Hongcai Shang

Beijing University of Chinese Medicine and Pharmacology, Peping, Beijing, China

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Publications (42)72.39 Total impact

  • Yinghui Jin · Yunyun Wang · Yao Zhang · Yue Ma · Yan Li · Cui Lu · Wei Wang · Ge Li · Hongcai Shang
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    ABSTRACT: Background: An increasing number of nursing practice guidelines (NPGs) of varying methodological and reporting quality have been issued and published in international journals. Currently the quality of NPGs in mainland China has not been explored. Objective: To assess the quality of NPGs in China mainland using the AGREE II (Advancing Guideline Development, Reporting and Evaluation in Health Care) instrument. Methods: The authors searched the electronic databases of Chinese Biomedical Literature Database, China National Knowledge Infrastructure, The VIP Database, Wan Fang Database, Chinese Master's Theses Full-Text Database, China Doctor Dissertation Full-Text Database, and China Proceedings of Conference Full-Text Database and the web of China Guideline Clearinghouse for NPGs in China published from the inception of databases to December, 2013?Four independent assessors rated the quality of each guideline using AGREEII. The authors classified NPGs into two types: evidence-based NPG (EB-NPG) and consensus-based NPG (CB-NPG), and compared their quality. The authors also considered whether the quality of NPGs changed over time. Results: Forty-two NPGs were appraised. Methodological rigor and reporting of NPGs were poor. Across all guidelines, the appraisers assigned the highest scores to the domain "scope and purpose," and the lowest scored to the domain of "editorial independence." EB-NPGs were significantly superior to the CB-NPGs in the domains of "stakeholder involvement"; "rigor of development," and "editorial independence." There was no improvement over time for all domains. Linking evidence to action: This research found an absence of a systematic guideline development methodology and a tendency to rely on expert opinion in the process of developing NPGs. The readers should consider these flaws and limitations when using recommendations in those NPGs.
    No preview · Article · Jan 2016 · Worldviews on Evidence-Based Nursing
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    ABSTRACT: Cardiovascular diseases (CVDs) have been regarding as “the world’s first killer” of human beings in recent years owing to the striking morbidity and mortality, the involved molecular mechanisms are extremely complex and remain unclear. Traditional Chinese medicine (TCM) adheres to the aim of combating complex diseases from an integrative and holistic point of view, which has shown effectiveness in CVDs therapy. However, system-level understanding of such a mechanism of multi-scale treatment strategy for CVDs is still difficult. Here, we developed a system pharmacology approach with the purpose of revealing the underlying molecular mechanisms exemplified by a famous compound saffron formula (CSF) in treating CVDs. First, by systems ADME analysis combined with drug targeting process, 103 potential active components and their corresponding 219 direct targets were retrieved and some key interactions were further experimentally validated. Based on this, the network relationships among active components, targets and diseases were further built to uncover the pharmacological actions of the drug. Finally, a “CVDs pathway” consisted of several regulatory modules was incorporated to dissect the therapeutic effects of CSF in different pathological features-relevant biological processes. All this demonstrates CSF has multi-scale curative activity in regulating CVD-related biological processes, which provides a new potential way for modern medicine in the treatment of complex diseases.
