrome differentiation based on stages for breast cancer and put it into practice. It also analyzed the foundations, ideas and approaches of the research of standardization of syndrome differentiation based on stages for breast cancer in light of the changes of spectrum of diseases, the weaknesses of modern medicine in treating breast cancer, and the existed problems in the update clinical practice.

Objective

To evaluate the effectiveness of traditional Chinese medicine (TCM) combined with western medicine on breast cancer after surgical resection.

Methods

Seventy-one patients with breast cancer received chemotherapy, radiotherapy, endocrine therapy and TCM following resection.

Results

None of the patients died during the follow-up period.Fifty-seven patients were treated with TCM shortly after undergoing resection.Two recurrences (3.5%) and 6 metastases (10.5%) were observed in 8 patients, whose median disease free survival was 5.9 years.Fourteen patients didn't receive TCM until recurrence or metastasis emerged, with a median disease free survival of 3.5 years.There was significant difference between the two groups (P=0.033).

Conclusion

TCM combined with western medicine is efficient in preventing and delaying recurrence and metastasis.

Background: It is reported that 30% to 80% schizophrenia patients suffered from hypersalivation when taking clozapine. Some investigations of the use of formulas of traditional Chinese medicine (TCM) to treat clozapine-induced hypersalivation suggested their potential treatment effects. In these formulas, Suoquan Pill (SQP) and Wuling Powder (WLP) were suggested to have therapeutic effects in improving clozapine-induced hypersalivation.
Methods and design: A prospective, double-blind, randomized, placebo-controlled study will be conducted to test the therapeutic effects of SQP and WLP in relieving hypersalivation in patients taking clozapine. A total of 45 patients will be enrolled into this study with 15 in each treatment group. Patients will receive medication according to their assigned group. Either SQP 10 g per oral dose twice daily, WLP 10 g per oral dose twice daily or placebo powder 10 g per oral dose twice daily will be prescribed to the patients for 8 weeks. The Drooling Severity Scale, Nocturnal Hypersalivation Rating Scale and sialoscintigraphy will be used as the primary outcome measures; the Clinical Global Impressions Severity, the Positive and Negative Syndrome Scale, the Abnormal Involuntary Movement Scale, the Simpson-Angus Scale and the TCM constitutional scale will be used as the secondary outcome measures
Discussion: It is hypothesized that SQP and WLP will have a beneficial effect in controlling clozapine-induced hypersalivation symptoms. It may also improve the life quality of psychotic patients by improving their mental status.

Objective

To observe hypoglycemic effects of Yunu Decoction, Zuogui Pill and Shenqi Pill, three compound traditional Chinese herbal medicines, in treatment of diabetes mellitus induced by alloxan in rats, and to compare the therapeutic effects among the three recipes for nourishing yin, clearing away heat, and nourishing yin and warming yang.
Methods

Diabetes mellitus was induced in rats with alloxan at a dose of 60 mg/kg via tail vain injection. The diabetic rats were randomly divided into four groups: alloxan model group, Yunu Decoction-treated group, Zuogui Pill-treated group and Shenqi Pill-treated group. Rats in the three recipe groups were administered intragastrically with water extraction of Yunu Decoction, Zuogui Pill, and Shenqi Pill accordingly for 10 days. Then the level of blood glucose was measured by glucose oxidase method and the glucose tolerance was determined.
Results

Compared with the normal rats, blood glucose level in the alloxan model group was obviously increased (P<0.05). Glucose levels in the three recipe groups were obviously decreased as compared with the alloxan model group (P<0.05), and glucose level in the Yunu Decoction-treated group after treatment was significant lower than before treatment (P<0.05). The glucose tolerance test indicated that rats in the alloxan model and three recipe groups revealed impaired glucose tolerance as compared with the normal rats, and there were no significant differences between the alloxan model group and the three recipe groups.
Conclusion

Yunu Decoction, Zuogui Pill and Shenqi Pill can effectively decrease the glucose level of the rats with diabetes mellitus induced by alloxan, and Yunu Decoction showed the best therapeutic effects. The glucose tolerance test shows that the three recipes cannot correct the abnormal metabolism of glucose.

