Heterogeneity of Outcomes Reporting in Trials Evaluating Traditional Chinese Medicine Breast Massage for Stasis Acute Mastitis: A Methodological Review

Objective To systematically analyze the current status of outcomes reporting in clinical trials on treating stasis acute mastitis with Traditional Chinese Medicine breast massage.Methods We searched CNKI,Wanfang,VIP,Sino Med,Pub Med,Web of Science,Embase,Cochrane library,JBI,CINAHL,Psyc INFO,Clinical Trials Registry Platform portal,Clinical Trials Registry,Australian New Zealand Clinical Trials Registry,Center Watch Registry from inception to May 15,2022 to find randomized controlled trials,non-randomized controlled trials,case series and cohort studies which reported the outcomes of stasis acute mastitis managed with Traditional Chinese Medicine breast massage,with search terms of mastitis,acute mastitis,lactation mastitis,puerperal mastitis,breast problem,breast engorgement,milk stasis,blocked ducked,breast pain,breast massage,and acupoint massage.Outcomes and the measurement schemes(measurement methods,timing of assessing outcome,frequency of assessing outcome,measurers)were extracted from the included studies.We used the Management of Otitis Media with Effusion in Children with Cleft Palate(MOMENT)to assess the quality of each study,then categorized outcomes derived from the included studies into different domains according to the Outcome Measures in Rheumatology Arthritis Clinic Trials(OMERACT)Filter 2.1 framework.Results We identified 85 clinical trials,in which 54 different outcomes were reported.A total of 81.2%(69/85)of studies were assessed as medium quality with a mean score of 2.6,and 18.8%(16/85)as low quality with a mean score of 0.9.These outcomes were organized in three core areas.Lump size(89.4%,76/85)was the most frequently reported outcome,followed by breast pain(69.4%,59/85)and milk excretion(68.2%,58/85).Five methods were used to assess lump size and four methods to assess breast pain.Conclusions The outcomes reported in clinical trials regarding stasis acute mastitis treated by Traditional Chinese Medicine breast massage are heterogeneous.Developing a core outcome set to achieve consistent standards for reporting outcomes and modalities for validation of the outcomes is clearly warranted.

Operating procedures of traditional Chinese medicine breast massage

Traditional Chinese medicine breast massage,also known as breast Tuina or manual expression of breast milk,is a technique of using certain manipulations to act on specific positions or acupoints of the breast to promote blood and lymphatic circulation of breast and facilitate the discharge of stagnant milk.This technique is widely used in China to treat breastfeeding problems such as breast engorgement,mastitis,and postpartum hypogalactia.In this article,we introduce the definition and standardization process of breast massage,elaborate the operating procedures of breast massage in detail,and summarize and discuss the current situation of its clinical application,so as to provide a reference for its wide application and in‑depth research.

Reabsorption of intervertebral disc prolapse after conservative treatment with traditional Chinese medicine:A case report

BACKGROUND Conservative treatments have been reported to diminish or resolve clinical symptoms of lumbar intervertebral disc herniation(LIDH)within a few weeks.CASE SUMMARY Computed tomography and magnetic resonance imaging(MRI)of the lumbar region of a 25-yearold male diagnosed with LIDH showed prolapse of the L5/S2 disc.The disc extended 1.0 cm beyond the vertebral edge and hung along the posterior vertebral edge.The patient elected a conservative treatment regimen that included traditional Chinese medicine(TCM),acupuncture,and massage.During a follow-up period of more than 12 mo,good improvement in pain was reported without complications.MRI of the lumbar region after 12 mo showed obvious reabsorption of the herniation.CONCLUSION A conservative treatment regimen of TCM,acupuncture,and massage promoted reabsorption of a prolapsed disc.