    Preview · Article · Jan 2016 · Scientific Reports
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    Xiao Sun · Liping Guo · Hongcai Shang · Ming Ren · Yue Wang · Da Huo · Xiang Lei · Hui Wang · Jingbo Zhai
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    ABSTRACT: At present, diabetes is a chronic disease of great cost and heavy burdens. The International Diabetes Federation has repeatedly warned that by 2025, the global number of diabetics would rise to 333 million from 194 million in 2003. Although the occurrence of diabetes in developing countries is lower, China has a large population, so that the number of cases is increased. At the same time, more people have prediabetes, a growing health concern where a large percentage of the patients develop full type 2 diabetes. In addition, the patients of diabetes easily incur complications such as blindness, kidney failure, and cardiovascular diseases that can seriously affect the patients’ quality of life and cause great economic burdens to family and society. Therefore, effective interventions for prediabetes are needed to prevent or delay the occurrence and development of diabetes. A randomized controlled trial that was assessed with pharmacoeconomic methods was undertaken in this study. The study term was 24 months (12 months for the intervention and 12 months for follow up). Four hundred participants, recruited from four cities in China: Beijing, Tianjin, Xian, and Naning, were randomized to the treatment group (JQJT tablets) and the control group (placebo). Participants included in this study had been diagnosed with prediabetes according to the criteria for western medicine and Traditional Chinese Medicine (TCM). The end-point effectiveness indexes included the incidence of diabetes and the reversion rate. The drug costs and lifestyle intervention costs were included in the total costs. The study used the cost-effectiveness analysis to discuss the economic advantage of the JQJT tablets. The outcomes of the study contained 2 sections,namely clinical outcomes and cost-effectiveness analysis outcomes. The clinical outcomes: the treatment group and control group had no significant statistical difference P> 0.05) on the baseline of situation; Jinqi Jiangtang tablet effectively reduced the incidence of diabetes mellitus and enhanced reversion rate. compared with the control group (p< 0.05); the scores of SF-36 of two groups had no significant difference P> 0.05); finally the compliance of participants between the two groups had no signicant difference. The cost-effectiveness analysis outcomes:in the intervention period of 12 months,on the aspect of reversion rate, the treatment group had better economic advantage by using cost-effectiveness ratio and the incremental cost-effectiveness ratio;on the aspect of the incidence of diabetes, the control group had better economic advantage by using cost-effectiveness ratio and the incremental cost-effectiveness ratio; in the follow-up peiod of 24 months, on the aspect of reversion rate, the treatment group had better economic advantage by using cost-effectiveness ratio and the incremental cost-effectiveness ratio, on the aspect of the incidence of diabetes, the control group had better economic advantage by using cost-effectivenes ratio and the incremental cost-effectiveness ratio.At the same time, these outcomes remained the same by sensitivity analysis. Assuming that prices and resident incomes rose 5%, the sensitiveness analysis shows that the two group affected by the paremeters changed little. The importance and effectiveness of lifestyle education and JinQi Jiangtang tablets was proven. In both the intervention period and follow-up, JinQi Jiangtang tablets combined with lifestyle education had a greater cost advantage effect than the lifestyle education alone on the reversion rate; the lifestyle education had a greater cost advantage effect than the JinQi Jiangtang tablets combined with lifestyle education on the incidence of diabetes. Trial registration Chinese Clinical Trials ChiCTR-TRC-09000401) , registered on 25 May 2009.
    Preview · Article · Nov 2015 · Trials
  • Xu Xue · Zhang Chao · Li PiDong · Zhang FeiLong · Gao Kuo · Chen JianXin · Hongcai Shang
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    ABSTRACT: Understanding the relationships between drugs and symptoms has broad medical consequences, yet a comprehensive description of the drug-symptom associations is currently lacking. Here, 1441 FDA-approved drugs were collected, and PCA was used to extract 122 descriptors which explained 91% of the variance. Then, a k-means++ method was employed to partition the drug dataset into 3 clusters, and 3 corresponding SVDD models (drug-likeness screening models) were constructed with an overall accuracy of up to 95.6%. Furthermore, 6878 herbal molecules from the TcmSP™ database were screened by the above 3 SVDD model to obtain 5309 candidate drug molecules with highly accept classification of 77.19%. To assess the accuracy of the SVDD models, 8559 herbal molecule-symptom co-occurrences were mined from Pubmed abstracts, involving 697 herbal molecules and 314 symptoms. Most of the 697 herbal molecules could be found in the accepted SVDD data (5309 molecules), showing the potential of the SVDD for the screening of drug candidates. Moreover, a herbal molecule-herbal molecule network and a herbal molecule-symptom were constructed. Overall, the results provided a new drug-likeness screening approach independent to abnormal training data, and the comprehensive collection of herbal molecule-symptom associations formed a new data resource for systematic characterization of the symptom-oriented medicines.
