Distribution of elements extracted from symptom patterns and characteristics of polysomnograph of common symptom patterns of insomnia with Traditional Chinese Medicine.

OBJECTIVE: To analyze the distribution and combined regulation of elements of symptom patterns in the diagnosis of insomnia with Traditional Chinese Medicine (TCM). METHODS: The samples were collected from the patients, diagnosed with insomnia, of Henan Province Hospital of TCM between June 2011 and September 2013. The symptom patterns in insomnia were extracted. Next, symptom differentiation, characteristics of polysomnography (PSG), distribution and combined regulation of these symptom patterns were conducted by tests. RESULTS: In total, 286 eligible patients were recruited. The main locations of the disease symptom elements were the brain and heart, and the main characteristics of the disease symptom elements were phlegm-heat, Yin-deficiency and Qi-stagnation. The elements from two or three symptom patterns were commonly manifested in patients with insomnia, especially from three symptom patterns. We also found that all TCM symptom patterns had an effect on polysomnographic indicators in PSG tests. CONCLUSION: The elements of symptom patterns in insomnia were identified as mainly fire-heat and phlegm-heat. The most common patterns of excess were pathogenic fire derived from stagnation of liver- Qi, and mental disturbance due to phlegm-heat, while the most common patterns of deficiency in both the heart and the spleen. There are many differences in PSG indicators of different syndrome patterns of insomnia.

Effect of Huqian Wan on liver-Yin and kidney-Yin deficiency patterns in patients with knee osteoarthritis.

OBJECTIVE: To observe the curative effect of Huqian Wan on liver and kidney-Yin deficiency knee osteoarthritis (KOA). METHODS: One hundred patients were randomly divided, into a treatment (50 patients) and control group (50 patients). In the treatment group, patients orally took the Chinese medicine Huqian Wan. Control group patients orally took Votalin, 75 mg, once a day, for 8 weeks. The visual analog scale (VAS), Western Ontario and McMaster University Osteoarthritis Index (WOMAC), and Medical Outcomes Study Short Form 36-Item Health Survey (SF 36) were used to evaluate the curative effect before treatment and after 8 and 16 weeks of treatment. RESULTS: VAS and WOMAC scores significantly decreased and SF 36 scores significantly increased after treatment in both groups compared with before treatment (P < 0.05). There were significant differences in VAS, WOMAC, and SF 36 score changes between the two groups at week 16 (P < 0.05). There was a significant increase in VAS and WOMAC scores in the control groups (P < 0.05) between weeks 8 and 16, but no significant difference was found in the treatment group (P > 0.05). CONCLUSION: Huqian Wan could effectively improve the clinical symptoms and quality of life in patients with KOA. It could also have a better and longer lasting curative effect without obvious adverse events compared with Votalin.

[Study on effect of Polygonatum sibiricum on Yin deficiency model rats induced by long-term overload swimming].

OBJECTIVE: To observe the effect of Polygonatum sibiricum on Yin deficiency model rats induced by long-term overload swimming. METHOD: Except for the normal group, all of the remaining rats performed the long-term overload swimming for eight weeks, with five days every week and once every day, to establish the Yin deficiency model. The daily swimming time increased from 10 min to 180 min at the end of the 7th week, with the water depth of 60 cm and the water temperature at 30 degrees C. After the success of the modeling, the rats were orally administered with different doses of aqueous extracts from P. sibiricum (2.5, 10 g x kg(-1)) for eight weeks. After the final administration, their blood were collected from orbits to measure immunoglobulin A, G and M (IgA, IgG, IgM), interleukin 2 and 6 (IL-2, IL-6) and cAMP, cGMP contents in plasma General behavioral indicators (weight, facial temperature, pain threshold and holding power) of rats were observed during the drug administration. RESULT: Compared with the model control group, aqueous extracts from P. sibiricum was given for eight weeks to significantly increase the rat weight and holding power of Yin deficiency model rats, decrease the facial temperature and the sensitivity of pain threshold, and increase IgA, IgG, IgM and IL-6 content and IgG content in serum, but without statistical difference. Aqueous extracts from P. sibiricum (10 g x kg(-1)) could also increase IL-2 content in serum, and decrease cAMP content and cAMP/cGMP ratio. CONCLUSION: P. sibiricum could improve the general behavioral indicators (weight, holding power, pain threshold and facial temperature), immunologic functions (IgA, IgG, IgM) and cyclic nucleotide (cAMP, cAMP/cGMP), so as to ameliorate such Yin deficiency symptoms as dysphoria in chestpalms-soles, weight loss, soreness and weakness of waist and knees, immunologic dysfunction and cyclic nucleotide system disorders.

Distribution of Traditional Chinese Medicine syndromes in diabetic kidney disease chronic kidney disease 1-5: a correlation study.

