Clinical application of traditional herbal medicine in five countries and regions: Japan;South Korea;China's Mainland;Hong Kong, China;Taiwan, China

Objective:To study the characteristics of the clinical application of traditional herbal medicine in five countries and regions where traditional medicine(TM)is widely used:Japan;South Korea;China's Mainland;Hong Kong,China;Taiwan,China.And to analyze,from multiple angles,the variations in the methods of TM used in each countries and regions.Methods:Fifty commonly used traditional herbs(TOP50)from classical formulae were selected,and descriptive statistics,correlation analyses,and Friedman test were used to compare methods of clinical application and dosages in the countries and regions of interest based on a retrospective review of randomly-selected medical records.Results:There were significant differences in sequencing TOP50 among the five countries and regions(P<.01).The adherence to the classical formulae,from strong to weak was Japan;China's Mainland;Taiwan,China;Hong Kong,China;South Korea.There were also significant differences in TOP50 dosing regimens(P<.01).Overall dosages of TOP50 from high to low were:China's Mainland;Hong Kong,China;Taiwan,China;South Korea;Japan.Finally,there were significant differences in the dosage intervals(P<.01),with dosage intervals from maximum to minimum as follows:China's Mainland;Taiwan,China;Hong Kong,China;South Korea;Japan.Conclusions:The clinical dosages of traditional herbal medicine used in the China's Mainland are relatively large compared with those prescribed in the other four countries and regions,and the range of dosages in China's Mainland is more flexible.On the other hand,clinical dosages of TOP50 are the lowest in Japan,where the dosage range is also the narrowest,supporting the idea that Doctors of Kampo medicine are highly cautious and are likely to adhere strictly to classical formulae,while Hong Kong,China and Taiwan,China are in the middle.The dosage of TOP50 in South Korea is significantly lower than that used in the China's Mainland;Hong Kong,China and Taiwan,China where the adherence to the classical formulae was the lowest,albeit slightly higher than that in Japan.The methods of clinical application of traditional herbal medicine in the five countries and regions were affected by multiple factors,including history,geography,climate,and culture.

Research on Traditional Herbal Medicine Culture of Guangxi Minorities

Guangxi Zluang Autoromous HRlegiom is a muli-ethnic area with l2.ethmic groups including Han Zuang,lao,Mliao,Dong,Mlaoma,Hti,,Jing,lYi,Siui,Celao,and Mlao.The traditional herbal melicime culure of Guangi ethnic minorties is an important comporent of the trxditional medlicine culture system of ethaie minorities in Guangi,andan exremely inportamt part of Chinas ethaic minoity medicine culture.Tle etihmic minorities of Gnamgi have acumulated rich experience in disease prevention andl treatment in the long process of prorluctiomn and life,and formed a unique minority medlical culture.

Traditional herbal medicine as adjunctive therapy for colorectal cancer:a scoping review

Background:A variety of therapy options are available for colorectal cancer,ranging from traditional medicine to complementary and alternative medicine.There is a growing body of evidence supporting the efficacy of complementary and alternative medicine.Therefore,the main aim of this study is to conduct a scoping evaluation of traditional and herbal medicine’s effectiveness as an additional therapy for colorectal cancer patients in clinical settings.Methods:A systematic search was conducted for all articles pertaining to clinical trials related to traditional herbal medicine(THM)with or without other treatments,such as chemotherapy,placebos,or other types of treatment,published from 2010 to November 13,2020,using four search engines,namely Medline,Web of Science,Cochrane Library,and Scopus.Results:The number of colorectal cancer patients in five trials ranged from 89 to 565 people.The THMs stated in these studies were catalpol(Rehmannia glutinosa extract),the traditional Japanese medicine Daikenchuto(mixture of herbal extracts)and Goshajinkigan,Chinese patent herbal medicine Aidi injection,and the traditional Chinese medicine Simo decoction.Positive results were reported in term of reduction of colorectal cancer tumour marker(by catalpol),improvement of gastrointestinal function following gastrointestinal surgery(by Daikenchuto and Simo decoction),better disease control rate and quality of life score(by combination of Aidi injection and chemotherapy),and a decrease in the incidence of oxaliplatin-induced peripheral neurotoxicity(Goshajinkigan).Conclusion:All studies demonstrated fewer adverse effects found in THM intervention groups,however,evidence pointing to THMs’favourable effects on colorectal cancer patients is still required.Therefore,researchers and clinicians are encouraged to perform more research in this area so that more evidence of THM’s efficacy and safety in clinical settings can be obtained.

