Safety Of Traditional Chinese Medicine Research Articles

Chemical nature of metabolic activation of natural products in traditional Chinese medicines possibly associated with toxicities

Ensuring the safety of traditional Chinese medicines (TCM) has perennially presented a universal challenge in the healthcare realm. Meticulous investigations into the toxicological intricacies of natural products are of paramount significance, particularly regarding the metabolic transformation of these substances and the subsequent generation of reactive intermediates. This biochemical process underlies the genesis of diverse toxic manifestations, including hepatotoxicity, nephrotoxicity, pulmonary toxicity, and genotoxicity. Compounds sorted within TCM, including pyrrolizidine alkaloids, anthraquinones, furanoterpenoids, alkenylbenzenes, bisbenzylisoquinoline alkaloids, flavonoids, and methylenedioxyphenyl derivatives, evince a spectrum of deleterious mechanisms upon metabolic activation. This review provides a comprehensive delineation of the pathways through which these compounds induce toxicity via metabolic activation. This review emphasizes the chemical mechanisms involved in the metabolic activation of natural products that may trigger a toxic cascade, rather than a superficial phenomenon. Furthermore, this study enriches the extant literature by delving into advancements in elucidating the mechanisms of toxicity engendered by metabolic activation. In conclusion, this review highlights the importance of scrutinizing the mechanisms of toxicity and provides insights into the judicious and safe use of TCM.

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

Today, as the use of traditional Chinese medicine (TCM) becomes increasingly 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” TCMs has overturned the traditional 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.

Efficacy and Safety of Traditional Chinese Medicine Combined with Western Medicine for the Treatment of COVID-19: A Systematic Review and Meta-analysis

Efficacy and Safety of Traditional Chinese Medicine Combined with Western Medicine for the Treatment of COVID-19: A Systematic Review and Meta-analysis

Efficacy of traditional Chinese medicine combined with Silibinin on nonalcoholic fatty liver disease: A meta-analysis and systematic review.

The efficacy and safety of traditional Chinese medicine (TCM) combined with Silibinin in the treatment of nonalcoholic fatty liver disease (NAFLD) are still inconclusive. This meta-analysis intends to evaluation to explore the clinical efficacy and quality assessment of traditional Chinese medicine in combination with Silymarin in the treatment of NAFLD, aiming to aims to provide evidence-based data analysis for researchers and clinical practitioners involved in TCM research for NAFLD, with the hope of facilitating wider adoption and application. In this meta-analysis, we searched PubMed, Embase, Cochrane Library, CNKI, Wanfang, CQVIP and CBM databases from the establishment of the databases to Oct 2023. The study proposed to include studies that reported combination of TCM with Silibinin and Silibinin alone in the treatment of NAFLD, excluding studies for which full text was not available or for which data extraction was not possible; studies using animal studies; reviews and systematic reviews. All data were processed by STATA15.1 statistical software. 16 randomized controlled trials (RCTs) were included in this meta-analysis. The sample size ranged from 48 to 120, with a total of 1335 patients, including 669 in the Combined treatment group and 384 in the Silibinin group. The findings indicated that the total effective rate of combined treatment group was significantly higher than that of Silibinin alone. Levels of alanine aminotransferase (ALT), aspartate aminotransferase (AST), total cholesterol (TC), triglycerides (TG), and gamma glutamyl transpeptidase (GGT) of combined treatment group were all significantly lower than that of western medicine alone. Additionally, after treating NAFLD with a combination of TCM and Silibinin, the TCM syndrome score were significantly lower than those observed with Silibinin alone. Traditional Chinese medicine in conjunction with Silibinin capsules has shown significant efficacy in the treatment of NAFLD, improving clinical symptoms, blood lipid levels, and liver function. Furthermore, it is essential to engage in multi-omics research, investigate iron death, and explore the gut microbiota as potential observational indicators for the diagnosis and inclusion criteria. Conducting more high-quality clinical experiments is necessary to further validate these findings.

