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MI2 White Paper…

Integrative Medicine and : Evidence and Practice

June 10, 2016

Acknowledgements

This paper was compiled by Emily Ratner, MD. Dr. Ratner is a board certified anesthesiologist and fellowship trained Integrative Medicine physician, with expertise in Medical and Mind Body Medicine. She was a Stanford Medical School faculty member for 23 years, where she enjoyed a robust Integrative Medicine practice for the last 10 years. Dr. Ratner was the Founding Co-Director of Stanford’s Division of Medical Acupuncture, charged with incorporating clinical services, education and research in an academic medical center. She was also Founding Co-Director of the PRIME program (Peer Support and Resiliency In MEdicine), one of the first and most comprehensive resiliency programs for Anesthesiology Residents in the US. On a national level, Dr. Ratner recently held leadership positions with the Academic Consortium for Integrative Medicine and Health, as an Executive Committee member and Co-Chair of the Governance Reform Committee. She has also been active in other national organizations over the years, including the American Society of Anesthesiology and the American Academy of Medical Acupuncture.

Additional thanks and credit for this document go to Pete Celano, Director of Consumer Health Initiatives at the MedStar Institute for Innovation (MI2); Leatt Gilboa, MI2 Project Manager and External Alliances Specialist; Paul Plsek, MI2 Innovator-in-Residence; and Roxanna Vera-y-Aragon, Executive Assistant, Office of the Chief Innovation Officer.

About the MedStar Institute for Innovation…

The Medstar Institute for Innovation is unique among innovation centers that are embedded in health systems. MI2’s approach is to create an innovation ecosystem across MedStar Health that fosters the vast creative talent and of its 31,000 associates and 6,000 physicians. MI2 itself has developed deep technical expertise in human factors engineering, health influence and engagement, innovative learning and simulation, and digital health and data science. MI2, chartered in 2008, also serves as the portal for engaging outside start- ups and entrepreneurial collaborators to apply new ideas and innovative approaches to care for people and advance health. For more information, see mi2.medstarhealth.org.

© 2016 MedStar Institute for Innovation

Date: June 10, 2016

From: Mark Smith, MD Chief Innovation Officer, MedStar Health Director, MedStar Institute for Innovation (MI2)

Dear Colleagues:

I am pleased to send you the MedStar Institute for Innovation’s White Paper on Integrative Medicine.

In its role to catalyze innovation that advances health, the MedStar Institute for Innovation has been investigating the potential application of Integrative Medicine (IM) within MedStar. IM is the seamless union of standard Western medicine with established approaches from other healing traditions (e.g., acupuncture, yoga, meditation) to relieve suffering, reduce stress, and enhance well-being and resilience. This review of the evidence on IM and its current state of practice within the US is the first product of that work, and I am excited by the possibilities that it reveals for us.

I was surprised, and I think you may be also, at the range of conditions for which there is good evidence for the effectiveness of IM approaches. IM enables us to do more to address health, wellbeing, pain, the suffering sometimes associated with treatment, and a variety of specific medical conditions. I urge clinical colleagues to review this evidence just as they would a new drug or procedure to see if these approaches might be suitable additions to the treatment plans for their patients.

I was also surprised to learn that roughly one-third of Americans are already using various IM approaches and spending roughly $12 billion annually on provider-based services. Further, some health systems are offering these services to patients for free, based simply on the impact they have seen them have on patient satisfaction and hospital ratings. There is a huge opportunity for mutual benefit here. Unfortunately, we also learned that local competitors have begun moving into this market ahead of us.

While it was not the focus of this research, I am also personally struck by another, very serious, angle on this topic— clinician burnout. Recent reports indicate that this phenomenon has reached epidemic proportions, and I suspect that you can see it in the faces of our front-line, care-giving colleagues, just as I can. There is good evidence that IM practices can also play an important role in an overall program to support clinician self-care, wellbeing and resiliency. A case could be made to invest in the development of IM services for this reason alone.

I am proud to put this product of MI2’s efforts into your hands. As you might guess, I played only a minor role in its production. Full credits are documented in the Acknowledgements section, but I would be remiss not to single out the report’s main author, Emily Ratner MD, to say a warm “thank you” for her tremendous effort. A quick skim of the 24 pages (!) of references will give you a good feel for the effort, and rigor, behind this report.

The time has come for MedStar to give serious consideration to approaches from Integrative Medicine. We should not and cannot ignore the evidence. We now know that we can do more to relieve suffering, reduce stress, and enhance well- being—among our patients… and our colleagues.

As you’ll see, it doesn’t matter so much where we start, only that we start.

© 2016 MedStar Institute for Innovation

© 2016 MedStar Institute for Innovation ii Executive Summary

Integrative Medicine is the seamless union of standard Western medicine with established approaches from other healing traditions (e.g., acupuncture, yoga) to relieve suffering, reduce stress, and enhance well-being and resilience.

Modern western medical practice works well for the management of specific reversible acute illness and injury. However, we know that it may not be as efficacious for the management of chronic illness or for the promotion of health and wellness over and above the absence of disease. Practices from other healing traditions can complement treatment because they emphasize healing in addition to curing, recognize the importance of touching all aspects of a person (mind, body, and spirit), emphasize the critical nature of lifestyle behaviors in creating health, and highlight the relational dimension of the therapeutic interaction between practitioner and patient.

We consider the following fifteen approaches to comprise Integrative Medicine:

• Mind-body approaches: Meditation, hypnosis, biofeedback, guided imagery, yoga, Tai Chi, Gong • Energy-based approaches: Acupuncture, craniosacral therapy, , • Body-based approaches: , • Biologically-based approaches: Supplements, aroma therapy

In Part 1 of this report, we review these approaches, along with four whole systems of . While they have not been as thoroughly researched as most standard western medical practices, we nevertheless found good evidence of effectiveness for certain conditions. The table below summarizes our findings and illustrates the wide variety of conditions for which IM practices have demonstrated effectiveness (grade A or B evidence: strong demonstration of effectiveness, likely effectiveness or possible effectiveness). Of course, current absence of evidence is not evidence of ineffectiveness; it is merely a indication of the historical lack of research focus on these therapies. This list may expand over time as these practices become more widely used and studied.

IM has much to offer today’s health care systems. Additional therapies to help address well-being and lifestyle issues can be useful in this era of population health focus and capitated payments. IM may also enables us to do more to relieve the suffering and dissatisfaction with care experienced by patients because of pain, or the side effects of some modern medical procedures and treatments (e.g., nausea during chemotherapy). Our findings further highlights the variety of specific mental and physical disorders that might be favorably impacted by methods from IM; in many cases through lower cost providers. Clinicians should review this evidence just as they would on any new drug or procedure to see if these approaches might be suitable additions to the treatment plans for their patients.

© 2016 MedStar Institute for Innovation iii

Physical and Psychological Well-Being and Lifestyle Issues General Well-Being/Mood Meditation, Craniosacral Therapy, Reiki Depression Meditation, Yoga, Tai Chi, Acupuncture, Massage Anxiety Meditation, Hypnosis, Biofeedback, Yoga, Acupuncture, Reiki Stress Guided Imagery, Tai Chi, Yoga, Reiki Smoking Cessation Hypnosis, Acupuncture Substance Abuse/Addiction Biofeedback Insomnia/Sleep Biofeedback, Yoga, Acupuncture, Massage Fall Prevention Tai Chi Cognitive Performance Tai Chi Somatization Meditation Motion Sickness Biofeedback Rynaud’s Disease Biofeedback Stroke Rehab Yoga Pain Management General Meditation, Tai Chi, Acupuncture Acute Massage Chronic Hypnosis, Biofeedback, Acupuncture, Massage Low back Yoga, Massage, Chiropractic Musculoskeletal/ Extremity/Joint Yoga, Acupuncture, Chiropractic Chronic Lateral Epicondylitis Craniosacral Therapy Neck Craniosacral Therapy, Chiropractic Headache/Migraine Biofeedback, Acupuncture, Chiropractic Peri-op Hypnosis, Acupuncture Pregnancy/Labor Craniosacral Therapy, Acupuncture Vulvar Vestibulitis Biofeedback Dysmenorrhea Acupuncture Procedure-Associated Suffering (Oncology, Surgery) Nausea and Vomiting associated with Meditation, Hypnosis, Acupuncture Chemotherapy Presurgical Mood Disturbance Guided Imagery Post-op Nausea and Vomiting Acupuncture Wound Healing/Immune Function Guided Imagery

Table continues next page…

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Specific Conditions Hypertension Biofeedback, Yoga, Tai Chi, Massage, Fish Oil, Qi Gong Hypertriglyceridemia Fish Oil Epilepsy/Seizures Biofeedback, Yoga Traumatic Brain Injury Biofeedback Psychosis Meditation Schizophrenia Yoga, Acupuncture PTSD Yoga, Acupuncture ADHD Biofeedback, Massage Osteoarthritis Yoga, Tai Chi, Acupuncture, Massage TMJ Disorder Biofeedback, Acupuncture COPD Tai Chi Pediatric asthma Massage Insulin Resistance Yoga Fibromyalgia Craniosacral, Therapy Massage Irritable Bowel Syndrome Hypnosis Constipation Biofeedback Urinary Incontinence Biofeedback Fecal Incontinence Biofeedback Prostatitis Acupuncture Postmenopausal Hot Flash Hypnosis Preterm Labor Hypnosis Warts Hypnosis

In Part 2 of the report, we look at the marketplace for IM, examine the current state of practice in the US, and describe how some health systems have approached investing in the establishment of IM services.

The marketplace for IM is substantial. Studies show that a third of Americans already utilize IM, spending roughly $34 billion annually, $12 billion of which goes to practitioner-based services. For MedStar Health, this extrapolates to an already existing local market of approximately $290 million annually spent on practitioner- based services.

Establishment of IM services within a conventional health system is no longer a high-risk, trail-blazing activity. A survey of 29 established—and successful—IM services within well-known academic health systems across the US (e.g., Mayo, Scripps, Allina, Stanford, Brigham & Womens) indicates that the first-movers into this market have already moved. However, there is by no means a single, well-defined response to the market need. This field of practice is in its adolescence; still experimenting and searching for the best approaches and combinations of things. We are still in the era of early adoption.

© 2016 MedStar Institute for Innovation v

The study of these first-movers, along with our broader set of interviews with IM champions in other leading health systems, sheds light on key success factors. We know what it takes to be successful and sustainable in establishing an IM program.

It is possible, and maybe even best, to start very small and adapt to meet needs as you go along. For example, the IM program at Allina Health Systems began as a three-person, inpatient service focused on pain management. Its cost was absorbed by the hospital and paid benefits in terms of increased patient satisfaction and improved hospital ratings. This initial effort has since grown to become the Penny George Institute for Health and Healing that provides a combination of reimbursable, absorbed cost and community benefit services at nine outpatient and inpatient locations throughout the Allina system.

Start-up costs can be minimized by the use of existing space, part-time providers, and avoiding the use of nurses or medical assistants who cannot also provide revenue generating services. On the benefits side of the equation, some IM services have demonstrated stand-alone profitability, while others return non-financial benefits in the form of higher patient satisfaction ratings, community benefit and enhanced reputation.

We found that it is not necessary to make a large, risky, all-or-nothing bet in the IM market. Starting small, doing more of what works and less of what doesn’t, learning and adapting as you go, is a very reasonable strategy.

MedStar’s local competitors have already recognized the potential benefits of IM services. While Johns Hopkins/Sibley is still in the starting-small stage, University of Maryland and George Washington University Medical Center have moved beyond that point and are quite well developed.

© 2016 MedStar Institute for Innovation vi

© 2016 MedStar Institute for Innovation vii Table of Contents

Executive Summary ...... iii Part 1 – A Comprehensive Review of Integrative Medicine and Health ...... 1 Introduction ...... 3 Traditions in Medicine and Health ...... 3 Terminology ...... 4 Physician and Practitioner Self-Care and Resiliency ...... 5 Complementary and Integrative Health: Categorizing the Evidence and Approaches ...... 6 Levels of Evidence ...... 6 Categorization of Integrative Medicine Approaches ...... 8 Mind-Body Approaches ...... 10 Meditation ...... 10 Hypnosis ...... 14 Biofeedback ...... 16 Guided Imagery ...... 18 Yoga ...... 19 Tai Chi ...... 22 Qi Gong ...... 24 Energy-Based Approaches ...... 25 Acupuncture ...... 25 Craniosacral Therapy ...... 29 Reiki ...... 30 Therapeutic Touch and Healing Touch ...... 31 Manipulative and Body-Based Approaches ...... 32 Massage ...... 32 Chiropractic ...... 34 Biologically-Based Approaches ...... 36 Supplements ...... 36 Fish Oil ...... 38 ...... 39 Whole Systems of Health ...... 40 Traditional Chinese Medicine (TCM) ...... 40 ...... 42 ...... 43 ...... 44 Part 1 Summary: The Evidence for Integrative Medicine ...... 46 Part 2 – The Practice of Integrative Medicine ...... 49 Public Perceptions of Integrative Medicine ...... 51 Market Size ...... 51 Who is Most Likely to Use It? ...... 51 Why is IM so popular? ...... 53 Comprehensive Review of Academic Health Systems with Integrative Medicine Programs ...... 54 Models of Care/Practice Organization ...... 54 Triage of New Patients ...... 55 Inpatient Services ...... 56 Types of Practitioners ...... 56

© 2016 MedStar Institute for Innovation viii Medical Conditions Most Commonly Treated Successfully at IM Centers ...... 58 Commonly Used Therapies ...... 59 Reimbursement ...... 59 Other Revenue Sources ...... 61 Referral Sources ...... 62 Factors Driving Long-Term Viability and Clinical Success ...... 62 Conclusion ...... 62 Descriptions of Three Successful Integrative Medicine Practices ...... 64 Penny George Institute for Health and Healing (PGIHH) at Allina Health Systems ...... 64 Institute for Health and Healing (IHH) at Sutter Health System ...... 70 Vanderbilt University Medical Center’s Osher Center for Integrative Medicine ...... 74 Lessons Learned From Other IM Centers and Their Leaders ...... 78 Evolution of National Integrative Medicine Organizations ...... 82 Academic Consortium for Integrative Medicine and Health (“The Consortium”) ...... 82 Academy of Integrative Health and Medicine (AIHM) ...... 82 National Center for Complementary and Integrative Health (NCCIH) ...... 83 Board Certification ...... 83 Education ...... 83 Integrative Medicine Programs in the Greater Baltimore-Washington Region ...... 84 Current Known State of Practice at MedStar Health ...... 84 University of Maryland School of Medicine Center for Integrative Medicine ...... 84 Johns Hopkins Integrative Medicine and Digestive Center and Johns Hopkins Sibley Hospital ...... 86 George Washington University Medical Center’s Center for Integrative Medicine (GWCIM) ...... 87 Inova Health System ...... 88 Part 2 Summary: The Practice of Integrative Medicine ...... 89 References: Annotated Bibliography Organized By Report Sections ...... 91 Introduction ...... 92 Complementary and Integrative Health Approaches ...... 93 Mind-Body Medicine Approaches ...... 93 Energy-Based Approaches ...... 101 Body-Based Approaches ...... 104 Biologically-Based Approaches ...... 107 Whole Systems of Health ...... 108 Public Perception of Integrative Medicine ...... 111 Comprehensive Review: Academic Health Systems with Integrative Medicine Programs ...... 112 Descriptions of Three Successful Integrative Medicine Practices ...... 113 Evolution of National Integrative Medicine Organizations ...... 113 Integrative Medicine Centers in the Greater Baltimore-Washington Region ...... 113 Appendix ...... 115 Appendix 1: Levels of Evidence for Acupuncture Studies...... 116 Appendix 2: Levels of Evidence for Biofeedback Studies ...... 117 Appendix 3: Levels of Evidence for Supplements ...... 118

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© 2016 MedStar Institute for Innovation x

Part 1 – A Comprehensive Review of Integrative Medicine and Health

© 2016 MedStar Institute for Innovation 1

© 2016 MedStar Institute for Innovation 2

Introduction

Traditions in Medicine and Health

Although Integrative Medicine and Health (IM) has become increasingly mainstream in the past few decades, it is actually an approach to healing that goes back millennia. Its roots are traceable back to Hippocrates, who observed, “it is more important to know what sort of person has a disease than to know what sort of disease a person has,” “let food be thy medicine and medicine be thy food,” and “walking is man’s best medicine.” These principles, reflecting the physician-patient relationship, the whole person, and the importance of lifestyle behaviors, comprise some of the fundamental tenets of IM.

Historically, modern western medical practice has been based on increasingly sophisticated knowledge of anatomy, physiology and disease dynamics, pharmacology, and molecular mechanisms operating at the cellular and subcellular levels. Groundbreaking scientific and technological advances have underpinned increasing specialization and sub-specialization of medicine in order to facilitate the incorporation of many of these innovative approaches and new technologies. While the advances in treatment, longevity, and — in many cases — cure have been breathtaking, one result has been a fragmented approach to medical practice (Rakel). And while this approach works extremely well for the management of specific reversible acute illness and injury, it may not be as efficacious for management of chronic illness or for the promotion of health and wellness over and above the absence of disease.

A counterpoint approach that does focus on health, wellness, and the mitigation of chronic illness is integrative medicine.

Integrative medicine combines modern standard western medical practices with established approaches from other healing traditions in such a way as to relieve suffering, reduce stress, and enhance well- being and resilience. It emphasizes healing in addition to curing, recognizes the importance of touching all aspects of a person (mind, body, and spirit), emphasizes the critical nature of lifestyle behaviors in creating health, highlights the relational dimension of the therapeutic relationship between practitioner and patient, and applies all these principles in concert in order to advance and achieve optimal health and not merely the absence of disease (UCSF & U of AZ IM Center websites).

Figure 1: Integrative Medicine seamlessly combines modern medicine with other healing traditions, with an emphasis on healing, integrating mind, body and spirit, and lifestyle behaviors in order to achieve optimal health. Photo source: http://pepsolutions.com/home/services/ integrative-medicine/ Accessed December 14, 2015.

© 2016 MedStar Institute for Innovation 3

IM emphasizes optimal health where the individual is empowered to choose appropriate lifestyle behaviors and health oriented practices, transferring some of the focus away from external sources of care and interventions. Duke Integrative Medicine’s Wheel of Health illustrates these concepts, calling attention to the individual’s central location, surrounded by choices (Duke IM website). (Figure 2)

Figure 2. Wheel of Health from Duke Integrative Medicine, showing complex relationships between an individual, self-care and professional care, clearly centered on the individual (Duke IM website).

Importantly, a recent comprehensive review of IM scientific and corporate literature reports implementation of three integrative medicine strategies could have immediate and significant effects on health benefits and cost savings in our health care system (Guaneri):

• Integrative lifestyle change programs to address chronic illness • Integrative interventions for depression • Integrative preventive strategies to support wellness

The time has come to seriously consider changing our approaches to disease, health, and healing.

Terminology

Unfortunately, the language describing IM is confusing, as there is no consensus amongst health professionals or the general public on standardized terms. How is IM different from , Complementary Medicine, Complementary and Alternative Medicine (CAM) and the newer phrase, Complementary and Integrative Health (CIH) approaches? The NIH institute, whose mission is “to define…the usefulness and safety of complementary and integrative interventions…,” has recently changed its name from the National Center for Complementary and Alternative Medicine (NCCAM) to the National Center for Complementary and Integrative Health (NCCIH), reflecting this shift.

© 2016 MedStar Institute for Innovation 4

For practical purposes in this report, the following definitions will be used:

• Integrative Medicine (IM) or Integrative Medicine and Health seamlessly combines modern medicine with established approaches from other healing traditions in order to relieve suffering, reduce stress, and enhance well-being and resilience. • Complementary and Integrative Healthcare or Complementary and Integrative Health Approaches (CIH) are terms that are roughly interchangeable with IM. • Alternative Medicine is the use of non-conventional therapeutic approaches, and specifically excludes conventional medical practices. • Complementary Medicine is the practice of non-conventional therapies in addition to conventional approaches, but the sum total of all approaches may not be significantly integrated with conventional treatment. Therapies may be practiced in a parallel fashion, without communication or coordination between practitioners. • Complementary and Alternative Medicine (CAM) is a commonly used umbrella term encompassing both Complementary and Alternative Medicine.

Physician and Practitioner Self-Care and Resiliency

An important principle of Integrative Medicine not described in these definitions is physician/ practitioner self-care and resiliency. Physician burnout rates have been increasing (46% to 54%), and these physicians make more medical errors and have diminished quality of medical practice, and their patients are less likely to follow care plans (Shanafelt, Ariely). A recent Time magazine article chronicling this concludes that “[d]octors are stressed, burned out, depressed, and when they suffer, so do their patients” (Oaklander). The underlying causes of this crisis are complex and beyond the scope of this paper, but physician and practitioner self-care and resiliency are essential elements in providing healthcare, and need to be acknowledged and addressed.

© 2016 MedStar Institute for Innovation 5

Complementary and Integrative Health: Categorizing the Evidence and Approaches

People often inquire about the usefulness of therapies encompassed by IM, asking, for example “Does acupuncture really work?” This is like asking “Do medications work?” or “Does surgery really work?” The answer to all three questions is “yes,” but further explanation is required. Anti-hypertensive medication controls high blood pressure but would be useless in treating pneumonia. Surgical removal of an appendix typically cures appendicitis but will not address pain coming from a gastric ulcer. In the same way, IM therapies such as acupuncture can be very effective in the treatment of chronic pain, but using it as primary treatment for coronary artery disease would be inappropriate.

Levels of Evidence

Clinical decision-making and diagnostic and therapeutic pathways and guidelines should be informed by scientific studies; this is modern-day evidence-based medicine. But it may be difficult for an individual practitioner to assess study quality or rationalize two contradictory results. Level of Evidence scales have been developed to aid in summarizing the robustness of the evidence in support of a given treatment (Center for Evidence Based Medicine at Oxford website).

Systematic reviews and meta-analyses are two methods used to evaluate multiple research studies and are generally regarded as the highest level of evidence. Randomized controlled double-blinded studies are considered to be robust granular scientific bases upon which systematic reviews and meta-analyses are constructed — with case reports, expert opinions, and animal and laboratory research considered to be less compelling support for a specific treatment. A pyramid depicting these types of publications, from highest level of evidence to lowest, is depicted below (Figure 3).

Figure 3. Figure depicting evaluation of scientific publications, with the stronger levels of evidence at the top of the pyramid, and less robust evidence at the bottom of the pyramid. Source: http://library.downstate.edu/EBM2/2100.htm SUNY Downstate Medical Center, Medical Research Library of Brooklyn. Evidence-based Medicine course. A Guide to Research Methods: The Evidence Pyramid.

© 2016 MedStar Institute for Innovation 6

Grading systems that categorize the level of evidence attempt to inform clinicians on how strong the evidence is in support of a given therapy. Table 1 below is an example, showing Grade A as the strongest recommendation for treatment based on levels of evidence coming from systematic review of randomized controlled trials or an individual randomized controlled trial.

Table 1. Levels of evidence and grades of recommendation. Source: Reproline, Johns Hopkins University. http://www.reproline.jhr.edu.

For the purposes of this report, this grading system for recommendations based on levels of evidence will be used when possible, modified to include meta-analyses as Grade A recommendations. Three approaches discussed in this manuscript—supplements, biofeedback, and acupuncture — have different levels of evidence scales specific to them that have been developed. These evaluation systems will be acknowledged in the appropriate section and are described in detail in the Appendix.

For ease of interpretation, the color-coding system below will describe general recommendations for usage based on the strength of evidence and the likelihood for effectiveness in treating a specific medical condition. It is loosely based on the A, B, C, D grading system from Johns Hopkins listed above (Table 1). However, in the grading system below, Grade D indicates either of two separate conditions — that data exists supporting ineffectiveness of treatment or that there is insufficient data to support effectiveness. This distinction will be made explicit when each approach is described.

Grade A: Strongly recommended based on evidence demonstrating Effectiveness or Likely Effectiveness Grade B: Recommended for certain individuals based on evidence demonstrating Possible Effectiveness Grade C: Possibly recommended for specific individuals if other approaches have failed or in other circumstances, based on Weak or Unclear Evidence of Effectiveness Grade D: Generally not recommended, as approach may be Ineffective or Possibly Ineffective. Data either supports ineffectiveness of treatment or there is insufficient evidence demonstrating effectiveness

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This paper presents a compendium of individual therapies often described as in the domain of Complementary and Alternative Medicine (CAM). We describe what each one is, how it is used, who practices it, and what the scientific evidence for efficacy is. Available scientific reviews will be described in the context of the usual levels of evidence recognized in conventional medicine when available. While scientific studies have been performed in some of these areas, their quality is highly variable; many symptoms and conditions have not been studied, and high quality studies are difficult to design. These interventions often do not lend themselves to accurate blinding and appropriate sham controls. Until recently, virtually no funding institutions have shown enthusiasm for funding studies with a multi-factorial approach to health and healing. Although some therapies have been studied enough to produce systematic reviews, most have not been studied in as wide a variety of conditions as desirable.

Categorization of Integrative Medicine Approaches

Individual Integrative Medicine approaches can be grouped into five broad categories. However, these are fluid demarcations, as some therapies can be classified into more than one area.

• Mind-Body Approaches: Meditation/Mindfulness Based Stress Reduction (MBSR), Hypnosis, Biofeedback, Guided Imagery, Yoga, Tai Chi, Qi Gong • Energy-Based Approaches: Acupuncture, Craniosacral Therapy, Reiki, Therapeutic/Healing Touch • Manipulative and Body- based Approaches: Massage, Chiropractic • Biologically-Based Approaches: Supplements/Herbs, Aromatherapy • Whole Systems of Medicine: Traditional Chinese Medicine (includes acupuncture), Ayurveda, Naturopathy, Homeopathy

Interest from members of the public and health care providers spans these categories. A recent study conducted by NIH’s National Center for Health Statistics identified the 10 most commonly used forms of integrative therapies in the US (Clark, Table 2). Table 3 lists the most common services and therapies provided in Integrative Medicine (IM) Centers around the country (Horrigan). We will say more about Horrigan’s study of successful IM centers in Part 2 of this white paper.

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Table 2. Ten Most Common CAM Therapies Among Adults – 2012 (Clark). Based on data from >88,000 adults, conducted in the home using a using a computer-assisted personal interview questionnaire, with telephone follow up if necessary. * – Dietary supplements other than vitamins and minerals.

70% Therapies Most Commonly Provided at IM Centers (percentage of IM centers offering various therapies)

60%

50%

40% 65% Food/ Nutrion 60% 30% Supplements 55% 51% 50% Yoga 49% Meditaon TCM/ Acupx Massage 41% 20% Medicaons

10%

0%

Table 3. Most commonly used therapies at IM Centers (Horrigan). TCM – Traditional Chinese Medicine. Acupx – acupuncture.

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Mind-Body Approaches

Mind-body practices are a large and diverse group of techniques that focus on the interactions between the brain, mind, and body. Techniques are typically taught or administered to others by a trained practitioner or teacher. They include many types of meditation, biofeedback, hypnosis, or spirituality (NCCIH website).

Meditation

Meditation is a mind-body practice that has a long history of use for increasing calmness and physical relaxation, improving psychological balance, coping with illness, and enhancing overall health and wellbeing. Most types of meditation originated in ancient religious and spiritual traditions. The majority of these practices have four elements in common: (Ludwig)

• a quiet location with as few distractions as possible • a specific, comfortable posture – sitting, lying down • a focus of attention – the sensations of the breath, a specially chosen word or set of words, or an object • an open attitude – letting distractions and thoughts come and go naturally without judging them

Two general types of meditation exist: concentrative and mindfulness. Concentrative meditation emphasizes focusing on an object or sound, sustaining attention until the mind achieves stillness. Continuous practice reportedly produces relaxation and clarity of mind (Krisanaprakornkit). Transcendental Meditation (TM) is an example of concentrative meditation, where attention is placed on a mantra or sound. TM has been found to be helpful in anxiety and hypertension (Krisanaprakornkit, Schneider).

Mindfulness meditation has become increasingly popular, and it is an integral part of Mindfulness Based Stress Reduction (MBSR) training. Mindfulness practice supports focusing on the present moment, noticing thoughts, feelings and sensations, and not judging oneself, others or anything else (Figure 4). One of the underlying assumptions undergirding mindfulness meditation is that we often ruminate about the past or worry excessively about the future, and very little time is actually spent paying attention to this present moment. Maintaining this focus helps us disengage from our strong attachments to beliefs, thoughts, and emotions, resulting in a greater sense of emotional balance and well-being (Ludwig).

Figure 4. Illustration depicting being mindful/mindfulness: the ability to focus on the present moment, in a non- judgmental way, not worrying about the past or the future. Source: https://www.mindfulvalley.com/about/ about-mbsr-mindfulness/, accessed November 11, 2015.

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Mindfulness Based Stress Reduction (MBSR) is an 8-week intensive training program in mindfulness meditation and yoga, is based on ancient healing practices, and meets on a weekly basis. Mindfulness practices help us focus our awareness on each moment, one after the other, in a nonjudgmental way, which is typically quite a challenge for all. Yoga — which some describe as movement meditation — is used to help improve flexibility, strength, and focus, in an attempt to counteract our culture's largely sedentary lifestyle. This is especially helpful for those with pain and chronic illnesses. The program brings meditation and yoga together so that the virtues of both can be experienced simultaneously. Growing in popularity since its 1979 inception, the standardized program is increasingly used in medical and nonmedical environments, including schools, prisons, and other institutions (Mindful Living Programs website).

Figure 5. Photo from Syracuse University, where a free MBSR course is offered to students. http://www.syr.edu/currentstudents/spotlights/service/mbsr.html, accessed November 11,2015.

