Evaluation Of Traditional Chinese Medicine Research Articles

Clinical research report on traditional Chinese patent medicines and traditional Chinese classic famous prescriptions (2022)

Objective: The paper is to comprehensively summarize and analyze the basic situation and methodological quality of clinical randomized controlled trials (RCTs) of traditional Chinese patent medicines and traditional Chinese classic famous prescriptions published in 2022, to provide evidence and reasonable suggestions for the advancement of clinical research and the formulation of policies and guidelines. Methods: The Evidence Database System of clinical evidence-based evaluation of traditional Chinese medicine was searched, and data from China National Knowledge Infrastructure (CNKI), PubMed, and other databases were supplemented. The search duration was from January 1, 2022, to December 31, 2022. RCTs of traditional Chinese patent medicines and traditional Chinese classic famous prescriptions were included as the source of clinical evidence, and published information, sample size, intervention, control measures, treatment course, methodological quality, and key link report were analyzed and evaluated. Results: A total of 1,464 RCTs of traditional Chinese patent medicines were included, which comprised 667 types of traditional Chinese patent medicines; “traditional Chinese patent medicines + Western medicine vs. Western medicine” was the most widely used intervention and control setting, involving 417 RCTs (28.48%). A total of 245 RCTs of traditional Chinese classic famous prescriptions were included, comprising 55 types of traditional Chinese classic famous prescriptions. “Decoction + conventional treatment vs. conventional treatment” was the most widely used intervention and control setting, with 87 RCTs (35.51%). Published RCTs on traditional Chinese patent medicines and traditional Chinese classic famous prescriptions were limited by the study design and implementation. Most “allocation concealment” and “blinding of patients and personnel” were rated as medium to high risk. There are insufficient reports on key research links such as experimental registration and ethical approval. Conclusions: The number of RCTs on traditional Chinese patent medicines has decreased in 2022, but there has been a slight improvement in the research quality and impact. There are relatively few studies on traditional Chinese classic famous prescriptions. Measures must be taken to improve clinical trial design, implementation, and reporting. Methodological experts should be invited to provide professional technical guidance on the trial design. In the research implementation process, attention should be paid to quality control, particularly the standardization of the randomized execution.

Safety evaluation of traditional Chinese medicine: new era, new strategy

Today, as the use of traditional Chinese medicine (TCM) becomes widespread globally, TCM is confronted with numerous new safety issues and challenges. In particular, the frequent emergence of safety issues/events such as liver and kidney injury associated with traditionally “non-toxic” TCM has overturned the conventional understanding of the toxicity and safety of TCM. This has also posed significant challenges to the development and internationalization of TCM. So, how should we understand the situation and problems of TCM safety? How can we scientifically solve the problems in evaluation and risk control of TCM? Our team proposes the following: First, we must keep pace with the times and view the issues of TCM safety in a dialectical manner, without exaggeration or underestimation. Second, we must break through the traditional perception that toxicity only came from the medicine itself, and innovate the theories of TCM toxicity. Third, we must establish precise prevention and control strategies for TCM with different types of toxicity, promoting a shift in the management of TCM safety risks from passive response to scientific and proactive control. On this basis, we have put forward the concept and methodological system of the “New Outlook on TCM safety”, hoping to provide new theories, strategies, methods, and successful examples for systematically solving the problems in the evaluation and risk control of TCM.

A fluorescence method based on malachite green/aptamer for detection of ochratoxin A in traditional Chinese medicines

