Traditional Chinese medicine versus western medicine as used in China in the management of rheumatoid arthritis: a randomized, single-blind, 24-week study.

This study is designed to compare the efficacy and safety of traditional Chinese medicine (TCM) with western medicine (WM) in the management of rheumatoid arthritis (RA). This is a 24-week, randomized, multicenter, single-blind study comparing TCM with WM (as used in China) carried out between June 2002 and December 2004 in nine research centers in China, involving 489 patients. Patients were randomized to receive TCM (n = 247), MTX and SSZ (n = 242). MTX was started at a dose of 5 mg to a final dose of 7.5-15 mg weekly. The maintenance dose was 2.5-7.5 mg weekly. The starting dose of SSZ was 0.25 g bid, increasing by 0.25 g a day once a week to a final dose of 0.5-1 g qid. The maintenance dose was 0.5 g tid to qid. Primary end point was the proportion of patients with response according to the American College of Rheumatology 20 % improvement criteria (ACR20) at weeks 24. At 24 weeks, ACR20 responses were 53.0 % in TCM group and 66.5 % in WM group, (P < 0.001) at 24 weeks. ACR 50 responses were 31.6 % of TCM group and 42.6 % in WM group, (P = 0.01). ACR70 responses were 12.6 % in TCM group and 17.4 % in WM group, (P = 0.14). Side effects were observed more frequently in WM group. In this study, ACR20, ACR50 responses at 24 weeks were significantly better in the WM treated group, by intention to treat (ITT) and per protocol analysis. The ACR 70 response showed no significant difference between the two groups. TCM, while effective in treating RA, appears to be less effective than WM in controlling symptoms, but TCM is associated with fewer side effects.

Efficacy of Wuda Granule on Recovery of Gastrointestinal Function after Laparoscopic Bowel Resection: A Randomized Double-Blind Controlled Trial.

OBJECTIVE: To evaluate the efficacy and safety of Wuda Granule (WDG) on recovery of gastrointestinal function after laparoscopic bowel resection in the setting of enhanced recovery after surgery (ERAS)-based perioperative care. METHODS: A total of 108 patients aged 18 years or older undergoing laparoscopic bowel resection with a surgical duration of 2 to 4.5 h were randomly assigned (1:1) to receive either WDG or placebo (10 g/bag) twice a day from postoperative days 1-3, combining with ERAS-based perioperative care. The primary outcome was time to first defecation. Secondary outcomes were time to first flatus, time to first tolerance of liquid or semi-liquid food, gastrointestinal-related symptoms and length of stay. Subgroup analysis of the primary outcome according to sex, age, tumor site, surgical time, histories of underlying disease or history of abdominal surgery was undertaken. Adverse events were observed and recorded. RESULTS: A total of 107 patients [53 in the WDG group and 54 in the placebo group; 61.7 ± 12.1 years; 50 males (46.7%)] were included in the intention-to-treat analysis. The patients in the WDG group had a significantly shorter time to first defecation and flatus [between-group difference -11.01 h (95% CI -20.75 to -1.28 h), P=0.012 for defecation; -5.41 h (-11.10 to 0.27 h), P=0.040 for flatus] than the placebo group. Moreover, the extent of improvement in postoperative gastrointestinal-related symptoms in the WDG group was significantly better than that in the placebo group (P<0.05). Subgroup analyses revealed that the benefits of WDG were significantly superior in patients who were male, or under 60 years old, or surgical time less than 3 h, or having no history of basic disease or no history of abdominal surgery. There were no serious adverse events. CONCLUSION: The addition of WDG to an ERAS postoperative care may be a viable strategy to enhance gastrointestinal function recovery after laparoscopic bowel resection surgery. (Registry No. ChiCTR2100046242).

[The development of quality of life questionnaire of Chinese medicine for postoperative patients with colorectal cancer and item screening].

OBJECTIVE: To develop quality of life questionnaire of Chinese medicine for postoperative patients with colorectal cancer (QLQ-CMPPCC), thus comprehensively and objectively evaluating the clinical efficacy of Chinese medicine and pharmacy in treating postoperative patients with colorectal cancer (CC). METHODS: The theoretical structure model of the questionnaire was addressed in combined with basic theories of Chinese medicine according to the principle of WHO quality of life (QOL). The primary questionnaire was developed using methods of structuralization policy making after we extensively retrieve various universal and specific questionnaires for CC cancer patients at home and abroad. The 205 CC patients were tested by questionnaire. The items were screened using experts grading method, item selection analysis, dispersion trends of standard deviation, t-test, correlation coefficient method, factor analysis,and Cronbach's alpha. RESULTS: The QLQ-CMPPCC was developed containing four domains of physical, psychological, independence, and social functions, involving 20 aspects and 54 items. Of them, non-fistula patients answered 43 items and fistula patients answered 46 items. One item covered the general QOL evaluation. CONCLUSIONS: QLQ-CMPPCC showed Chinese medical features. It comprehensively reflected the connotation of QOL for postoperative CC patients. It could be taken as a tool for evaluating Chinese medical efficacy for postoperative CC patients.