Future development of Good Agricultural Practice in China under globalization of traditional herbal medicine trade

Traditional herbal medicine(THM)is an important part of the traditional Chinese medicine culture.Due to its high medicinal potential,it should not only serve for the Chinese people’s medical use,but also contribute to the world medicine,THM for the international market must be standardized and large-scale,and produced according to the"Good Agriculture Practice"(GAP).The quality of THM directly affects the patient’s treatment status and safety of use.Therefore,the quality assurance of THM runs through the entire process of research and development,production and clinical practice.The standardized production and cultivation of THM is the starting point of the THM industry chain and plays a decisive role in the economic development of the THM industry.This article summarizes the development history,limitations and future development of GAP,and clarifies the opportunities for THM in the rapid development of the international and domestic Chinese medicine industry.In addition,analyzing the deficiencies that were existing in the former GAP implementation process and by suggesting science-based quality measures,it is hoped to stipulate improved GAP guidelines in the future and to lay the foundation for a modern THM international trade.

Mapping the Dementia Research Area at the Micro-Level Using Co-terms Analysis and Positioning for Traditional Herbal Medicine

Objective： To identify the position of traditional herbal medicine in dementia research field using mapping technology. Methods： Keywords for dementia and traditional herbal medicine for treating dementia were used to extract scientific articles from the Web of Science database from January 2000 to July 2010. A co- occurrence matrix was created based on the concurrent set of author＇s keywords occurring in each scientific article, and technology network maps were created from similarity index matrices. Results： Twenty specialized research areas were identified in the dementia field, and the relationship strength was 0.2-0.6. Many research fields were associated with diagnosis and risk factors for dementia. Additionally, the mechanism or cause of dementia is an actively studied field. Traditional herbal medicine for treating dementia was located on a map near the cortical dementia diagnosis and therapy, and frontotemporal dementia research field with a relationship strength of 0.53 and 0.31-0.33 respectively, which demonstrates that traditional herbal medicine for dementia occupies an independent research area with a relationship to existing scientific research fields. Conclusion： Traditional herbal medicine can provide an alternative and complementary approach for treating dementia as evidenced by a scientific mapping analysis.

TRADITIONAL HERBAL MEDICINES IN LITHUANIA

Lithuania is an Eastern European country with 60 miles of sandy coastline to the open Baltic Sea.The country can be divided into 4 ethnographic regions with specific nature scenery,soil,traditions and linguistic dialects.Lithuania experienced many political changes through the centuries leading finally to regained independence and EU membership in 2004.Geographical,climatic conditions,

In vitro study on the antiviral activity of 9 extracts of traditional Chinese herbal medicine against the human respiratory syncytial virus

Objective:To study the in vitro virucidal activity of 9 extracts of traditional Chinese herbal medicine(the water extracts of Evodia lepta,Clausena lansium,Clerodendrum cyrtophyllum,Callicarpa nudiflora,Nauclea officinalis and Elaeagnus gonyanthes,the alcohol extracts of Nauclea officinalis,Elaeagnus gonyanthes and Zanthoxylumarmatum)on human respiratory syncytial virus(HRSV).Methods:The cytotoxic effect of the extracts on cells was evaluated by a cell viability assay using the CCK-8 method,a concentration of the extracts with cell viability greater than 50%was selected for the follow-up anti-HRSV effect assay,the 50%effective concentration(EC50)was assessed by an in vitro cell infection model.Results:The EC50s of the water extract from Clerodendrum cyrtophyllum,Callicarpa nudiflora and Elaeagnus gonyanthes were 0.05 mg/mL,0.03 mg/mL and 0.05 mg/mL,and the therapeutic index(TI)of them were 18.60,21.67 and 56.80 respectively.Conclusion:The water extracts of Clerodendrum cyrtophyllum,Callicarpa nudiflora and Elaeagnus gonyanthes possess the activity of anti-HRSV virus.