A label-free fluorescence method based on malachite green/aptamer was developed for the detection of ochratoxin A(OTA) in traditional Chinese medicines. Malachite green itself exhibits weak fluorescence. Upon interaction with the aptamer specific to OTA, the G-quadruplex structure of the aptamer provides a protective microenvironment for malachite green, which significantly enhances its fluorescence signal. After OTA is added, preferential binding occurs between the aptamer and OTA, and malachite green will be released from the aptamer, which weakens the fluorescence signal. According to this principle, this paper established a fluorescence method with the aptamer of OTA as the recognition element and malachite green as the fluorescent probe for the detection of OTA in traditional Chinese medicines. The key experimental factors such as the concentrations of metal ions, aptamer, and malachite green were optimized to improve the performance of the method. OTA was detected under the optimal experimental conditions, and the results showed that with the increase in OTA concentration, the fluorescence signal gradually weakened. Within the range of 20-1 000 nmol·L~(-1), the OTA concentration was linearly correlated with the fluorescence signal ratio ΔF/F(ΔF=F_0-F, where F_0 is the fluorescence signal of aptamer/malachite green, and F is the fluorescence signal of OTA/aptamer/malachite green), with R~2 of 0.995. The limit of detection of the established method was 7.1 nmol·L~(-1). Furthermore, three substances structurally similar to OTA and two mycotoxins that may coexist with OTA were selected for experiments, which aimed to examine the cross-reactivity and specificity of the established method. The cross-reactivity experiments demonstrated that the interferers did not significantly affect the fluorescence signal of the detection system. The specificity experiments revealed that when mycotoxins were mixed with OTA, the fluorescence signal generated by the mixture closely resembled that of OTA itself. The results indicated that even in the presence of interferents, the established method remained unaffected and demonstrated excellent specificity. Additionally, this method exhibited remarkable reproducibility and stability. In the case of simple centrifugation and dilution of traditional Chinese medicine samples(Puerariae Lobatae Radix, Sophorae Flavescentis Radix, and Periplocae Cortex), the OTA detection method was applicable, with recovery rates ranging from 91.5% to 121.3%. Notably, this approach does not need complex pretreatment of traditional Chinese medicines while offering simple operation, low detection costs, and short detection time. Furthermore, by incorporating aptamers into the quality evaluation of traditional Chinese medicines, this method expands the application scope of aptamers.

Translational analysis of data science and causal learning in real-world clinical evaluation of traditional Chinese medicine

Abstract Real-world clinical evaluation of traditional Chinese medicine (RWCE-TCM) is a method for comprehensively evaluating the clinical effects of TCM, with the aim of delving into the causality between TCM intervention and clinical outcomes. The study explored data science and causal learning methods to transform RWD into reliable real-world evidence, aiming to provide an innovative approach for RWCE-TCM. This study proposes a 10-step data science methodology to address the challenges posed by diverse and complex data in RWCE-TCM. The methodology involves several key steps, including data integration and warehouse building, high-dimensional feature selection, the use of interpretable statistical machine learning algorithms, complex networks, and graph network analysis, knowledge mining techniques such as natural language processing and machine learning, observational study design, and the application of artificial intelligence tools to build an intelligent engine for translational analysis. The goal is to establish a method for clinical positioning, applicable population screening, and mining the structural association of TCM characteristic therapies. In addition, the study adopts the principle of real-world research and a causal learning method for TCM clinical data. We constructed a multidimensional clinical knowledge map of “disease-syndrome-symptom-prescription-medicine” to enhance our understanding of the diagnosis and treatment laws of TCM, clarify the unique therapies, and explore information conducive to individualized treatment. The causal inference process of observational data can address confounding bias and reduce individual heterogeneity, promoting the transformation of TCM RWD into reliable clinical evidence. Intelligent data science improves efficiency and accuracy for implementing RWCE-TCM. The proposed data science methodology for TCM can handle complex data, ensure high-quality RWD acquisition and analysis, and provide in-depth insights into clinical benefits of TCM. This method supports the intelligent translation and demonstration of RWD in TCM, leads the data-driven translational analysis of causal learning, and innovates the path of RWCE-TCM.

Quality Consistency Evaluation of Traditional Chinese Medicines: Current Status and Future Perspectives.

Quality consistency evaluation of traditional Chinese medicines (TCMs) is a crucial factor that determines the safe and effective application in clinical settings. However, TCMs exhibit diverse, heterogeneous, complex, and flexible chemical compositions, as well as variability in preparation processes. These characteristics pose greater challenges in researching the consistency of TCMs compared to chemically synthesized and biological drugs. Therefore, it is paramount to develop effective strategies for evaluating the quality consistency of TCMs. From the starting point of quality properties, this review explores the strategy used to evaluate quality consistency in terms of chemistry-based strategy (chemical consistency) and the biology-based strategy (bioequivalence). Among them, the chemistry-based strategy is the mainstream, and biology-based strategy complements the chemistry-based strategy each other. Furthermore, the emerging chemistry-biology strategies (overall evaluation) is discussed, including individually combining strategy and integration strategy. Finally, this review provides insights into the challenges and future perspectives in this field. By highlighting current status and trends in TCMs quality consistency, this review aims to contribute to establishment of generally applicable chemistry-biology integrated evaluation strategy for TCMs. This will facilitate the advancement toward a higher stage of overall quality evaluation.