Effectiveness of Traditional Chinese Medicine With Liver-Soothing Function for Hyperplasia of Mammary Glands: A Systematic Review and Meta-analysis

ObjectivesHyperplasia of the mammary gland (HMG) is a proliferative condition triggered by an imbalance in endocrine hormones. Studies have revealed the potential role of Traditional Chinese Medicine (TCM) in treating endocrine disorders. TCM offers the advantages of multi-target regulation, significant therapeutic effects, and fewer side effects. TCM exhibits a liver-soothing function, improving clinical efficacy and relieving symptoms including hyperplasia and pain. Therefore, in this systematic review, we investigated the efficacy and safety of TCM with liver-soothing effects in alleviating HMG. MethodsEight databases were searched to obtain randomized controlled trials “(RCTs)” on the use of “Traditional Chinese Medicine with the liver-soothing function” for “hyperplasia of mammary glands.” The quality of collected studies was evaluated using Cochrane Collaboration’s risk of bias tool. Data were extracted from good-quality studies using RevMan. Stata 15.0 software was used for meta-analysis. ResultsIn total, 24 studies with 2,584 patients were included in this investigation. Among them, 1,312 patients in the intervention group received TCM with liver-soothing function and 1,272 patients in the control group received conventional Western medicine or other TCM. TCM with liver-soothing function outperformed the control group in terms of clinical efficacy. Furthermore, TCM with liver-soothing function significantly decreased HMG-associated adverse events, breast pain score, lump score, and other scores. ConclusionTCM with liver-soothing properties can effectively improve clinical efficacy and prevent adverse reactions in patients with HMG. More rigorous RCTs are warranted in the future to provide more concrete evidence.

Efficacy and safety of traditional Chinese medicine in the treatment of menopause-like syndrome for breast cancer survivors: a systematic review and meta-analysis

BackgroundIn recent years, breast cancer (BC) incidence and mortality have been the highest in females. Menopause-like syndrome (MLS), arising from hypoestrogenism caused by endocrine therapy, significantly affects the quality of life for females. Traditional Chinese Medicine (TCM) has advantages in ameliorating MLS, but the efficacy of TCM in patients with BC has not been systematically evaluated.MethodsA comprehensive search was performed on PubMed, Web of Science, Embase, Ovid, Cochrane Library, China National Knowledge Infrastructure, Wanfang database, Chinese Scientific Journals Database, and Clinical Trial Registry from inception to September 4, 2023. The Cochrane Risk of Bias assessment tool was used for the quality evaluation of the randomized controlled trials (RCTs). Review Manager 5.4 software was used for statistical analysis, and the Grading of Recommendations Assessment, Development, and Evaluation was used for quality evaluation of the synthesized evidence.ResultsThis review included 42 studies involving 3112 female patients with BC. The results showed that the TCM group was better at decreasing the Kupperman Menopausal Index (KMI) scores (standardized MD, SMD = − 1.84, 95% confidence interval, CI [− 2.21–-1.46], Z = 9.63, P < 0.00001). Regarding the main symptoms of MLS, the TCM groups could significantly decrease the scores of hot flashes and night sweats (SMD = − 0.68, 95% CI [− 1.1–-0.27], Z = 3.24, P = 0.001), paraesthesia (SMD = − 0.48, 95% CI [− 0.74–-0.21], Z = 3.53, P = 0.0004), osteoarthralgia (SMD = − 0.41, 95% CI [− 0.6–0.21], Z = 4.09, P < 0.0001), anxiety (MD = − 0.85, 95% CI [− 1.13, − 0.58], Z = 6.08, P < 0.00001) and insomnia (MD = − 0.61, 95% CI [− 0.8, − 0.43], Z = 6.51, P < 0.00001). TCM can effectively improve the symptoms of MLS in patients with BC. Moreover, TCM could improve the objective response rate (ORR) by 50% (RR = 1.5, 95% CI [1.37–1.64], Z = 9.01, P < 0.00001). Follicle-stimulating hormone (FSH) and oestradiol (E2) had no significant difference compared with the control group (p = 0.81 and p = 0.87), and luteinizing hormone (LH) in the TCM group decreased significantly (MD = − 0.99, 95% CI [− 1.38, − 0.5], Z = 5.01, P < 0.00001). This means that the use of TCM does not negatively affect endocrine therapy and may even have a synergistic effect. The incidence of adverse events (AEs) was lower in the TCM groups than in the control groups.ConclusionsThe meta-analysis stated that TCM could better improve the MLS of patients, alleviate related symptoms, and did not increase adverse drug reactions in BC survivors. This review brings more attention to MLS, and the present findings shed light on the potential applications of TCM in the treatment of MLS in BC survivors.

