Wei Mu

Liver Damage Associated with Polygonum multiflorum Thunb.: A Systematic Review of Case Reports and Case Series.

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.

The Antihyperglycemic Effects of Rhizoma Coptidis and Mechanism of Actions: A Review of Systematic Reviews and Pharmacological Research

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.

Is Deqi an Indicator of Clinical Efficacy of Acupuncture? A Systematic Review

Objective. Despite the systematic literature review of the current evidence, we aim to answer the question “ is Deqi an indicator of clinical effects in acupuncture treatment?” Methods. We systematically searched CNKI, VIP, Wanfang Data, PubMed, Embase, and the CENTRAL for three types of study: (1) empirical research probing into the role of Deqi in acupuncture; (2) mechanism studies examining the effect of Deqi on physiological parameters in animal models and human subjects; (3) clinical studies that compared the outcome of acupuncture with Deqi with that of acupuncture without Deqi. Two reviewers independently extracted data, undertook qualitative or quantitative analysis, and summarized findings. Results. The ancient Chinese acupuncturists valued the role of Deqi as a diagnostic tool, a prognosis predictor, and a necessary part of the therapeutic procedure. Findings from modern experimental research provided preliminary evidence for the physiological mechanism that produced Deqi. Few clinical studies generated conflicting evidence of the comparative effectiveness of acupuncture with Deqi versus acupuncture without Deqi for a variety of conditions. Conclusion. The current evidence base is not solid enough to draw any conclusion regarding the predicative value of natural Deqi for clinical efficacy or the therapeutic value of manipulation-facilitated Deqi.

Clinical Research of Traditional Chinese Medicine Needs to Develop Its Own System of Core Outcome Sets

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.

Internal challenge to clinical trial project management: strategies for managing investigator compliance.

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.

A summary and evaluation of current evidence for myocardial infarction with Chinese medicine

ObjectiveTo provide evidence-based recommendations for clinical application and provoke thoughts for future researchers by conducting a comprehensive summary and evaluation of the current evidence profile for the role of Chinese medicine (CM) in treating myocardial infarction (MI).MethodsOnline databases including PubMed, EMBase, Cochrane Library, Chinese National Knowledge Infrastructure (CNKI), Chinese Biomedical Medicine (CBM), VIP Journal Integration Platform, and Wanfang database were systematically searched for literatures on CM in treating MI. After screening, studies were categorized into 5 types, i.e. systematic review (SR), randomized controlled trial (RCT), observational study, case report and basic research. General information was abstracted, and the quality levels of these studies and their conclusions were summarized and assessed.ResultsA total of 452 studies including 10 SRs, 123 RCTs, 47 observational studies, 28 case reports, and 244 basic researches were selected. Clinical studies centered primarily on herbal decoction and mostly were not rigorously performed. High-quality studies were predominantly on Chinese patent medicines (CPMs) such as Danshen Injection (丹参注射液), Shenmai Injection (参麦注射液), Shengmai Injection (生脉注射液) and Qishen Yiqi Dripping Pills (芪参益气滴丸). The most frequently observed pattern of drug combination was decoction plus injection. Results of SRs and clinical studies showed that CM may reduce mortality, decrease risk of complication, reduce myocardial injury, improve cardiac function and inhibit ventricular remodeling. Findings from basic researches also supported the positive role of CM in reducing infarct size and myocardial injury, promoting angiogenesis, preventing ventricular remodeling and improving cardiac function. According to the current evidence body, CM has proven effects in the prevention and treatment of MI. It is also found that the effects of CPMs vary with indications. For instance, Shenmai Injection has been found to be especially effective for reducing the incidence of acute clinical events, while CPMs with qi-nourishing and bloodcirculating properties have been proven to be effective in inhibiting ventricular remodeling. High quality evidence supports the use of CM injection for acute MI and CPM for secondary prevention. Reports on adverse events and other safety outcomes associated with CM for MI are scarce.ConclusionsSufficient evidence supported the use of CM as an adjuvant to Western medicine for preventing and treating MI. The choice of drug use varies with disease stage and treatment objective. However, the quality of the evidence body remains to be enhanced.

