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diagnosis was unclear. The majority of doctors felt placebos were ethically acceptable in some circumstances. Study 2: Qualitative results indicate that trial recruitment and retention depend on a set of convictions forged largely as a result of contextual factors peripheral to the intervention, including the friendliness and helpfulness of research centre staff and status of the administering practitioner. These convictions also influence the reporting of the study outcomes, particularly if participants experience uncertainties when choosing an appropriate response. The findings suggest that participants in clinical trials are actively involved in shaping the research process, rather than passive recipients of treatment. Conclusions: The clinical and ethical implications of the widespread use of placebos in primary care will be discussed. The outcomes of CAM trials and very probably most CAM treatments particularly those involving contact interventions, should be regarded not as matters of fact, but as products of complex environmental, social, interpretive and biological processes. In this paper, we develop and present a ‘theory of active participation’ which offers a framework for understanding the impact of non-specific placebo processes in clinical trials and possibly clinical practice. http://dx.doi.org/10.1016/j.eujim.2012.07.053 Integrative medicine in the perspective of P4 Medicine Gian Franco Gensini Florence University Faculty of Medicine, Florence, Italy P4 Medicine originates from a very popular acronym in the United States. The original P4s derive from marketing in which the P4s are product, price, place and promotion, and that means having the right product with the right price placed appropriately in order to be attractive and promoted in the right way. Currently, P4 Medicine is a very serious subject that takes specific part in the 7th European Framework Program. P4 Medicine means ‘Predictive, Preventive, Personalised, and Participatory Medicine’. I believe that all medicine enjoys from the approach related to these four words, but perhaps it is appropriate to consider that integrative medicine represents in reality what is useful for the sick person in the most extensive and complete way. The concept of ‘Participatory and Personalised Medicine’ is a synergistic concept because personalised medicine requires a clear participation and comprehension of all elements that represent the person who needs care and who is not necessarily sick but just needs support and help. In this sense, there is the renewed attention to narrative medicine that dominated the field when the medicine had limited therapeutic treatments, but fully developed empathy and capacity to comprehend the patient’s needs. Today, the attention to personalised medicine is often understood in a limited way as a genetic medicine, genomic medicine in which pharmacogenetics and pharmacogenomics are certainly useful elements for personalisation.
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However, we cannot forget that ‘Personalisation’ comes from higher, comes from general medicine, comes from ethnic medicine in which we have now a clear indication of more appropriate therapeutic approaches that often differ in relation to ethnicity but also among different subjects of the same ethnicity. The possibility of identifying the additional elements typically distributed in oncology, but also widely present in oncoemathology and in cardiovascular diseases, represents today the elements in which the term ‘Personalised’ actually means the attention to: patient needs and experiences, possible consequences of previous diseases, life and nutrition attitudes that certainly are a very important element in the response to any pathogen and therapeutic issue. Today, there is a possibility to ‘personalize’ in a precise manner and in this ‘personalisation’ the contribution of medicines that integrate classical pathophysiological medicines is certainly an appropriate way to clarify the concept of P4. At a time when the concept of system biology is moving appropriately to system medicine even to higher levels of complexity, it is correct to imagine that an enzyme reaction is necessary realised in a context with different times and places that requires a precise knowledge of everything in order to place the reaction that is represented by the organism; it is absolutely clear that when we add the variable disease condition, this leads to the addition of levels of complexity but in fact it represents an attempt to describe the complexity of current medicine. I believe that full awareness of all this combined with the classical trend of integrative medicine offers the maximum knowledge of how to be the person who can offer personalised medicine solutions in the best possible way. This should represent the renewed base that has always been done but never defined precisely. Now we have the opportunity to define these concepts in a precise way. I believe that we all can obtain the conjunction and synthesis on what the classical medicine offers and how integrative medicine can offer further indications on improvement of patient care, health and the quality of life. It emphasises improved personal measurements and personalised treatments as the key to improving health care. http://dx.doi.org/10.1016/j.eujim.2012.07.054 Memorial Sloan-Kettering’s Integrative Medicine Service Virgilio Sacchini Memorial Sloan Kettering Cancer Center, New York, USA The Integrative Medicine Service has an activity of about 20 000 inpatient and outpatient visits per year. Integrative medicine supplements mainstream cancer treatments with complementary therapies, many of them ancient healing methods, to control physical and emotional symptoms and speed recovery. It includes touch therapies such as massage, mind–body therapies such as meditation and self-hypnosis, nutrition consultations, yoga and fitness training, music therapies and acupuncture. The philosophy of the Service is that complementary therapies are not alternatives to mainstream medical care. Rather they serve as adjuncts to traditional treatments to help alleviate stress