A case-control retrospective study for the effect of Shoutai Wan on IVF-ET pregnancy outcome.

It has a long history of preventing and treating disease using traditional Chinese medicine (TCM). In recent years, it has been widely used in adjuvant therapies of in vitro fertilization - embryo transfer (IVF-ET) in China. To observe the effect and safety of Shoutai Wan on pregnancy outcomes after IVF-ET. A total of 352 patients who underwent IVF-ET from July 1, 2020 to June 30, 2021. The participants who only received routine luteal support during clinical pregnancy of FET were defined as the control group, and others who received TCM decoction Shoutai Wan for prevention of miscarriage and routine luteal support were defined as the Chinese medicine protection Shoutai Wan group (St group). This project has been approved by the Ethics Committee of Run Run Shaw Hospital Affiliated to Zhejiang University School of Medicine (Approval NO: 2023-0305). The results of this retrospective cohort study revealed that Shoutaiwan combined with luteal support treatment can significantly decreased the miscarriage rate in pregnancy undergoing IVF-FET compared to the group accepted only luteal support treatment (P = .001). Meanwhile, St during pregnancy did not affect fetal birth weight (P = .354), and there was no adverse event in the St group reported, which confirmed the safety of TCM for fetus protection during pregnancy. This study not only provides evidences for the clinical administration of Shoutai Wan in IVF-ET, but also provides a novel direction for basic research into the subsequent innovative application of TCM.

A systematic review of the efficacy of traditional Chinese medicine retention enema in the treatment of ulcerative colitis

The objective of this study is to summarize the efficacy and safety of traditional Chinese medicine (TCM) enema in the treatment of ulcerative colitis (UC). The randomized controlled trials on TCM enema intervention in the treatment of UC were searched in seven databases: PubMed, Embase, Web of Science, CBM, CNKI, Wanfang Database, and VIP Database from January 1, 2013 to June 6, 2022, and the data were analyzed using RevMan 5.3 software. A total of 18 studies involving 1514 UC patients were included. Meta analysis results showed that compared with conventional Western medicine, Chinese medicine enema had a significant effect on UC, and the clinical effective rate of the experimental group using Chinese medicine enema was 4.45 times that of the control group using conventional Western medicine (odds ratio = 4.45, 95% confidence interval [3.27, 6.06]). Therefore, Chinese medicine enema is effective in the treatment of UC, and can significantly reduce related symptoms.

Efficacy and Safety of Traditional Chinese Medicines as a Complementary Therapy Combined With Chemotherapy in the Treatment of Gastric Cancer: An Overview of Systematic Reviews and Meta-Analyses.

In China, traditional Chinese medicines (TCMs), as a complementary therapy combined with chemotherapy, is widely used in the treatment of gastric cancer (GC). In order to systematically evaluate and synthesize existing evidence to provide a scientific basis for the efficacy and safety of this complementary therapy, we present an overview of systematic reviews (SRs) and meta-analyses (MAs) on the topic of TCMs as a complementary therapy in combination with chemotherapy for the treatment of GC. SRs/MAs on TCMs combined with chemotherapy for GC were comprehensively searched in 8 databases. Methodological quality, risk of bias, reporting quality, and quality of evidence were assessed using the Assessment of Multiple Systematic Reviews 2 (AMSTAR-2), the Risk of Bias in Systematic (ROBIS) scale, the Preferred Reporting Items for Systematic Reviews and Meta-Analyses 2020 (PRISMA 2020), as well as the Grading of Recommendations Assessment, Development, and Evaluation (GRADE) system. Thirteen published SRs/MAs were included in our study. In terms of methodology, all SRs/MAs were considered to be of very low quality. Only 3 SRs/MAs has been assessed as low risk of bias. None of the SRs/MAs has been fully reported on the checklist. A total of 97 outcome indicators extracted from the included SRs/MAs were evaluated, and only 1 item was assessed as high quality. TCMs may be an effective and safe complementary therapy in combination with chemotherapy for the treatment of GC. However, this conclusion must be treated with caution as the quality of the evidence provided by SRs/MAs is generally low.

