Advanced applications of mass spectrometry imaging technology in quality control and safety assessments of traditional Chinese medicines.

ETHNOPHARMACOLOGICAL RELEVANCE: Traditional Chinese medicines (TCMs) have made great contributions to the prevention and treatment of human diseases in China, and especially in cases of COVID-19. However, due to quality problems, the lack of standards, and the diversity of dosage forms, adverse reactions to TCMs often occur. Moreover, the composition of TCMs makes them extremely challenging to extract and isolate, complicating studies of toxicity mechanisms. AIM OF THE REVIEW: The aim of this paper is therefore to summarize the advanced applications of mass spectrometry imaging (MSI) technology in the quality control, safety evaluations, and determination of toxicity mechanisms of TCMs. MATERIALS AND METHODS: Relevant studies from the literature have been collected from scientific databases, such as "PubMed", "Scifinder", "Elsevier", "Google Scholar" using the keywords "MSI", "traditional Chinese medicines", "quality control", "metabolomics", and "mechanism". RESULTS: MSI is a new analytical imaging technology that can detect and image the metabolic changes of multiple components of TCMs in plants and animals in a high throughput manner. Compared to other chemical analysis methods, such as liquid chromatography-mass spectrometry (LC-MS), this method does not require the complex extraction and separation of TCMs, and is fast, has high sensitivity, is label-free, and can be performed in high-throughput. Combined with chemometrics methods, MSI can be quickly and easily used for quality screening of TCMs. In addition, this technology can be used to further focus on potential biomarkers and explore the therapeutic/toxic mechanisms of TCMs. CONCLUSIONS: As a new type of analysis method, MSI has unique advantages to metabolic analysis, quality control, and mechanisms of action explorations of TCMs, and contributes to the establishment of quality standards to explore the safety and toxicology of TCMs.

Erding formula and bioactive markers in hyperuricemia: towards rational scientific approaches for the modernization of Traditional Chinese Medicine

Introduction: Traditional Chinese Medicine (TCM) represents one of the first holistic approaches in the world to treat and prevent disease. Herbal medicine is one of the major therapeutic remedy in TCM. It often involves multi-herb therapies instead of single herb preparations. Parallel to western medicine, hundreds of herbal formulas have been made available as finished products. Currently, the use of herbal products is popular as treatment option or to complement western medicine. Indications of the herbal formulas were established by TCM terms such as heat-clearing and/or detoxifying which lack modern pharmacological meanings. It is difficult for people without relevant background to understand such terms and their implications for treatments. Furthermore, due to the quality control issues of herbal medicines which contain multiple constituents, consumers may be confronted with the risk of using unstandardized products. Hence, in this thesis, the modernization of TCM is discussed through employing scientific pharmaceutical approaches to a traditional formula, called Erding formula (EF). The aim was to investigate if a new indication, hyperuricemia, can be assigned to a heat-clearing and detoxifying formula. Our hypothesis was: Can Erding formula be used for hyperuricemia treatment and is esculetin a bioactive marker for this new indication? Methods: A hypoxanthine and potassium oxonateinduced hyperuricemic mouse model, a xyleneinduced inflammatory mouse model, and an acetic acidinduced pain model were used to investigate EF and its constituent herbs. The quantity of esculetin was measured by high-performance liquid chromatography. The therapeutic effect of esculetin was assessed using potassium oxonate induced hyperuricemic mouse model, and esculetin and its metabolites were characterized in serum via ultra-performance liquid chromatographyquadrupole time-of-flight mass spectrometry. To develop a modern dosage form, a laboratory-scale wet bead milling approach was employed to prepare esculetin nanocrystals. The formulation was further optimized by design of experiment, and an optimized formulation was then characterized for its saturation solubility and short-term stability. Results: The study showed that EF and Viola yedoensis Makino (Viola) lowered uric acid (UA) levels, while EF and all four individual herbs had antiinflammatory and analgesic activities. These findings revealed that EF was able to treat hyperuricemia and suggested that Viola was the main herb in EF on reducing UA levels. The study showed that esculetin significantly reduced UA levels and six metabolites of esculetin were identified in serum. This confirms that esculetin was absorbed and is a suitable bioactive and quality control marker for EF in hyperuricemia treatment. An esculetin-Povacoat nanocrystal formulation with a 200 nm particle size was successfully prepared. The formulation presented up to a 1.5-fold increase in saturation solubility compared to the bulk esculetin and it was stable for 180 days. Conclusion: The studies proved that Erding formula can be used for hyperuricemia treatment with esculetin as bioactive quality control marker. As well, a new nano-sized formulation of the bioactive marker, esculetin, was created. This presented the possibility to develop an innovative nanotechnological product of the active substances derived from herbal medicine. The findings facilitated a better understanding of TCM terms and concept through mechanistic scientific experiments. This study revealed a potential pathway and an idea to modernize TCM without setting aside its unique concepts. This might increase the global acceptance of TCM products. Furthermore, the TCM concept might be useful in the development of multi-component drug products