When meditating in the style of Mindfulness Based Stress Reduction (MBSR), one sits in a comfortable position, often in a chair, or on the floor on a cushion or meditation stool, or even lying on a yoga mat (Figure 6). MBSR was developed in a population with chronic pain, and minimizing uncomfortable positions when starting the practice is important in these populations. A relaxed but alert position is preferable. Focused attention is then brought to the breath, at the level of the abdomen, where it expands when inhaling and contracts when exhaling. Attention can also be brought to the tip of the nostrils, noticing the cool temperature of the air upon inhalation, and the warmer temperature on exhalation.

There are different formal practices, including guided meditations, where a teacher or recording of a teacher will lead the practice. For example, a “body scan” meditation is commonly used in MBSR, where one focuses on body parts sequentially, starting at the feet, and working upwards to the head. Commonly, if not inevitably, thoughts, sensations, and feelings come up during the practice. The meditator is encouraged to notice whatever arises, then let go of whatever it is — without judging oneself as being a “bad” or an “inadequate” meditator. The next step is bringing the focus of attention back to that particular body part to which the teacher is describing. The practice of meditation is not ridding the mind of thoughts, sensations, and emotions, but recognizing when they arise, and letting them go. This is not considered a “failure” although many beginning meditators think that is the case. This is merely the process, and why it is called a practice.

Informal practice occurs when one tries to approach everyday life with the same awareness of each moment, acknowledging whatever arises in a nonjudgmental fashion, letting it go, and being present for whatever is occurring.

Mindfulness Based Cognitive Therapy (MBCT) is an 8 week group program based on integration of elements of Cognitive Behavioral Therapy and components of MBSR programs (Ma). It has been recently evaluated by the Veteran’s Health Administration, along with MBSR programs.

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Conditions for Which Meditation is Used

Meditation is used for a wide variety of conditions, especially those related to stress. It is commonly used in patients with pain; stress; depression; anxiety; psychological disorders; chronic illness; and conditions exacerbated by stress including hypertension, irritable bowel syndrome, and insomnia. One of the first MBSR studies demonstrated effectiveness in decreasing the duration of psoriasis plaque outbreaks, which are thought to be exacerbated by stress (Kabat-Zinn). Meditation is widely used to promote well-being and optimal health.

Evidence

The Veteran’s Health Administration’s Evidence-Based Synthesis Program (ESP) has studied treatment options for targeted healthcare priorities of veterans, specifically looking at non-traditional therapies (Hempel). Results of their extensive analysis of systematic reviews and recent large randomized controlled clinical trials (RCTs) examining the use of mindfulness based interventions, including MBSR and MBCT, are summarized in the evidence charts below (Tables 4 and 5, respectively, see next page).

Evidence of potential positive effect was found when these techniques were used to enhance physical and psychological health in chronic illness, depression, anxiety, somatization, pain, psychosis, and other mental illness. In addition, research suggests that practicing meditation may reduce blood pressure, symptoms of irritable bowel syndrome, and insomnia (NCCIH website). MBSR was recently found to prevent acute respiratory illness, as incidence, severity, duration of illness, and number of work days missed was decreased in these individuals in a high quality randomized controlled clinical trial (Barrett).

Risks and Complications

Although generally considered to be safe, musculoskeletal discomfort can occur if one meditates in an uncomfortable position for prolonged periods of time. Participants are instructed to find a comfortable position, whether it is sitting on a chair, on a meditation cushion, or lying down. Intrusive, repetitive, or troubling thoughts may arise during meditation that uncover pre-existing trauma, sometimes necessitating further psychological work. Some meditation teachers are professional counselors, which can be especially helpful in this situation.

Practitioners

There is no licensing of meditation teachers. Although different meditation styles typically have various levels of training, almost all require a potential instructor to have a significant personal meditation practice. MBSR teacher training is a well-defined process involving individual practice as well as specific instruction on the curriculum used. Certification of MBSR teachers is issued from the Center for Mindfulness at the University of Massachusetts Medical School.

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Applications Based on Evidence: MBSR Grade A / B: Evidence of Grade C: Unclear Grade D: Evidence of Positive Effect Evidence Potentially No Effect • Health Enhancement • Stroke Care • Fibromyalgia • Chronic illness • PTSD (MBSR + MBCT) • Psychological health • Cognitive function • Depression & Anxiety (MBSR + MBCT) Associated w/Cancer • Improved Patient (MBSR + MBCT) Experiences (MBSR + MBCT)

Table 4. Recommendations based on Levels of Evidence for Mindfulness Based Stress Reduction (MBSR). MBCT – Mindfulness Based Cognitive Therapy; MBSR + MBCT – combination of Mindfulness Based Stress Reduction and Mindfulness Based Cognitive Therapy (Hempel)

Applications Based on Evidence: Mindfulness Approaches Other Than MBSR Grade A-B: Evidence of a Grade C: Unclear Grade D: Evidence of Potential Positive Effect Evidence Potentially No Effect • Depression • General Health • Fibromyalgia • Somatization • Psychological Health • Mental Illness (MBCT) • Substance Use • Depression/Anxiety • Distress Associated w/Cancer • Mood Disorder • Pain • Cancer • Anxiety • Rumination • Psychosis • Smoking Cessation • Correctional Care • Intellectual Disability • Eating Disorders • Hot Flashes • Multiple Sclerosis • Sleep • Obsessive Compulsive Disorder

Table 5. Recommendations based on Levels of Evidence for Other Mindfulness Interventions (non-MBSR). MBCT – Mindfulness Based Cognitive Therapy (Hempel).

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Hypnosis

Hypnosis is a state of consciousness involving focused attention with reduced peripheral awareness and an increased capacity to respond to suggestions (Elkins, Barabasz). A metaphor that further clarifies this concept is: “Hypnosis is to consciousness what a telephoto lens is to a camera. What you see, you see with great detail, but you’re less aware of the context” (Spiegel).

Hypnotherapy is the use of hypnosis in the treatment of a medical or psychological disorder or concern. Hypnotizability is an individual’s ability to experience suggested alterations in physiology, sensations, emotions, thoughts, or behavior during hypnosis; hypnotic induction is a procedure designed to induce hypnosis (Elkins, Barabasz).

Figure 6. Photo of patient learning from hypnotherapist. Photo source: http://www.goodtherapy.org/learn-about-therapy/types/hypnotherapy. Accessed Dec 12, 2015.

An important component of preparing an individual to experience hypnosis is education. It is critical to alleviate fears and clarify any misconceptions about the experience. For example, hypnosis is not a procedure performed on an individual by someone else. All hypnosis is self-hypnosis, although it can be taught and guided. Subjects never lose consciousness, are aware of where they are and their actions, and cannot be forced to do or say things they wouldn’t do in a waking state. They are always in control of the experience (Gurgevich).

Hypnosis requires three key factors: absorption, dissociation, and suggestibility. The process of hypnosis can be compared to going to a movie. Viewers become absorbed in the content of the movie, dissociate from what’s going on around them, then are more open to suggestions offered to them. So if a frightening image appears on the screen, the viewer may become alarmed, yet continues to have complete control, and may choose to purchase a snack at the concession stand, or leave the movie altogether (Gurgevich).

That being said, people are less likely to critically judge what is suggested to them, as they are less aware of what is normally in their consciousness, so caution must be used. One must undergo appropriate training in order to guide individuals in hypnosis (Gurgevich).

Conditions for Which Hypnosis is Used

Some experts recommend trying hypnosis for any disorder, as the risk benefit ratio is so favorable (Gurgevich). Hypnosis is commonly used for treating anxiety disorders, acute and chronic pain, headaches, emotional distress, skin disorders, gastrointestinal problems (irritable bowel syndrome, constipation), nausea and vomiting from chemotherapy, hot flashes in breast cancer survivors, insomnia, smoking cessation, and desired changes in habits. It is also used around the time of medical procedures (surgery, invasive radiological

© 2016 MedStar Institute for Innovation 14 procedures), as it has been found to reduce pain, anxiety, procedure time, and cost (Lang, Tefikow). It has also been used to stop pre-term labor, with some success (Eke). Hypnosis is not just used for treating medical conditions, it can be used to enhance wellness—it improves concentration and can enhance athletic performance.

Evidence

Table 6 shows the relative levels of evidence supporting hypnosis in the scientific literature. The strongest evidence is in chronic pain, surgery, irritable bowel syndrome, and pain and anxiety around procedures. Less robust but convincing RCT evidence of efficacy has been reported in chemotherapy induced nausea and vomiting, labor pain, non cardiac chest pain, smoking cessation, low back pain, wart regression, postmenopausal hot flashes, and pre term labor. Many case and personal reports of extraordinary regression of specific skin diseases exist, too.

Applications Based on Evidence: Hypnosis Grade A: Meta-Analyses Grade A: Randomized Grade B & C: Other Grade D: Evidence Controlled Trials Trials/Cases Supports Inefficacy • Chronic Pain • Interventional radiology • Skin diseases • Induction of labor • Surgery procedures • IBS • Nausea and vomiting • Pain and Anxiety, due to chemotherapy especially around • Labor pain surgery • Non cardiac chest pain • Smoking cessation • Low Back Pain • Warts • Postmenopausal hot flashes • Pre-term labor

Table 6. Evidence for the Efficacy of Hypnosis in Specific Medical Conditions (Adachi, Eke, Elkins, Ford, Gurgevich, Jones, Lang, Madden, Nishi, Spanos, Tahiri, Tan, Tefikow, Zeltzer).

Risks and Complications

Negative side effects are very rare and usually minor, but can include headaches, drowsiness, confusion, and (even less frequently) anxiety (Lynn).

Practitioners

Experts recommend referring to a hypnosis practitioner licensed in a clinical specialty and who is also certified by the American Society of Clinical Hypnosis, where comprehensive training and supervised practice is required prior to certification (Gurgevich).

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Biofeedback

Biofeedback is a mind-body, self-regulation technique, where an individual learns how to voluntarily change his or her own physiological activity in order to improve health and performance. Measuring instruments record heart or respiratory rate, heart rate variability, muscle activity, or electrical activity in the brain (EEG), and then rapidly "feed back" information to the user. The presentation of this information — often in conjunction with changes in thinking, emotions, and behavior — supports desired physiological changes. With training, measuring these parameters isn’t necessary, as the individual can elicit the desired changes without “feedback” (AAPB 2008, Frank) (Figure 7).

Figure 7. How biofeedback works. Biofeedback can take the form of audiovisual feedback from a computer or other device analyzing data. Physiological parameters measured might include EEG, heart rate variability, respiratory rate, or muscle tension. (Sources: http://www.stress-relief-tools.com/how-biofeedback-works.html, Accessed November 6, 2015 and https://en.wikipedia.org/wiki/File:Biofeedback_en.svg. Accessed November 16, 2015.)

Patients typically require a number of training sessions to learn how to measure a specific physiologic function and understand the significance of the “fed-back” information (e.g. fast heart rate or decreased heart rate variability may indicate stress, Figure 8). They subsequently learn to modify the measured parameter, using methods such as breathing exercises, meditation, or guided imagery. Patients may become aware of thoughts, feelings, and behaviors they can learn to self-regulate, thus mastering the practice of biofeedback without physical monitoring.

Figure 8. Heart rate variability tracings, showing patterns associated with frustration (top figure) and calmness, “The Zone” (bottom figure). Source: http://sharpbrains.com/blog/2006/11/19/ trader-peak-performance-and-biofeedback- programs/ Accessed December 14, 2015.

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Conditions for Which Biofeedback is Used

Biofeedback is used to treat a wide variety of conditions and diseases, including urinary incontinence, anxiety, migraine and tension headache, chronic pain, constipation, hypertension, stress, Reynaud’s phenomenon, and many medical conditions exacerbated by stress.

Evidence

Five levels of evidence have been described in order to grade the quality of biofeedback studies. A description of these levels of evidence is listed in Appendix 2. While only one condition was found to meet the highest level of evidence—urinary incontinence in females—numerous studies demonstrate that biofeedback was effective in anxiety, ADHD, chronic pain, and many other conditions (Table 7).

Applications Based on Evidence: Biofeedback Level 5: Effective Level 4: Level 3: Probably Level 2: Possibly Level 1: Not and specific Effective Effective Effective Empirically Supported • Urinary • Anxiety • Alcoholism/ • Asthma • Eating Disorders Incontinence, • ADHD Substance Abuse • Autism • Immune Function female • Chronic Pain • Arthritis • Bell’s Palsy • Spinal Cord Injury • Constipation • DM • Cerebral Palsy • Syncope • Epilepsy • Fecal Incontinence • CFS/Fibromyalgia • Headache • Insomnia • COPD • Hypertension • Neck Pain • Cystic fibrosis • Motion Sickness • TBI • Depressive • Reynaud’s Disease • Urinary Incontinence, Disorders • TMJ Disorders Male • Erectile • • Vulvar Vestibulitis Dysfunction • Hand Dystonia • IBS • PTSD • RSI • Respiratory failure/Mechanical Ventilation • Stroke • Tinnitus • Urinary Incontinence- Children

Table 7: Level of Evidence for Biofeedback Effectiveness in Specific Medical Conditions. ADHD – Attention Deficit/Hyperactivity Disorder; TMJ – Temporomandibular Joint Disease; DM – Diabetes Mellitus; TBI – Traumatic Brain Injury; COPD – Chronic Obstructive Pulmonary Disease; CFS – Chronic Fatigue Syndrome; IBS – Irritable Bowel Syndrome; PTSD – Post-Traumatic Stress Disorder; RSI - Repetitive Strain Injury. (Frank, Glombiewski, Herderschee, Iqbal, Ma, Nestoriuc, Qaseem, Yucha)

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Risks and Complications

In general, biofeedback is considered safe when performed by an appropriately trained practitioner. Biofeedback devices require appropriate maintenance—just as any medical device does—and should be used for the purpose of biofeedback only, as they are not intentionally made for diagnostic purposes.

Practitioners

Most states don’t regulate who can perform biofeedback, and legally, it is considered within the scope of practice for a number of practitioners including psychologists, physical therapists, nurses, physicians, and social workers. However, these practitioners may not have had any specific training in biofeedback.

The Biofeedback Certification International Alliance (BCIA) certifies appropriately credentialed health care professionals who have documented appropriate course work, practical training in biofeedback, and who pass a written certification examination. The Association for Applied Psychophysiology and Biofeedback strongly urge patients to receive treatment from individuals who hold certification through the BCIA (BCIA and AAPB websites).

Guided Imagery

In guided imagery mind-body relaxation people are taught to focus on pleasant images to replace negative or stressful feelings. Guided imagery may be self-directed or led by a practitioner or a recording. It is often used in combination with meditation, biofeedback, and hypnosis. Recent studies revealed guided imagery, coupled with relaxation and or breathing interventions, decreased presurgical mood disturbance, boosted postsurgical immune function and enhanced wound healing (Table 8, Broadbent, Cohen).

Figure 9. Example of a relaxing image that might be described while using guided imagery. Source: http://www.missecoglam.com/health/item/11968-hypnotherapy-with- pam-crane. Accessed December 8, 2015.

Applications Based on Evidence: Guided Imagery Grade A / B: Evidence of Positive Effect • Stress and negative mood • Presurgical mood disturbance • Post-op immune function • Post-op wound healing

Table 8. Recommendations based on Levels of Evidence for the use of Guided Imagery for various conditions (Broadbent, Cohen)

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Yoga

Yoga is a mind-body practice with historical origins in ancient India. Like other meditative movement practices used for health purposes, various styles of yoga typically combine physical postures (asanas), breathing techniques (pranayama), and meditation (dhyanas) (Massey). In the US, Hatha yoga is most commonly practiced, emphasizing postures (asanas) and breathing exercises (pranayama). Some of the major styles of hatha yoga are Iyengar, Ashtanga, Kundalini, and Bikram yoga (Table 9).

Yoga Style Description Iyengar Strict attention to posture and alignment. May use belts and blocks to help alignment Ashtanga Physically demanding, as participants jump from one posture to another. Emphasizes strength, flexibility and stamina Kundalini Believed to release Kundalini energy, thought to be a primal energy located at the base of the spine. Involves asanas, but emphasis is on chanting and breathing Bikram Also known as “hot” yoga, practiced in a room at 100°F, performing a series of 26 asanas. Thought to cleanse the body and increase flexibility

Table 9. Descriptions of popular types of yoga practiced in the US and Europe (Adapted from Massey).

The 2007 National Health Interview Survey found that yoga was one of the top 10 complementary and integrative health approaches used among U.S. adults, with an estimated 6 percent of adults—more than 13 million people—using yoga for health purposes in the 12 months preceding the survey (NCCIH website).

Diverse groups of people practice yoga. It is often taught in classes at yoga studios, health clubs, resorts, hospitals, clinic, or privately.

Figure 10. Yoga is practiced by diverse groups of people in the US. Left: Actor Robert Downey Jr practicing yoga. Photo from http://blog.iheartmyyogi.com/ accessed November 13, 2015. Right: Stroke survivors in modified half moon yoga pose. http://www.clarksvilleonline.com/2012/ 07/27/american-heart-association-reports- yoga-may-help-stroke-survivors-improve-balance/, courtesy Roudebush VAMC and Indiana University, accessed November 6, 2015.

Conditions for Which Yoga is Used

Although initially developed as a way to live in harmony with nature, yoga practitioners were observed to enjoy good health. Mental, physical, and spiritual development is a part of this practice, and the majority of Americans who practice yoga do so to maintain health and well-being. However, it is sometimes used for specific indications: 10% use it for treating musculoskeletal conditions and 16% use it for other medical indications. Interestingly, 22% of individuals who practice yoga were referred to the practice by their physician, implying a degree of acceptance of this healing approach by some physicians (NCCIH website, Figure 11).

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Figure 11: Diagram showing that the majority of Americans practice yoga to maintain health; 26.5% do so for medical conditions; and of these individuals, 22% said their doctor recommended it. Source: NCCIH website, https://nccih.nih.gov/news/ multimedia/infographics/yoga, accessed November 15, 2015.

Medical conditions for which yoga is used include low back pain, depression, musculoskeletal pain, osteoarthritis, PTSD, anxiety, chronic diseases, prevention of coronary artery disease, diabetes mellitus, stress- related disorders, asthma, menopausal symptoms, and side effects of cancer treatment.

Risks and Complications

In general, yoga is a low risk approach, however it is important to find a well-trained, experienced yoga teacher and be cautious with challenging poses. A knowledgeable primary care provider can give guidance, although many may not have adequate training to make informed recommendations. Patients with osteoporosis and osteopenia are cautioned to avoid spinal flexion postures, as vertebral compression fractures have been reported in this population (Sinaki). Some suggest avoiding yoga altogether in this population, as no data exists supporting it has benefits in the population (Verrastro).

Other adverse effects are primarily musculoskeletal involving soreness, although inversion postures (head and shoulder stand) have been (rarely) associated with headache and new or worsening eye problems such as glaucoma or vascular events. Patients with glaucoma are cautioned to avoid inversion postures, and those with musculoskeletal conditions are cautioned to avoid “forceful” forms of yoga (NCCIH website, Coeytaux).

Evidence

Evaluating evidence for yoga in the treatment for specific conditions is problematic as so many diverse practices are in use. For example, Iyengar Yoga was found not to be helpful in asthma treatment, although other types of yoga practice were found to help quality of life and some lung volume measures in asthmatic patients.

The Veteran’s Health Administration’s Evidence-Based Synthesis Program (ESP) has extensively reviewed the scientific yoga literature, including nine diagnoses of interest to their population. Those authors report yoga decreases pain and improves disability in patients with low back pain. Other reviewers also note evidence of positive effect in patients with depression and anxiety (Coeytaux, Verrastro, Table 10).

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Some evidence of potential positive effect exists in improving markers of cardiovascular disease (decreasing hypertension, cholesterol, triglycerides), insomnia in cancer patients, musculoskeletal pain, pain and improved range of motion in osteoarthritis, and some behavioral markers for schizophrenia in the short term. Yoga may be useful as an adjunctive therapy to medications in those with controlled seizure disorders, but authors cautioned it is not effective in uncontrolled seizure disorders and should not be used instead of medications. Yoga has been found to decrease insulin resistance and decrease HgbA1c (long term marker of elevated blood glucose), and some studies have found it useful in stress management and PTSD.

Applications Based on Evidence: Yoga Grade A: Evidence Grade B: Evidence of Grade D: No Firm of Effectiveness Possible Effectiveness Evidence of Effectiveness • Low Back Pain • Cardiovascular • Asthma • Depression Disease • Uncontrolled Seizure • Anxiety • Insomnia disorder • Musculoskeletal Pain • Osteoarthritis • Schizophrenia • Seizure Disorder Controlled w/Medications • Insulin Resistance • Stroke Rehab • Stress • PTSD

Table 10. Recommendations based on levels of evidence for the use of yoga in various medical conditions. (Coeytaux, Broderick, Cohen, Cramer, Haaz, Hartley, Lazaridou, Panebianco, Sabina)

Practitioners

No state or federal regulation of yoga instructors exists, and the absence of standardized credentialing for yoga teachers can make finding an experienced well-trained yoga teacher difficult. Because of the wide variety of yoga practices, it may be challenging for an individual to know which style of yoga practice may be most appropriate. One credentialing organization—the Yoga Alliance—offers a 200 and 500 hour curriculum for yoga teacher training that covers anatomy and hands on practice as well as yoga philosophy, while Iyengar instructor training requires 2-5 years of training (Verrastro, Massey).

The International Association of Yoga Therapists (IAYT) http://www.iayt.org and the Yoga Alliance https://www.yogaalliance.org/yogaregistry have online search tools that can be helpful when looking for a practitioner.

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Tai Chi

Tai Chi (pronounced “tie jee”) is a mind body practice that originated in China as one of the martial arts, which have long been intertwined with medicine in Asia. Tai Chi, an “internal” martial art, is sometimes referred to as “moving meditation.” Practitioners move the body slowly and gently, while breathing deeply and meditating. Internal martial art practices like Tai Chi or Kung Fu emphasize circular motions, often at a slower pace than external martial arts like karate or tae kwon do (Massey, American Tai Chi and Qigong Association).

In areas where there is a large Chinese community, it is common to see groups of people practicing Tai Chi and other martial arts together in public, often in parks. Tai Chi is often taught in classes by an instructor, and may be offered at gyms, community centers or hospitals. Many individuals in the US who practice Tai Chi do so in a gym class setting, often meeting once per week for 2 or more months, with variable rates of individual practice at home in between classes.

Figure 12. Photo of Michelle Obama practicing Tai Chi in Chengdu, China. Source: http://www.scmp.com/news/ china/ article/1457572/fashion-contest-focus-first-lady- diplomacy-during-michelle-obamas-china. Accessed December 8, 2015.

Conditions for Which Tai Chi is Used

Tai Chi is used for multiple indications and is often practiced proactively to promote good health and mind-body-spirit balance, especially in China. Many studies have been performed in the elderly; fall prevention, hypertension, and cognitive performance are three areas thought to be especially promising regarding efficacy. Tai Chi is likely helpful in treating conditions such as pain, osteoarthritis, depression, COPD, and maintaining and building muscle strength. Although practiced to promote general health and psychological wellbeing, improve quality of life, and in patients with cancer, osteoporosis, cardiovascular disease, Parkinson’s Disease, insomnia, and stroke rehabilitation, the evidence for effectiveness is not as strong for these conditions (Table 11).

Evidence

Tai Chi is another non-traditional therapy extensively reviewed by the Veteran’s Health Administration’s Evidence-Based Synthesis Program (VHA-ESP), in order to allow stakeholders to make informed recommendations regarding its use. The authors reported difficulty evaluating Tai Chi studies due to the wide variety of practice styles, intervention duration, and intervention intensity.

The most promising evidence for conditions where Tai Chi was found to be helpful is in the prevention of falls in non-institutionalized individuals, treatment of hypertension, and enhancing cognitive performance. However, osteoarthritis, pain, balance confidence, depression, COPD, and muscle strength are all conditions for

© 2016 MedStar Institute for Innovation 22 which evidence of improvement exists (Table 11). Authors of a subsequent review in 2015 report improved balance control ability and flexibility, postulating these improvements may be responsible for the decrease in falls seen with Tai Chi practice (Huang).

While the largest volume of Tai Chi research has been performed addressing general health benefits, psychological well-being, or effects in the elderly, the supporting evidence is unclear, largely because of concerns about study quality or outcome measurement choices. Additional conditions where the evidence is unclear include cancer, osteoporosis, cardiovascular disease, infections, rheumatoid arthritis, insomnia, Parkinson’s Disease, and stroke rehabilitation.

Evidence demonstrates Tai Chi is not effective in the treatment of diabetes, improving aerobic capacity, increasing life participation in the elderly, or decreasing falls inside of institutions.

Applications Based on Evidence: Tai Chi Grade B: Evidence of Grade C: Unclear Grade D: Evidence of No Possible Effectiveness Evidence Effect • Fall Prevention Outside • General Health • Diabetes Institutions* • Psychological Wellbeing • Aerobic capacity • Hypertension* • Quality of Life • Life Participation • Osteoarthritis • Cancer • Falls Inside Institutions • Pain • Osteoporosis • Balance Confidence • Cardiovascular Disease • Depression • Infections • Cognitive Performance* • Rheumatoid Arthritis • COPD • Insomnia • Muscle Strength • Parkinson’s Disease • Stress • Stroke Rehabilitation

Table 11. Recommendations based on Levels of Evidence for Efficacy of Tai Chi in Various Conditions *Tai Chi though to be more promising in these conditions (Hempel, Massey, Ni)

Risks and Complications

Tai Chi is considered a very low risk intervention, although temporary mild muscle soreness and knee pain can occur when first starting to practice.

Practitioners

In the United States, no license or standard training is required for teachers, although certification programs exist, and the practice is not regulated by state or Federal governments.

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Qi Gong

Qi Gong (pronounced “chee kung” or “chee gong”) is thought to be the foundation of most martial arts, and is also a centuries-old mind-body practice combining postures and gentle movements with mental focus, breathing, and relaxation. For many westerners, distinguishing the difference between Tai Chi and Qi Gong may be difficult, as they may appear to be quite similar when practiced to an outside observer. One form—Medical Qi Gong—is a procedure where the practitioner uses the palms of the hands placed on or near a patient, with the intention of healing (Massey, NCCIH).

Few studies have been performed in the English language regarding Qi Gong, but there is some evidence that Qi Gong may be helpful in the treatment of high blood pressure and neck pain (Massey, Table 12).

Figure 13. Practicing Qi Gong, a centuries old mind-body practice, in a park. Source: http://kaleidoscope.cultural-china.com/en/9Kaleidoscope4251.html. Accessed December 8, 2015.

Applications Based on Evidence: Qi Gong Grade C: Weak or Unclear Evidence • Hypertension • Neck pain

Table 12. Recommendations based on Levels of Evidence for the use of Qi Gong for various medical conditions (Massey)

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Energy-Based Approaches

The fundamental principle underlying energy-based (or human energetic) approaches is the modification, manipulation, or alteration of certain energy dimensions in the body. Some experts classify human energetic therapies based on whether the energy professed to be manipulated is veritable, which means it can be measured in a laboratory; or putative, meaning most believe it cannot be measured. The energy that is thought to be influenced in the following approaches is generally not considered to be measureable by laboratory methods, although some practitioners assert this is not the case (Rindfleisch).

Acupuncture

Acupuncture is one of the major components of Traditional Chinese Medicine (TCM), although it is often used as a stand-alone therapy in the United States. TCM is an entire system of health comprised of five major components, including acupuncture, , massage, mind-body practices, and nutrition counseling. It will be further described in an upcoming section. The underlying philosophy of this system is that energy, also known as Qi (pronounced “chee”), circulates in the human body in channels called meridians, and free flow of this energy is consistent with good health. It is postulated that disease states and pain cause energy blockages, and stimulating acupuncture points (acupoints) on these meridians can normalize Qi flow, thus restoring good health and pain free states.

Figure 14. Charts displaying acupuncture points on meridians. Reference: Fascia as the Anatomical Basis for Acupuncture Points and meridians. https://bowenbelfast.wordpress.com/category/ news/, accessed November 16, 2015.

From a scientific perspective, the exact mechanism of action remains unclear, although evidence suggests that stimulating acupuncture points causes the body to release substances that relieve pain or help the body return to more normal function. These substances include endorphins—the body’s natural pain killers— and neurotransmitters, such as serotonin, norepinephrine and GABA (Yun). In rat models, it has been shown to decrease acute and chronic pain and inflammation (Kavoussi).

When undergoing acupuncture treatments for a specific problem (e.g. low back pain), patients typically undergo a treatment trial of 1-2 treatments per week for 1-2 months in order to differentiate responders from non-responders. Approximately 70% of patients respond to acupuncture, for them this trial becomes the start

© 2016 MedStar Institute for Innovation 25 of a program of therapy. Non-responders are advised to try other therapies. Small acupuncture needles (0.1- 0.35 mm in diameter) are inserted into acupuncture points primarily located on meridians on the head, trunk, and extremities, often in locations seemingly unrelated to where symptoms may be experienced (Figures 14 and 15). For example, a patient with gastrointestinal symptoms may have needles placed in points on the abdomen, as well as points in the upper and lower extremities.

Each treatment lasts between 15-45 minutes, and 5-25 needles are typically inserted, depending on the style of acupuncture practiced. Most patients fall asleep during the treatments, as they feel relaxed, likely because of natural factors released into the blood stream as a response to acupuncture point stimulation.

Figure 15. Acupuncture needles being placed, then left in place for the duration of a treatment. Figures from public domain.