[Distribution of Chinese medicine syndrome patterns and its laws in patients with polycystic ovarian syndrome].

OBJECTIVE: To study the distribution laws of the Chinese medicine syndrome patterns and its correlated symptoms in patients with polycystic ovarian syndrome (PCOS), and the possible correlation between Chinese medicine syndrome patterns and PCOS associated parameters, thus to provide a guidance for selecting proper indices in curative effectiveness assessment. METHODS: Using clinical epidemiological methods and mathematical statistics, the Chinese medicine syndrome patterns were studied in 228 PCOS patients. The distribution features of Chinese medicine syndrome patterns were summarized. RESULTS: Shen-deficiency blood-stasis syndrome was the most frequently seen in PCOS patients, followed by Pi-deficiency phlegm-dampness syndrome, Pi-Shen yang-deficiency syndrome, and Shen-yin deficiency syndrome. Positive correlation existed between serum levels of follicle stimulating hormone (FSH) and Pi-Shen yang-deficiency syndrome. Positive correlation existed between fasting blood sugar (FBS), waist to hip ratio (WHR), body mass index (BMI), fasting insulin (FIN), and Hirsutism score and Pi-deficiency phlegm-dampness syndrome. Positive correlation existed between serum levels of prolactin (PRL), estradiol (E2 ) and qi stagnancy and blood stasis syndrome. Positive correlation existed between serum progesterone (PRG) level, FSH, FIN, BMI, acne score and Gan stagnancy and blood heat syndrome. Positive correlation existed between luteinizing hormone (LH) and Shen-deficiency blood-stasis syndrome. Besides, LH/FSH >3 was possibly more frequently seen in Pi-deficiency phlegm-dampness syndrome and Pi-Shen yang-deficiency syndrome. Family heritability could be seen in each syndrome patterns. Among them, female heritability was more often seen in Shen-deficiency blood-stasis syndrome, while male heritability was more often seen in Shen-yin deficiency syndrome. CONCLUSIONS: Shen-deficiency blood-stasis syndrome, Pi-deficiency phlegm-dampness syndrome, Pi-Shen yang-deficiency syndrome, and Shen-yin deficiency syndrome were most frequently seen in PCOS patients. The sex hormones (including 6 items), FBS, FIN, WHR and BMI, etc. were correlated with each Chinese medicine syndrome pattern to various extents, which could be taken as reference in Chinese medicine syndrome differentiation.

[Culture and quality of life assessment in Chinese populations].

OBJECTIVE: To investigate the impact of cultural factors on quality of life (QOL) and to identify appropriate ways of dividing sub-populations for population norm-based quality of life assessment. METHODS: The WHOQOL-BREF was used as a QOL instrument. Another questionnaire was developed to assess cultural values. A cross-sectional survey was undertaken in 1090 Guangzhou residents, which included 635 respondents from communities and 455 patients who visited outpatient departments of hospitals. Cronbach's a coefficients and item-domain correlation coefficients were calculated to test the reliability and validity of the WHOQOL-BREF, respectively. Student t test, ANOVA and stepwise multiple linear regression analysis were performed to identify the variables that might have an impact on the QOL. Two regression models with and without including cultural variables were constructed, and the extent of impact exerted by the cultural factors was assessed through a comparison of the change of adjusted R square values. RESULTS: A total of 1052 (96%) valid questionnaire were returned. The Cronbach's alpha coefficients of the WHOQOL-BREF ranged from 0.67 to 0.78. Age, education, occupation and family income were correlated with all of the domains of the WHOQOL-BREF. Chronic condition was correlated with physical, psychological, and social relationship domains of the WHOQOL-BREF. Gender was correlated with physical and psychological domains of the WHOQOL-BREF. The multiple regression analysis showed that social and demographic factors contributed to 6.3%, 13.6%, 10.4% and 8.7% of the predicted variances for the physical, psychological, social relationship, and environment domains, respectively. Social support, horizontal collectivism, vertical individualism, escape acceptance, fear of death, health value, supernatural belief had a significant impact on QOL. However, social support was the only one factor that had an impact on all of the four QOL domains. CONCLUSION: It is necessary to divide sub-cultural populations for population norm-based QOL assessment. Further research is needed to develop a practical approach to the sub-cultural population division.

