WP6 – Pharmacology in clinical studies

The objectives of WP6 are as follows:

  • To develop a competent network of clinical scientists working at the interface of CHM and Western Medicine with leadership and energy
  • To develop an unbiased review of current research in the functional genomics of CHM
  • To define areas of special interest for study in CHM clinical research with special emphasis on practical, safe and potentially effective areas with a real hope of improving patient care through informing future clinical practice
  • To establish expert guidelines for clinical research in functional genomics and CHM. To provide these online in an interactive format
  • To establish an EU-Chinese forum for ongoing discussion and improvements in CHM clinical research.

During the past 24 months, WP6 continued expanding its clinical network within EU member states and China, reviewed literature related to the clinical use of CHM and constructed a survey questionnaire, which has been launched online.

WP6 activities
  • WP6 kick-off meeting: The meeting was set up in 2009 and all WP members were invited to join. The aim of the meeting was to discuss the 3-year action plan of the WP and to identify members for each deliverable.
  • Building a CHM-focused clinical expert network in EU member states: Many WP6 members have already played key roles at an international level in setting up links/contacts with leading organisations/federations across Europe and China. After the kick-off meeting, these members helped form a network of clinical experts through their organisations/federations.
  • CHM survey: The first phase survey was carried out in the UK only to evaluate the questionnaire and to explore attitude of integration of complementary (including CHM) and alternative medicine and Western healthcare. Self-administered questionnaires to the CHM practitioners in the UK. The second phase of the survey was launched online and data are being collected and full report will be written shortly.
  • WP6 members worked together to review literature related to clinical use of CHM and put together a report, which also includes agreed conclusions of literature review and list of clinical areas. Dr. Andrew Flower, Profs. George Lewith, Claudia Witt, Kenneth Muir et al also worked together on drafting a clinical CHM guidelines. The drafted article has been circulated among WP6 members for comments.
WP6 deliverables

During the past 24 months, WP6 focused on the following deliverables:

  • D6.1 – WP6 kick-off meeting (month 6): The phase-I kick-off meeting of WP6 was held on the 8th - 9th October 2009 at Royal Berkshire Hotel, Ascot, London, UK. The WP6 Coordinator Prof. Kenneth Muir organised the meeting together with Dr. Jin Xu of the University of Warwick following the important start-up work by Prof. George Lewith from the University of Southampton and other colleagues. Ten WP6 members attended this meeting. Members of the work package agreed on WP6 aims and a 3-year action plan of this specific work package. The activities discussed at the meeting included the planned survey on CHM, international network of clinical CHM studies, reviewing the literature related to CHM in clinical studies and elaboration of areas for future research and producing expert guidelines for clinical studies into CHM efficacy and functional genomics/metabolomics. A report has been submitted on time.
  • D6.2 – Building of a clinical expert network in TCM in all the 11 EU Member States in this consortium (month 6):The clinical network was created and the network includes Pan-European Federation of TCM – a European TCM professional organisation, Association of Traditional Chinese Medicine (UK), CAMbrella and RCHM. This deliverable was completed within the first 6 months.
  • D6.3 – Setup and maintenance of website on clinical use of CHM and the application of functional genomics to foster debate (month 6): Important literatures on seminal studies in clinical studies in CHM have been identified and have, and will continue to be, added to the GP-TCM website. Particular focus will be paid to those studies that are using functional genomics to further understand TCM. The activity of this deliverable is ongoing.
  • D6.4 – CHM survey (month 12): Prior to launch the survey, preliminary work was carried out. A study entitled “Attitudes towards the Integration of Complementary (including CHM) and Alternative Medicine and Western Healthcare” was completed by researchers from Nottingham and Warwick Universities. The study involved the distribution of a questionnaire designed to accumulate information and opinions about the use of alternative medicines in the UK and the further research that would be required to foster more widespread use of TCM and complementary therapies.
  • The survey has now been extended to phase 2 and a further questionnaire designed around the specific uses and practices of CHM and acupuncture. Data collection has also been extended across Europe in collaboration with WP8 (Acupuncture). The survey also aims to explore the expertise of TCM professionals, to find out the most common conditions treated by TCM practitioners and their views on effectiveness to ultimately help develop clinical guidelines of TCM usage internationally. The questionnaire has been developed and made available online. The questionnaire consists of easy-reading and easy-understanding questions in both Chinese and English. The questionnaire is web based and is available through the following link:  http://www.surveymonkey.com/s/GP-TCM.
  • D6.5 – Report on the reviewed literature relating to clinical use of TCM (month 12): The report focuses on systematic reviews published in the Cochrane library and other peer reviewed English language journals. These provide more robust evidence than can be obtained from most individual clinical trials.
  • D6.6 – Agreed conclusions of literature review reported (month 12): This deliverable followed on from the work of deliverable D6.5 and the conclusions of the review has been summarised in the report. The evidence from Cochrane reviews is not always conclusive. The numbers involved were frequently too small, the methodological quality of the trials was generally poor, and the studies were highly heterogeneous. However these reviews do provide preliminary evidence supporting the use of CHM in the treatment of these conditions. These findings need to be verified by future research.
  • D6.7 – Focus list of clinical areas and approaches to be supported written (month 18): The group restricted their focus to a limited number of conditions: (i) those that are an important public health condition; (ii) those that do not have an effective Western medicine; (iii) A member within the work package had particular interest and expertise in; (iv) Other conditions in which there is recent evidence of promise. On this basis the following conditions were identified and are considered further in D6.5:
    • Endometriosis
    • Polycystic ovary disease
    • Prostate diseases including benign, pre-malignant and malignant
    • Breast cancer, including early disease and treatment of side effects in Western therapy
    • Selected skin diseases – in particular, eczema/psoriasis
    • Irritable bowel disease
    • Impaired glucose tolerance
    • Other conditions in which there have been recent studies into TCM clinical use and suggestive evidence of clinical effectiveness.
  • D6.8 – Recommendations on the application of functional genomic studies to the study of CHMs in patients: The recommendations were for the further development and application of the high-throughput screening technologies (HTS).  These developments mean that the search for single “active principles” in plants, based on the assumption that a plant has one or a few ingredients that determine its therapeutic effects, can now evolve into an approach which is more appropriate to traditional systems of medicine like CHM.
WP6 Members:
Beneficiary members

