The traditional Chinese medicine prescription patterns of Sjögren׳s patients in Taiwan: A population-based study

Ethnopharmacological relevance

Traditional Chinese medicines (TCM), when given for symptom relief, have gained widespread popularity among Sjögren?s patients. The aim of this study was to analyze the utilization of TCM among Sjögren?s patients in Taiwan.

Materials and methods

The usage, frequency of service, and the Chinese herbal products prescribed among Sjögren?s patients were evaluated in a cohort of 1,000,000 beneficiaries recruited from the National Health Insurance Research Database. The logistic regression method was employed to estimate the odds ratios (ORs) for utilization of a TCM.

Results

More than 90% of Sjögren?s patients received TCM out-patient services at least once during the study period. Patients with secondary Sjögren?s syndrome were more likely to seek TCM treatment than those with primary Sjögren?s syndrome. The aOR for those suffering from at least one rheumatologic disease was 1.56 (95% CI: 1.26–1.93), those with two rheumatologic diseases was 1.98 (95% CI: 1.29–3.04), while those with three or more rheumatologic diseases was 7.86 (95% CI: 1.09–56.58). Compared to Sjögren?s patients who used no medical treatment, the aOR for those who took one type of conventional medication was 1.55 (95% CI: 1.25–1.92), those who took two types was 1.98 (95% CI: 1.60–2.47) while those who took three or more types was 2.91 (95% CI: 2.20–3.84). Qi-Ju-Di-Huang-Wan (Lycium Berry, Chrysanthemum, and Rehmannia Pill) was the most frequently prescribed formula among Sjögren?s patients.

Conclusion

Qi-Ju-Di-Huang-Wan is the most commonly prescribed Chinese herbal formula for Sjögren?s syndrome and its effects should be taken into account by healthcare providers.     

Prescription pattern of Chinese herbal products for hypertension in Taiwan: A population-based study

Ethnopharmacological relevance

Traditional Chinese medicine (TCM) has been commonly used in Asia country. The aim of this study is to analyze the utilization of TCM among hypertensive patients in Taiwan.

Materials and methods

The use of TCM for primary hypertensive patients was evaluated using a randomly sampled cohort of 1,000,0s recruited from the National Health Insurance Research Database in 5-year period from 2006 to 2010.

Results

Overall, 49.7% (n=42,586) of primary hypertension utilized TCM and 12.1% (n=5132) of them used TCM for the treatment of hypertension. Among the top 10 most frequently prescribed herbal formulae, Tian-Ma-Gou-Teng-Yin, Gout-Teng-San, Liu-Wei-Di-Huang-Wang and its derivatives were found to be the most common herbal formulae prescribed by TCM doctors for the treatment of hypertension in Taiwan.

Conclusion

This study showed the utilization pattern of Chinese herbal product in patients with hypertension. Further researches and clinical trials are needed to evaluate the efficacy of these Chinese formulae or its ingredients in treating hypertension.     

Pharmacovigilance practice and risk control of Traditional Chinese Medicine drugs in China: current status and future perspective

Ethnopharmacological relevance

Traditional Chinese Medicine (TCM), including Traditional Chinese Medicine drugs (TCM drugs), has been playing a very important role in health protection and disease control for thousands of years in China. Relying on natural products, mainly of herbal origin, used either as raw materials for decoction, as prepared herbal medicines or as formulated traditional medicines, TCM is still widely accepted by Chinese people, especially for chronic diseases treatment. This extensive use warrants safety measures and so TCM drug safety monitoring and risk management are becoming increasingly important tasks for the Chinese State Food and Drug Administration (SFDA).

Methods

The Adverse Drug Reaction (ADR) monitoring system in China was established both for western and TCM drugs in 1989 as a voluntary reporting system with a National Center collecting and compiling reports. Serious or multi-case reports on individual TCM drug or formulated products are detailed in the Chinese ADR Information Bulletin to inform the public and Drug Administrative authorities for risk management.