[A study of scale response for Health Scale of Traditional Chinese Medicine].

OBJECTIVE: To select appropriate descriptors for responses of the Health Scale of Traditional Chinese Medicine (HSTCM). METHODS: A cross-sectional investigation was carried out among 28 hospital staff members by using 151 scale descriptors. This investigation involved all the descriptors from the initial version of HSTCM. Each response scale had five ordinal descriptors, including two anchors at extreme levels and three intermediates. The participants were invited to determine the two anchors of extreme levels, and then to place each descriptor on a 10-centimeter (0 to 10 cm) line according to where they considered the descriptor lay in relation to the two anchors. RESULTS: The selection of scale descriptors was based on comprehensive considerations regarding the median, average score and standard deviation of each descriptor. The main rule of selection was to choose the descriptor of extreme level anchor with a median value closer to 0 or 10, and the same for the selection of descriptors of the intermediates, which should possess a median value closer to 2.5 or 5 or 7.5. If two descriptors had similar median values, we compare the average score and/or the standard deviation of these descriptors and prefer to keep the one containing either an average score closer to anchor point or a less value of standard deviation. Furthermore, the codes of Chinese language were also considered. Four kinds of response scales including capacity, frequency, evaluation, and intensity with a total of 85 scale descriptors were selected. For HSTCM, a total of 8.24% (7/85) descriptors for 14.9% (7/47) items were revised based on the study results. CONCLUSION: The scale descriptors selected are suitable for HSTCM and the results can be referenced in developing similar health profile assessment.

Chinese herbal medicine for the treatment of cough variant asthma: a study protocol for a double-blind randomized controlled trial.

BACKGROUND: Cough variant asthma (CVA) is one of the leading causes of chronic coughing. The main treatment is currently anti-inflammatory medication. However, the coughing may return or be aggravated and lung function may deteriorate once the anti-inflammatory treatment is stopped. The effect of Chinese herbal medicine (CHM) on chronic coughing is remarkable, but high-quality evidence supporting its effectiveness is still lacking. This trial aims to evaluate the safety and efficacy, especially the long-term efficacy, of CHM plus anti-inflammatory medications for the treatment of CVA. METHODS/DESIGN: A randomized placebo-controlled double-blind trial will be conducted. It will consist of a 3-month intervention followed by a 6-month follow-up period. The target sample size is 60 patients with CVA who are between 18 and 70 years old. The eligible subjects will be allocated randomly into the experimental or control group in a ratio of 1:1. Patients in the experimental group will take CHM granules (4.9 g twice daily), while patients in the control group will be given a matched placebo. An administration of salmeterol/fluticasone propionate combination for 12 weeks will be the basic therapy for the two groups. The primary outcome is the cough visual analog scales (CVAS). The secondary outcomes include quality of life, rate of symptom relapse, lung function, and blood tests. A safety assessment will also be performed during the trial. DISCUSSION: The evidence gathered by the trial will be a valuable addition to informing treatment options for patients with CVA. TRIAL REGISTRATION: http://www.chictr.org.cn , ID: ChiCTR-IOR-16009148. Registered on 3 September 2016.

Can increasing the prevalence of vegetable-based diets lower the risk of osteoporosis in postmenopausal subjects? A systematic review with meta-analysis of the literature.

