The Association Between Traditional Chinese Medicine Body Constitution Deviation and Essential Hypertension: A Case-Control Study.

BACKGROUND: The prevention and treatment of hypertension is valued globally. The World Health Organization advocates combining traditional medicines in the prevention and treatment of diseases. Traditional Chinese medicine (TCM) assumes that diseases originate from the attenuation of one's body constitution. A few studies have found that hypertension is correlated with TCM body constitution. However, body constitution is also affected by living environment. Therefore, investigating the correlation between deviations in body constitution and essential hypertension in different living environments is necessary to provide the basis for using TCM in combination with conventional Western medicine to prevent and treat hypertension. PURPOSE: The aim of this study was to explore the association between TCM body constitution deviation and essential hypertension. METHODS: A case-control study was designed. Participants were selected from the outpatient clinics and neighboring communities of a regional teaching hospital in southern Taiwan. The study included 210 hypertension and 210 nonhypertension cases. Blood pressures were measured using an electronic sphygmomanometer to confirm the presence or absence of hypertension. The TCM Body Constitution Questionnaire, demographic datasheet, and hypertension-related factors questionnaire were used to collect data. RESULTS: A higher proportion of patients with body constitution deviation were found in the hypertension group than the nonhypertension group. The proportions of patients with Yin-Xu, Yang-Xu, and stasis constitution were 44.8%, 32.4%, and 30.6%, respectively, in the hypertension group and 28.6%, 25.2%, and 19.6%, respectively, in the nonhypertension group. After performing univariate analysis, the results showed significant differences between the two groups in terms of average body mass index; emotional traits of anger, worry, and fear; hyperlipidemia; hyperuricemia; Yin-Xu constitution; and stasis constitution. However, the multivariate analysis revealed having a Yin-Xu constitution to be a risk factor of essential hypertension after adjusting for age, gender, body mass index, emotional traits, drinking habit, hyperlipidemia, and hyperuricemia. CONCLUSIONS/IMPLICATIONS FOR PRACTICE: The results suggest that Yin-Xu and stasis constitutions are respectively associated with essential hypertension. The findings offer a valuable reference to governments and healthcare professionals to prevent the risk of essential hypertension. Screening and healthcare measures for TCM Yin-Xu or stasis constitution may be included in related prevention plans to minimize public exposure to the risk factors of essential hypertension.

The Relationship between Stasis-Stagnation Constitution and Peripheral Arterial Disease in Patients with Type 2 Diabetes.

Objectives. In traditional Chinese medicine, Yu-Zhi (YZ, indicating stasis and stagnation) constitution describes a body that tends to express abnormal circulatory conditions. This study identified the linkage between YZ constitution and peripheral arterial disease (PAD) in patients with type 2 diabetes. Methods. Patients over 20 years of age who had had type 2 diabetes for 5 years or longer were recruited. PAD was diagnosed if the ankle-brachial index score was ≤0.9 in either leg. Level of YZ constitution was accessed by an YZ Constitution Questionnaire. Results. A total of 712 patients (354 men and 358 women) with a mean age of 61.5 ± 10.6 years and diabetes duration of 13.1 ± 6.7 years were recruited. The prevalence of PAD among our patients was 7.2%. Multivariate logistic regression revealed significant correlations between PAD and, respectively, YZ score, age, diabetes duration, current smoking, and hs-CRP. Conclusion. In addition to traditional risk factors, YZ constitution was statistically associated with PAD in patients with type 2 diabetes. This result invites further research into the effectiveness of traditional Chinese medicine to treat YZ constitution.

BCQ-: a body constitution questionnaire to assess Yin-Xu. Part I: establishment of a provisional version through a Delphi process.

BACKGROUND: Nowadays, the individual differences are emphasized in personalized medicine. Traditional Chinese Medicine (TCM) which prescribes tailored treatment based on each patient's different body constitution may provide new strategy to break the bottleneck of modern medicine (MM). Therefore, to integrate TCM into MM, an objective, reliable and rigorous diagnostic tool is necessary for the assessment of TCM constitution of each individual. This study aimed to develop a provisional version of the Yin-Xu Constitution Questionnaire (BCQ-), because evaluating the level of individual's Yin deficiency (Yin-Xu) by his manifestations is frequently involved in TCM clinical trials. METHODS: The provisional version of BCQ- was developed using a step-by-step approach: 1) to form the research team and select a panel of 26 experts who had both MM and TCM educational background and professional training for Delphi method; 2) to generate questionnaire items from literature review and Delphi process, refine these items to be colloquially acceptable, and evaluate their face and content validities by Delphi process again; 3) to evaluate the difficulty of answering these questions by a pilot study with 81 participants whose age ranged from 20 to 60 years. RESULTS: After 2 rounds of Delphi process, 22 colloquially appropriate questions were established and answered without difficulty by the 81 participants. CONCLUSIONS: This provisional version of BCQ- appeared to have considerable face and content validities and may be the basis to develop an advanced Yin-Xu questionnaire. The reliability and validity of BCQ- were further tested in the second part of the study.