Many clinical studies showed that the traditional Chinese medicine (TCM) syndromes in stroke have been dynamically changing since the onset of the disease. The changing of TCM syndromes can be attributed to multiple correlative factors such as age, sex, area distribution, underlying diseases, and constitutional factor. Data-driven methods involving multivariate statistical methods and descriptive approach have been used to analyze the regularity of dynamically changed TCM syndromes of stroke. However, expressing non-linear relationship between symptom or correlative factors and syndrome patterns by data-driven models is challenging. Model-driven methods involving artificial neural networks and Bayesian networks are new methods for studying the changes in TCM syndromes in patients with stroke. In this review, the authors summarized the studies of dynamically changed patterns of stroke syndromes based on data-driven methods and some clinical trials on TCM syndromes based on model-driven methods. Further studies are needed to improve the understanding of the dynamically changing regularity of TCM syndromes for stroke by using model-driven methods so as to develop appropriate and timely TCM treatments.

On the basis of medical literature review and clinical research experience, the authors analyzed the reasons for low recognition rate of depression and poor progress of traditional Chinese medicine (TCM) differentiation of depression in this paper and put forward that depressive episode symptoms and the corresponding common terminology classification of Chinese and Western medicine should be the breakthrough points. Through symptom stratification and combination, as well as distinguishing between primary and secondary symptoms, the comprehensive integrative medicine clinical assessment of depression was explored so as to further obtain expert consensus and provide a methodology reference for the TCM differentiation of depression and the research of etiology and pathogenesis.

Objective

To develop an inquiry scale for diagnosis of heart system syndromes, and to discuss the provisional standardization of the inquiry method in traditional Chinese medicine (TCM).
Methods

Based on scale-making method, Chinese medicine theory and literature searching, an inquiry scale for diagnosis of heart system syndromes in TCM was developed. Statistics method, frequency counting and Delphi method were used for analysis. The inquiry scale was revised and tested repeatedly to check the test reliability, internal consistency reliability, and content validity, etc.
Results

The inquiry scale for diagnosis of heart system syndromes mainly covered basic data, chief complaint, history of present illness (accompanying symptoms) and past history, with appendix of inspection and palpation information as well as diagnosis made according to traditional Chinese and Western medicine. Among them, general inquiries covered fever and chills, sweating, head-body and chest-belly symptoms, taste and diet, stool and urine, sleep, mood, and gynecologic symptoms, which were scaled in 8 dimensions. And 66 symptom variables were screened finally. The scale had a good content validity and its coefficient alpha was 0.82. For the results of test-retest reliability, the Kappa values of using the scale for diagnosis of heart-qi deficiency, heart-yang deficiency, turbid phlegm, and cold coagulation twice by the same doctor ranged from 0.74 to 1, showing that the consistency of the scale was relatively high. The Kappa values of evaluation of scorer reliability in diagnosis of heart-qi deficiency, heart-yang deficiency, and heart-yin deficiency were also high, which were 0.63, 0.72, 1 and 0.48 respectively. Other results of diagnosis had low-consistency or even no diagnostic agreement.
Conclusion

The research on the scale for inquiry in TCM indicates that it is feasible for the standardization of inquiry scale for diagnosis of heart system syndromes in TCM, offering a reference for research on the inquiry scales for other systems.

As the post-genome era is approaching, omics has become a hot topic in the research field of life sciences and is also widely used in traditional Chinese medicine (TCM) research. For discussing the correlation between syndromes and omics, the authors explored the application of genomics, proteomics and metabonomics in the study of syndrome classification from the macroscopic view, after a systematic and normative study of the literature. The authors drew the conclusion that research into the correlation between syndromes and omics has great clinical significance in terms of the scientific application and quantification of TCM treatment based on syndrome differentiation.

In this paper, factors contributing to the formation of pulse wave were analyzed based on hemodynamic principles. It is considered that formation of pulse wave was related to its propagation and reflection characteristics. Propagation of the pulse wave was characterized by pulse wave velocity, and reflection of the pulse wave was characterized by reflection coefficient. Pulse wave velocity and reflection coefficient were proposed as the eigenvectors of pulse wave in pulse diagnosis of traditional Chinese medicine, and support vector machine (SVM) was used to recognize slippery pulse, stringy pulse and plain pulse. Pulse wave velocity and reflection coefficient of the slippery, stringy and plain pulses in healthy people were calculated in this study, and SVM with Gaussian radial basis function was used for classifying. Results showed that pulse wave velocity and reflection coefficient with physiological and pathological significance had advantages in distinguishing slippery pulse, stringy pulse and plain pulse, which offered a new idea for recognizing pulse condition.

Objective

To analyze and compare the curriculum and delivery of a Chinese and Australian university-level Chinese medicine program. 

Methods

A review of PubMed and the Chinese National Knowledge Infrastructure for relevant educational papers was undertaken. Online and paper documents available at the University of Technology Sydney (UTS) and the Chengdu University of Traditional Chinese Medicine (CDUTCM) were read and analyzed. In addition, in-depth interviews with academics from the two universities were conducted during 2014 to 2015. 