Investigation on the cognitive status and the infiltration path of Traditional Chinese Medicine among residents in Liaoning Province

To understand citizens’awareness,trust and attitude towards Tradition Chinese medicine(TCM),to seek the best penetration path of TCM products and culture,to analyze their influencing factors,and to provide suggestions and countermeasures,a non-probabilistic judgment sampling method was used to conduct a survey among 459 people online with the help of Questionnaire Star and 434 valid questionnaires were collected.The survey shows that residents have a high degree of recognition and identification of Chinese medicine;citizens are rational when choosing TCM products,and the recognition of the emerging TCM culture infiltration path is low.Different social and demographic factors affect citizens’awareness,trust and attitude towards TCM,as well as the choice of infiltration path(P<0.05).

Treatment of 140 cerebral palsied children with a combined method based on traditional Chinese medicine(TCM)and western medicine

Objective:To observe and evaluate a method that is effective and practical for treatment of cerebral palsied(CP)children in China.Method:The patient's age and disease type and individual specific conditions were considered in choosingtherapy methods accordingly:Chinese herbs,acupuncture,auricnlar seed pressure,point finger pressing,massage,orthopedichand manipulation,physiotherapy,occupational therapy,language therapy,etc.Meanwhile we created a new CP treatment modelthat combines hospitalized treatment with family therapy.Results:The majority of CP patients improved greatly in motor andsocial adaptation capacities after treatment.Wilcoxon paired rank sum test analysis showed that there were significant differencesbetween the data before and after treatment(P<0.01).Conclusion:This combined therapy method,based on traditional Chinesemedicine and western medicine plus family supplemental therapy,is an effective and practical treatment strategy for CP children inChina.

Analysis on medication rule of traditional Chinese medicine treating chemotherapy-induced diarrhea based on traditional Chinese medicine(TCM) inheritance computing platform system

Objective:To dig deeper into the traditional Chinese medicine treatment rules of chemotherapy-induced diarrhea with traditional Chinese medicine(TCM)inheritance computing platform system.Methods:Taking“traditional Chinese medicine”,“chemotherapy”and“diarrhea”as the theme words,comprehensive search of the database of CNKI,Wanfang and VIP from its inception to November 2020 was conduct-ed.The formulas of external treatment of traditional Chinese medicine for chemotherapy-induced diarrhea were included and the association rule,clustering and factor analysis were carried out.Results:A total of 145 papers,57 prescriptions meeting the inclusion criteria were collected,among which high-frequency drugs including Baizhu(Atractylodis macrocephalae rhizoma),Fuling(Poria),Dangshen(Codonopsisradix),Huanglian(Coptidis rhizoma),Zhigancao(Glycyrrhizae radix et rhizoma praeparata cum melle)were the most commonly used.The confidence level was set as 0.7 and the support level was set as 10,12 core compatibility groups were obtained,and 6 categories were cluster analyzed.Conclusion:The principle of external treatment of chemotherapy-induced diarrhea is mainly“restore deficiency and benefiting qi”,“benefiting water infiltration and dampness”,“clearing heat”and“inducing astringency”.Prescription combination and new prescription combination based on traditional Chinese medicine(TCM)inheritance computing platform system can be used as reference for clinicians and applied in primary hospitals.

Traditional Chinese Medicine and Standardization——Origin and development of TCM

Traditional Chinese Medicine (TCM) is the medical science based on theories and practicing experience of traditional Chinese medicine to study transferring principles of health and sickness,as well as prevention, diagnosis,treatment,rehabilitation and healthcare.TCM is marked with its long history of development,integrated theory system and abundant practicing experience.