Fluorescence sensing techniques for quality evaluation of traditional Chinese medicine: a review

Traditional Chinese medicine (TCM) is highly valued and widely used worldwide. However, their complex compositions and various preparation processes have brought considerable challenges to the quality evaluation of Chinese medicines....

Nephrotoxicity assessment of podophyllotoxin-induced rats by regulating PI3K/Akt/mTOR-Nrf2/HO1 pathway in view of toxicological evidence chain (TEC) concept

Adverse reactions to traditional Chinese medicine have hindered the healthy development and internationalization process of the traditional Chinese medicine industry. The critical issue that needs to be solved urgently is to evaluate the safety of traditional Chinese medicine systematically and effectively. Podophyllotoxin (PPT) is a highly active compound extracted from plants of the genus Podophyllum such as Dysosma versipellis (DV). However, its high toxicity and toxicity to multiple target organs affect the clinical application, such as the liver and kidney. Based on the concurrent effects of PPT's medicinal activity and toxicity, it would be a good example to conduct a systematic review of its safety. Therefore, this study revolves around the Toxicological Evidence Chain (TEC) concept. Based on PPT as the main toxic constituent in DV, observe the objective toxicity impairment phenotype of animals. Evaluate the serum biochemical indicators and pathological tissue sections for substantial toxic damage results. Using metabolomics, lipidomics, and network toxicology to evaluate the nephrotoxicity of PPT from multiple perspectives systematically. The results showed that PPT-induced nephrotoxicity manifested as renal tubular damage, mainly affecting metabolic pathways such as glycerophospholipid metabolism and sphingolipid metabolism. PPT inhibits the autophagy process of kidney cells through the PI3K/Akt/mTOR and Nrf2/HO1 pathways and induces the activation of oxidative stress in the body, thereby causing nephrotoxic injury. This study fully verified the feasibility of the TEC concept for the safety and toxicity evaluation of traditional Chinese medicine. Provide a research template for systematically evaluating the safety of traditional Chinese medicine.

Discrimination of Radix Astragali from Different Growth Patterns, Origins, Species, and Growth Years by an H1-NMR Spectrogram of Polysaccharide Analysis Combined with Chemical Pattern Recognition and Determination of Its Polysaccharide Content and Immunological Activity.

The fraud phenomenon is currently widespread in the traditional Chinese medicine Radix Astragali (RA) market, especially where high-quality RA is substituted with low-quality RA. In this case, focused on polysaccharides from RA, the classification models were established for discrimination of RA from different growth patterns, origins, species, and growth years. 1H Nuclear Magnetic Resonance (H1-NMR) was used to establish the spectroscopy of polysaccharides from RA, which were used to distinguish RA via chemical pattern recognition methods. Specifically, orthogonal partial least squares discriminant analysis (OPLS-DA) and linear discriminant analysis (LDA) were used to successfully establish the classification models for RA from different growth patterns, origins, species, and growth years. The satisfactory parameters and high accuracy of internal and external verification of each model exhibited the reliable and good prediction ability of the developed models. In addition, the polysaccharide content and immunological activity were also tested, which was evaluated by the phagocytic activity of RAW 264.7. And the result showed that growth patterns and origins significantly affected the quality of RA. However, there was no significant difference in the aspects of origins and growth years. Accordingly, the developed strategy combined with chemical information, biological activity, and multivariate statistical method can provide new insight for the quality evaluation of traditional Chinese medicine.

Identification of potential quality markers of Zishen Yutai pill based on spectrum-effect relationship analysis.