A typical response is temporary symptom relief that increases in duration and intensity after each treatment. As this occurs, the time in between treatments lengthens and may conclude when symptoms are either eliminated or controlled. However, for chronic problems, maintenance acupuncture treatments may be necessary - perhaps on a monthly or quarterly basis - depending on the patient’s response. Much like in patients with chronic problems such as hypertension who take daily medication, ongoing treatment is often indicated for optimal health.

Acupressure is the stimulation of acupoints using pressure instead of piercing the skin with a needle. Individuals can stimulate points on their own bodies, an adhesive metal or plastic bead can be temporarily attached to an acupoint, or practitioners can massage them (Figure 16). The indications for usage and mechanism of action are similar to those for acupuncture. is usually more easily tolerated by children, and can be used in adults who prefer to avoid needles, or in the rare occasion when needle placement is contraindicated.

Figure 16. Acupressure involves stimulation of acupuncture points without needles. Typically, these points are massaged or pressed with the fingers. Figure from WebMD, http://www.webmd.com/pain-management/ss/slideshow-acupuncture-overview, accessed November 15, 2015.

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Conditions for Which Acupuncture is Used

In the United States, acupuncture is most commonly used for treatment of pain of all types: low back, neck, joint, dental, and head ache. It is also used for a wide range of other problems, including symptom management in patients with cancer (nausea, vomiting, and fatigue), postoperative nausea, vomiting, pain and ileus, gastrointestinal symptoms, anxiety, and depression. Acupuncture can also be used to promote well-being and disease prevention. The World Health Organization’s 2003 report listed 100 indications for acupuncture, including acute respiratory conditions, asthma, gastrointestinal disorders, neurologic disorders, and musculoskeletal and dental pain, although these high recommendations were viewed by some as controversial and biased (WHO). Since that time, many systematic reviews have been published and evaluated.

Evidence

Much of the evidence base for the efficacy of acupuncture is contradictory and complex, partly because acupuncture is a difficult therapy to study for various methodological reasons. However, in the last two decades, the quality of research studies has markedly improved. One complicating factor in interpreting the scientific evidence is which classification schema for diagnostic conditions is used. Many systematic reviews have shown acupuncture to be effective in the treatment of chronic pain; however other reviews looking at only chronic back pain are less convincing, even though up to 50% of patients in the chronic pain studies had low back pain.

The Veteran’s Health Administration’s Evidence-Based Synthesis Program has studied acupuncture use in targeted healthcare priorities of veterans (Hempel). Results of their extensive analysis of systematic reviews and recent large randomized controlled clinical trials (RCTs) in various medical conditions were recently published. Four levels of evidence were identified and criteria are described in Appendix 3. A summary of the applications for acupuncture based on evidence is provided in Table 13 below.

Applications Based on Evidence: Acupuncture Grade A: Evidence Of Grade B: Evidence of Grade C: Unclear Evidence Grade D: Evidence of Positive Effect Possible Positive Effective of Positive Effect No Positive Effect • Headache • Dysmenorrhea • Back Pain • Carpal Tunnel • Chronic Pain • Cancer Pain • Neck Pain Syndrome • Migraine • Osteoarthritis • Surgery Analgesia • Nausea in Pregnancy • General Pain • Fibromyalgia • Alcohol • Labor Pain • Shoulder Pain Dependence, • Prostatitis • Rheumatoid Arthritis • Cocaine Addiction • TMJ • Cancer Adverse Effects • Insomnia • IBS • Smoking cessation • Hypertension • PONV • Opiate Addiction • Depression • Drug Addiction • Schizophrenia • Anxiety • PTSD • Ankle Sprain • Postoperative Pain

Table 13: Levels of Evidence for Acupuncture Effectiveness in Specific Medical Conditions. TMJ- Temporomandibular Joint Syndrome, PONV – Postoperative Nausea and Vomiting, PTSD – Post- Traumatic Stress Disorder, IBS – Irritable Bowel Syndrome (Hempel, Ezzo, Linde, Michelfelder, Pennick, Sun, Trinh, Vickers).

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Risks and Complications

In general, the risks and complications of acupuncture treatment are minimal. There is a small incidence of bruising or slight bleeding at the site of needle placement, temporary soreness at a needle site, and a much lower risk of infection. Most modern practices use sterile disposable needles; if a practitioner re-uses non- disposable needles, modern medical sterilization techniques are necessary in order to avoid the risk of blood borne illnesses such as Hepatitis B, Hepatitis C, and HIV/AIDS. Very rare incidences of pneumothorax and even death from aberrant needle placement have been reported, but this should not be an issue if treatments are carried out by cautious practitioners knowledgeable in anatomy.

Practitioners

Acupuncture is commonly practiced by licensed acupuncturists (LAc), who complete at least 3 years of training at a College of Oriental medicine. Physicians may also practice acupuncture, and the training requirements vary from state to state. In some states, acupuncture is considered within the scope of medical practice for physicians, therefore no legal requirements for training exist. In states where there is little regulation, hospital systems may grant privileges only to those physicians who have had adequate training, the definition of which is hospital-dependent. Physicians may achieve board certification in acupuncture through the American Board of Medical Acupuncture although it is not required.

Licensure Requirements for Physicians in District of Columbia, Maryland, and Virginia

In the District of Columbia, physicians must complete 250 hours of acupuncture education and apply for licensure through the Department of Health in order to practice acupuncture legally.

In Maryland, physicians must document 300 hours of acupuncture training and register with the state medical board. Dentists intending to practice acupuncture for indications other than dental conditions must complete a 3 year program just as licensed acupuncturists do.

In Virginia, medical doctors (MD), doctors of (DO), chiropractors, and podiatrists can practice acupuncture following 200 hours of instruction. Podiatrists can only treat pain syndromes originating in the human foot.

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Craniosacral Therapy

Craniosacral therapy (CST) is described as a hands-on whole-body evaluation and treatment approach which uses gentle palpation techniques to release fascial restrictions occurring along the craniosacral system. The craniosacral system is defined as the area from the to the tailbone: a compartment made up of the dural membrane surrounding the brain and spinal cord and its bony attachments, the joints and sutures interconnecting these bones, and the enclosed cerebrospinal fluid (Upledger 2004). A craniosacral rhythm may be assessed via palpation, and a trained craniosacral therapist treats abnormalities with gentle manipulation (Haller). It is thought correcting these abnormalities allows the body to heal itself.

CST is used for many indications (see Table 14), including myofascial, musculoskeletal and radicular pain, chronic pain, arthritis, headache, temporomandibular joint syndrome, traumatic injuries, postoperative rehabilitation, and degenerative diseases of the nervous system. However, few high quality studies exist proving efficacy, although recent trials showed CST effective in the treatment of neck pain; pelvic girdle pain in pregnant women; and pain, anxiety, and quality of life in fibromyalgia (Heller, Elden, Castro-Sanchez, Mataran- Penarrocha).

Figure 17. Craniosacral therapy, a treatment approach, using gentle palpation techniques. Source: http://gentlespirit.massagetherapy.com/craniosacral-balancing. Accessed December 8, 2015.

Applications Based on Evidence: Craniosacral Therapy (CST) Grade A / B: Evidence of Grade C: Weak or Unclear Positive Effect Evidence • general wellbeing • myofascial, musculoskeletal • neck pain and radicular pain • pelvic girdle pain in pregnant • chronic pain women • arthritis • pain, anxiety and quality of life • headache in fibromyalgia • temporomandibular joint • chronic lateral epicondylitis syndrome • traumatic injuries • postoperative rehabilitation • degenerative diseases of the nervous system

Table 14. Recommendations based on Levels of Evidence for the use of Craniosacral Therapy (CST) for various medical conditions (Heller, Elden, Castro-Sanchez, Mataran- Penarrocha)

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Reiki

Reiki is an energy based therapy where practitioners place their hands lightly on or just above a person, with the goal of facilitating the patient’s healing response. Experts report that inadequate evidence exists concluding that Reiki is helpful in any condition (NCCIH), although some studies exist showing improvements in stress, anxiety, mood, and pain (Bowden, Cuneo, Olson, Thrane, Vitale, Table 15).

Figure 18. Reiki practitioner with hands placed just above patient. Source: http://thespiritscience.net/2015/08/10/what-does-reiki-really-do-to-our-bodies/. Accessed December 8, 2015.

Applications Based on Evidence: Reiki Grade A / B: Evidence of Grade C: Weak or Unclear Positive Effect Evidence • stress • pain • anxiety • improved mood

Table 15. Recommendations based on Levels of Evidence for the use of Reiki for various medical conditions (Bowden, Cuneo, Olson, Thrane, Vitale)

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Therapeutic Touch and Healing Touch

Therapeutic Touch is a contemporary healing technique developed in the 1970s, based on ancient practices, where gentle touch is used to enhance healing in another individual (Rindfleisch, Therapeutic Touch website).

Healing Touch is another nurturing energy therapy that uses gentle touch to assist in balancing physical, mental, emotional, and spiritual well-being. This technique supports an individual’s natural ability to heal. Healing Touch was founded in 1989 as a continuing education program for nurses, massage therapists, and other health care professionals. Extensive instruction and training are required for certification (Rindfleisch, Healing Touch International website).

While some studies show beneficial results from healing and therapeutic touch for anxiety, depression, stress, mood, increased heart rate variability, pain and wound healing (Table 15), review authors are unable to draw robust conclusions due to type and quality of studies (Hammerschlag 2014).

Figure 19. Healing Touch is often practiced by nurses. Source: http://healthnews.uc.edu/publications/findings/?/7146/7161/ Accessed December 8, 2015.

Applications Based on Evidence: Therapeutic & Healing Touch Grade C: Weak or Unclear Evidence • anxiety • depression • stress • mood • increased heart rate variability • pain • wound healing

Table 16. Recommendations based on Levels of Evidence for the use of Therapeutic and Healing Touch for various medical conditions (Hammerschlag 2014)

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Manipulative and Body-Based Approaches

Massage

Massage is the rubbing, kneading and manipulation of muscles and other soft tissues of the body. Massage therapists most often use their hands and fingers, but may use their forearms, elbows, feet, or another instrument for therapeutic purposes.

Figure 20. Photo of massage therapy. Photo source: http://livingwellifitness.com/massage/ Accessed December 6, 2015.

Many different types of massage may be used, some of which may be geared towards relaxation, while others may have more specific targets. Swedish massage involves the therapist using long strokes, kneading, deep circular movements, vibration, and tapping. Sports massage combines Swedish massage techniques and deep tissue massage to release muscle tension. Myofascial trigger point therapy focuses on painful points causing discomfort at another area in the body when pressure is applied. Some therapies may be limited to specific parts of the body, such as hand or foot massage, and some massage practices may be combined with other therapies, such as aromatherapy for enhanced patient experience (NCCIH website).

Figure 21. Photo of foot massage (left) and hand massage (right). Photo sources: http://www.ban-tiya-thai-massage.ch/ and http://kapowartnow.com/for-adults. Accessed December 6, 2015.

Conditions for Which Massage is Used

Massage is commonly used for relaxation, general wellness, low back pain, neck pain, cancer pain, arthritis, rehabilitation after injury, fibromyalgia, perioperative anxiety, hypertension, HIV/AIDS, and asthma in children.

Risks and Complications

In general, massage therapy is considered to have few risks when performed by a trained practitioner. Some pregnant women should avoid massage therapy, although it can be helpful when used safely. Individuals with bleeding disorders, low platelet counts or who take anticoagulants should avoid forceful and deep tissue massage in order to avoid bleeding or bruising. Wounds should not be directly massaged, and deep pressure

© 2016 MedStar Institute for Innovation 32 should not be used over an area where a patient has tumor, unless approved by the patient’s health care provider (NCCIH).

Evidence

Systematic reviews and meta-analyses—a high level of evidence—have found massage to be useful in the treatment of acute and chronic low back pain, cancer pain, depression, and improving pain, anxiety, and depression in patients with fibromyalgia. Strong evidence for effectiveness was also found in hypertension, pre- hypertension, and improving the quality of life in patients living with HIV/AIDS (Furlan, Hillier, Lee, Li, Liao, Patel, Yuan).

Individual randomized controlled trials, less robust evidence than systematic reviews or meta-analyses, demonstrated massage to be helpful in treating pain and anxiety, in patients undergoing surgery and medical procedures, and for asthma in children. In Stage 1 and stage 2 breast cancer patients, massage reduced depression, anxiety, and anger, and enhanced immunity. Studies also found massage effective in the treatment of knee osteoarthritis, sleep quality in post-partum women, and improved mood and behavior in children with ADHD (Armstrong, Ko, Ucuzal, Field, Hernandez-Reif, Khilnani, Perlman).

Unclear evidence exists whether massage can be helpful in long-term neck pain relief, dementia, asthma in adults, and stress reduction in health care personnel (Patel, Hansen, Ruotsalainen). No evidence exists supporting the use of massage in the prevention of pressure sores, and elbow and knee tendinitis, and more high quality research is necessary in these areas (Loew, Zhang).

Applications Based on Evidence: Massage Grade A: Evidence of Grade C: Unclear Evidence of Grade D: No Evidence to Effectiveness Effectiveness Support Recommendation • Low Back Pain, Acute and • Neck Pain • Pressure Sore Prevention Chronic • Dementia • Elbow Tendinitis • Cancer Pain • Stress Reduction in Health • Knee Tendinitis • Fibromyalgia Care Personnel • Hypertension, Pre-hypertension • Quality of Life Improvement in HIV/AIDS • Depression • Perioperative Pain and Anxiety • Asthma in Children • Breast Cancer • ADHD • Osteoarthritis • Sleep in Postpartum Period

Table 17. Recommendations based on Levels of Evidence for use of massage in various medical conditions. Sources: Furlan, Hillier, Lee, Li, Lao, Patel, Yuan, Hou, Field, Hernandez-Reif, Khilnani, Perlman, Armstrong, Ko, Ucuzal, Zhang, Loew, Hansen, Ruotsalainen.

Practitioners

In the US, 44 states and the District of Columbia regulate massage therapists. Some cities, counties, or other local governments may have additional regulations. Training standards and requirements for massage therapists vary greatly by state and locality.

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Chiropractic

Chiropractic is a health care profession that focuses on the relationship between the body's structure and its functioning, using a hands-on, medication-free approach. Although practitioners may use a variety of treatment approaches, they primarily manipulate the spine or other body parts to correct alignment problems in order to alleviate pain, improve function, and support the body's natural ability to heal itself. Manipulations may be performed manually or using a device to apply a controlled force. Chiropractors are also trained to recommend therapeutic and rehabilitative exercises, and provide nutritional, dietary, and lifestyle counseling. Additional treatment techniques utilized include therapeutic ultrasound, electrical muscle stimulation, ice, heat, traction, and soft-tissue massage (NCCIH, ACA websites).

Figure 22. Photo showing chiropractic manipulation. Source: http://americanpregnancy.org/

Typically, an initial evaluation is performed and a course of treatments is recommended. The duration, frequency, and types of therapies recommended are dependent on the condition, patient, and practitioner. Frequent visits are often recommended—sometimes multiple days per week—as the hands on approach of chiropractic medicine requires the practitioner to perform repeated manipulations on the patient. Chiropractic treatment is often used in children as well as adults and the elderly.

Figure 23. Left: Chiropractic manipulation of the neck. Right: Chiropractor uses an adjustment tool on the back of a patient. © Matthew Lester Courtesy: National Center for Complementary and Integrative Health. Sources: Photo on left - http://www.betterhealthpractice.com.au. Accessed December 7, 2015. Photo on right - https://nccih.nih.gov/news/multimedia/gallery/ manipulative.htm, Accessed December 14, 2015.

Conditions for Which Chiropractic is Used

Chiropractic care is most commonly used to treat neuromusculoskeletal problems, especially back, neck and joint pain, and headaches, although it has been used in many other conditions, such as dizziness, fibromyalgia, PMS, painful periods, pneumonia, ear infections, asthma, hypertension, and infantile colic (ACA website, Bryans).

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Risks and Complications

Most side effects of chiropractic treatments are benign and may include temporary headache, fatigue, or discomfort. However, there are concerning reports of rare severe complications, including vertebrobasilar artery (VBA) stroke, spinal cord injury, vertebral disc extrusion, and epidural hematoma. Some authors conclude that data is inadequate characterizing the incidence of adverse reactions after chiropractic care, and express urgency in calling for further investigations (Gouveia). Other authors report the incidence of VBA stroke after chiropractic care is the same as that after seeing a primary care physician (PCP), and suggest that VBA stroke associated with chiropractic and PCP visits is likely due to patients with headache and neck pain from VBA dissections seeking care before their stroke (Cassidy).

Evidence

The evidence of the effectiveness of chiropractic manipulation is unclear, and systematic reviews are contradictory. Some reviews show that spinal manipulation and mobilization without exercise are effective in numerous conditions, such as low back pain, certain types of headache and dizziness, some joint disorders, and neck pain (Table 18, Bronfort). However, other reviews show that some of these conditions may be improved only if spinal manipulation is used in addition to other chiropractic treatment, such as exercise, trigger point therapy, or electrical stimulation (Bryans, Gross, Walker).

Another review of systematic reviews reports chiropractic spinal manipulation has not been shown to be effective in the treatment of any medical condition with the possible exception of back pain (Ernst). In children, the evidence is inconclusive regarding the effectiveness for otitis media and enuresis, and it is not effective for infantile colic and asthma when compared to sham manipulation (Bryans).

Applications Based on Evidence: Chiropractic Grade B: Evidence of Grade C: Unclear Grade D: Evidence of Effectiveness Evidence of Effectiveness Ineffectiveness • Low Back Pain: Acute, • Otitis Media in Children • Asthma Subacute and Chronic • Enuresis in Children • Dysmenorrhea • Migraine Headache • Hypertension • Headache, Cervicogenic • Infantile Colic • Dizziness, Cervicogenic • Extremity Joint Problems • Neck Pain: Acute, Subacute

Table 18. Recommendations based on Levels of Evidence for effectiveness for chiropractic manipulation/mobilization only (not including exercise) in the treatment of various medical conditions. Cervicogenic – coming from neck, Coccydynia-tailbone pain, TMJ- Temporomandibular Joint Dysfunction, PMS – Premenstrual syndrome, Otitis media – middle ear infection, Enuresis – bed wetting, Dysmenorrhea – painful menstrual periods (Bronfort, Bryans, Gross, Walker, Ernst).

Practitioners

Accredited chiropractic colleges offer a 4-year Doctor of Chiropractic (DC) degree program that includes classroom and patient care experience, and some graduates may then choose to pursue a 2-3 year residency for training in specialized fields. In order to practice, all chiropractors must pass national board examinations and become state-licensed. The scope of practice varies by state in areas such as the dispensing or selling of dietary supplements and the use of other complementary health approaches such as acupuncture or homeopathy (NCCIH website, ACA website). Spinal manipulative therapy may also be practiced by osteopathic physicians, naturopathic physicians, physical therapists, and some medical doctors.

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Biologically-Based Approaches

Biologically-based approaches involve naturally occurring substances that are used to treat illnesses or promote wellness. Products may contain only one or combine multiple active ingredients.

Supplements

Dietary supplements, more commonly referred to as just “supplements” are defined as products that:

• Contain one or more dietary ingredient including vitamins, minerals, herbs, other botanicals, antioxidants, amino acids, etc • Are ingested orally • Are labeled as a dietary supplement • Are intended to supplement – not replace - a healthy diet (NCCIH website)

This discussion will focus on non-vitamin, non-mineral supplementation—the most common CAM therapy in use in the US—taken by nearly 18% of the US population. The Natural Medicine Database recognizes 1300 substances used to formulate 91,000 commercially available products. It describes their uses, effectiveness, safety and level of scientific evidence (Natural Medicine Comprehensive Database). The most commonly used supplements are given in Table 19 (Clark).

Ten Most Commonly Used Nonvitamin Nonmineral Supplements

50 45 40 35 30 25 44 20

Percentage % 15 10 14.7 5 9 7.3 7.3 5.1 4.5 4.5 0 3.9 3.9

Table 19. Ten most commonly used non-vitamin non-mineral supplements in the US in 2012, shown as a percentage of all non-vitamin non-mineral supplement use (Clark).

Regulation

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The Food and Drug Administration (FDA) and the Dietary Supplement Health and Education Act of 1994 (DSHEA) created regulations for supplements that are different than those covering conventional foods and drug products (FDA website).

• Dietary supplements are not approved by the government for safety and effectiveness before they are marketed. • Manufacturers are required to evaluate the safety and labeling of products before marketing to ensure they meet all federal regulations and they are prohibited from marketing products that are adulterated or misbranded. • Manufacturers are not required to get FDA approval before producing or selling dietary supplements although they must register their facilities with the FDA. • If a new ingredient is added to an existing supplement, that ingredient is reviewed—but not approved—by the FDA for safety only, not effectiveness. • The FDA is responsible for taking action against any adulterated or misbranded dietary supplement product after it reaches the market. • While the FDA regulates dietary supplement labeling, the Federal Trade Commission (FTC) regulates supplement advertising.

So how does a consumer decipher which supplements are safe and effective? In terms of safety in manufacturing practices, consumers can look for one of three seals on product labels that indicate appropriate manufacturing standards were met (Figure 24). The FDA’s current good manufacturing practices (cGMP, GMP) require consistent manufacturing of a product regarding identity, purity, strength, and composition. The US Pharmacopeial Convention also verifies products with GMP standards, and the independent Consumer Lab verifies product ingredients, strength, and contaminants (FDA, USP and CL websites). Regarding effectiveness, websites such as the NCCIH, Natural Medicine Comprehensive Database, and Consumer Lab have information regarding the uses, safety, and effectiveness of products.

Figure 24. Examples of seals of approval shown on supplement labels indicating the manufacturer passed standardized testing for appropriate manufacturing practices. There is no one GMP seal design, but the letters GMP or cGMP (current Good Manufacturing Practices) are displayed on the label (FDA, USP, CL websites)

Practitioner Qualifications

Supplements are widely available as over-the-counter products at most grocery stores, drug stores, and vitamin specialty shops. No certification process is required for individuals who recommend supplements. Naturopathic medical schools, , and integrative medicine educational programs typically emphasize supplement usage, so these practitioners likely have a broad depth of knowledge. Some physicians, nutritionists, dieticians, and pharmacists may also have extensive knowledge about supplements, but this is not always the case. Traditional Chinese Medicine (TCM) practitioners and many Licensed Acupuncturists are knowledgeable about Chinese herbal products, as herbal medicine plays a large part in the practice of TCM.

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Fish Oil

Fish oil is the most commonly consumed non-vitamin, non-mineral supplement in the US. The beneficial components of fish oil are omega-3 fatty acids (FAs), which are present in high levels in fish such as herring, kipper, mackerel, salmon, sardine, and trout. Omega-3 FAs have anti-inflammatory and antithrombotic effects, explaining why they are commonly used for prevention and treatment of cardiovascular conditions. Humans cannot produce or convert other dietary fats into omega-3 FAs, so if fish is not readily available in the diet, supplementation may be recommended (Natural Medicine Comprehensive Database website).

Figure 25. Fatty fish have high levels of Omega-3 fatty acids, which have anti- inflammatory and anti-thrombotic effects. Photo source: DogsNaturally website.

Conditions for Which Fish Oil Supplement is Used

Fish oil from dietary sources or from supplementation is used for a wide variety of ailments although evidence may not always support these uses. They include elevated blood levels of lipids and triglyceride, coronary heart disease, hypertension, stroke, bipolar disorder, depression, rheumatoid arthritis, osteoporosis, Reynaud’s syndrome, weight loss, asthma, prevention of re-stenosis of coronary angioplasty sites (PTCA) and coronary artery bypass grafting (CABG), and many other conditions (Natural Medicine Comprehensive Database).

Omega-3 fatty acid supplementation was found to decrease health care costs in men with a history of heart attacks, by decreasing future heart attacks and other cardiovascular deaths (Herman 2012).

Side Effects

Fish oil is generally recognized as safe when used orally, appropriately, and in doses of 3 grams per day and less. At higher doses, some individuals may have increased risk of bruising, bleeding, and immune function suppression. Fatty fish may contain toxins like mercury, polychlorinated biphenyls (PCBs), and dioxin, so consuming fish oil in large amounts from dietary sources may be unsafe. Symptoms of excessive toxin ingestion include tremor, numbness, tingling, difficulty concentrating, and visual problems (Natural Medicine Comprehensive Database).

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Evidence

A well-developed level of evidence schema exists for supplements describing five categories of effectiveness (see Appendix 3). Table 20 below lists the relative effectiveness of fish oil supplementation in select medical conditions.

Applications Based on Evidence: Fish Oil Level 5: Level 4: Likely Level 3: Possibly Level 2: Possibly Level 1: Likely Effective Effective Effective Ineffective Ineffective • Hyper- • Cardiovascular • Macular degeneration • Angina • Diabetes triglyceridemia disease prevention • Cirrhosis • Re-stenosis post • Claudication angioplasty/CABG • Gingivitis • Asthma • H pylori infection • Atherosclerosis • HIV/AIDS • ADHD • Migraine headache • Bipolar disorder • Osteoarthritis • Dysmenorrhea • Pneumonia • Heart failure • Hypertension • Obesity • Osteoporosis • Reynaud’s syndrome • Rheumatoid Arthritis • Stroke

Table 20. Recommendations for use and levels of evidence regarding the effectiveness of fish oil in select medical conditions. CABG – coronary artery bypass grafting; ADHD – attention deficit hyperactivity disorder (Natural Medicine Comprehensive Database).

Aromatherapy

Another biologically based therapy is aromatherapy, defined as the use of essential oils from plants to enhance physical and mental wellbeing. Administration can be via inhalation, using a steam infusion or a burner, or massaging through the skin. Aromatherapy is often used in conjunction with massage, making scientific study of this single intervention more difficult. Some small and observational studies have reported clinical improvement in patients with depression, dysmenorrhea, anxiety, nausea and fatigue and pain in end-of-life.

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Whole Systems of Health

Practitioners of Traditional Chinese Medicine (TCM), Ayurveda, Naturopathy, and Homeopathy consider each of these to be complete medical systems in and of themselves. These approaches do not fall under the previous four classifications of Integrative Medicine, but TCM, Ayurveda, Naturopathy, and Homeopathy have some components of mind-body, energy-based, manipulative/body based, and biologically based practices. Because most of these TCM systems are complex and use multiple therapies, scientific data do not exist either supporting or refuting the entire system’s effectiveness. Some data may exist regarding a single component of the system, like acupuncture in TCM or an Ayurvedic herbal remedy, but in most cases, conclusions about the entire system of health cannot be drawn by examining one aspect of the system.

Traditional Chinese Medicine (TCM)

In China, TCM is a system of primary health care that encompasses many different practices that can generally be classified into five broad categories:

• Herbal medicine • Acupuncture • Massage - (Chinese therapeutic massage) • Mind Body practices – Tai Chi, Qi Gong • Nutrition

The traditional beliefs on which TCM is based include (Australian Acupuncture and Chinese Medicine Association website):

• Taoism – the philosophical tradition that emphasizes living in harmony with the Tao, which is sometimes described as “the way,” or “path,” or something that is the source of and force behind everything that exists. • The human body – as a miniature version of the universe. • Harmony – between two opposing yet complementary forces, yin and yang, is essential for good health both internally and in relation to the external environment. • Five elements – fire, earth, wood, metal, and water symbolically represent all phenomena, including the stages of human life, and explain the functioning of the body and how it responds to disease. • Qi – a vital energy that flows throughout the body, and performs multiple functions in maintaining health (NCCIH, Helms). • A holistic approach – to understanding normal function and disease processes. • Prevention focus – focuses as much on the prevention of illness as it does on the treatment.

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Figure 26. Left: Depiction of the balance of Yin and Yang, with opposing forces in harmony. Source: http://wbvc.bc.ca/acupuncture/ivas-points/crib-3/ Right: Chinese herbs. Source: https://healthnutritionandexercise.wordpress.com/2015/06/11/can- traditional-chinese-medicine-be-used-for-cancertreatment/. Both accessed Dec 8, 2015.

Conditions for Which Traditional Chinese Medicine is Used

In the United States, individuals may use one part of TCM integrated into other types of care. For example, a patient may use acupuncture combined with medications for optimal health, herbal medicine for dysmenorrheal, or Tai Chi to help with fall prevention.

Risks and Complications

Herbal medicines used in TCM are sometimes marketed as dietary supplements, as was discussed in the section on supplements, but this is not always the case. Some products may be safe, but there have been reports of products contaminated with pharmaceutical agents, toxins, or heavy metals, or not containing the ingredients listed. They may have interactions with medications, and some herbs have been linked to serious health complications. For example, in 2004, the FDA banned the sale of ephedra containing supplements, but the ban does not apply to TCM remedies, one of which is Ma Huang, which is the Chinese herb ephedra (NCCIH website).

Risks and complications of acupuncture, Tai Chi, and Qi Gong, all of which are considered low risk practices, are detailed in previous sections.

Evidence

As most scientific studies are performed examining single therapies, it is not possible to comment on the efficacy of TCM as an entire system. Scientific research for acupuncture, Tai Chi, and Qi Gong are detailed in previous sections.

Practitioners

TCM schools in the US frequently offer a 3-4 year program, which may include all five broad categories of therapies. They may also offer Masters and Doctoral level programs. Each state has different regulations regarding the licensing of practitioners.

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Ayurveda

Ayurveda also known as Ayurvedic Medicine is one of the world’s oldest medical systems. It originated in India more than 3,000 years ago and remains one of that country’s traditional health care systems. The majority of India’s population uses Ayurvedic medicine exclusively or combined with conventional medicine, and it is practiced in varying forms in Southeast Asia (NCCIH). India’s government and other institutes throughout the world support clinical and laboratory research on Ayurvedic medicine, all within the context of the Eastern belief system. However, Ayurveda has not been extensively studied as part of conventional medicine.

