Protocol to study the effects of Traditional Chinese Medicine on patients with coronary heart disease showing phlegm-heat-stasis symptom pattern.

OBJECTIVE: To describe a protocol to assess the effects of Traditional Chinese Medicine (TCM) on patients with coronary heart disease (CHD) showing symptoms of phlegm-heat-stasis symptom pattern. METHODS: This is a single-blind randomized controlled trial that will be conducted in the First Teaching Hospital of Tianjin University of TCM and 60 patients with CHD showing phlegm-heat-stasis symptom pattern will be included. Patients will be randomly divided into either a treatment group (Qingre Huatan formulae + Western Medicine) or to a control group (conventional Western Medicine only) for 7-14 d. Primary patient outcomes will be vascular endothelial function and quality of life. Measurement data will be expressed as mean ± standard deviation using t-test analysis or repeated-measure variance analysis. Enumeration data will be expressed by cases and percentages, using χ2 analysis, and rank sum test will be used for ranked data. RESULTS: This study further verified the effectiveness and safety of Qingre Huatan formulae for the phlegm-heat-stasis syndrome pattern of CHD on the basis of previous studies on the characteristics of syndromes and medication rules. DISCUSSION: Phlegm-heat-stasis symptom pattern has become a common manifestation in CHD. Standardized Western medications together with TCM have been extensively used in China and have developed into a comprehensive treatment model. Our trial will help formulate recommendations for symptom maintenance and provide clinical evidence for the application of TCM for patients with CHD showing phlegm-heat-stasis symptom pattern.

Study on syndrome differentiation and treatment in the management of chronic stable coronary artery disease to improve quality of life.

BACKGROUND: Chronic stable coronary artery disease (SCAD) is a general term for all kinds of coronary artery disease (CAD), which includes patients with chronic stable angina, old myocardial infarctions, and also stable condition after revascularization (i.e., percutaneous coronary intervention, coronary artery bypass graft). According to 2012 AHA/ACC guidelines, the objective of the treatment for SCAD is to maintain or recover patients' exercise tolerance, quality of life, and avoid complication like heart failure, so as to decrease mortality, eliminate symptoms, and avoid adverse reactions. Traditional Chinese medicine (TCM) has 2000 years of history in managing CAD and has its advantages in improving quality of life. Using scientific method to evaluate, demonstrate, and conclude the clinical curative effect of TCM is an extremely important task for both TCM and integrative Chinese and Western medicine in the treatment of CAD. METHODS: This research is to collect real effective cases from authoritative TCM cardiologists' clinic, so as to build a TCM diagnosis and treatment information database that involve 2000 patients from 32 different top-3 hospitals of china. The primary outcome includes EuroQol-5 Dimensions and Four diagnostic method of TCM, and secondary outcome includes angina score and some laboratory indexes like electrocardiograms, dynamic electrocardiogram, ultrasonic cardiogram, and treadmill exercise testing. This research uses SPSS17.0. to do the statistical analysis application. Enumeration data use χ test and measurement data which fit normality test use t test. The analysis of drugs usage in different diseases, different syndromes and different life quality effect will use principal component analysis, factorial analysis, clustering analysis. and point mutual information method, and so on. RESULTS: This research, based on past syndromes research and real clinical effective chronic SCAD cases, aim to build a TCM diagnosis and treatment information database.

Ethyl acetate extract from Panax ginseng C.A. Meyer and its main constituents inhibit α-melanocyte-stimulating hormone-induced melanogenesis by suppressing oxidative stress in B16 mouse melanoma cells.

ETHNOPHARMACOLOGICAL RELEVANCE: Hyperpigmentation disease involves darkening of the skin color due to melanin overproduction. Panax ginseng C.A. Meyer is a well-known traditional Chinese medicine and has a long history of use as a skin lightener to inhibit melanin formation in China, Korea and some other Asian countries. However, the constituents and the molecular mechanisms by which they affect melanogenesis are not fully clear. AIM OF THE STUDY: The purpose of this study was to identify the active ingredient in Panax ginseng C.A. Meyer extract that inhibits mushroom tyrosinase activity and to investigate the antioxidative capacity and molecular mechanisms of the effective extract on melanogenesis in B16 mouse melanoma cells. MATERIALS AND METHODS: Aqueous extracts of Panax ginseng C.A. Meyer were successively fractionated with an equal volume of chloroform, ethyl acetate, and n-butyl alcohol to determine the effects by examining the activity of mushroom tyrosinase. The effective fraction was analyzed using HPLC and LC-MS. The antioxidative capacity and the inhibitory effects on melanin content, cell intracellular tyrosinase activity, and melanogenesis protein levels were determined in α-melanocyte-stimulating hormone (α-MSH)-treated B16 mouse melanoma cells. RESULTS: The ethyl acetate extract from Panax ginseng C.A. Meyer (PG-2) had the highest inhibiting effect on mushroom tyrosinase, mainly contained phenolic acids, including protocatechuic acid, vanillic acid, p-coumaric acid, salicylic acid, and caffeic acid, and exhibited apparent antioxidant activity in vitro. PG-2 and its main constituents significantly decreased melanin content, suppressed cellular tyrosinase activity, and reduced expression of tyrosinase protein to inhibit B16 cells melanogenesis induced by α-MSH, and no cytotoxic effects were observed. They also inhibited cellular reactive oxygen species (ROS) generation, increased superoxide dismutase (SOD) activity and glutathione (GSH) level in α-MSH-treated B16 cells effectively. And those activities of its main constituents could reach more than 80% of PG-2. The ROS scavengers N-acetyl-L-cysteine (NAC) had a similar inhibitory effect on melanogenesis. CONCLUSIONS: These results suggest that ethyl acetate extract from Panax ginseng C.A. Meyer has the highest effect on inhibiting melanogenesis, and that its main components are polyphenolic compounds, which may inhibit melanogenesis by suppressing oxidative stress. This work provides new insight into the active constituents and molecular mechanisms underlying skin-lightening effect of Panax ginseng C.A. Meyer.