Medicina Tradicional Chinesa (MTC) representa uma das primeiras abordagens holísticas em âmbito global para tratar e prevenir doenças. A fitoterapia consiste na principal terapia na MTC. Frequentemente, envolve terapias com múltiplas ervas em vez de preparações individuais. Paralelamente à medicina ocidental, centenas de fórmulas herbais foram disponibilizadas como produtos acabados. Atualmente, o uso de produtos fitoterápicos é popular como opção de tratamento ou para complementar a medicina ocidental. As indicações das fórmulas fitoterápicas foram estabelecidas pelos termos da MTC, tais como "limpeza pelo calor e / ou desintoxicante", que não têm significados farmacológicos modernos. É difícil para a população em geral e mesmo para profissionais sem histórico relevante na área entender tais termos e suas implicações para os tratamentos. Além disso, devido às questões de controle de qualidade dos medicamentos fitoterápicos que contêm múltiplos constituintes, os pacientes podem ser confrontados com o risco de usar produtos não padronizados. Assim, nessa tese, a modernização da MTC é discutida por meio da utilização de abordagens farmacêuticas científicas para uma fórmula tradicional, denominada fórmula de Erding (FE). O objetivo foi o de investigar se uma nova indicação, a hiperuricemia, pode ser atribuída a uma fórmula desintoxicante e de compensação de calor. Nossa hipótese foi: a fórmula de Erding pode ser usada para tratamento de hiperuricemia e a esculetina é um marcador bioativo para essa nova indicação? Foi empregado modelo de camundongo hiperuricêmico induzido por hipoxantina e oxonato de potássio, outro modelo de camundongo inflamatório induzido por xileno e, adicionalmente, modelo de dor induzida por ácido acético. Esses modelos foram usados para investigar a FE e suas ervas constituintes. A quantidade de esculetina foi determinada por cromatografia líquida de alta eficiência. O efeito terapêutico da esculetina foi avaliado utilizando modelo de camundongo hiperuricêmico induzido por oxonato de potássio, e a esculetina e seus metabólitos foram caracterizados no soro por cromatografia líquida de alto desempenho - espectrometria de massa. Para desenvolver forma farmacêutica moderna, uma abordagem de moagem em escala úmida reduzida foi empregada tendo em vista a preparação de nanocristais de esculetina. A formulação foi ainda otimizada empregado planejamento experimental. Essa fórmula foi caracterizada quanto à sua solubilidade de saturação e estabilidade a curto prazo. O estudo mostrou que a FE e a Viola yedoensis Makino (Viola) reduziram os níveis de ácido úrico (AU), enquanto a FE e as quatro plantas individuais apresentaram atividades antiinflamatória e analgésica. Esses resultados revelaram que a FE foi capaz de tratar a hiperuricemia e sugeriu que a viola foi a principal erva da FE na redução dos níveis de AU. O estudo mostrou também que a esculetina reduziu significativamente os níveis de AU e os seis metabólitos da esculetina foram identificados no soro. Tal resultado confirma que a esculetina foi absorvida e pode ser usada como marcador de controle bioativo e de qualidade para FE, no tratamento da hiperuricemia. A formulação de nanocristais de esculetin-povacoat® apresentou tamanho de partícula de 200 nm. A formulação apresentou aumento de 1,5 vezes na solubilidade de saturação em comparação com a esculetina em escala micrométrica e manteve-se estável durante 180 dias. Os estudos comprovaram que a fórmula de Erding pode ser utilizada no tratamento da hiperuricemia empregando a esculetina como marcador bioativo de controle de qualidade. Além disso, foi desenvolvida formulação inovadora, em escala nanométrica, do marcador bioativo, a esculetina. Esse resultado permitiu desenvolver produto com base nanotecnológica das substâncias ativas derivadas do fitoterápico, assim comol permitiram melhor compreensão dos termos e dos conceitos da MTC por meio de experimentos científicos mecanicistas. Esse estudo revelou potencial para a modernização da MTC sem excluir seus conceitos únicos. Isso pode aumentar a aceitação global dos produtos MTC. Além disso, o conceito de MTC pode ser útil no desenvolvimento de medicamentos de múltiplos componentes

Development status and prospects of international standardization of medical devices of Traditional Chinese Medicine.