Study on the Key to Massage Therapy of Traditional Chinese Medicine

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Review: The vital role of traditional Chinese medicine (TCM) in the prevention and treatment of COVID-19 and the etiology and pathogenic mechanism of COVID-19 based on TCM theory

"Yi"is defined in traditional Chinese medicine theory as the general pathological conditions of epidemics.Throughout thousands of years of history,TCM has been playing an essential role in preventing and treating epidemics in China.Showing significant efficacy against severe acute respiratory syndrome(SARS)in 2002 and 2003,a medical intervention involving TCM was applied at the beginning of the pandemic of the corona virus disease 2019(COVID-19),and has been found with good preventive and curative value in clinical practice.In this study,the etiology and pathogenic mechanism of COVID-19 was discussed on a TCM theory basis,and the clinically effective prevention and treatment methods/prescriptions were summarized.It is suggested that TCM has been playing a unique and vital role in preventing and treating COVID-19,and thus contributes greatly to public health.

The effect of traditional Chinesemedicine washing combined withmassage for neonataljaundice： a meta-analysis

Objective： To systematically assess the effect of traditional Chinese medicine washing （TCM washing） combined withmassage for the treatment of neonatal jaundice.Methods and analysis： Databases, including PubMed, the Cochrane Library, Embase, Web of Science, the ChineseBiomedical Literature Database （CBM）, CNKI, and Wanfang Data were electronically searched for randomizedcontrolled trials （from inception to July 2017）. The methodological qualities of included trials were evaluated by theCochrane risk of bias assessment tool. The meta-analysis was performed by using RevMan 5.3 software.Results： Overall, thirteen trials with a total of 1998 participants were included. The results of meta-analysis indicatedthat TCM washing combined with massage group was significantly superior to the control group in the first meconiumtime （MD, -16.67; 95% CI, -24.59 to -8.74; P〈0.001）, time for transformation of meconium （MD, -15.44; 95% CI,-23.59 to -7.28; P〈0.001）, transcutaneous bilirubin index changes [after treating three days （MD, -1.99; 95% CI, -2.57 to-1.40; P〈0.001）, after treating four days （MD, -1.86; 95% CI, -2.77 to -0.95; P〈0.001）, after treating five days （MD,-2.44; 95% CI, -3.47 to -1.42; P〈0.001）, after treating six days （MD, -2.23; 95% CI, -3.30 to -1.16; P〈0.001）, and thechanges of serum bilirubin levels [after treating five days （MD, -3.17; 95% CI, -5.83 to -0.50; P=0.02）, after treating sixdays （MD, -1.63; 95% CI, -3.10 to -0.16; P=0.03）, after treating fifteen days （MD,-1.20; 95% CI, -1.99 to -0.41; P=0.003）.Conclusions： TCM washing combined with massage may be an effective therapy for the treatment of neonatal jaundice.It can accelerate the excretion of meconium, shorten the time for transformation of meconium, and decreasetranscutaneous bilirubin index and the level of serum bilirubin. But it should be careful to interpreting these findings.Well-designed RCTs are needed to further clarify the conclusion.

The Great Significance of Establishing Strategic Status of Traditional Chinese Medicine (TCM)

Traditional Chinese Medicine(TCM), based on the philosophic idea of “correlation between man and nature” and “balance of Yin and Yang” and characterized by “integrated concept” and “syndrome identification & treatment determination”, adjusts and activates the self-recuperating ability to rectify its differentiation from normality of human body to meet the goal of preventing and treating diseases mainly by means of traditional Chinese medicinal herbs, acupuncture and moxibustion, etc. The idea of “Human should be in harmony with Nature including bacterium, virus, etc., but not to exterminate microbe in a large scale”, held and promoted by TCM gives, rise to a delicate physiological equilibrium kept between man and microbe and this is just the development trend of medical science in future. For thousands years, TCM has made indelible contribution to the reproduction and prosperity of the Chinese nation, and under the countless attacks of pestilence has never made its people’s death in millions, not such as once occurred in Europe. TCM is also characterized by its “simple, convenient, cheap and effective”method of treatment” and is especially good at preventing and treating chronic diseases, complicate multi-system diseases and new-type virus diseases. Therefore, only when the sanitation and healthcare system is established can the health of 13 billion people in China and the problem of shortage of doctor and medicine for 900 million rural population and large number of poverty-stricken urban population be solved. It is strongly suggested that five promotion projects, namely: TCM policy and statute guarantee, TCM qualified personnel cultivation, TCM scientific research, development of TCM in rural areas and TCM administrative system reform should be carried out in real earnest to make TCM develop in a sustainable way.