Introduction: The current quality evaluation of traditional Chinese medicine (TCM) is difficult to attribute to clinical efficacy due to the complexity of TCM. Zishen Yutai pill (ZYP), a well-known traditional Chinese patent medicine, has been widely used to prevent recurrent miscarriage and treat threatened abortion. However, the chemical components of ZYP are unknown, and there is no convincing quality control method applied on ZYP. Although ZYP has been found to promote endometrial receptivity and treat impending abortion, the substantial basis of the therapeutic effects is unclear. The aim of this study was to clarify the quality markers correlated with the potential medicinal activities and provide a theoretical foundation for scientific quality control and product quality improvement of ZYP. Methods: The chemical constituents of ZYP were comprehensively analyzed by offline two-dimensional liquid chromatography-mass spectrometry (2DLC-LTQ-Orbitrap-MS). The efficacy of the 27 ZYP orthogonal groups was investigated using the HTR-8/SVneo oxidative damage model and migration model in vitro, as well as the endometrial receptivity disorder mouse model and premature ovarian failure mouse model in vivo. Based on the efficacy and mass spectral results, spectrum-effect relationship analysis was used to identify the chemical components with corresponding pharmacological activities. Results: A total of 589 chemical components were found in ZYP, of which 139 were not identified in the literature. The potential quality markers for ZYP were successfully identified through orthogonal design and spectrum-effect relationship analysis. By combining mass spectrum data and pharmacological results of 27 orthogonal groups, 39 substances were identified as potential quality markers. Conclusion: The approaches used in this study will provide a feasible strategy for the discovery of quality markers with bioactivity and further investigation into the quality evaluation of TCM.

Problems and thoughts in clinical safety evaluation of traditional Chinese medicine

Amid the modernization and internationalization of traditional Chinese medicine(TCM), the safety of TCM has attracted much attention. At the moment, the government, scientific research teams, and pharmaceutical enterprises have made great efforts to explore methods and techniques for clinical safety evaluation of TCM. Although considerable achievements have been made, there are still many problems, such as the non-standard terms of adverse reactions of TCM, unclear evaluation indicators, unreasonable judgment methods, lack of evaluation models, out-of-date evaluation standards, and unsound reporting systems. Therefore, it is urgent to further deepen the research mode and method of clinical safety evaluation of TCM. Based on the current national requirements for the life-cycle management of drugs, this study focused on the problems in the five dimensions of clinical safety evaluation of TCM, including normative terms, evaluation modes, judgment methods, evaluation standards, and reporting systems, and proposed suggestions on the development of a life-cycle clinical safety evaluation method that conformed to the characteristics of TCM, hoping to provide a reference for future research.

Assessing the quality consistency of red yeast medicinal material by five-wavelength fusion fingerprint and ultraviolet quantum fingerprint corresponding with antioxidant activity analysis

In this study, a five-wavelength fusion fingerprint (FWFFT) combined with all-ultraviolet(UV) and antioxidant methods was used to explore the quality consistency of red yeast (RYT) samples. 1,1-Diphenyl-2-picrylhydrazyl Free Radical (DPPH) was used for antioxidant experiments, combined with high performance liquid chromatography (HPLC), and grey correlation analysis (GCA) was performed with chromatographic peak area. The results showed that multi-wavelength fusion technology compensates for the shortcomings of single-wavelength technology, and the combination with UV avoids of the one-sidedness of single technology. Simultaneously, the fingerprint peak of the sample and the antioxidant activity had a high correlation, and the antioxidant activity had a corresponding relationship with the content of the two controls. This study provides a comprehensive and reliable method for the quality consistency evaluation of traditional Chinese medicines (TCM).