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and anxiety, reduce pain, promote well-being and speed recovery. They also must be evidence based with measurable results that can be tested and evaluated. “We do not do fringe or quack therapies based on anecdotal claims.” The benefits of complementary therapies can be dramatic. For example, one large study led by the Chief of Service, Dr. Barrie Cassileth, found that cancer patients reported a 50% reduction in symptoms such as pain and stress after one 20-min massage session. In addition, multiple studies have established that acupuncture helps control symptoms related to cancer and its treatments, including pain, anxiety, depression, dry mouth and shortness of breath. Massage, music therapy and guidance for meditation are provided to inpatients free of charge, and other remedies are available as needed. Referrals to the Integrative Medicine Service come from medical staff as well as from patients themselves and their caregivers. The outpatient centre is designed to create a calm, spa-like atmosphere that promotes feelings of serenity and well-being. Coming for a massage or yoga session is a respite for many patients and caregivers amid a period of stress and anxiety. The outpatient centre is also open to the general public, and it takes referrals from oncologists at other hospitals and in private practice. The Integrative Medicine Service recently combined two existing objectives – stress reduction and physical activity – into a new initiative called Training for Treatment and Beyond. The programme is designed to provide newly diagnosed patients with tools to withstand the consequences of a cancer diagnosis. To help patients control emotional stress, a self-hypnosis CD is available in the Memorial Sloan-Kettering Center. Data show that self-hypnosis shortly before surgery, even for a few minutes, results in shorter stays in the recovery room and the hospital. The other component of the initiative involves incorporating physical activity as part of the treatment plan following a cancer diagnosis. To test whether this is feasible at a major cancer centre, the Integrative Medicine Service is undertaking a pilot effort with the Memorial Sloan-Kettering prostate surgery group. The service recently developed an exercise DVD that is issued to patients scheduled for prostate surgery as part of standard preparation, just as every patient receives a chest X-ray or has blood drawn. During follow-up care, the patients will be asked if they have adhered to the exercise guidelines, by either using the DVD or engaging in related activities. The service also conducts extensive research in collaboration with other senior laboratory and clinical scientists at Memorial
Sloan-Kettering. Much of the research relates to whether a complementary therapy alleviates cancer-related symptoms such as pain or anxiety. However, the service also investigates treatments that may help fight cancer itself. In 2005, the National Institutes of Health awarded Memorial Sloan-Kettering $8 million over 5 years to serve as one of six botanical research centres – and the only one focussed on cancer. With Dr. Cassileth and immunologist Philip O. Livingston serving as co-directors, the Memorial Sloan-Kettering Research Center for Botanical Immunomodulators works in collaboration with the Institute of Chinese Medicine in Hong Kong to investigate the potential of beta glucans, the essential constituent of medicinal mushroom extracts, to modify the immune response in ways that could fight cancer. As part of this effort, a small, proof-of-principle clinical trial is testing this extract in patients with myelodysplasia (a bone marrow disorder that impairs production of normal blood cells) to see whether it can delay or prevent progression to leukaemia by stimulating the activity of immune cells called neutrophils. Additional botanicals research includes a clinical trial of the herbal medicine called Sho-saiko-to (SST). The study investigates whether SST is effective in treating liver inflammation and injury caused by chronic hepatitis C. Hepatitis C can lead to liver cancer, so we are looking into whether giving SST to patients would slow down the damage to the liver and reduce the chance of cancer. An internationally popular component of the Integrative Medicine Service is its About Herbs Web site. Launched in 2003, the site contains comprehensive, evidence-based information regarding approximately 250 herbs, botanicals, vitamins and other over-the-counter agents, as well as unproved methods. For each herb, vitamin or botanical, there are two listings – one for patients and one for oncology professionals – which include purported uses, possible side effects and interactions and any clinical trials of the supplement. About Herbs is popular among patients and the medical community alike, drawing a high number of visits. From the start, the Integrative Medicine Service was intended to be a prototype programme that could be modelled at other institutions. Physicians from other hospitals/countries can visit for 1- or 2-week ‘observation experiences’ to learn how integrative medicine is practised. The service also offers training programmes and certification courses for practitioners. http://dx.doi.org/10.1016/j.eujim.2012.07.055