OBJECTIVES: Several epidemiological investigations have assessed the association between vegetable-based diet intake (VDI) and risk of osteoporosis in postmenopausal subjects (OPS), but the outcomes have been inconsistent. We performed a review of the updated literature to evaluate this correlation. METHODS: We searched for relevant studies published in September 2018 or earlier. Two researchers conducted eligibility assessment and data extraction. Discrepancies were resolved through consultation with a third expert. Pooled odds ratios (ORs) were calculated with 95% confidence intervals (CIs). RESULTS: Ten studies, which included 14,247 subjects, were identified. On comparing the highest category of VDI consumption with the lowest category of VDI consumption, the pooled OR for OPS was 0.73 (95% CI = 0.57-0.95), i.e., participants with a higher intake of vegetables had a 27% (95% CI = 5-43%) lower risk of OPS. Significant benefits were found on subgroup analyses of case-control studies (OR, 0.61 [95% CI, 0.48-0.78]), but not on subgroup analyses of cross-sectional studies (OR, 0.82 [95% CI, 0.57-1.16]). The synthesized effect estimates were in the direction of decreased risk of OPS on subgroup analyses of the femoral region (OR, 0.57, 95% CI = 0.41-0.80) and the lumbar spine (OR = 0.55, 95% CI = 0.38-0.81), but not on subgroup analyses of the calcaneus (OR = 0.85, 95% CI = 0.33-2.16) and the lumbar and/or femoral region (OR = 1.04, 95%CI = 0.79-1.38). Positive results were observed on pooled analyses of the Dual energy X-ray absorptiometry (DEXA) measurement method (OR, 0.72 [95% CI, 0.54-0.95]), but not on pooled analyses of the Standardized Quantitative Ultrasound (QUS) measurement method (OR, 0.85 [95% CI, 0.33-2.16]). This might have resulted from a type II error due to wide confidence intervals and less number of included studies. CONCLUSION: This meta-analysis seemingly confirms that higher consumption of VDI was associated with a lower risk of OPS. Taken together, these results highlight the need for future high-quality design-based trials on quantified vegetable intake and OPS.

Does Routine Anti-Osteoporosis Medication Lower the Risk of Fractures in Male Subjects? An Updated Systematic Review With Meta-Analysis of Clinical Trials.

Background: Several epidemiological articles have reported the correlations between anti-osteoporosis medication and the risks of fractures in male and female subjects, but the specific efficacy of anti-osteoporosis medication for male subjects remains largely unexplored. Objective: The aim of this study was to evaluate the correlation between anti-osteoporosis medication and the risk of fracture in relation to low bone mass [including outcomes of osteoporosis, fracture, and bone mineral density (BMD) loss] in male subjects analyzed in studies within the updated literature. Methods: Randomized controlled trials (RCTs) that analyzed the effectiveness of a treating prescription for male subjects with osteoporosis (or low BMD) and that focused on the outcomes of fracture were included. Relevant studies from Embase, Web of Science, PubMed, and Chinese database of CNKI were retrieved from inception to January 30th, 2019. Two staff members carried out the eligibility assessment and data extraction. The discrepancies were settled by consultation with another researcher. We calculated the pooled relative risks (RRs) based on 95% confidence intervals (CIs). Results: Twenty-seven documents (28 studies) with 5,678 subjects were identified. For the category of bisphosphonates, significant results were observed in pooled analyses for decreased risk of the vertebral fracture domain (RR, 0.44 [95% CI, 0.31-0.62]), nonvertebral fracture domain (RR, 0.63 [95% CI, 0.46-0.87]), and clinical fracture domain (RR, 0.59 [95% CI, 0.48-0.72]) compared with those of controls. Participants with bisphosphonates had a 56% (95% CI = 38-69%) lower risk of vertebral fractures, 37% (95% CI = 13-54%) lower risk of nonvertebral fractures, and 41% (95% CI = 28-52%) lower risk of clinical fractures. Furthermore, meta-analyses also demonstrated a decreased risk of the vertebral fracture domain via treatment with risedronate (RR, 0.45 [95% CI, 0.28-0.72]) and alendronate (RR, 0.41 [95% CI, 0.23-0.74]), but not with calcitriol, calcitonin, denosumab, ibandronate, monofluorophosphate, strontium ranelate, teriparatide, or zoledronic acid, compared with that of controls. Conclusions: This systematic review confirms that bisphosphonates were connected with a decreased risk of vertebral fractures, nonvertebral fractures, and clinical fractures for male subjects with osteoporosis. Future research is needed to further elucidate the role of nonbisphosphonates in treating fractures of osteoporosis subjects.

Can Dietary Intake of Vitamin C-Oriented Foods Reduce the Risk of Osteoporosis, Fracture, and BMD Loss? Systematic Review With Meta-Analyses of Recent Studies.