Traditional Chinese herbal medicine plus triple therapy in treating Helicobacter pylori-induced chronic atrophic gastritis: a meta-analysis and cumulative meta-analysis

Objectives:To evaluate the benefits of traditional Chinese herbal medicine(TCHM)plus triple therapy(TT)in the management of Helicobacter pylori(H.pylori)-induced chronic atrophic gastritis(CAG).Methods:A comprehensive access and electronic database search were carried out from inception to June 2020.Prospective randomized trials(TCHM plus TT vs.TT)were selected to assess the eradication rate of H.pylori(ER of H.pylori),clinical symptom relief rate(SRR),treatment-related adverse reactions(TRAR)and 95%confidence intervals(CI)in the meta-analysis and cumulative meta-analysis(CMA).Meta-regression analysis was used to analyze heterogeneity between studies and publication bias.Results:33 studies contained 3,226 participants were included.Compared with the TT group,TCHM plus TT group showed a significantly higher ER of H.pylori(OR=4.14,95%CI:3.21-5.35;P=0.000)and SRR(OR=4.50,95%CI:3.59-5.64).Meanwhile,the TRAR of TCHM plus TT remedy was significantly lower than TT monopoly(RR=0.43,95%CI:0.29-0.64;P=0.000).The results of the CMA,sorted by publication year,duration of treatment,and sample size,confirmed that combined treatment remedy was superior to TT monopoly in respect of ER of H.pylori and SRR.Conclusions:The present study obtained reliable and convincing evidence suggesting that TCHM plus TT remedy was efficacious and safe in treating H.pylori-induced CAG.

Medical Relics Related to Li Shizhen Collected in Shanghai Museum of Traditional Chinese Medicine

This article introduces various editions of Ben Cao Gang Mu(《本草纲目》Compendium of Materia Medica)and displays or collects in the Shanghai Museum of Traditional Chinese Medicine(TCM),along with many other works on the study of Li Shizhen.Li Shizhen is not only a distinguished physician and pharmacist in the Ming dynasty of China but also a great scientist in human history.The most prominent contribution Li had made was sorting and developing the traditional Chinese herbal medicine,with the compilation of Ben Cao Gang Mu(《本草纲目》Compendium of Materia Medica),which represented the highest level of pharmaceutical development of TCM from a new starting line.

Rikkunshito increases peripheral incretin-hormone levels in humans and rats

BACKGROUND It was reported that rikkunshito(TJ-43)improved the cisplatin-induced decreases in the active form of ghrelin in plasma;however,other effects on gastrointestinal hormones have not been investigated.AIM To investigate the effects of TJ-43 on peripheral levels of incretin hormones,including gastric inhibitory polypeptide(GIP)and glucagon-like polypeptide-1(GLP-1),in humans and rats.METHODS Patients were divided into two groups,namely patients who received TJ-43 immediately following surgery[TJ-43(+)group]and those who received TJ-43 on postoperative day 21[TJ-43(-)group],and the plasma levels of active GIP and active GLP-1 were assessed.In animal experiments,rats were treated with TJ-43[rat(r)TJ-43(+)group]or without[rTJ-43(−)group]by gavage for 4 wk,and the plasma active GIP and active GLP-1 levels were measured.The expression of incretin hormones in the gastrointestinal tract and insulin in the pancreas were investigated by immunohistochemistry.Furthermore,the cyclic adenosine monophosphate activities were assessed in pancreatic tissues from rats treated with or without TJ-43 in vivo,and the blood glucose levels and plasma insulin levels were measured in rats treated with or without TJ-43 in oral glucose tolerance tests.RESULTS In humans,the active incretin hormone levels increased,and values were significantly greater in the TJ-43(+)group compared those in the TJ-43(-)group.In rats,the plasma active incretin levels significantly increased in the rTJ-43(+)group compared with those in the rTJ-43(-)group.GIP and GLP-1 expressions were enhanced by TJ-43 treatment.Moreover,plasma insulin levels increased and blood glucose levels were blunted in the rTJ-43(+)group.CONCLUSION The results show that TJ-43 may be beneficial for patients who undergo pancreatic surgery.

