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Background and aims GP-TCM is the 1st EU-funded Coordination Action consortium dedicated to traditional Chinese medicine (TCM) research. This paper aims to summarise the objectives, structure and activities of the consortium and introduces the position of the consortium regarding good practice, priorities, challenges and opportunities in TCM research. Serving as the introductory paper for the GP-TCM Journal of Ethnopharmacology special issue, this paper describes the roadmap of this special issue and reports how the main outputs of the ten GP-TCM work packages are integrated, and have led to consortium-wide conclusions. Materials and methods Literature studies, opinion polls and discussions among consortium members and stakeholders. Results By January 2012, through 3 years of team building, the GP-TCM consortium had grown into a large collaborative network involving ∼200 scientists from 24 countries and 107 institutions. Consortium members had worked closely to address good practice issues related to various aspects of Chinese herbal medicine (CHM) and acupuncture research, the focus of this Journal of Ethnopharmacology special issue, leading to state-of-the-art reports, guidelines and consensus on the application of omics technologies in TCM research. In addition, through an online survey open to GP-TCM members and non-members, we polled opinions on grand priorities, challenges and opportunities in TCM research. Based on the poll, although consortium members and non-members had diverse opinions on the major challenges in the field, both groups agreed that high-quality efficacy/effectiveness and mechanistic studies are grand priorities and that the TCM legacy in general and its management of chronic diseases in particular represent grand opportunities. Consortium members cast their votes of confidence in omics and systems biology approaches to TCM research and believed that quality and pharmacovigilance of TCM products are not only grand priorities, but also grand challenges. Non-members, however, gave priority to integrative medicine, concerned on the impact of regulation of TCM practitioners and emphasised intersectoral collaborations in funding TCM research, especially clinical trials. Conclusions The GP-TCM consortium made great efforts to address some fundamental issues in TCM research, including developing guidelines, as well as identifying priorities, challenges and opportunities. These consortium guidelines and consensus will need dissemination, validation and further development through continued interregional, interdisciplinary and intersectoral collaborations. To promote this, a new consortium, known as the GP-TCM Research Association, is being established to succeed the 3-year fixed term FP7 GP-TCM consortium and will be officially launched at the Final GP-TCM Congress in Leiden, the Netherlands, in April 2012.

Ethnopharmacological relevance Cancer patients in all cultures are high consumers of herbal medicines (HMs) usually as part of a regime consisting of several complementary and alternative medicine (CAM) modalities, but the type of patient, the reasons for choosing such HM-CAM regimes, and the benefits they perceive from taking them are poorly understood. There are also concerns that local information may be ignored due to language issues. This study investigates aspects of HM-CAM use in cancer patients using two different abstracting sources: Medline, which contains only peer-reviewed studies from SCI journals, and in order to explore whether further data may be available regionally, the Thai national databases of HM and CAM were searched as an example. Materials and methods The international and Thai language databases were searched separately to identify relevant studies, using key words chosen to include HM use in all traditions. Analysis of these was undertaken to identify socio-demographic and clinical factors, as well as sources of information, which may inform the decision to use HMs. Results Medline yielded 5638 records, with 49 papers fitting the criteria for review. The Thai databases yielded 155, with none relevant for review. Factors associated with HM-CAM usage were: a younger age, higher education or economic status, multiple chemotherapy treatment, late stage of disease. The most common purposes for using HM-CAM cited by patients were to improve physical symptoms, support emotional health, stimulate the immune system, improve quality of life, and relieve side-effects of conventional treatment. Conclusions Several indicators were identified for cancer patients who are most likely to take HM-CAM. However, interpreting the clinical reasons why patients decide to use HM-CAM is hampered by a lack of standard terminology and thematic coding, because patients' own descriptions are too variable and overlapping for meaningful comparison. Nevertheless, fears that the results of local studies published regionally are being missed, at least in the case of Thailand, appeared to be unfounded.

Ethnopharmacological relevance Buruli ulcer (BU) is the third most common mycobacterial infection in the world, after tuberculosis and leprosy and has recently been recognized as an important emerging disease. This disease is common in West Africa where more than 99% of the burden is felt and where most affected people live in remote areas with traditional medicine as primary or only option. Reports indicate that the ethnopharmacological control approach of the disease in such settings has shown promise. However, no or very few compilations of traditional knowledge in using medicinal plants to treat BU have been attempted so far. This review aimed to record medicinal plants used traditionally against BU in three countries in West Africa: Ivory Coast, Ghana and Benin and for which ethnopharmacological knowledge supported by pharmacological investigations has been reported. The information recorded in this review will support further pharmacological research to develop appropriate drugs for a better BU control. Material and methods A systematic review of the literature on ethnobotanical use and anti-BU activity of plants reported for BU treatment was performed. The approach consisted to search several resources, including Technical Reports, Books, Theses, Conference proceedings, web-based scientific databases such as publications on PubMed, Science direct, Springer, ACS, Scielo, PROTA, Google and Google scholar reporting ethnobotanical surveys and screening of natural products against Mycobacterium ulcerans. This study was limited to papers and documents published either in English or French reporting ethnopharmacological knowledge in BU treatment or pharmacological potency in vitro. This review covered the available literature up to December 2014. Results The majority of reports originated from the three most affected West African countries (Cote d’Ivoire, Ghana and Benin). Though, 98 plant species belonging to 48 families have been identified as having anti-BU use, many have received no or little attention. Most of the pharmacological studies were performed only on 54 species. To a lesser extent, ethnopharmacological knowledge was validated in vitro for only 13 species. Of those, seven species including Ricinus comminus, Cyperus cyperoides (cited as Mariscus alternifolius), Nicotiana tabacum, Mangifera indica, Solanum rugosum, Carica papaya, and Moringa oleifera demonstrated efficacy in hospitalised BU patients. Four isolated and characterized compounds were reported to have moderate bioactivity in vitro against M. ulcerans. Conclusions This review compiles for the first time ethnopharmacologically useful plants against BU. The phamacological potential of 13 of them has been demonstrated in vitro and support BU evidence-based traditional medicines. In addition, 7 species showed activity in BU patients and have emerged as a promising source of the traditional medicine for treatment of BU. Yet, further safety and efficacy study should be initiated prior any approval as alternative therapy. Overall, a huge gap in knowledge appeared, suggesting further well-planned and detailed investigations of the in vitro, in vivo, and safety properties of the claimed anti-BU plants. Therefore, plants with medicinal potential should be scrutinized for biologically active compounds, using bioassay-guided fractionation approach to provide new insights to find novel therapeutics for BU control.