Results

 The two Chinese medicine programs share the common goal of providing health services to the local community, but differ in some aspects when the curricula are compared. Areas such as student profile, curriculum structure, teaching approaches and education quality assurance were found to be different. The UTS program adopts a “flipped learning” approach with the use of educational technology aiming at improving learning outcomes. On the other hand, the CDUTCM has better clinical facilities and specialist physician resources.

Conclusion

A better understanding of the different curricula and approaches to Chinese medicine education will facilitate student learning and educational outcomes.

With the progress and development of science and technology, biomedical technology has been widely used in traditional Chinese medicine (TCM) research. However, TCM and Western medicine developed and came into being at different times and from different cultural backgrounds. Their targets are to study and explore the objective laws of human life activities from different angles and by different means. To study and evaluate TCM simply by the diagnosis and treatment standards of Western medicine cannot truly reflect the characteristics of TCM. Lots of clinical phenomena in the diagnosis and treatment in TCM cannot be revealed scientifically. It might be a significant pattern to combine the study of TCM with Western medicine, based on double-screening model of combining disease with syndrome types, following up evidence-based medical research steps, and making use of systematic review and data mining to analyze the inherent laws of TCM symptoms.

The article analyzed the contemporary study of pattern recognition of tongue images in traditional Chinese medicine by computer technology from its key sectors. It regards that the methods of orthogonal design and evaluation of image quality should be introduced to get a high-quality and practicable condition. In the field of tongue image segmentation, multiple methods used together are expected to improve the effect of segmentation. A scientific and canonical standard of tongue diagnosis based on comprehensive experts' experience with Delphi evaluation method and multi-center experts diagnosis on internet are also very essential. The study of pattern recognition on tongue image is still concentrated on the color. Further study should be extended to achieve quantification. And a comprehensive diagnosis on pattern recognition of tongue image is the aim that should be focused on later.

Objective

To treat patients with vascular mild cognitive impairment (VMCI) using traditional Chinese medicine (TCM), it is necessary to classify the patients into TCM syndrome types and to apply different treatments to different types. In this paper, we investigate how to properly carry out the classification for patients with VMCI aged 50 or above using a novel data-driven method known as latent tree analysis (LTA).

Method

A cross-sectional survey on VMCI was carried out in several regions in Northern China between February 2008 and February 2012 which resulted in a data set that involves 803 patients and 93 symptoms. LTA was performed on the data to reveal symptom co-occurrence patterns, and the patients were partitioned into clusters in multiple ways based on the patterns. The patient clusters were matched up with syndrome types, and population statistics of the clusters are used to quantify the syndrome types and to establish classification rules.

Results

Eight syndrome types are identified: Qi deficiency, Qi stagnation, Blood deficiency, Blood stasis, Phlegm-dampness, Fire-heat, Yang deficiency, and Yin deficiency. The prevalence and symptom occurrence characteristics of each syndrome type are determined. Quantitative classification rules are established for determining whether a patient belongs to each of the syndrome types.

Conclusion

A solution for the TCM syndrome classification problem for patients with VMCI and aged 50 or above is established based on the LTA of unlabeled symptom survey data. The results can be used as a reference in clinic practice to improve the quality of syndrome differentiation and to reduce diagnosis variances across physicians. They can also be used for patient selection in research projects aimed at finding biomarkers for the syndrome types and in randomized control trials aimed at determining the efficacy of TCM treatments of VMCI.

There lack scientific methods for evaluating the treatment of cancer pain with external therapies of traditional Chinese medicine (TCM). The level of clinical study in this field needs to be improved. The authors assert that when external therapies of TCM are applied to treat cancer pain, different types of cancer pain should be distinguished and treatment should be applied according to such a differentiation. Under this framework scientific evaluation can be conducted. The authors also assert that the findings of randomized, blinded and controlled trials should be given particular attention, and it is necessary to include titration of morphine into clinical trails of external therapies for the treatment of cancer pain, not only complying with the three-ladder principle for treating cancer pain suggested by the World Health Organization, but also not influencing the effect evaluation of external therapies of TCM on cancer pain. Patient diaries recording pain were revised as observation indexes. The primary indicator of efficacy was the pain intensity score and the secondary indicators were the equivalent of morphine and the remission rate of pain. The time to onset, remission duration and comparison of assessment of pain influence can mirror the characteristics of external therapies of TCM on cancer pain.

