1. Integrating Complementary and Alternative Medicine (CAM) with Allopathy Introduction to Health Care Georgetown University School of Medicine February 02, 2007 Merging old and new through Evidence Steven M. Schwartz, MD

2. Institute of Medicine: Committee Recommendation “The committee recommends that health profession schools (e.g. schools of medicine, nursing, pharmacy, and allied health) incorporate sufficient information about CAM into the standard curriculum…to enable licensed professionals to competently advise their patients about CAM.” Complementary and Alternative Medicine (CAM) in the United States Institute of Medicine Report, January 2005

3. Educational Initiative in CAM at Georgetown U School of Medicine Broad objective By the end of the project period, all graduates of Georgetown University School of Medicine will have an improved level of awareness about CAM information and practices, so that they will be able to understand and follow advances in CAM, as well as advise and communicate more effectively with their patients

4. Learning Objectives Define complementary and alternative medicine (CAM) –List domains and provide description and examples –Describe relationship to conventional medicine Describe use of CAM is the US –Prevalence of use –Characteristics of users and practitioners –Implications for clinicians Discuss strategies for evaluation and integration –Disparate paradigm –Role of evidence in CAM and Conventional –Levels of integration

5. Definitions Alternative Medicine –Used in place of conventional medicine Complementary Medicine –Used together with conventional medicine Integrative Medicine –Combines CAM and conventional medical therapies for which there is some high-quality scientific evidence of safety and effectiveness

6. Complementary and Alternative Medicine (CAM) Broad range of healing philosophies and practices not taught widely in medical schools, not generally used in hospitals, and not usually reimbursed by medical insurance companies Healing therapies that typically fall outside the Western biomedical model of disease, diagnosis, and treatment ( Drivdahl 1998 ) Conventional Medicine Allopathy/Osteopathy Disease model using pharmaceuticals and surgery as primary modes of treatment

7. The list of what is considered to be CAM changes continually as those therapies that are proven to be safe and effective become adopted into conventional health care and as new approaches to health care emerge. NCCAM 2003 Complementary and Alternative Medicine (CAM) “ Once there is evidence (for a CAM therapy) it is not alternative or complementary it is conventional” (Siwek)

8. The practice of medicine that reaffirms the importance of the relationship between practitioner and patient, focuses on the whole person, is informed by evidence, and makes use of all appropriate therapeutic approaches, healthcare professionals and disciplines to achieve optimal health and healing ( Consortium Academic Health Centers for Integrative Medicine, 2004 ) Integrative Medicine

9. CAM Domains Alternative Medical Systems Mind-Body Interventions Biological-Based Therapies Manipulative and Body-Based Methods Energy Therapies (as categorized by NCCAM, http://nccam.nih.gov)

10. CAM Domains Image removed rights unavailable ( graphic of the 5 CAM domains)

11. Whole Medical Systems Complete systems of theory and practice that have evolved independent of and prior to the conventional biomedical approach –Traditional Systems (TCM, Ayurveda, Tibetan, etc.) –Naturopathic Medicine (health restoration rather than disease treatment) –Homeopathy (“like cures like”) (as categorized by NCCAM, http://nccam.nih.gov)

12. Mind-body Interventions Techniques designed to facilitate the mind’s capacity to affect bodily function and symptoms –Meditation –Breathing techniques –Imagery –Biofeedback –Prayer and Spirituality (as categorized by NCCAM, http://nccam.nih.gov)

13. Biologically Based Therapies Includes natural and biologically-based practices, interventions, and products, many of which overlap with conventional medicine’s use of dietary supplements –Herbal therapies (plant or plant products) –Special diets (Atkins, Ornish, Pritkin) –Orthomolecular (mega-dose vitamins) –Biological therapies (shark cartilage, bee pollen) (as categorized by NCCAM, http://nccam.nih.gov)

14. Manipulative and Body - Based Methods Methods that are based on manipulation and/or movement of the body –Chiropractic –Massage Therapy –Osteopathic Medicine (as categorized by NCCAM, http://nccam.nih.gov)

15. Energy therapies Energy therapies focus on either energy fields originating within the body (biofields) or those from other sources (electromagnetic fields) –Qi Gong (TCM: combines movement, meditation and breathing) –Reiki (Japanese: channeling spiritual energy) –Therapeutic Touch (“laying of hands”) (as categorized by NCCAM, http://nccam.nih.gov)

16. Use of CAM Therapies in the US Estimates from 1990 to 1997, increase from 34% to 42% of public use CAM Visits to CAM providers (629 million) exceeded visits to primary care physicians (386 million) CAM related out-of-pocket expenditures >$27b Majority of CAM users do not reject conventional medicine, but find CAM to be more congruent with their own values, beliefs, and philosophical orientations toward health and life (Eisenberg DM et al Trends in Alternative Medicine use in the United States: 1990-1997; results of a follow-up national survey, JAMA, 1998)