[Scientific Evaluation of TCM Clinical Outcomes Rating Scale for Heart Failure Based on Patients Report].

OBJECTIVE: To evaluate the reliability, validity, and responsiveness of traditional Chinese medicine (TCM) clinical outcomes rating scale for heart failure (HF) based on patients' report. METHODS: TCM clinical outcomes rating scale for HF (TCM-HF-PRO) were evaluated based on 340 HF patients' report from multiple centers. The completion of the investigation was recorded. Cronbach's α coefficient and split-half reliability were used for reliability analysis, and factor analysis was used to assess the construct validity of the rating scale. Pearson correlation analysis was then used for criterion validity analysis. Discriminant analysis was used to assess the responsiveness of the scale. All 340 HF patients having complete TCM-HF-PRO data were assigned to the treatment group and the control group by central randomization. The total TCM-HF-PRO scores of the two groups were compared using paired t-test to reflect the longitude responsiveness of the scale before treatment and at week 2 after treatment. RESULTS: (1) The recycling rate of the scale was 100.0%. One of them was not filled completely, which was rejected thereby. So the completion rate was 99.7%. The completion time for TCM-HF-PRO scale ranged 15 to 25 min. (2) The Cronbach's α coefficient of rating scale was 0.903, split-half reliability was 0.844 and 0.849. (3) Confirmatory factor analysis showed that 7 factors and items formed according to maximum load factor basically coincided with the construct of the rating scale, 7 factors accumulated contribution rate was 43.8%. TCM clinical outcomes rating scale for HF based on patients' report was relatively better correlated with the Minnesota living with HF questionnaire (r = 0.726, P < 0.01). (4) Discriminant analysis showed that the rating scale correctly classified more than 78.8% of case studies having confirmed initial differential diagnosis by experts. The total scale of the rating scale decreased more in the two group after treatment, with significant difference as compared with before treatment (P < 0.01. CONCLUSION: TCM clinical outcomes rating scale for HF based on patients' report had good reliability, validity and responsiveness, hence it could be used to assess clinical efficacy for HF patients.

[Expert survey for Chinese medicine syndrome characteristics of different clinical types of coronary artery disease based on the Delphi method].

OBJECTIVE: To carry out expert survey for traditional Chinese medicine (TCM) syndrome characteristics of different clinical types of coronary artery disease (CAD). METHODS: By using Delphi method, we carried out two rounds of nationwide expert surveys for modern TCM characteristics of syndrome elements and syndrome types of CAD. RESULTS: Based on expert consensus, qi deficiency, blood stasis, phlegm turbidity, qi deficiency blood stasis, and intermingled phlegm and blood stasis are common TCM syndromes for different clinical types of CAD. Of them, qi stagnation, blood stasis, phlegm turbidity, heat accumulation, cold coagulation, yang deficiency, deficiency of both qi and yang were more often seen in patients with unstable angina than in those with stable angina. Qi deficiency, yin deficiency, and deficiency of both qi and yin were less seen. We could see more excess syndrome and less deficiency syndrome (such as qi deficiency, yin deficiency, etc.) in acute ST-segment elevation myocardial infarction (STEMI) than acute non-ST-segment elevation myocardial infarction (NSTEMI). Qi deficiency, blood stasis, water retention, yang deficiency, phlegm turbidity, yin deficiency, Xin-qi deficiency, and qi deficiency blood stasis induced water retention are the most common TCM syndrome types of CAD heart failure (HF). Blood deficiency, yin deficiency, heat accumulation, deficiency of both Xin and Pi, deficiency of both qi and blood, deficiency of both qi and yin, yin deficiency and fire hyperactivity were more often seen in CAD arrhythmias. CONCLUSIONS: TCM syndrome distributions of different clinical types of CAD have common laws and individual characteristics. Results based on the expert consensus supplied evidence and support for clinical diagnosis and treatment of CAD.

