The Nordic Integrative Medicine Center will conduct clinical trials, registries, comparative effectiveness and clinical research in the Department of IM Clinical Research, inspired by the clinical research being conducted by Dean Ornish’s Preventative Medicine Research Institute (PMRI) and the Duke Integrative Medicine

The NIM Clinical Research Department will aim to do fundamental science research in the areas of psychoneuroimmunology and -endocrinology to further explore and explain the mind-body mechanisms, and lay the foundation for new and improved integrated therapies. In general, the NIM Center will search for publications on clinical trials and meta-analyses nationally and internationally on all the areas of integrative medicine applied in the center, and become a knowledge resource and databank on IM-related treatment methods and their safety and efficacy, also setting up its own high quality clinical trials in promising and relevant areas. This will additionally be useful in registering and approving the different therapists, their schools and methods, and provide information to both consumers and authorities about safety and efficacy.

Research projects in yoga, mindfulness and other therapies will rely on recruitment via general practitioners and hospital ambulatory care, and via informational material, media and word of mouth.

The aim is to eventually produce larger RCT’s in collaboration with the Danish Universities and the University Hospitals. Other important areas of research are:
➢ Mapping the use of, attitudes towards and demand for integrative treatment options in the northern countries, in collaboration with the Danish Health and Medicines Authority, Statistics Denmark and the University of Copenhagen (KU)
➢ Research in IM cost-effectiveness. Cost-benefit studies will be an important tool in policy making and fundraising for further activity and research.

The Department will consist of offices and various kinds as laboratories in which the clinical research will be carried out. The research team will consist of medical doctors, research scientist and Ph.D. students with a background within medical or nature science as well as healthcare practitioners. All will receive the necessary training and education in integrative medicine.

Two phases for the establishment of the NIM Clinical Research Department:

Phase 1: In phase one, the primary focus for the NIM Clinical Research Department will be to evaluate the work being done in the medical centre. Here, all registries will be saved and used for evaluation. The outcomes of the treatment of the patients in the medical centre will be measured and the comparative effectiveness will be evaluated in order to provide the best care for the patients. Also, the Clinical Research Department will study and measure the outcomes of the different programs in each department. This research will be ongoing throughout all phases.

Phase 2: In the second phase, clinical scientific-based evidence research will be conducted within selected important fields. The NIM Clinical Research Department will examine the effect of certain lifestyle changes on the health, prevention and treatment of certain patient groups with respect to selected diseases or conditions such as:

• Cancer
• Diabetes
• Heart Disease
• Multiple Sclerosis
• Stress
• Depression
• Overweight
• Chronic pain

In addition, the effect of certain lifestyle change programmes on the changes of expression of different genes and epigenetic modifiers that are known to be involved in the on-and offset of different diseases will be studied. The types of lifestyle changes may vary and can be both nutritional programs and physical exercise programs (‘normal’ exercise, yoga, qigong) as well as stress management (meditation, mindfulness).

In general terms, the Department of IM Clinical Research will conduct innovative novel clinical research in close collaboration with academic hospitals and research units in Europe and abroad. Our aim is to make advances in this field and directly benefit patients and save lives. Clinical Research conducted by the PMRI as a model for the NIM Clinical Research Department In numerous randomized controlled trials conducted over the past ten years, Dean Ornish, MD, has found that people with severe coronary heart disease were able to stop or reverse it without the use of drugs or surgery by making comprehensive lifestyle changes.

The interventions used included stress management through yoga and meditation, a low- fat vegetarian diet, smoking cessation, moderate exercise, and social support. These trials were published in the Journal of the American Medical Association, The Lancet, and other major medical journals.(1) The June 2008 Proceedings of the National Academy of Sciences published Ornish’s more recent work in prostrate cancer, which demonstrated that lifestyle change can affect gene expression.(2)

The researchers found that improved nutrition, stress management, walking, and psychosocial support changed the expression of over 500 genes in men with early-stage prostate cancer. They also discovered that oncogenes associated with breast cancer and prostate cancer, as well as genes that cause heart disease, oxidative stress, and inflammation were downregulated or “turned off,” whereas protective genes were upregulated or “turned on” by lifestyle change.