Rikkunshito increases appetite by enhancing gastrointestinal and incretin hormone levels in patients who underwent pyloruspreserving pancreaticoduodenectomy: A retrospective study

BACKGROUND Rikkunshito(TJ-43)relieves gastrointestinal disturbance by increases in the levels of acylated ghrelin.AIM To investigate the effects of TJ-43 in patients undergoing pancreatic surgery.METHODS Forty-one patients undergoing pylorus-preserving pancreaticoduodenectomy(PpPD)were divided into two groups;patients took daily doses of TJ-43 after surgery or after postoperative day(POD)21.The plasma levels of acylated and desacylated ghrelin,cholecystokinin(CCK),peptide YY(PYY),gastric inhibitory peptide(GIP),and active glucagon-like peptide(GLP)-1 were evaluated.Oral calorie intake was assessed at POD 21 in both groups.The primary endpoint of this study was the total food intake after PpPD.RESULTS The levels of acylated ghrelin were significantly greater in patients treated with TJ-43 than those in patients without TJ-43 administration at POD 21,and oral intake was significantly increased in patients treated with TJ-43.The CCK and PYY levels were significantly greater in patients treated with TJ-43 than those in patients without TJ-43 treatment.Furthermore,the GIP and active GLP-1 levels increased and values at POD 21 were significantly greater in patients treated with TJ-43 than those in patients without TJ-43 administration.Insulin secretion tended to increase in patients treated with TJ-43.CONCLUSION TJ-43 may have advantages for oral food intake in patients in the early phase after pancreatic surgery.Further investigation is needed to clarify the effects of TJ-43 on incretin hormones.

Traditional Chinese Herbal Medicine for Perimenopausal Depression of Chinese Women:A Meta-analysis

Objective: The objective of this study is to evaluate the effectiveness and safety of traditional Chinese herbal medicine(TCHM) in treatment of perimenopausal depression(PD) in China. Methods: To identify randomized controlled trials, an electronic search has been conducted through databases as follows: PubMed, the Cochrane Central Register of Controlled Trials, Web of Science, Chinese Biological Medicine Database, China National Knowledge Infrastructure Database, Chinese Scientific Journal Database, and WanFang Digital Periodicals Database.Methodological quality was evaluated by Cochrane Collaboration's tool which is able to assess the risk of bias in Review Manager Software.What's more, meta-analysis was performed by using Cochrane Collaboration's RevMan 5.2 software,(Nordic Cochrane Centre, Cochrane Collaboration, Copenhagen, and Denmark). Dichotomous data were analyzed by using relative risk(RR) and 95% confidence interval(CI).Continuous variables were analyzed using weighted mean differences(WMDs) and 95% CI. Subgroup analysis was performed by the type of medicine which was used in the experimental group. Results: This meta-analysis includes 11 randomized control trials with 818 patients.Compared to the control group(RR: 1.14, 95% CI: [1.03, 1.26], P = 0.009 and WMD:-2.09, 95% CI: [-3.58,-0.18]), the experimental group had a significant higher clinical efficacy rate and relatively lower Hamilton Depression Rating Scale(HAM-D) score. For clinical efficacy rate, the results varied depending on the detail treatment measures of the experimental group. In the experimental group with TCHM,no significant difference was observed(RR: 1.14, 95% CI: [0.97, 1.33]), while in the experimental group combined with western medicine,a significant difference in the clinical efficacy rate between the experimental group and control group showed up(RR: 1.15, 95% CI: [1.01,1.32], P = 0.04). For the HAM-D score, subgroup analyses revealed that the pure TCHM therapy was not associated with significant HAM-D score reduction compared to the control group(WMD:-2.48, 95% CI: [-6.00,1.03], P = 0.17). However, in the experimental group where western medicine was added to, the HAM-D score decreased statistically compared to the control group(WMD:-1.88, 95% CI: [-3.58,-0.18], P = 0.03). There is no serious adverse event in both groups. Conclusions: Combination therapy of TCHM and western medicine is more effective in treating PD in terms of clinical efficacy rate. However, the results should be interpreted with caution due to the mediocre methodological quality of the included trials.