17. CAM Use among Adults in US: 2002 NCCAM and CDC’s National Center for Health Statistics(Barnes et al 2004) Data from 2002 National Health Interview Survey Nationally representative sample of 31,044 US adults Questions on 27 types of CAM including 10 provider- based therapies, specific types of diets, a range of mind-body therapies, and the use of prayer for health purposes Analysis includes demographic factors, medical conditions treated, and reasons for using CAM

18. CAM Use in the United States 62% of adults used CAM in the past year More women than men; higher educated; sicker; with more pain Top 10: –43% prayed for self –24% others prayed for you –19% natural products –12% deep breathing exercises –10% participate in prayer group – 8% meditation – 8% chiropractic – 5% yoga – 5% massage – 4% diet-based therapies Barnes et al., CDC ADR, 2004

21. 0nly 17% if exclude prayer

22. Most people use CAM to treat themselves since only 12% used a licensed CAM practitioner 1.7% each for Atkins and vegetarian diets

25. CAM Use in the US 21% of patients in primary care practices reported using CAM for the same health problem for which they sought conventional care on that visit (Palinkas 2000) 16-18% of patients taking prescription medications also take herbal remedies (Kaufman 2002) Between 60 and 94% of rheumatic disease patients use CAM (Ramos-Remus 1999)

26. CAM Use in the US <40% of therapies used were disclosed to the physician Why? Because they were not asked. (Eisenberg DM et al Trends in Alternative Medicine use in the United States: 1990- 1997; results of a follow-up national survey, JAMA, 1998)

27. Why does this matter? The substantial overlap between use of prescription medications and herbal supplements raises concerns about unintended interactions. Patient use of CAM is often a clue to values and preferences that need to be acknowledged. Kaufman 2002

28. Who Uses CAM? More educated In poorer health More affluent Possess a holistic orientation to health Had a ‘transformational experience’ Identification with environmentalism, feminism, spirituality Report chronic anxiety, pain, back problems (Astin et al. JAMA,1998)

29. Why do people use CAM? Desire for health and wellness Prevention Pain control Conventional treatments not effective Paradigm/Belief system Time? Being heard? Trust?

30. Paradigm beliefs and values Conventional Disease is defined by specific pathology Organ is externally broken (congenital acquired or invaded) Dx and Tx based on grouping “diabetics” War model “Battle cancer” Physician has the cure Pt follows orders adapted from Curtis 2003 CAM The body has self- healing potential. Body mind and spirit are all important. Illness is system out of balance Therapy must be individualized. People are responsible for their own healing.

31. CAM Economics Americans spend more out-of-pocket for CAM than for all other health care needs CAM is big business 56% of Americans believe their health plans should cover CAM Many health insurers and HMOs now cover CAM: Blue Cross of Washington and Alaska, Oxford Health, Prudential, Kaiser Permanente

32. Who Provides CAM Therapies? Medical doctors CAM practitioners Traditional healers

33. Eisenberg, D.M. et al., Credentialing Complementary and Alternative Medical Providers. Ann Intern Med. 2002;137:965-973. Conventional Health Care Providers: Conventional vs. CAM Practitioners

34. Eisenberg, D.M. et al., Credentialing Complementary and Alternative Medical Providers. Ann Intern Med. 2002;137:965-973. Schools for Health Professionals

35. Consortium of Academic Health Centers for Integrative Medicine –Duke University –Harvard University –University of Arizona –UCSF –University of Maryland –University of Massachusetts –University of Minnesota –Albert Einstein College of Medicine/ Beth Israel Medical Center –Georgetown University –Thomas Jefferson University –Columbia University –University of Michigan –George Washington University –Oregon Health Sciences University –University of Calgary –UCLA –University of Hawaii –University of Medicine and Dentistry of New Jersey –University of Pennsylvania –University of Pittsburgh –University of Texas-Galveston –University of Washington –University of Connecticut –University of New Mexico –University of Alberta –Wake Forest University –Laval University –University of California at Irvine

36. State of Research in CAM Research funding at NIH FY 1992 OAM $ 2.0 M FY 1998 OAM$ 19.5 M FY 1999 NCCAM$ 50.0 M FY 2004 NCCAM $ 117.7 M Total CAM at NIH $ 273.4 M http://nccam.nih.gov

37. NCCAM R25 Grant Institutions Children’s Hospital – Boston Rush College of Nursing University of Minnesota University of North Carolina University of Texas-Galveston Georgetown University Maine Medical Center Tufts University University of Michigan University of Washington Oregon Health Sciences University U California-San Francisco University of Kentucky University of Washington School of Nursing American Medical Student Association

38. Desire for Future Training >50% of the students would like enough knowledge to personally provide their patients: –Nutritional supplements advise their patients on: –Acupuncture –Herbal medicine –Chiropractic –Massage

39. Evaluating CAM Key Conclusions  Same principles and standards of evidence of treatment effectiveness should apply to all conventional and CAM interventions  Emphasize health services research and consider ethical, legal, and social implications of CAM research and integrated medicine  Ensure rigor in CAM studies IOM Study on CAM (Jan 2005)

40. Evaluating CAM/AM Use Evidence-Based Medicine The conscientious, explicit, and judicious use of current best evidence in making decisions about the care of individual patients. The practice of evidence based medicine means integrating individual clinical expertise with the best available external clinical evidence from systematic research. Integration of best research evidence with clinical expertise and patient values.

