Guideline on Establishing Diagnostic Criteria for Chinese Medicine Syndromes.

AIM: To formulate the guideline for the development of diagnostic criteria for Chinese medicine syndromes, which can contribute to standardization of development of Chinese medicine syndrome diagnostic standards. METHODS: We embark into account on the development of Guideline on Establishing Diagnostic Criteria for Chinese Medicine Syndromes through Delphi method with reference to the existing technical system of diagnostic criteria for Chinese medicine syndromes and relevant criteria. RESULTS: Our guideline specifies principles, methods, and procedures for the formulation of diagnostic criteria for Chinese medicine syndromes. CONCLUSIONS: It is a comprehensive and systematic evidence-based guideline, and we hope this guideline can be applied as a reference in developing diagnostic criteria for Chinese medicine syndromes in other disciplines. It is also applicable to the formulation of diagnostic criteria for relevant clinical, educational, and scientific research by hospitals, institutes, and academies.

[Serum metabolomics of chronic obstructive pulmonary disease with lung-Qi deficiency syndrome].

The present study analyzed the potential biomarkers of chronic obstructive pulmonary disease(COPD) with lung-Qi deficiency syndrome by non-targeted metabolomics and explored the biological basis of this syndrome. Blood samples of 96 COPD patients with lung-Qi deficiency syndrome(COPD with lung-Qi deficiency syndrome group) and 106 healthy people(healthy control group) were collected, and the metabolic profiles of both groups were analyzed by ultra-high performance liquid chromatography-quadrupole-time-of-flight mass spectrometry(UPLC-Q-TOF-MS). Multivariate statistical analysis and differential metabolite screening were carried out by using Progenesis QI and Simca-P. Metabolic pathways were constructed through the MetaboAnalyst. Seven potential biomarkers, such as L-cystathionine, protoporphyrinogen Ⅸ, and citalopram aldehyde, were identified. Compared with the results in the healthy control group, the content of citalopram aldehyde, N1-methyl-2-pyridone-5-carboxamide, and 11ß,17ß-dihydroxy-4-androsten-3-one was significantly up-regulated, while that of the other four compounds such as L-cystathionine, dihydrotestosterone, protoporphyrinogen Ⅸ, and D-urobilinogen was down-regulated. These potential biomarkers involved six metabolic pathways, including cysteine and methionine metabolism, porphyrin and chlorophyll metabolism, drug metabolism of cytochrome P450, steroid hormone biosynthesis, glycine, serine, and threonine metabolism, and nicotinate and nicotinamide meta-bolism. This study is expected to provide a certain scientific basis for the research on traditional Chinese medicine syndrome of COPD with lung-Qi deficiency syndrome from the molecular biology level.

Traditional Chinese medicine ZHENG identification of bronchial asthma: Clinical investigation of 2500 adult cases.

OBJECTIVES: This study aims to employ more comprehensive approaches to analyze the primary and secondary symptoms of clinical common TCM ZHENG of bronchial asthma according to the clinical investigation of 2500 adult cases. METTHODS: Patients met the inclusion criteria were surveyed by associate chief physician or chief physician through the TCM Clinical investigation questionnaire containing general demographic information, signs and symptoms, tongue and pulse conditions. Firstly, absolute frequency, cumulative frequency, Chi-squared test were adopted to reflect the clinical common ZHENG in three asthma stages, then the logistic regression analyses, the frequency methods were combined to distinguish the primary and secondary symptoms of the common ZHENG. RESULTS: Of the 2500 questionnaires, 2428 valid questionnaires were got, with the number in acute exacerbation stage was 1273, and that 586 in chronic persistent stage, and 569 in clinical remission stage, in which the number of excess syndromes, the deficiency-excess complex syndromes and deficiency syndromes corresponding to the above three stage respectively accounted on 55.7%, 69.97%, and 76.50%. According to the distribution of each ZHENG, ten clinical common ZHENG were distinguished by criteria of the frequency percent value at least 10.0% and cumulative percent value reach to 70% or above. Then based on the OR and frequency value of each symptom, the primary symptoms were tentative identified by OR value≧3 with percent value≧50%, and that of the secondary symptoms were OR value between 1 and 3 with percent value between 25% and 50%. CONCLUSIONS: Ten common ZHENG of asthma with each primary and secondary symptoms in three stages are identified through the clinical investigation: Exterior cold with interior fluid retention, Phlegm-turbidity obstructing the lung, Phlegm-heat obstructing the lung, Wind-phlegm obstructing the lung, Blood stasis, Qi deficiency of the lung, Qi deficiency of the lung and spleen, Qi deficiency of the lung and kidney, Qi and Yin deficiency of the lung and kidney, Yang deficiency of the lung and kidney.

Functional and psychosocial effects of pulmonary Daoyin on patients with COPD in China: study protocol of a multicenter randomized controlled trial.