Disease-based Toxicology on Safety Assessment Strategy and Application for Herbal and Traditional Medicines

The safety issue on herbal and traditional medicines(H&TM) is one of the most challenging problems and serious concern worldwide. With scientific endeavor and further exploration, we came to realize that there are great differences between H&TM and synthetic drugs in many aspects, such as medical theory, medication experience, compatibility, processing, toxicological characteristics, and safety evaluating requirements. In the current preclinical models for synthetic drugs, the safety assessment results of some conventional deemed 'nontoxic' H&TM were not well consistent with clinical situations, which resulted in major difficulties to understand the mechanisms and guide the safe and rational uses of these H&TM. Thus, based on the traditional Chinese medicine toxicity theory called You Gu Wu Yun, this paper introduces a novel safety assessment strategy for H&TM, named as disease-based toxicology. It aims to cognize the relativity and susceptibility of the toxicity of H&TM, and then to enhance controllability in new drug development and clinical applications. It also provides a theoretical practice for the traditional Chinese medicine toxicity theory and a methodological promotion for the future development of the precision toxicology for H&TM.

Challenges in Research and Development of Traditional Chinese Medicines

This review is briefly to recall the history of research and development (R&D) of Chinese materia medica (CMM) and to discuss the challenges of Chinese traditional and herbal medicines (CTHM) facing the modern science and technology. The R&D of CTHM is thought to be an important pathway for new drug discovery. Since1949, about 140 approved new drugs have been developed, among which about 80 originated directly or indirectly from medicinal plants. CTHM has gained interest from the international medical, biomedical, and pharmaceutical institutions as a valuable source of potential medicines. For the modernization of CMM and innovative research of CTHM, there are following challenges to be faced: (1) to evaluate the efficacy, pharmacological properties, action mechanism, and active chemical constituents; (2) to develop new methodologies for the quality and safety of CTHM; (3) to apply new '-omics' techniques to accelerate drug discoveries developed from CTHM; and (4) to apply international practices including good agricultural practice, good manufacturing practice, good laboratory practice, and good clinical practice in the R&D of CTHM.

Buyang Huanwu Decoction fraction protects against cerebral ischemia/reperfusion injury by attenuating the inflammatory response and cellular apoptosis

Buyang Huanwu Decoction fraction extracted from Buyang Huanwu Decoction contains saponins of Astragalus, total paeony glycoside and safflower flavones. The aim of this study was to demonstrate the neuroprotective effect and mechanism of Buyang Huanwu Decoction fraction on ischemic injury both in vivo and in vitro. In vivo experiments showed that 50-200 mg/kg Buyang Huanwu Decoction fraction reduced infarct volume and pathological injury in ischemia/reperfusion rats, markedly inhibited expression of nuclear factor-KB and tumor necrosis factor-a and promoted nestin protein expression in brain tissue. Buyang Huanwu Decoction fraction （200 mg/kg） exhibited significant effects, which were similar to those of 100 mg/kg Ginkgo biloba extract. In vitro experimental results demonstrated that 10-100 mg/L Buyang Huanwu Decoction fraction significantly improved cell viability, decreased the release of lactate dehydrogenase and malondialdehyde levels, and inhibited the rate of apoptosis in HT22 cells following oxygen-glucose deprivation. Buyang Huanwu Decoction fraction （100 mg/L） exhibited significant effects, which were similar to those of 100 mg/L Ginkgo biloba extract. These findings suggest that Buyang Huanwu Decoction fraction may represent a novel, protective strategy against cerebral ischemia/reperfusion injury in rats and oxygen-glucose deprivation-induced damage in HT22 cells in vitro by attenuating the inflammatory response and cellular apoptosis.

