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.

Effectiveness and safety of traditional Chinese medicine decoction for diabetic gastroparesis:A network meta-analysis

BACKGROUND Diabetic gastroparesis(DGP)is a prevalent complication of diabetes that impairs people's quality of life and places a significant financial burden on them.The gastrointestinal symptoms of DGP patients can be improved by several Traditional Chinese Medicine(TCM)decoctions that have been shown to be effective in treating the disease.There are still many unanswered questions regarding the identification of appropriate therapeutic agents for the treatment of DGP in clinical practice.AIM To analyze the efficacy of several TCM decoctions in the treatment of DGP using Bayesian network meta-analysis for reference.METHODS PubMed,EMBASE,Cochrane Library,Web of Science,China National Knowledge Infrastructure,The China Biology Medicine DVD,Wanfang,and CQVIP were searched from inception to September 17,2022,to collect randomized controlled trials(RCTs)about TCM decoctions for DGP.Clinical effects and symptom scores were the primary outcomes.Additionally,we assessed motilin(MOT),somatostatin(SS),gastrin(GAS),gastric emptying rate,gastric emptying time,and adverse drug events as secondary outcomes.RESULTS A total of 67 eligible RCTs involving 4790 DGP patients and 7 TCM decoctions were included.The results of network meta-analysis(NMA)and surface under the cumulative ranking curve showed that with western medicine(WM)as a common control,the Banxia Xiexin Decoction(BXXD)+WM was most effective in clinical effects and enhancing early satiety scores;the Simo decoction(SMD)+WM was most effective in improving nausea and vomiting scores and anorexia scores,bloating scores;the Chaishao Liujunzi Decoction(CSLJD)was most effective in MOT,the Zhishi Xiaopi Decoction(ZSXPD)was most effective in SS and upgrading emptying rate;the Jianpi Xiaozhi Decoction was most effective in GAS;the CSLJD+WM was most effective in improving gastric emptying time.CONCLUSION These NMA results suggest that the BXXD+WM and SMD+WM may be one of the potential optimal treatments.Due to various limitations,further large-sample,double-blind,multi-center randomized RCTs are needed.

Exploring the compatibility theory of traditional Chinese medicine formulae:the disassembled prescriptions study

Traditional Chinese medicine(TCM)has become very popular in the treatment of complex diseases worldwide in recent decades.Despite the promising performance of TCM,how herbs work synergistically in a formula and their therapeutic targets remain ambiguous.This largely limits the correct use and modernization of TCM formulas clinically.The study of disassembled prescriptions is important for investigating the compatibility theory of Chinese medicines.By dissecting the mechanisms of TCM formulae,the compatibility principles of some well-known formulae,such as Realgar-Indigo naturalis,have been elucidated to a certain extent.In this review,several common methods of disassembled prescription studies are summarized,including those of single herb or mineral,sub-prescription,active ingredients or effective parts,large formulae,and systems pharmacology studies,as well as the methods of grouping based on the properties or efficacy of Chinese medicines,in order to provide evidence for formulae study.Moreover,some challenges to be addressed in disassembled prescriptions studies have been identified in this review.

Analysis on the formation principle and present situation of nano phase state of multi-component self-assembly of traditional Chinese compound medicine decoction

Traditional Chinese medicine decoction is a complex polydispersed phase system containing real solution,colloid solution,emulsion and suspension.The compound decoction of traditional Chinese medicine has complex components,including saponins,alkaloids,polysaccharides,flavonoids,amino acids and so on,which can be self-assembled to form gels,fibers,micelles,vesicles and so on.The self-assembled nano-phase not only neutralizes the single drug and reduces the toxicity and side effects,but also has its own pharmacological effects,which complement each other to achieve synergistic effect,so as to achieve the role of drug supplement,which is of research significance.The formation principle,solubilization and synergism principle and characterization method of multi-component self-assembly of traditional Chinese medicine compound decoction are discussed in this paper.

