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State-of-the-art evidence of traditional Chinese medicine for treating coronavirus disease 2019

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Journal of Traditional Chinese Medical Sciences 2022年第1期9卷 2-6页

作者： Jianping Liu Fei Dong nicola robinson Center for Evidence-Based Chinese Medicine Beijing University of Chinese MedicineBeijing100029China Institute of Chinese Medicine Epidemic Disease Beijing University of Chinese MedicineBeijing100029China Institute of Health and Social Care London South Bank UniversityLondonSE10AAUK

Traditional Chinese medicine has widely been used internationally in the treatment of coronavirus disease 2019(COVID-19)since January *** has been great interest in initiating clinical studies testing different Chinese medicine therapies for COVID-19,but the majority of registered studies have yet to move forward due to a lack of COVID-19 patients in China's *** aim of this article was to systematically review the current clinical research evidence on Chinese medicine for treating COVID-19 from international and domestic bibliographic databases to reflect on the advances in this field.

关键词： COVID-19 Evidence Prevention Randomized controlled trial Rehabilitation Traditional Chinese medicine Treatment

Integrative Medicine——Traditional Chinese Medicine,A Model?

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Chinese Journal of Integrative Medicine 2011年第1期17卷 21-25页

作者： nicola robinson Faculty of Health and Human Sciences Thames Valley UniversityUnited Kingdom

The paper explores the concept of integrative medicine（IM） in relation to complementary and alternative medicine（CAM）.It contrasts IM available in China to its availability in the *** second part of the paper highlights tools which could facilitate opportunities for *** paper concludes with a plea to ensure and maintain the integrity of traditional Chinese medical practice,and to continue to increase developing the evidence base through a funded European Coordination Action between EU member states and China.

关键词： integrative medicine traditional Chinese medicine evidence based medicine

Methodological Approaches to Developing and Establishing the Body of Evidence on Post-marketing Chinese Medicine Safety

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Chinese Journal of Integrative Medicine 2013年第7期19卷 494-497页

作者：廖星 nicola robinson Institute of Basic Research in Clinical Medicine China Academy of Chinese Medical Sciences Faculty of Health and Social Care London South Bank University

ABSTRACT Evidence based medicine demands the highest form of scientific evidence to demonstrate the efficacy and clinical effectiveness for any therapeutic intervention in order to provide best care. It is however accepted that in the absence of scientific evidence, personal experience and expert opinion together with professional judgement are critical. Obtaining evidence for drug safety, post- marketing surveillance （PMS） has focussed on follow up of observational cohorts exposed to a particular drug in order to estimate the incidence of adverse drug reactions （ADRs）. Evidence on PMS of Chinese herbal products is still limited, in particular for herbal injections. The aim of this article is to suggest a new model of ascertaining the safety of Chinese medicine using a more comprehensive approach for collecting data. To collect safety data on the Chinese herbal injection, Kudiezi, a mixed methods approach is proposed using 18 hospital information systems to detectADRs in order to prospectively observe 30,000 patients over 3 years. Evidence will also be collected using a questionnaire survey and through a sample of semi structured interviews. This information based on the expert opinion and the experience of clinicians will produce additional data on the frequency and types of side effects in clinical practice. Furthermore semi structured interviews with a random sample of patients receiving the injection will be carried out to ascertain any potential side effects missed. It is hoped that this comprehensive approach to data collection will accumulate wider evidence based on individual traditional Chinese medicine care and treatment and provide important feedback to the national data collection system to ensure completeness of ADR data recording, monitoring and any potential wider effects through developing improved ADR guidelines.

关键词： post-marketing medicine Chinese medicine observational study expert opinion evidence

The Importance of Evidence for the Integration of Traditional and Complementary Medicine into Western Healthcare?