As Traditional Chinese Medicine (TCM) becomes widely used in many countries around the world, global demand for intelligent and modernized medical devices of TCM is increasing. Medical devices of TCM have played an important role in diagnosis and treatment of disease. Standardization on medical devices of TCM cannot only be beneficial to ensuring the life safety of patients, but also to enhancing the effectiveness of diagnosis and treatment. This paper includes (1) classification and trends in medical devices of TCM; (2) status review on international standardization of medical devices of TCM; (3) key technical factors in developing international standards for medical devices of TCM and (4) prospects for international standardization development of medical devices of TCM.

Fire needle therapy for blood stasis syndrome of plaque psoriasis: A protocol for systematic review and meta-analysis.

BACKGROUND: Plaque psoriasis (PSO) is a common clinical chronic inflammatory skin disease. The incidence rate is increasing year by year due to the fast pace of work and unhealthy diet. Fire needle has been widely used in the treatment of PSO. However, the efficacy of fire needle for PSO is uncertain. Thus, the purpose of this systematic review is to evaluate the effectiveness and safety of fire needle for PSO (blood stasis syndrome). METHODS: The following electronic databases will be searched from inception to October 2020:PubMed, Web of Science, Embase, Cochrane Library, China National Knowledge Infrastructure, WangFang Database, Chinese Science Journal Database, Chinese Biomedical Literature Database. In addition, other documents that meet the requirements will be manually searched, including conference papers, dissertations, etc. All randomized controlled trials using fire needle to treat PSO (blood stasis syndrome) that meet the criteria for inclusion will be included. The primary outcomes are clinical efficacy, Psoriasis area and severity index. Secondary outcomes include Itchy, TCM evaluation standard syndrome score, Dermatological quality of life index, and adverse events. To complete data synthesis and assess the risk of bias, we will use the RevMan V.5.3 software. RESULTS: The review results will be published in a peer-reviewed journal. CONCLUSION: This study will provide high-quality evidence based medicine to evaluate the effectiveness and safety of fire needle for PSO (blood stasis syndrome), and further seek its scientific and effective chinese medicine treatment methods. INPLASY REGISTRATION NUMBER: INPLASY202120007.

The study on the clinical effectiveness and safety of traditional Chinese medicine acupoint catgut embedding guided by musculoskeletal ultrasound in the treatment of nerve root sciatica: A protocol for systematic review and meta-analysis of randomized controlled trials.

BACKGROUND: Nerve root sciatica (NRS) is a common orthopedic disease, which usually occurs between 20 and 40 years of age, and the incidence rate is increasing year by year and is being younger. The disease has no special effect of treatment, clinically generally taking the symptomatic treatment, such as taking short-term glucocorticoids, sedatives, analgesics, and so on. Long-term use of drugs will adversely affect the patient's gastrointestinal tract, liver, and kidney function. The surgical treatment has a high risk of surgery, high cost, side effects, and other problems, so the choice of treatment method has always been a difficult problem in clinical and scientific research. The study shows that 90% of patients with sciatica can be cured by non-surgical treatment, so conservative therapy is often used in the treatment of sciatica, traditional Chinese medicine treatment methods in the treatment of NRS has been widely used, which has achieved good results, but there is no evidence of evidence-based medicine. Therefore, this study uses systematic evaluation to conduct the scientific evaluation of the clinical effectiveness and safety of traditional Chinese medicine acupoint catgut embedding guided by musculoskeletal ultrasound in the treatment of NRS, and provide evidence-based medical evidence support for the treatment of NRS. METHODS: Using the computer to retrieve the PubMed, ScienceDirect, Web of Science, Embase, Cochrane Library, CNKI, VIP, WANFANG Database, and CBM. Using the subject words and terminology words to retrieve the Chinese-English database and retrieve a randomized controlled study on the clinical effectiveness and safety of traditional Chinese medicine acupoint catgut embedding guided by musculoskeletal ultrasound in the treatment of NRS, and the range of search time is January 1990 to January 2021. The searched literature is screened and evaluated by two researchers respectively according to the inclusion and exclusion criteria. If there is disagreement, discussing it with the third researcher to determine the final inclusion of the literature. Using the RevMan 5.3 software to conduct the meta-analysis. RESULTS: This study will compare the effectiveness and safety of traditional Chinese medicine acupoint catgut embedding guided by musculoskeletal ultrasound in the treatment of NRS. CONCLUSION: The results of this study will be published in internationally influential academic journals to provide evidence-based medical evidence for the clinical effectiveness and safety of traditional Chinese medicine acupoint catgut embedding in the treatment of NRS. ETHICS AND DISSEMINATION: This study does not involve specific patients, and all research data comes from publicly available professional literature, so an ethics committee is not required to conduct an ethical review and approval of the study. OSF REGISTRATION NUMBER: DOI 10.17605/OSF.IO/Q492E.