    No preview · Article · Nov 2015 · Pharmacological Research
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    ABSTRACT: To assess the efficacy and safety of Xuebijing injection for the treatment of severe acute pancreatitis ( SAP ). An extensive search of related literatures from the Cochrane Library, EMBASE, China Biology Medicine ( CBM ), CNKI, VIP and Wanfang data up to March 2014 was performed. Randomized controlled trials ( RCTs ) regarding Xuebijing injection for the treatment of SAP were collected regardless of languages. Jadad scale was taken for quality evaluation of the included studies by two researchers. The patients in control group were given conventional treatment, and those of the Xuebijing group were given Xuebijing injection on the top of conventional treatment. The Cochrane Collaboration RevMan 5.2 software was used for data analysis regarding the effect of Xuebijing injection on the mortality, incidence of complication, effective rate, the length of stay in hospital, and the safety of the drug in patients with SAP. A total of 15 published reports meeting the inclusion criteria were enrolled. The methodological quality of the trials was low. Meta analysis showed that the mortality in Xuebijing group was significantly lower [ odds ratio ( OR ) = 0.37, 95% confidence interval ( 95%CI ) = 0.17 - 0.77, P = 0.008 ], and the incidence of complication was also significantly decreased ( OR = 0.26, 95%CI = 0.14 - 0.45, P < 0.000 01 ) as compared with those of control group. The effective rate in Xuebijing group was significantly higher than that of the control group [ relative risk ( RR ) = 0.85, 95%CI = 0.80-0.91, P < 0.000 01 ]. The length of stay in hospital in Xuebijing group was significantly shorter than that of the control group [ mean difference ( MD ) = -5.28, 95%CI = -6.69 to -3.86, P < 0.000 01 ]. Adverse reactions of Xuebijing injection were reported in 2 studies. The adverse reaction in one study was headache and nausea, which were relieved by adjusting the speed of intravenous infusion, and mild rash was reported in another case, and it disappeared after the withdrawal of Xuebijing. The currently available evidence shows that Xuebijing injection may have some therapeutic effect on SAP. Because of the low methodological quality of the included trials, multi-center and high-quality RCTs with large sample sizes are needed to provide stronger evidence.
    No preview · Article · Aug 2015 · Zhonghua wei zhong bing ji jiu yi xue
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    ABSTRACT: Acute exacerbation is a common cause of hospitalization in patients with chronic heart failure, and coronary heart disease is the most common cause. Shenfu injection, a Traditional Chinese Medicine injection, widely used in the adjuvant treatment of patients with acute exacerbation of chronic heart failure, shows some treatment effect in improving the symptoms and the quality of life, but it lacks the rigorous clinical evaluation of research reports. This paper describes the protocol for the clinical assessment of Shenfu injection loading in the treatment of patients with acute exacerbation of chronic heart failure. This protocol adopts the design of a prospective, randomized, multicenter, blind imitation, placebo-controlled trial to assess the efficacy and safety of Shenfu injection loading in the treatment of patients with acute exacerbation of chronic heart failure due to coronary heart disease. The research will be carried out in 12 hospitals in China and is expected to enroll 160 inpatients with acute exacerbation of chronic heart failure due to coronary heart disease (yang and qi deficiency syndrome). On the basis of the conventional therapy of western medicine, patients will be randomized to either the treatment group (100 ml 5% glucose injection + 50 ml Shenfu injection) or the control group (150 ml 5% glucose injection) for 7 ± 1 days and follow-up for 28 ± 3 days. The primary outcomes are New York Heart Association cardiac function classification and Traditional Chinese Medicine syndromes. The secondary outcomes are left ventricular ejection fraction, brain natriuretic peptide level, Lee's heart failure score, 6-minute walking distance, and the incidence and readmission rate of cardiovascular events (including the emergency rate due to acute exacerbation of chronic heart failure). This trial will assess the effect of loading Shenfu injection in the treatment of patients with acute exacerbation of chronic heart failure caused by coronary heart disease (yang-qi deficiency syndrome) on the symptoms and signs of heart failure, exercise tolerance, and other aspects, and observe its influence on the short-term prognosis with follow-up. The results of the study will provide clinical research evidence for application of Shenfu injection in the treatment. This trial was registered on 26 December 2012 at the Chinese Clinical Trials Register (Identifier: ChiCTR-TRC-12002857 ).