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World Journal of Traditional Chinese Medicine 2016年第1期2卷 74-79页

作者： nicola robinson Allied Health Sciences School of Health & Social Care London South Bank University

Policy makers should consider improving access to treatments normally considered outside of healthcare in the west, particularly given the recent WHO strategy. However, research on integrating traditional and complementary medicines(T&CM) into conventional health care is lacking. T& CM approaches, may provide a cost effective option given the increase in chronic diseases with evidence of effectiveness of T& CM being key if such approaches are to be offered as part of integrative patient care, in most countries, an integrated healthcare approach is unavailable to patients. Evidence based clinical guidelines on T& CM should influence care provision. However evidence that is available may not even be cited. Poor use of evidence may possibly be a reflection of lack of knowledge and/or biases of guideline developers but additionally stakeholders vary in their perceived need for evidence to implement health policy change. Journal editors should focus on publishing high quality manuscripts, with clear rationales, design and reporting frameworks. Researchers should consider carrying out careful feasibility studies prior to conducting trials taking into account the UK Medical Research Council's framework on complex interventions. Examples of feasibility studies highlighting their importance for trial design are given in this paper. If preparation for more definitive studies is conducted this will in turn improve the quality of research being designed, executed and published and subsequently encourage the inclusion of evidence by guideline developers. Robust evidence is necessary in order to inform governments' health policies providing appropriate T&CM interventions which can ultimately help to provide best patient care.

关键词： Integrated medicine traditional and complementary medicine clinical guidelines evidence based medicine Delphi Technique acupuncture

Approach to Assess Adequacy of Acupuncture in Randomized Controlled Trials:A Systematic Review

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Chinese Journal of Integrative Medicine 2023年第8期29卷 730-737页

作者： SHI Lan-jun TIAN Zi-yu HU Xiao-yi XIU Wen-cui JIAO Rui-min HU Xiang-yu nicola robinson GANG Wei-juan JING Xiang-hong Institute of Acupuncture and Moxibustion China Academy of Chinese Medical SciencesBeijing(100700)China Centre for Evidence-Based Chinese Medicine Beijing University of Chinese MedicineBeijing(100029)China School of Health and Social Care London South Bank UniversityLondon(SE1OAA)United Kingdom

Objective To summarize and identify the available instruments/methods assessing the adequacy of acupuncture in randomized controlled trials(RCTs)for proposing a new improved *** A systematic literature search was carried out in 7 electronic databases from inception until 21st November *** study evaluating the adequacy or quality of acupuncture,specifying specific acupuncture treatment-related factors as criteria of subgroup analysis,or developing an instrument/tool to assess the adequacy or quality of acupuncture in an RCT was *** information,characteristics and contents of acupuncture adequacy assessment were presented as frequencies and *** Forty studies were included in this systematic ***-five studies(87.50%)were systematic reviews,none of which used formal methods to develop the assessment instruments/methods of acupuncture adequacy;of 5 methodological studies,only 1 study used a relatively formal ***-two studies(82.05%)assessed the components of acupuncture,while 7(17.95%)assessed the overall quality of *** independent assessment instrument/method was used to assess acupuncture adequacy in 29 studies(74.35%),whereas as one part of a methodological quality assessment scale in 10(25.65%).Only 9(23.00%)studies used the assessment results for subgroup analysis,sensitivity analysis or the criteria for inclusion in the *** Assessment contents for adequacy or quality of acupuncture in RCTs hadn’t still reached consensus and no widely used assessment tools *** methodology of available assessment instruments/scales is far from formal and rigorous.A new instrument/tool assessing adequacy of acupuncture should be developed using a formal method.

关键词： acupuncture adequacy assessment quality randomized clinical trial systematic review

Key elements required to publish a good article:consensus among executive editors of Traditional Chinese Medicine and integrative medicine journals——a Delphi study

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Journal of Traditional Chinese Medicine 2015年第3期35卷 335-342页

作者： Hu Xiaoyang robinson nicola Yu He Liu Jianping School of Health and Social Care London South Bank University School of Basic Medicine Beijing University of Chinese Medicine Centre for Evidence-Based Chinese Medicine Beijing University of Chinese Medicine