Traditional Chinese medicine prescriptions and herbs for the treatment of hypothyroidism:a narrative review

The increasing prevalence of hypothyroidism,which can cause endocrine dysfunction,abnormal neurological function,and cardiovascular and cerebrovascular injuries,poses serious health problems.Thyroid hormone supplementation constitutes the current main therapeutic method for hypothyroidism,yet it has many limitations and risks and is not suitable for everyone.Therefore,it is necessary to seek alternative and complementary treatment methods.It has been proven in practice that traditional Chinese medicine(TCM)possesses multi-channel comprehensive characteristics for the treatment of hypothyroidism and has more advantages than single thyroid hormone supplementation.Through a comprehensive examination of existing literature about TCM efficacy in addressing hypothyroidism,we have meticulously consolidated the most recent research findings on prescriptions and herbal substances employed in the treatment of this condition.Furthermore,we have explicated their respective functions in the management of hypothyroidism,thereby offering valuable perspectives and recommendations for the prospective utilization of natural remedies in its treatment.

Identifying medication regularity of traditional Chinese medicine and potential pharmacological mechanism of Jiedu Sangen decoction in colorectal cancer treatment by data mining and network pharmacology

Objective:Colorectal cancer(CRC)is one of the most common malignancies in the world,and traditional Chinese medicine(TCM)is widely used in its treatment in China.However,the medication rules of TCM for CRC treatment remain unclear.Therefore,data mining combined with network pharmacology was utilized to establish treatment principles and rules.Methods:The CRC cases treated at Zhejiang Provincial Hospital of Chinese Medicine from January 1,2016 to October 31,2021 were analyzed using data mining methods.UPLC-Q/TOF-MS analysis was performed to identify the chemical composition of Jiedu Sangen decoction(JSD).Network pharmacology was used to reveal the therapeutic mechanism of JSD.Results:A total of 312 cases 2,998 prescriptions that met the inclusion criteria used 343 kinds of traditional Chinese medicines.The nature of the herbs used in treatment was mainly warm and mild.The taste was mainly sweet,bitter,and pungent.The meridian tropisms were mainly the spleen meridian,followed by lung and stomach meridians.Tonifying and replenishing herbs were the most frequently used in treatment.High-frequency herbs were classified into 11 categories by cluster analysis,and 42 association rules were obtained by association rule analysis.Combined with complex network analysis,3 core prescriptions for clinical CRC treatment were obtained.Jiedu Sangen decoction contains 64 chemical ingredients,out of which 31 active ingredients were identified,including polydatin,caffeic acid,and glutamic acid,along with 130 potential targets such as AKT1,SRC,and MAPK1.Jiedu Sangen decoction may play a role in regulating inflammation,immunity,metabolism,and hormones in the development of CRC via pathways such as the relaxin signaling pathway,IL-17 signaling pathway,prolactin signaling pathway,and T cell receptor signaling pathway.Conclusions:This study summarizes the treatment and medication principles for clinical CRC treatment,promoting the inheritance and development of the traditional Chinese medical experience.

Determination of Liquiritigenin, Liquiritin, Isoliquiritigenin and Isoliquiritin in Extract of Traditional Chinese Medicine Sijunzi Decoction by High-Performance Liquid Chromatography

Aim An HPLC-UV method for the analysis of Traditional Chinese Medicine （TCM） preparation, Sijunzi decoction, has been developed. Four flavonoid marker compounds, liquiritigenin, liquiritin, isoliquiritigenin, and isoliquiritin, from Radix Glycyrrhizae were quantitatively analyzed in this preparation. Methods The separation was performed on a reversed-phase C18 column by using a gradient elution with mobile phase of （A） water-formic acid （100∶0.04, V/V） （pH 3） and （B） acetonitrile. The mobile phase gradient was set from 0-5 min at 10% of B and 45 min to 90% of B. The assay was carried out at a flow rate of 0.2 mL·min-1 at room temperature with the UV detection wavelengths at 280 nm and 368 nm. Results The extract （25 mg·mL^-1） of Sijunzi decoction contains 1.47 μg·mL^-1 liquiritigenin, 16.40 μg·mL^-1 liquiritin, 0.66 μg·mL^-1 isoliquiritigenin, and 2.12 μg·mL^-1 isoliquiritin. The recoveries for the sample preparation of the markers were 102.2%, 97.7%, 100.3%, and 99.9%, respectively. Conclusion The method is simple and accurate. This study reports a routine quantitative method for the analysis of multiple components in Sijunzi decoction by HPLC.