Background: Several epidemiological studies have been performed to evaluate the association of dietary intake of vitamin C-oriented foods (DIVCF) with risk of fracture and bone mineral density (BMD) loss, but the results remain controversial. Therefore, we conducted a systematic meta-analysis to assess this correlation. Methods: We searched EmBase, PubMed, Web of Science, and the Chinese database CNKI for relevant articles published up to August 2019. Pooled relative risks (RRs) with 95% confidence intervals (CIs) were calculated using the random- or fixed-effects model. Discrepancies were resolved by consultation with a third expert. Results: A total of 13 eligible articles (including 17 studies) with 19,484 subjects were identified for the present meta-analysis. The pooled RR of hip fracture for the highest vs. lowest category was 0.66 (95% CI, 0.47-0.94) for DIVCF, i.e., people with a greater frequency of Vitamin C uptake had a 34% (95% CI, 6%-53%) lower prevalence of hip fracture. In subgroup analyses stratified by study design, gender, and age, the negative associations were statistically significant. Furthermore, the statistical analysis of the association between DIVCF and risk of osteoporosis (RR, 0.66; 95% CI, 0.48-0.92), BMD at the lumbar spine (pooled r, 0.15; 95% CI, 0.09-0.23), and BMD at the femoral neck (pooled r, 0.20; 95% CI, 0.11-0.34) showed beneficial effects of DIVCF. Conclusion: Our meta-analysis indicates that DIVCF is negatively associated with the risk of hip fracture, osteoporosis, and BMD loss, suggesting that DIVCF decreases the risk of hip fracture, osteoporosis, and BMD loss.

Yin-Cold or Yang-Heat Syndrome Type of Traditional Chinese Medicine Was Associated with the Epidermal Growth Factor Receptor Gene Status in Non-Small Cell Lung Cancer Patients: Confirmation of a TCM Concept.

Traditional Chinese Medicine (TCM) therapies should be tailored according to the different syndrome types. In order to identify the relationship between the TCM Yin-cold (YC) or Yang-heat (YH) syndrome types and the EGFR gene status, we prospectively studied 310 NSCLC patients. TCM YH or YC was diagnosed by three TCM experts. TCM symptoms and signs were entered into a binary cluster analysis. The relationships between the EGFR gene status, YH or YC syndrome types, and classification by cluster analysis were analyzed using the chi-square test and multivariate logistic regression. In the 299 patients who had their EGFR gene tested, 45.24% YC (76/168) and 25.95% YH (34/131) patients had EGFR mutations (p = 0.001). Among the 292 patients entered into the cluster analysis, 132 were classified into group A, with signs and symptoms similar to YC, whereas 160 group B patients were similar to YH. In the 281 patients with EGFR tested, 45.67% group A (58/127) and 28.57% group B patients (44/154) had EGFR mutations (p = 0.003). The EGFR status was independently correlated with TCM syndrome type and classification by cluster analysis on multivariate logistic regression. NSCLC patients with YC were more likely to have EGFR gene mutations.

Oral PSORI-CM01, a Chinese herbal formula, plus topical sequential therapy for moderate-to-severe psoriasis vulgaris: pilot study for a double-blind, randomized, placebo-controlled trial.

BACKGROUND: To provide evidence that the Chinese herbal medicine (CHM) PSORI-CM01 combined with Western medicine reduces the relapse rate of psoriasis vulgaris (PV), we plan to conduct a large-scale randomized control trial (RCT). In order to improve and perfect the RCT, this pilot study was designed to determine the feasibility and the potential of a modified protocol for the full-scale RCT. METHODS: Eligible patients with psoriasis vulgaris (PV) were enrolled into a randomized comparison in which all subjects received topical sequential therapy and PSORI-CM01 or placebo for 12 weeks. The primary outcome measure was the relapse rate. Treatment response was computed from Psoriasis Area and Severity Index (PASI), body surface area (BSA), and Dermatology Life Quality Index (DLQI). The secondary outcome measures included time to relapse, time to onset, rebound rate, PASI score, pruritus scores on the Visual Analog Scale (VAS), BSA, DLQI and SF-36 (short form health survey), and incidence of serious adverse events (SAEs). RESULTS: Six of 7 (86 %) subjects reached the PASI-50 in the CHM group compared with nine of 10 (90 %) in the placebo group during the treatment period. Among the subjects who reached PASI-50, one out of six subjects (17 %) relapsed in the CHM group during the treatment period compared with six out of nine patients in the placebo group (67 %). No subjects met the rebound criteria. Changes to baseline in the PASI scores were not significantly different between the two groups (t = 1.764, P = 0.098). CONCLUSION: Oral PSORI-CM01 combined with topical sequential treatment showed a smaller recurrence rate (P = 0.118) than placebo combined with the same topical therapy for moderate-to-severe PV in this pilot study. TRIAL REGISTRATION: Chinese Clinical Trial Registry ( http://www.chictr.org.cn/searchproj.aspx ) ChiCTR-TRC-13003233 ; date of registration: 15 April 2013.