Its approaches to health and disease promote the use of herbal compounds, special diets, and other unique health practices. Key concepts of Ayurvedic medicine include universal interconnectedness amongst people, their health, and the universe; the body’s constitution (prakriti); and life forces (), which are often compared to the biologic humors of the ancient Greek system. Using these concepts, Ayurvedic physicians prescribe individualized treatments, including compounds of herbs or proprietary ingredients, along with diet, exercise, and lifestyle recommendations.

Figure 27. Foods used in Ayurvedic diets. Source: http://ayurvedicvillage.com/blog/ eating-in-ayurvedic-style/#.Vmb_acrBYew, Accessed December 8, 2015.

Conditions for Which Ayurvedic Medicine is Used

Individuals may go to Ayurvedic practitioners for various health-related purposes, including primary care, overall well-being, and treatment of illness.

Risks and Complications

Ayurvedic products may contain herbs only, or a combination of herbs, metals, minerals, or other materials. Some of these products may be harmful if used improperly or without the direction of a trained practitioner (NCCIH). A 2008 study found 20% of Ayurvedic products procured from US or Indian manufacturers contained lead, mercury, or arsenic in levels that exceeded acceptable daily intake of toxic metals (Saper).

Evidence

As most scientific studies are performed examining single therapies, it is not possible to comment on the efficacy of Ayurveda as an entire system. Most clinical trials for Ayurvedic approaches have been small, or had research design or methodological problems, which makes drawing conclusions difficult. However, an Ayurvedic treatment including 40 herbal compounds was found to be as effective as conventional treatment for rheumatoid arthritis. Some studies have shown that turmeric may be helpful for inflammatory conditions, and boswellia (frankincense) may be helpful in osteoarthritis (NCCIH, Cameron).

Practitioners

No states license Ayurvedic practitioners, although a few have approved Ayurvedic schools. Many Ayurvedic practitioners are licensed in other health care fields, such as midwifery or massage (NCCIH).

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Naturopathy

Naturopathy, also known as Naturopathic Medicine, is defined as the practice of medicine for the treatment of human diseases with natural agents, emphasizing individuality and the innate healing capacity of the patient (Ahmad, Litchy). It evolved from a combination of traditional practices and health care approaches popular in Europe during the 19th century.

Naturopathic practitioners may use many different treatment approaches including (NCCIH website):

• Dietary and lifestyle changes • Stress reduction • Herbs and other dietary supplements • Homeopathy • Manipulative therapies • Exercise therapy • Practitioner-guided detoxification • Psychotherapy and counseling

Conditions for Which Naturopathy is Used

Individuals may go to naturopathic practitioners for various health-related purposes, including primary care, overall well-being, and treatment of illness.

Risks and Complications

Some warn that using naturopathic therapies instead of allopathic treatments—not in addition to— could delay appropriate treatment of illness.

Evidence

As most scientific studies are performed examining single therapies, it is not possible to comment on the efficacy of Naturopathy as an entire system.

Practitioners

Naturopathic physicians generally complete a 4-year, graduate-level program at an accredited naturopathic medical school. Licensing exists in only 16 states and the District of Columbia, and it requires graduation from a 4-year naturopathic medical college and passing an exam (Litchy).

Traditional naturopaths, also known simply as naturopaths, may receive training from programs that do not have a standardized curriculum and are not accredited. Traditional naturopaths are often not eligible for licensing.

Physicians, osteopathic physicians, chiropractors, dentists, and nurses sometimes offer naturopathic treatments, functional medicine, and other holistic therapies, having pursued additional training in these areas. Training programs may be highly variable (NCCIH).

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Homeopathy

Homeopathy is a highly controversial alternative medical system developed in Germany at the end of the 18th century. The two underlying theories of homeopathy are

• Like cures like – a disease can be cured by a substance that produces similar symptoms of a specific illness in healthy people. • Law of minimum dose – the lower the dose of the medication, the greater its effectiveness. Many homeopathic remedies are so diluted that no molecules of the original substance remain.

A primary reason for the controversy surrounding homeopathy is its underlying theories contradict fundamental laws of chemistry and physics.

Homeopathic remedies are derived from substances that come from plants, minerals or animals. They are often formulated as sugar pellets to be placed under the tongue. Treatments are tailored to each individual, and it is common that different people with the same condition will receive different treatments (NCCIH).

Figure 28. Homeopathic remedy in sugar pellet. Photo source: http://tarahomeopathy.blogspot.com/ Accessed December 8, 2015.

Conditions for Which Homeopathy is Used

Individuals may use homeopathy for a long list of conditions, including recurrent otitis media, pharyngitis, ADHD, enuresis, constipation, diarrhea, asthma, allergic rhinitis, eczema, juvenile arthritis, chronic bronchitis, and recurrent pneumonia in children. In adults, homeopathy is used for anxiety, bruising, poisoning, anemia, HIV/AIDS, insomnia, vertigo, tinnitus, depression, rheumatoid arthritis, and many more acute and chronic problems.

Risks and Complications

Although many homeopathic remedies are highly diluted and unlikely to cause harm, some products may contain substantial amounts of active ingredients and could therefore cause side effects or drug interactions. Some warn that using homeopathic remedies instead of allopathic treatments—not in addition to—could delay appropriate treatment of illness.

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Evidence

The NCCIH reports there is little evidence to support homeopathy as an effective treatment for any specific condition. Numerous Cochrane and other reviews describe the lack of evidence for efficacy in ADHD, flu prophylaxis and treatment, chronic asthma, hot flashes in women with breast cancer, and to induce labor (Heirs, McCarney, Rada, Smith). However, some reviews suggest that homeopathic remedies may be useful in irritable bowel syndrome, fibromyalgia, otitis media in children, bronchitis, and to prevent or reduce symptoms of the side effects of cancer treatment (Peckham, Boehm, Fixen, Zanasi, Kassab).

Interestingly, some basic science evidence exists supporting the hypothesis that extremely dilute solutions may still retain the activity of the now absent active agent. Belon, et al demonstrated that solutions of histamine so diluted they should not contain a single molecule could inhibit basophil activity, the typical function of histamine. Toliopoulos, et al reported a homeopathic remedy increased natural killer cell activity in advanced cancer patients.

Controversy extends to whether homeopathy may work via the effect, and two opposing views of this argument come from analysis of the same data (Rutten, Shang). So it is no surprise that articles with titles like “Should doctors recommend homeopathy?” abound in the literature, with authors adamantly articulating the evidence in favor of and against homeopathy’s use (Fisher).

Practitioners

State laws vary regarding the practice of homeopathy, although commonly, individuals who are licensed to practice medicine or another health care profession can legally practice homeopathy. In some states, unlicensed professionals may practice homeopathy. Only three states have homeopathic licensing boards for MDs and DOs. Two of these states also license homeopathic assistants who may perform medical services under the supervision of a homeopathic physician (NCCIH).

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Part 1 Summary: The Evidence for Integrative Medicine

Our review of fifteen Integrative Medicine Therapies and four whole systems of traditional medicine indicates that while these approaches have not been as thoroughly researched as most standard western medical practices, there nevertheless exists good evidence of effectiveness of IM for certain conditions.

Table 21 provides a summary from all the previous evidence tables, organized by condition treated. It looks only at those IM approaches that have demonstrated effectiveness at Grade A or B (strong demonstration of effectiveness, likely effectiveness or possible effectiveness). Approaches currently demonstrating only weak or unclear evidence are not included. Of course, current absence of evidence is not evidence of ineffectiveness; it is merely a indication of the historical lack of research focus on these therapies.

It is clear from Table 21 that Integrative Medicine—combining modern standard western medical practices with established approaches from other traditions—has much to offer today’s health care systems. Additional therapies to help address well-being and lifestyle issues can be useful in the modern era of population health focus and capitated payments. IM may also enables us to do more to relieve the suffering and dissatisfaction with care experienced by patients because of pain, and the side effects of some modern medical procedures and treatments. Table 21 further highlights the variety of specific mental and physical disorders that might be favorably impacted by methods from IM; in many cases through lower cost providers. Current medical providers who treat these conditions should review the evidence just as they would a new drug or procedure to see if these approaches might be suitable additions to the recommended treatment plans for their patients.

This growing body of evidence, and the growing interest by the public, makes it hard for progressively- minded health systems to ignore Integrative Medicine. In Part 2 of this report we will look at these trends and the responses to them that some leading health systems are already making.

Physical and Psychological Well-Being and Lifestyle Issues General Well-Being/Mood Meditation, Craniosacral Therapy, Reiki Depression Meditation, Yoga, Tai Chi, Acupuncture, Massage Anxiety Meditation, Hypnosis, Biofeedback, Yoga, Acupuncture, Reiki Stress Guided Imagery, Tai Chi, Yoga, Reiki Smoking Cessation Hypnosis, Acupuncture Substance Abuse/Addiction Biofeedback Insomnia/Sleep Biofeedback, Yoga, Acupuncture, Massage Fall Prevention Tai Chi Cognitive Performance Tai Chi Somatization Meditation Motion Sickness Biofeedback Rynaud’s Disease Biofeedback Stroke Rehab Yoga

Table continues next page…

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Pain Management General Meditation, Tai Chi, Acupuncture Acute Massage Chronic Hypnosis, Biofeedback, Acupuncture, Massage Low back Yoga, Massage, Chiropractic Musculoskeletal/ Extremity/Joint Yoga, Acupuncture, Chiropractic Chronic Lateral Epicondylitis Craniosacral Therapy Neck Craniosacral Therapy, Chiropractic Headache/Migraine Biofeedback, Acupuncture, Chiropractic Peri-op Hypnosis, Acupuncture Pregnancy/Labor Craniosacral Therapy, Acupuncture Vulvar Vestibulitis Biofeedback Dysmenorrhea Acupuncture Procedure-Associated Suffering (Oncology, Surgery) Nausea and Vomiting associated with Meditation, Hypnosis, Acupuncture Chemotherapy Presurgical Mood Disturbance Guided Imagery Post-op Nausea and Vomiting Acupuncture Wound Healing/Immune Function Guided Imagery Specific Conditions Hypertension Biofeedback, Yoga, Tai Chi, Massage, Fish Oil, Qi Gong Hypertriglyceridemia Fish Oil Epilepsy/Seizures Biofeedback, Yoga Traumatic Brain Injury Biofeedback Psychosis Meditation Schizophrenia Yoga, Acupuncture PTSD Yoga, Acupuncture ADHD Biofeedback, Massage Osteoarthritis Yoga, Tai Chi, Acupuncture, Massage TMJ Disorder Biofeedback, Acupuncture COPD Tai Chi Pediatric asthma Massage Insulin Resistance Yoga Fibromyalgia Craniosacral, Therapy Massage Irritable Bowel Syndrome Hypnosis Constipation Biofeedback Urinary Incontinence Biofeedback Fecal Incontinence Biofeedback Prostatitis Acupuncture Postmenopausal Hot Flash Hypnosis Preterm Labor Hypnosis Warts Hypnosis

Table 21. Conditions where IM approaches have demonstrated effectiveness at Grade A or B—strong demonstration of effectiveness or likely effectiveness, and possible effectiveness. (Specific references provided in previous sections.)

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Part 2 – The Practice of Integrative Medicine

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Public Perceptions of Integrative Medicine

Market Size

The most recent data from the National Health Statistics Report indicate 33% of adults utilized some form of complementary health approach in the previous year (Clark, Barnes). In the MedStar catchment area of over 9 million, this translates into over 3 million people using these therapies.

Out-of-pocket expenditures for IM therapies in the US in 2007 was $33.9 billion, with approximately $11.9 billion spent on practitioner visits and $22 billion spent on self care purchases of products, classes, and materials (Nahin). If the local focus initially is on a practitioner based IM program, conservatively, this implies that the local market is approximately $290 million. (Assuming $10 billion spent nationally on practitioner visits x 2.9%, MedStar’s catchment area population; see Table 22.)

Total out of pocket expenditures for IM in 2007 in US $33.9 billion

Amount spent on practitioner based services $11.9 billion

MedStar Health’s catchment area 2.9% of US population (9.2 million people)

Projected amount spent on IM practitioner based services in MedStar’s catchment area $290 million (2.9% of $10 billion (conservative) = $290 million)

Table 22. Local market share for practitioner based IM services in the MedStar catchment area. Source: Pete Celano, MBA, Director of Consumer Affairs, MedStar Institute for Innovation, based on national data (Nahin).

Who is Most Likely to Use It?

Individuals most likely to use IM tend to be educated, women, over 40 years old, and of higher socioeconomic status. Baby boomers (born 1946-1964) used IM therapies significantly more than the silent generation (born 1925-1945), even though the silent generation reported twice as many chronic illnesses and more painful conditions (Ho).

These demographics favor the potential IM market in the DC Metro area, as it was recently reported as one of the richest and best educated in the country (Reuters). That being said, IM is just as effective in individuals with a lower socioeconomic status and education, and it was recently reported that those with restricted access to conventional care are more likely to use IM (Su). Recent trends in IM show that non-Hispanic white adults are increasing their use of IM, while non-white adults have decreased usage (Clark).

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Patients with serious illnesses or distressing treatment side effects have a higher usage rate of IM; some surveys say up to 60% (Richardson). Patients with back, neck and joint pain, arthritis, anxiety, and high cholesterol are more frequent users as are individuals with a whole person perspective on health and healing. Populations associated with cultural groups interested in environmentalism, feminism, spirituality, and personal growth are more likely to use IM as well (Astin, Richardson, Su; Table 23).

Who is Mostly Likely to Use Integrative Medicine?

Well educated

Female > male

> 40 years old (but 11.6% of children use some form of IM)

Baby boomers (born 1946-1964) > Silent generation (born 1925-1945)

High socioeconomic status

Decreased access to conventional care

Non-Hispanic white adults > Non-white adults

Poorer health status

Diagnoses: Back, neck or joint pain; arthritis; anxiety; high cholesterol, cancer

Holistic orientation to health

Cultural groups interested in environmentalism, feminism, spirituality, personal growth

Table 23. Demographic characteristics of individuals most likely to use Integrative Medicine (Astin, Richardson, Su).

A recent study of oncology inpatients reported that 95% would use complementary and integrative health approaches while they were hospitalized if these approaches were available. Nutritional counseling and massage were most commonly cited (77% and 76%, respectively), while 50% expressed interest in receiving acupuncture, biofeedback and mindfulness meditation (Table 24, Liu).

Patient Desire for IM: Inpatient Oncology

Type of IM Approach Percent

Nutritional Counseling 77%

Massage 76%

Acupuncture 50%

Biofeedback 50%

Mindfulness Meditation 50%

Table 24. Percentage of inpatient cancer patients who would use a complementary or integrative health approach if it was offered while they were hospitalized. (Liu)

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Why is IM so popular?

Some cite dissatisfaction with conventional medicine as fueling IM’s growth. Poor patient-provider relationships, overemphasis of technology, and the ineffectiveness of modern medicine to address chronic illness factors in to patients looking elsewhere for relief. Patients have grown wary of pharmaceuticals, concerned about harmful medication side effects, understandably so, as adverse drug reactions are the 6th most common cause of death in hospitalized patients (Lazarou, Rakel). These factors along with increasing medication costs entice patients to look for less invasive treatments with less potential risk. The prevalence of stress in our culture may also drive some to investigate additional ways to find relief from daily pressures and anxiety.

An increased focus on optimal health and wellness as part of the modern zeitgeist is also consistent with an Integrative Medicine approach. Lifestyle behaviors have a huge bearing on well-being and are emphasized in IM approaches. Recently it was reported that millennials want a healthcare system that includes mind-body therapies, embraces healthy food, clean air, and spirituality, so one might expect even greater interest as they age (Keckley).

Factors Driving the Popularity of Integrative Medicine

Dissatisfaction with conventional medicine

Poor patient-provider relationships

Overemphasis on technology

Ineffectiveness of conventional medicine in chronic disease treatment

Concern about adverse drug side effects

Increased stress

Increased focus on optimal health and wellness

Table 25. Factors thought to be driving patients to Integrative Medicine practices (Lazarou, Rakel).

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Comprehensive Review of Academic Health Systems with Integrative Medicine Programs

In 2012, the Bravewell Collaborative, a philanthropic organization working to improve healthcare, commissioned an extensive survey of 29 successful Integrative Medicine Centers in the US, to determine how IM was being practiced throughout the US. This is the most comprehensive analysis to date of how Integrative Medicine and Health is practiced in the US. The following section is a summary of their findings, unless otherwise referenced (Horrigan).

Models of Care/Practice Organization

Three models of Integrative Medicine (IM) practice models were identified in the 29 successful centers: consultative care, comprehensive care, and primary care (Table 26). Some IM programs have a discrete identified physical space; others operate virtually or dispersed within the space of existing clinical programs.

Table 26. Frequency of practice models of IM at 29 successful IM centers. Source: Horrigan B, Lewis S, Abrams D, Pechura C. Integrative Medicine in America: How Integrative Medicine is Being Practiced in Clinical Centers Across the United States. The Bravewell Collaborative, 2012.

Consultative care occurs when IM physicians work in close collaboration with the patient’s primary provider, but do not act as the primary care physician. UCSF’s Osher Center for IM and Osher’s Clinical Center at Brigham and Women’s Hospital are examples of this model within a physical center. This type of program may also be administratively and physically housed inside a specific clinical department, as Mayo’s Center for IM is embedded in the Department of Internal Medicine.

A subset of consultative care is focused consultative care. In focused consultative care, IM programs may concentrate or focus on a specific group of medical conditions, such as cancer, pain management, or the perioperative setting. An advantage of this model is that it creates a built-in referral system with very high patient volumes. The down side of this model is that there may be insufficient referrals from this smaller subset of the medical system. (Novey).

In the comprehensive care model, an integrative practitioner manages care for a specific condition during the course of treatment, and the patient continues to have a primary care provider for other health issues. Scripps Center for IM in La Jolla, CA, Cancer Treatment Centers of America, and the Jefferson-Myrna Brind Center of IM in Philadelphia, PA utilize this model.

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In the primary care model, family medicine physicians, internists, pediatricians and nurse practitioners are also trained in IM and act as the primary care providers for patients throughout their lives. One caveat regarding new program formation with this model is that it can be perceived as direct competition with already existing primary care practices (Coulter). The Marino Center for Integrative Health in Massachusetts, Continuum Center for Health and Healing in NYC, and the 11th Street Family Health Services in Philadelphia, PA are examples of this model.

Additional models of care include the virtual model, where CAM services are dispersed throughout a hospital system without a physical center. This “clinic without walls” typically uses existing medical staff to add complementary therapies to more traditional approaches (Coulter). The virtual model may be used in combination with a physical IM Center, as in Allina’s Health System, informally known as a hub and spoke model. Inpatient programs for IM exist in which personnel provide services in specific in-hospital areas and may also work at an affiliated outpatient IM center.

The spa model, more commonly affiliated with the hotel/service industry, caters to high end clients who are willing to pay for expensive services in a retreat-like environment. Miraval and Canyon Ranch, both with locations in Arizona are examples of this model (Coulter).

Triage of New Patients

Seventy-nine percent of centers surveyed allow patients to be seen by a specific type of practitioner (acupuncturist, massage therapist) without prior physician consultation. A minority of centers (21%) initially direct patients to an integrative physician or nurse practitioner for evaluation, then develop a treatment plan and refer to additional practitioners. Of the centers that don’t require an initial physician or nurse practitioner evaluation, integrative medicine practitioners are trained to identify when the patient should be referred to a physician or other primary care provider for medical assessment.

Table 27. How IM centers triage new patients. Source: Survey of 29 successful IM center in Horrigan B, Lewis S, Abrams D, Pechura C. Integrative Medicine in America: How Integrative Medicine is Being Practiced in Clinical Centers Across the United States. The Bravewell Collaborative, 2012.

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Inpatient Services

Inpatient services are offered in 52% of the surveyed IM Centers. Types of services offered include massage, guided imagery, acupuncture/acupressure, biofeedback, mindfulness training, and Reiki. At Allina’s Abbott Northwestern Hospital, the program has been so successful in reducing inpatient pain, anxiety, and nausea, that the other 10 hospitals in the Allina system are instituting these programs. Abbott Northwestern Hospital’s inpatient IM program was initially funded by philanthropy and matching hospital grants, and it is currently funded as part of the hospital budget. Patients are not charged for these services.

Table 28. Centers offering inpatient services. Fifty-two percent of surveyed centers provide inpatient services. Source: Horrigan B, Lewis S, Abrams D, Pechura C. Integrative Medicine in America: How Integrative Medicine is Being Practiced in Clinical Centers Across the United States. The Bravewell Collaborative, 2012.

Types of Practitioners

The most frequently employed practitioners are physicians, acupuncturists, massage therapists, meditation instructors, nutritionists and yoga instructors (Table 29).

Table 29. Percentage of surveyed centers employing specific practitioners. Meditation instructors include MBSR (Mindfulness Based Stress Reduction) teachers; acupuncturist refers to either a LAc (Licensed Acupuncturist) or MD acupuncturist. Source: Horrigan B, Lewis S, Abrams D, Pechura C. Integrative Medicine in America: How Integrative Medicine is Being Practiced in Clinical Centers Across the United States. The Bravewell Collaborative, 2012.

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However, at least 40% of centers also employ psychologists, energy therapists (Healing Touch/Reiki practitioner), nurse practitioners, biofeedback practitioners, and hypnotherapists. Less commonly working at IM Centers are chiropractors, pain specialists, psychiatrists, naturopaths, physical therapists, exercise physiologists, physician assistants, health coaches, osteopaths, ayurvedic, and homeopathic practitioners (Table 30).

Table 30. Additional types of practitioners at surveyed IM Centers. Source: Horrigan B, Lewis S, Abrams D, Pechura C. Integrative Medicine in America: How Integrative Medicine is Being Practiced in Clinical Centers Across the United States. The Bravewell Collaborative, 2012.

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Medical Conditions Most Commonly Treated Successfully at IM Centers

The IM centers were asked which 5 of 20 health conditions were most successfully treated at their center. Chronic pain, gastrointestinal disorders, depression/anxiety, cancer, and stress were the most commonly cited conditions (Table 28). In addition to those five conditions, patients are commonly treated for a wide variety of other problems, including fatigue, sleep disorders, fibromyalgia, acute pain, headache, obesity, allergies, diabetes, immune disorders, before and after surgery, rheumatoid and osteoarthritis, and heart disease (Table 31).

Table 31. Percentage of surveyed IM centers stating the listed condition was among their top 5 most successfully treated conditions. Source: Horrigan B, Lewis S, Abrams D, Pechura C. Integrative Medicine in America: How Integrative Medicine is Being Practiced in Clinical Centers Across the United States. The Bravewell Collaborative, 2012.

Other conditions for which the centers reported successful treatments are listed in Table 32.

Condition Percentage Fatigue/Sleep Disorders 48% Fibromyalgia 42% Acute Pain 35% Headache 26% Obesity 19% Allergies 17% Diabetes 17% Immune Disorder 16% Post-op 16% Pre-op 15% Arthritis 14% Heart Disease 13% ADHD 11% Asthma 9% Hypertension 7%

Table 32. Additional conditions showing the percentage of surveyed IM centers stating the listed condition was among their top 5 most successfully treated conditions. Source: Horrigan B, Lewis S, Abrams D, Pechura C. Integrative Medicine in America: How Integrative Medicine is Being Practiced in Clinical Centers Across the United States. The Bravewell Collaborative, 2012.

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Commonly Used Therapies

As already mentioned, the most commonly used therapies at IM Centers are food/nutritional interventions, supplements, yoga, meditation, Traditional Chinese Medicine/acupuncture, massage and conventional pharmaceuticals (see Table 3 in Part 1 of this white paper).

Fifteen or more of the 29 centers surveyed reported the following patterns of treatment for the 20 most commonly treated conditions:

• Food/nutrition is used for all conditions except acute pain • Supplements are used for all conditions except pre-operative care • Meditation is used for all conditions except ADHD and allergies • Yoga is used for all conditions except ADHD, allergies, and post-operative care • Relaxation techniques are used for all conditions except ADHD, allergies, and immune disorders • Herbal and botanical remedies are used for all conditions except ADHD, and pre- and post- operative care. • Breathing exercises are used for all conditions except ADHD and allergies.

Reimbursement

There is a great diversity of reimbursement for IM therapies, depending on numerous factors, including type of modality, geographical region, and specific insurance plan. Some IM Centers may accept only cash payments, although many centers have a hybrid model, where some services are covered by insurance payments and others are not. Often the insurance carrier determines whether a service is covered or not, so at a particular center, acupuncture may be covered for one person, but not for another.

Table 33. Percentage of surveyed centers receiving cash and/or insurance reimbursement for specific interventions. Source: Horrigan B, Lewis S, Abrams D, Pechura C. Integrative Medicine in America: How Integrative Medicine is Being Practiced in Clinical Centers Across the United States. The Bravewell Collaborative, 2012.

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In the group of centers surveyed, cash is the most frequent form of payment. The interventions that have the highest frequency of insurance reimbursement are given in Table 34.

Table 34. Interventions at surveyed IM centers most frequently covered by insurance. Source: Horrigan B, Lewis S, Abrams D, Pechura C. Integrative Medicine in America: How Integrative Medicine is Being Practiced in Clinical Centers Across the United States. The Bravewell Collaborative, 2012.

Table 35 gives the percentage of centers who receive reimbursement of services by cash, insurance, or Medicare/Medicaid.

Table 35. Sources of payment for care. The percentages may not add up to 100, as some centers may accept cash and insurance for the same service, depending on whether the service for an individual is covered by insurance. The percentages may be less than 100, as some centers may not offer a particular therapy. Source: Horrigan B, Lewis S, Abrams D, Pechura C. Integrative Medicine in America: How Integrative Medicine is Being Practiced in Clinical Centers Across the United States. The Bravewell Collaborative, 2012.

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In summary, medical insurance is most likely to cover IM consultation, acupuncture, psychology/ psychiatry services, nutrition, pre and post-operative care, and mind-body therapies. Massage, exercise classes, yoga, healing touch, and other energy therapies are less likely to be covered by insurance companies. However, this is widely variable by location, insurance company, and employer, and is continuously changing.

Other Revenue Sources

Retail sales. Almost half of centers surveyed generate revenue from retail sales of vitamins, supplements, remedies, or other products (Table 36).

Table 36. Percentage of surveyed centers participating in retail sales. Source: Horrigan B, Lewis S, Abrams D, Pechura C. Integrative Medicine in America: How Integrative Medicine is Being Practiced in Clinical Centers Across the United States. The Bravewell Collaborative, 2012.

Training Programs and Consulting. Although not investigated in the Bravewell survey, many centers generate revenue by other means. The Penny George Institute for Health and Healing at Allina Health Systems has a Transformative Nurse Training Program where their personnel train nurses at other institutions. Duke University has a year long Leadership Program in Integrative Healthcare where participants learn from national IM experts and are subsequently paired with a Duke’s Fuqua School of Business Faculty member to craft a business plan or other final project for IM programming. The Penny George Institute for Health and Healing, the Cleveland Clinic, and other centers provide fee-based consulting services to other institutions interested in implementing IM programs.

Subscription Services. A newer financial model that is evolving in order to address financial challenges involves a subscription service, where a quarterly or yearly fee is paid for a certain number of visits with a physician and/or other practitioner, possibly involving additional services. The subscription service may work best for IM Centers that use a primary care system of IM care, but this subscription service model has not been around long enough to be adequately evaluated. Another payment model involves contracting with large employers who pay part of the subscription fee, allowing an individual to pay only a modest amount up front.

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Referral Sources

Nearly two-thirds of patients are self-referred to the IM Centers; and nine centers reported that more than 50% of their patients are referred from within their healthcare system. Five centers receive more than 90% of their patients from within their own healthcare organization, which suggests acceptance and integration into the parent organization. Most centers reported a low percentage of patients referred from local practitioners outside of their healthcare system.

Factors Driving Long-Term Viability and Clinical Success

The study authors collated the most common factors driving success, and divided them between those critical for long-term viability and those linked to clinical success (Table 37).

Bravewell Report Summary Insights Factors Linked to Long-Term Viability: Strong relationships within the Center’s affiliated health system Development of educational programs for the affiliated health system Strong community outreach Meeting the needs of the local market Monitoring financial performance, sound core business practices Continuing faculty and practitioner development Development of a strong philanthropic community Factors Linked to Clinical Success: Patient empowerment, listening to patients Maintaining a healing environment Treating the whole person Providing hope Evidence-informed approach to care Developing best practices

Table 37. Factors driving long-term viability and clinical success in surveyed IM centers. Source: Horrigan B, Lewis S, Abrams D, Pechura C. Integrative Medicine in America: How Integrative Medicine is Being Practiced in Clinical Centers Across the United States. The Bravewell Collaborative, 2012.

Conclusion

Bravewell’s comprehensive review of 29 IM Centers in the US provides a wealth of significant data that can be used effectively to inform the practice of Integrative Medicine.

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Descriptions of Three Successful Integrative Medicine Practices

Penny George Institute for Health and Healing (PGIHH) at Allina Health Systems

The Penny George Institute for Health and Healing (PGIHH) was founded in 2003 and is housed within the Allina Health System in Minneapolis, MN. Allina comprises 14 hospitals and almost 200 outpatient clinics throughout Minnesota and reports an annual revenue of $3.6 billion.

Inpatient Integrative Medicine services began at Allina’s flagship Abbott Northwestern Hospital (ANH) one year prior to the opening of the PGIHH Outpatient Center, which was founded in 2003 by philanthropic support from the George Family Foundation and the Ted and Dr. Roberta Mann Foundation, with matching $1.0 million per year support for the first 5 years by ANH.