OBJECTIVE: To analyze the distribution of Traditional Chinese medicine (TCM) syndromes in patients with diabetic kidney disease (DKD) and its related factors. METHODS: We enrolled 435 patients with DKD, who were not undergoing dialysis, admitted to the Department of Nephrology, First Medical Center, Chinese PLA General Hospital from April 2020 to August 2021. Analysis of their TCM syndromes and related factors was carried out. RESULTS: The 435 patients included 109, 117, 86, and 123 chronic kidney disease (CKD) 1-2, CKD3, CKD4, and CKD5 cases, respectively. With the progression of CKD1-5, the proportion of Yin deficiency and dry heat syndrome, and that of Qi and Yin deficiency syndrome showed a downward trend, whereas the proportion of spleen-kidney Yang deficiency, blood deficiency, blood stasis, water stagnation, and phlegm turbidity syndromes showed an upward trend; the differences were statistically significant (P < 0.05). Multivariate logistic regression analysis showed that Yin deficiency and dry heat syndrome was positively correlated with hemoglobin [odds ratio (OR) = 1.022, P = 0.005], albumin (OR = 1.058, P = 0.006), and estimated glomerular filtration rate (eGFR) (OR = 1.020, P < 0.001) but negatively correlated with male sex (OR = 0.277, P = 0.004). Qi and Yin deficiency syndrome was positively correlated with albumin (OR = 1.056, P < 0.001) and eGFR (OR = 1.008, P = 0.022) but negatively correlated with age (OR = 0.977, P = 0.023). Liver-kidney Yin deficiency syndrome was positively correlated with age (OR = 1.028, P = 0.021) and glycosylated hemoglobin (OR = 1.223, P = 0.007) but negatively correlated with total cholesterol (OR = 0.792, P = 0.006). Spleen-kidney Yang deficiency syndrome was negatively correlated with hemoglobin (OR = 0.977, P < 0.001), albumin (OR = 0.891, P < 0.001), and eGFR (OR = 0.978, P < 0.001) but positively correlated with high density lipoprotein (OR = 3.376, P = 0.001). CONCLUSION: With CKD1-5 progression, TCM syndromes changed from Yin deficiency and dry heat syndrome to syndrome of deficiency of both Qi and Yin, liver-kidney Yin, and spleen-kidney Yang deficiency syndromes. TCM syndromes were correlated with laboratory test results.

Study on blood pressure rhythm in hypertensive patients withdeficiency syndrome and a random forest model for predicting hypertension withdeficiency syndrome.

OBJECTIVE: To investigate blood pressure rhythm (BPR) in Yin deficiency syndrome of hypertension (YDSH) patients and develop a random forest model for predicting YDSH. METHODS: Our study was consistent with technical processes and specification for developing guidelines of Evidence-based Chinese medicine clinical practice (T/CACM 1032-2017). We enrolled 234 patients who had been diagnosed with primary hypertension without antihypertensive medications prior to the enrollment. All participants were divided into Yin deficiency group (YX, n = 74) and non-Yin deficiency group (NYX, n = 160). Participants were professionally grouped by three experienced chief Traditional Chinese Medicine (TCM) physicians according to four examinations (i.e., inspection, listening and smelling, inquiry and palpation). We collected data on 24 h ambulatory blood pressure monitoring (ABPM) and YDSH rating scale. We divided 24 h of a day into 12 two-hour periods [Chen-Shi (7:00-9:00), Si-Shi (9:00-11:00), Wu-Shi (11:00-13:00), Wei-Shi (13:00-15:00), Shen-Shi (15:00-17:00), You-Shi (17:00-19:00), Xu-Shi (19:00-21:00), Hai-Shi (21:00-23:00), Zi-Shi (23:00-1:00), Chou-Shi (1:00-3:00), Yin-Shi (3:00-5:00), Mao-Shi (5:00-7:00)] according to the theory of "midnight-midday ebb flow". We used random forest to build the diagnostic model of YDSH, with whether it was Yin deficiency syndrome as the outcome. RESULTS: Compared with NYX group, YX group had more female participants with older age, lower waist circumference, body mass index (BMI), diastolic blood pressure (DBP), and smoking and drinking rate (all P ＜ 0.05). The YDSH rating scores of YX group [28.5 (21.0-36.0)] were significantly higher than NYX group [13.0 (8.0-22.0)] (P < 0.001), and the typical symptoms of YX group included vexing heat in the chest, palms and soles, dizziness, dry eyes, string-like and fine pulse, soreness and weakness of lumbus and knees, palpitations, reddened cheeks, and tinnitus (all P < 0.05). The ratio of non-dipper hypertension in YX group was higher than in NYX group (56.9% vs 44.4%, P = 0.004). Compared with NYX group, 24 h DBP standard deviation (SD), nighttime DBP SD, Si-Shi DBP, Si-Shi mean arterial pressure (MAP), Hi-Shi systolic blood pressure (SBP), Hi-Shi DBP, Hi-Shi MAP, Zi-Shi SBP, Zi-Shi DBP, Zi-Shi MAP, Chou-Shi SBP SD, Chou-Shi DBP SD, Chou-Shi SBP coefficient of variation (CV) were lower in YX group (all P ＜ 0.05). Binary Logistic Regression analysis showed that the diagnosis of YDSH was positively correlated with age, heart rate, YDSH rating scores, and four TCM symptoms including vexing heat in the chest, palms and soles, string-like and fine pulse, soreness and weakness of lumbus and knees, and reddened cheeks (all P ＜ 0.05), but was negatively correlated with smoking (P﹥0.05). In addition, the diagnosis of YDSH was positively correlated with daytime SBP SD, nighttime SBP SD, nighttime SBP CV, and Hi-Shi SBP CV, but was negatively correlated with 24 h SBP CV, daytime DBP SD, nighttime DBP SD, and Hi-Shi DBP (all P ＜ 0.05). Hi-Shi SBP CV had independent and positive correlation with the diagnosis of YDSH after adjusting the variables of age, gender, course of hypertension, BMI, waist circumference, SBP, DBP, heart rate, smoking and drinking (P = 0.029). Diagnostic model of YDSH was established and verified based on the random forest. The results showed that the calculation accuracy, specificity and sensitivity were 77.3%, 77.8% and 76.9%, respectively. CONCLUSION: The BPR was significantly attenuated in YDSH patients, including lower 24 h DBP SD and nighttime DBP SD, and Hi-Shi SBP CV is independently correlated with the diagnosis of YDSH. The prediction accuracy of diagnosis model of YDSH based on the random forest was good, which could be valuable for clinicians to differentiate YDSH and non-Yin deficiency patients for more effective hypertensive treatment of TCM.