Precise application of Beichaihu and Nanchaihu in classical formulas

To maintain the precision and stability of the efficacy of classical formulas, this study compared the origins and specifications of Bupleuri Radix and revealed the precise application regularity of Bupleurum chinense(Beichaihu) and Bupleurum scorzonerifolium(Nanchaihu) in classical formulas. The efficacy and indications of formulas with Bupleuri Radix as the sovereign drug in the Treatise on Cold Damage and Miscellaneous Diseases(Shang Han Za Bing Lun) were investigated. The difference in the efficacy of Bupleuri Radix as well as the differences in the chemical composition, and liver-protecting and lipid-lowering effects of the decoctions of Beichaihu and Nanchaihu were analyzed with LC-MS technology based on the CCl_4-induced liver injury model in mice and sodium oleate-induced HepG2 hyperlipidemia cell model. The results showed that seven classical formulas with Bupleuri Radix as the sovereign drug in the Treatise on Cold Damage and Miscellaneous Diseases were mainly used in the treatment of digestive, metabolic, immune, circulatory, and other diseases. Bupleuri Radix mainly played the functions of protecting the liver, benefiting the gallbladder, and lowering the lipid, and had different focuses in different formulas. There were 14 differential components in the decoctions of Beichaihu and Nanchaihu, and the chemical structures of 11 components were identified, including 10 saponins and one flavonoid. The results of the liver-protecting efficacy experiment showed that compared with the Nanchaihu decoction, Beichaihu decoction could reduce the serum aspartate aminotransferase(AST) activity in liver injury model mice(P<0.01). The results of the lipid-lowering efficacy experiment proved that Beichaihu and Nanchaihu decoctions both showed highly significant differences in lowering the total cholesterol(TC) and triglyceride(TG) content in HepG2 cells(P<0.01), and Nanchaihu decoction was superior to Beichaihu decoction in lowering the lipid. The results of this study preliminarily proved that there were differences in chemical composition, and liver-protecting and lipid-lowering effects of Beichaihu and Nanchaihu decoctions, indicating that it was necessary to determine the precise origin of Bupleuri Radix in the clinical formulation of traditional Chinese medicine. The study provides a scientific basis for both precise clinical medication and purpose-based accurate quality evaluation of traditional Chinese medicine in clinical application.

Post-marketing effectiveness evaluation of traditional Chinese medicine in paradigm based on "proving efficacy, conforming standard, and exploring mechanism":a case study of Danhong Injection

At present, new concepts, new technologies, and new methods are emerging in the field of medical research, breaking through the inherent thinking patterns and research models, and promoting the transformation of the research paradigm of traditional Chinese medicine(TCM). This paper gave a case study of clinical research in Danhong Injection in the treatment of chronic stable angina, and based on the background of the study, index evaluation model, experimental design method, blind implementation of placebo, data management system, and exploration of clinical efficacy mechanism of traditional Chinese medicine compounds under the framework of modular pharmacology, the scientific idea of "proving efficacy, conforming standard, and exploring mechanism" was used as the guideline to discuss the research model of reevaluation of the effectiveness of post-marketing TCM varieties. This paper drew a target network map of Danhong Injection in the treatment of chronic stable angina for the first time, which was composed of targeted functional modules. By combining evidence-based clinical research with modular pharmacology framework, changes in the pharmacolo-gical mechanism were finally associated with changes in clinical efficacy, and the advantages of phenotypic correlation of efficacy were explored. This study is expected to provide references for the post-marketing effectiveness evaluation and new ideas for the phenotypic pharmacological mechanism study of multi-target TCM compounds and precise treatment, thereby promoting the innovative development of TCM.

In situ visual and content changes analysis of coumarins in Radix Angelicae dahuricae by LSCM combined with LC-MS technology

In this study, a simple, accurate and green localization method of coumarins in Radix Angelicae dahuricae was established with fresh Radix Angelicae dahuricae as research material to reveal the distribution and accumulation of coumarins, based on frozen section and fluorescence imaging technology. The best frozen section conditions were established by comparing the effects of different cryoprotectants on the quality of Radix Angelicae dahuricae's frozen sections, according to the loss of coumarins and the complexity of the operation process. The coumarin components in Radix Angelicae dahuricae at different stages were located and quantitatively analyzed, and coumarin components distribution positions and content changes were identified using fluorescence imaging combined with LC-MS technology. The results showed that 30 μm slice thickness with 15 % glycerin protectant treatment is the best condition for frozen section. Fluorescence imaging showed that coumarins in Radix Angelicae dahuricae were mainly distributed in secretory tissue, the content over different periods showed an “S” curve of growth and coumarins reached their highest content in early September. The distribution and accumulation of coumarins in roots were revealed, which provided a reference for the synthesis and metabolism mechanism of metabolites in medicinal plants and the quality evaluation of traditional Chinese medicine.

Simultaneous Evaluation of Dissolution and Absorption Study of Compound Danshen Tablets and Capsules Based on Cellular Electrical Sensing Model.