Effectiveness and safety of traditional Chinese medicine for bone loss associated with endocrine therapy in patients with breast cancer: a systematic review and meta-analysis

Effectiveness and safety of traditional Chinese medicine for bone loss associated with endocrine therapy in patients with breast cancer: a systematic review and meta-analysis

Re-evaluation for systematic reviews of traditional Chinese medicine in the treatment of chronic bronchitis.

Chronic bronchitis (CB) is a common clinical chronic respiratory disease, which has a high incidence in the middle aged and elderly population. With the development of the disease, the number of acute attacks becomes more and more frequent, which leads to the continuous decrease of lung function. If not treated in time, it will lead to a variety of complications and seriously affect the quality of life of patients. Traditional Chinese medicine (TCM) or TCM combined with western medicine is highly effective in the treatment of CB disease. In recent years, there are many systematic reviews on the use of TCM therapy in the treatment of CB, and the efficacy and safety of TCM in the treatment of CB diseases are evaluated. The aim of this study was to re-evaluate the Meta analysis/Systematic reviews (MAs/SRs) of TCM for the treatment of CB, aiming to provide a clinical basis for the treatment of CB by TCM. Retrieval among Chinese and English databases such as China National Knowledge Infrastructure, Wanfang database, China Scientific Journals Database, SinoMed, PubMed, Web of Science, The Cochrane Library and EMbase, etc. were conducted within the duration from database establish Tion date to March 2023.The included research was independently conducted by 2 researchers for literature screening, data extraction, and quality evaluation. The AMSTAR 2 scale was used to evaluate the quality of the report, the PRISMA 2020 statement evaluated the quality of the report, the ROBIS tool evaluated the risk of bias, and the GRADE quality evaluation tool evaluated the quality of the evidence. Fifteen MAs/SRs were included, for a total of 224 studies involving 20,710 patients with CB. The 15 studies included in AMSTAR 2 are of very low quality. The ROBIS evaluation results showed that 8 MAs/SRs were considered to have high risk and 7 with low risk. The PRISMA 2020 report quality showed evaluation results of the included studies scores between 24 and 30, among them 13 with high quality and 2 with low quality. The GRADE system results showed that, within 70 outcome indicators, only 14 of them have moderate quality for evidence, with 31 for low quality, 25 for very low quality, and none for high quality. The MAs/SRs methodological quality of using TCM for treatment CB is generally poor, the quality of reports as well as evidence are generally low, and the risk of bias is high, therefore we should treat these results with caution.

Effectiveness and Safety of Traditional Chinese Medicine in Treatment of Primary Sjögren's Syndrome Patients: A Meta-analysis.

Primary Sjögren's Syndrome (pSS) is an autoimmune disease. It can damage the salivary and lacrimal glands and is characterized by dry mouth and eye symptoms, which seriously affects people's normal life. Both modern medicine and Traditional Chinese medicine (TCM) have certain effects in treating SS. However, there are different theories about which treatment is more appropriate. The aim of this research was to compare the efficacy and safety of TCM to Western Medicine in the treatment of pSS. We collected randomized controlled trials (RCTs) of TCM, integrating traditional Chinese and Western medicine for the treatment of pSS in Chinese and foreign databases. A total of 13 articles were eventually included with 780 cases. The final results were expressed in odds ratio (OR), mean difference (MD), 95% confidence interval (CI), and overall effect (z). The effective rate was 86.03% in the TCM group and 67.75% in the western medicine group. Results of the effective rate were OR = 3.57; 95% CI = 2.44-5.23; z = 6.56; p＜0.00001, ESR were MD = -6.90; 95% CI = -10.76--3.05; z = 3.51; p = 0.0005＜0.05, Schirmer's test were MD = 3.39; 95% CI = 1.92-4.86; z = 4.5; p＜0.00001, salivary flow were MD = 0.62; 95% CI = 0.16-1.07; z = 2.63; p = 0.009＜0.05, and adverse reactions were OR = 0.35; 95% CI = 0.17-0.72; z = 2.84; p = 0.004. TCM has a remarkable effect on the treatment of pSS. Among them Yiguanjian decoction and Liuwei Dihuang decoction were effective prescriptions with the highest frequency of application. Rehmanniae Radix (Rehmannia glutinosa Libosch.) and Ophiopogonis Radix (Ophiopogon japonicus (L. f.) Ker-Gawl.) were the most frequently used TCM.