Figure 29. The Penny George Institute for Health and Healing, on the campus of Abbott Northwest Hospital in Minneapolis, Minn. Photo by Emily Ratner, MD.

Prior to initiating the Integrative Medicine program, the Founding Executive Director spent months cultivating relationships with physician leaders, executives, nursing leadership, administrators, and staff looking for champions who would support development of an IM program. A formal employee survey identified individuals who were trained and in some cases, already quietly practicing IM or CAM therapies. The survey brought to light individuals who were interested and supportive, thus allowing formation of a network of advocates and a future referral base.

The IM program started for inpatients only, focusing on pain management. The team was made up of 3 practitioners: a nurse with advanced degrees in holistic nursing and pain management, an acupuncturist, and a massage therapist. A referral would be made, the nurse would perform a consultation, meet with the team, and make treatment recommendations. Hospitalists were enthusiastic supporters, as patients felt better and clinical outcomes were improved. Inpatient referrals increased, and the reputation of the program spread quickly. Other inpatient services requested IM for their patients, so additional IM teams specific to each service line (Cardiology, Oncology, etc) were formed. These services were provided free of charge to patients, and leaders reported this was due to an inability to come up with an appropriate method to bill inpatients.

At the same time the inpatient IM program was starting, construction of the outpatient center on the ANH campus commenced. It was built in 9 months, and for the first 3 months, only employees were treated as outpatients, in order to test the system and build internal support.

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Model of Care

The Penny George Institute for Health and Healing is a distinct center within the Allina Health System, uses a consultative model of care, and has philanthropic and hospital financial support. Integrative services are available at 9 outpatient and inpatient locations throughout the Allina system. The LiveWell® Fitness Center houses nutrition, fitness, and motivational coaching staff who offer private sessions as well as classes.

Outpatient: Access to Services

PGIHH’s main outpatient clinic on the ANH campus has 4500 square feet, 13 exam/treatment rooms and a studio for classes. The clinic itself is an excellent example of an Optimal Healing Environment, designed to promote a soothing atmosphere in a restorative setting (Rakel, Jonas). Two smaller outpatient clinics are located on other campuses, one with 2500 square feet and 6 exam/treatment rooms and the other with 4200 square feet with 10 exam/treatment rooms.

Patients enter the system either by choosing a particular practitioner, or scheduling a general IM consultation in order to develop a treatment plan.

Outpatient: Practitioners Employed and Services Provided

A wide variety of practitioners and outpatient services are provided as listed in Table 38. Most practitioners do not work full time clinically at the outpatient center.

Penny George Institute for Health and Healing (Allina Health) Types of Practitioners Providing Outpatient Services Outpatient Services Provided Physicians IM Consultation Nurse practitioner IM Consultation Licensed acupuncturists Traditional Chinese Medicine/Acupuncture Exercise specialists/physiologist Private and group classes/Personal training Massage therapist Massage Health and wellness coaches Health coaching Nutrition specialists Nutrition consultation and classes Psychologists Psychological Counseling Spiritual direction professional Counseling Tobacco cessation RN specialist Tobacco cessation program Physical therapist Fitness and training programs Biofeedback therapist Biofeedback Yoga instructors Yoga classes

Table 38. Outpatient practitioners and services offered at the Penny George Institute for Health and Healing. Sources: Personal communication and http://www.allinahealth.org/ Penny-George-Institute-for-Health-and-Healing/ Accessed November 14, 2015.

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Outpatient: Multidisciplinary Case Conferences

The practitioners at the PGIHH outpatient clinic have case conferences once per week that all practitioners attend. This is an important part of providing high quality patient care, as practitioners discuss how to best provide care for challenging patient problems.

Outpatient: Finances

Reimbursable outpatient services include:

• Integrative Medicine Consultations (MD/NP) • Acupuncture • Nutrition • Biofeedback • Resilience Training

Retail services include:

• Massage • Classes (Healing Touch, Mindfulness Training, MBSR, Yoga, etc) • LiveWell Fitness Programs and Services • On site store with CDs, yoga supplies

In order to reduce overhead expenses, there are very few support staff. There are no medical assistants, and nurses provide billable services or teach classes.

In 2013, the outpatient clinic was modestly profitable, with a 1% margin. They are working toward a 3- 5% margin.

As illustrated in Table 39, services that are revenue positive in the outpatient clinic include IM consultations and acupuncture. Consultations are billed using evaluation and management codes, as in a conventional medical setting. However, scheduling problems such as late appointment cancellations and no shows make efficient utilization of resources problematic. Classes are also revenue positive, with an 8-10% margin. These include group acupuncture, mindfulness training, exercise classes, resiliency training, stress reduction, and weight management offerings. Spiritual direction counseling services break even. Biofeedback loses money because of insurance coverage issues. Massage and yoga are revenue negative and are perceived as loss leaders.

Penny George Institute for Health and Healing (Allina Health) Revenue positive Revenue neutral Revenue negative outpatient services outpatient services outpatient services IM consultations by MDs and NP Spiritual counseling Biofeedback Acupuncture Yoga Classes Massage

Table 39. Revenue generation by outpatient services. Source: Personal communication, PGIIH leadership.

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Inpatient: Access to Services

The inpatient service is robust with 20,000 inpatient visits per year. Referrals made for inpatient IM services are received by the care team through the electronic medical record. The work flow of how these requests are handled is described in Figure 30 below.

IM Team assigns Referral request sent appropriate IM IM Praconer to Integrave Medicine New referrals and assesses and ongoing paents praconer, who reviews (IM) team through treats paent at reviewed by IM team EMR, consults other Electronic Medical bedside, charts each weekday morning health care professionals Record (EMR) as needed visit in EMR

Figure 30. Work flow of inpatients referred for IM Services at Abbott Northwestern Hospital/Allina Health Systems. Source: Personal communication, Pat Vitale, Manager, Center for Training and Innovation, Penny George Institute, Allina Health System.

Inpatient: Multidisciplinary Case Discussions

The inpatient practitioners discuss cases each morning prior to seeing patients. This process is valued as an integral part of providing optimal patient care, as practitioners discuss treatment plans for challenging problems.

Inpatient: Practitioners Employed, Services Offered and Finances

Fewer types of practitioners and services are available for inpatients than for outpatients, but they are offered free of charge to patients. Although initial funding was by philanthropy and matching hospital grants, these services are now part of the hospital budget, and include practitioner salaries, malpractice insurance, and supplies.

As illustrated in Figure 31, the inpatient program at Abbott Northwestern Hospital has 11.6 FTE practitioners, and averages > 800 treatments/month, or an average of 3-4 treatments per weekday per FTE. Of note, efficiency issues exist as the number of unsuccessful visit attempts was >500, which is 33% of all attempted visits (Figure 31).

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Figure 31. Inpatient programming at Abbott Northwestern Hospital, Allina Health Systems. Source: Personal communication with Pat Vitale. ANW = Abbott Northwestern Hospital

IM consultation, Traditional Chinese Medicine/acupuncture services, massage, and music therapy are inpatient services offered (Figure 32).

Penny George Institute for Health and Healing (Allina Health) Types of Practitioners Providing Inpatient Services Provided Inpatient Services Advanced practice nurse IM consultation Licensed acupuncturists Traditional Chinese Medicine/Acupuncture Massage therapists Massage Music therapist Music therapy

Figure 32. Inpatient practitioners and services offered through the Penny George Institute of Health and Healing at Allina Health Systems. Sources: Personal communication and http://www.allinahealth.org/Penny-George-Institute-for-Health- and-Healing/Providers/ Accessed December 4, 2015.

The hospital has been willing to support these services, as their internal data shows patient satisfaction and hospital rankings have improved as a result of IM. Early in their history, one hospital president wanted to discontinue funding the program, but supportive non-IM physicians rallied and insisted that funding the inpatient IM program continue.

Inpatient studies have documented decreased pain and anxiety by 50% when IM approaches are utilized (Dusek). Ongoing research investigating the financial implications of IM, points to a decrease in charges of $1000 per hospital stay (Jeff Dusek, PhD, Director of Research, PGIIH, personal communication).

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Other Staffing Information

All providers are employees and have malpractice insurance coverage through Allina Health System. Outpatient providers are credentialed, and each type of provider has a scope of practice document, job description, and job requirements, including degree, license, experience and additional certifications.

Non-Clinical Revenue Sources

PGGIH has a long history of education and training of health care professionals. In 2015, they established the Center for Training and Innovation in Healthcare, in order to broaden their ability to influence health care. Their training offerings include a Transformational Nurse Training program, Holistic Nurse Training, Leadership Training, Resiliency During Transition program, Mindfulness and Aromatherapy programs, as well as many others. Many of these programs were initially offered to Allina personnel, and they are currently being offered nationally and internationally to individuals as well as institutions. Consulting services are also available to other institutions interested in instituting IM programs. These programs all generate revenue and help offset non-profitable offerings of the PGGIH.

Research

PGIHH has a very active research arm that is part of BraveNet, the national practice-based research network of IM Centers previously referenced. They successfully acquire grant funding, with a significant amount coming from NIH. Perceived as leaders in IM research, PGIHH focuses on how IM can improve patient outcomes and studies the financial impact of incorporating IM into hospital practices. Their research findings inform their clinical practice, and leaders throughout the IM world often point to their studies and practices as support for models of IM care.

Summary

The Penny George Institute for Health and Healing has a fee-for-service consultative model of outpatient care, with free-of-charge clinical services embedded into an inpatient practice funded by the hospital. Hospital funding of these inpatient services demonstrates the high regard with which the hospital views IM, and is an impressive endorsement. Robust philanthropic support allowed for program initiation and development of new programs over the years. Professional training programs and consulting help to keep the center financially viable. Perceived as leaders in research with subsequent integration of their findings into successful clinical practice, the PGIHH is viewed as a successful model for IM clinical care, professional training, and research in the US.

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Institute for Health and Healing (IHH) at Sutter Health System

The Institute for Health and Healing (IHH), founded in 2000, is housed in the Sutter Health System in Northern California. Sutter is comprised of 24 hospitals, 34 ambulatory surgery centers, and numerous cardiac, cancer, acute rehabilitation, and behavioral health centers, reporting annual revenues of $10.1 billion.

The IHH’s main location is in San Francisco, originally part of the California Pacific Medical Center (CPMC), located across the street from one of CPMC’s main hospitals. IHH started with this outpatient center location, and later added 3 additional outpatient locations in Greenbrae, Sacramento, and Santa Rosa, all in California. CPMC eventually became part of the Sutter Health System, and IHH did as well. IHH is currently expanding to more outpatient centers in the Sutter Health System, and they offer inpatient services in six Sutter Health West Bay Region Hospitals. Their leaders attribute much of their success to adapting to health system changes, maintaining their vision to provide the best IM care possible in the region, and expanding locations and services as they are able.

IHH initially was initially funded 100% through philanthropy. It currently has a $14 million budget, with only 12% of that budget coming from philanthropy.

Figure 33. Entry to California Pacific Medical Center/Sutter Health’s Institute for Health and Healing, San Francisco, CA. Source: http://www.yelp.com/biz_photos/institute-for- health-and-healing-san-francisco-4?select=OdTQapWUbDIoo40UYDQUAw. Accessed December 3, 2015.

Strategic Goals

IHH intends to expand consumer access to IM services throughout Sutter. To accomplish this goal, they plan to develop a system-wide IM service line, with a champion and steering committee, system-wide organizational structure, and resources to support innovation and dissemination.

Outpatient Care

The IHH has had a consultative model of care and is currently initiating a primary care model of care at the San Francisco clinic. Each new patient is entitled to a free 10-minute phone appointment with a Nurse Intake Coordinator who answers questions and provides guidance regarding IM services options. The patient may be triaged directly to a practitioner (massage, bodywork, guided imagery, psychotherapy, acupuncture, nutrition) or to a physician or nurse practitioner for consultation.

The San Francisco IHH clinic is currently undergoing renovation in order to accommodate their new Integrative primary care clinic.

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Strong patient demand for IM outpatient services has spurred clinic growth (Table 40). The average annual growth in the Santa Rosa Clinic is 155%; at the Greenbrae clinic it is 89% and in San Francisco it is 35%. In 2014, over 20,000 patient encounters were spread across these 3 outpatient clinics.

Instute for Health and Healing (Suer) Outpaent Visits Growth 25000

20000

15000 SR Clinic GB Clinic 10000 SF Clinic 5000

0 2011 2012 2013 2014

Table 40. Strong patient demand drives increasing number of patient visits in 3 clinics. SR – Santa Rosa, GB – Greenbrae, SF – San Francisco. Source: Judith Tolson, Regional Director, Institute for Health and Healing at Sutter Health Systems. October 29, 2015.

Practitioners Employed/Services Provided

A wide variety of patient care practitioners are employed at Sutter’s IM clinics, and they are listed with their respective FTEs in Table 41.

Institute for Health and Healing (Sutter Health) SF Clinic GB Clinic SR Clinic Sac Clinic Practitioner Type FTE FTE FTE FTE Physician/NP 3.7 2.0 Hiring 1.2, hiring Acupuncturist 0.9 0.4 0.8 hiring Massage/Bodywork 1.9 0.9 1.0 --- Chiropractor 0.8 0.4 0.4 --- Psychotherapist 0.6 0.4 0.4 --- Nutritionist 0.4 0.2 0.2 --- Aesthetician 0.9 ------Total FTE 9.2 4.5 2.9 1.2

Table 41. Types of practitioners and number of full time equivalents (FTE) at each clinic site. SF – San Francisco, GB-Greenbrae, SR – Santa Rosa, Sac – Sacramento. NP – nurse practitioner. Source: Judith Tolson, Regional Director, Institute for Health and Healing at Sutter Health Systems. October 29, 2015.

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The types of services provided at the San Francisco branch of IHH are listed below in Figure 34.

Institute for Health and Healing (Sutter Health) Outpatient Services Provided in San Francisco Clinic Free Nurse Consultation by Phone Physician and Nurse Practitioner Consultation Chinese Medicine/Acupuncture Chiropractic Osteopathy Psychotherapy and Guided Imagery Nutrition Skin and Body Care Therapeutic Massage and Bodywork Feldenkrais

Figure 34. Types of outpatient services provided at San Francisco IHH Clinic. Source: Judith Tolson, Regional Director, Institute for Health and Healing/Sutter Health Systems. October 29, 2015.

Multidisciplinary Case Conference

A weekly case conference that all practitioners attend is highly valued. New projects and challenging cases are discussed, which optimizes patient care and cultivates a close community of practitioners within the clinic.

Outpatient Finances

The payer mix at IHH is 70% commercial insurance, 15% Medicare/MediCal (California’s Medicaid system), and 15% cash. Some outpatient care is provided free of charge to qualifying patients as community service—it is part of the Sutter culture. This is either funded by Sutter Health, profits from IHH’s retail stores, or donations/philanthropy. In 2014, $368,000 was used to fund patient care.

Physician, acupuncture, chiropractic, nurse practitioner, and psychotherapy practices are profitable (Figure 35). Physicians trained in acupuncture, osteopathy, or functional medicine may generate additional revenue by procedures or supplement sales. The proceeds of supplement sales support free care for patients who would otherwise be unable to afford services. No funds from these sales are provided to the practitioner, nor is a referral to store sales incentivized in any way. The stores stock pharmaceutical-grade supplements and are convenient for patients, so they often purchase items onsite. Retail sales of other products are also profitable.

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Institute for Health and Healing (Sutter Health) Profitable Outpatient Services Physician services Acupuncture Chiropractic services Nurse practitioner services Psychotherapy Retail sales

Figure 35. Services at Sutter’s Institute for Health and Healing that are profitable. Source: Judith Tolson, Regional Director, Institute for Health and Healing/Sutter Health Systems. October 29, 2015.

Non-Clinical Revenue Sources

All four clinic locations have retail stores, where pharmaceutical grade supplements and other products are sold. They plan to open an online store in 2016. IHH raised $670,121 in community donations in 2014.

Inpatient Care

Inpatient services available at some Sutter locations include spiritual care, healing harp, gentle massage, guided imagery, and expressive arts. These services are offered to patients free of charge, and the expenses are covered by a combination of philanthropy and the hospital operating budget. Similar to the Allina Health System, this financial support demonstrates Sutter Health’s commitment to IM, and is a ringing endorsement of how highly it is valued within the health system. While the inpatient practice is robust, the outpatient practice forms the core of the system.

Summary

Sutter’s Institute for Health and Healing leaders attribute their success to staying nimble and adapting to new situations, including changing and merging health systems, opportunities for expansion within their system, and staying true to their vision of providing the best Integrative Medicine Care in the San Francisco Bay Area.

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Vanderbilt University Medical Center’s Osher Center for Integrative Medicine

Vanderbilt’s Center for Integrative Health is part of the Vanderbilt University Medical Center and is integrated within the medical school and campus. Conceived in 2007, it is nationally recognized as a financially sustainable IM Center. Receiving a grant from the Bernard Osher Foundation in 2014, it was subsequently named the Osher Center for Integrative Medicine at Vanderbilt. The following information focuses on how the center started and its financial aspects; its source is from a presentation by and personal communication with Susan Carter, MMHC, Administrative Director.

Figure 36. Photos of Vanderbilt’s Osher Center for Integrative Medicine’s inviting entrance and lobby. Source: http://news.vanderbilt.edu/archived-news/vanderbilt- view/articles/2008/ 12/01/east-meets-west.68019.html. Accessed December 23, 2015.

Starting the Center, the Mission

Caring for the whole person—mind, body, and spirit—with compassion, is the mission of the center and was kept in the forefront when making key decisions. They emphasized recognizing who their target population was, what services they wanted to offer, and what role the center wanted to play.

They chose to build a clinical model, as opposed to focusing on research initially, and started with clinicians who understood the imperative to have a financially sustainable model. The goal was to create a data- driven, productivity-based culture of passionate gifted clinicians and providers, in a physical center, using a consultative care model.

Getting Started, Nuts and Bolts

Prior to starting the center, leaders gathered a group of integrative health experts from around the country for a two-day planning retreat. Opting to “start small” with 2 FTE’s was emphasized as a key to their success, with an eye to minimizing overhead costs. “Buying” percentages of two faculty members’ salaries and contracting part-time practitioners was the strategy used to achieve this goal, and increased demand drove increases in time spent working at the Center. The initial two faculty members were the Medical Director physician who provided IM consultation and a psychologist who provided counseling and other services. Non- faculty contracted consultants included a physical therapist, acupuncturist, and massage therapist who were paid a percentage of revenue they generated.

Not hiring nurses, medical assistants, or physician’s assistants was intentional, and done in order to keep overhead costs low. A certain amount of cross training of practitioners and office personal ensued, but it was acknowledged that care needed to be taken in order not to overburden personnel.

Internal and external outreach efforts were robust and cultivated referral sources. Modalities were judiciously selected, focusing on those that were evidence-based, readily acceptable, and built trust.

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Center personnel built relationships with other departments as their patient population came primarily from pain management, oncology, rheumatology and cardiology services. Educational initiatives—teaching medical students, residents, fellows, grand rounds, supervising practica—encouraged integration throughout the rest of the medical center. Psychology students placed in other clinics saw uninsured patients, thus building awareness, understanding, and credibility with additional departments, generating additional referrals. All practitioner visits were documented on the electronic medical record.

Pilot programs were created with Vanderbilt’s health plan utilizing integrative therapies, in order to create savings for the system. Substantial marketing efforts included open houses, public radio, Google ads, broadcast emails, and community presentations and demonstrations.

Financial Models

Clinical services, patient volume, revenue generation, payor mix and other operational details were closely monitored in order to best assess the clinic’s finances. Insurance-based services included integrative health consultations, health psychology visits, psychotherapy, mindfulness-based therapy groups, and physical therapy. Self-pay services included acupuncture, massage, movement (Yoga, Tai Chi, Qigong) and nutrition visits, as these therapies were typically not covered by insurance.

Vanderbilt’s Osher Center for Integrative Medicine Insurance Based Services Self-Pay Services Integrative Health Consultations Acupuncture Health Psychology Visits Massage Psychotherapy Movement (Yoga, Tai Chi, Qigong) Mindfulness-Based Therapy Groups Nutrition Visits Physical Therapy

Table 42. How Vanderbilt’s services are reimbursed. Source: Susan Carter, MMHC, Administrative Director, Vanderbilt’s Osher Center for Integrative Medicine.

Twenty eight percent of revenues came from professional fees, 61% from technical fees (includes facility fees), 6% from acupuncture, 2% from massage and 3% from classes and workshops (Table 43).

Table 43. Programs and modalities as a total percentage of revenue generated. Source: Susan Carter, MMHC, Administrative Director, Vanderbilt’s Osher Center for Integrative Medicine.

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As shown in Table 44, the highest volume services provided are psychology (43%), acupuncture (23%), physical therapy (10%), medical consultations and visits (9%) and massage (8%).

Table 44. Programs and modalities as a percentage of volume. Source: Susan Carter, MMHC, Administrative Director, Vanderbilt’s Osher Center for Integrative Medicine.

The payor mix was 34% Blue Cross Blue Shield, 28% private pay, 19% other commercial insurance, and 17% Medicare (Table 45). Of note, Medicaid does not cover many of these services in Tennessee, as is the case in most states.

Table 45. Payor mix for IM services at Vanderbilt’s Center for Integrative Medicine. Source: Susan Carter, MMHC, Administrative Director, Vanderbilt’s Osher Center for Integrative Medicine.

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Clinical Volume and Annual Growth

In 2009, the Osher clinic began with 4500 square feet and slightly more than 3900 clinic visits. The percentage growth over the next few years ranged between 15-66%. The clinic was expanded to 9000 square feet, and currently in 2015-2016 is expanding to 16,000 square feet (Table 46).

Table 46. Annual growth of clinical volume from 2009 to 2013. Source: Susan Carter, MMHC, Administrative Director, Vanderbilt’s Osher Center for Integrative Medicine.

Building Community Within the Center

Weekly multi-disciplinary conferences are used to discuss challenging patient cases and administrative issues, and to learn from educational offerings. These are also opportunities for practitioners to learn from each other and build a sense of community. Twice a year special team building activities are held, which also fosters a sense of community within the center.

Summary

Vanderbilt’s IM leaders attribute its success to multiple factors, including a well thought out initiation phase focused on starting small, staged expansion, robust outreach efforts, community building of center employees, and staying true to their mission to provide compassionate care.

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Lessons Learned From Other IM Centers and Their Leaders

Information was solicited from personal communication with other IM leaders, IM center personnel, IM Center site visits, published reports of IM practice in the US, a five year detailed case study describing the creation and demise of an IM Center, other peer reviewed and textbook publications, and personal communication with multiple national leaders of IM Centers (Tables 47 and 48).

Lessons learned can be categorized into five major areas associated with successful programs:

• Implementation Requirements and Recommendations • Business and Financial • Clinical Operations and Personnel • Clinical Care • Education

Overall Lessons Learned

Overall lessons learned from other IM Centers’ experiences that can be applied to development of a successful IM program include: strong leadership and vision, sound financial planning, early attention to adequate marketing support, and clear clinical, operational, and educational objectives. In addition, many leaders emphasized the importance of having a physician champion with both conventional and IM expertise, starting new IM practices on a small scale, keeping overhead low, educating CAM professionals who are used to solo practice in nonconventional settings, and remaining true to the high clinical and ethical standards of providing compassionate integrative care.

A more detailed list of lessons learned in each of the five categories follows.

Implementation Requirements and Recommendations

• Obtain healthcare system leadership support • Develop mission, vision, goals in alignment with health system • Identify physician champion with conventional and IM training • Assess needs of hospital staff, community • Assess hospital staff’s training, attitudes, willingness to refer • Start small • Start with niche market – oncology, pain management, perioperative • Consider starting with pain points within system (readmission rates, aromatherapy in hospital area with unpleasant odors) • Cultivate relationships with advocates in key positions within health system • Develop credentialing procedures for practitioners • Choose location considering patient demographics, likely physician referrals • Appealing, attractive practice environment • Avoid competing with health system players already practicing

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Business and Financial

• Develop sound business plan based on facts • Monitor financial performance, utilize sound core business practices • Recognize the true value of IM is not in short term revenue generation • Acknowledge start-up costs • Provide adequate funding and support for robust marketing efforts • Develop strong philanthropic effort • Allow adequate time to develop program, 3-5 year ROI • Embed IM services in existing clinical department, service line, or clinic or center – there will be have lower initial overhead costs than starting a new IM Center • Keep overhead low, may initially hire different practitioner types with fractions of FTE

Clinical Operations and Personnel

• Develop clear job descriptions • Define roles, obligations, and lines of authority • Commit to hiring only highly trained, effective practitioners • Use scheduling systems to maximize for high utilization • Document clinical outcomes • Focus on good communication with referring MDs • Provide for faculty and practitioner development • Offer regular multi-disciplinary patient conferences

Clinical Care

• Construct and live by a clear vision of providing compassionate integrative care • Treat the whole person • Emphasize patient empowerment/listen to patients • Provide hope • Create an healing, attractive physical space practice area • Adopt an evidence-informed approach to care • Develop best practices

Education

• Offer physician, nursing, staff, community, and patient education in IM • Educate practitioners regarding professionalism, communication, working in teams (CAM practitioners traditionally often work alone, not in hospital setting) • Acknowledge other differences between conventional and CAM practitioners and bridge gaps with education • Provide ongoing practitioner, physician, staff education

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Site Visits Health System/Location The Penny George Institute for Health and Healing Allina Health System/Minneapolis, MN The Institute for Health and Healing Sutter Health System/San Francisco, CA Selected Publications Description, Publication Date Integrative Medicine in America: How Integrative Medicine is Commissioned study examining IM practices in 29 IM Being Practiced in Clinical Centers Across the United States Centers in the US, 2012. Hospital-Based Integrative Medicine: A case study of the Five year NCCIH funded study describing rise and fall of an barriers and factors facilitating the creation of a center IM center, 2008. The Business of Integrative Medicine Textbook chapter in Rakel’s definitive IM text, 2012.

Table 47. Site visit locations and selected publications used as source materials for recommendations.

Personal Communication Affiliated Institution Donald Abrams, MD Chief of Hematology/Oncology at San Francisco General Hospital; Professor of Clinical Medicine, UCSF; Past Medical Director, UCSF Osher Center for Integrative Medicine San Francisco, CA; Past President, Society of Integrative Oncology Tara DeMarco, PhD UCSF Osher Center for IM, Program Manager, San Francisco, CA Lori Knutson, RN, BSN, HNB-BC Founding Executive Director, Penny George Institute for Health and Healing, Allina Health, Minneapolis, MN; Senior Director of Health and Wellness Services, Touchstone Mental Health, Minneapolis, MN Adam Perlman, MD, MPH Executive Director, Duke Integrative Medicine Associate Vice President for Health and Wellness Duke University School of Medicine, Durham, NC Ben Kligler, MD Research Director, Vice Chair, Department of Integrative Medicine Albert Einstein College of Medicine Mount Sinai/Beth Israel Medical Center, NY, NY; Past Chair, Academic Consortium for Integrative Health and Medicine Ather Ali, ND Founding Director, Integrative Medicine at Yale Director, Yale Adult and Pediatric IM Center; Executive Committee, Academic Consortium for IM and Health Fredi Kronenberg, PhD Founding Director, Richard and Hinda Rosenthal Center for CAM Columbia University, NY, NY; Consulting Professor, Department of Anesthesiology Stanford University School of Medicine, Stanford, CA; Co-Founder, North American Menopause Society; Founding Editor, Journal of Alternative and Complementary Health Annie Moore, MD, MBA Medical Director, Patient Coordinated Services University of Colorado School of Medicine, Denver CO; Past Associate Director, Duke Integrative Medicine, Durham NC; Past Medical Director, Women’s Primary Care and Integrative Health Oregon Health and Science University, Portland, OR Brent Bauer, MD Director, Mayo Clinic Complementary and Integrative Medicine Program, Mayo Clinic, Rochester, MN; Executive Committee, Academic Consortium for IM and Health Susan Carter, MMHC Administrative Director, Osher Center for Integrative Medicine Vanderbilt University School of Medicine, Nashville TN; Treasurer, Academic Consortium for Integrative Medicine and Health Roy Elam, MD Medical Director, Osher Center for Integrative Medicine, Vanderbilt University School of Medicine, Nashville TN Victoria Maizes, MD Executive Director, University of Arizona Center for Integrative Medicine; Clinical Professor, University of Arizona College of Medicine, Tucson, AZ Sian Cotton, PhD Executive Director, Center for Integrative Health and Wellness, University of Cincinnati College of Medicine Molly Roberts, MD Board of Directors, Academy of Integrative Health and Medicine Past President, American Holistic Medical Association

Table 48. Sources of personal communications regarding IM Center recommendations.

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Evolution of National Integrative Medicine Organizations

Academic Consortium for Integrative Medicine and Health (“The Consortium”)

Formerly known as the Consortium of Academic Health Centers for Integrative Medicine (CAHCIM), this organization originated in 2000 with leaders from 8 academic medical centers: Duke, Harvard, Stanford, UCSF, University of Arizona, University of Maryland, University of Massachusetts, and the University of Minnesota. It has rapidly grown to 60 institutional members as of 2015. The mission of the Consortium is “to advance the principles and practices of integrative healthcare within academic institutions. The Consortium provides its institutional membership with a community of support for their academic missions and a collective voice for influencing change.”

The goals of the Consortium are:

• To support and mentor academic leaders, faculty, and students to advance integrative healthcare curricula, research, and clinical care • Disseminate information regarding rigorous scientific research, educational curricula in integrative health, and sustainable models of clinical care • Inform health care policy

Although initially membership was limited to academic medical centers, it was recognized that health systems often meet the criteria of membership and share in the Consortium’s mission and goals. Therefore, health systems that have substantial IM programs in 2 of the following categories are eligible for membership: clinical, education, or research. The Consortium sponsors highly regarded national and international research, educational, and clinical conferences. At this time, memberships are available for institutions, not individual members (ACIMH website).