This study explores the dissolution mechanism and absorption process of compound Danshen tablets (CDTs) and compound Danshen capsules (CDCs) in vitro. Taking the cell index as the evaluation index of dissolution and absorption of multi-component solid preparations of CDTs and CDCs, it breaks through the idea of traditional research. We used real-time cell-based assay (RTCA) to provide a new idea and method for the consistency evaluation of traditional Chinese medicine (TCM) compound preparations. The drug dissolution and absorption simulation system (DDASS) was established to obtain the dissolution and absorption samples of compound Danshen solid preparations at different time points. The cell index (CI) of the sample to H9C2 cells was detected by RTCA technology, and the dissolution and absorption percentage were calculated based on this index to obtain the dissolution and absorption kinetics model. Meanwhile, one batch of tablets and one batch of capsules (batch numbers ZKC1816 and 202101001) were selected to conduct the overall animal pharmacodynamic experiment to verify the feasibility of drug effect evaluation with cell index as an indicator. The best fitting model of dissolution curves of each batch of CDTs and CDCs is the Weibull model. There was a good correlation (r > 0.86) between the dissolution-absorption-pharmacodynamic curve. Based on RTCA technology, we have established the comprehensive evaluation method for cell biology of compound Danshen solid preparations in line with the overall concept of TCM and a synchronous evaluation system of dissolution and absorption in vitro of new TCM compound solid preparations.

Study and Application of Molecularly Imprinted Electrochemical Sensor Based on AuNPs/N-GR@CS for Highly Selective Recognition of Trace Hyperoside

Establishing a high-selectivity and rapid detection technology for trace index components in complex samples is of great significance for real-time and on-site drug quality evaluation. In this study, a molecularly imprinted electrochemical sensor with highly selective recognition and detection of trace hyperoside was prepared using chitosan functionalized Nitrogen-doped graphene composite coated with gold nanoparticles (AuNPs/N-GR@CS) as electrode substrate modification material, and the deposition of AuNPs further improved the conductivity of the modified electrode. With the aid of molecular imprinting technology, polymer films with high selectivity and identification of hyperoside were successfully prepared on glassy carbon electrodes (GCE) by self-assembly using hyperoside as template molecule and acrylamide as functional monomer. Because the acrylamide can accept protons through the olefinic double bond and firmly polymerize with each other, while it binds with hyperoside through hydrogen bonds. Therefore, the hyperoside can be easily dissociated in the eluate, which offers a condition for formating a molecularly imprinted polymer film to highly select hyperoside. The highly conductive N-GR@CS modified at the bottom of the polymer film provides the possibility to electrocatalyze hyperoside, and facilitate electron transfer to amplify the response signal. Under the optimized experimental conditions, the sensor showed a detection limit was 6.42 × 10−8 mol l−1 (S/N = 3) with a good linear relationship in the range of 2.15 × 10−7 to 2.15 × 10−5 mol l−1. Moreover, it displayed good reproducibility and stability, and could realize the direct and highly selective detection of trace hyperoside in complex samples. In consequence, this study is expected to provide a convenient and reliable method for on-site real-time evaluation of traditional Chinese medicine (TCM) quality with reference to the index components.

Application of comprehensive evaluation methods in the clinical efficacy evaluation of traditional Chinese medicine: a narrative review

Background and Objective: Clinical effect is necessary for the inheritance and development of traditional Chinese medicine (TCM). The conventional single primary outcome evaluation method is difficult to reflect the advantages of multi-target and multi-dimensional treatment of TCM. The comprehensive evaluation method can combine multiple dimensional outcomes such as Western medicine-related outcomes, TCM-related syndromes, and patient report outcomes into a single-dimensional comprehensive outcome, which can reflect the advantages of the multi-dimensional efficacy of TCM, and has been gradually applied to the clinical efficacy of TCM in recent years. In this study, we aimed to introduce comprehensive evaluation methods and guide TCM researchers use these methods correctly, then provide methodological aid for the comprehensive and objective evaluation of true clinical effect of TCM.