CUPID: a protocol of a randomised controlled trial to identify characteristics of similar Chinese patent medicines

Introduction 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. Method and analysis 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. Ethics and dissemination 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. Trial registration number Chinese clinical trials register ChiCTR-TTRCC-14004406.

Toward evidence-based Chinese medicine: Status quo, opportunities and challenges

How to test the treatments of Chinese medicine (CM) and make them more widely accepted by practitioners of Western medicine and the international healthcare community is a major concern for practitioners and researchers of CM. For centuries, various approaches have been used to identify and measure the efficacy and safety of CM. However, the high-quality evidence related to CM that produced in China is still rare. Over the recent years, evidence-based medicine (EBM) has been increasingly applied to CM, strengthening its theoretical basis. This paper reviews the past and present state of CM, analyzes the status quo, challenges and opportunities of basic research, clinical trials, systematic reviews, clinical practice guidelines and clinical pathways and evidence-based education developed or conducted in China, pointing out how EBM can help to make CM more widely used and recognized worldwide.

Acupuncture for constipation in patients with stroke: protocol of a systematic review and meta-analysis

Introduction Constipation is one of the most common complications in patients with stroke. Acupuncture has gained increased popularity for the management of constipation. However, there is a lack of supportive evidence on the efficacy of acupuncture for poststroke constipation. This systematic review aims to collect and critically appraise all the available evidence about the efficacy and safety of the acupuncture for constipation in poststroke patients. Methods and analysis A comprehensive search of Pubmed, Embase, Cochrane Central Register of Controlled Trials, Web of Science, four Chinese databases (National Knowledge Infrastructure (CNKI), Chinese Biomedical Literatures database (CBM), Wanfang Digital Periodicals (WANFANG) and Chinese Science and Technology Periodicals (VIP) database), one Japanese medical database (National Institute of Informatics, CiNii) and one Korean medical database (Oriental Medicine Advanced Searching Integrated System, OASIS) will be conducted to identify randomised controlled trials of acupuncture for constipation in poststroke patients. There is no restriction on language or publication status. The primary outcome measure will be frequency of bowel movement. The risk of bias will be assessed using the approach recommended by Cochrane Handbook for Systematic Reviews of Interventions. We will conduct the meta-analysis to synthesise the evidence for each outcome, if possible. The heterogeneity will be statistically assessed using a χ2 test and I2 statistic. This protocol is developed following the guideline of Preferred Reporting Items for Systematic Reviews and Meta-analyses Protocols 2015. Ethics and dissemination The ethical approval is not required because no primary data are collected. The findings will be presented at scientific conferences or a peer-reviewed scientific journal. PROSPERO registration number CRD42017076880.

JinqiJiangtang tablets for pre-diabetes: A randomized, double-blind and placebo-controlled clinical trial

This study observed the efficacy and safety of JinqiJiangtang tablets (JQJT tablets, a traditional Chinese patent medicine) for pre-diabetes. Four hundred patients with pre-diabetes at five centres were treated for 12months and followed for an additional 12months to investigate the preventative effects of JQJT tablets (Registration ID: ChiCTR-PRC-09000401). The incidence rate of diabetes mellitus was the primary endpoint. The risk of converting from pre-diabetes to diabetes was 0.58-fold less in the JQJT tablets group than in the placebo group [HR (95% CI): 0.58 (0.384, 0.876), P = 0.010]. Furthermore, the probability of achieving normalized blood glucose was 1.41-fold greater in the JQJT tablets group than in the placebo group [HR (95% CI): 1.41 (1.002, 1.996), P = 0.0049]. ITT analysis revealed that the incidence of diabetes upon treatment completion was 16.5% in the JQJT tablets group compared with 28.9% in the control group. The percentage of patients with normalized blood glucose upon 12-month intervention was 41.8% in the JQJT tablets group compared with 27.8% in the control group. JQJT tablets could be an effective intervention for preventative treatment of Type 2 diabetes mellitus.