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The need for research into health promotion and CAM (Complementary and Alternative Medicine) was the title of the third meeting of the MEP CAM Interest Group of the European Parliament held on October 11th, 2011 in the Parliament. The meeting was chaired by MEP Sirpa Pietikäinen, PEP Fin. The meeting participants first listened to a presentation entitled ‘CAM and the Research Framework Programmes’ given by Mr. Ole Olesen, Senior Scientific Officer, Infectious Diseases & Public Health unit, DG Research and Innovation. This was followed by a presentation on The Contribution of Complementary Medicine to European Public Health – Towards a Research Agenda by Prof Dr Harald Walach, of the European University Viadrina Frankfurt/Oder, Germany.
After a brief introduction to DG Research and the structure and content of the health theme in the current EU FP7 research framework programme, Mr Olesen referred to two current research projects in CAM (CAMbrella and TCM) funded under FP7 that take up most of 5.5 million euros currently invested in CAM research. He then presented the change in thinking within DG Research that will underpin the new research framework programme FP8 or ‘Horizon 2020’, 2013-2020. The switch is to a broader common strategic framework that includes common strategies with a focus on ‘societal challenges’. Among the societal challenges identified is ‘Health, demographic change and wellbeing’ - how to provide better health while maintaining an economically sustainable healthcare system. Under this challenge three main areas of activity were outlined, prevention, treatment and healthcare sustainability, all of which CAM has the potential to contribute to. In conclusion he stated that he thought Horizon 2020 may aim at a broader, more holistic approach to health, including additional focus on well-being. but that, as always, research activities selected for funding are selected on competitive basis of scientific excellence, impact and implementation.
In describing the added value of CAM as a patient oriented multi therapeutic approach to treatment and health, Prof. Walach outlined the advantages of CAM as well as the problems and obstacles which confront CAM in receiving sufficient support for much needed research. Mainstream orientation and predominance in classical pharmacological research as well as very little industry support and marginal support, mostly from small charitable sources, prohibit adequate large scale research in CAM in Europe. International comparisons reveal that WHO has declared CAM and traditional medicines important elements in healthcare worldwide and also demonstrate that considerable funds are dedicated to CAM research in other countries (e.g. USA $128 million for 2011). As a way forward, Prof. Walach strongly recommended the provision for funding for CAM research be included in the health research strategic framework of Horizon 2020. He argued in favour of a ring-fenced approach focusing on model validity and European consortia, asked for specific and knowledgeable reviewers to be included in evaluation panels and recommended as a strategy following the recommendations of the roadmap that will be outlined by the CAMbrella project towards the end of 2012.
In the ensuing discussion on the objectives of Horizon 2020, the potentially new and open as well as holistic approach of the programme was underlined. In principle it would seem to offer CAM much better research opportunities than before. It was agreed that CAM has to be seen as an important ‘innovation factor’ in Horizon 2020. However, the selection criteria for projects, the traditional orientation of conventional reviewers and the role of the Programme Committee (national governments) in setting the priorities for the Framework - and for the Annual Work - Programmes are still existing barriers for CAM research at EU level. Members of the CAM Interest Group agreed that the European Parliament has an important role to play in introducing and safeguarding the opportunities for CAM research in the new research programme during its forthcoming discussion in Parliament and that these issues must be taken up accordingly.
Presentations and background document can be found here.
The newsletter highlights EUROCAM, the alliance of patients, doctors and practitioners in the field of CAM, which is committed to raising public awareness of the public-health benefits of CAM, especially in terms of prevention and health promotion, patient safety, patient-centred health services, mental health, palliative care, health economics and healthy ageing.
Responding to increasing use of CAM by the European public, the European Commission's Directorate-General for Research has funded CAMbrella, a project to develop a roadmap for future European research in CAM that is appropriate for Europe's health care needs.
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This investigation is particularly interesting because, even though several clinical studies have demonstrated an effect of highly diluted homeopathic medicines, until now their action had not been directly observable.