In September 2008, a related study published in The Lancet Oncology showed that these same integrative medicine interventions increased telomerase, the enzyme that lengthens telomeres, which are the ends of our chromosomes that control how long we live.(3)

The researchers found that telomerase, and thus telomere length, increased by almost 30% in only three months, suggesting that integrative lifestyle interventions can not only reverse disease but may also extend life span. Stress reduction is a critical aspect of lifestyle change programs.

Conventional therapies, such as pharmaceutical interventions or surgeries, typically treat symptoms but do not address the causes of most chronic disease, which are often rooted in unhealthy lifestyles and high stress levels. In a related body of research, the Transcendental Meditation program, which helps individuals self-regulate the activity of physiological stress response systems, has been demonstrated to be an effective intervention for people with cardiovascular disease.

Similarly, various Mindfulness Based Stress Reduction programs, which reduce distress and promote emotional regulation through increased self- awareness, have proven extremely helpful for people living with chronic diseases such as chronic fatigue syndrome, chronic pain, and cancer.

A meta-analysis of 107 studies looking at stress reduction and blood pressure concluded that the Transcendental Meditation program alone was able to reduce both systolic and diastolic high blood in
a significant number of the subjects.(4) A series of NIH-funded trials demonstrated that patients participating in the Transcendental Meditation program showed important reductions in hypertension, antheroscerosis, and insulin resistance.(5)

A meta-analysis of Mindfulness Based Stress Reduction programs involving pain, cancer, heart disease, depression, and anxiety patients demonstrated that mindfulness practice can significantly improve both health and mental health states.6 The INTERHEART study, published in September 2004 in The Lancet, followed 30,000 men and women on six continents and found that changing lifestyle could prevent at least 90% of all heart disease.(7)

Projecting forward, if only ten percent of the coronary angioplasty procedures and coronary bypass operations were avoided by utilization of lifestyle change programs, it would result in a savings of $10 billion dollars annually. The Preventive Medicine Research Institute conducted a demonstration project in collaboration with eight hospitals to determine if comprehensive lifestyle changes could be a safe and effective alternative
to bypass surgery or angioplasty.

After one year, almost 80% of participants were able to safely avoid heart surgery or angioplasty, and Mutual of Omaha calculated saving almost $30,000 per patient in the first year.8 In a second demonstration project, Highmark BlueCross and BlueShield of Pittsburgh, Pennsylvania, partnered with hospitals in West Virginia, Pennsylvania, Illinois, and Nebraska to test the Dean Ornish Program for Reversing Heart Disease for those people with coronary artery disease.

According to the 2003 BlueCross medical management report, these comprehensive lifestyle changes reduced total health care costs by 50% for those patients after only one year. A third demonstration project of more than 2,000 patients at 22 hospital sites showed dramatic improvements in angina in more than 83% of patients.(9)

With direct health care costs of angina alone running more than $1 million per person over a lifetime, a low-cost effective treatment could save millions of dollars. As lifestyle interventions are studied in other chronic diseases, this same cost savings capacity is being duplicated. A recent diabetes study published in the Journal of Internal Medicine evaluated individuals at high risk for diabetes mellitus and found “lifestyle intervention to be cost effective in all age groups.”(10)

The cost (which included direct and non-direct medical expenses adjusted over gained quality years) was approximately $8,800 for the lifestyle intervention compared with a $29,900 cost for an oral drug (metformin) intervention. Additionally, cost analysis studies published in Psychosomatic Medicine and the American Journal of Managed Care show that the practice of Transcendental Meditation lowered health insurance utilization, hospital inpatient days, hospital admissions and hospital outpatient visits for all categories of disease studied.(11, 12)