The correlation between traditional Chinese medicine constitution and primary osteoporosis: A systematic review and meta-analysis.

BACKGROUND: In recent years, as societal awareness of the risks associated with primary osteoporosis (POP) has deepened, numerous studies have explored the relationship between POP and Traditional Chinese Medicine (TCM) constitution types. To further clarify the TCM constitution types closely associated with POP and provide evidence-based medical support for the prevention and treatment of osteoporosis from a TCM perspective, we have employed evidence-based methods to investigate the relationship between POP and TCM constitution types. METHODS: We conducted a comprehensive search of observational studies on the relationship between POP and TCM constitutional types in databases, including PubMed, Embase, MEDLINE, Web of Science, Chinese National Knowledge Infrastructure (CNKI), Wanfang, and Chinese Scientific Journal Database (VIP), up to October 2023. RESULTS: After literature selection, data extraction, and bias assessment, 29 studies were included in the meta-analysis, comprising 20 cross-sectional studies and 9 case-control studies. Using R software (version 4.2.3), we analyzed the distribution of TCM constitutional types in POP patients and compared the TCM constitutional types between POP patients and healthy individuals. The meta-analysis results revealed that in POP patients, Yang-deficiency constitution accounted for 22.7% (95% CI: 19.8-25.8%), Yin-deficiency constitution accounted for 15.8% (95% CI: 13.0-18.6%), and Qi-deficiency constitution accounted for 14.1% (95% CI: 12.2-16.0%). The proportions of the three mentioned TCM constitutions all exceed that of the Balanced constitution, with the balanced constitution accounting for 12.3% (95% CI: 7.4-18.1%). The proportions of Yang-deficiency, Yin-deficiency, and Qi-deficiency constitutions were higher in POP patients compared to healthy individuals, with odds ratios (OR) of 2.36 (95% CI: 1.43-3.89), 1.69 (95% CI: 1.36-2.04), and 1.80 (95% CI: 1.23-2.64), respectively, while the Balanced type was lower in POP patients with an OR of 0.16 (95% CI: 0.11-0.23) compared to healthy individuals. CONCLUSION: The evidence suggests that the Yang-deficiency constitution, Yin-deficiency constitution, and Qi-deficiency constitution are the predominant TCM constitutional types in POP patients. Furthermore, Yang-deficiency constitution, Yin-deficiency constitution, and Qi-deficiency constitution may serve as potential risk factors for POP, while the Balanced constitution may act as a protective factor.

Gene expression profiling of rat livers with yin-deficiency-heat syndrome.