A holistic strategy for quality and safety control of traditional Chinese medicines by the “iVarious” standard system

An effective quality control system is the key to ensuring the quality, safety and efficacy of traditional Chinese medicines(TCMs). However, the current quality standard research lacks top-level design and systematic design,mostly based on specific technologies or evaluation methods. To resolve the challenges and questions of quality control of TCMs, a brand-new quality standard system, named "iVarious", was proposed. The system comprises eight elements in a modular format. Meaning of every element was specifically illustrated via corresponding research instances. Furthermore, frankincense study was taken as an example for demonstrating standards and research process, based on the "i Various" system. This system highlighted a holistic strategy for effectiveness,security, integrity and systematization of quality and safety control standards of TCMs. The establishment of"i Various" integrates multi-disciplinary technologies and progressive methods, basis elements and key points of standard construction. The system provides a novel idea and technological demonstration for regulation establishment of TCMs quality standards.

Applications of HPLC/MS in the analysis of traditional Chinese medicines

In China, traditional Chinese medicines （TCMs） have been used in clinical applications for thousands of years. The successful hyphenation of high-performance liquid chromatography （HPLC） and mass spectrometry （MS） has been applied widely in TCMs and biological samples analysis. Undoubtedly, HPLC/MS technique has facilitated the understanding of the treatment mechanism of TCMs. We reviewed more than 350 published papers within the last 5 years on HPLC/MS in the analysis of TCMs. The present review focused on the applications of HPLC/MS in the component analysis, metabolites analysis, and pharmacokinetics of TCMs etc. 50% of the literature is related to the component analysis of TCMs, which show that this field is the most popular type of research. In the metabolites analysis, HPLC coupled with electrospray ionization quadrupole time-of-flight tandem mass spectrometry has been demonstrated to be the powerful tool for the characterization of structural features and fragmentation behavior patterns. This paper presented a brief overview of the applications of HPLC/MS in the analysis of TCMs. HPLC/MS in the fingerprint analysis is reviewed elsewhere.

Study progress in therapeutic effects of traditional Chinese medicine monomer in severe acute pancreatitis

Severe acute pancreatitis (SAP) is a common acute abdomen clinical problem characterized by high mortality, mul-tiple complications, complicated pathogenesis and difficult treatment. Recent studies found traditional Chinese medicine (TCM) monomers have markedly good effect for treating SAP. Many TCM monomers can inhibit pancreatin, resist inflammation, im-prove microcirculation and immunoloregulation, etc. to block the pathological progress of SAP in multiple ways, reduce com-plications and lower mortality with rapid effects. It is significant for enhancing SAP treatment to deeply understand the current situation in TCM monomers for treating SAP and take precious references therein. This article summarizes the treating effects and mechanisms of TCM monomers for SAP in recent years.

基于SCORE-TCM的中医药团体标准抽样评价方案设计

目前,各社会团体积极参与中医药标准的制定和发布,特别是“十四五”以来,中医药团体标准化工作更是迎来了提质增效的关键阶段。深入评估社会团体发布的中医药标准质量,是推进中医药团体标准工作的关键环节和重点任务。前期已研制并形成了中医药团体标准评价体系(System of Consortium Standards Rating and Evaluation of Traditional Chinese Medicine, SCORETCM)。在上述背景下,本研究通过专家共识法,设计了一套基于SCORE-TCM的中医药团体标准抽样评价方案,应用场景为对于特定社会团体发布的标准,或各团体发布的特定技术类别的标准进行快速评估。该方案涵盖了标准抽样、材料收集、标准评价、结果解读的完整流程,为中医药团体标准的抽样评价工作提供了参考方案。