Objective

To screen common traditional Chinese medicine (TCM) syndrome factors of chronic renal failure (CRF) via questionnaire investigation among experts.

Methods

A questionnaire was developed based on the results of our previous researches. The investigation was carried out with the questionnaire among experts who are engaged in clinical research and treatment of nephrosis with the title of chief or associate chief physician from 15 hospitals in China. Common TCM syndrome factors of CRF were obtained based on the data analysis of the mean value on general evaluation, cumulative percentage and coefficient of variation.

Results

A total of 114 sets of the questionnaire were sent out and all of them were returned back, 113 of which were effective. The recovery rate was 100%. The TCM syndrome factors were regarded as common factors of CRF syndrome if the cumulative percentage was more than or equal to 60% and the coefficient of variation was less than or equal to 0.35. The syndrome factors related to the disease location were the kidney, spleen, stomach, heart, and lung; the syndrome factors related to the disease type were dampness, turbid toxin, blood stasis, water retention, and phlegm which belong to excess type, and qi deficiency, yin deficiency, yang deficiency, blood deficiency, and essence deficiency which belong to deficiency type.

Conclusion

The common TCM syndrome factors of CRF were obtained from the representative experts through the questionnaire investigation among the experts. The results enable us to have a deeper understanding of the disease in view of TCM compared with the previous literature data and may contribute to the establishment of TCM syndrome diagnosis criteria of the disease in the future.

Objective

To explore the main characteristics of syndromes in traditional Chinese medicine (TCM) in post-stroke depression (PSD) and to provide basis for treatments with TCM herbs.
Methods

According to diagnostic criteria of PSD, stroke patients and depression patients from Department of Neurology, First Affiliated Hospital, Anhui University of Traditional Chinese Medicine were assigned into cerebral stroke group (150 cases), depression group (151 cases) and PSD group (123 cases). Neuropsychological assessments and imaging and biochemical analyses were conducted. TCM syndrome differentiation for these diseases was performed. We also determined the characteristics of TCM syndromes of PSD, relative risk of the syndromes and their correlations with ages as well.
Results

Scores of qi stagnation and blood stasis, liver qi depression, and transformation of fire due to qi stagnation in PSD group were significant higher than those in cerebral stroke group (P<0.05, P<0.01). In cerebral stroke group, majority of the patients displayed one syndrome, while in PSD and depression groups, the patients had three or more syndromes. Of these syndromes, the incidence rate of syndrome of liver qi depression complicated with transformation of fire due to qi stagnation or flaring of fire due to yin deficiency was high. The syndrome of liver qi depression occurred much more frequently in PSD group and depression group than in cerebral stroke group (P<0.05, P<0.01). The logistic regression analysis showed that the syndrome of qi stagnation and blood stasis had high relative risk to PSD. The syndrome of deficiency of heart and spleen was positively correlated with age in cerebral stroke group.
Conclusion

The main TCM syndromes of PSD and depression are qi stagnation and blood stasis, liver qi depression, and transformation of fire due to qi stagnation. The syndrome of deficiency of heart and spleen is closely related to age among the stroke patients. The syndrome of qi stagnation and blood stasis serves as an independent risk factor for PSD. The more complicated the syndromes are, the more serious depression becomes.

The development of health-related quality of life (HRQL) instrument in traditional Chinese medicine (TCM) is increasing rapidly in China, but few studies focus on their necessity. This study explores the necessity of the development of TCM instruments from both theoretical and practice perspectives, and aims to explain whether the adoption of the cross-medical style is valid. Through theoretical analysis, both TCM and Western medicine instruments show the same objectives, whereas TCM instruments are more suitable for the Chinese social behavior, customs and expectations. In practical analysis, 47 TCM instruments were identified, among which 17 had 18 corresponding Western medical instruments. In the domains layer, except for physiological, psychological and social factors, TCM instruments focus more on the harmony between body and spirit, humanity and nature or human and society and the constitution, etc. In the facts layer, TCM instruments focus on the emotions, initiative social intercourse, TCM symptoms, diet, sleep, taste, feces and urine, etc. In addition, significant differences existed in the methods of information selection. There is no need to modify cross-medical style research except when TCM characteristic terms exist, but attention must be paid to the influence of culture in different areas. Therefore, the TCM instruments can resolve the limitations of the application of Western medical instruments to the Chinese setting, while also having remarkable abilities of information coverage and detection. Both forms of instruments have the capacity and requirement to inter-communicate with each other in order to serve the whole Chinese cultural system. Generally speaking, there is no need to modify the instruments in cross-medical style research. But this point requires further demonstration in the rigorous designed clinical trials.