OBJECTIVE: To explore the nature of "Yin internal heat caused by Yin-deficiency," in terms of the theory of Traditional Chinese Medicine, by studying energy metabolism in rats with Yin-deficiency-heat syndrome and analyzing the gene expression profile of their livers. METHODS: A Yin-deficiency-heat syndrome model was induced in rats using three Chinese medicinal herbs. Glycogen and triglycerides in blood plasma, and the enzyme activity of ATP in livers were measured colorimetrically. Triiodothyronine (T3), thyroxine (T4), and thyroid stimulating hormone levels in blood plasma were also measured with enzyme linked immunosorbent assay. The gene expression profile of livers was detected with gene chip analysis. Differentially expressed genes were screened out and classified according to Gene Ontology. The accuracy of results were examined with reverse transcription-polymerase chain reaction. RESULTS: Compared with the control group, body weight (P < 0.05) and hepatic glycogen (P < 0.05) were significantly lower in the Yin-deficiency-heat syndrome group. Moreover, toe temperature (P < 0.01) and triglyceride (P < 0.05), Na(+) -K(+)-ATPase (P < 0.01), Mg(2+)-ATPase (P < 0.01), T3 (P < 0.05), and T4 (P < 0.01) levels were significantly higher. There were 99 differentially expressed genes in livers from the Yin-deficiency-heat syndrome group. Genes were mainly related to sterol synthesis (Pc = 0.0392), defense response (Pc = 0.0448), and sterol metabolism (Pc = 0.0533). CONCLUSION: Abnormal expression genes in rats with Yin-deficiency-heat syndrome prompted the synthesis and metabolism of cholesterol, increased energy consumption, and reduced defense response. This gene expression might be the molecular mechanism underlying "internal heat caused by Yin-deficiency" in the rats with Yin-deficiency-heat syndrome.

Traditional Chinese medicine diagnoses in persons with ketamine abuse.

OBJECTIVES: To explore the distribution of TCM patterns in ketamine users and the inter-rater reliability of TCM diagnosis among TCM practitioners. METHODS: Eighty-four subjects recruited from substance abuse clinics and non-governmental counseling services catering for ketamine abusers were examined by one or two TCM practitioners. The distribution and inter-rater reliability of the TCM diagnoses between the two TCM practitioners were described and measured. RESULTS: Seven TCM patterns were differentiated. The four most common patterns were the Heart Yin deficiency (29.8%), Kidney Yang deficiency (26.2% Kidney Yin deficiency (19.0%), and Spleen Yang deficiency (14.3%). The agreement between the two TCM practitioners was 59%; the kappa for the three most common patterns was 0.472 (P = 0.003). The proportion of men was lower in the Kidney Yin deficiency group (18.8%), in comparison to the Heart Yin deficiency (60.0%, P = 0.009) and Kidney Yang deficiency group (59.1%, P = 0.013). CONCLUSION: The differences between the TCM groups in terms of the source of referral and number of drug uses other than ketamine were of borderline significance. Further research should focus on validating diagnostic tools and improving inter-rater reliability in TCM to enhance the quality of clinical trials of TCM treatments for ketamine abuse.

Construction of a traditional Chinese medicine syndrome-specific outcome measure: the Kidney Deficiency Syndrome Questionnaire (KDSQ).

BACKGROUND: Development of Traditional Chinese Medicine (TCM) syndrome-specific outcome measures is needed for the evaluation of TCM syndrome-specific therapies. We constructed a Kidney Deficiency Syndrome Questionnaire (KDSQ) for the evaluation of the common TCM syndromes Kidney-Yin Deficiency Syndrome (KDS-Yin) and Kidney-Yang Deficiency Syndrome (KDS-Yang) in middle-aged women with menopausal symptoms. METHODS: KDS-Yin and KDS-Yang were traditionally defined by expert opinion were validated by exploratory factor analysis (EFA) and structural equation modeling (SEM). Content validity was tested by EFA on a sample of 236 women from a seminar and SEM on another sample of 321 women from a postal survey. Other psychometric properties were tested on 292 women from the seminar at baseline and two systematically selected sub-samples: 54 who reported no changes in discomforts 11-12 days after the baseline and 31 who reported changes in discomforts 67-74 days after the baseline. All participants completed the KDSQ, the Greene Climacteric Scale and the standard 12-item Short Form Health Survey. RESULTS: The EFA and SEM established the measurement models of KDS-Yin and KDS-Yang supporting content validity of the KDSQ. Internal consistency was good (Cronbach's Alpha >0.70). Construct validity was supported by theoretically-derived levels of correlation with the established external measures. Test-retest reliability was strong (ICC(agreement): KDS-Yin, 0.94; KDS-Yang, 0.93). The KDSQ was responsive to changes over time as tested by effect size and longitudinal validity. CONCLUSIONS: The KDSQ was a valid and reliable measure for KDS-Yin and KDS-Yang in Hong Kong Chinese middle-aged women with menopausal symptoms.