Traditional Chinese Medicine Induced Liver Injury

Traditional Chinese Medicine (TCM) is popular around the world and encompasses many different practices with parti-cular emphasis on herbal TCM. Using the PubMed database, a literature search was undertaken to assess the extent herbal TCM products exert rare hepatotoxicity. Analysis of reported cases revealed numerous specified herbal TCM products with potential hepatotoxicity. Among these were An Shu Ling, Bai Fang, Bai Xian Pi, Ban Tu Wan, Bo He, Bo Ye Qing Niu Dan, Bofu Tsu Sho San, Boh Gol Zhee, Cang Er Zi, Chai Hu, Chaso, Chi R Yun, Chuan Lian Zi, Ci Wu Jia, Da Chai Hu Tang, Da Huang, Du Huo, Gan Cao, Ge Gen, Ho Shou Wu, Hu Bohe You, Hu Zhang, Huang Qin, Huang Yao Zi, Hwang Geun Cho, Ji Gu Cao, Ji Ji, Ji Xue Cao, Jiguja, Jin Bu Huan, Jue Ming Zi, Kamishoyosan, Kudzu, Lei Gong Teng, Long Dan Xie Gan Tang, Lu Cha, Ma Huang, Mao Guo Tian Jie Cai, Onshido, Polygonum multiflorum, Qian Li Guang, Ren Shen, Sairei To, Shan Chi, Shen Min, Shi Can, Shi Liu Pi, Shou Wu Pian, Tian Hua Fen, White flood, Wu Bei Zi, Xi Shu, Xiao Chai Hu Tang, Yin Chen Hao, Zexie, Zhen Chu Cao, and various unclassified Chinese herbal mixtures. Causality was firmly established for a number of herbal TCM products by a positive reexposure test result, the liver specific scale of CIOMS (Council for International Organizations of Medical Sciences), or both. Otherwise, the quality of case data was mixed, especially regarding analysis of the herb ingredients because of adulteration with synthetic drugs, contamination with heavy metals, and misidentification. In addition, non-herbal TCM elements derived from Agaricus blazei, Agkistrodon, Antelope, Bombyx, Carp, Fish gallbladder, Phellinus, Scolopendra, Scorpio, and Zaocys are also known or potential hepatotoxins. For some patients, the clinical course was severe, with risks for acute liver failure, liver transplantation requirement, and lethality. In conclusion, the use of few herbal TCM products may rarely be associated with hepatotoxicity in some susceptible individuals, necessitating a stringent pretreatment evaluation of the risk/benefit ratio, based on results of multicenter, randomized, double-blind, placebo-controlled clinical trials.

Effects of ephedrine on expression of Nogo-A and synaptophysin in neonatal rats following hypoxic-ischemic brain damage