41. Effect of Hypericum perforatum (St John's wort) in major depressive disorder: a randomized controlled trial. JAMA. 287(14):1807-14, 2002 Apr 10 “This study fails to support the efficacy of H perforatum in moderately severe major depression.” Full response occurred in 31.9% of the placebo-treated patients vs 23.9% of the H perforatum-treated patients (P =.21) and 24.8% of sertraline-treated patients (P =.26). Evidence Examples Authors conclusion: Results:

42. Against Depression, a Sugar Pill Is Hard to Beat Placebos Improve Mood, Change Brain Chemistry in Majority of Trials of Antidepressants By Shankar Vedantam Tuesday, May 7, 2002; Page A01 Evidence Examples “96 antidepressant trials between 1979 and 1996 showed that in 52 percent of them, the effect of the antidepressant could not be distinguished from that of the placebo” -Kahn

43. Moseley et al. A controlled trial of arthroscopic surgery for osteoarthritis of the knee. NEJM. 347(2):81-8, 2002 Jul 11 180 patients randomly assigned to arthroscopic debridement, arthroscopic lavage, or placebo surgery. Results:”At no point did either of the intervention groups report less pain or better function than the placebo group”. “Furthermore, the 95 percent confidence intervals for the differences …exclude any clinically meaningful difference.” Evidence Examples

44. Evidence in Allopathy Many conventional treatments have been adopted without good quality research are costly are invasive are likely to have adverse effects AND often provide inadequate relief.

45. And CAM? CAM interventions generally are low cost(?) are low-risk are free of serious side effects* AND are widely used. Evidence Growing for and against

46. CAM: Evidence and Research Some common conditions Low back pain Osteoarthritis

47. CAM: Evidence and Research Low Back Pain Current evidence for: Acupuncture Massage Spinal manipulation – acute>chronic Stress management Cherkin 2001; Ernst 2001; Furlan 2002; Astin 2004

48. CAM: Evidence and Research Low Back Pain Research in progress on Acupuncture Yoga, exercise, and self-care education Usual care vs alternatives –Acupuncture –Massage –Chiropractic www.nccam.nih.gov/clinicaltrials

49. CAM: Evidence and Research Osteoarthritis Current evidence for Acupuncture Exercise Herbal medicine (devil’s claw, willow bark) Homeopathy Supplements (glucosamine, chondroitin)

50. Graphic removed rights unavailable Grahic depicts safety on verticle efficacy on horizontal - guideline for recommendations to pts.

51. Towards Integration Ask and listen to our patients, Use best evidence Advocate for better evidence-based research Acknowledge the patient values that may be more relevant to a given individual or for a particular situation.

52. Owen 2001 Integrative Medicine Opportunity to bring together strengths and balance weaknesses of different systems of health care For the benefit of patients

53. Questions?

54. Botanicals and Dietary Supplements (Bonus material not on exam)

55. Use of Natural Products 19% of adults use natural products, including herbal medicine, functional foods (garlic), and animal-based supplements (glucosamine) during past 12 months ( Barnes et al 2004 ) Herbal therapy is used by 12-14% of the US population, up from 2.5% in 1990 ( Kaufman 2002 ) 16-18% of patients taking prescription medications also take herbal remedies

57. Challenges of Natural Products Safety is assumed, not proven Products are not standardized Contamination with drugs and heavy metals Allergic reactions Some are toxic Interactions with drugs Replacing proven therapies

58. Dietary Supplement Health and Education Act 1994 (DSHEA) Law defined a new category of food: a product intended to supplement the diet Contains one or more of the following: –Vitamin –Mineral –Herb or other botanical (not tobacco) –Amino acid –Any other dietary substance Structure-function claims permitted Product must not be intended to diagnose, treat, cure or prevent any disease

59. No requirement to prove safety or efficacy before marketing Product is considered safe, unless proven UNSAFE by FDA No regulation of manufacturing process Dietary Supplement Health and Education Act 1994 (DSHEA)

60. Issues Regarding Herbs and Dietary Supplements Effectiveness –Do they do what they say they do? Safety –Do they have side effects? Quality assurance –Are they what they say they are? Drug interactions –What do they do to other prescribed medications?

61. Strategies for integration of CAM Protect against dangerous practices. Permit practices that are harmless and that may help. Promote and use practices that are safe and effective. Partner with patients and encourage communication about CAM. Jonas 2000

62. Question: Is “permit” the right word here? Do physicians have the power to “permit” practices that their patients choose?

63. Advising patients about CAM Use evidence for efficacy safety to place therapy on continuum recommend accept discourage Weiger 2002

64. Maizes 1999 Integrative Medicine Requires a paradigm shift from Disease-centered approach of conventional biomedicine to an approach in which patient values and participation of patients are central.

65. Towards Integration The satisfaction that patients report from relationship-centered and individualized CAM therapies serves to remind us: We can never know with certainty what therapy- alternative or otherwise- will work for an particular patient, no matter what randomized controlled clinical trials indicate.