Patient classification of hypertension in Traditional Chinese Medicine using multi-label learning techniques.

BACKGROUND: Hypertension is one of the major risk factors for cardiovascular diseases. Research on the patient classification of hypertension has become an important topic because Traditional Chinese Medicine lies primarily in "treatment based on syndromes differentiation of the patients". METHODS: Clinical data of hypertension was collected with 12 syndromes and 129 symptoms including inspection, tongue, inquiry, and palpation symptoms. Syndromes differentiation was modeled as a patient classification problem in the field of data mining, and a new multi-label learning model BrSmoteSvm was built dealing with the class-imbalanced of the dataset. RESULTS: The experiments showed that the BrSmoteSvm had a better results comparing to other multi-label classifiers in the evaluation criteria of Average precision, Coverage, One-error, Ranking loss. CONCLUSIONS: BrSmoteSvm can model the hypertension's syndromes differentiation better considering the imbalanced problem.

Formulating appropriate statistical hypotheses for treatment comparison in clinical trial design and analysis.

We discuss the problem of properly defining treatment superiority through the specification of hypotheses in clinical trials. The need to precisely define the notion of superiority in a one-sided hypothesis test problem has been well recognized by many authors. Ideally designed null and alternative hypotheses should correspond to a partition of all possible scenarios of underlying true probability models P={P(ω):ω∈Ω} such that the alternative hypothesis Ha={P(ω):ω∈Ωa} can be inferred upon the rejection of null hypothesis Ho={P(ω):ω∈Ω(o)} However, in many cases, tests are carried out and recommendations are made without a precise definition of superiority or a specification of alternative hypothesis. Moreover, in some applications, the union of probability models specified by the chosen null and alternative hypothesis does not constitute a completed model collection P (i.e., H(o)∪H(a) is smaller than P). This not only imposes a strong non-validated assumption of the underlying true models, but also leads to different superiority claims depending on which test is used instead of scientific plausibility. Different ways to partition P fro testing treatment superiority often have different implications on sample size, power, and significance in both efficacy and comparative effectiveness trial design. Such differences are often overlooked. We provide a theoretical framework for evaluating the statistical properties of different specification of superiority in typical hypothesis testing. This can help investigators to select proper hypotheses for treatment comparison inclinical trial design.

Efficacy and safety of Huxin formula in patients after CABG: a multicenter, double-blind, randomized clinical trial.

BACKGROUND: Coronary artery bypass grafting (CABG) is widely used in the treatment of coronary artery disease. A multicenter, double-blind, randomized, controlled clinical trial was designed to evaluate the efficacy and safety of Huxin Formula post CABG. PATIENTS AND METHODS: 270 inpatients with coronary heart disease participated in this study. CABG patients in the control group were treated with placebo, while patients in the experimental group were treated with Huxin Formula 1 week after the surgery. All patients were treated for 6 months and followed up for another 6 months. The main outcomes (death, nonfatal myocardial infarction, repeat revascularization, and readmission) were assessed 360 days after treatment, and secondary outcomes (frequency and scores of angina pectoris, etc.) were assessed 0, 90, 180, 270, and 360 days after treatment. RESULTS: Our results showed no significant difference between the 2 groups for the primary endpoints. In patients with cardiac function class II (New York Heart Association), the score of angina pectoris was significantly lower (3.88 ± 3.86 vs. 5.45 ± 3.59) and the frequency of angina pectoris attacks was less (0.96 ± 1.01 vs. 1.36 ± 0.94) after 90 days of treatment with Huxin Formula compared to placebo (p < 0.05). In patients with 3 coronary vessel lesions, the cardiac function class (1.14 ± 0.35 vs. 1.05 ± 0.21) after 360 days was significantly higher in the control group compared to the treatment group (p < 0.05). There were no obvious adverse reactions. CONCLUSION: Huxin Formula may improve cardiac function of patients with 3 coronary vessel lesions and relieve symptoms of patients with cardiac function class II but failed to show superiority in primary outcomes.

Analysis on the Chinese medicine syndromes and demographic characteristics of patients with influenza-like illness in clinics of China.