A complementary chromatographic strategy for integrated components characterization of Imperatae Rhizoma based on convergence and liquid chromatography combined with mass spectrometry and molecular network

The complexity of natural ingredients and the diversity of preparations are the major obstacles to the quality evaluation of traditional Chinese medicines (TCMs). A more comprehensive characterization of herbal compounds using different types of chromatographic separation techniques and covering a diverse polarity range can help evaluate the quality of TCMs. In this study, we first proposed a comprehensive method for characterizing compounds derived from Imperatae Rhizoma by combining the complementary strengths of UPCC-QTOF-MS (ultra-performance convergence chromatography coupled with quadrupole-time of flight mass spectrometry) with UPLC-QTOF-MS (ultra-performance liquid chromatography coupled with quadrupole-time of flight mass spectrometry). The method based on the UNIFI scientific platform significantly shortened the analysis time and enabled a more comprehensive characterization of known and unreported compounds. Meanwhile, a feature-based molecular network (FBMN) was established on the Global Natural Product Social (GNPS) to infer potential compounds by rapidly classifying and visualizing these components. A total of 62 compounds in Imperatae Rhizoma were jointly characterizedand classified into six types. In comparison, the UPCC-QTOF-MS technology individually characterized 17 components, including lactones, phenols, aldehydes, phenylpropanoids, and small polar organic acids. The UPLC-QTOF-MS technology characterized 16 compounds mainly phenylpropionic acids, flavonoid glycosides, and chromone glycosides. Furthermore, three types of characteristic compounds could be well aggregated into an FBMN approach. Five possible potential new compounds were detected through the supplementary identification of GNPS and the correlation analysis of vicinal known compounds. The strategy was first applied to Imperatae Rhizoma and facilitated the characterization of a large quantity of data to provide comprehensive chemical composition results. This approach can be easily extended to the study of the material basis of other herbs or preparations in order to improve the accuracy of herb quality evaluation.

A novel quantified palatability evaluation method (saliva evaluation combined with electronic tongue evaluation) for Traditional Chinese Medicine oral formulations based on oral stimulation

This study investigates the usefulness of saliva determination for the palatability evaluation of Traditional Chinese Medicine (TCM) oral formulations as a complement to the electronic tongue (E-tongue) method. In this study, the response threshold and intensity of saliva amount evaluation method on different concentration of five taste standard substances was verified with the human sense and E-tongue sense. Fifty-eight kinds of TCM oral formulations and basic taste substances were utilized to assess the applicability of the novel method, which compared with the results of E-tongue evaluation. According to the PCA map, the oral stimulation of TCM oral formulations were divided into three groups (Group 1: SM < 0.05; Group 2: SM = 0.05; Group 3: SM > 0.05). In this study, the results of PLS revealed that the responses of E-tongue sensors could be characterized 71.9% of the SM information (R2 = 71.9%). These showed that the taste stimulation of TCM had certain influence in SM. And the sensors of CA, JE, GA, and HA were critical parameters on palatability evaluation of TCM oral formulations. In conclusion, SM can be used to characterize the chemical and mechanical senses of TCM oral formulation. And it can be predicted the palatability of TCM according to the classification results of E-tongue.

Real-World Evidence of Traditional Chinese Medicine (TCM) Treatment on Cancer: A Literature-Based Review.

While randomized controlled trials (RCTs) are the gold standard for evidence-based medicine, they do not always reflect the real condition of patients in the real-world setting, which limits their generalizability and external validity. Real-world evidence (RWE), generated during routine clinical practice, is increasingly important in determining external effectiveness of the tightly controlled conditions of RCTs and is well recognized as a valuable complement to RCTs by regulatory bodies currently. Since it could provide new ideas and methods for clinical efficacy and safety evaluation of traditional Chinese medicine (TCM) and high-quality evidence support, real-world study (RWS) has received great attention in the field of medicine, especially in the field of TCM. RWS has shown desirable adaptability in the clinical diagnosis and treatment practice of traditional Chinese medicine. Consequently, it is increasingly essential for physicians and researchers to understand how RWE can be used alongside clinical trial data on TCM. Here, we discuss what real-world study is and outline the benefits and limitations of real-world study. Furthermore, using examples from TCM treatment on cancer, including Chinese herbal medicine, acupuncture, moxibustion, integrated TCM and Western medicine treatment, and other treatments, we elaborate how RWE can be used to help inform treatment decisions when doctoring patients with cancer in the clinic.