BACKGROUND: Chronic obstructive pulmonary disease (COPD) is a major public health problem worldwide. Pulmonary rehabilitation (PR) is an established intervention for the management of patients with COPD. Exercise training is an important part of PR, and its effectiveness in patients with COPD is well established. However, alternative methods of PR training such as Daoyin have not been appropriately studied. Hence, alternative forms of exercise training that require less exercise equipment and no specific training place should be evaluated. This paper describes the study protocol of a clinical trial that aims to determine if pulmonary Daoyin training will improve the exercise capacity and psychosocial function of patients with COPD in China. METHODS AND DESIGN: A multicenter, randomized, controlled trial will be conducted. A total of 464 patients meeting the inclusion criteria will be enrolled into this study with 232 patients in each of the trial group and the control group. Based on patient education, patients in the trial group will receive pulmonary Daoyin and continue with their usual therapy for three months. In the control group, patients will continue with their usual therapy. The primary outcome measures are exercise capacity assessed by the six-minute walking distance test and lung function. Secondary outcomes include dyspnea and quality of life. Measurements will be taken at baseline (month 0) and after the study period (month 3). DISCUSSION: It is hypothesized that pulmonary Daoyin will have beneficial effects in improving exercise capacity and psychosocial function of patients with stable COPD, and will provide an alternative form of exercise training that is accessible for the large number of people with COPD. TRIAL REGISTRATION: This trial has been registered in ClinicalTrials.gov. The identifier is NCT01482000.

[An expert analysis of diagnostic criteria for traditional Chinese medicine syndromes of chronic obstructive pulmonary disease at acute exacerbation stage].

OBJECTIVE: To investigate the common syndromes, clinical symptoms and characteristics of chronic obstructive pulmonary disease at acute exacerbation stage (AECOPD). METHODS: Delphi method was used to organize the AECOPD expert questionnaire. This questionnaire was distributed to 30 selected experts of respiratory diseases. The resulting data were statistically analyzed by Chi-square test and statistical description such as mean, coefficient of variation and ratio of full marks. Common syndrome: mean≥3.00, coefficient of variation <30% and ratio of full marks≥10% and common clinical symptoms: for major symptoms present, the index mean≥4.00 and coefficient of variation <30% and for minor symptom, index mean≥3.00 and coefficient of variation <30% were used as criteria. RESULTS: Twenty-nine valid expert questionnaires were received. The coefficient of positivity was 96.67%, of authority was 0.835 and of coordination equals 0.359 (χ(2)=463.15, P=0.001). The mean, coefficient of variation and ratio of full marks for AECOPD syndrome of wind and cold invasion of lung were 4.12, 21.50%, and 34.48%, respectively. Those for syndrome of exogenous cold-evil and fluid-retention were 4.39, 14.32%, 48.28%; those for syndrome of wind and heat invasion of lung were 3.54, 30.77%, 6.90%;those for syndrome of phlegm-heat obstruction of the lung were 4.85, 9.23%, 89.66%; those for syndrome of pulmonary stagnation of phlegm were 4.36, 15.57%, 48.28%; those for syndrome of external cold and internal heat were 4.59, 16.27%, 65.52%; those for syndrome of retention of phlegm and blood stasis in the lung were 4.54, 12.70%, 55.17%; those for syndrome of qi deficiency of the lung and spleen were 3.25, 27.30%, 13.79%; those for syndrome of qi deficiency of the lung and kidney were 3.32, 27.24%, 13.79%; those for syndrome of qi-yin deficiency of the lung and kidney were 3.29, 28.98%, 24.14%; those for syndrome of yin deficiency of the lung and kidney were 2.98, 32.71%, 3.45%; those for syndrome of blood stasis were 4.67, 10.29%, 62.07% and those for syndrome of fu shi were 3.07, 30.01%, 6.90%, all respectively. The blood stasis and fu shi were accompanying syndromes. CONCLUSION: Seven common syndromes of AECOPD are wind and cold invasion of lung, exogenous cold-evil and fluid-retention, phlegm-heat obstruction in the lung, pulmonary stagnation of phlegm qi deficiency of the lung and spleen, qi deficiency of the lung and kidney, as well as qi-yin deficiency of the lung and kidney. One additional syndrome that accompanies many of the afore-mentioned syndromes was blood stasis.

Shenmai injection for chronic pulmonary heart disease: a systematic review and meta-analysis.

OBJECTIVES: This study sought to evaluate the efficacy and safety of shenmai injection for chronic pulmonary heart disease (CPHD). METHODS: A systematic review was conducted of clinical trials that compared shenmai injection plus conventional medicine treatment versus conventional medicine treatment alone. Randomized controlled trials of clinical therapeutic studies on CPHD by shenmai injection were included. Searches were applied to the following electronic databases: the PubMed (1977-2008), the Cochrane Library, EMBASE, AMED, Chinese BioMedical Literature Database, and CBM. No blinding and language restriction was used. Data were extracted independently by 2 reviewers. All trials included were analyzed according to the criteria of the Cochrane Handbook. Review Manager 5.0 software was used for data analysis. RESULTS: Thirty-three (33) randomized clinical trials (2617 patients) with low methodological quality were included. Compared to conventional medicine treatment alone, shenmai plus conventional medicine treatment showed significant improvement in New York Heart Association classification of clinical status (odds ratio 0.24; 95% confidence interval 0.19-0.30), five studies had reported adverse events. No serious adverse effects were reported in any of the included trials. CONCLUSIONS: While there is some evidence that suggests potential effectiveness of shenmai plus conventional medical treatment for CPHD, the results of this study were limited by the methodological flaws, unknowns in concealment of allocation, number of dropouts, and blinding methods in the studies. Long-term and high-quality studies are needed to provide clear evidence for the future use of shenmai injection.