Plum-blossom needle plus Chinese herbal medicine for alopecia areata: A protocol for systematic review and meta analysis.

BACKGROUND: Alopecia areata (AA) is a common, inflammatory, nonscarring type of hair loss that is characterized by depression, anxiety and social isolation. In recent years, Plum-blossom needle plus Chinese herbal medicine has gradually shown its clinical advantages and been more and more widely used in China. Whereas, there has been no systematic review and meta-analysis. The purpose of this study is to estimate the safety and effectiveness of Plum-blossom needle plus Chinese herbal medicine in AA treatment. METHODS: Seven databases as following: PubMed, Embase, Cochrane Library, China National Knowledge Infrastructure (CNKI), Chinese Scientific Journal Database (VIP), and Chinese Biomedical Literatures Database (CBM) will be searched from their inception to August 2020. Two reviewers (LBL and ZYZ) will respectively regulate research selection, data extraction, and risk of bias assessment. A third reviewer will be settled to consulting, if necessary. Review Manager Software 5.4 will be implemented for this study. RESULTS: The results will be published in a peer-reviewed medical journal. This meta-analysis will provide a synthetic review of the credible evidence for the treatment of Plum-blossom needle plus Chinese herbal medicine with AA. CONCLUSIONS: This systematic review and meta-analysis expects to provide high-quality evidence regarding the synergistic effect of Plum-blossom needle plus Chinese herbal medicine treatment for AA.

Effects of a health education program targeted to Chinese women adhering to their cultural practice of doing the month: A randomized controlled trial.

BACKGROUND: "Doing the month" is a prevalent Chinese postpartum custom which is believed to restore health after delivery. However, some traditional practices are potentially harmful for women's health. OBJECTIVES: To examine the effect of an evidence-based health education program on Chinese postpartum women's adherence to traditional practices of doing the month and the effect of adherence to doing the month on maternal physiological and psychological health. METHODS: A randomized controlled trial was conducted. During December 2016-July 2017, we recruited postpartum women at a tertiary hospital. Women randomized to the intervention group received evidence-based health education within 1 week after returning home and received a second visit 1 month later. The control group received routine postpartum home visits. Adherence to doing the month was measured by the Adherence to Doing-the-Month Practices questionnaire (ADP). Maternal physical health was measured by the Chair Stand Test and Postpartum Symptom Checklist. Maternal psychological health was measured by the Edinburgh Postnatal Depression Scale (EPDS). Descriptive statistics, t-test, and chi-squared test were used to analyze the differences in scores and symptoms of the two groups. RESULTS: We recruited 124 eligible postpartum women and 108 of them (54 intervention group, 54 control group) completed this study. The ADP score of the intervention group was significantly lower than that of the control group (p < 0.001). The number of participants in the experimental group with poor appetite and indigestion was significantly lower than that of control group. No significant differences were found in numbers of symptoms and average EPDS scores between the 2 study groups (p > 0.05). CONCLUSIONS: Evidence-based health education can reduce postpartum women's adherence to some traditional practices of doing the month and improve women's physical health.