Results

About 10–15% of the ADR reports received by the National Center are related to TCM drugs and mainly pertaining to the formulated products. In certain cases, the suspension of a particular TCM preparation is decided by SFDA China.

Conclusion

The model of safety monitoring and risk management of TCM drugs is still under exploration. Indeed, the characteristics and risk factors associated with these drugs require both proper understanding and control of the risk by strengthening standardization of clinical applications, basic science research, quality control in manufacturing, exploration of the actives monitoring methodology and enhancement of international communication and cooperation.     

Danggui to Angelica sinensis root: Are potential benefits to European women lost in translation? A review

Ethnopharmacological relevance

Danggui (Chinese Angelica root; Dong quai; Angelica sinensis (Oliv.) Diels.) is a traditional Chinese herbal remedy with a long history of use in China, Korea and Japan. Even today it is still one of the herbs most commonly used by Traditional Chinese Medicine (TCM) practitioners in China, as well as Europe. It is mainly used for the treatment of women's reproductive problems, such as dysmenorrhea, amenorrhoea, menopause, among others. Using Angelica sinensis (Oliv.) Diels. root as the example, this Review examines the ease with which the use of a Traditional Chinese Herbal Remedy can be transposed from one culture to another. By examining the more recent literature, a number of aspects are considered by the author to be potentially lost in translation: (i) identity and quality (phytochemistry); (ii) tradition of use and processing (smoke-drying, stir-frying, with and without wine); (iii) method of use and traditional types of Chinese herbal medicines; (iv) ethnic differences (Caucasian vs. Asian); (v) efficacy, safety and potential for western drug–herb interactions.

Materials and methods

This review is based on evaluation of the literature available in scientific journals, textbooks, electronic sources such as ScienceDirect, PubMed, Scopus, etc., as well as other web-sites.

Results

A vast amount of information concerning the use of Angelica sinensis exists in the public domain. Many aspects associated with the use of the root are deemed problematical, such as identity, processing, amount and types of constituents, tradition of use in combination with other Chinese herbs, ethnicity of users, etc. Numerous constituents have been isolated with phthalides, ferulic acid and polysaccharides showing biological activities.

Conclusion

In spite of the potential activities associated with the traditional use of danggui, and the many trials using the Chinese system of ‘Zheng differentiation’, well-designed western-style clinical trials carried out using the authenticated, chemically standardized crude drug material to confirm clinical efficacy are in short supply. However increasing research into Angelica sinensis extracts and constituents shows that many of the traditional uses are not without scientific basis.     

Toona sinensis Roem tender leaf extract inhibits SARS coronavirus replication

Aim of the study

Severe acute respiratory syndrome (SARS) is a life-threatening disease caused by the SARS coronavirus (SARS-CoV). The development of new antiviral agents for SARS-CoV is an important issue. We tried to find potential resource from Traditional Chinese medicine (TCM) for development of new drugs against SARS-CoV.

Materials and Methods

Our team recruited the potential TCM formulae (also known as Kampo) from two TCM books, Shang-Han Lun (Discussion of Cold-Induced Disorders) and Wen-Bing Tiau-Bein (Differential Management of Febrile Diseases). Several herbs, which were believed to be beneficial for SARS by experienced TCM doctors were also recruited. In addition, a vegetable polular in Taiwan, China and Malaysia, the tender leaf of Toona sinensis Roem (also known as Cedrela sinensis, belongs to the family Meliacceae) was also recruited under the suggestion of botanic experts. These TCM products and plant extrats were then tested for the effectiveness against SARS-CoV in vitro.

Results

Only TSL-1, the extract from tender leaf of Toona sinensis Roem was found to have an evident effect against SARS-CoV with selectivity index 12∼17.

Conclusion

This paper reports for the first time that extract from a vegetable, the tender leaf of Toona sinensis Roem, can inhibit SARS-CoV in vitro. Thererfore, the tender leaf of Toona sinensis Roem may be an important resource agninst SARS-CoV.     