Traditional Chinese Medicine ZHENG Identification Provides a Novel Stratification Approach in Patients with Allergic Rhinitis.

Background. We aimed to apply the ZHENG identification to provide an easy and useful tool to stratify the patients with allergic rhinitis (AR) through exploring the correlation between the quantified scores of AR symptoms and the TCM ZHENGs. Methods. A total of 114 AR patients were enrolled in this observational study. All participants received the examinations of anterior rhinoscopy and acoustic rhinometry. Their blood samples were collected for measurement of total serum immunoglobulin E (IgE), blood eosinophil count (Eos), and serum eosinophil cationic protein (ECP). They also received two questionnaire to assess the severity scores of AR symptoms and quantified TCM ZHENG scores. Multiple linear regression analysis was used to determine explanatory factors for the score of AR manifestations. Results. IgE and ECP level, duration of AR, the 2 derived TCMZHENG scores of "Yin-Xu - Yang-Xu", and "Qi-Xu + Blood-Xu" were 5 explanatory variables to predict the severity scores of AR symptoms. The patients who had higher scores of "Yin-Xu - Yang-Xu" or "Qi-Xu + Blood-Xu" tended to manifest as "sneezer and runner" or "blockers," respectively. Conclusions. The TCM ZHENG scores correlated with the severity scores of AR symptoms and provided an easy and useful tool to stratify the AR patients.

Comparison of a Chinese Herbal Medicine (CCH1) and Lactulose as First-Line Treatment of Constipation in Long-Term Care: A Randomized, Double-Blind, Double-Dummy, and Placebo-Controlled Trial.

Many institutionalized patients and their healthcare providers are dissatisfied with current laxative therapy. This study compared therapeutic efficacy, safety, and laxative cost of an herbal formula (CCH1) and lactulose for long stay patients with constipation. In this double-blind, double-dummy, and placebo-controlled trial, we randomized 93 residents with chronic constipation from two long-term care facilities in Taiwan to receive either CCH1 with lactulose placebo or CCH1 placebo with lactulose for 8 weeks, then followed up for 4 weeks without study medication. Both treatments were effective and well tolerated for patients, but CCH1 produced more spontaneous bowel movements, less rectal treatments, less amount of rescue laxative, and lower laxative cost than lactulose during treatment. No significant differences were found in stool consistency, stool amount, global assessment, and safety concerns. In conclusion, our results suggest that CCH1 may have better efficacy and could be used as an alternative option to lactulose in the treatment of constipation in long-term care.

BCQ-: A Body Constitution Questionnaire to assess Yin-Xu. Part II: evaluation of reliability and validity.

BACKGROUND: Based on the Traditional Chinese Medicine (TCM) theory and guided by the principles of modern medicine (MM), we aimed to develop an effective and reliable diagnostic tool using self-reported data in order to assess the Yin-Xu body constitution. In this study, we further evaluated a provisional 22-item version of the Yin-Xu Body Constitution Questionnaire (BCQ-) previously derived from the Delphi process. METHODS: A total of 1,272 eligible participants aged between 20 and 60 years was recruited. The participants had received health examination in teaching hospitals and had not shown any disease onset in the prior month. The factor structure of the BCQ- was explored, and the reliability and validity of each derived factor (scale) were evaluated. RESULTS: Exploratory factor analysis revealed 5 factors corresponding to the manifestations of the diminishing Yin-Xu level in 5 different body areas: head, 4 limbs, gastrointestinal tract, body surface, and abdominal cavity. 3 items with low factor loading (<0.4) were dropped, resulting in a 19-item BCQ-. Cronbach's α ranged from 0.57 to 0.85, and the intra-class correlation coefficients were greater than 0.7 for most items. The diagnoses of Yin-Xu by both the BCQ- and experienced TCM doctors were consistent. The concurrent validity showed that higher Yin-Xu scores were associated with lower hemoglobin. CONCLUSIONS: The final BCQ- measures the Yin-Xu constitution of 5 different body areas. The questionnaire is a reliable, valid, and potentially useful instrument for evaluating the Yin-Xu constitution in clinical research and practice.