Introduction of Western Medicines into China and Improvement on Decoctions during Modern China

During the late Qing dynasty(1840 A.D.-1912 A.D.),a large quantity of Western medicines entered China,which continuously impacted the traditional Chinese medicine(TCM)market and revealed the shortcomings of Chinese medicines.Some personages in the TCM community followed the trend of learning from the West,and attempted to reform TCM,with the improvement on decoction becoming an important aspect of this effort.Through debates and trials,the improvement on decoction underwent three stages of conceptual evolution:“taking Chinese medicines as the foundation and referring to the dosage forms of Western medicines”,“introducing Western techniques to serve the preparation of decoctions”and“integrating the theories of TCM and Western medicine to improve decoctions”.The study highlights the effective complementarity between modern TCM and Western medicine in the field of pharmacy,and provides valuable experience and support for the reevaluation of the value of TCM in contemporary society.

New treatment for gastroesophageal reflux disease:Traditional Chinese medicine Xiaochaihu decoction

Gastroesophageal reflux disease(GERD)has a high prevalence worldwide.Li et al performed a well-designed study on the efficacy of modified Xiaochaihu decoction(MXD)for GERD,which showed that MXD is an optional therapy for GERD beyond proton pump inhibitors(PPIs).The herbal granule administration mode minimized the bias from traditional herbal formula in clinical trials.One limitation of that study was that it lacked records of side effects and rescue medication.As a chronic disease with recurrent symptoms,GERD rehabilitation requires prolonged observation of the clinical course with MXD therapy.

Clinical Comparison and Analysis of Decoction of Traditional Chinese Medicine Combined with Ear Acupoint Application and Simple Artificial Tears in the Treatment of Dry Eye Syndrome

OBJECTIVE: To study the clinical comparison and analysis of decoction of Traditional Chinese Medicine(TCM) combined with ear acupoint application and simple artificial tears in the treatment of dry eye syndrome. METHODS:A total of 62 patients(124 eyes) with dry eye syndrome treated in the Department of Ophthalmology of The 4th People's Hospital of Shenyang from July 2017 to March 2018 were selected and equally divided into 2 groups according to the admission order. The observation group received the combination therapy of TCM decoction and ear acupoint application, while the control group was given the simple artificial tears. The symptom score after 2 weeks, 4 weeks, and 8 weeks as well as the indicators including break-up time(BUT), Schirmer I test(SIT) and fluorescein(FL) were recorded and compared between groups. RESULTS: The symptom scores had no difference before treatment(P > 0.05), and were better in the observation group than those in the control group after treatment(P < 0.05). At 2 weeks, 4 weeks, and 8 weeks after the treatment, the amelioration level of BUT, SIT, and FL indicators in the observation group was better than that of the control group(P < 0.05). CONCLUSION: Compared with the artificial tears treatment method, the TCM decoction combined with ear acupoint application can significantly ameliorate the tear film stability, tear secretion, and reduce ocular surface damage for dry eye patients.

Prescription and treatment rules for the prescriptions containing Poria cocos and Atractylodes macrocephala couplet medicine based on traditional Chinese Medicine inheritance support platform

Objectives:To provide a theoretical basis for the development of the new products of Poria cocos-Atractylodes macrocephala couplet medicine.Methods:All prescription preparations containing Poria cocos and Atractylodes macrocephala were collected from the Drug Standards of the Ministry of Public Health Drug Standard·Traditional Chinese Medicine Set Prescription Preparation(called Traditional Chinese Medicine Set Prescription Preparation for short).After standardization,the information of each prescription preparation was input into the Chinese Traditional Medicine Inheritance Support Platform(V2.5),and the relevant rules of the software were adopted.Data mining methods were used to analyze the frequency of drugs,main symptoms and diseases in prescriptions,and to analyze the regularity of prescriptions.The prescription rules of top 2 high frequency attending syndromes and diseases were analyzed.Results:There were total of 337 prescription preparations containing couplet medicine of Poria cocos and Atractylodes macrocephala,107 kinds of main symptoms and 66 kinds of diseases.The high frequency syndromes were deficiency of Qi and blood and weakness of spleen and stomach,and the high frequency syndromes were anorexia and irregular menstruation.Conclusion:The couplet medicine of Poria cocos-atractylodes macrocephala prescription is mainly used to treat digestive tract diseases and gynecological diseases;it mostly takes tonifying deficiency efficat.It can treat different diseases being compatible with different medicinal materials.The study can provide theoretical basis for clinical application and new drug development of the couplet medicine of Poria cocos-atractylodes macrocephala.