A promising approach for understanding the mechanism of Traditional Chinese Medicine by the aggregation morphology

Objective

Previous work has found that the Traditional Chinese Medicine (TCM) form aggregates in the aqueous solution, and the activities of two Chinese herbal formulae against three cardiovascular targets were aggregates-related. This paper further studied the molecular morphology composed of aggregation and single active molecule in TCM.

Methods

We take Pueraria lobata (Willd.) Ohwi (PUE) as an example. By means of dynamic light scattering (DLS), transmission electron microscopy (TEM), and high performance liquid chromatography–mass spectrometry (HPLC–MS), the mechanism and active components of the aggregates in PUE have been studies. Besides the relationship between aggregation and therapeutic activities in the vivo level has been studied by hemorheological method.

Results

Puerarin, daidzein, daidzin, genistein, these cardiovascular bioactive compounds existed in the aggregates. Three kinds of aggregation processes by the bioactive molecules in the solution were elucidated: (1) the aggregation of single molecule oneself; (2) the aggregation between different single molecules; (3) the aggregation between different single molecules and the primary metabolites. Furthermore, the therapeutic activity of PUE solution was aggregates-related in vivo level.

Conclusions

The aggregation morphology of molecules in TCM might be a promising way to study the mechanism of TCM, even to develop an approach of new nanomedicine of TCM.     

Investigation into the mechanism of Eucommia ulmoides Oliv. based on a systems pharmacology approach

Ethnopharmacology relevance

Though Traditional Chinese Medicine (TCM) has long been playing a significant role in the maintenance of health for people in Asia as well as many other places, the mechanism of its action still remains ambiguous for most of the plants used in TCM, such as Eucommia ulmoides Oliv., a kind of herb that is widely used to help regulate hypertension and the immune system nowadays. However, its functioning mechanism is still unknown. Thus it is necessary to exploit the mechanism of Eucommia ulmoides Oliv.

Methods

A systems pharmacology approach combining drug-likeness evaluation, oral bioavailability prediction, multiple drug targets prediction as well as network pharmacology techniques has been used.

Results

This comprehensive systematic approach helps successfully to identify 41 candidate compounds contained in Eucommia ulmoides Oliv. while 39 potential targets hit by these ingredients and helps to uncover the synergistic mechanism of action on a systematic level.

Conclusions

Our work successfully explains the mechanism of the efficiency of Eucommia ulmoides Oliv. for the treatment of hypertension and enhancing immune. These results not only provide a new insight for the understanding of the chemical and pharmacological basis of Eucommia ulmoides Oliv., but also provide an efficient way for drug discovery from herbal medicine.     

The rise of traditional Chinese medicine and its materia medica: A comparison of the frequency and safety of materials and species used in Europe and China

Ethnobotanical relevance

Due to the global rise in the use of traditional Chinese medicine (TCM), Chinese materia medica (medicinal materials, or CMM) are giving cause for concern over their evidence base, safety/possible toxicity, questionable quality and use of endangered species of both animals and plants. However, little if anything is actually known about the range of species used to produce CMM used in Europe and even in China. This study represents the first attempt to identify and compare the most important CMM used in both regions, to begin the process of assessing the risks to public health and possible future benefits.

Materials and methods

Data were collected from a convenience sample of TCM practitioners in the EU and mainland China, using a paper/online survey. Among other questions, respondents were asked (1) which conditions they most commonly treated using CMM and the likelihood of them using herbal manufactured products and decoctions in addition to raw herbs; (2) the perceived frequency with which they observed adverse events to CMM; (3) the frequency and reasons for use of 1 herbal formula and 6 specific individual herbs; (4) an open question about other CMM they used, including materials of non-plant origin. Data were entered into PASW statistics package and analysed using frequency tables, cross-tabulations and chi-squared tests to compare EU and Chinese results.