Treatment of constipation in long-term care with Chinese herbal formula: a randomized, double-blind placebo-controlled trial.

OBJECTIVES: This study is aimed to evaluate the therapeutic efficacy and safety of CCH1, modified from an ancient herbal formula in Traditional Chinese Medicine, for the residents with constipation in long-term care. METHODS: In this randomized, double-blind, placebo-controlled trial, 90 residents from three long-term care units were randomized to 8 weeks of treatment with CCH1 or placebo and then the subjects were followed up for an additional 4 weeks. RESULTS: The mean numbers of weekly spontaneous bowel movement in the CCH1 group were greater than in the placebo group during the treatment phase of 8 weeks (p < 0.05); the greatest difference was during weeks 1-4 (6.2 ± 2.2 versus 3.4 ± 2.1, p < 0.001). Smaller mean numbers of weekly rectal treatments were observed with CCH1 compared with placebo during weeks 1-8 (p < 0.05). The mean numbers of weekly rescue laxative tablets of magnesium oxide were significantly less in the CCH1 group than in the placebo group during the entire 12-week period (p < 0.01), with the greatest difference during weeks 5-8 (14.4 ± 16.3 versus 33.4 ± 23.5, p < 0.001). No significant safety concerns were noted. CONCLUSIONS: The six-herb formula (CCH1), compared with placebo, is effective on the treatment of constipation in long-term care. However, its maintenance effect needs further trial. Comparison of efficacy or cost-effectiveness with current laxatives is encouraged.

Postoperative care with Chinese herbal medicine or amoxicillin after functional endoscopic sinus surgery: a randomized, double-blind, placebo-controlled study.

BACKGROUND: A number of herbal preparations have been reported being used as adjunctive treatment of patients with chronic rhinosinusitis (CRS) after functional endoscopic sinus surgery (FESS). This study was designed to examine the efficacy of Chinese herbal medicine (CHM) in the postoperative care of post-FESS patients. METHODS: Patients with CRS who underwent FESS were prospectively enrolled in the study. Before surgery, they were evaluated by various methods, including the Chinese version of the Rhinosinusitis Outcome Measure (CRSOM-31), nasal endoscopy, acoustic rhinometry, and computed tomography (CT). After surgery, they were randomized to take CHM (Tsang-Erh-San extract granules and Houttuynia extract powder) for 8 weeks, amoxicillin for 4 weeks, or placebo. They were revaluated by CRSOM-31, nasal endoscopy, and acoustic rhinometry at 8 weeks and by CT at 12 weeks after surgery. RESULTS: Ninety-seven patients (33 in the CHM group, 34 in the amoxicillin group, and 30 in the placebo group) completed the study. In the CHM group, CRSOM-31 and endoscopic scores significantly decreased, and the second minimal cross-sectional area of the nasal cavity measured by acoustic rhinometry significantly increased after treatment. In the amoxicillin and placebo groups, CRSOM-31, endoscopic, and CT scores significantly decreased after treatment. However, there were no significant differences in subjective and objective treatment outcomes among three groups of patients. CONCLUSION: Our results showed there was no significant benefit of using CHMs (Tsang-Erh-San extract granules and Houttuynia extract powder) or oral amoxicillin in post-FESS care of CRS patients. Additional investigation is necessary for post-FESS care.

BCQ+: a body constitution questionnaire to assess Yang-Xu. Part II: Evaluation of reliability and validity.

INTRODUCTION: Integrated medicine has become an important issue in this century. In order to bridge the gap between traditional Chinese medicine (TCM) and modern medicine, we have established a first final version of a Yang-Xu constitution questionnaire, the BCQ+, in a previous study. The objective of the present investigation is to assess the reliability and validity of the BCQ+. PARTICIPANTS AND METHODS: A total of 1,310 eligible participants, aged between 20-60, no disease onset in the past month, who received health examination in teaching hospitals were recruited. The BCQ+ was developed and psychometrically evaluated to ascertain and validate the factor structure of the BCQ+. Furthermore, the reliability and validity of the BCQ+ were examined. RESULTS: 19 items from the BCQ+ were developed. Exploratory factor analysis identified 5 primary domains that represent the Yang-Xu constitution and correspond to the diminishing energy levels of 5 different body areas: head, chest, limbs, abdominal cavity, and body surface. Cronbach's alpha ranged between 0.55-0.88 and the intraclass correlation coefficients were >0.7 for most of the 19 questions. The diagnoses of Yang-Xu by the BCQ+ and an experienced TCM doctor were consistent. Systolic blood pressure (SBP) was used as an indicator of concurrent validity of the BCQ+, and it was found that higher Yang-Xu scores were associated with a lower SBP. CONCLUSIONS: Five domains with 19 items in the BCQ+ were developed. The BCQ+ is a valid and potentially useful tool for evaluating the Yang-Xu constitution in clinical practice and research.