Academy of Integrative Health and Medicine (AIHM)

This organization is an international, inter-professional member-centric organization that educates clinicians in integrative health and medicine. The AIHM’s training incorporates evidence-informed research, emphasizes person-centered care, and embraces global healing traditions. Their stated goal is to transform health care by combining science and compassion. They offer CME educational courses, a national conference, and have just begun offering a 2 year IM Fellowship for physicians, naturopaths, chiropractors, nurses, physician assistants, licensed acupuncturists, and other professionals.

AHIM was formed in 2014, by the merging of the American Holistic Medical Association (AHMA) and the American Board of Integrative Holistic Medicine (ABIHM). The ABIHM has offered board certification for the last 15 years (AIHM website).

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National Center for Complementary and Integrative Health (NCCIH)

The National Center for Complementary and Integrative Health (NCCIH) is the Federal Government’s lead agency for scientific research on complementary and integrative health approaches. They are 1 of the 27 institutes and centers that makes up the National Institutes of Health (NIH) within the US Department of Health and Human Services. Their mission is to define, through rigorous scientific investigation, the usefulness and safety of complementary and integrative health interventions and their roles in improving health and health care. Their current funding level for 2015 is $124 million, underscoring the government’s recognition of the importance of IM (NCCIH website).

Board Certification

Until recently, board certification in IM was offered solely through the ABIHM. However, the American Board of Physician Specialties now offers Integrative Medicine Board Certification (ABOIM). Eligibility to take the board exam requires either fellowship training at an approved program or with other specific types of training and experience that is described in detail (ABPS website).

Education

There are 22 ABOIM approved IM fellowships including the University of Arizona Fellowship Program, UCLA, Scripps, GW, Mayo, and the University of Kansas. Programs may be 1-2 years in duration and the focus varies—research, clinical, specialty—depending on the program (ABPS website). Some fellowships are residential and focus on clinical work, while others are a combination of distance learning with shorter residential components.

Georgetown University Medical Center has a unique Master’s Degree Program in CAM, offered through the Division of Integrative Physiology. Their mission is to educate open-minded health care providers and scientists eager to explore the state of the evidence in the areas of complementary and integrative medicine with objectivity and rigor (Georgetown CAM/MS website).

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Integrative Medicine Programs in the Greater Baltimore- Washington Region

Current Known State of Practice at MedStar Health

Preliminary research into IM at MedStar revealed two areas where CAM therapies are offered and three hospitals teaching yoga classes (Tables 49 and 50). Georgetown University Medical Center hosts two IM/CAM educational programs (Table 51). This information is subject to change and addition.

Clinical Services Offered Location/Description Good Health Center MedStar Good Samaritan. One of the most comprehensive, low cost health enhancement facilities in Maryland. Established in 1992, the center provides free and low cost community screenings, support groups, seminars and CAM therapies such as massage, acupuncture, Tai Chi, and Yoga. Headache clinic Georgetown. Acupuncture/acupressure.

Table 49. Sample of clinical services already offered within MedStar system. CAM – Complementary and Alternative medicine.

Classes Location Yoga classes MedStar St. Mary’s in Leonardtown, MD. Yoga classes MedStar Good Samaritan, MMMC

Table 50. Sample of classes already offered within MedStar system.

Educational Programs Location/Description CAM Masters Degree Program* Georgetown. MBM Program Georgetown, Medical student program.

Table 51. Georgetown University Medical School IM/CAM educational programs. MBM – Mind Body Medicine, CAM- Complementary and Alternative Medicine. * Program undergoing name change to Complementary and Integrative Biomedical Science Masters Degree Program.

The above services, classes, and educational programs were identified via word of mouth and internet searches. It is likely there is much more IM activity within MedStar Health, but the extent of activity is not currently known. As MedStar has 6000 affiliated physicians, 30,000 associates, and 1000 residents, a systematic approach identifying practicing, trained, and interested individuals within the system is crucial if an organized, coordinated program throughout the MedStar system is desired.

University of Maryland School of Medicine Center for Integrative Medicine

The Center for Integrative Medicine (CIM) at the University of Maryland School of Medicine was established in 1991, one of the first IM centers founded in an academic medical center. Originating as a project in the Department of Anesthesiology with a focus on pain management, it developed into its own division within the Department of Family Medicine as its research and education aspects grew. It later achieved “Program” status, allowing for greater interdisciplinary collaboration.

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The CIM emphasizes an approach to healing that values mind, body, and spirit, and is committed to:

• Evaluating the scientific foundation of complementary medicine • Educating health professionals and the public • Integrating evidence-based complementary therapies into clinical care to help people achieve and maintain optimal health and well-being

Today, the center has a staff of more than 35 physicians, faculty members, researchers, and administrators, and is comprised of four divisions: patient care, education, research, and informatics.

Clinical Care

The Center for Integrative Health and Healing (CIHH) is the clinical practice of the CIM. It is located at the University of Maryland Rehabilitation and Orthopaedic Institute in Baltimore. The types of practitioners working at the center include integrative physicians, licensed acupuncturists, a psychologist, psychotherapist, dietician, chiropractor, massage therapist, practitioner, Reiki masters, reflexologists, and a rolfer. ( is a holistic system of soft tissue manipulation and movement education that organizes the whole body in gravity.) Services offered are listed in Table 52. Acupuncture services are also available in Family Medicine.

Clinical Services offered at the Center for Integrative Medicine at the University of Maryland Acupuncture Breathwork Chiropractic manipulation/physical therapy Homeopathy Integrated pain clinic Integrative behavioral health and psychotherapy Integrative care for cancer patients following active treatment Integrative care for functional bowel disorders Integrative care for Lyme & Infectious Diseases Integrative yoga psychotherapy Life coaching Massage Micronutrient infusions Nutrition Physician care Reiki Rolfing

Table 52. Clinical services offered at the CIM at the University of Maryland. Source: http://www.compmed.umm.edu/patient_clinic.asp. Accessed December 14, 2015.

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Education

The Center is integrated with the University of Maryland School of Medicine’s curriculum. It offers coursework to undergraduate medical students, residents, and fellows. A recent collaboration with the School of Nursing aims to train nurses in aspects of IM. Other educational offerings include workshops and classes in Healing Pathways, Qigong, Tai Chi, writing for wellness, yoga, and yoga teacher training.

Research

The Center for Integrative Medicine’s focus on research has been especially successful, receiving numerous NIH grants and becoming an NIH Center of Excellence for research in complementary medicine. Research topics include pain-related conditions, cancer treatment, bowel disorders, addiction, and fertility.

Informatics

The Center gathers literature on complementary medicine and coordinates the complimentary medicine field of the International Cochrane Collaboration (CIM of University of Maryland website).

Johns Hopkins Integrative Medicine and Digestive Center and Johns Hopkins Sibley Hospital

The Johns Hopkins Integrative Medicine and Digestive Center, embedded in the Department of Medicine’s Division of Gastroenterology (GI) and Hepatology, opened in September of 2008.

This center’s practice appears to be a comprehensive care model, where GI and Hepatology problems are addressed with a variety of therapies, conventional and complementary. The Center’s 11 practitioners include physicians, massage therapists, acupuncturists, psychotherapists, and nutritionists. They care for patients with a wide range of conditions and concerns; including chronic conditions, prevention concerns, and healthy lifestyle change. Numerous therapies are offered in addition to digestive health services (Table 53).

Clinical Services Offered at the Johns Hopkins Integrative Medicine and Digestive Center Acupuncture/Chinese Medicine Digestive health services, including endoscopic procedures Integrative psychotherapy Counseling Meditation Guided imagery Nutrition consultation Therapeutic massage Craniosacral therapy Reflexology Women’s health program Cancer care program

Table 53. Clinical services offered at the Johns Hopkins Integrative Medicine and Digestive Center. http://www.hopkinsmedicine.org/ integrative_medicine_digestive_center/services/. Accessed December 14, 2105.

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The center engages in research, including clinical trials such as acupuncture treatment for idiopathic gastroparesis and the Johns Hopkins Migraine Study. The Center’s educational offerings include webinars, online videos, and articles (Johns Hopkins Integrative Medicine and Digestive Center website).

This center had encompassed the majority of Integrative Medicine work at Johns Hopkins until recently, when Johns Hopkins Sibley Hospital in Washington DC started an Integrative Health program through its Cancer Care program. Clinical services include massage, acupuncture, nutrition consultation, and psychosocial health. In addition to their physician medical director, they employ a licensed acupuncturist, oncology dietician specialist, oncology social worker, outpatient palliative care nurse practitioner, and 2 oncology massage therapists (Johns Hopkins Sibley Memorial Center, Cancer Integrative Health website).

George Washington University Medical Center’s Center for Integrative Medicine (GWCIM)

The GW Center for Integrative Medicine (GWCIM) was established in 1998 within the Medical Faculty Associates and as part of George Washington University Medical Center (GWUMC). However, in 2001 it became a separate entity in order to have more operational and practice flexibility. Ties between GWCIM and the GWUMC remain, especially in education, and some physicians have faculty appointments at GWUMC.

Clinical Care

This center has a blended practice model of consultative and primary care and a broad diversity of practitioners and services offered. Types of practitioners employed include integrative physicians, a hypnotherapist, naturopath, physician assistant, Tai Chi Chuan instructor, integrative yoga therapist, therapeutic yoga teacher, biofeedback practitioner, Alexander technique teacher, mindfulness teacher, nutritionist, Rolfer, indoor environmental consultant, massage therapists, health coaches, Reiki masters, acupuncturists, Chinese Medicine practitioners, counselors and psychotherapists. Numerous clinical services are offered (Table 54).

Clinical Services Offered at GW CIM Acupuncture/Chinese Medicine Nutritional Counseling Alexander Technique Psychotherapy Biofeedback Holistic Primary Care Craniosacral/Osteopathic Manipulation Reiki Hypnotherapy Sexual Counseling/Disorder Management IM Consultation Yoga

Integrative Geriatric Consultation/Primary Care Women’s Health and Holistic Gynecology Infrared Light Therapy Mindfulness Based Stress Reduction (MBSR) IV Therapies Integrative Health Coaching Massage Therapy Indoor Environmental Consulting by InSitu Meditation Genetic Profile Results Interpretation Mind-Body Medicine European Mistletoe Injection Therapy Naturopathic Medicine/Integrative Oncology Rolfing Structural Integration

Table 54. Clinical Services offered at GW Center for Integrative Medicine. Source: http://www.gwcim.com/about/. Accessed December 15, 2015.

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Education

The Medical Director and former Medical Director of GWCIM Co-Direct a 4 year Integrative Medicine Track for GW Medical Students. The center houses a unique Integrative Geriatric and Palliative Care Fellowship Program, and fellows who successfully complete the program are eligible to sit for Board examinations in Integrative Medicine, Geriatrics, and Palliative Care Medicine. The center has also hosted a Naturopathic Residency Program.

Research

Past and current research topics include yoga, intravenous Vitamin C administration, Reiki, and a multicenter chelation therapy study.

Inova Health System

Inova Health System does not appear to have a substantive effort in Integrated Medicine. A family physician trained in Integrative Medicine practices in Falls Church, as part of Inova’s Concierge practice. Some complementary therapies appear to be offered through their cancer centers, including healing touch, art and music therapy, yoga, meditation, guided imagery, mindfulness training, and Reiki (Inova websites).

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Part 2 Summary: The Practice of Integrative Medicine

Part 1 of this report establishes the clinical case for taking a closer look at Integrative Medicine. IM therapies add to clinicians’ options for enhancing health and relieving suffering. In Part 2, we make the marketplace-based case for considering an investment in the establishment of IM services.

The marketplace for IM is substantial. Studies show that a third of Americans already utilize IM, spending roughly $34 billion annually. Of that total, $12 billion goes to practitioner-based services. For MedStar Health, this extrapolates to an already existing local market of approximately $290 million annually spent on practitioner-based services. Capturing just a small portion of that market would make a significant contribution to top-line revenues for any health system.

Establishment of IM services within a conventional health system is no longer a high-risk, trail-blazing activity. The Bravewell Collaborative surveyed 29 established—and successful—IM services within well-known academic health systems across the US (e.g., Mayo, Scripps, Allina, Stanford, Brigham & Womens). This study reveals a field of practice in its adolescence; still experimenting and searching for the best approaches and combinations of things. The survey found variation among these 29 centers in terms of models of care, conditions treated, services offered, practitioners employed, inpatient versus outpatient focus, referral processes, payer mixes and financial flows. So, while the first-movers have already moved, there is by no means a single, well-defined response to the market need. We are still in the era of early adoption.

The study of these first-movers sheds light on key success factors (Table 55). These lessons-learned are confirmed by our broader set of interviews with IM champions in other leading health systems. We know what it takes to be successful and sustainable.

Factors Linked to Long-Term Viability: Strong relationships within the Center’s affiliated health system Development of educational programs for the affiliated health system Strong community outreach Meeting the needs of the local market Monitoring financial performance, sound core business practices Continuing faculty and practitioner development Development of a strong philanthropic community Factors Linked to Clinical Success: Patient empowerment, listening to patients Maintaining a healing environment Treating the whole person Providing hope Evidence-informed approach to care Developing best practices

Table 55. Factors driving long-term viability and clinical success in surveyed IM centers. Source: Horrigan B, Lewis S, Abrams D, Pechura C. Integrative Medicine in America: How Integrative Medicine is Being Practiced in Clinical Centers Across the United States. The Bravewell Collaborative, 2012.

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Going beyond the learning from Bravewell, our in-depth study of three established IM centers also indicates that it is possible, and maybe even best, to start very small and adapt to meet needs as you go along. For example, the IM program at Allina Health Systems began as a three-person, inpatient service focused on pain management. It has since grown to become the Penny George Institute for Health and Healing that provides services at nine outpatient and inpatient locations throughout the Allina system. Similarly, Vanderbilt University Medical Center’s IM program began with 2 FTEs, but has since grown to become the Osher Center for Integrative Medicine providing over 10,000 clinic visits annually.

These case studies illustrate that start-up costs can be minimized by the use of existing space, part-time providers, and avoiding the use of nurses or medical assistants who cannot also provide revenue generating services. On the benefits side of the equation, these cases show that some IM services can be profitable on their own, but profitability is not the only attractor. Non-financial benefits include patient and provider satisfaction, community benefit and enhanced reputation. For example, IM is valued so highly at Allina and Sutter—patient satisfaction and hospital ratings improved markedly with inpatient IM services, especially at Allina—that these services are provided free of charge to patients.

The bottom line is that it is not necessary to make a large, risky, all-or-nothing bet in the IM market. Starting small, doing more of what works and less of what doesn’t, learning and adapting as you go, is a very reasonable strategy.

It appears that MedStar’s local competitors have already recognized the potential benefits of IM services. University of Maryland, Johns Hopkins/Sibley, and George Washington University Medical Center have already begun to establish these services. Hopkins/Sibley in still in the starting small stage, while UM and GW have moved beyond that point and are quite well developed. We could find no evidence of a substantive effort in Inova.

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References: Annotated Bibliography Organized By Report Sections

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Introduction

Ariely D, Lanier WL. Disturbing trends in physician burnout and satisfaction with work-life balance: Dealing with malady among the nation’s healers. Mayo Clinic Proceedings Dec 2015;90(12):1593-1596. Editorial commenting on the disturbing trend of increasing burnout in physicians, pointing out that over half of all physicians are burned out, speculating on some of the causes.

Duke Integrative Medicine. Wheel of Health https://www.dukeintegrativemedicine.org/patient-care/wheel-of- health/ Accessed 11/23/15. Duke’s Integrative Medicine paradigm illustrating the complex relationships between the mind-body connection, movement, exercise, rest, nutrition, personal and professional development, physical environment, relationships, communication and spirituality.

Guarneri E, Horrigan BJ, Pechura CM. The Efficacy and Cost Effectiveness of Integrative Medicine: A Review of the Medical and Corporate Literature. The Bravewell Collaborative, June 2010. Authors recommend 3 integrative strategies that would promoting immediate significant health benefits and cost savings: Integrative lifestyle change programs for those with chronic disease, integrative interventions for patients with depression and integrative preventive strategies to support wellness in all populations.

Oaklander M. Life/Support: Inside the movement to save the mental health of America’s doctors. TIME Magazine 2015;186(9-10):42-51. Time Magazine article discussing the disturbing situation of American physicians, pointing out that 400 physicians commit suicide per year, pointing out that’s equivalent to 2-3 medical school classes annually.

Rakel D, Weil A. Philosophy of Integrative Medicine, in Integrative Medicine, 3rd edition, Rakel D, ed. Philadelphia: Elsevier Saunders, 2012:2-6. Introductory chapter of comprehensive IM textbook, discussing the history and underlying philosophy of Integrative Medicine.

Shanafelt TD, Hasan O, Dyrbye LN, Sinsky C, Satele D, Sloan J, West CP. Changes in burnout and satisfaction with work-life balance in physicians and the general US working population between 2011 and 2014. Mayo Clin Proc Dec 2015;90(12):1600-1613. Disturbing study showing physician burnout increased from 45.5% to 54.4% from 2011 to 2014 and satisfaction with work life balance decreased from 48.5% to 40.9%, while these rates remained unchanged in the general population during this same time frame.

UCSF Osher Center for Integrative Medicine website. http://www.osher.ucsf.edu/about-us/what-is-integrative- medicine/Accessed November 15, 2015. Website of Osher’s UCSF Center for Integrative Medicine, describing their services.

University of Arizona http://integrativemedicine.arizona.edu/about/definition.html. The Center defines integrative medicine (IM) as healing-oriented medicine that takes account of the whole person, including all aspects of lifestyle. It emphasizes the therapeutic relationship between practitioner and patient, is informed by evidence, and makes use of all appropriate therapies.

Yusuf S, Hawken S, Ounpuu S, Dans T, Avezum A, Lanas F, McQueen M, Budaj A, Pais P, Varigos J, Lisheng L, on behalf of the INTERHEART study investigators. Effect of potentially modifiable risk factors associated with myocardial infarction in 52 countries (the INTERHEART study): case control study. Lancet 2004;364(9438):937- 52. Impressive international study reporting that abnormal lipids, smoking, hypertension, diabetes, abdominal obesity, psychosocial factors, and diet and exercise behaviors are responsible for 90% of heart attacks, and that modifying lifestyle behaviors has the potential to prevent most premature heart attacks.

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Complementary and Integrative Health Approaches

Center for Evidence Based Medicine, University of Oxford. http://www.cebm.net/oxford-centre-evidence-based- medicine-levels-evidence-march-2009/ Website accessed January 25, 2016. Website of distinguished Center for Evidence Based Medicine at Oxford, with extensive explanations of types of scientific studies and levels of evidence.

Clark TC, Black LI, Stussman BJ, Barnes PM, Nahin RL. Trends in the use of complementary health approaches among adults: United States, 2002-2012. US Department of Health and Human Services, Centers for Disease Control and Prevention, National Center for Health Statistics. National Health Statistics Reports, Number 79, Feb 10, 2015. Comprehensive governmental report comparing national estimates of complementary health approach usage between 2002, 2007 and 2012. Nonvitamin, nonmineral dietary supplements were most commonly used, and Yoga, Tai Chi and Qi gong use increased over this decade.

Horrigan B, Lewis S, Abrams D, Pechura C. Integrative Medicine in America: How Integrative Medicine is Being Practiced in Clinical Centers Across the United States. The Bravewell Collaborative, 2012. Extensive survey of 29 Integrative Medicine Centers in the US, describing the current state of practice, patient populations and health conditions most commonly treated, core practices, models of care, reimbursement of services, values and principles underlying care and the biggest factors driving successful implementation.

Mind-Body Medicine Approaches

Meditation

Barrett B, Hayney MS, Muller D, Rakel D, Ward A, Obasi CN, Brown R, Zhang Z, Zgierska A, Gern J, West R, Ewers T, Barlow S, Gassman M, Coe CL. Meditation of Exercise for Preventing Acute Respiratory Infection: A Randomized Controlled Trial. Annals of Family Medicine 2012;10(4):337-346. High quality RCT showing MBSR was helpful in preventing acute respiratory illness, as measured by decreased incidence, severity, duration and number of days of work missed as compared to control.

Fortney L. Recommending Meditation. In Rakel D, ed. Integrative Medicine, 3rd ed. Elsevier Saunders 2013:873- 881. Chapter in comprehensive textbook reviewing the history, fundamentals, uses and research of meditation.

Hempel S, Taylor SL, Marshall NJ, Miake-Lye IM, Beroes JM, Shanman R, Solloway MR, Shekelle PG. Evidence Map of Mindfulness. VA Evidence-Based Synthesis Program (ESP) Center Project #05-226;2014. Overview of mindfulness research, reporting improvements in depression, overall health, chronic illness, psychological and mental health issues, and limited evidence shows mindfulness improves pain, anxiety and psychosis.

Huang HP, He M, Wang HY, Zhou M. A meta-analysis of the benefits of mindfulness-based stress reduction (MBSR) on psychological function among breast cancer (BC) survivors. Breast Cancer March 2015; DOI 10.1007/s12282-015-0604-0. Meta-analysis reporting a positive effect of MBSR on psychological function and quality of life on breast cancer survivors.

Kabat-Zinn J, Wheeler E, Light T, Skillings A, Scharf MJ, Cropley TG, Hosmer D, Berhnard JD. Influence of a mindfulness meditation-based stress reduction intervention on rates of skin clearing in patients with moderate to sever psoriasis undergoing phototherapy (UVB) and photochemotherapy (PUVA). Psychosom Med 1998 Sep-

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Oct;60(5):625-32. A brief mindfulness meditation-based stress reduction intervention in patients with psoriasis increased the rate of resolution of psoriatic lesions.

Khoury B, Sharma M, Rush SE, Fournier C. Mindfulness-based stress reduction for healthy individuals: A meta- analysis. Journal of Psychosomatic Research June 2015; 78(6):519-528. Meta-analysis reporting MBSR is moderately effective in reducing stress, depression, anxiety and distress and improving quality of life in healthy individuals.

Krisanaprakornkit T, Sriraj W, Piyavhatkul N, Laopaiboon M. Meditation therapy for anxiety disorders. Cochrane Database of Systematic Reviews 2006, Issue 1. Art. No.: CD004998. DOI: 10.1002/14651858.CD004998.pub2. Cochrane review reporting transcendental meditation (TM) is as effective as biofeedback and relaxation therapy for the treatment of anxiety.

Ludwig DS, Kabat-Zinn J. Mindfulness in Medicine. JAMA 2008;300(11):1350-1352. doi:10.1001/jama.300.11.1350. Authors define mindfulness, consider possible mechanisms, explore clinical applications, and identify challenges to the field.

Ma SH, Teasdale JD. Mindfulness-Based Cognitive Therapy for Depression: Replication and exploration of differential relapse prevention effects. Journal of Consulting and Clinical Psychology 2004;72(1):31-40. RCT demonstrating that MBCT was better than usual treatment for preventing relapse in patients with a history of major depression.

Mindful Living Programs website. What is MBSR? http://www.mindfullivingprograms. com/whatMBSR.php. Accessed November 11,2015. Website describing MBSR and offering in-person and online MBSR training.

National Center for Complementary and Integrative Health webpage. https://nccih.nih.gov /health/meditation/overview.htm. Accessed December 5, 2015. Website of NCCIH describing meditation with links to other information regarding meditation practices.

Schneider RH, Staggers F, Alexander CN, Sheppard W, Rainforth M, Kondwani K, et al. A randomized controlled trial of stress reduction for hypertension in older African Americans. Hypertension 1995;26:820-7. RCT demonstrating significant decreases in systolic and diastolic blood pressure in elderly African American with high blood pressure who used Transcendental Meditation.

Wolsko P.M., Eisenberg D.M., Davis R.B.: Use of mind-body medical therapies: results of a national survey. J Gen Intern Med 2004;19:43-50. Survey of more than 2000 Americans reporting 18.9% had used mind body therapy in the past year.

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Hypnosis

Adachi T, Fujino H, Nakae A, Mashimo T, Sasaki J. A meta-analysis of hypnosis for chronic pain problems: A comparison between hypnosis, standard care and other psychological interventions. International Journal of Clinical and Experimental Hypnosis 2014;62(1), 1-28, DOI: 10.1080/00207144. 2013.841471. Meta-analysis evaluating the efficacy of hypnosis in the treatment of chronic pain found moderate treatment benefit when compared to standard treatment.

Eke AC, Ezebialu IU, Eleje GU. Hypnosis for preventing preterm labour (Protocol). Cochrane Database of Systematic Reviews 2012, Issue 11. Art. No.: CD010214. DOI: 10.1002/14651858.CD010214. Cochrane protocol describing studies where hypnosis was effective in the treatment of pre-term labor.

Elkins GR, Barabasz AF, Council JR, Spiegel D. Advancing Research and Practice: The Revised APA Division 30 Definition of Hypnosis. American Journal of Clinical Hypnosis 2015;57:4, 378-385, DOI: 10.1080/00029157.2015.1011465. Reports rationale behind development of and the new concise definitions of hypnosis, hypnotic induction, hypnotizability and hypnotherapy.

Elkins GR, Fisher WI, Johnson AK, Carpenter JS, Keith TZ. Clinical hypnosis in the treatment of postmenopausal hot flashes: a randomized controlled trial. Menopause. 2013 Mar;20(3):291-8. doi: 10.1097/GME.0b013e31826ce3ed RCT demonstrating hypnosis resulted in significant reduction in self- reported and physiologically measured hot flashes.

Ford AC, Quigley AMM, Lacy BE, Lembo AJ, Saito YA, Schiller LR, Soffer EE, Spiegel BMR, Moayyedi P. Effect of Antidepressants and Psychological Therapies, Including Hypnotherapy, in Irritable Bowel Syndrome: Systematic Review and Meta-Analysis. Am J Gastroenterol 2014; 109:1350–1365; doi:10.1038/ajg.2014.148; published online 17 June 2014. Systematic review and meta-analysis demonstrating hypnosis was helpful in treating the symptoms of IBS.

Gurgevich S. Self-Hypnosis Techniques. In Rakel D, ed. Integrative Medicine, 3rd ed. Philadelphia: Elsevier Saunders, 2012:836-842. Hypnosis review detailing principles and practical aspects of clinical use of self- hypnosis.

Jones H, Cooper P, Miller V, Brooks N, Whorwell PJ. Treatment of non-cardiac chest pain: a controlled trial of hypnotherapy. Gut 2006;55:1403-1408 doi:10.1136/gut.2005.086694. RCT demonstrating hypnosis improves pain, overall well being and decreases medication usage in patients with non-cardiac chest pain.

Lang EV, Berbaum KS, Pauker SG, Faintuch S, Salazar GM, Lutgendorf S, Laser E, Logan H, Spiegel D. Beneficial effects of hypnosis and adverse effects of empathic attention during percutaneous tumor treatment: When being nice does not suffice. J Vasc Interv Radiol 2008;19:897-905. Fascinating RCT demonstrating patients undergoing percutaneous tumor treatment who had hypnosis during the procedure had less pain, anxiety, pain medication and adverse effects than patients in the empathy and standard treatment groups. Patients in the empathy group had more adverse effects than in the standard treatment group as well, and the authors postulate that empathic approaches with an external focus of attention do not enhance patients’ self coping, resulting in more adverse effects.

Lang EV, Rosen MP. Cost Analysis of Adjunct Hypnosis with Sedation during Outpatient Interventional Radiologic Procedures. Radiology 2002;222:375-382. Analysis of prospective randomized controlled trial demonstrating adjunct hypnosis with sedation for interventional radiologic procedures reduces pain, anxiety, procedure time as well reducing the cost by $338 per each procedure.

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Lynn SJ, Martin DJ, Frauman DC. Does hypnosis pose special risks for negative effects? A master class commentary. Int J Clin Exp Hypn 1996 Jan;44(1):7-19. Commentary reporting on review of research on hypnosis, noting a 5-31% incidence of transient posthypnotic negative effects, including headaches, dizziness and confusion.

Madden K, Middleton P, Cyna AM, Matthewson M, Jones L. Hypnosis for pain management during labour and childbirth. Cochrane Database Syst Rev. 2012 Nov 14;11:CD009356. doi: 10.1002/14651858.CD009356.pub2. Cochrane review reporting 7 RCTs showed promise for the use of hypnosis for pain management in labor and delivery.

Nishi D, Shirakawa MN, Ota E, Hanada N, Mori R. Hypnosis for induction of labour. Cochrane Database Syst Rev. 2014 Aug 14;8:CD010852. doi: 10.1002/14651858.CD010852.pub2. No RCTs were able to be included in this review to evaluate the use of hypnosis for induction of labor.

Spanos NP, Williams V, Gwynn. Effects of hypnotic, placebo and salicylic acid treatments on wart regression. Psychosomatic Medicine 1990;52:109-114. RCT demonstrating hypnosis was superior to topical salicylic acid, placebo or no treatment control in the treatment of warts.

Spiegel D. Tranceformation: Hypnosis in Brain and Body. NCCIH webinar, https://nccih.nih.gov/training/videolectures/17/2, accessed September 25, 2015. National Center for Complementary and Integrative Health webinar reviewing hypnosis.

Tahiri M, Mottillo S, Joseph L, Pilote L, Eisenberg MJ. Alternative smoking cessation aids: A meta-analysis of randomized controlled trials. The American Journal of Medicine.2012;125(6):576-584. Meta-analysis showing that 4 RCTs using hypnosis for smoking cessation suggest it may be efficacious.