Informe diário de evidências COVID-19: busca realizada em 22 de julho de 2020 / COVID-19 daily evidence report: search conducted on July 22, 2020

O Informe Diário de Evidências é uma produção do Ministério da Saúde que tem como objetivo acompanhar diariamente as publicações científicas sobre tratamento farmacológico e vacinas para a COVID-19. Dessa forma, são realizadas buscas estruturadas em bases de dados biomédicas, referentes ao dia anterior desse informe. Não são incluídos estudos pré-clínicos (in vitro, in vivo, in silico). A frequência dos estudos é demonstrada de acordo com a sua classificação metodológica (revisões sistemáticas, ensaios clínicos randomizados, coortes, entre outros). Para cada estudo é apresentado um resumo com avaliação da qualidade metodológica. Essa avaliação tem por finalidade identificar o grau de certeza/confiança ou o risco de viés de cada estudo. Para tal, são utilizadas ferramentas já validadas e consagradas na literatura científica, na área de saúde baseada em evidências. Cabe ressaltar que o documento tem caráter informativo e não representa uma recomendação oficial do Ministério da Saúde sobre a temática. Foram encontrados 20 artigos e 10 protocolos.

Informe diário de evidências COVID-19: busca realizada em 5 de maio de 2020 / COVID-19 daily evidence report: search conducted on May 5, 2020

Essa é uma produção do Departamento de Ciência e Tecnologia (Decit) da Secretaria de Ciência, Tecnologia, Inovação e Insumos Estratégicos em Saúde (SCTIE) do Ministério da Saúde (Decit/SCTIE/MS), que tem como missão promover a ciência e tecnologia e o uso de evidências científicas para a tomada de decisão do SUS, tendo como principal atribuição o incentivo ao desenvolvimento de pesquisas em saúde no Brasil, de modo a direcionar os investimentos realizados em pesquisa pelo Governo Federal às necessidades de saúde pública. Informar sobre as principais evidências científicas descritas na literatura internacional sobre tratamento farmacológico para a COVID-19. Além de resumir cada estudo identificado, o informe apresenta também uma avaliação da qualidade metodológica e a quantidade de artigos publicados, de acordo com a sua classificação metodológica (revisões sistemáticas, ensaios clínicos randomizados, entre outros). Foram encontrados 10 artigos e 20 protocolos.

A acupuntura na percepção de indivíduos com hipertensão arterial atendidos em uma unidade de pronto atendimento / Acupuncture in the perception of hypertensive individuals in an emergency medical unit

A hipertensão arterial sistêmica (HAS) é uma condição clínica multifatorial caracterizada por níveis elevados e sustentados de pressão arterial. A acupuntura tanto no tratamento sistêmico, auricular e/ou emergencial, estabiliza os sintomas da HAS e auxilia na redução dos fatores de risco para o desenvolvimento de doenças cardiovasculares. O objetivo do estudo foi compreender a percepção de indivíduos hipertensos, atendidos em uma unidade de pronto atendimento sobre a acupuntura. Trata-se de uma pesquisa descritiva, qualitativa, realizada na cidade de Cascavel ­ PR. Os participantes da pesquisa responderam a seguinte questão norteadora: "O que o sr. (sra.) sabe a respeito da acupuntura?". Participaram do estudo 36 indivíduos, sendo a maioria do sexo feminino, idade média de 52,2 anos e a maior parte com Ensino Fundamental incompleto. Com relação ao conhecimento sobre a acupuntura, 61% dos participantes desconhecem a técnica. As respostas favoráveis corresponderam a 39% e foram agrupadas em categorias: técnica com agulhas; utilizada para o tratamento do estresse; conhecimento por meio da mídia; traz benefícios. Ao final do estudo conclui-se que a maior parte dos indivíduos abordados desconhece a técnica de acupuntura. Os que demonstram conhecimento se limitam nos benefícios e possibilidades da técnica. A divulgação da acupuntura e a sua implantação no Sistema Único de Saúde, colaborariam para que esta visão se ampliasse e mais pessoas dos mais variados níveis socioeconômicos tivessem acesso aos benefícios da técnica.