[Correlation between essential elements of Chinese medicine syndrome and the lung function in patients with acute aggravating chronic obstructive pulmonary disease].

OBJECTIVE: To study the correlation between essential elements of Chinese medicine syndrome (EECMS) and the lung function in patients with acute aggravating chronic obstructive pulmonary disease (AACOPD). METHODS: Adopting clinical epidemiological method, the Chinese medicine syndrome of 199 AACOPD patients with various grades of the lung function was differentiated, and EECMS in them were picked up, summarized and analyzed statistically. RESULTS: Along with the deteriorating of the lung ventilation, the EECMS of disease-position was progressed correspondingly, i.e. in patients with lung function of grade I, disease was positioned mainly on Fei (88.89%); in patients of grade II, on Fei-Shen (25.97%), Fei-Pi (9.09%), and Fei-Gan (3.90%); in those of grade III, on Fei-Shen (51.32%), Fei-Pi (7.89%), Fei-Pi-Shen (19.74%), and Fei-Pi-Shen-Xin (2.63%); in those of grade IV: on Fei-Shen (56.76%), Fei-Pi-Shen (27.03%). The EECMS of disease-property was also progressed, that for excessive syndromes were disposed as: grade I - II, phlegm (23.76%); grade III: phlegm-heat (30.26%), phlegm-stasis (15.79%), and phlegm-retention (9.21%); grade IV: phlegm-stasis (24.32%), phlegm-heat-stasis (29.73%), phlegm-retention-stasis (2.70%); and for deficiency syndromes were arranged as qi-deficiency --> qi-yin deficiency --> qi-yang deficiency --> qi-yin-yang deficiency. CONCLUSION: The lung function could be taken as the objective and quantitative index for the progression of Chinese medicine syndromes in patients with AACOPD.

[Experimental study on Qi deficiency and blood stasis induced by muti-factor stimulation in rats].

OBJECTIVE: Animal model of Qi deficiency and blood stasis was established by muti-factor stimulation in rats. METHOD: Healthy SD rats were chronically stimulated randomly by muti-factor methods (chronic sleep deprivation and feed with moderately high lipid and sugar food). Then the indices of hemorheology, plasma total lipids, vasoactive molecules, blood pressure (BP) and ventricular pressure (VP) were measured. RESULT: The results as well as the analysis of etiology and pathology suggested that model rats could objectively reflect the clinical characteristics of Qi deficiency and blood stasis syndrome. Blood viscosity at low level, plasma content of angiotensin II (Ang II) and endothelin (ET) significantly increased in model rats, while BP and VP significantly decreased (P < 0.05). On the other hand, Buyang Huanwu decoction could lower down the level of AngII in serum and blood viscosity at low level in rats induced by some stimulus, whereas BP and VP elevated significantly (P < 0.05). CONCLUSION: Animal model of Qi deficiency and blood stasis induced by muti-factor stimulation including chronic sleep deprivation and feed with moderately high lipid and sugar food could facilitate further study on blood stasis syndrome and screening of Chinese herbal drugs in promoting blood circulation and removing blood stasis.

Effect of Yinian Jiangya Yin on primary hypertension in early stage--a clinical observation on 40 patients.

OBJECTIVE: To observe the effect of Yinian Jiangya Yin (Decoction for lowering blood pressure to prolong life) on patients with early hypertension and its mechanism on the function of vascular endotheliocytes. METHODS: The 79 patients with early primary hypertension belonging to the TCM syndrome of stagnation of phlegm and blood stasis in meridians and hyperactivity of the liver-yang were randomly divided into a treatment group of 40 patients treated with Yinian Jiangya Yin and a control group of 39 patients treated with Tianma Gouteng Yin (Decoction of Gastrodia and Uncaria). The changes in score of TCM syndrome and in blood pressure before and after treatment were observed in the two groups. The contents of nitrogen monoxide (NO) and endothelin (ET) in serum after treatment were determined. RESULTS: There was a statistical difference (P < 0.05) in score of TCM syndrome, effect of lowering blood pressure, and the contents of ET and NO in serum after treatment between the two groups. CONCLUSION: The effect of Yinian Jiangya Yin on improving TCM syndrome of patients with primary hypertension in early stage and on lowering blood pressure may be related to its regulating the imbalanced condition between ET and NO for restoring the function of endothelium-dependent vasodilation.

Changes in Heart Rate Variability in Patients with Spleen-Qi Deficiency Syndrome.