[Preliminary study on the combination of the analytical hierarchy process and Delphi methods in Chinese medicine clinical research].

The combination of the analytical hierarchy process (AHP) and Delphi method can overcome the strong subjectivity and poor authority in the simple use of AHP, get rid of the shackles of established thinking and take fully advantages of the experiences of experts' knowledge. By a set of quantitative calculation method, we can determine the relative importance of each factor or the relative weight of the order value, thus providing the support for clinical decision making. In this article, on the basis of the combination of AHP and Delphi method, the authors explore the Chinese medicine etiology of coronary heart disease.

Clinical epidemiology survey of the traditional Chinese medicine etiology and syndrome differentiation of coronary artery disease: study protocol of a multicenter trial.

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 5000 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. TRIAL REGISTRATION: This study protocol was registered at the Chinese Clinical Trial Registry on November 27, 2011 in both Chinese and English editions and the registration number is ChiCTR-ECS-11001728.

[Application of Delphi method in traditional Chinese medicine clinical research].

In recent years, Delphi method has been widely applied in traditional Chinese medicine (TCM) clinical research. This article analyzed the present application situation of Delphi method in TCM clinical research, and discussed some problems presented in the choice of evaluation method, classification of observation indexes and selection of survey items. On the basis of present application of Delphi method, the author analyzed the method on questionnaire making, selection of experts, evaluation of observation indexes and selection of survey items. Furthermore, the author summarized the steps of application of Delphi method in TCM clinical research.

Contemporary treatment of Western and Chinese medicine for cardiac syndrome X.

Clinical reports on cardiac syndrome X (CSX) have been increasing in recent years. In general, CSX does not increase the cardiovascular mortality, but it can affect the patient's quality of life (QOL) and increase the incidence rates of cardiovascular and cerebrovascular events. Although a variety of drugs and therapies have been utilized in the clinical treatment, the management of CSX still represents a major challenge due to its unclear pathogenesis. It is necessary to explore more effective treatment programs. Many attempts have been made on trials of the Chinese medicine (CM) treatment for CSX and proved that CM has a certain advantage in efficacy to improve clinical symptoms and QOL. CM may provide a new approach for the effective treatment of CSX.

[Effects of Shenmai Injection on serum concentration and pharmacokinetics of digoxin in dogs with heart failure].

OBJECTIVE: To explore the effects of Shenmai Injection (SMI), a compound traditional Chinese herbal medicine, on pharmacokinetics and serum concentration of digoxin when applied together with digoxin. METHODS: Twenty dogs with heart failure were randomly divided into 4 groups: control group and low-, medium- and high-dose SMI groups, with 5 dogs in each group. After intravenous injection of digoxin injection at a dose of 7.41 µg/kg, dogs in the control group were administered intravenously with normal saline 20 mL daily for 5 d, and the other groups were intravenously administered with SMI at the doses of 0.517, 1.034 and 1.551 mL/kg respectively. After the administration, the blood was collected at designed time points. Serum concentration of digoxin was determined by high-performance liquid chromatography with electrospray tandem mass spectrometry (HPLC/MS/MS). RESULTS: The low-, medium- and high-dose SMI showed different effects on the pharmacokinetics of digoxin: the low-, medium- and high-dose SMI revealed a tendency to decrease the elimination half-life (T(1/2ß)) of digoxin. The low-dose SMI showed a tendency to decrease the digoxin concentration. Serum clearance (CL) in the low-dose SMI group was higher than that in the control, and also significantly higher than those in the medium- and high-dose SMI groups (P<0.05). The area under concentration-time curve (AUC(0→∞)) in the low-dose SMI group was lower than that in the control group (P=0.05); the AUC(0→72 h) and AUC(0→∞) in the low-dose SMI group were significantly lower than those in the medium- and high-dose SMI groups. Low-dose SMI accelerated the clearance of digoxin in blood. CONCLUSION: Low-, medium- and high-dose SMI shows different effects on pharmacokinetics of digoxin and reveals a tendency to shorten T(1/2ß) of digoxin. Low-dose SMI can accelerate the clearance of digoxin in blood.

[Current status of study on impacts of Chinese herbal drugs and their preparations on pharmacokinetics].

Since Chinese herbal drugs and their preparations were usually applied in combining with digoxin in modern clinical practice, high attention was accordingly widely paid to their impacts on the pharmacokinetics of digoxin. The researches in the recent years dealing with this topic were reviewed in the paper, involving the Chinese herbs, including Radix Ginseng, Radix Salviae Miltiorrhizae, Venenum Bufonis, Folium Seu Cortex Nerii Indici, St John's wort, Fructus Crataegi, and Semen Ginkgo, as well as the Chinese herbal preparations including Shengmai Injection, Milkvetch Injection, Liushen Pill, Kyushin, and Di'ao Xinxuekang, etc.