Results

From a total of 747 useable questionnaires (420 from China, 327 from the EU) of those responding from the EU, TCM was generally more commonly used for obstetric/gynaecological and dermatological conditions, compared to neurological and gastrointestinal diseases in China. Disorders treated by Chinese practitioners were more varied, and often more serious, than those treated by their European counterparts, and the range of materials used in China was wider. The potential for toxicity was not high in either region, but although greater in China due to the use of more potent CMM, the incidence of side effects was perceived to be higher by EU practitioners.

Conclusions

Very few of the species used to prepare CMM in the EU in this study give rise to safety concerns from what is known from the scientific and other literature, and in China only a few toxic CMM appear to be commonly used, some of them only after processing and mainly for serious disorders. The main cause for concern is likely to be interaction with prescribed medication, especially in central nervous system and cardiovascular conditions where drug interactions have previously been reported most frequently and which would currently be more applicable in China than Europe.     

Scientific validation of the different purification steps involved in the preparation of an Indian Ayurvedic medicine, Lauha bhasma

Ethnopharmacological relevance

Lauha bhasma (iron ash) is one of the iron-based herbo-metallic preparations used in Ayurvedic medicine for treating various ailments due to iron deficiency.

Materials and methods

The preparation of Lauha bhasma (iron ash) requires normal purification (heat treatment in vegetable and animal products), special purification (treatment with herbal constituents) and calcination steps aimed at converting the raw material to a suitable therapeutic form. In this study, we have systematically and scientifically evaluated through a series of qualitative tests and modern analytical tools the importance of the treating media.

Results

Our data demonstrates that these steps are necessary to remove the grease and scales in the raw material. While heating, microcracks appeared on the surface of the iron, which improved the reactivity with the herbal constituents in addition to incorporating nanostructured features. Further, the use of plant products facilitated the removal of Fe³⁺ present in the raw material by forming soluble complexes. The Fe²⁺ present in the raw materials also forms an insoluble complex with the herbal constituents in the presence of UV radiation.

Conclusions

In conclusion, our data summarily suggest that the purification steps involved in the preparation of Lauha bhasma (iron ash) are critical.     

The use of Chinese herbal products and its influence on tamoxifen induced endometrial cancer risk among female breast cancer patients: A population-based study

Ethnopharmacological relevance

The increased practice of traditional Chinese medicine (TCM) worldwide has raised concerns regarding herb–drug interactions. The purpose of our study was to analyze the use of Chinese herbal products (CHPs) and to estimate the influence of the use of CHP on tamoxifen induced endometrial cancer risk among female breast cancer patients in Taiwan.

Methods

All patients newly diagnosed with invasive breast cancer receiving tamoxifen treatment from January 1, 1998 to December 31, 2008 were selected from the National Health Insurance Research Database. The usage, frequency of service, and CHPs prescribed among the 20,466 tamoxifen-treated female breast cancer patients were analyzed. The logistic regression method was employed to estimate the odds ratios (ORs) for utilization of CHPs. Cox proportional hazard regression was performed to calculate the hazard ratios (HRs) for subsequent endometrial cancer for CHP non-users and CHP users among female breast cancer patients who had undergone tamoxifen treatment.

Results

More than half of the subjects had ever used a CHP. Jia-Wei-Xiao-Yao-San (Augmented Rambling Powder) and Shu-Jing-Huo-Xue-Tang (Channel-Coursing Blood-Quickening Decoction) were the two most commonly used CHPs. The HR for the development of endometrial cancer among CHP users was 0.50-fold (95% CI=0.38–0.64) compared to that of CHP non-users.

Conclusion

More than half of the study subjects had ever used a CHP. Jia-Wei-Xiao-Yao-San was the most commonly used CHP. Among female breast cancer patients who had undergone tamoxifen therapy, CHP consumption decreased the risk of subsequent endometrial cancer. Exploring potential Chinese herb–tamoxifen interactions and integrating both healthcare approaches are beneficial to the overall health outcomes of tamoxifen-treated female breast cancer patients.     