Tan G, Rintala DH, Jensen MP, Fukui T, Smith D, Williams W. A randomized controlled trial of hypnosis compared with biofeedback for adults with chronic low back pain. Eur J Pain. Feb;19(2):271-80. doi: 10.1002/ejp.545. Epub 2014 Jun 17. RCT demonstrating hypnosis was superior for pain control and sleep quality than the active control in patients with chronic low back pain.

Tefikow S, Barth J, Maichrowitz S, Beelmann A, Strauss B, Rosendahl J. Efficacy of hypnosis in adults undergoing surgery or medical procedures: a meta-analysis of randomized controlled trials. Clinical Psychology Review.2013;33(5):623-636. Meta-analysis of >2500 patients undergoing medical or surgical procedures demonstrating positive treatment effects compared to standard care or attention control on emotional distress, physiological parameters, recovery, and surgical procedure time.

Zeltzer L, LeBaron S, Zeltzer PM. The Effectiveness of Behavioral Intervention for Reduction of Nausea and Vomiting in Children and Adolescents Receiving Chemotherapy. J Clin Oncol.1984 Jun;2(6):683-90. Randomized controlled clinical trial showing hypnosis and supportive counseling reduced nausea and vomiting due to chemotherapy in children.

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Biofeedback

Andrasik F, Grazzi L. Biofeedback and behavioral treatments: Filling some gaps. Neurol Sci 2014: 35(Suppl 1):S121-S127. Article reporting biofeedback and other related behavioral approaches have long been known to be effective to treat headache, and this article discusses further behavioral treatment approaches.

Association for Applied Psychophysiology and Biofeedback. About Biofeedback. www.aapb.org /i4a/pages/index.dfm?pageid=3678#l Accessed November 4, 2015. Defines biofeedback, as determined by task force of AAP, BCIA and ISNR in 2008.

Association for Applied Psychophysiology and Biofeedback website. Find a Practitioner. http://www.aapb.org/i4a/pages/index.cfm?pageid=3297. Accessed November 9, 2015. Description of state licensing, scope of practice and certification of biofeedback practitioners.

Biofeedback Certification International Alliance website. Overview of Clinical Entry-Level Biofeedback Certification. http://www.bcia.org/i4a/pages/index.cfm?pageid=3637. Accessed November 9, 2015. Overview of clinical entry-level biofeedback certification, outlining basic information, requirements and other steps to achieve certification.

Frank DL, Khorshid L, Kiffer JF, Moravec CS, McKee MG. Biofeedback in medicine: Who, when, why and how? Mental Health in Family Medicine 2010;7:85-91. An overview of biofeedback training, research, and which conditions and types of patients would likely benefit from biofeedback interventions.

Glombiewski JA, Bernardy K, Hauser W. Efficacy of EMG and EEG biofeedback in fibromyalgia syndrome: A Meta- Analysis and a systematic review of randomized controlled trials. Evidence Based Complementary and Alternative Medicine, Volume 2013 (2013), Article ID 962741, 11 pages. Meta-analysis and systematic review of 7 biofeedback studies demonstrating that EMG biofeedback significantly decreased pain intensity compared to a control group.

Herderschee R, Hay-Smith EJC, Herbison GP, Roovers JP, Heineman MJ. Feedback or biofeedback to augment pelvic floor muscle training for urinary incontinence in women. Cochrane Database of Systematic Reviews 2011, Issue 7. Art. No.: CD009252. DOI: 10.1002/14651858.CD009252. Cochrane review reporting biofeedback or feedback itself may be beneficial with pelvic floor muscle training in women with urinary incontinence.

Iqbal ZA, Rajan R, Khan SA, Alghadir AH. Effect of Deep Cervical Flexor Muscles Training Using Pressure Biofeedback on Pain and Disability of School Teachers with Neck Pain. Journal of Physical Therapy Science. 2013;25(6):657-661. doi:10.1589/jpts.25.657. Study showed significant decrease in pain and disability scores in teachers with neck pain when using biofeedback for neck muscle training compared to a control group.

Ma C, Szeto GP, Yan T, Wu S, Lin C, Li L. Comparing biofeedback with active exercise and passive treatment for the management of work-related neck and shoulder pain: a randomized controlled trial. Archives of Physical Medicine and Rehabilitation 2011(92)6:849-858. Randomized controlled trial demonstrating biofeedback significantly improved neck pain as compared to an exercise intervention, passive treatment and control group. This improvement persisted for 6 months, the duration of the follow up period.

Nestoriuc Y, Martin Al. Efficacy of biofeedback for migraine: A meta-analysis. Pain 2007 (128):111-127. Meta- analysis of 55 studies demonstrating biofeedback was effective in treating migraines and the effect persisted for 17 months post intervention compared to controls.

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Qaseem A, Dallas P, Forciea MA, Starkey M, Denberg TD, Shekelle P, et al. Nonsurgical Management of Urinary Incontinence in Women: A Clinical Practice Guideline From the American College of Physicians. Ann Intern Med. 2014;161:429-440. The American College of Physicians guidelines for the treatment of urinary incontinence in women recommends non-pharmacologic first line treatment. High quality evidence reveals pelvic floor muscle training in conjunction with biofeedback was effective at improving and achieving urinary incontinence.

Yucha C, Montgomery D. Evidence-Based Practice in Biofeedback and Neurofeedback. Wheat Ridge: Association for Applied Psychophysiology and Bio-feedback, 2008. Review of evidence-based practice of biofeedback and neurofeedback in various medical conditions, including headache, hypertension and TMJ syndrome.

Guided Imagery

Broadbent E, Kahokehr A, Booth RJ, Thomas J, Windsor JA, Buchanan CM, Wheeler BRL, Sammour T, Hill AG. A brief relaxation intervention reduces stress and improves surgical wound healing response: A randomized trial. Brain, Behavior and Immunity. 2012; 26:212-217. Study demonstrating a 45 minute relaxation and guided imagery intervention used daily for 3 days pre and 7 days post operatively increased wound healing as measured by hydroxyproline wound deposition post laparoscopic cholecystectomy.

Broadbent E, Koschwanez HE. The psychology of wound healing. Curr Opin Psychiatry. 2012 Mar;25(2):136-40. doi: 10.1097/YCO.0b013e32834e1424. Psychological interventions such as guided imagery and relaxation techniques can reduce stress and negative mood states and improve wound healing, as shown in 2 studies using biological markers.

Cohen L, Parker PA, Vence L, Savary C, Kentor D, Pettaway C, Babaian R, Pisters L, Miles B, Wei Q, Wiltz L, Patel T, Radvanyi L. Presurgical stress management improves postoperative immune function in men with prostate cancer undergoing radical prostatectomy. Psychosom Med 2011; 73:218 – 225. A brief, low-cost stress management intervention consisting of guided imagery and breathing exercises delivered to men undergoing surgery for prostate cancer was shown to decrease presurgical mood disturbance and boost postsurgical immune function, as demonstrated by biological markers.

Yoga

Aboagye E, Karlsson ML, Hagberg J, Jensen I. Cost-effectiveness of early interventions for non-specific low back pain: A Randomized Controlled Study Investigating Medical Yoga, Exercise Therapy and Self-Care Advice. J Rehabil Med 2015;47:167-173. European RCT demonstrating 6 weeks of medical yoga therapy is a cost- effective early intervention for non-specific low back pain.

Broderick J, Knowles A, Chadwick J, Vancampfort D. Yoga versus standard care for schizophrenia. Cochrane Database of Systematic Reviews 2015;(10)Art.No:CD010554.DOI:10.1002/14651858.CD0 10554.pub2. Cochrane review reporting positive evidence of yoga vs. standard-care control in patients with schizophrenia, but study quality limitations makes it difficult to form strong conclusions.

Coeytaux RR, McDuffie J, Goode A, Cassel S, Porter WD, Sharma P, Meleth S, Minnella H, Nagi A, Williams Jr JWW. Evidence Map of Yoga for High Impact Conditions Affecting Veterans. VA ESP Project #09-010;2014. Review of systematic reviews, showing yoga was helpful in improving low back pain and depression, although studies looking at depression had a high risk of bias.

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Cohen, L., Warneke, C., Fouladi, R. T., Rodriguez, M. A. and Chaoul-Reich, A. Psychological adjustment and sleep quality in a randomized trial of the effects of a Tibetan yoga intervention in patients with lymphoma. Cancer 2004;100: 2253–2260. doi: 10.1002/cncr.20236 Randomized control trial of lymphoma patients demonstrated yoga improved sleep quality and decreased sleep medication usage as compared to a control group.

Cramer H, Lauche R, Heller H, Steckhan N, Michalsen A, Dobos G. Effects of yoga on cardiovascular disease risk factors: A systematic review and meta-analysis. International Journal of Cardiology 2014;(173):170-183. Systematic review and meta-analysis reported yoga improved systolic and diastolic blood pressure, waist circumference, waist/hip ratio, total cholesterol, HDL, VLDL, triglycerides, HbA1c, and insulin resistance, although there were methodological drawbacks of many of the studies. The authors recommend yoga as an ancillary intervention for the general population and for patients with increased risk of cardiovascular disease.

Cramer H, Posadzki P, Dobos G, Langhorst J. Yoga for asthma: A systematic review and meta-analysis. Ann Allergy Asthma Immunol 2014;112:503-510. Systematic review and meta-analysis concluding there’s insufficient evidence to support the routine use of yoga for asthmatic patients, although it could be considered an ancillary intervention or alternative to breathing exercises.

Haaz S, Bartlett SJ. Yoga for Arthritis: A Scoping Review. Rheum Dis Clin N Am 2011(37):33-46. Review article of studies using yoga for arthritis, showing reduced tender/swollen joints, pain, disability and improved self- efficacy and mental health, with no adverse events reported.

Hartley L, Dyakova M, Holmes J, Clarke A, Lee MS, Ernst E, Rees K. Yoga for the primary prevention of cardiovascular disease. Cochrane Database of Systematic Reviews 2014, Issue 5. Art. No.: CD010072. DOI: 10.1002/14651858.CD010072.pub2. Cochrane reviewing reporting yoga has favorable effects on diastolic blood pressure, HDL cholesterol and triglycerides, but the authors considered the results as exploratory as the studies were small, short term and of limited quality.

Lazaridou A, Philbrook, P, Tzika AA. Yoga and Mindfulness as Therapeutic Interventions for Stroke Rehabilitation: A Systematic Review, Evidence-Based Complementary and Alternative Medicine 2013; Article ID 357108, 9 pages. doi:10.1155/2013/357108 Systematic review showing yoga and mindfulness could be clinically helpful in stroke rehabilitation, showing improvements in cognition, mood, balance and stress reduction, but further research is necessary.

Massey PB. Prescribing Movement Therapies. In Integrative Medicine, 3rd ed. Ed: Rakel D. Elsevier Saunders 2013:826-827. Textbook chapter describing the history, theory and clinical applications of yoga.

National Center for Complementary and Integrative Health (NCCIH), https://nccih.nih.gov/health/yoga, Accessed 11/13/15. NIH branch dedicated to Integrative Health, estimates that 6% of American adults – more than 13 million people - used yoga for health purposes in the previous 12 months.

National Center for Complementary and Integrative Health (NCCIH): https://nccih.nih.gov/news/ multimedia/infographics/yoga, accessed November 15, 2015. Diagrams describing yoga usage patterns, recommendations for safety and impact on low back pain.

Panebianco M, Sridharan K, Ramaratnam S. Yoga for epilepsy. Cochrane Database of Systematic Reviews 2015, Issue 5. Art. No.: CD001524. DOI: 10.1002/14651858.CD001524.pub2. Cochrane systematic review showing some positive effect of yoga on seizure disorders, but authors recommend yoga as an additional treatment to medications, and not as the sole method of treatment.

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Sabina AB, Williams AL, Wall HK, Banal S, Chop G, Katz DL. Yoga intervention for adults with mild-to moderate asthma: A pilot study. Ann Allergy Asthma Immunol 2005;94(5):543-8. RCT demonstrating Avenger yoga conferred no appreciable benefit in patients with mild-to-moderate asthma vs. a stretching control condition.

Sinai, M. (2013), Yoga Spinal Flexion Positions and Vertebral Compression Fracture in Osteopenia or Osteoporosis of Spine: Case Series. Pain Practice, 13: 68–75. doi: 10.1111/j.1533-2500.2012.00545.x Clinical report warning of yoga-induced vertebral compression fractures in patients with osteopenia and osteoporosis, specifically related to spinal flexion postures.

Verrastro G. Yoga as therapy: When is it helpful? Journal of Family Practice 2014;(63)9:6 pages. Author reports good evidence supporting the use of yoga for low back pain, depression and anxiety, and fair evidence for its use in asthma, menopausal symptoms, hypertension and balance improvement. Includes helpful information on how to find a yoga instructor and information on instructor training.

Tai Chi and Qi Gong

American Tai Chi and Qigong Association: The Overview of Tai Chi. Supreme Chi Living, An Online Journal. http://www.americantaichi.net/TaiChiOverview.asp. Accesses November 12, 2015. Defines and describes Tai Chi as a mind-body practice where a practitioner moves the body slowly and gently while breathing deeply and meditating, explaining this is why Tai Chi is sometimes called “moving meditation.”

Hempel S, Taylor SL, Solloway M, Miake-Lye IM, Beroes JM, Shanman R, Shekelle PG. Evidence Map of Tai Chi. VA Evidence- based Synthesis Program (ESP) Project #ESP 05-226;2014. Comprehensive review of Tai Chi systematic reviews published before 2014, reporting the strongest positive effect occurs in fall prevention, hypertension, and cognitive performance, although osteoarthritis, pain, balance confidence, depression, COPD, and muscle strength also seem to be improved.

Huang Y, Liu X. Improvement of balance control ability and flexibility in the elderly Tai Chi Chuan (TCC) practitioners: A systematic review and meta-analysis. Archives of Gerontology and Geriatrics 2015; 60:233-238. Systematic review and meta-analysis reporting Tai Chi Chuan increases balance control ability and flexibility, postulating these effects may be why TCC improves fall prevention in the elderly.

Massey PB. Prescribing Movement Therapies. In Integrative Medicine, 3rd ed. Ed Rakel D. Elsevier Saunders 2013:823-824. Summary of Tai Chi in the context of an “internal” martial art, including evidence for its use in clinical conditions, description of practice, certification and the absence of state or federal license regulations.

National Center for Complementary and Integrative Health. https://nccih.nih.gov/taxonomy/term/249 Accessed February 2, 2016. NCCIH website describing Qi Gong as a discipline from traditional Chinese Medicine that combines gentle physical movements, mental focus and deep breathing.

National Qigong Association. What is Qigong? http://nqa.org/about-nqa/what-is-qigong/ Accessed November 12,2015. Defines Qigong as an ancient Chinese health system that integrates physical postures, breathing techniques and focused intention.

Ni X, Liu S, Lu F, Shi X, Guo X. Efficacy and safety of Tai Chi for Parkinson’s Disease: A systematic review and meta-analysis of randomized controlled trials. PLoS ONE 9(6):e99377. June 2014. doi:10.1371/journal.pone.0099377 Systematic review and meta-analysis reporting improvements in mobility and balance in patients with Parkinson’s Disease practicing Tai Chi.

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Energy-Based Approaches

Rindfleisch JA. Human Energetic Therapies In Rakel D, ed. Integrative Medicine, 3rd ed. Elsevier Saunders 2013:980-987. Textbook chapter cataloguing energy based therapies.

Acupuncture

Ezzo J, Richardson MA, Vickers A, Allen C, Dibble S., Issell BF, Lao L, Pearl M, Ramirez G, Roscoe JA, Shen J, Shivnan JC, Streitberger K, Treish I, Zhang G. Acupuncture-point stimulation for chemotherapy-induced nausea or vomiting (Review). Cochrane Database of Systematic Reviews, 2006, vol 2. Cochrane review adding to literature supporting acupuncture use in postperative nausea and vomiting, by reporting electroacupuncture is effective for chemotherapy induced acute vomiting. Acupressure is also effective in the treatment of acute nausea due to chemotherapy.

Hempel S, Taylor SL, Solloway MR, Miake-Lye IM, Beroes JM, Shanman R, Booth MJ, Siroka AM, Shekelle PG. Evidence Map of Acupuncture. VA Evidence-Based Synthesis Program (ESP) Center Project #05-226;2013. Complex, extensive review of 183 systematic reviews and recent large acupuncture trials since 2005, showing evidence of a positive effect for acupuncture for the treatment of chronic pain, headache, and migraine headache and evidence of a potential positive effect in dysmenorrhea, osteoarthritis, cancer pain, labor pain, insomnia, smoking cessation, postoperative nausea and vomiting, depression and schizophrenia, amongst other conditions.

Kavoussi B, Ross BE. The neuroimmune basis of anti-inflammatory acupuncture. Integrative Cancer Therapies 2007;6(3):251-257. Review article presenting evidence that the anti-inflammatory actions of acupuncture are mediated via the reflexive central inhibition of the immune system.

Linde K, Allais G, Brinkhaus B, Manheimer E, Vickers A, White AR. Acupuncture for migraine prophylaxis. Cochrane Database of Systematic Reviews, 2009. DOI: 10.1002/14651858.CD001218. pub2. Cochrane review reporting acupuncture is of benefit in acute migraine attacks and in routine care, and that acupuncture has fewer adverse effects and is at least as effective as – and perhaps more effective than - routine care for migraine prophylaxis.

Linde K, Allais G, Brinkhaus B, Manheimer E, Vickers A, White AR. Acupuncture for tension-type headache. Cochrane Database of Systematic Reviews, 2009. DOI: 10.1002/14651858.CD007587. Cochrane review reporting acupuncture is effective in the treatment of tension headaches.

Michelfelder AJ. Acupuncture for headache. In Rakel D, ed. Integrative Medicine, 3rd ed. Philadelphia: Elsevier Saunders, 2012:950-955. Chapter in comprehensive Integrative Medicine textbook reviewing acupuncture in general, as well as in the treatment of headache.

Ng SS, Leung WW, Mak TW, Hon SS, Li JC, Wong CY, Tsoi KK, Lee JF. Electroacupuncture reduces duration of postoperative ileus after laparoscopic surgery for colorectal cancer. Gastroenterology. 2013;144:307–313.e1. This is the largest study published to date evaluating the use of electro-acupuncture for reducing post-operative ileus and length of hospital stay after laparoscopic surgery for colorectal cancer.

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Pennick V, Liddle SD. Interventions for preventing and treating pelvic and back pain in pregnancy. Cochrane Database of Systematic Reviews 2013. DOI: 10.1002/14651858.CD001139.pub3. Cochrane review reporting acupuncture is helpful in preventing and treating pelvic and back pain in pregnancy.

Sun Y, Gan TJ, Dubose JS, Habib AS. Acupuncture and related techniques for postoperative pain: A systematic review of randomized controlled trials. Br J Anaesth 2008;101(2):151-60. Systematic review of RCTs demonstrating acupuncture decreased postoperative pain, opioid consumption, nausea, dizziness, sedation, pruritis and urinary retention.

Trinh K, Graham N, Gross A, Goldsmith CH, Wang E, Cameron IA, Kay TM, Cervical Overview Group. Acupuncture for neck disorders. Cochrane Database of Systematic Reviews 2006. DOI: 10.1002/ 14651858.CD004870.pub3. Cochrane review reporting that acupuncture was helpful in the treatment of chronic neck pain.

Vickers AJ, Cronin AM, Maschino AC, Lewith G, MacPherson H, Foster NE, Sherman KJ, Witt CM, Linde K. Acupuncture for Chronic Pain. Arch Intern Med. 2012; 172(19):1444-1453. Meta-analysis reporting acupuncture is effective in the treatment of chronic pain.

World Health Organization. Acupuncture: Review and Analysis of Reports on Controlled Clinical Trials. Available at: http://apps.who.int/medicinedocs/pdf/s4926e/s4926e.pdf. Accessed 9/25/2015. Controversial WHO 2003 report listing over 100 indications for acupuncture.

Craniosacral Therapy (CST)

Castro-Sánchez AM, Matarán-Peñarrocha GA, Sánchez-Labraca N, Quesada-Rubio JM, Granero-Molina J, Moreno-Lorenzo C. A randomized controlled trial investigating the effects of craniosacral therapy on pain and heart rate variability in fibromyalgia patients. Clinical Rehabilitation 2011; 25(1):25-35. doi: 10.1177/0269215510375909. RCT demonstrating craniosacral therapy improved medium-term pain symptoms in patients with fibromyalgia.

Elden H, Östgaard HC, Glantz A, Marciniak P, Linnér AC, Olsén MF. Effects of craniosacral therapy as adjunct to standard treatment for pelvic girdle pain in pregnant women: a multicenter, single blind, randomized controlled trial. Acta obstetricia et gynecologica Scandinavica 2013; 92(7):775-82. doi: 10.1111/aogs.12096. RCT showing craniosacral therapy improved morning pain symptoms in pregnant women with pelvic girdle pain, although treatment effects were small.

Haller H, Lauche R, Cramer H, Rampp T, Saja FJ, Ostermann T, Dobos G. Craniosacral therapy for the treatment of chronic neck pain: A randomized sham-controlled trial. Clin J Pain 2015 Sep3. [epub ahead of print] RCT demonstrating craniosacral therapy was better than sham for neck pain and may improve functional disability and quality of life up to 3 months post intervention.

Matarán-Peñarrocha GA, Castro-Sánchez AM, Garcia GC, Moreno-Lorenzo C, Carreño TP, Zafra MD. Influence of craniosacral therapy on anxiety, depression and quality of life in patients with fibromyalgia. Evidence-based Complementary and Alternative Medicine: eCAM 2011; 2011:178769. doi: 10.1093/ecam/nep125. Craniosacral therapy improves anxiety and quality of life in patients with fibromyalgia.

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Upledger JE. Craniosacral therapy. Founder’s review in Seminars in Integrative Medicine December 2004;2(4):159-166. Informative article by the founder of craniosacral therapy, explaining the underlying theory and anatomy behind it.

Reiki

Bowden D, Goddard L, Gruzelier J. A randomized controlled single-blind trial of the efficacy of Reiki at benefitting mood and well-being. Evidence Based Complementary Alternative Medicine 2011; DOI: 10.1155/2011/381862. RCT demonstrating Reiki decreased stress and anxiety and improved mood.

Cuneo CL, Curtis Cooper MR, Drew CS, Naoum-Heffernan C, Sherman T, Walz K, Weinberg J. The effect of Reiki on work-related stress of the registered nurse. Journal of Holistic Nursing 2011; 29(1):33-43. doi: 10.1177/0898010110377294. Study demonstrating Reiki reduced work related stress in participating nurses.

National Center for Complementary and Integrative Health. https://nccih.nih.gov/health/reiki/ introduction.htm. Accessed December 5, 2015. NIH institute website defining Reiki and reporting scientific studies have not conclusively proved that Reiki is effective in any condition, although it’s been studied in pain, anxiety, fatigue and depression.

Olson K, Hanson J. Using Reiki to manage pain: a preliminary report. Cancer Prevention and Control 1997; 1(2): 108-13. A pilot study of 20 volunteers showing Reiki improved pain relief.

Thrane S, Cohen SM. Effect of Reiki therapy on pain and anxiety in adults: An in-depth literature review of randomized trials with effect size calculations. Pain Management Nursing 2014; 15(4): 897-908. DOI: 10.1016/j.pmn.2013.07.008. Review suggesting Reiki may be effective in reducing pain and anxiety, but additional study is necessary to make stronger recommendations.

Vitale AT, O’Connor PC. The effect of Reiki on pain and anxiety in women with abdominal hysterectomies: A quasi-experimental pilot study. Holistic Nursing Practice 2007; 20(6): 263-72. Study reporting patients receiving Reiki post-hysterectomy has decreased pain, anxiety and required less pain medication.

Therapeutic and Healing Touch

Hammerschlag R, Marx BL, Aickin M. Nontouch Biofield Therapy: A systematic review of human randomized controlled trials reporting use of only nonphysical contact treatment. The Journal of Alternative and Complementary Medicine 2014;20(12):881-892. Systematic review of biofield therapies using nonphysical touch treatments (external Qi Gong, Healing Touch, Reiki and Therapeutic Touch) unable to draw robust conclusions due to type and quality of studies. However, beneficial results were found in anxiety, depression, stress, mood, increased heart rate variability and pain.

Healing Touch International website. http://www.healingtouchinternational.org/, Accessed December 5, 2015. Website describing healing touch, its benefits, training and certification process.

Marletta G, Canfora A, Roscani F, Cernicchiaro L, Cutrera M, Russo M, Artioli G, Sarli L. Complementary medicine (CAM) for the treatment of chronic pain: Scientific evidence regarding the effects of healing touch massage. Acta Biomed for Health Professions 2015;86(supl 2):127-133. Review article suggesting healing touch could be

© 2016 MedStar Institute for Innovation 103 helpful in patients with pain, anxiety and fatigue, although firm conclusions cannot be drawn secondary to study limitations.

Therapeutic Touch website. www.therapeutictouch.org/, Accessed December 5, 2015. Website describing therapeutic touch, its benefits and training programs.

Body-Based Approaches

Massage

Armstrong K, Dixon S, May S, Patricolo GE. Anxiety reduction in patients undergoing cardiac catheterization following massage and guided imagery. Complement Ther Clin Pract 2014;Nov;20(4):334-8. This study indicates providing massage or massage with guided imagery prior to cardiac catheterization reduces anxiety.

Cherkin DC, Sherman KJ, Kahn J, Wellman R, Cook AJ, Johnson E, et al. A Comparison of the Effects of 2 Types of Massage and Usual Care on Chronic Low Back Pain: A Randomized, Controlled Trial. Ann Intern Med. 2011;155:1- 9. RCT demonstrating structural and relaxation massage improved pain in disability in patients with chronic low back pain.

Field T., Henteleff T., Hernandez-Reif M., et al.: Children with asthma have improved pulmonary functions after massage therapy. J Pediatr 1998;132:854-858. RCT demonstrating children undergoing massage therapy had decreased anxiety, improved airway caliber and improved control of asthma.

Furlan AD, Giraldo M, Baskwill A, Irvin E, Imamura M. Massage for low-back pain. Cochrane Database of Systematic Reviews 2015, Issue 9. Art. No.: CD001929. DOI: 10.1002/14651858.CD001929.pub3. Cochrane review observing short term functional improvement in sub-acute and chronic low back pain compared to inactive controls when undergoing massage therapy.

Hansen NV, Jørgensen T, Ørtenblad L. Massage and touch for dementia. Cochrane Database of Systematic Reviews 2006, Issue 4. Art. No.: CD004989. DOI: 10.1002/14651858.CD004989.pub2. Cochrane Review reporting a limited evidence base for the use of massage and touch in patients with dementia, and call for more research to provide definitive evidence.

Hernandez-Reif M, Ironson G, Field T, Hurley J, Katz G, Diego M, Weiss S, Fletcher MA, Schanberg S, Kuhn C, Burman I. Breast cancer patients have improved immune and neuroendocrine functions following massage therapy. Journal of Psychosomatic Research 2004;57(1):45-52. RCT demonstrating patients with Stage 1 or 2 breast cancer undergoing massage postoperatively had reduced depression, anxiety and anger, and improved immune function.

Hillier SL, Louw Q, Morris L, Uwimana J, Statham S. Massage therapy for people with HIV/AIDS. Cochrane Database of Systematic Reviews 2010, Issue 1. Art. No.: CD007502. DOI: 10.1002/14651858.CD007502.pub2. Authors report some evidence to support the use of massage therapy to improve quality of life for people living with HIV/AIDS, especially in combination with other stress management modalities, and it may have a positive effect on immune function.

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Hou WH, Chiang PT, Hsu TY, Chiu SY, Yen YC. Treatment Effects of Massage Therapy in Depressed People: A Meta-Analysis. J Clin Psychiatry 2010;71(7):894-901. Meta-analysis reporting massage improves depressive symptoms.

Khilnani S, Field T, Hernandez-Reif M, Schanberg S. Massage therapy improves mood and behavior of students with attention-deficit/hyperactivity disorder. Adolescence [serial online]. Winter2003 2003;38(152):623-637. Accessed December 6, 2015. RCT demonstrating massage in children with ADHD improved short-term mood state and longer-term classroom behavior.

Ko YL, Lee HJ. Randomized controlled trial of the effectiveness of using back massage to improve sleep quality among Taiwanese insomnia postpartum women. Midwifery. 2014 Jan;30(1):60-4. Massage significantly improved maternal sleep quality in the post partum period.

Lee SH, Kim JY, Yeo S, Kim SH, Lim S. Meta-Analysis of Massage Therapy on Cancer Pain. Integr Cancer Ther. 2015.Jul;14(4):297-304. Meta-analysis reporting massage is effective for cancer pain relief, especially for surgery-related pain.

Li YH, Wang FY, Feng CQ, Yang XF, Sun YH. Massage therapy for fibromyalgia: a systematic review and meta- analysis of randomized controlled trials. PLoS One. 2014. Feb 20;9(2). Systematic review and meta-analysis demonstrating massage therapy with duration ≥ 5 weeks had beneficial immediate effects on improving pain, anxiety, and depression in patients with fibromyalgia.

Liao IC, Chen SL, Wang MY, Tsai PS. Effects of massage on blood pressure in patients with hypertension and pre- hypertension: A meta-analysis of randomized controlled trials. Journal of Cardiovascular Nursing 2016;31(1):73- 83. Meta-analysis reporting medium effect of massage on systolic blood pressure and small effect on diastolic blood pressure in patients with hypertension or pre-hypertension.