    Full-text · Article · May 2015 · Trials
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    ABSTRACT: Objective. To summarize the characteristics and analysis of relevant factors and to give references for prevention and further study of liver damage associated with Polygonum multiflorum Thunb. (HSW), we provide a systematic review of case reports and case series about liver damage associated with HSW. Methods. An extensive search of 6 medical databases was performed up to June 2014. Case reports and case series involving liver damage associated with HSW were included. Results. This review covers a total of 450 cases in 76 articles. HSW types included raw and processed HSW decoction pieces and many Chinese patent medicines that contain HSW. Symptoms of liver damage occur mostly a month or so after taking the medicine, mainly including jaundice, fatigue, anorexia, and yellow or tawny urine. Of the 450 patients, two cases who received liver transplantation and seven who died, the remaining 441 cases recovered or had liver function improvement after discontinuing HSW products and conservative care. Conclusion. HSW causes liver toxicity and may cause liver damage in different degrees and even lead to death; most of them are much related to long-term and overdose of drugs. Liver damage associated with HSW is reversible, and, after active treatment, the majority can be cured. People should be alert to liver damage when taking HSW preparations.
    Full-text · Article · Jan 2015 · Evidence-based Complementary and Alternative Medicine
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    Hongbo Cao · Jingbo Zhai · Nan Li · Hongxia Cao · Xiang Lei · Wei Mu · Zhi Liu · Hui Wang · Hongcai Shang
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    ABSTRACT: Traditional Chinese medicine (TCM) has accumulated some experience in curing stable angina pectoris (SAP) and efficacy has been demonstrated. Chinese patent medicines, known as modern dosage forms of TCM, can attain the desired effect in clinical application only with the guidance of TCM syndrome theory. However, due to their use by a large number of persons with little knowledge of TCM theories and practices, their efficacy and reputation have been seriously affected. Two common syndrome types of SAP in TCM, 'qi deficiency and blood stasis' and 'qi stagnation and blood stasis', will be studied in 144 subjects from four TCM hospitals in Tianjin in China using a partial crossover design. The two syndromes will be broken down into six symptom combinations; patients will select a combination of the most distressing to them, and then will be randomised into two groups. Each group, on the basis of routine medication, will be administered one kind of Chinese patent drug: Qishenyiqi Dripping Pills or Compound Danshen Dripping Pills. The treatment characteristics of the two medicines will be evaluated with the COME-PIO method developed by our research team. This protocol has been approved by the medical ethics committee of Tianjin University of TCM (registration number TJUTCM-EC20130005). The study is safe and reliable. Chinese clinical trials register ChiCTR-TTRCC-14004406. Published by the BMJ Publishing Group Limited. For permission to use (where not already granted under a licence) please go to http://group.bmj.com/group/rights-licensing/permissions.
    Full-text · Article · Nov 2014 · BMJ Open
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    Ji-huang Li · Ai-ju Liu · Hui-qin Li · Yan Wang · Hongcai Shang · Guo-qing Zheng
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    ABSTRACT: Buyang Huanwu decoction (BHD) is a famous herbal prescription that has been used to treat stroke for centuries. Recent studies reported that the use of BHD had been extended to treat various kinds of disorders according to the TCM syndrome theory of Treating Different Diseases with the Same Method (TDDSM). Here, an overview of systematic reviews (SRs) of BHD for healthcare were conducted to interpret the TCM theory of TDDSM and its target of vascularity in an evidence-based manner. Literature searches were carried out in 5 databases to search SRs of BHD for any indication up to August 2013. Thirteen eligible SRs were identified that reported a wide range of vascular conditions. Based on the Overview Quality Assessment Questionnaire scores, the quality of included SRs was varied, with an average score of 4 points. We found that there is premature evidence for the use of BHD for healthcare, whereas BHD was well tolerable in all patients. BHD can be used to treat many disorders with the same therapeutic principle of invigorating Qi to activate blood circulation, which is essentially a manifestation of the TDDSM and is likely to account for targeting the specific pathogenesis of vascular diseases.