BACKGROUND： Central nervous system axons regenerate poorly following neonatal hypoxic-ischemic brain damage （HIBD）, partly due to inhibitors, such as Nogo-A. Very few studies have addressed the regulation of Nogo-A in neonatal rats following HIBD. However, numerous studies have shown that ephedrine accelerates neuronal remodeling and promotes recovery of neural function in neonatal rats following HIBD. OBJECTIVE： To investigate the effects of ephedrine on expression of Nogo-A and synaptophysin in brain tissues of neonatal rats following HIBD. DESIGN, TIME AND SETTING： A completely randomized, controlled study was performed at the Immunohistochemistry Laboratory of the Research Institute of Pediatrics, Children＇s Hospital of Chongqing Medical University from August 2008 to March 2009. MATERIALS： Ephedrine hydrochloride （Chifeng Pharmaceutical Group, China）, rabbit anti-Nogo-A polyclonal antibody （Abcam, UK）, and rabbit anti-synaptophysin polyclonal antibody （Lab Vision, USA） were used in this study. METHODS： A total of 96 healthy, neonatal, Sprague Dawley rats were randomly assigned to three groups （n = 32）： sham operation, HIBD, and ephedrine. The HIBD model was established by permanent occlusion of the left common carotid artery, followed by 2 hours of hypoxia （8% oxygen and 92% nitrogen）. In the sham operation group, the left common carotid artery was exposed, but was not ligated or subjected to hypoxia. Rats in the ephedrine group were intraperitoneally injected with ephedrine immediately following HIBD, with 1.5 mg/kg each time. Rats in the sham operation and HIBD groups were injected with an equal volume of saline. All neonatal rats were treated once daily for 7 days. MAIN OUTCOME MEASURES： Histopathological damage to the cortex and hippocampus was determined by hematoxylin-eosin staining. Expression of Nogo-A and synaptophysin was detected using immunohistochemical staining. RESULTS： Neuronal degeneration and edema were observed in the hypoxJc-Jschemic cortex and hippocampus by hematoxylin-eosin staining. Compared with the sham operation group, the levels of Nogo-A significantly increased in the HIBD group at various time points （P 〈 0.01）. Nogo-A expression was significantly reduced in the ephedrine group compared with the HIBD group （P 〈 0.01）. Synaptophysin expression was significantly decreased in the hypoxic-ischemJc cortex, compared with the sham operation group （P 〈 0.01）. Synaptophysin levels were significantly increased in the ephedrine group, compared with the HIBD group （P 〈 0.01）. CONCLUSION： Altered Nogo-A expression was associated with inversely altered synaptophysin expression. The use of ephedrine normalized expression levels of Nogo-A and synaptophysin following HIBD.

Exploring Traditional Chinese Medicine by A Novel Therapeutic Concept of Network Target

Traditional Chinese medicine（TCM） holds a holistic theory, and specializes in balancing disordered human body using numerous natural products, particularly Chinese herbal formulae. TCM has certain treatment advantages for patients suffering from various complex diseases. However, due to the complex nature of TCM, it remains difficult to unveil such holistic medicine by the current reductionism research strategies, which treat both herbal ingredients and targets in isolation. Recently, an emerging network pharmacology approach has been introduced to tackle this bottleneck problem. A TCM-derived novel therapeutic concept, ＂network target＂, which is different from the Western medicine＇s ＂onetarget＂ concept, has been proposed from China. The network target strategy is able to illustrate the complex interactions among the biological systems, drugs, and complex diseases from a network perspective, and thus provides an innovative approach to access ancient remedies in a precision manner and at a systematic level, which also highlights TCM＇s potential in current medical systems.

Review of the Regulations for Clinical Research in Herbal Medicines in USA

In 2012,USA Food and Drug Administration（FDA） approved 39 new drugs,however,there are only two botanical drugs（one topical and one oral）approved by FDA since the publication of the FDA＇s industry guidelines for the botanical drug product in June 2004.The approval shows the Western guideline can be used for herbal medicines,authors investigate current regulation on herbal medicine clinical research,identify challenges conducting clinical trials,and seek to produce some guidance for potential investigators and sponsors considering a clinical trial in this area.Key words were formulated for searching on Medline and FDA website to locate relevant regulations for clinical research in herbal medicines to understand current environment for herbal medicine usage and examine the barriers affecting herbal medicine in clinical trials.Authors critically explore case study of the 1st FDA approved botanical drugs,Veregen（sinecatechins）,green tea leaves extract,a topical cream for perianal and genital condyloma.In consideration of current regulation environment in USA,based on the findings and analysis through the literature review and Veregen case study,authors produce and propose a Checklist for New Drug Application of Herbal Medicines for potential investigators and sponsors considerina in a herbal medicine clinical trial.

THE REGISTRATION OF TCM PRODUCTS UNDER EU TRADITIONAL HERBAL MEDICINAL PRODUCT DIRECTIVE

The Traditional Herbal Medicinal Products Directive(THMPD)2004/24/EC is a regulatory process established to enable high quality herbal medicines to be registered as an OTC product,with medical claims(as allowed for OTC drugs)on the packaging and in the patient information leaflet.For those products which are eligible to be registered they must firstly,be only for mild and self-limiting ailments。