Efficacy and safety of traditional Chinese medicine nursing intervention in postoperative patients after gastrectomy.

Gastrectomy is a technically demanding procedure for gastric cancer patients that is associated with different degrees of postoperative complications (POCs). Perioperative traditional Chinese medicine (TCM) nursing intervention presents benefits for improving the survival of patients with gastric cancer. However, the effects of TCM nursing intervention on POCs and the prognosis of patients with gastric cancer following surgery are far from clear. In the present study, the effects of TCM nursing intervention on POCs, postoperative physical capacity, metal status, long-term survival and recurrence were investigated in patients with gastric cancer after gastrectomy. In total, 1,032 patients with gastric cancer were included in the study. The patients underwent a gastrectomy and were randomly divided into two groups: The TCM nursing intervention group (TCM group; n=520) and the routine nursing intervention group (control group; n=512). Postoperative pain score, hospital stay, POCs, postoperative gastrointestinal function, frequency of postoperative symptoms, inflammatory index, quality of life, physical capacity, mental status, survival and recurrence were compared after gastrectomy in the TCM and control groups. The treatment-related adverse events of TCM in patients after gastrectomy were recorded in the TCM nursing intervention group. The outcomes showed that TCM nursing intervention decreased the postoperative pain score and hospital stay, improved gastrointestinal function, and decreased the POCs and the inflammation index compared with the control group. In addition, TCM nursing intervention improved physical capacity, quality of life, depression, anxiety, immune activity, long-term survival and recurrence in patients with gastric cancer after gastrectomy. Furthermore, TCM nursing intervention was only associated with a low number of adverse events. In conclusion, outcomes in this study indicate that perioperative TCM nursing intervention improves POCs, mental status, long-term survival and reduces the recurrence of patients with gastric cancer, suggesting that TCM nursing intervention is efficacious and safe with regard to improving the prognosis in these patients after gastrectomy (Retrospective clinical trial registration number, 2015001CW1; name of the register, The First Hospital of Harbin; date of registration, May 7, 2015).

Effectiveness and safety of traditional Chinese medicine for diabetic retinopathy: A systematic review and network meta-analysis of randomized clinical trials.

Diabetic retinopathy (DR) is currently recognized as one of the most serious diabetic microangiopathies and a major cause of adult blindness. Commonly used clinical approaches include etiological control, microvascular improvement, and surgical intervention, but they are ineffective and have many side effects. Oral Chinese medicine (OCM) has been used for thousands of years to treat DR and is still widely used today, but it is unclear which OCM is more effective for DR. To estimate relative effectiveness and safety profiles for different classes of OCMs for DR, and provide rankings of the available OCMs. The search time frame was from the creation of the database to January 2023. RevMan 5.3 and Stata 14.0 software were used to perform the systematic review and Network meta-analyses (NMA). A total of 107 studies and 9710 patients were included, including 4767 cases in the test group and 4973 cases in the control group. Based on previous studies and clinical reports, and combined with the recommendations of Chinese guidelines for the prevention and treatment of DR, 9 OCMs were finally included in this study, namely Compound Xueshuantong Capsules, Qiming Granules, Compound Danshen Dripping Pills, Hexue Mingmu Tablets (HXMM), Qiju Dihuang Pills (QJDH), Shuangdan Mingmu Capsules (SDMM), Danggui Buxue Decoction (DGBX), Xuefu Zhuyu Decoction and Buyang Huanwu Decoction. When these nine OCMs were analyzed in combination with conventional western medicine treatment (CT) compared with CT alone, the NMA results showed that HXMM + CT has better intervention effect on the overall efficacy of DR patients, HXMM + CT has better effect on improving patients' visual acuity, SDMM + CT has better effect on inhibiting vascular endothelial growth factor, DGBX + CT has better effect on reducing fundus hemorrhage area, HXMM + CT has better effect on reducing fasting blood glucose, and QJDH + CT has better effect on reducing glycated hemoglobin. When there are not enough clinical indicators for reference, SDMM + CT or HXMM + CT treatments can be chosen because they are effective for more indicators and demonstrate multidimensional efficacy. This study provides evidence that combining OCMs with CT leads to better outcomes in all aspects of DR compared to using CT alone. Based on the findings, we highly recommend the use of SDMM or HXMM for the treatment of DR. These two OCMs have demonstrated outstanding efficacy across multiple indicators.