OBJECTIVE: To investigate Chinese medicine (CM) patterns and epidemiological characters of patients with influenza-like illness (ILI) syndromes in clinics in China. METHODS: A prospective multi-center observational epidemiology survey on the clinical CM patterns of ILI and its prevalence was conducted from September 2009 to April 2010. A unified survey questionnaire was developed for data collection of ILI symptoms and CM patterns. Totally 45 hospitals from 22 provinces, municipality cities and autonomous regions of China participated this study. The collected data were input by EPI-data v3.1 and analyzed by SPSS 18.0, which included descriptive analysis and Chi-square test for group comparison. RESULTS: A total of 5,967 ILI patients were included in the study. The proportion of the 18-34 aged group (56.2%) was the largest; students (41.0%) were more than other occupations. Majority of the patients had the wind-heat invading Lung (Fei) syndrome (76%), while in Southwest China mainly wind-heat invading Lung syndrome and wind-cold tightening the exterior syndrome occurred. The typical symptoms of ILI were ranked as fatigue (80.9%), cough (72.2%), sore throat (67.2%), muscular soreness (67.1%), headache (65.4%), aversion to cold (60.1%), thirst (55.1%) and nasal obstruction (48.1%). CONCLUSIONS: The ILI patients in clinics were mainly teenagers and young adults. In regard to CM syndrome, wind-heat invading Lung syndrome prevailed in all regions except the Southwest China. The characteristics of CM syndrome of ILI patients may be relevant to age and region distribution.

Chinese medicine combined with calcipotriol betamethasone and calcipotriol ointment for Psoriasis vulgaris (CMCBCOP): study protocol for a randomized controlled trial.

BACKGROUND: Psoriasis causes worldwide concern because of its high-prevalence, as well as its harmful, and incurable characteristics. Topical therapy is a conventional treatment for psoriasis vulgaris. Chinese medicine (CM) has been commonly used in an integrative way for psoriasis patients for many years. Some CM therapies have shown therapeutic effects for psoriasis vulgaris (PV), including relieving symptoms and improving quality of life, and may reduce the relapse rate. However, explicit evidence has not yet been obtained. The purpose of the present trial is to examine the efficacy and safety of the YXBCM01 granule, a compound Chinese herbal medicine, with a combination of topical therapy for PV patients. METHODS/DESIGN: Using an add-on design, the trial is to evaluate whether the YXBCM01 granule combined topical therapy is more effective than topical therapy alone for the treatment of PV. The study design is a double-blind, parallel, randomized controlled trial comparing the YXBCM01 granule (5.5 g twice daily) to a placebo. The duration of treatment is 12 weeks. A total of 600 participants will be randomly allocated into two groups, YXBCM01 granule group and placebo group, from 11 general or dermatological hospitals in China. Topical use of calcipotriol betamethasone for the first 4 weeks and calcipotriol ointment for the remaining 8 weeks will be the same standard therapy for the two groups. Patients will be enrolled if they have a clinical diagnosis of PV, a psoriasis area severe index (PASI) of more than 10 or body surface area (BSA) of more than 10%, but PASI of less than 30 and BSA of less than 30%, are aged between 18 and 65-years-old, and provide signed informed consent. The primary outcome, relapse rate, is based on PASI assessed blindly during the treatment. Secondary outcomes include: (i) relapse time interval, (ii) time to onset, (iii) rebound rate, (iv) PASI score, (v) cumulative consumption of medicine, (vi) the dermatology quality life index (DLQI), and (vii) the medical outcomes study (MOS) item short form health survey (SF-36). Analysis will be on intention-to-treat and per-protocol subject analysis principles. DISCUSSION: To address the effectual remission of the YXBCM01 granule for PV, this trial may provide a novel regimen for PV patients if the granule can decrease relapse rate without more adverse effects. TRIAL REGISTRATION: Chinese Clinical Trial Registry (http://cwww.chictr.org): ChiCTR-TRC-13003233, registered 26 May 2013.

A multicentre randomized clinical trial on efficacy and safety of huxin formula in patients undergoing percutaneous coronary intervention.

Percutaneous coronary intervention (PCI) is widely used in clinical treatment of coronary artery disease. However, the effects of PCI on preventing restenosis after revascularization and improving the quality of life were not satisfying. Huxin Formula is formulated by modifying an experienced Chinese medicine formula and has been widely used in clinical practice due to its marked effects on coronary heart disease. A multicentre double-blind randomized controlled clinical trial was designed to evaluate the effects and safety of Huxin Formula in patients undergoing PCI. Our results showed that there was no significant difference between the two groups in main outcomes. For patients with ejection fraction (EF) >50%, score of the quality of life scale was higher in treatment group compared with control group. For patients with unstable angina, score of the quality of life scale in 360 days was significantly higher in treatment group compared with control group (P < 0.05). No obvious adverse reaction was found in the use of Huxin Formula. In conclusion, Huxin Formula, believed to be a safe treatment for patients after PCI, has benefits in improving the quality of life in patients with unstable angina though it failed to show superiority in primary and secondary outcomes.