Pulse spectrum analysis, a faster and easier way to predict outcome of sepsis?

In order to provide a faster and easier way for outcome prediction of sepsis, this study aimed to characterize the pattern of arterial pulse spectrum by a rat cecum ligation and puncture (CLP) model and explore whether specific harmonic components of pulse spectrum are associated with the mortality of CLP rats, followed by the comparison of accuracy between these specific variables and IL-6. Nineteen Sprague-Dawley rats receiving CLP were analyzed. Femoral artery of each rat was catheterized for blood pressure recording and blood sampling in the first 24 hours after CLP. The former was for off-line pulse spectrum analysis, and the latter for IL-6 assay. These rats were observed for 3-day mortality after CLP, and were divided into survivor or non-survivor groups. Differences of the hemodynamic profile, IL-6, and changes of the harmonics between the 2 groups were analyzed by using the Mann-Whitney test. Kaplan-Meier curves were constructed to characterize cumulative survival with the best prognostic cutoff point. The characteristic changes of pulse spectrum were different between survivors and non-survivors. The percentage differences of the 2nd harmonic proportion (C2) increased significantly from the 10th hour after CLP, and was higher in the non-survivors. Serum levels of IL-6 were also higher in the non-survivor group. Analyzed by Kaplan-Meier survival curve for 3-day mortality, C2 had a higher accuracy than IL-6 as a predictor. The pulse spectrum analysis may be applied to evaluate the prognosis of CLP rats, and the rapidly and highly elevated C2 harmonic had a strong association with the 3-day mortality of CLP rats.

BCQ+: a body constitution questionnaire to assess Yang-Xu. Part I: establishment of a first final version through a Delphi process.

INTRODUCTION: Assessing an individual's level of Yang deficiency (Yang-Xu) by its manifestations is a frequent issue in traditional Chinese medicine (TCM) clinical trials. To this end, an objective, reliable and rigorous diagnostic tool is required. This study aimed to develop a first final version of the Yang-Xu Constitution Questionnaire. METHODS: We conducted 3 steps to develop such an objective measurement tool: 1) the research team was formed and a panel of 26 experts was selected for the Delphi process; 2) items for the questionnaire were generated by literature review and a Delphi process; items were reworded into colloquial questions; face and content validity of the items were evaluated through a Delphi process again; 3) the difficulty of the questionnaire was evaluated in a pilot study with 81 subjects aged 20-60 years. RESULTS: The literature review retrieved 35 relevant items which matched the definition of 'constitution' and 'Yang-Xu'. After a first Delphi process, 22 items were retained and translated into colloquial questions. According to the second part of the Delphi process, the content validity index of each of the 22 questions ranged between 0.85-1. These 22 questions were evaluated by 81 subjects, 2 questions that were hard to tell the difference were combined; 3 questions were modified after the research team had discussed the participants' feedback. Finally, the questionnaire was established with 21 questions. CONCLUSIONS: This first final version of a questionnaire to assess Yang-Xu constitution with considerable face and content validity may serve as a basis to develop an advanced Yang-Xu questionnaire.

A new noninvasive approach to detect the artery's pulsating properties via tissue control method.

This paper presents a new approach, named as Tissue Control Method, to obtain the pulsating properties for artery. These properties are the variations of blood vessel diameter, instantaneous intra-arterial blood pressure, and the dynamic impedances of blood vessel. By maintaining the stiffness of tissue and tracking the variations of blood pressure at a critical location, it decouples the effect of the arterial pulsation from the tissue and measures the variations of the blood vessel diameter. Then employ the identification technique to obtain the mechanical impedances of the arterial blood vessel, and subsequently estimate the instantaneous blood pressure in the artery. The results of animal experiments show that the Tissue Control Method is feasible to detect the pulsating properties of the artery.

On measuring the instantaneous blood pressure in an artery via the tissue control method.