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.

Ethno-pharmacological relevance The scientific proof and clinical validation of Chinese herbal medicine (CHM) require a rigorous approach that includes chemical standardization, biological assays, animal studies and clinical trials. Aim of the study To assess the experimental design of animal studies on the activity of CHM by selection and scrutinizing of a series of papers in some major disease areas. Materials and methods We have analyzed the English publications reported in MEDLINE (ISI web of knowledge). Results Our data showed that (i) research of CHM during the last 10 years had been highly intensified and become more accessible worldwide through increased publications in English, although still most authors had Chinese names; (ii) English journals publishing animal research of CHM were comparable to those publishing animal studies of non-Chinese phytotherapy in terms of impact factor; and (iii) published data on authentication and quality control of CHM, as well as research design of animal studies were far from sufficient to meet the criteria needed to support their reproducibility and reliability. Conclusions and perspectives The recent decade witnessed an increase in CHM research activities and CHM English publications. Based on common problems identified in publications on CHM animal studies, we have proposed a checklist that could help in preliminary selection of publications lacking the most common problems and thus would be useful for a quick search of reproducible CHM regimens that are likely to be effective in a given context. The second application of this checklist is to help avoid the most common problems when designing experiments.

Ethnopharmacological relevanceGP-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 methodsA 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.ResultsA 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.ConclusionThe 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.

Ethnographic relevance Clinical trials investigating Chinese herbal medicine (CHM) have been frequently criticised for their lack of scientific rigour. As part of the GP-TCM project a team of experienced clinical researchers and CHM practitioners have developed clinical trial guidelines for CHM that combine an appreciation for traditional methods of practice with detailed and practical advice on research methodology. Materials and methods This paper presents an executive summary of this work. It introduces the practice of CHM and the key considerations that need to be addressed whilst researching this traditional medical system. Results These guidelines emphasise the importance of identifying best practice, and then developing and applying appropriate and rigorous research methodologies to investigate CHM as a whole system. Conclusions It is hoped that this will encourage a thoughtful and meticulous process of investigation that will clarify the contribution that CHM can make to our future healthcare. Innovative new approaches are considered including the application of the new “omic” technologies and systems biology as a way of enhancing our understanding of traditional practice

Aim: In this article, we comment on the current international discourse on khat, we highlight pitfalls and and suggest balanced national international regulatory actions. Method: A brief an focussed review of the available literature on khat and health and examples from our own research are provided. Results: The use patterns of catha edulis (khat) have changed throughout the last decades. During this period khat has had a remarkable economic boom and developed from a niche crop to the backbone of the regional economy. Now it contributes to the livelihoods of millions of people. Today, khat use is often the proverbial “Door in the wall” for large parts of the populations in African and Arab countries beyond the traditional user groups. Its use is often excessive and not restricted by social regulation mechanisms. Under such conditions, problematic khat use patterns develop rapidly, exemplified by the growing group of binge users, and it gets even prevalent among especially vulnerable groups such as children, people with mental disorders or pregnant women. The currently existing scientific evidence suggests that problematic use patterns not the use per se can be linked to numerous health consequences. Conclusion: This paper argues that changed patterns of khat use are a burden for some of the most underdeveloped countries in the world. But the debate around khat is stuck between extreme poles arguing for prohibition or for de-regulation. Here, we call for a balanced action of governments and international organizations leaving behind the decades of debilitating debate pro vs. contra scheduling and banning khat leaves. Instead, regulation and harm-reduction measures are urgently needed. We suggest a number of steps that should be taken immediately to better understand current khat use patterns, to address noxious excesses and to relieve suffering. © 2009 Elsevier Ireland Ltd. All rights reserved.

Bangladesh has a rich traditional plant-medicine use, drawing on Ayurveda and Unami medicine. How these practices translate into people׳s homes and lives vary. Furthermore, the overlap between food and medicine is blurred and context-specific. This paper explores the food-medicine interface as experienced by Bengali women in their homes, in the context of transnational and generational changes.