Effect of Sanqi Oral Liquid on the expressions of CD4⁺, CD8⁺ and CD68⁺ cells in 5/6 nephrectomized rats with chronic renal failure.

OBJECTIVE: To explore the mechanisms of Chinese herbal medicine Sanqi Oral Liquid, composed of Astragalus membranaceus and Panpax notoginseng, in alleviating renal injury by observing its effect on the expressions of CD4(+), CD8(+) and CD68(+) cells in 5/6 nephrectomized rats with chronic renal failure. METHODS: A total of 102 SD rats were randomly divided into six groups: three treatment groups were administrated with high, medium and low dosage of Sanqi Oral Liquid respectively by gavage; a normal group, a 5/6 nephrectomized model group, and a group treated with coated aldehyde oxygenstarch were used as controls. Following oral administration of Sanqi Oral Liquid for 12 weeks, the general condition and renal pathological changes were observed, and the renal function, platelet count (PLT) and the expressions of CD4(+), CD8(+) and CD68(+) cells were determined for each group. RESULTS: There were proliferation of mesangial matrix, renaltubularnecrosis and obvious tubulointerstitial fibrosis in the model group, and they were much milder in the treatment groups. Compared with the model group, the amounts of blood urea nitrogen (BUN), serum creatinine (Scr) and PLT in the treatment groups decreased (P<0.05 for all); and in the group administrated of medium dosage of Sanqi Oral Liquid, the expression of CD4(+) cells was up-regulated and those of CD8(+) and CD68(+) cells were down-regulated (P<0.05 for all), leading to an increased ratio of CD4(+)/CD8(+)(P<0.01). CONCLUSION: Sanqi Oral Liquid has a significant effect on regulating lymphocyte subsets, reducing the infiltration of macrophages in renal tissues and alleviating tubulointerstitial fibrosis, and this may be one of mechanisms of Sanqi Oral Liquid in delaying the progression of chronic kidney diseases.

[Impacts of acupuncture and moxibustion on outcome indeices of depression patients' subjective reports].

OBJECTIVE: To assess the clinical efficacy of acupuncture and moxibustion on depression in view of the outcome indicators of the patient subjective reports. METHODS: One hundred and sixty-three cases of depression being in compliance with the inclusive standards were randomized into a soothing-liver and regulating-mind group, an acupoint-shallow-puncturing group and a non-acupoint-shallow-puncturing group. In the soothing-liver and regulating-mind group, the conventional acupuncture was applied to the four-gate points [Hegu (LI 4) and Taichong (LR 3)], Baihui (GV 20) and Yintang (EX-HN 3), the direct moxibustion with moxa cone was applied to the four-flower points [Geshu (BL 17), Danshu (BL 19)]. Finally, the intradermal needling was used at Xinshu (BL 15) and Ganshu (BL 18). In the acupoint-shallow-puncturing group, the acupoints selected were same as those in the soothing-liver and regulating-mind group. But the needle insertion was shallower and the time of moxibustion was shorter. In the non-acupoint-shallow-puncturing group, the spots that were 10 mm lateral to those acupoints in the soothing-liver and regulating-mind group were selected. The operation was same as that in the acupoint-shallow-puncturing group. The treatment was given twice a week in three groups. Totally, 12 weeks of treatment were required. The score of symptom checklist 90 (SCL-90), the self-report symptom inventory was observed before treatment, 1 month and 3 months after treatment separately so as to assess the corresponding short-term, mid-term and long-term efficacies of the program of acupuncture and moxibustion for soothing the liver and regulating the mind. RESULTS: In each time-point after treatment, for the scores of somatization, obsessive-compulsive symptom, interpersonal sensitivity, depression, anxiety, hostility, paranoid ideation, psychoticism and the other 8 dimensionalities, in comparison between the soothing-liver and regulating-mind group and the non-acupoint-shallow-puncturing group, the differences were significant statistically (all P < 0.05). For the scores of depression, anxiety and hostility, in comparison between the soothing-liver and regulating-mind group and the acupoint-shallow-puncturing group, the differences were significant statistically (all P < 0.05). CONCLUSION: Acupuncture and moxibustion can improve the scores of SCL-90 scale for the patients with depression. The outcome indicators of the patient subjective reports can accurately assess the clinical efficacy.