This paper presents a non-invasive approach to measuring the instantaneous arterial blood pressure based upon the tissue control method. According to animal experiments, there exists a pressed location where the mean blood pressure in the artery is equivalent to the mean pressure measured on the skin. At this location, the stiffness measured on the skin is equivalent to the stiffness of the tissue only. By means of the tissue control method, the pulsations of the artery are excluded from tissues. The displacement measured on the skin and the tracking pressure obtained from the controller identify the dynamical impedance of the blood vessel, and then estimate the instantaneous intra-arterial blood pressure. The experimental results show that errors of mean blood pressure, systolic blood pressure and diastolic blood pressure are less than 4%, and indicate that the tissue control method is a feasible way to detect the instantaneous arterial blood pressure.

Zhi-fuzi, a cardiotonic Chinese herb, a new medical treatment choice for portal hypertension?

Zhi-Fuzi (Radix Aconiti lateralis preparata) is prescribed fairly frequently in Chinese medicine clinical practice for treating the complications of cirrhosis. However, scientific evidence regarding its efficacy and safety has not been available until now; in addition, its treatment efficacy has not yet been evaluated in well-designed clinical trials. Hence, we investigated the hemodynamic effects of Zhi-Fuzi in conscious rats with portal vein ligation (PVL) and the safety in normal rats. Our study included 3 parts: (i) early administration during which the hemodynamic effects of low and high doses of Zhi-Fuzi (0.4 and 0.8 g/kg twice daily) and propranolol (15 and 30 mg/kg twice daily) administered for 14 days after PVL on male Sprague-Dawley rats were evaluated; (ii) late administration during which the other group of PVL rats received 2.4 g/kg of Zhi-Fuzi twice daily from the 15th to 28th postoperative day; hemodynamic effects were measured when the Zhi-Fuzi treatment was finished; and (iii) safety evaluation during which 2 groups of normal rats were administered Zhi-Fuzi (0.4 and 0.8 g/kg twice daily) for 14 days; biochemical and histopathologic studies were completed after hemodynamic measurement. In early administration the portal pressures in rats receiving low and high doses of Zhi-Fuzi, low and high doses of propranolol, and distilled water were 13.81 +/- 0.11, 11.59 +/- 0.07, 17.09 +/- 0.06, 14.52 +/- 0.29, and 20.11 +/- 0.22 mm Hg, respectively. The high dose of Zhi-Fuzi exerted more portal hypotensive effects than propranolol and simultaneously ameliorated the systemic arterial hypotension in PVL rats. The late administration of Zhi-Fuzi also significantly reduced the elevated portal pressure (14.56 +/- 0.19 vs. 19.50 +/- 0.31 mm Hg in control, P < 0.05). There were no adverse effects seen in normal rats receiving Zhi-Fuzi. The results suggest that Zhi-Fuzi is a potential drug for the prophylaxis and treatment of portal hypertension.

Different patterns of pulse spectrum between survivors and non-survivors during progressive hemorrhage in rats.

Previous work from our laboratory has demonstrated that the percentage differences of 2nd (C2) and 3rd (C3) pulse harmonics related to Kidney and Spleen were both increased toward another steady state in rats after acute hemorrhage. Therefore, it is suggested that changes in pulse spectra might represent the ability of animals to survive a model of progressive hemorrhage. In this study, the difference of the pulse spectra patterns between survivors and non-survivors after progressive hemorrhage (by loss of 5%, 10% or 20% of the estimated blood volume) in anesthetized rats is determined. Seven rats, dead within 2 hours after a loss of 20% of the estimated blood volume hemorrhage, were defined as 'non-survivors'. The other eleven rats, more than 2 hours after hemorrhage, were defined as 'survivors'. Pulse waves of arterial blood pressure before and after the hemorrhage were measured in parallel to the pulse spectrum analysis. Data among different phases were analyzed using one-way analysis of variance (ANOVA) with Duncan's test for pairwise comparisons. Differences between survivor and non-survivor groups at each phase were analyzed using Student's t-test. A mixed-effects linear regression model was applied to evaluate the relationship in harmonics, which significantly differed between the two groups. The study results showed that in rats, during progressive hemorrhage, the percentage differences of 2nd harmonic proportion increased significantly; however, the result failed to show any significant difference between survivors and non-survivors. After the third blood withdrawal process, the percentage differences of 3rd harmonic proportion increased more significantly in the survivors. In addition, the percentage differences of 1st harmonic proportion related to the Liver for the survivor group was significantly lower than that of the non-survivors. After analysis with the mixed linear regression model, C3 and C1 demonstrated a linear regression relationship, and there existed significant differences between survivors and non-survivors. These results suggest that C3 might play an important role in physiology regarding surviving capability after progressive hemorrhage.