Systemic arterial hypertension (SAH) is a multifactorial clinical condition characterized by elevated and sustained blood pressure levels. Acupuncture in both systemic, auricular and/or emergency treatment stabilizes the symptoms of SAH and helps to reduce the risk factors for the development of cardiovascular diseases. The aim of the study was to understand the perception of hypertensive individuals attended at an Emergency Medical Unit about acupuncture. This is a descriptive, qualitative research carried out in the city of Cascavel, in the state of Paraná. The survey participants answered the following guiding question: "What do you know about acupuncture?". Thirty-six people took part in the study, most of them were female, average age of 52.2 years and the majority had an incomplete secondary education. In terms of their knowledge about acupuncture, 61% of the participants did not know the technique. The favorable answers corresponded to 39% and were grouped in categories: technique with needles; used for treating stress; knowledge through media; benefits. At the end of the study, it was concluded that most of the participants in the study were unaware of the acupuncture technique. Those who demonstrate knowledge showed that it was limited in the benefits and possibilities of the technique. The dissemination of acupuncture and its implantation in the Public Health System would collaborate so that these thoughts could be further developed, and more people of the most varied socioeconomic levels could have access to its benefits.

Traditional Chinese Medicine and Intestinal Microbiota: A Complementary and Integrative Health Approach to Ameliorate Obesity-Related Diseases.

The incidence of obesity and obesity-related diseases, such as type 2 diabetes mellitus and nonalcoholic fatty liver disease, is increasing worldwide, which threatens quality of life and human health. "The toxins in the stool enter the body and blood and then cause a variety of diseases"; this quote illustrates that the Chinese ancients recognized the negative effects of harmful intestinal metabolites on the body. As the largest microecosystem in the human body, intestinal microbiota and their metabolites affect the nutrition, metabolism, and immune function of the host, which is an important pathogenic factor in obesity and obesity-related diseases. Herbal-based supplements are used for many years in the treatment of obesity, type 2 diabetes mellitus, and nonalcoholic fatty liver disease in China. Traditional herbal medicine contains fiber, polyphenols, and polysaccharides that exert prebiotics-like activities in the prevention and treatment of obesity-related diseases. This article provides a systematic mini-review of the literature concerning traditional Chinese medicine for modulation of the intestinal microbiota to ameliorate obesity, type 2 diabetes mellitus, and nonalcoholic fatty liver disease in China. Initially, the relationship between traditional Chinese medicine and intestinal microbiota was introduced, followed by specific research results on this relationship based on 25 original articles. Therefore, this mini-review will provide a complementary and integrative approach for the treatment of these obesity-related diseases.

A portable back massage robot based on Traditional Chinese Medicine.

OBJECTIVE: A portable back massage robot which can complete the massage operations such as tapping, kneading and rolling was designed to improve the level of intelligence and massage effect. An efficient full covered path planning algorithm was put forward for a portable back massage robot to improve the coverage. BACKGROUND: Currently, massage robots has become one of important research focuses with the increasing requirements for healthcare. The massage robot is difficult to be widely accepted as there are problems of massage robot in control, structure, and coverage path planning. METHOD: The 3D electromagnetic simulation model was established to optimize electromagnetic force. By analyzing the Traditional Chinese Medicine massage operation and the demands, the path planning algorithm models were established. The experimental platform of the massage robot was built. RESULTS: The simulation results show presented path planning algorithm is suitable for back massage, which ensures that the massage robot traverse the entire back area with improved massage coverage. The tested results show that the massage effect is best when the duty cycle is in the range of 1/8 to 1/2, and the massage force increases with the increase of the input voltage. CONCLUSIONS: The massage robot eventually achieved the desired massage effect, and the proposed efficient algorithm can effectively improve the coverage and promote the massage effect.

Tongue diagnosis indices for upper gastrointestinal disorders: Protocol for a cross-sectional, case-controlled observational study.