OBJECTIVE:To explore consensus among Traditional Chinese Medicine(TCM)/ integrative medicine(IM) journal executive editors in China regarding:(a)Their perceptions about the differences between papers published in Chinese/English journals;(b)the key elements required for publishing a good quality paper;(c) how editors manage and decide on the manuscripts submitted to their ***:A three classic round Delphi was conducted with a purposive sample of TCIWIM Chinese journal executive *** key themes and items generated from six open ended questions in the first round were redistributed to the editors in two subsequent questionnaire rounds and scored on a five-point Likert ***,reliability and stability of responses were assessed between the editors in the same round and between ***:All ten editors initially agreeing to participate completed the three rounds,provided 60 comments in the first round,relating to 6 themes on:elements of publishing good quality article;differences between Chinese and English published articles;reasons for low quality of Chinese studies;maintaining the journal's good reputation;initiatives and strategies;and differences between Chinese and English versions of the same *** levels of consensus were reached for 97%***-class correlation(ICC) coefficient for agreement among editors was high in both second and third round and there was a good stability between the two ***:High inter/intra-editor agreement was identified in the differences between TCM/IM research papers published in English and *** standards and probity are keys in elevating the reputation of ***' perspectives in maintaining and improving quality journal can be viewed as fundamental for editors and researchers in publishing any articles.

关键词：中国传统医学出版质量中西医结合行编辑杂志期刊论文 Delphi 编辑管理

Effectiveness and Safety of Chinese Medicine at Shenque(CV 8)for Primary Dysmenorrhea:A Systematic Review and Meta-Analysis of Randomized Controlled Trials

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Chinese Journal of Integrative Medicine 2023年第4期29卷 341-352页

作者： YAN Li-jiao FANG Min ZHU Si-jia WANG Zhi-jie HU Xiao-yang LIANG Shi-bing WANG Dou YANG Dan SHEN Chen nicola robinson LIU Jian-ping Centre for Evidence-Based Chinese Medicine Beijing University of Chinese MedicineBeijing 100029China Department of Oncology Shanxi Provincial Hospital of Traditional Chinese MedicineTaiyuan 030012China Primary Care and Population Sciences Faculty of MedicineUniversity of SouthamptonSO165STUnited Kingdom Research Design Service South Central National Institute of Health ResearchSouthamptonSO166YDUnited Kingdom Department of Nursing Beijing Friendship HospitalBeijing 100050China School of Nursing Beijing University of Chinese MedicineBeijing 100029China Institute of Health and Social Care London South Bank UniversityLondonSE10AAUnited Kingdom

Background:Primary dysmenorrhea(PD)is the most common complaint associated with menstruation and affects up to three-quarters of women at some stage of their reproductive *** Chinese medicine,navel therapy,treatment provided at Shenque(CV 8),is used as a treatment option for ***:To evaluate the effect of navel therapy on pain relief and quality of life in women with PD,compared with Western medicine(WM).Methods:China National Knowledge Infrastructure(CNKI),Chinese Scientific Journal Database(VIP),Sino Med and Wanfang Database,MEDLINE,the Cochrane Library,Embase,Web of Science,and the International Clinical Trial Registry of the *** Institutes of Health were searched from their inceptions to April 1,*** controlled trials(RCTs)assessing therapeutic effects of navel therapy on PD were eligible for *** Man 5.4 software was used for data *** certainty of the evidence was assessed using the online GRADEpro ***:Totally 24 RCTs involving 2,614 participants were *** applied to acupuncture point CV 8 included:herbal patching,moxibustion or combined navel therapy(using at least 2 types of stimulation).Compared to placebo,there was a significant effect in favor of navel therapy on reducing overall menstrual symptom scores at the end of treatment[mean difference:-0.82,95%confidence interval(CI):-1.00 to-0.64,n=90;1 RCT].As compared with Western medicine,navel therapy had a superior effect on pain intensity as assessed by Visual Analogue Scale at the end of treatment[standardized mean difference(SMD):-0.64,95%CI:-1.22 to-0.06,I^(2)=80%,n=262;3 RCTs];on symptom resolution rate at 3-month follow-up(risk ratio:1.94,95%CI:1.47 to 2.56,n=1527,I^(2)=38%;13 RCTs);and on global menstrual symptoms score at the end of treatment(SMD:-0.67,95%CI:-0.90 to-0.45,I^(2)=63%,n=990;12 RCTs).Subgroup analyses showed either a better or an equivalent effect comparing navel therapy with Western *** major adverse