    Full-text · Article · Jun 2014 · Evidence-based Complementary and Alternative Medicine
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    Hui Wang · Wei Mu · Hongcai Shang · Jia Lin · Xiang Lei
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    ABSTRACT: Rhizoma Coptidis (Huang Lian in Chinese pinyin) is among the most widely used traditional Chinese herbal medicines and has a profound history of more than 2000 years of being used as a therapeutic herb. The antidiabetic effects of Rhizoma Coptidis have been extensively investigated in animal experiments and clinical trials and its efficacy as a promising antihyperglycemic agent has been widely discussed. In the meantime, findings from modern pharmacological studies have contributed the majority of its bioactivities to berberine, the isoquinoline alkaloids component of the herb, and a number of experiments testing the antidiabetic effects of berberine have been initiated. Therefore, we conducted a review of the current evidence profile of the antihyperglycemic effects of Rhizoma Coptidis as well as its main component berberine and the possible mechanism of actions, in order to summarize research evidence in this area and identify future research directions.
    Full-text · Article · Apr 2014
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    ABSTRACT: The practice of traditional Chinese medicine (TCM) has a profound history in many Asian countries. TCM syndrome is a set of characteristic physical signs and symptoms shared by a group of patients. Syndrome diagnosis and treatment assignment according to the identified TCM syndrome is a long-held practice of Chinese medicine. Owing to its distinctive way of interpreting illness and administering care, medical practitioners not well educated in TCM theories and practices are generally incapable of giving out prescriptions for Chinese patent drugs. Currently, the existence of a multitude of Chinese patent drugs marked with largely identical indications is further complicating this situation. In this multicenter, randomized, controlled, double-blind, double-dummy clinical trial, in which we will use the comparative effectiveness research method, we will compare the efficacy of two commonly used Chinese patent medicines for angina patients diagnosed with qi deficiency and blood stasis syndrome. A total of 160 patients will be recruited and randomly assigned to receive either (1) QiShenYiQi dripping pills, Tongxinluo placebo and routine medication or (2) Tongxinluo capsules, QiShenYiQi placebo and routine medication. These treatment regimens will be carried out for 4 weeks, followed by a 10-day washout period and a 4-week crossover phase in which the treatments in the two patient groups will be exchanged. Patients will be allowed to choose symptoms that matter most to them and will be grouped accordingly. Patient-reported outcomes such as the Seattle Angina Questionnaire score and the 15-point Likert scale score will be measured and reported. The minimally clinical important difference will be calculated and used for efficacy assessment, and correspondence analysis will be performed to identify the best indications for each drug. The goal of the study is to establish a methodology for the precise identification of the characteristic indications for which a Chinese patent drug is most effective. The findings of this study will inform the practicality of the proposed evaluation method.Trial registration: Chinese clinical trials register Chi CTRTTRCC13003732.
    Full-text · Article · Mar 2014 · Trials
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    Full-text · Article · Feb 2014 · Evidence-based Complementary and Alternative Medicine
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    Wei Mu · Hongcai Shang
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    ABSTRACT: Objective. To define patient values, identify their manifestations in a randomized clinical trial, and investigate the possible implications for clinical research of traditional Chinese medicine. Methods. We categorized patient values manifestations into patient choice, preference, compliance, and patient-reported outcomes and summarized the underlying personal values through purposeful electronic searches for relevant reports. By hypothesizing a set of positive versus negative circumstances occurring in the enrollment, intervention allocation, treatment, and the follow-up stage of a trial, it is possible to discuss the potential implications of patient values manifestation on a trial with traditional Chinese medicine. Results. Patient values and its manifestations are ubiquitous in the process of clinical research with traditional Chinese medicine. These values may provide motivation for participation or engender the internal and external validity of the study. Conclusions. Trialists should attach sufficient importance to the needs and concerns of individual participant. To incorporate patient values into the design and conduct of a clinical study with traditional Chinese medicine, researchers are recommended to adopt participant-friendly design and use patient-reported outcomes, take convenience-for-patients measures, and help foster rational beliefs and behaviors of trial participants.