Ameliorative and neuroprotective effect in MPTP model of Parkinson's disease by Zhen-Wu-Tang (ZWT), a traditional Chinese medicine

Aim of the study

Traditional Chinese medicine Zhen-Wu-Tang (ZWT) is a well-known PentaHerbs formula from “Treatise on Febrile Disease”. This study is to elucidate its neuroprotective effect and mechanism of ameliorative effect of the syndrome of Parkinson's disease (PD).

Materials and methods

The ameliorative effect of ZWT on symptom of PD through behavior tests including: swimming test, the tail suspension test and open-field test was investigated. The neuroprotective effect of dopaminergic neurons from the striatum and frontal cortex of brain was detected by high performance liquid chromatography with electrochemical detection (HPLC-ECD).

Results

This study proved that ZWT could ameliorate the typical symptom of PD and protect dopaminergic system.

Conclusion

These results suggested that ZWT possessed protective and ameliorative properties of dopaminergic neurons.     

Capillary blood flow in patients with dysmenorrhea treated with acupuncture

Objective

To observe capillary blood flow at acupoints during acupuncture treatment of primary dysmenorrhea and gain new insights into its analgesic mechanism.

Methods

Patients with primary dysmenorrhea were enrolled and randomly assigned to a treatment or control group. Subjects' symptoms were differentiated into various Traditional Chinese Medicine (TCM) syndromes and treated for 10 sessions with puncturing acupuncture or self-pressing right-hand Hegu (LI 4), adding other acupoints based on syndrome. Laser speckle was used to compare the change in the vasomotor amplitude and perfusion of the capillaries in Hegu (LI 4) before and during the treatment. Each subject was required to finish the period pain symptoms observation form, verbal rating scales, numerical rating scale, pain rating index, face rating scale, Zung self-rating depression scale, Zung self-rating anxiety scale, and numerical rating scale before and after treatments.

Results

After 10 sessions, the symptom scores, pain index (PI), and visual analog scale (VAS) decreased significantly in treatment group. The volume of blood flow in Hegu (LI 4) declined slightly. No significant evidence supported that needling caused capillary contraction, but the capillary vasomotor amplitude at Hegu (LI 4) increased remarkably.

Conclusion

Acupuncture can increase the capillary blood flow, thus promoting the flow of Qi and blood in terms of TCM theory, which facilitates pain relief.     

Meta-analysis of Traditional Chinese Medicine in treating functional dyspepsia of liver-stomach disharmony syndrome

Objective

To systematically assess the clinical effectiveness of traditional Chinese medicine (TCM) in the treatment of functional dyspepsia (FD) of liver-stomach disharmony syndrome by meta-analysis.

Methods

Random controlled trials (RCTs) were retrieved from databases, including Pubmed, China national knowledge infrastructure, Wanfang Data, VIP Information, and the Cochrane Library. Trials were selected according to inclusion criteria. The effects of traditional Chinese medicine (TCM) versus prokinetic agents in the treatment of functional dyspepsia (FD) of liver-stomach disharmony syndrome were compared by meta-analysis. RevMan 5.0.24 was used for data analysis. The effective rate was assessed by odds ratios (ORs), and 95% confidence intervals (Cls) were calculated. The cure rate was analyzed by the Peto OR. Simple statistical analysis was chosen to assess the frequency of prescribed Chinese herbs in treating this syndrome.

Results

Thirteen trials were included, involving 1153 patients, and these were of poor methodological quality. Twelve studies mentioned the effective rate and cure rate. TCM therapy showed a better clinical effect rate compared with that with prokinetic agents [OR: 3.2, 95% CI (2.27, 4.51)]. The TCM group also had a better cure rate than that in the group of prokinetic agents [Peto OR: 2.26, 95% CI (1.61, 3.18)]. With regard to the frequency of Chinese herbs used in these 13 trials, Baishao (Radix Paeoniae), Chaihu (Radix Bupleuri), and Gancao (Radix Glycyrrhizae) were mostly prescribed, followed by Xiangfu (Rhizoma Cyperi), Zhishi (Fructus Aurantii Immaturus), Zhiqiao (Fructus Aurantii), Foshou (Citrus medica var.sarcodactylis), and Chenpi (Pericarpium Citri Reticulatae). No serious adverse effects were reported.