Evidence mapping analysis of clinical research on traditional Chinese medicine in treatment of vertigo

In this study, the evidence map system was used to sort out the clinical research evidence on traditional Chinese medicine(TCM) treatment of vertigo and understand the evidence distribution in this field. CNKI, Wanfang, VIP, SinoMed, PubMed, EMbase, and Web of Science were searched for the clinical randomized controlled trial(RCT) and systematic reviews/Meta-analysis on TCM treatment of vertigo in recent five years, and the evidence was analyzed and presented in the form of text and charts. The Cochrane handbook for systematic reviews of interventions was used to evaluate the quality of the clinical RCT, and the AMSTAR mea-surement tool was used to evaluate the quality of the systematic reviews/Meta-analysis. A total of 382 RCTs and eight systematic reviews/Meta-analysis were included. In recent five years, the number of published articles has been on the rise. There were many intervention measures and TCM therapies for vertigo. Outcome indicators mainly included clinical efficacy, TCM syndrome score, vertigo score, occurrence of adverse reactions, and effective rate. The overall quality of clinical RCT and systematic reviews/Meta-analysis was low. Most studies have proven the potential efficacy of TCM in treating vertigo, but there was still no clear clinical evidence of efficacy. The results show that TCM has advantages in the treatment of vertigo, but there are also problems. More high-quality studies are still lacking, suggesting that more large-sample and multi-center RCT should be conducted in the future, and the quality of relevant syste-matic reviews/Meta-analysis should be improved to fully explore the advantages of TCM in the treatment of vertigo, and provide strong support for the effectiveness and safety of TCM in the treatment of vertigo.

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.

A quality-comprehensive-evaluation-index-based model for evaluating traditional Chinese medicine quality

BackgroundEvaluating traditional Chinese medicine (TCM) quality is a powerful method to ensure TCM safety. TCM quality evaluation methods primarily include characterization evaluations and separate physical, chemical, and biological evaluations; however, these approaches have limitations. Nevertheless, researchers have recently integrated evaluation methods, advancing the emergence of frontier research tools, such as TCM quality markers (Q-markers). These studies are largely based on biological activity, with weak correlations between the quality indices and quality. However, these TCM quality indices focus on the individual efficacies of single bioactive components and, therefore, do not accurately represent the TCM quality. Conventionally, provenance, place of origin, preparation, and processing are the key attributes influencing TCM quality. In this study, we identified TCM-attribute-based quality indices and developed a comprehensive multiweighted multi-index-based TCM quality composite evaluation index (QCEI) for grading TCM quality.MethodsThe area of origin, number of growth years, and harvest season are considered key TCM quality attributes. In this study, licorice was the model TCM to investigate the quality indicators associated with key factors that are considered to influence TCM quality using multivariate statistical analysis, identify biological-evaluation-based pharmacological activity indicators by network pharmacology, establish real quality indicators, and develop a QCEI-based model for grading TCM quality using a machine learning model. Finally, to determine whether different licorice quality grades differently reduced the inflammatory response, TNF-α and IL-1β levels were measured in RAW 264.7 cells using ELISA analysis.ResultsThe 21 quality indices are suitable candidates for establishing a method for grading licorice quality. A computer model was established using SVM analysis to predict the TCM quality composite evaluation index (TCM QCEI). The tenfold cross validation accuracy was 90.26%. Licorice diameter; total flavonoid content; similarities of HPLC chromatogram fingerprints recorded at 250 and 330 nm; contents of liquiritin apioside, liquiritin, glycyrrhizic acid, and liquiritigenin; and pharmacological activity quality index were identified as the key indices for constructing the model for evaluating licorice quality and determining which model contribution rates were proportionally weighted in the model. The ELISA analysis results preliminarily suggest that the inflammatory responses were likely better reduced by premium-grade than by first-class licorice.ConclusionsIn the present study, traditional sensory characterization and modern standardized processes based on production process and pharmacological efficacy evaluation were integrated for use in the assessment of TCM quality. Multidimensional quality evaluation indices were integrated with a machine learning model to identify key quality indices and their corresponding weight coefficients, to establish a multiweighted multi-index and comprehensive quality index, and to construct a QCEI-based model for grading TCM quality. Our results could facilitate and guide the development of TCM quality control research.