In the Indian research study the effect of different homeopathic potencies of Aconitum napellus, Arsenicum album, Gelsemium sempervirens, Phosphorus, Pulsatilla nigricans, and Sulphur on heart rate variability and blood flow variability were recorded in 77 subjects within an age range of 18-35. The results show a range of responses that are varied and interesting e.g. a pattern seems to emerge from these experiments that medium potencies such as 30c and 200c have probable action on heart rate variability and higher potencies such as 1M have probable action on blood flow variability. However, the authors state this is an exploratory study and that ‘These are observations from exploratory experiments in emerging areas of physiologic variability and need validation by repeated experiments of this type. Detection of response was the primary objective of this study, which has been achieved. The number of subjects in each group was small; hence it was not possible to show the statistical significance of the results, an aspect that will be covered in future studies.’
With the use of the medical analyzer, the researchers may have found a way to move research in the area of ultramolecular homeopathic preparations forward. Their research study suggests that it is possible to record the response of homeopathic medicines on physiologic parameters of the autonomic nervous system, thus offering a means of measuring a direct physiologic effect in an objective, rather than subjective, manner.
Mishra N, Muraleedharan KC, Paranjpe AS, Munta DK, Singh H, Nayak C (2011) An Exploratory Study on Scientific Investigations in Homeopathy Using Medical Analyzer. Journal of Alternative and Complementary Medicine, 17:705-710.
Homeopathy is controversial because medicines in high potencies such as 30c and 200c involve huge dilution factors which are many orders of magnitude greater than Avogadro’s number, so that theoretically there should be no measurable remnants of the starting materials. No hypothesis which predicts the retention of properties of starting materials has been proposed nor has any physical entity been shown to exist in these high potency medicines.
Using market samples of metal-derived medicines from reputable manufacturers, the researchers have demonstrated for the first time by Transmission Electron Microscopy (TEM), electron diffraction and chemical analysis by Inductively Coupled Plasma-Atomic Emission Spectroscopy (ICP-AES), the presence of physical entities in these extreme dilutions, in the form of nanoparticles of the starting metals and their aggregates.
The confirmed presence of nanoparticles challenges current thinking about the role of dilution in homeopathic medicines. Concrete evidence of the presence of particles as found by this team could help take the research in homeopathy a step forward in understanding these potentised medicines and also help to positively change the perception of the scientific community towards this mode of treatment.
Chikramane PS, Suresh AK, Bellare JR, Kane SG (2010). Extreme homeopathic dilutions retain starting materials: A nanoparticulate perspective. Homeopathy, 99: 231-242 [PubMed]
Back in 2005 the government rejected these complementary (CAM) therapies, arguing they failed to meet the legal requirement of scientific evidence of the three criteria of efficacy, cost-effectiveness and suitability. These three criteria to accept a therapy in the list for reimbursement, are required by the law.
The reversal in policy follows a nationwide vote in 2009 in which two-thirds of Swiss backed expanding the Swiss Federal constitution by an article stipulating that the Federal government and cantons shall ensure that, within the scope of their jurisdiction, complementary medicine is taken into consideration.
As far as the cost-effectiveness of these therapies are concerned, data published in an article in the Swiss Medical Journal* show that even though consultations with doctors who have an additional qualification in homeopathy or other complementary therapies are significantly longer than those in conventional medicine - and leading to a higher patient satisfaction - the total costs per patient per year are not higher and the costs per doctor per year are even 29% lower than in conventional medicine.
The economic benefit of these therapies may have been sufficiently demonstrated, but the health authorities are not yet convinced of the efficacy of the complementary therapies. A federal commission in December 2010 even recommended to strike them permanently from the list because of a 'lack of scientific evidence'. Nevertheless the government has given the medical CAM associations some respite. The associations will have to present conclusive evidence for the efficacy of the complementary therapies by 2017, thus leaving them some time to fill in the gaps for those therapies that so far have not, or only partially, managed to fully meet this requirement.
The evidence is then to go before a recognised international institute for an independent scientific assessment. That institute could be the National Center for Complementary and Alternative Medicine in the USA or the National Institute of Clinical Excellence in the UK.
The government’s decision also includes provisions to boost research and training in the field, which would not be counter-productive, even if there is a negative result for the therapies after the trial period.
* the article in the Swiss Medical Journal - Schweizerische Ärztezeitung is available here, in German only.