BACKGROUND: Upper gastrointestinal disorders are common in clinical practice, for example, gastritis, peptic ulcer disease, and gastroesophageal reflux disease. Panendoscopy or upper gastrointestinal endoscopy is viewed as the primary tool for examining the upper gastrointestinal mucosa, and permitting biopsy and endoscopic therapy. Although panendoscopy is considered to be a safe procedure with minimal complications, there are still some adverse effects, and patients are often anxious about undergoing invasive procedures. Traditional Chinese medicine tongue diagnosis plays an important role in differentiation of symptoms because the tongue reflects the physiological and pathological condition of the body. The automatic tongue diagnosis system (ATDS), which noninvasively captures tongue images, can provide objective and reliable diagnostic information. METHODS: This protocol is a cross-sectional, case-controlled observational study investigating the usefulness of the ATDS in clinical practice by examining its efficacy as a diagnostic tool for upper gastrointestinal disorders. Volunteers over 20 years old with and without upper gastrointestinal symptoms will be enrolled. Tongue images will be captured and the patients divided into 4 groups according to their panendoscopy reports, including a gastritis group, peptic ulcer disease group, gastroesophageal reflux disease group, and healthy group. Nine primary tongue features will be extracted and analyzed, including tongue shape, tongue color, tooth mark, tongue fissure, fur color, fur thickness, saliva, ecchymosis, and red dots. OBJECTIVES: The aim of this protocol is to apply a noninvasive ATDS to evaluate tongue manifestations of patients with upper gastrointestinal disorders and examine its efficacy as a diagnostic tool.

Antioxidant and immunomodulatory activities of Oviductus ranae in mice

Oviductus ranae (OR) is a traditional Chinese medicine, which was first recorded in the Compendium of Materia Medica in the Ming Dynasty. OR contains high amounts of proteins and elicits therapeutic effects on neurasthenia, insomnia, and respiratory symptoms, which are related to oxidative stress and immunodeficiency. This study aimed to obtain the potential of OR for the development of functional food possessing antioxidant and immune-enhancement functions in the same dose. In antioxidant evaluation, OR can significantly decrease malondialdehyde and protein carbonyls (P < 0.05, P < 0.01) and significantly increase total superoxide dismutase and glutathione in a dose-dependent manner (P< 0.05, P < 0.01) against ethanol-induced oxidative stress in mice at 0.1, 1.0, and 3.0 g/kg BW. In immunomodulatory evaluation, OR could significantly enhance the phagocytosis of liver macrophages (P < 0.05, P < 0.01), delayed-type hypersensitivity response (P < 0.05, P < 0.01), hemolytic activity (P < 0.05), antibody-producing cells (P < 0.05), and natural killer cell activity (P < 0.05) in the same dose range described in antioxidant evaluation compared with those in the normal control. OR slightly influenced lymphocyte proliferation, peritoneal macrophage phagocytosis, and immune organ indices in mice. Thus, 3.0 g/kg BW OR showed potential for the development of functional food with antioxidant and immune-enhancement activities

Theoretical basis, application, reliability, and sample size estimates of a Meridian Energy Analysis Device for Traditional Chinese Medicine Research.

OBJECTIVES:: The Meridian Energy Analysis Device is currently a popular tool in the scientific research of meridian electrophysiology. In this field, it is generally believed that measuring the electrical conductivity of meridians provides information about the balance of bioenergy or Qi-blood in the body. METHODS AND RESULTS:: PubMed database based on some original articles from 1956 to 2014 and the authors clinical experience. In this short communication, we provide clinical examples of Meridian Energy Analysis Device application, especially in the field of traditional Chinese medicine, discuss the reliability of the measurements, and put the values obtained into context by considering items of considerable variability and by estimating sample size. CONCLUSION:: The Meridian Energy Analysis Device is making a valuable contribution to the diagnosis of Qi-blood dysfunction. It can be assessed from short-term and long-term meridian bioenergy recordings. It is one of the few methods that allow outpatient traditional Chinese medicine diagnosis, monitoring the progress, therapeutic effect and evaluation of patient prognosis. The holistic approaches underlying the practice of traditional Chinese medicine and new trends in modern medicine toward the use of objective instruments require in-depth knowledge of the mechanisms of meridian energy, and the Meridian Energy Analysis Device can feasibly be used for understanding and interpreting traditional Chinese medicine theory, especially in view of its expansion in Western countries.

Theoretical basis, application, reliability, and sample size estimates of a Meridian Energy Analysis Device for Traditional Chinese Medicine Research