Prof. Nicola Robinson (WP6 Co-Coordinator, London South Bank University, UK)

Prof. Bruce Hendry (WP6 Deputy Coordinator, King’s College London, UK)

Ms. Dan Jiang (WP6 Assistant Coordinator, Doctor of TCM, UK)

Prof. George Lewith (University of Southampton, UK)

Prof. Chenghai Liu (Shanghai University of Traditional Chinese Medicine, China)

Prof. Peter Hylands (King’s College London, UK)

Dr. Joëlle Nortier (Université Libre de Bruxelles, Belgium)

Dr. Ava Lorenc (London South Bank University, UK)

Prof. Lei Wang (Capital Medical University, China)

Non-beneficiary members

Prof. Kenneth Muir (WP6 Co-Coordinator, University of Warwick, UK)

Dr. Artitaya Lophatananon (University of Warwick, UK)

Dr. Andrew Flower (University of Southampton, UK)

Prof. Jianping Liu (Beijing University of Chinese Medicine, China)

Prof. Liping Zhao (Shanghai Jiaotong University, China)

Prof. Claudia M. Witt (Charité University Medical Center, Germany)

Dr. Volker Scheid (University of Westminster, UK)

Dr. Huijun Shen (University of Lincoln, UK)

Prof. Aiping Lu (China Academy of Chinese Medical Sciences, China)

Dr. Hongcai Shang (Tianjin University of Traditional Chinese Medicine, China)

Prof. Alan Bensoussan (University of Western Sydney, Australia)

Dr. Prat Boonyawongviroj (Thailand Ministry of Public Health, Thailand)

Dr. Porntep Siriwanarangsun (Thailand Ministry of Public Health, Thailand)

Ms. Rebecca Richmond (University of Oxford, UK)

Prof. Sarah Stewart-Brown (The University of Warwick, UK)

Prof. Odd Georg Nilsen (Norwegian University of Science and Technology, Norway)

Mr. Mazin Al-Khafaji (Avicenna, UK)

Dr. Karen Pilkington (the University of Westminster, UK)

Advisor Board member:

Prof. Boli Zhang (Tianjin University of Traditional Chinese Medicine, China)

WP6 Contact:

Prof. Nicola Robinson

WP6 Co-Coordinator

Faculty of Health and Social Care

London South Bank University

103 Borough Road

London

SE1 0AA

UK

Tel:  +44 207 815 7940

Fax: +44 207 815 8490

E-mail: robinsn4@lsbu.ac.uknicky.robinson@lsbu.ac.uk

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