Conclusion

TCM therapy shows a superior effective rate and cure rate compared with those in prokinetic agents in the treatment of FD of liver-stomach disharmony syndrome. However, further strictly designed RCTs are required because of the poor quality of included trials.     

Screening of the topical anti-inflammatory activity of the bark of Acacia cornigera Willdenow, Byrsonima crassifolia Kunth, Sweetia panamensis Yakovlev and the leaves of Sphagneticola trilobata Hitchcock

Ethnopharmacological relevance

An investigation of topical anti-inflammatory activity was undertaken on plants used in Central America traditional medicine.

Aim of study

Four herbal drugs used in the folk medicine of Central America to treat inflammatory skin affections (Acacia cornigera bark, Byrsonima crassifolia bark, Sphagneticola trilobata leaves and Sweetia panamensis bark) were evaluated for their topical anti-inflammatory activity.

Materials and methods

Petroleum ether, chloroform and methanol extracts were obtained for herbal medicines and then extracts were tested on Croton oil-induced ear dermatitis model in mice.

Results

Almost all the extracts reduced the Croton oil-induced ear dermatitis in mice and the chloroform ones showed the highest activity, with ID₅₀ (dose giving 50% oedema inhibition) values ranging from 112 μg/cm² (Byrsonima crassifolia) to 183 μg/cm² (Sphagneticola trilobata). As reference, ID₅₀ of the non-steroidal anti-inflammatory drug indomethacin was 93 μg/cm².

Conclusions

Lipophilic extracts from these species can be regarded as potential sources of anti-inflammatory principles.     

Future development of global regulations of Chinese herbal products

Ethnopharmacological relevance

GP-TCM is the first EU-funded Coordination Action consortium dedicated to traditional Chinese medicine (TCM) research. One of the key deliverables of the Work Package 7 in GP-TCM was to investigate information of the existing requirements for registration of TCM products listed by global regulatory bodies. The paper aims to collate data and draw comparison of these regulations. Case studies are also presented to illustrate the problems involved in registering TCM products in different regions worldwide.

Materials and methods

A collaborative network task force was established during the early stage of the GP-TCM project and operated through exchanges, teleconferences and focused discussions at annual meetings. The task force involved coordinators, academics who are actively involved with R&;D of Chinese herbal medicines, experts on monographic standards of Chinese materia medica, representatives from regulatory agencies, experts from industries in marketing Chinese medicines/herbal medicines and natural products. The co-ordinators took turns to chair teleconferences, led discussions on specific issues at AGM discussion sessions, at joint workshops with other work-packages such as WP1 (quality issues), WP3 (toxicology issues) and WP6 (clinical trial issues). Collectively the authors were responsible for collating discussion outcomes and updating written information.

Results

A global overview of regulations on herbal registration has been compiled during the three years of the consortium. The regulatory requirements for registration of herbal products in the EU and China were compared, and this is extended to other regions/countries: Africa, Australia, Brazil, Canada, Japan, Russia, South Korea, Taiwan, and the United States. A wide variation of the regulations for the categories of herbal products exists: food (functional food, novel foods, dietary food for special medical purpose, foods for particular nutritional use, food supplement); cosmetic, traditional herbal medicine products; herbal medicines for human use and veterinary use.

Conclusion

The regulatory issues for registration of herbal products are complicated among the countries and regions worldwide. The information summarised in the text is for reference only. Some regulations which are presented in this review are still in legislation process and may change in due course. Before taking any regulatory action, readers are advised to consult current official legislation and guidance and/or to seek appropriate professional advice. The lessons learnt from global regulation of TCM will provide valuable insights for regulation of other traditional medicine such as Ayurveda and Unani medicine, as well as other forms of indigenous medicine. The WHO is well placed to co-ordinate a consultation process with the aim of putting forward suggestions for harmonisation to key regulatory agencies.