OBJECTIVES: The Meridian Energy Analysis Device is currently a popular tool in the scientific research of meridian electrophysiology. In this field, it is generally believed that measuring the electrical conductivity of meridians provides information about the balance of bioenergy or Qi-blood in the body. METHODS AND RESULTS: PubMed database based on some original articles from 1956 to 2014 and the authoŕs clinical experience. In this short communication, we provide clinical examples of Meridian Energy Analysis Device application, especially in the field of traditional Chinese medicine, discuss the reliability of the measurements, and put the values obtained into context by considering items of considerable variability and by estimating sample size. CONCLUSION: The Meridian Energy Analysis Device is making a valuable contribution to the diagnosis of Qi-blood dysfunction. It can be assessed from short-term and long-term meridian bioenergy recordings. It is one of the few methods that allow outpatient traditional Chinese medicine diagnosis, monitoring the progress, therapeutic effect and evaluation of patient prognosis. The holistic approaches underlying the practice of traditional Chinese medicine and new trends in modern medicine toward the use of objective instruments require in-depth knowledge of the mechanisms of meridian energy, and the Meridian Energy Analysis Device can feasibly be used for understanding and interpreting traditional Chinese medicine theory, especially in view of its expansion in Western countries.

The Effect and Mechanism of Transdermal Penetration Enhancement of Fu's Cupping Therapy: New Physical Penetration Technology for Transdermal Administration with Traditional Chinese Medicine (TCM) Characteristics.

BACKGROUND: In this paper, a new type of physical penetration technology for transdermal administration with traditional Chinese medicine (TCM) characteristics is presented. Fu's cupping therapy (FCT), was established and studied using in vitro and in vivo experiments and the penetration effect and mechanism of FCT physical penetration technology was preliminarily discussed. METHODS: With 1-(4-chlorobenzoyl)-5-methoxy-2-methylindole-3-ylacetic acid (indomethacin, IM) as a model drug, the establishment of high, medium, and low references was completed for the chemical permeation system via in vitro transdermal tests. Furthermore, using chemical penetration enhancers (CPEs) and iontophoresis as references, the percutaneous penetration effect of FCT for IM patches was evaluated using seven species of in vitro diffusion kinetics models and in vitro drug distribution; the IM quantitative analysis method in vivo was established using ultra-performance liquid chromatography-tandem mass spectrometry technology (UPLC-MS/MS), and pharmacokinetic parameters: area under the zero and first moment curves from 0 to last time t (AUC0-t, AUMC0-t), area under the zero and first moment curves from 0 to infinity (AUC0-∞, AUMC0-∞), maximum plasma concentration (Cmax) and mean residence time (MRT), were used as indicators to evaluate the percutaneous penetration effect of FCT in vivo. Additionally, we used the 3K factorial design to study the joint synergistic penetration effect on FCT and chemical penetration enhancers. Through scanning electron microscopy (SEM) and transmission electron microscope (TEM) imaging, micro- and ultrastructural changes on the surface of the stratum corneum (SC) were observed to explore the FCT penetration mechanism. RESULTS: In vitro and in vivo skin permeation experiments revealed that both the total cumulative percutaneous amount and in vivo percutaneous absorption amount of IM using FCT were greater than the amount using CPEs and iontophoresis. Firstly, compared with the control group, the indomethacin skin percutaneous rate of the FCT low-intensity group (FCTL) was 35.52%, and the enhancement ratio (ER) at 9 h was 1.76X, roughly equivalent to the penetration enhancing effect of the CPEs and iontophoresis. Secondly, the indomethacin percutaneous ratio of the FCT middle-intensity group (FCTM) and FCT high-intensity group (FCTH) were 47.36% and 54.58%, respectively, while the ERs at 9 h were 3.58X and 8.39X, respectively. Thirdly, pharmacokinetic data showed that in vivo indomethacin percutaneous absorption of the FCT was much higher than that of the control, that of the FCTM was slightly higher than that of the CPE, and that of the FCTM group was significantly higher than all others. Meanwhile, variance analysis indicated that the combination of the FCT penetration enhancement method and the CPE method had beneficial effects in enhancing skin penetration: the significance level of the CPE method was 0.0004, which was lower than 0.001, meaning the difference was markedly significant; the significance level of the FCT was also below 0.0001 and its difference markedly significant. The significance level of factor interaction A × B was lower than 0.0001, indicating that the difference in synergism was markedly significant. Moreover, SEM and TEM images showed that the SC surfaces of Sprague-Dawley rats treated with FCT were damaged, and it was difficult to observe the complete surface structure, with SC pores growing larger and its special "brick structure" becoming looser. This indicated that the barrier function of the skin was broken, thus revealing a potentially major route of skin penetration. CONCLUSION: FCT, as a new form of transdermal penetration technology, has significant penetration effects with TCM characteristics and is of high clinical value. It is worth promoting its development.