Many functional diseases are related to dysautonomia, and heart rate variability has been used to assess dysautonomia. However, heart rate variability has not been studied in Spleen-Qi deficiency syndrome (SQDS). Healthy volunteers (n = 37) and patients with SQDS (n = 67), recruited from the Clinic of the State University of Ecatepec Valley were included in the study. Outcome measures were average heart rate, standard deviation of the normal-to-normal heartbeat intervals, low frequency (LF), high frequency (HF) power, and the LF/HF ratio. Also, intestinal peristalsis, gastrointestinal symptoms (GSs), fatigue, and level of attention were measured. Standard deviation of the normal-to-normal heartbeat intervals (17 ± 2.3%) and HF (14 ± 3.1%) were lower in SQDS patients (17 ± 1.3%) than in healthy volunteers. SQDS patients had higher heart rate, LF power, LF/HF ratio, and fatigue scores (9.6 ± 1.12%, 16 ± 2.1%, 22 ± 3.8%, and 21 ± 4.1%). The fatigue correlated positively with the LF/HF ratio and negatively with HF power. The SQDS group had lower concentration performance (16.2 ± 1.9%) in the d2 test. The intestinal peristalsis showed a reduction (15 ± 1.3%) as compared with control. GS score and peristalsis correlated negatively with HF. Our results suggest that the pathology of SDQS could be associated with a low vagal tone which causes a decrease in peristalsis, increased fatigue, reduced attention, and appearance of GSs.

The distribution of Yin-Deficient symptoms and their relationship on survival rate in cancer patients with Yin-Deficiency.

Yin-Deficiency (YD), representing a status of the human body under lack of nutrition and fluid in traditional Chinese medicine, is commonly seen in late stage of cancer patients. It is not known whether the severity of YD related symptoms/signs can predict the survival rate of cancer patients. This study evaluated the distribution of Yin-deficiency symptoms/signs (YDS) in cancer patients with YD, and investigated whether the severity of YDS can predict the survival rate of cancer patients with YD. From 5 January 2007 to 5 May 2007, we selected 43 cancer patients with diagnosis of YD from hospitalized patients and outpatients. The severity of YD was evaluated by a questionnaire. We further estimated the cumulative probabilities of the survival rates over 4 months since the start of study by the Kaplan-Meier product-limit method, and compared the differences among groups with various severities in each symptom/sign with the use of the log-rank test. The results revealed that, the 3 most common YDS were sleeplessness with annoyance, less or non-coated tongue with or without redness and dry mouth. In the survival rate analysis, only 2 parameters, rapidly small pulse (p = 0.002) and less-or non-coated tongue with paleness (p = 0.017), were found to be related to the decrease of cancer patients with YD. This suggests that, both rapidly small pulse and less-or non-coated tongue without redness may be used as predictors for the estimation of survival rate in cancer patients with YD.

[Relationship between plasma protein expression profiles and states of Zang-Fu organs in patients with phlegm or blood stagnation syndromes due to hyperlipidemia and atherosclerosis].

OBJECTIVE: To investigate the relationship between the plasma biomarker proteins and the states of Zang-Fu organs in patients with phlegm or blood stagnation syndromes due to hyperlipidemia and atherosclerosis. METHODS: The states of Zang-Fu organs in 146 patients with hyperlipidemia and atherosclerosis were diagnosed by syndrome differentiation of traditional Chinese medicine. The plasma proteins from these patients were separated by two-dimensional polyacrylamide gel electrophoresis (2-DE). Differential protein profiling was established by Image Master 6.0 software, and the differential proteins were analyzed by quadrupole time of flight mass spectrometry (Q-TOF-MS). The association between the plasma biomarker proteins and the states of Zang-Fu organs was analyzed by graphical models. RESULTS: The biomarker proteins such as fibrinogen gamma chain, albumin and apolipoprotein AI (precursor) in discrimination of the patients with phlegm syndrome from phlegm accumulating with stagnation syndrome were correlated with the deficiency of kidney-qi, heart-qi and spleen-qi. Among the four biomarker proteins in discrimination of the patients with phlegm syndrome from blood stagnation syndrome, albumin, adrenomedullin binding protein (precursor) and haptoglobin (precursor) were correlated with the deficiency of kidney-qi and heart-qi, but complement component C4 was independent of the deficient Zang-Fu organs. The biomarker albumin was associated with the deficiency of kidney-qi, heart-qi and spleen-qi, and adrenomedullin binding protein (precursor) was correlated with the deficiency of spleen-qi in discrimination of the patients with blood stagnation syndrome from phlegm accumulating with stagnation syndrome. As the potential biomarker proteins in discrimination of the patients with non-phlegm and non-stagnation syndrome from phlegm accumulating with stagnation syndrome, the fibrinogen beta chain was related with the deficiency of kidney-qi, and apolipoprotein AI (precursor) was correlated with both the deficiency of kidney-qi and heart-qi. CONCLUSION: There exists inherent correlation between the states of Zang-Fu organs and the plasma probable biomarker proteins in the patients with different phlegm or blood stagnation syndromes due to hyperlipidemia and atherosclerosis.