    Full-text · Article · Dec 2013 · Evidence-based Complementary and Alternative Medicine
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    ABSTRACT: Pancreatic fibrosis, a prominent histopathological feature of chronic pancreatitis (CP) and pancreatic ductal adenocarcinoma, is essentially a dynamic process that leads to irreversible scarring of parenchymal tissues of the pancreas. Though the exact mechanisms of its initiation and development are poorly understood, recent studies suggested that the activation of pancreatic stellate cells (PSCs) plays a critical role in eliciting such active course of fibrogenesis. Anthraquinone compounds possess anti-inflammatory bioactivities whereas its natural derivative rhein has been shown to effectively reduce tissue edema and free-radical production in rat models of inflammatory conditions. Apart from its anti-inflammatory properties, rhein actually exerts strong anti-fibrotic effects in our current in-vivo and in-vitro experiments. In the mouse model of cerulein-induced CP, prolonged administration of rhein at 50 mg/kg/day significantly decreased immunoreactivities of the principal fibrotic activators alpha-smooth muscle actin (α-SMA) and transforming growth factor-beta (TGF-β) on pancreatic sections implicating the activation of PSCs, which is the central tread to fibrogenesis, was attenuated. Consequently, the overwhelmed deposition of extracellular matrix proteins fibronectin 1 (FN1) and type I collagen (COL I-α1) in exocrine parenchyma was found accordingly reduced. In addition, the expression levels of sonic hedgehog (SHH), which plays important roles in molecular modulation of various fibrotic processes, and its immediate effector GLI1 in pancreatic tissues were positively correlated to the degree of cerulein-induced fibrosis. Such up-regulation of SHH signaling was restrained in rhein-treated CP mice. In cultured PSCs, we demonstrated that the expression levels of TGF-β-stimulated fibrogenic markers including α-SMA, FN1 and COL I-α1 as well as SHH were all notably suppressed by the application of rhein at 10 μM. The present study firstly reported that rhein attenuates PSC activation and suppresses SHH/GLI1 signaling in pancreatic fibrosis. With strong anti-fibrotic effects provided, rhein can be a potential remedy for fibrotic and/or PSC-related pathologies in the pancreas.
    Full-text · Article · Dec 2013 · PLoS ONE
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    ABSTRACT: Currently, quality issues concerning clinical research of traditional Chinese medicine (TCM) have come into the spotlight. It has been recognized that poorly-devised research methodology largely restricted the development of clinical research in TCM. The choice of appropriate outcome measurements is key to the success of clinical research; however, the current procedure for outcomes selection in clinical research of TCM is problematic due to the underdevelopment of clinical methodology. Under this circumstance, we propose the introduction to the concept of Core Outcome Set (COS) and discuss the feasibility of developing a COS system that caters for clinical studies in TCM, in the hope that the outcome evaluation system could be up to international standards.
    Full-text · Article · Nov 2013 · Evidence-based Complementary and Alternative Medicine
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    Wenke Zheng · Hui Wang · Li Zhang · Zhaoxiang Bian · Hongcai Shang
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    ABSTRACT: At present, the design of an ideal placebo control in acupuncture studies challenges researchers. Previously devised sham acupuncture techniques have reported various imperfections; therefore, the specific effects of acupuncture cannot be accurately examined in clinical trials primarily because of interferences from the placebo effects. Guided by evidence-based medicine (EBM) theories, we have made an initial attempt to establish a set of control methods for use in acupuncture studies, which is named the target disease-guided placebo-controlled (TIGER) design. In a trial using the TIGER design, participants suffering simultaneously from a predefined target disease and a pseudo target disease will be recruited and randomized to receive identical acupuncture intervention measures. As a result, the interventions not only appear the same but also produce the same stimulations in both groups. The patients in the treatment group will be informed of the actual target disease that the treatment aims for, whereas patients in the control group will be informed that the treatment is for the pseudotarget disease. It is speculated that no psychological response will be aroused in the control group. During data analysis, changes in the outcome measures of the patients in the control groupreveal the real therapeutic effect of acupuncture, and those of patients in the treatment group show both the real and placebo acupuncture effect. In this article, we explain how to put this design into use in a planned randomized clinical trial of acupuncture for the treatment of migraine. This approach can eliminate the acupuncture placebo effect in the control group that may confound trial results. It is possible to observe the specific and placebo effects of acupuncture for the target disease separately using the TIGER design. The proposed TIGER design has limitations.It is designed for clinical studies focusing on the specific effects of acupuncture, and it needs to be tested and verified for practicality and feasibility in various clinical research settings.