Loew LM, Brosseau L, Tugwell P, Wells GA, Welch V, Shea B, Poitras S, De Angelis G, Rahman P. Deep transverse friction massage for treating lateral elbow or lateral knee tendinitis. Cochrane Database of Systematic Reviews 2014, Issue 11. Art. No.: CD003528. DOI: 10.1002/14651858.CD003528.pub2. Cochrane review showing no evidence for the use of massage therapy in knee or elbow tendinitis.

National Center for Complementary and Integrative Health, https://nccih.nih.gov/health/massage/ massageintroduction.htm#hed1. Accessed December 6, 2015. Broad summary of massage therapy, describing conditions for which it’s used, scientific evidence, and training licensing and certification.

Patel KC, Gross A, Graham N, Goldsmith CH, Ezzo J, Morien A, Peloso PMJ. Massage for mechanical neck disorders. Cochrane Database of Systematic Reviews 2012, Issue 9. Art. No.: CD004871. DOI: 10.1002/14651858.CD004871.pub4. Cochrane review unable to make practice recommendations of massage for mechanical neck disorders because of poor study methodology, although they noted as a stand alone treatment it provided immediate or short term effectiveness.

Perlman AI, Sabina A, Williams A, Njike V, Katz DL. Massage Therapy for Osteoarthritis of the Knee: A Randomized Controlled Trial. Arch Intern Med. 2006;166(22):2533-2538. doi:10.1001/archinte. 166.22.2533. RCT demonstrating massage in knee osteoarthritis improved pain, stiffness, physical function, range of motion and time to walk 50 feet.

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Ruotsalainen JH, Verbeek JH, Mariné A, Serra C. Preventing occupational stress in healthcare workers. Cochrane Database of Systematic Reviews 2015, Issue 4. Art. No.: CD002892. DOI: 10.1002/14651858.CD002892.pub5. Cochrane review reporting low quality evidence suggesting massage, meditation and cognitive behavioral therapy may be helpful in preventing occupational stress in healthcare workers, but call for more research in order to draw firm conclusions.

Ucuzal M, Kanan N. Foot massage: effectiveness on postoperative pain in breast surgery patients. Pain Manag Nurs. 2014;15(2):458-65. Study demonstrating foot massage in breast surgery patients was effective in postoperative pain management.

Yuan SL, Matsutani LA, Marques AP. Effectiveness of different styles of massage therapy in fibromyalgia: a systematic review and meta-analysis. Man Ther 2015;20(2):257-64. Overall, most styles of massage therapy consistently improved the quality of life of fibromyalgia patients.

Zhang Q, Sun Z, Yue J. Massage therapy for preventing pressure ulcers. Cochrane Database of Systematic Reviews 2015, Issue 6. Art. No.: CD010518. DOI: 10.1002/14651858.CD010518.pub2. Cochrane review unable to find any studies looking at massage therapy for the prevention of pressure ulcers, reporting no evidence to support or deny its effectiveness.

Chiropractic

American Chiropractic Association. https://www.acatoday.org/index.cfm. Accessed December 7, 2015. Website of the American Chiropractic Association, describing general and detailed information about chiropractic practice, research and education.

Bronfort G, Haas M, Evans R, Leininger B, Triano J. Effectiveness of manual therapies: the UK evidence report. Chiropractic and Osteopathy 2010;18:3. DOI: 10.1186/1746-1340-18-3. Systematic review reporting manipulation/mobilization is effective for acute, subacute and chronic low back pain, migraine and cervicogenic headache, cervicogenic dizziness, several joint conditions, and acute/subacute neck pain.

Bryans R, Decina P, Descarreaux M, Duranleau M, Marcoux H, Potter B, Ruegg RP, Shaw L, Watkin R, White E. Evidence-based guidelines for the chiropractic treatment of adults with neck pain. J Manipulative Physiol Ther 2014;37:42-63. Chiropractic care interventions can improve outcomes in acute and chronic neck pain, with increased benefit shown where a multimodal approach was used.

Cassidy JD, Boyle E, Cote P, He Y, Hogg-Johnson S, Silver FL MD, Bondy SJ. Risk of Vertebrobasilar Stroke and Chiropractic Care: Results of a Population-Based Case-Control and Case-Crossover Study. Spine 2008;33:S176–S183. Authors report vertebrobasilar artery (VBA) stroke after chiropractic and primary care physician (PCP) visits is the same, and suggest that headache and neck pain from VBA dissection is what brings patients to seek care before to their stroke.

Ernst E. Chiropractic: A Critical Evaluation. Journal of Pain and Symptom Management 2008;35(5):544-562. Critical review of chiropractic reporting that with the exception of back pain, chiropractic spinal manipulation has not been shown to be effective for any medical condition, and it may have adverse effects.

Gouveia LO, Castanho P, Ferreira JJ. Safety of chiropractic interventions: A systematic review. Spine 2009;34:E405–E413. Systematic review concluding there is no robust data concerning the incidence or prevalence of adverse reactions to chiropractic interventions, and calls for urgently needed investigations.

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Gross AR, Hoving JF, Haines TA, Goldsmith CH, Kay T, Aker P, Bronfort G, Cervical Overview Group. A Cochrane Review of Manipulation and Mobilization for Mechanical Neck Disorders. Spine 2004;29:1541–1548. Cochrane review reporting mobilization and/or manipulation when used with exercise are beneficial for persistent mechanical neck disorders, but without exercise, they were not effective.

National Center for Complementary and Integrative Health (NCCIH)website, section on Chiropractic. https://nccih.nih.gov/health/chiropractic/introduction.htm. Accessed December 6,2015. NCCIH website describing an overview of chiropractic, including its use, evidence and safety.

Walker BF, French SD, Grant W, Green S. A Cochrane review of combined chiropractic interventions for low back pain. Spine 2011;36:230–242. Cochrane review reporting slightly improved pain and disability in the short term and pain in the mid-term in patients with low back pain undergoing combined chiropractic interventions, but authors claim these effects are too small to be clinically relevant.

Biologically-Based Approaches

Supplements

Clark TC, Black LI, Stussman BJ, Barnes PM, Nahin RL. Trends in the use of complementary health approaches among adults: United States, 2002-2012. US Department of Health and Human Services, Centers for Disease Control and Prevention, National Center for Health Statistics. National Health Statistics Reports, Number 79, Feb 10, 2015. Comprehensive governmental report comparing national estimates of complementary health approach usage between 2002, 2007 and 2012. Nonvitamin, nonmineral dietary supplements were most commonly used, and Yoga, Tai Chi and Qi gong use increased over this decade.

Consumer Lab. https://www.consumerlab.com/Accessed December 5, 2015. Independent resource, which has tested more than 4400 products, identifying the best quality health and nutrition products for consumers and health care providers.

Herman PM, Poindexter BL, Witt CM, Eisenberg DM. Are complementary therapies and integrative care cost- effective? A systematic review of economic evaluations. BMJ Open 2012;2:e001046. Doi:10.1136/bmjopen- 2012-001046 Comprehensive rigorous systematic review of cost-effectiveness of complementary and integrative therapies identifying emerging evidence of cost-effectiveness and possible cost savings with acupuncture in patients with acute and chronic low back pain, headache, neck pain, hip and knee osteoarthritis, and allergic rhinitis. Cost-effectiveness with possible cost savings was also found in patients undergoing spinal manipulation and chiropractic treatment in back pain. Omega -3 Fatty Acid supplementation was found to decrease costs in men with a history of heart attacks by decreasing fatal heart attacks and other cardiovascular deaths.

National Center for Complementary and Integrative Health (NCCIH) website. https://nccih.nih.gov/ health/supplements. Accessed December 5, 2015. NIH institute website dedicated in Integrative Medicine, describing supplements, with information about 95 nonvitamin nonmineral supplements.

Natural Medicines Comprehensive Database. http://naturaldatabase.com. Accessed December 5, 2015. Extensive database of 1300 substances used to formulate >91,000 products, with descriptions of uses, effectiveness, safety, and level of scientific evidence supporting its use.

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US Food and Drug Administration (FDA) website. http://www.fda.gov/Drugs/DevelopmentApproval Process/Manufacturing/ucm169105.htm. Accessed December 5, 2015. FDA website defining current good manufacturing practice for dietary supplements.

US Pharmacopeial Convention (USP) website. http://www.usp.org/usp-verification-services/usp-verified-dietary- supplements. Accessed December 5, 2015. Website of scientific nonprofit organization that sets standards for the identity, strength, quality and purity of medicines, food ingredients and supplements.

Aromatheraphy

Marchand LR. End-of-Life Care in Integrative Medicine, 3rd edition, Rakel D, ed. Philadelphia: Elsevier Saunders, 2012:749. Chapter in definitive IM textbook, discussing various uses of integrative approaches in palliative care, including aromatherapy.

Smith CA, Collins CT, Crowther CA. Aromatherapy for pain management in labour. Cochrane Database of Systematic Reviews 2011, Issue 7. Art. No.: CD009215. DOI: 10.1002/14651858.CD009215. This review found only 2 articles looking at aromatherapy in labor pain, and determined there was insufficient data to make any recommendations.

Whole Systems of Health

Traditional Chinese Medicine (TCM)

Australian Acupuncture and Chinese Medicine Association, Ltd. http://www.acupuncture.org.au/ Health_Services/Traditional_Chinese_Medicine.aspx In Australia, acupuncture and Chinese herbal medicine are the 2 most commonly used therapies of Traditional Chinese Medicine (TCM), which is a primary health care system including exercise, diet, lifestyle advice and breathing exercises.

Helms JM. Acupuncture Energetics: A Clinical Approach for Physicians. Medical Acupuncture publishers, Berkeley, CA, 1995. Comprehensive textbook used to teach physicians the basics of Medical Acupuncture and some aspects of Chinese Traditional Medicine.

National Center for Complementary and Integrative Health website, Traditional Chinese Medicine. https://nccih.nih.gov/health/whatiscam/chinesemed.htm. NCCIH website describing key points, background, safety issues and references regarding Traditional Chinese Medicine.

Ayurveda

Cameron M, Chrubasik S. Oral herbal therapies for treating osteoarthritis. Cochrane Database of Systematic Reviews 2014, Issue 5. Art. No.: CD002947. DOI: 10.1002/14651858.CD002947.pub2. Cochrane review showing Piasclidine – a proprietary product of avocado soyabean unsaponifiables – improved pain relief in osteoarthritis, and Boswellia serrata showed trends of improvement, and warrants further investigation.

National Center for Complementary and Integrative Health, Ayurveda. https://nccih.nih.gov/health/ ayurveda/introduction.htm#hed4. NCCIH website describing key points, background, safety issues and references regarding Ayurveda.

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Saper RB, Kales SN, Sehgal A, Khouri N, Davis RB, Paquin J, Thuppil V, Kales SN. Lead, mercury and arsenic in US and Indian-manufactured Ayurvedic medicines sold via the Internet. JAMA 2008;300(8):915-23. doi:10.1001/jama.300.8.915. Study reporting 20% of Ayurvedic medicines contained lead, mercury or arsenic in amounts that exceeded standards for acceptable daily intake of toxic metals.

Naturopathy

Ahmad A, Ginnebaugh KR, Li Y, Padhye SB, Sarkar FH. Molecular targets of naturopathy in cancer research: Bridge to modern medicine. Nutrients 2015, 7(1), 321-334; doi:10.3390/nu7010321. Article defines naturopathy as the practice of medicine for the treatment of human diseases with natural agents.

Litchy AP. Naturopathy physicians: Holistic primary care and integrative medicine specialists. Journal of Dietary Supplements 2011;8(4):369-377. Article describing the principles of naturopathic medicine, which includes recognizing the healing power of nature, emphasizing prevention, finding the root cause of illness, and treating the whole person.

National Center for Complementary and Integrative Health, Naturopathy. https://nccih.nih.gov/health/ naturopathy. Accessed December 7, 2015. NCCIH website describing education, licensure and how naturopaths practice.

Homeopathy

Belon P, Cumps J, Ennis M, Mannaioni PF, Sainte-Laudy J, Roberfroid M, Wiegant FAC. Inhibitions of human basophil degranulation by successive histamine dilutions: Results of a European multicentre trial. Inflammation Research 1999;48(1):17-18. Multicenter trial demonstrating that extremely dilute concentrations of histamine – such that mathematically no histamine molecule remain – inhibited human basophil degranulation, which is the usual response to histamine.

Boehm K, Raak C, Cramer H, Lauche R, Ostermann T. Homeopathy in the treatment of fibromyalgia—a comprehensive literature-review and meta-analysis. Complementary Therapies in Medicine 2014; 22(4):731-742. Review suggesting homeopathy may be of benefit in fibromyalgia, although these are preliminary conclusions.

Fisher P, Ernst E. Should doctors recommend homeopathy? BMJ 2015;351:h3735 doi:10.1136/ bmj.h3735. Discussion regarding controversy over whether homeopathic remedies work and if they should be recommended.

Fixsen A. Should homeopathy be considered as part of a treatment strategy for otitis media with effusion in children? Homeopathy 2013; 102(2): 145-150. Several trials and studies looking at homeopathy in otitis media suggest it is helpful, although the volume of data is small.

Heirs M, Dean ME. Homeopathy for attention deficit/hyperactivity disorder or hyperkinetic disorder. DOI: 10.1002/14651858.pub2. Little evidence of any benefit of homeopathy in ADHD was found.

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Kassab S, Cummings M, Berkovitz S, van Haselen R, Fisher P. Homeopathic medicines for adverse effects of cancer treatments. Cochrane Database of Systematic Reviews 2009, Issue 2. Art. No.: CD004845. DOI: 10.1002/14651858.CD004845.pub2. Preliminary data supports the efficacy of topical calendula for prophylaxis of acute dermatitis during radiation therapy and Traumeel S mouthwash in the treatment of chemotherapy- induced stomatitis.

Mathie RT, Frye J, Fisher P. Homeopathic Oscillococcinum® for preventing and treating influenza and influenza- like illness. Cochrane Database of Systematic Reviews 2015, Issue 1. Art. No.: CD001957. DOI: 10.1002/14651858.CD001957.pub6. Cochrane review reporting insufficient good evidence to enable robust conclusions about Oscillococcinum® in the prevention or treatment of influenza and influenza-like illness, secondary to low quality of eligible studies.

McCarney RW, Linde K, Lasserson TJ. Homeopathy for chronic asthma. Cochrane Database of Systematic Reviews 2004, Issue 1. Art. No.: CD000353. DOI: 10.1002/14651858.CD000353.pub2. Insufficient evidence exists to recommend the use of homeopathy in the treatment of asthma.

National Center for Complementary and Integrative Health, Homeopathy. https://nccih.nih.gov/ health/homeopathy. Accessed December 8, 2015. NCCIH website describing the key points, overview, research, side effects and risks of homeopathy.

Peckham EJ, Nelson EA, Greenhalgh J, Cooper K, Roberts ER, Agrawal A. Homeopathy for treatment of irritable bowel syndrome. Cochrane Database of Systematic Reviews 2013, Issue 11. Art. No.: CD009710. DOI: 10.1002/14651858.CD009710.pub2. Pooled analysis of 2 small studies suggests possible benefit for clinical homeopathy using the remedy asafetida over placebo for constipation-predominant IBS.

Rada G, Capurro D, Pantoja T, Corbalán J, Moreno G, Letelier LM, Vera C. Non-hormonal interventions for hot flushes in women with a history of breast cancer. Cochrane Database for Systematic Reviews 2010, Issue 9. Art. No.: CD004923. DOI: 10.1002/14651858.CD004923.pub2. No benefit was seen with homeopathic treatment of hot flashes in breast cancer patients, but only one RCT was included in the analysis.

Rutten ALB, Stolper DF. The 2005 meta-analysis of homeopathy: the importance of post-publication data. Homeopathy 2008;97(4):169-177. Authors report that post publication data analysis of 2005 meta-analysis does not support the conclusion that homeopathy is a placebo effect.

Shang A, Huwiler-Muntener K, Nartey L, Juni P, Dorig S, Sterne JAC, Pewsner D, Egger M. Are the clinical effects of homeopathy placebo effects? Comparative study of placebo-controlled trials of homeopathy and allopathy. The Lancet 2005;366(9487):726-732. Analysis of homeopathy and allopathic trials determining that the effects of homeopathy reported are more likely placebo than effects reported from allopathic medicine.

Smith CA. Homeopathy for induction of labour. Cochrane Database for Systematic Reviews 2003, Issue 4. Art. No.: CD003399. DOI: 10.1002/14651858.CD003399. Insufficient evidence to recommend the use of homeopathy in order to induce labor.

Toliopoulos IK, Simos Y, Bougiouklis D, Oikonomidis S. Stimulation of natural killer cells by homeopathic complexes: an in vitro and in vivo pilot study in advanced cancer patients. Cell Biochemistry & Function 2013; 31(8): 713-718. In vivo and in vitro pilot study demonstrating increased natural killer cell cytotoxic activity in advanced cancer patients.

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Zanasi A, Mazzolini M, Tursi F, Morselli-Labate AM, Paccapelo A, Lecchi M. Homeopathic medicine for acute cough in upper respiratory tract infections and acute bronchitis: a randomized, double-blind, placebo-controlled trial. Pulmonary Pharmacology & Therapeutics 2014; 27(1): 102-108. RCT demonstrating homeopathic cough syrup was effective in reducing cough severity and sputum viscosity in patients with URI’s and acute bronchitis.

Public Perception of Integrative Medicine

Astin JA. Why patients use alternative medicine? JAMA.1998;279(19):1548-1553.doi:10.1001/ jama. 279.19.1548. Survey results indicating individuals with more education, poorer health status, holistic orientation to health, and those with diagnoses of anxiety, back problems, chronic pain, urinary tract problems are more likely to use CAM.

Barnes PM, Bloom B, Nahin RL. Complementary and alternative medicine use among adults and children: United States, 2007. Natl Health Stat Report 2008;(12):1-23. Study reporting 38.3% of adults and 11.8% of children reported using CAM in the US in 2007.

Clark TC, Black LI, Stussman BJ, Barnes PM, Nahin RL. Trends in the use of complementary health approaches among adults: United States, 2002-2012. US Department of Health and Human Services, Centers for Disease Control and Prevention, National Center for Health Statistics. National Health Statistics Reports, Number 79, Feb 10, 2015. Comprehensive governmental report comparing national estimates of complementary health approach usage between 2002, 2007 and 2012. Nonvitamin, nonmineral dietary supplements were most commonly used, and Yoga, Tai Chi and Qi gong use increased over this decade.

Ho TF, Rowland-Seymour A, Frankel ES, Li SQ, Mao JJ. Generational differences in complementary and alternative medicine (CAM) use in the context of chronic diseases and pain: Baby boomers versus the silent generation. J Am Board Fam Med 2014;27:465-473. Study reporting baby boomers use CAM therapies significantly more often than the silent generation (43% vs. 35%), even though the silent generation reported twice as many chronic diseases and more painful conditions.

Keckley P. What do Millennials want from the healthcare system? The Health Care Blog. http://thehealthcareblog.com/blog/2014/03/18/what-do-millennials-want-from-the-healthcare-system/ Accessed December 10, 2015. Article describing how millennials want a health system that embraces mind- body therapies, embraces health food, clean air and spirituality alongside medicines.

Lazarou J, Pomeranz BH, Corey PN. Incidence of adverse drug reactions in hospitalized patients. JAMA 1998;279:1200-1205. Adverse drug reactions were found to e between the 4th and 6th most common cause of death in hospitalized patients.

Liu R, Chang A, Reddy S, Hecht FM, Chao MT. Improving patient centered care: A cross-sectional survey or prior use and interest in complementary and integrative health approaches among hospitalized oncology patients. The Journal of Alternative and Complementary Medicine 2015;00(0);1-6. Study showing that 95% of oncology inpatients were interested in having at least one complementary and integrative health approach if it was offered. Seventy seven percent were interested in nutritional counseling, 75% in massage, and 50% were interested in each of the following: acupuncture, biofeedback and mindfulness meditation.

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Nahin RL, Barnes PM, Stussman BJ, Bloom B. Costs of complementary and alternative medicine (CAM) and frequency of visits to CAM practitioners: United States, 2007. Natl Health Stat Report 2009 Jul 30;18:1-14. Analysis of CAM costs in the US in 2007, showing adults spent $33.9 billion out of pocket on visits to CAM practitioners and purchases of CAM products. Approximately 1/3 of this amount ($11.9 billion) was spend on practitioner visits, and $14.8 billion was spent on purchase of nonvitamin, nonmineral, natural products.

Rakel D, Weil A. Philosophy of Integrative Medicine, in Integrative Medicine, 3rd edition, Rakel D, ed. Philadelphia: Elsevier Saunders, 2012:2-6. Introductory chapter of comprehensive IM textbook, discussing the history and underlying philosophy of Integrative Medicine.

Reuters. “Washington area richest, most educated in US: report.” Washingtonpost.com. 2006-06-08. http://www.washingtonpost.com/wp-dyn/content/article/2006/06/08/AR2006060800133.html Retrieved 2I012-11-19. Accessed November 20, 2015. Washington post article reporting the greater Washington area has the highest household median income, more than 42% of DC area residents have a bachelor’s degree and 19% have a graduate degree.

Richardson MA, Sanders T, Palmer JL, Greisinger A, Singletary SE. Complementary/Alternative Medicine Use in a Comprehensive Cancer Center and the Implications for Oncology. J Clin Oncol 2000;18:2505-2514. Study showing 62.6% of patients with cancer used CAM approach, not including spiritual practices.

Su D, Li L. Trends in the use of complementary and alternative medicine in the United States: 2002-2007. Journal of Health Care for the Poor and Underserved 2011;22(1):296-310. Assessment of recent trends, reporting CAM use more likely in those with restricted access to conventional care. Also reports increased usage of provider based CAM, such as chiropractic care, massage and acupuncture, especially in non-Hispanic whites.

Comprehensive Review: Academic Health Systems with Integrative Medicine Programs

Coulter ID, Ellison MA, Hilton L, Rhodes HJ, Ryan G. Hospital-Based Integrative Medicine: A Case Study of the Barriers and Factors Facilitating the Creation of a Center. Rand Corporation, 2008. Comprehensive review a California IM Center’s 2001 failure. Reasons cited for its closure include false assumptions regarding patient volume, referral patterns, lack of market research and coordination amongst internal departments, and an unrealistic business plan.

The Institute for Health and Healing at Sutter Health Systems. http://www.cpmc.org/services/ihh/ Accessed February 4, 2016. Website describing the IHH’s extensive successful IM program.

Novey DW. The Business of Integrative Medicine, in Integrative Medicine, 2rd edition, Rakel D, ed. Philadelphia: Elsevier Saunders, 2007:57-70. Textbook chapter describing a stepped approach to starting an IM Center or Service.

Penny George Institute for Health and Healing. http://www.allinahealth.org/Penny-George-Institute-for-Health- and-Healing/ Accessed February 4, 2016. Website describing the PGIHH’s extensive successful IM center.

Vanderbilt’s Osher Center for Integrative Medicine website. http://www.vanderbilthealth.com/osher/ Accessed February 4, 2016. Website for highly successful IM center, describing its services.

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Descriptions of Three Successful Integrative Medicine Practices

Johnson JR, Crespin DJ, Griffin KH, Finch MD, Rivard RL, Baechler CJ, Dusek JA. The effectiveness of integrative medicine interventions on pain and anxiety in cardiovascular inpatients: a practice-based research evaluation. BMC Complement Altern Med 2014 Dec 13;14:486. doi: 10.1186/1472-6882-14-486. Large retrospective analysis of > 57,000 inpatients with cardiovascular disease, showing a 50% decrease in pain and anxiety when treated with integrative medicine interventions.

Rakel D, Jonas W. Creating Optimal Healing Environments in Integrative Medicine, 3rd edition, Rakel D, ed. Philadelphia: Elsevier Saunders, 2012. Textbook chapter describing the optimal healing environment, which includes the social, psychological, spiritual, physical and behavioral components of health care.

Evolution of National Integrative Medicine Organizations

Academic Consortium for Integrative Medicine and Health website. https://www.imconsortium.org/ Accessed December 14, 2015. Website of national organization of academic institutions and health systems whose goal is to advance the development of IM through education, research, clinical care and informing health policy.

Academy of Integrative Health and Medicine website. https://aihm.org/Accessed December 14, 2015. Website of international, interprofessional member-centric organization that educates and trains clinicians in integrative health and medicine.

American Board of Physician Specialties. http://www.abpsus.org/integrative-medicine-eligibility Accessed December 14, 2015. Website of the ABPS describing IM board eligibility and process to become board certified.

National Center for Complementary and Integrative Health. https://nccih.nih.gov/ Website of one of NIH’s Institutes, with $124 million in funding for 2015, whose mission is to define, through rigorous scientific investigation, the usefulness and safety of integrative health interventions and their roles in improving health and health care.

Integrative Medicine Centers in the Greater Baltimore-Washington Region

Center for Integrative Medicine at the University of Maryland School of Medicine. http://www. compmed.umm. edu/default.asp. Accessed December 14, 2015. University of Maryland’s Center for Integrative Medicine website describing its broad research experience, as well as education and clinical services.

Georgetown University Medical Center Master’s Degree Program in Physiology – Complementary and Alternative Medicine (CAM) website. https://cam.georgetown.edu/. Accessed December 18, 2015. Website describing Georgetown’s innovative Master’s Degree program in CAM.

GW Center for Integrative Medicine. http://www.gwcim.com/ Accesses February 4, 2016. Website describing wide array of clinical services, in addition to education and research activities.

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Johns Hopkins Integrative Medicine and Digestive Center. http://www.hopkinsmedicine.org/ integrative_medicine_digestive_center/about/. Accessed December 14, 2015. Website of IM Center embedded within the department of Gastroenterology and Hepatology at Johns Hopkins, describing its clinical, education and research programs.

Johns Hopkins Sibley Memorial Center, Cancer Integrative Health. http://www.hopkinsmedicine.org/sibley- memorial-hospital/patient-care/specialty/cancer/integrative-medicine.html Accessed February 4, 2016. Website of relatively new Integrative Health program aimed specifically towards cancer patients.

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Appendix

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Appendix 1: Levels of Evidence for Acupuncture Studies.

Source: Hempel S, Taylor SL, Solloway MR, Miake-Lye IM, Beroes JM, Shanman R, Booth MJ, Siroka AM, Shekelle PG. Evidence Map of Acupuncture. VA Evidence-Based Synthesis Program (ESP) Center Project #05-226;2013.

Levels of Evidence Criteria

Level 1: Evidence of no effect Reviews where there was evidence of no positive effect, or where results in control groups are equivocal or better than in the acupuncture group

Level 2: Unclear Evidence Conflicting results either across multiple reviews, or within a review when the authors report inconclusive results.

Level 3: Evidence of Potential Reviews show individual or pooled effects of RCTs that were positive, but the Positive Effect evidence base was insufficient to draw firm conclusions, despite the statistically significant positive treatment effect.

Level 4: Evidence of Positive Used for clinical areas with evidence of a statistically significant positive effect Effect of acupuncture, where the evidence base was sufficient to draw conclusions, thus recommending the intervention without major concerns.

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Appendix 2: Levels of Evidence for Biofeedback Studies

Source: Frank DL, Khorshid L, Kiffer JF, Moravec CS, McKee MG. Biofeedback in medicine: Who, when, why and how? Mental Health in Family Medicine 2010;7:85-91.

Levels of Evidence Criteria

Level 1: Not Empirically Supported only by non-peer reviewed anecdotal reports and/or case studies. Supported

Level 2: Possibly Efficacious Supported by at least 1 study with sufficient statistical power and outcome measures, but without randomization to a control condition.

Level 3: Probably Efficacious Supported by multiple observational, clinical, wait-list controlled, within-subject and intra-subject replication studies that demonstrate efficacy.

Level 4: Efficacious Meets all following criteria: Treatment found to be statistically significantly superior in randomized controlled study to control (no treatment, alternative treatment group, sham) or equivalent to a treatment of established efficacy with sufficient power to detect moderate differences; population studied has specific problem w/clearly delineated inclusion criteria, study used valid and clearly specified outcome measures related to the diagnosis with appropriate data analysis; diagnostic and treatment variable and procedures are clearly defined such that replication is possible by independent researchers; and the superiority or equivalence of biofeedback has been shown in at least two independent research settings

Level 5: Efficacious and Meets all Level 4 criteria, and treatment has been shown to be statistically Specific superior to credible sham therapy, pill or alternative bona fide treatment in at least two treatment settings.

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Appendix 3: Levels of Evidence for Supplements

Source: Natural Medicines Comprehensive Database. http://naturaldatabase.com. Accessed December 5, 2015.

Levels of Evidence Criteria

Level 1: Likely Ineffective High level of reliable clinical evidence showing ineffectiveness for its use for a specific indication. Individuals are typically discouraged from using this product.

Level 2: Possibly Ineffective Some clinical evidence showing ineffectiveness for a specific indication, but the evidence is limited by quantity, quality or contradictory findings. Evidence shows negative outcomes for a given indication without valid evidence to the contrary. Individuals are typically discouraged from using this product.

Level 3: Possibly Effective Some clinical evidence supporting its use for a specific indication, but the evidence is limited by quantity, quality or contradictory findings. Evidence shows positive outcomes for a given indication without valid evidence to the contrary. Product may be effective for some people, but not recommended for most.

Level 4: Likely Effective Very high level of reliable clinical evidence supporting its use for a specific indication. Evidence from multiple RCTs or meta-analysis showing positive outcomes. Products generally considered appropriate to recommend.

Level 5: Effective Very high level of reliable clinical evidence supporting its use for a specific indication. Evidence from multiple RCTs or meta-analysis showing positive outcomes, and evidence is consistent with FDA approval. Products generally considered appropriate to recommend.

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