Version updates of strategies for drug discovery based on effective constituents of traditional Chinese medicine

The discovery of effective constituents of traditional Chinese medicine (TCM) is an important approach in new drug development. Several well-known drugs, such as artemisinin, berberine, and ephedrine have been developed using this approach. However, the efficacy and safety of TCM, two key issues for drug development based on TCM clinical experience, remain unclear worldwide. The discovery strategy of relevant constituents is the most important step for determining efficacy and safety, which still a key scientific problem that restricts the development of new drugs. Furthermore, TCM formulas used as clinical drugs address a specific TCM syndrome (Zheng), and the complexity of the formula and vagueness of the syndrome make the identification of the effective constituents related to clinical effectiveness challenging. Over decades, researchers have developed transdisciplinary technologies and research methodologies to identify effective constituents in vivo. In this paper, the history of strategy development for identifying the effective constituents related to the clinical efficacy of TCM is reviewed and summarized. The main approaches include the phytochemical method, which involves the classical systematic separation and screening (extraction, separation, purification, structure identification, and activity test); bioactivity-guided separation; serum pharmacochemistry of TCM in vivo; and Chinmedomics, which connects in vivo constituents with the biomarkers of the relevant TCM syndrome. Chinmedomics is a promising strategy that conforms to the theory and characteristics of TCM. By clarifying the effective constituents, targets and pathways of medicines, it can promote the discovery of lead compounds and the research of innovative drugs, and continuously promote the modernization of TCM. Graphical abstract: http://links.lww.com/AHM/A64.

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.

Whole-course management of traditional Chinese medicine in the treatment of EGFRIs related skin toxicity in lung cancer: A series of clinical studies.

e21047 Background: Epidermal growth factor receptor inhibitors (EGFRIs) significantly prolong the survival of advanced lung cancer patients. Skin toxicities are the most common side effects caused by EGFRIs, which have the limited standard treatment, and seriously affect the long-term use of EGFRIs and the quality of life. Rash is the main type in the early stage of skin toxicity, and xerosis commonly complicated by pruritus usually occurs in the later stage regularly. Our team carried out a series of clinical studies, taking advantage of traditional Chinese medicine (TCM) in syndrome differentiation and treatment, to observe the efficacy and safety of TCM in the treatment of EGFRIs-related skin toxicity following in order. Methods: From September 2016 to September 2018, patients who occurred xerosis after using EGFRIs were enrolled and randomly divided into the treatment group and control group, respectively receiving Zizao Yangrong granules (ZYG) and placebo granules combined with vitamin E ointment. And then from August 2018 to September 2020, patients suffering from EGFRIs-related moderate to severe rash were enrolled and randomly divided into the treatment group and the control group, receiving Zhiyang Pingfu liquid and placebo liquid respectively, combined with minocycline and methylprednisolone for 14 days. Finally, based on the participants of the preliminary clinical trials, progression free survival (PFS) was determined by telephone follow-up every 3 months in patients with EGFRIs-related xerosis. Results: 66 patients finished the study of EGFRIs-related xerosis. The effective rates of xerosis among the treatment group and the control group were 84.8% and 69.7% (P &lt; 0.05). The patients in the experimental group had better quality of life than that in the control group (P = 0.045). 54 patients finished the topical TCM for moderate to severe rash study, which the effective rates among the treatment group and the control group were 81.48% and 55.56% (P = 0.040). The median total dose of oral minocycline administration in the treatment group was lower than that in the control group (1000mg vs. 1400mg). In the end, 54 patients who received ZYG were successfully followed up. The median PFS in the treatment group was 41.6 months, and 40.9 months in the control group (HR = 0.85, 95%CI 0.48~1.51, P = 0.586). The median DLQI score of the 19 patients who received ZYG more than 8 weeks was 6, significantly higher than 4 before treatment (P＜0. 001). Conclusions: TCM had the great efficacy and safety in the treatment of EGFRIs related dermal toxicity, significantly improving the quality of life for patients. Long-term application of TCM will not affect the PFS of EGFRIs. The series of clinical studies suggested that the whole-course management of TCM in the treatment of EGFRIs related skin toxicity can increase the overall benefit of advanced lung cancer patients. Clinical trial information: ChiCTR1800017053 .