    Preview · Article · Oct 2013 · Trials
  • Wang Yue · Lu Xiao · Wei Mu · Jingbo Zhai · Shuo Zhang · Xiao Sun · Dongmei Xing · Hongcai Shang
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    ABSTRACT: Objectives A comprehensive summary and evaluation of the current evidence profile of the role of traditional Chinese medicine (TCM) in myocardial infarction management was conducted to provide evidence-based recommendations for clinical application and evoke thoughts for future researchers. Methods We systematically searched CNKI, VIP, CBM, PubMed and the Cochrane Library for literature on TCM for myocardial infarction. After screening, studies were categorised in terms of type into five levels, i.e. systematic review (SR), randomised controlled trial (RCT), observational study, case study and basic research. General information was abstracted, and quality of these studies and conclusions made were summarised and assessed. Results A total of 452 studies involving 10 SRs, 123 RCTs, 47 observational studies, 28 case studies and 244 basic researches were included. Clinical studies centred primarily on herbal decoction and most were not rigorously performed. High quality studies were predominantly on patent drugs such as Danshen injection, Shenmai injection, Shengmai injection and Qishen Yiqi dripping pills. A summary of findings from systematic reviews and clinical research show that TCM may reduce mortality, decrease risk for complication, reduce myocardial injury, improve cardiac function and inhibit ventricular remodelling. Results of experimental studies also support the active role of TCM in reducing infarct size and myocardial injury, promoting angiogenesis, preventing ventricular remodelling and improving cardiac function. According to the current bodies of evidence, TCM has proven effects in the prevention and treatment of myocardial infarction. It is also found that the effects of Chinese patent drugs vary with indications. For instance, Shenmai injection has been observed especially effective for reducing incidence of acute clinical events, and patent drug with qi-nourishing and blood-circulating properties has been proved good at inhibiting ventricular remodelling. High-quality evidence supports the use of TCM injection for acute myocardial infarction and Chinese patent drug medication for secondary prevention. Reports on adverse events and other safety outcomes associated with Chinese medicine are not many. Conclusions Firstly, sufficient evidence has been drawn from all five types of studies in relation to the use of TCM as an adjuvant to conventional Western medicine for prevention and treatment of myocardial infarction. Scientific and rational use of TCM in combination with western medicine is therefore recommended, taking into consideration of the stage of the disease and therapeutic goals of the patients. For example, herbal decoction and Qishen Yiqi dripping pills are recommended for patients recovering from a myocardial infarction and for secondary prevention, whereas for patients with acute myocardial infarction Shenmai injection would be a good choice. Secondly, the quality of the bodies of evidence remains to be enhanced, and improvements can be made from the following aspects: 1) Some significant research subjects are worthy of further exploration, such as the benefits of and potential risks posed by the concomitant use of Chinese medicine and western drugs with cardiovascular protective properties; 2) The quality of both original and secondary research need to be enhanced, 3) Highlights should be given to the monitoring and reporting of adverse events associated with the use of Chinese medicine; and 4) To promote standard reporting of TCM clinical research.
    No preview · Article · Oct 2013 · Heart (British Cardiac Society)
  • Hongbo Cao · Hongcai Shang · Wei Mu · Jinbo Zhai · Yazhu Hou · Hui Wang
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    ABSTRACT: Managing compliance in a clinical research, especially in a multi-centre randomized clinical trial (MRCT) is vital. We now feel the need to take a look at the once overlooked area of investigator compliance as it may provide resources necessary for producing satisfactory trial outcomes. To analyze investigator performance and examine their adherence behavior using data collected and information gained from the MISPS-TCM, a Chinese national research project. Four researchers were responsible for collecting relevant information and investigating the compliance behavior of participants in MISPS-TCM. The Data Management Committee of MISPS-TCM offered us the number of withdrawal at each site and other site information. Reports on investigator compliance events were provided by the Monitoring Committee. Records of any misconduct of or errors made by the investigator were collected from the Center's daily management diary. Other information sources included trial managers and investigators at the Center or at different sites of the study. Investigator compliance can be an important determinant of trial outcomes and the degree of compliance may have detrimental effects on the reliability of findings of an MRCT, directly or indirectly. Trial managers of future MRCTs should take a firm grip on investigator compliance from the following aspects. First, physicians should be provided with more opportunities. Second, we created and recommended the 'Five Step Method' for evaluating investigators. Third, measures must be taken to secure investigator compliance. Fourth, evaluation of investigator compliance in an MRCT needs to be made.