关键词： navel therapy Shenque primary dysmenorrhea quality of life systematic review meta-analysis

Bromelain and Cardiovascular Risk Factors in Diabetes:An Exploratory Randomized,Placebo Controlled,Double Blind Clinical Trial

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Chinese Journal of Integrative Medicine 2016年第10期22卷 728-737页

作者：黎七妹倪青廖星高怀林 nicola robinson School of Health and Social Care London South Bank University Department of Endocrinology Guang'anmen Hospital China Academy of Chinese Medical Sciences Institute of Basic Research in Clinical Medicine China Academy of Chinese Medical Sciences Department of Endocrinology Yiling Hospital Affiliated to Hebei Medical University

Objective： To assess whether the dietary supplement （bromelain） has the potential to reduce plasma fibrinogen and other cardiovascular disease （CVD） risk factors in patients with diabetes. Methods： This randomized placebo controlled, double blind, parallel design, efficacy study was carried out in China and investigated the effect of 12 weeks of bromelain （1,050 mg/day） on plasma fibrinogen, This randomized controlled trial （RCT） recruited 68 Chinese diabetic patients [32 males and 36 females; Han origin, mean age of 61.26 years （standard deviation （SD）, 12.62 years）] with at least one CVD risk factor. Patients were randomized into either bromelain or placebo group. While bromelain group received bromelain capsule, the placebo group received placebo capsule which consisted inert ingredient and has no treatment effect. Subjects were required to take 1,050 mg （3× 350 mg） of either bromelain or starch-tiffed placebo capsules, two to be taken （2 × 350 mg） after breakfast and another （350 mg） after dinner, daily for 12 weeks. Plasma fibrinogen, CVD risk factors and anthropometric indicators were determined at baseline and at 12 weeks. Results： The change in the flbrinogen level in the bromelain group at the end of the study showed a mean reduction of 0.13 g/L （standard deviation （SD） 0.86g/L） compared with the mean reduction of 0.36 g/L （SD 0.96 g/L） for the placebo group. However, there was no significant difference in the mean change in fibrinogen between the placebo and bromelain groups （mean difference=0.23g/L （SD 0.22 g/L）, P=0.291）. Similady, the difference in mean change in other CVD risk factors （blood lipids, blood pressure）, blood glucose, C-reactive protein and anthropometric measures between the bromelain and placebo groups was also not statistically significant. Statistical differences in fibrinogen between bromelain and placebo groups before the trial despite randomization may have influenced the results of this study. Conclusion： This RCT failed to show a

关键词： cardiovascular disease fibrinogen diabetes bromelain randomized control trial

To Establish A Body of Evidence on Safety for Postmarketing Chinese Medicine：A New Research Paradigm

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Chinese Journal of Integrative Medicine 2017年第3期23卷 226-232页

作者： LIAO Xing XIE Yan-ming nicola robinson WANG Yong-yan Institute of Basic Research in Clinical Medicine China Academy of Chinese Medical Sciences Beijing 100700 China

The issue of safety evaluation on postmarketing Chinese medicines has become a hot topic in China’s mainland recently. Researchers and decision-makers can obtain a variety of evidence resources about safety in order to evaluate the safety profile for postmarketing Chinese medicines. A registry study on ten Chinese medicine injections for postmarketing surveillance has come to the end. From such a study observing more than 300,000 patients for more than 4 years, a theoretical research question emerges, that is, how to identify and evaluate safety evidence systematically. We put forward a brand new research paradigm on the theory level, which is to establish a body of evidence on safety evaluation for postmarketing Chinese medicine. Therefore, multiple information sources were explored and extracted from preclinical experiments for toxicity, postmarketing clinical trials for efficacy and safety evaluation, registry study for surveillance, retrospective data analysis from hospital information system and spontaneous response system, and case reports and systematic review from literature. Greater efforts for this idea and cooperation with experts in this field both in China and abroad are urgently needed.

关键词： postmarketing Chinese medicine safety research Kudiezi Injection body of evidence