中医药团体标准评价体系(SCORE-TCM)解读

本文全面解读了中医药团体标准评价体系(System of Consortium Standards Rating and Evaluation of Traditional Chinese Medicine,SCORE-TCM)。SCORE-TCM是结合定性与定量评价,全面评估中医药团体标准在制定主体、文本编写、技术内容、推广应用和实施效益等几方面特征的综合评价工具。文中详述了SCORE-TCM的构建目的、定义和构建过程,解释了评价指标体系中的各项指标,并对每项指标的评价材料进行介绍。本文旨在帮助中医药团体标准的制定者、第三方评价机构和其他相关方更好地理解SCORE-TCM各评价条目的含义,更有效地运用于中医药团体标准的自评价或第三方评价,SCORE-TCM将为《中医药团体标准管理办法》的贯彻实施,以及中医药团体标准的高质量发展提供技术支持。

Early metabolism evaluation making traditional Chinese medicine effective and safe therapeutics

Increasing attention is being paid to the scientific evaluation of traditional Chinese medicine （TCM）. As many TCMs are capable of biotransformation in the gastrointestinal tract, attention to biotransforrnation of TCM in the gastrointestinal tract may lead to discovery of the active components and active mechanisms. In this article, we review reports that host metabolic enzymes and intestinal bacteria may be responsible for the metabolism of TCM. Good understanding of the in vivo course of TCM will help us to know how to conduct metabolism evaluation of TCM by using in vitro human-derived system. This evaluation system will create new views on TCM as effective and safe therapeutic agents.

A General Introduction of HIV/AIDS Treatment with Traditional Chinese Medicine in China

This paper gives a general introduction of HIV/AIDS treatment with Traditional Chinese Medicine (TCM) in China during the past 20 years. Although the role of TCM in treatment of HIV/AIDS is promising,there is still a long way to go.

Terahertz spectrum clustering of traditional Chinese medicine based on first derivative characteristics

In order to deal with the unclear absorption peak caused by the absorption peak overlap of traditional Chinese medicine(TCM)and other mixtures,a method of three unsupervised clustering algorithms as K-means,K-medoids and Fuzzy C-means(FCM)combined with the first derivative characteristics of terahertz absorption spectrum,is proposed to perform the terahertz spectra clustering of Sanchi and other three kinds of TCM compared with their easily-confused products(ECPs).These three unsupervised clustering methods complement the scope of the supervised learning classification method.The first derivative of the spectrum could amplify the difference in the absorption coefficient with different substances,so that the obvious absorption peak can be revealed.Experiments shows that these three clustering algorithms can achieve good results by combining the origin absorption coefficient with its first-order derivative as the characteristic data,and among which K-means does the best with the accuracy of95.32%.Compared with pure absorption coefficient data clustering,the accuracy in this study has been significantly improved,especially for the non-absorption-peak TCM classification.And the accuracy of K-means algorithm is improved by5.38%.Besides,clustering algorithms in this study have strong anti-interference ability to the error data.

Multimodal integrated strategy for the discovery and identification of quality markers in traditional Chinese medicine

With the modernization and internationalization of traditional Chinese medicine(TCM),the requirement for quality control has increased.The quality marker(Q-marker)is an important standard in this field and has been implemented with remarkable success in recent years.However,the establishment of Qmarkers remains fragmented and the process lacks systematicity,resulting in inconsistent quality control and insufficient correlation with clinical efficacy and safety of TCM.This review introduces four multimodal integrated approaches that contribute to the discovery of more comprehensive and accurate Qmarkers,thus aiding in the establishment of new quality control patterns based on the characteristics and principles of TCM.These include the whole-process quality control strategy,chemical-activity-based screening method,efficacy,safety,and consistent combination strategy,and TCM theory-guided approach.Furthermore,methodologies and representative examples of these strategies are described,and important future directions and questions in this field are also proposed.