    No preview · Article · Aug 2013 · Journal of Evidence-Based Medicine
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    ABSTRACT: Background. Several types of drugs have been recommended for the secondary prevention of myocardial infarction (MI). However, these conventional strategies have several limitations, such as low adherence, high cost, and side effects during long time use. Novel approaches to this problem are still needed. This trial aimed to test the effectiveness and safety of Qi-Shen-Yi-Qi Dripping Pills (QSYQ), a multi-ingredient Chinese patent medicine, for the secondary prevention of MI. Methods and Findings. A total of 3505 eligible patients were randomly assigned to QSYQ group (1746 patients) or aspirin group (1759). Patients took their treatments for 12 months. The final follow-up visit took place 6 months after the end of the trial drugs. The 12-month and 18-month estimated incidences of the primary outcome were 2.98% and 3.67%, respectively, in the QSYQ group. The figures were 2.96% and 3.81% in the aspirin group. No significant difference was identified between the groups. Conclusions. This trial did not show significant difference of primary and secondary outcomes between aspirin and QSYQ in patients who have had an MI. Though inconclusive, the result suggests that QSYQ has similar effects to aspirin in the secondary prevention of MI.
    Full-text · Article · Jul 2013 · Evidence-based Complementary and Alternative Medicine
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    ABSTRACT: Background Diabetic nephropathy (DN) is a major microvascular complication with diabetes. In China, an estimated 34.7 percent of people diagnosed with diabetes have renal complications and a further 50 percent die of renal failure. Hence, identification of alternative treatments for these patients should be given priority. The Shenyan Kangfu tablet (SYKFT) is a new formulation of an existing and widely acclaimed Chinese herbal tea for treating qi-yin deficiency syndrome. Because a considerable portion of DN patients presenting with symptoms of swelling, fatigue and weak limbs would be diagnosed with qi-yin deficiency syndrome according to the traditional Chinese medicine (TCM) diagnostic criteria, we hypothesize that SYKFT may represent a complementary drug for DN patients with the corresponding syndrome. In view of this, we have designed a trial to assess the efficacy and safety of SYKFT for patients with diabetic nephropathy exhibiting signs of qi and yin deficiency. Methods This is a multicenter, double-blind, randomized controlled trial (RCT). The total target sample size is planned at 80 participants, with a balanced (1:1) treatment allocation. The experimental intervention will be SYKFY plus irbesartan (SI regimen) and the control intervention will be a placebo plus irbesartan (PI regimen). Participants will receive two courses of medication treatment each lasting 8 weeks. The primary outcome will be the composite of the quantitative 24-hour urinary protein level and urinary albumin excretion rate (UAER). Changes in urine albumin-to-creatinine ratio (UACR) and DN staging, and TCM symptom improvement will be the secondary outcome measures. Adverse events (AEs) will be monitored throughout the trial. Discussion This study will be the first placebo-controlled RCT to assess whether SYKFT plus irbesartan will have beneficial effects on enhancing overall response rate (ORR), changing DN staging, improving clinical symptoms, and reducing the frequency of AEs for DN patients with qi-yin deficiency syndrome. The results of this trial will help to provide evidence-based recommendations for clinicians. Trial registration Chinese Clinical Trials Register, Identifier: ChiCTR-TRC-12002182
    Full-text · Article · Jun 2013 · Trials

Publication Stats

327 Citations
72.39 Total Impact Points

Institutions

  • 2015
    • Beijing University of Chinese Medicine and Pharmacology
      Peping, Beijing, China
  • 2008-2015
    • Tianjin University of Traditional Chinese Medicine
      T’ien-ching-shih, Tianjin Shi, China
  • 2009-2013
    • Tianjin University
      T’ien-ching-shih, Tianjin Shi, China
    • Sichuan University
      Hua-yang, Sichuan, China