Development and validation of Yin-Deficiency Questionnaire.

This study describes development and validation of a questionnaire as an adjunct to Traditional Chinese Medicine diagnosis of Yin-Deficiency Syndrome (Yin-DS). The Yin-Deficiency Questionnaire 1 (Yin-DQ1) consists of 10 items. Seventy-nine healthy volunteers and 44 patients diagnosed with Yin-DS were enrolled for the evaluation of discriminant validity and factorial validity. Another group of 83 healthy volunteers participated for test-retest reliability test. Internal consistency was high in both groups (Cronbach's alpha = 0.8615). Test-retest reliability (Spearman's rank correlation coefficient) ranged from 0.54 to 0.79 (p < 0.01). Factor analysis demonstrated that a two factor solution best explained the variance in responses (51.62%). The scores of all items in patients diagnosed with Yin-DS were significantly higher compared with those of healthy volunteers. The data show the internal consistency, test-retest reliability and strong discriminative properties of the Yin-DQ1. Further research determining the optimal cut-off score for Yin-DS and testing its usage as an outcome measure in a clinical trial is needed.

[Observation on effects of Zhiling Capsule in treating 400 patients with various types of cancer in mid-ad-vanced stage].

OBJECTIVE: To observe the efficacy of Zhiling Capsule (ZLC) in improving symptoms and quality of life (QOL) in patients with various types of cancer in mid-advanced stage. METHODS: A multi-centre randomized and controlled trial was conducted. Four hundred patients with mid-advanced cancer were assigned to two groups: the treatment group (300 cases) treated with ZLC and the control group (100 cases) with Pingxiao Capsule (PXC), both were given orally for two weeks. Clinical symptoms, QOL, weight and adverse reactions were observed before and after treatment. RESULTS: Improving rate of symptom, increasing rates of QOL and weight in the treatment group were all higher than those in the control group (P<0.05); and no obvious adverse reaction was observed in the two groups. CONCLUSION: ZLC could alleviate the qi-yin deficiency syndrome and pain syndrome and improve QOL in patients with various types of cancer in mid-advanced stage.

[Correlation of propagated sensation along meridian and TCM constitution].

OBJECTIVE: To explore the correlation between propagated sensation along meridian (PSM) and TCM constitution at different age stages. METHODS: According to age, 840 participants were divided into a youth group (326 cases), a middle aged group (243 cases) and an elderly group (271 cases). The TCM constitution of all the participants was evaluated, and the PSM test was performed. The distribution of TCM constitution, the occurring rate and transmission of PSM in each group were observed and compared; the correlation between PSM and the TCM constitution was preliminary investigated by Logistic regression analysis. RESULTS: The distribution of nine types of TCM constitution in three groups:the proportion of normal constitution and partial constitution were significantly different (all P<0.05); the occurring rate and transmission of PSM in three groups were not significantly different (all P>0.05); the proportion of occurring rate for nine types of TCM constitutions in the whole population, from high to low, presented special intrinsic quality, neutral quality, yin-deficiency quality, qi-deficiency quality, yang-deficiency quality, damp-heat quality, phlegm-dampness quality, qi-stagnation quality and blood-stasis quality; besides, the proportion of occurring rate for different TCM constitutions in the youth group, middle aged group and elderly group was similar to that of whole population. The Logistic regression analysis results indicated the neutral quality (P=0.025) and special intrinsic quality (P=0.018) were positively while blood-stasis quality (P=0.043) was negatively related with PSM in all subjects; the qi-deficiency quality (P=0.025), phlegm-dampness quality (P=0.019), blood-stasis quality (P=0.012) and qi-stagnation quality (P=0.035) were negatively related with PSM in youth group; the neutral quality (P=0.001) was positively related with PSM inthe middle aged group; the neutral quality (P=0.006) and yin deficiency quality (P=0.004) were positively related with PSM in the elderly group. CONCLUSIONS: The occurrence of PSM in different age stages is related with TCM constitution, which could be increased in clinical treatment to improve acupuncture efficacy.

[Characteristics of Deqi Induced by Needling Zusanli (ST 36) in 527 Healthy Volunteers with Different Constitutions].