Applicability of Zipfs Law in Traditional Chinese Medicine Prescriptions

Objective Traditional Chinese medicine(TCM)prescriptions have been used to cure diseases in China for thousands of years,in which many TCM herbs have no definite common quantity.Some key TCM herbs are commonly used and thus deserve in-depth investigations based on a more acceptable classification method.This study analyzes whether TCM prescriptions follow Zipf's law and attempts to obtain the thresholds of key TCM herbs based on the application of Zipfs law;Methods A total of 84,418 TCM prescriptions were collected and standardized.We tested whether Zipf's law and Zipfs distribution fit the Chinese herb distributions.A linear fitting experiment was performed to verify the relationship between the frequency distribution and frequency of TCM herbs.Results The distribution of TCM herbs in TCM prescriptions conformed to Zipf's law.Accordingly,the thresholds were obtained for the key TCM herbs.Conclusion The distribution of TCM herbs in TCM prescriptions follows Zipfs law.

Analysis on the rules of prescriptions for ischemic stroke based on the traditional Chinese medicine inheritance auxiliary system

In China,traditional Chinese medicine is widely used in the treatment of ischemic stroke,but its prescription rules needs to be further studied.This paper uses the traditional Chinese medicine inheritance auxiliary system(a software)to analyze the composition rules of a large number of prescriptions for the treatment of ischemic stroke,and discusses the clinical rationality of the new prescriptions.We found that the prescriptions for the treatment of ischemic stroke are mainly composed by herbs for promoting blood circulation and removing blood stasis,dredging collaterals and tonifying deficiency,and some of the new prescriptions are also in line with this characteristic.This paper can provide reference for clinical prescription in the treatment of ischemic stroke and the development of related new drugs.

Research Progress in the Application of Network Pharmacology in Traditional Chinese Medicine and Compound Prescriptions

Network pharmacology is a new discipline based on the theory of systems biology,mainly for network analysis of biological systems.It selects specific signal nodes for multi-target drug molecular design.This article summarizes the application of network pharmacology in traditional Chinese medicine and compound prescriptions in recent years from the research progress of network pharmacology,the current research status of single herbs,and the research and application of compound prescriptions.

Discussion on the Application of Ascending and Descending Property of Traditional Chinese Medicine in Compatibility of Clinical Prescriptions

Through the method of literature mining,the classics of traditional Chinese medicine,materia medica works,medical cases and documents are studied.Based on common prescriptions for the treatment of diseases such as abnormal Zang-fu viscera and qi movement,dysfunction,etc.,and combined with the theory of ascending and descending property of traditional Chinese medicine,the application of ascending and descending property of traditional Chinese medicine in clinical prescription compatibility and the factors affecting the application are summarized.The ascending and descending properties of traditional Chinese medicine have been widely used in prescription compatibility for the clinical treatment of impairment of purifying and descending function of the lung,spleen and stomach's ascending and descending disorders and heart-kidney noninteractionpatte.

A Systematic Review on Chemical Constituents of Suanzaoren Decoction, a Traditional Chinese Medicine Prescription

Traditional Chinese Medicine prescription Suanzaoren decoction (SZRD) is composed of Ziziphi Spinosae Semen, Chuanxiong Rhizoma, Anemarrhenae rhizoma, Poria and Licorice. It was used to treat central nervous system diseases such as insomnia and anxiety for thousands of years. This paper aims to systematically understand varieties and quantities of compounds and clarify chemical components of SZRD, subsequently to further provide the reference for phytochemistry and pharmacology researches of SZRD. Our results showed that SZRD contained 145 components, including flavonoids, triterpenoids, steroids, coumarins, phthalides, and volatile oils, etc., while five-single herbs contain 1104 components. Only in terms of compound number, there were 80 common components in SZRD and its five herbs, which accounted for 6.8% of total compounds in all 5 herbs and 55.2% of compounds in SZRD. The components of SZRD were not simply the sum of one in every single herb. It is necessary to perform parallel studies among SZRD and its herbs. This review discussed the problems that existed in the chemical research of SZRD and pointed out the direction for its further research.

A Skopos Theory-based Study of Translation Principles of Traditional Chinese Medicine Decoctions

English translations of Traditional Chinese medicine(TCM)terms and prescriptions need standardizing to minimize ambiguity as the popularity of TCM spreads globally.Herein an evaluation guide for translation of TCM decoctions in English into diverse social,cultural and medical systems,is proffered which integrates Skopos theory and Li Zhaoguo’s principles of English translation(conciseness of lexical composition,information accuracy,and similarity in lexical composition).Based on a case study of the traditional herbal medicine Mahuang Xingren Gancao Shigao Tang,direct translation methods with concise lexical composition are determined to most clearly convey the sophisticated and verbose original TCM prescription.

Efficacy and safety of the decoction of nourishing marrow and raising energy in terms of Traditional Chinese Medicine in patients with vascular dementia:a randomized controlled trial

OBJECTIVE: To explore the efficacy and safety of the decoction of nourishing marrow and raising energy in terms of Traditional Chinese Medicine(TCM) in patients with vascular dementia.METHODS: Totally 86 patients with vascular dementia patients hospitalized from September 2010 to January 2015 were recruited and randomly divided into two groups: control group and observation group. Patients in control group received the conventional treatment, whereas patients in another group were treated with the therapy of nourishing marrow and raising energy according to the theory of TCM. Blesse dementia scale scores were measured before and after the treatment for both groups and adverse effect was documented as well.RESULTS: After treatment, Blesse dementia scale scores reduced in both groups, and the difference in score reduction between the two groups was significant(P<0.05). The rate of adverse events was significantly lower in observation group than in control group(P<0.05).CONCLUSION: Our results demonstrate that the decoction of nourishing marrow and raising energy was an effective and safe alternative to vascular dementia in human subjects.

Discussion on the Application of Real-World Study in the Inheritance and Development of Empirical Prescriptions of Traditional Chinese Medicine

Objective To study the research on real-world data and to provide new ideas and methods for the inheritance and development of empirical prescriptions of traditional Chinese medicine(TCM).Methods The disadvantages of using randomized controlled trials for empirical prescriptions of TCM and the advantages of using real-world study(RWS)were analyzed by summarizing the previous RWS and the empirical prescriptions.Meanwhile,the methods for marketing of new TCMs derived from empirical prescriptions of TCM,the data source and trial design of the RWS were discussed.Results and Conclusion RWS can provide new ideas for the listing of new TCMs.With the improvement of relevant laws and regulations,RWS will promote the development of TCM greatly.To promote the application of RWS in the inheritance and development of empirical prescriptions of TCM,the government should improve laws and regulations as soon as possible,and enterprises and research institutions should strengthen patient privacy protection and clarify the responsible parties.

Treatment of abdominal compartment syndrome in severe acute pancreatitis patients with traditional Chinese medicine

AIM: To investigate the therapeutic effect of traditional Chinese traditional medicines Da Cheng Qi Decoction (Timely-Purging and Yin-Preserving Decoction) and Glauber's salt combined with conservative measures on abdominal compartment syndrome (ACS) in severe acute pancreatitis (SAP) patients. METHODS: Eighty consecutive SAP patients, admitted for routine non-operative conservative treatment, were randomly divided into study group and control group (40 patients in each group). Patients in the study group received Da Cheng Qi Decoction enema for 2 h and external use of Glauber's salt, once a day for 7 d. Patients in the control group received normal saline (NS) enema. Routine non-operative conservative treatments included non-per os nutrition (NPON), gastrointestinal decompression, life support, total parenteral nutrition (TPN), continuous peripancreatic vascular pharmaceutical infusion and drug therapy. Intra-cystic pressure (ICP) of the two groups was measured during treatment. The effectiveness and outcomes of treatment were observed and APACHE Ⅱ scores were applied in analysis. RESULTS: On days 4 and 5 of treatment, the ICP was lower in the study group than in the control group(P < 0.05). On days 3-5 of treatment, acute physiology and chronic health evaluation Ⅱ (APACHE Ⅱ) scores for the study and control groups were significantly different (P < 0.05). Both the effectiveness and outcome of the treatment with Da Cheng Qi Decoction on abdominalgia, burbulence relief time, ascites quantity, cyst formation rate and hospitalization time were quite different between the two groups (P < 0.05). The mortality rate for the two groups had no significant difference. CONCLUSION: Da Cheng Qi Decoction enema and external use of Glauber's salt combined with routine non-operative conservative treatment can decrease the intra-abdominal pressure (IAP) of SAP patients and have preventive and therapeutic effects on abdominal compartment syndrome of SAP.