OBJECTIVE: To explore the relationship between the theory of constitution in terms of Chinese medicine and clinical efficacy of acupuncture treatment via analyzling the characteristics of Deqi during acupuncture stimulation of Zusanli (ST 36) in healthy volunteers with different constitutions. METHODS: In the present study, a total of 527 healthy undergraduate student volunteers (267 girls and 260 boys) were recruited. They received questionnaire first about their constitutions in accordance with Professor WANG Qi's Classification and Determination of Constitution in terms of Chinese medicine. Then, the subjects were asked to take a supine position on a check-bed, a qualified acupuncturist held a sterilized fifiform needle to rapidly insert it into ST 36 and manipulated the acupuncture needle with uniform reinforcing-reducing technique at a frequency of about 60-90 times/min and an amplitude of 0.3-0.5 cm. The status of Deqi was assessed by using visual analogue scale (VAS). RESULTS: Needling sensations mainly involve soreness, numbness, heaviness, distension, dull pain and propagated sensations along meridian (PSC). During acupuncture stimulation, most subjects experienced distension sensation, accounting for 90.3%, followed by soreness, accounting for 45.9%. Except for PSC reaction, the rest 5 needling sensations had no statistical difference in their occurrence rates in those subjects with different constitutions (P>0.05). The PSC appeared a higher incidence in yin-yang harmony(balanced) constitution subjects than in qi- deficiency, yang-deficiency, blood-stagnation and qi-stagnation constitution subjects (P<0.05). The intensity of soreness was obviously stronger in the balanced constitution subjects than in qi-deficiency, yang-deficiency, yin-deficiency, phlegm-damp, damp-heat and qi-stagnation constitution subjects (P<0.05), while the intensity of distension sensation was apparently stronger in the balanced constitution subjects than in simpleyang-deficiency subjects (P<0.05). CONCLUSIONS: Except for PSC, the Deqi sensations of soreness, numbness, heaviness, distension and dull pain induced by acupuncture stimulation of ST 36 are comparable in the occurrence rates in healthy volunteer subjectswith different (9 types of) constitutions in terms of Chinese medicine, whereas the intensity of soreness may be the important factor for acupuncture induced pain relief. A certain correlation between the constitution and acupuncture effectiveness exists, suggesting that acupuncture treatment should vary from patient to patientin clinical practice.

[Clinical efficacy on xerosis conjunctivitis of liver and kidney yin deficiency treated with SHI's acupuncture manipulation].

OBJECTIVE: To compare the efficacy of the patients of xerosis conjunctivitis with liver and kidney yin deficiency among the combined therapy of acupuncture and Shi's manipulation, common acupuncture and artificial tears therapy. METHODS: One hundred and eight patients were randomized into an acupuncture group, a SHI's manipulation group and an artificial tears group, 36 cases in each group. A total of 15 cases dropped out before the end of the study, including 4 cases in the acupuncture group, 6 cases in the SHI's manipulation group, and 5 cases in the artificial tears group. In the acupuncture group, acupuncture was applied to Jingming (BL 1) and Qiuhou (EX-HN 7) on the affected side, and the bilateral Sanyinjiao (SP 6) and Taixi (KI 3). The needles were retained for 20 min. In the SHI's manipulation group, on the basis of the treatment as the acupuncture group, Shuigou (GV26) was added and stimulated with SHI's acupuncture manipulation. In these two groups, acupuncture was given 3 times a week totally for 3 weeks. In the artificial tears group, sodium hyaluronate eye drops were used, 5 times a day, for 3 weeks totally. Separately, before treatment, at the moment after the 1st treatment and 3 weeks after treatment, the subjective symptom score, Schirmer I test, breakup time (BUT) of tear film were observed in each group. RESULTS: (1) Subjective symptom score: at the moment after the 1st treatment and 3 weeks after treatment, the scores in each group were all reduced significantly as compared with those before treatment (all P < 0.05). At the moment after the 1st treatment, the score in the SHI's manipulation group and the artificial tears group was reduced apparently as compared with that in the acupuncture group (both P < 0.05). In 3 weeks of treatment, the score in the SHI's manipulation group was reduced apparently as compared with the acupuncture group and the artificial tears group (both P < 0.05). (2) For Schirmer I test, at the moment of the 1st treatment, the result in the SHI's manipulation group and the artificial tears group was improved significantly as compared with that before treatment (both P < 0.05). In 3 weeks of treatment, the result in the acupuncture group and the SHI's manipulation group group was improved significantly as compared with that before treatment (both P < 0.05). At the moment of the 1st treatment, the result in the artificial tears group was improved significantly as compared with the acupuncture group and the SHI's manipulation group (both P < 0.05). In 3 weeks of treatment, the result in the acupuncture group and the SHI's manipulation group was better than that in the artifi-cial tears group separately (both P < 0.05). (3) For BUT, the result in the acupuncture group and the SHI's manipulation group was prolonged significantly as compared with that before treatment and was prolonged apparently as compared with that in the artificial tears group (both P < 0.05) in 3 weeks of treatment. CONCLUSION: The intervention of SHI's acupuncture manipulation relieves the subjective symptoms of xerosis conjunctivitis of liver and kidney yin deficiency and achieves the same efficacy as the common acupuncture and artificial tears treatment. It does not present the apparent advantages as the common acupuncture in the short term for promoting the tear secretion and tears film repair.