Developed by the National Network of Libraries of Medicine South Central Region

1. CLiC Spring Workshop 2008 Will duct tape cure my warts?Complementary and Alternative Medicine ResourcesFebruary 26, 2008Dana Abbey, MLSNational Network of Libraries of Medicinedana.abbey@uchsc.edu Developed by the National Network of Libraries of Medicine South Central Region

2. Objectives • Have knowledge of the definition and types of Complementary and Alternative Medicine (CAM) • Have greater knowledge of the history of CAM and it's impact on medical practice • Have greater understanding of usage of CAM • Increase confidence in evaluating health websites • Increase skills in avoiding “bad science” found on the Internet or in the news • Become more proficient in searching for evidence of the effectiveness of CAM

3. Agenda • Definitions • History and Impact • Usage and Therapies • Evaluating Web Sites • Avoiding Bad Science • Recommended Websites • Reviewing the Evidence

4. garlic pills cabbage alfalfa pills How do you get rid of a wart? castor oil banana peel iodine toothpaste Windex potato nail polish raw meat duct tape silk thread witch hazel dandelion juice cigarette ashes aloe apple cider orange peel quarters

5. Assess Your Knowledge of CAM The Food and Drug Administration (FDA) regulates dietary supplements. Partially true: as of June 2007 the FDA requires good manufacturing practices (GMP) of supplements Chiropractic care is still considered a type of CAM therapy. True: it is a manipulative and body-based practice Manufacturers need to register a dietary supplement with the FDA before producing it. False: unless it contains a “new dietary ingredient” (an ingredient not marketed before October 1999) Although CAM is gaining in popularity, to date there have been no clinical trials conducted on this type of therapy. False: there are nearly 40,000 CAM clinical trials referenced in PubMed

6. What is CAM? • Complementary and Alternative Medicine CAM is a group of diverse medical and health care systems, practices, and products that are not presently considered to be part of conventional medicine (NCCAM) • Complementary: together with • aromatherapy to help with pain after surgery • Alternative: in place of • using garlic to lower blood pressure • “A comprehensive health care program which we now call ‘integrative care,’ which incorporates the best of conventional evidence-based Western bioscience with evidence-based complementary therapies.” David Eisenberg, M.D. Director of the Division for Research and Education in Complementary and Integrative Medical Therapies and the Osher Institute at Harvard Medical School)

7. Frontline: The New Frontier

8. CAM becomes “legit” • 1990 • Wilk et al v. AMA • 1991 • NIH Office of Alternative Medicine established • 1992 • Chantilly Workshop/Report • 1994 • Dietary Supplement Health and Education Act

9. CAM becomes “legit” • 1995 • NIH Office of Dietary Supplements http://ods.od.nih.gov/ • FDA declassifies Acupuncture needles as experimental product • 1996 • NIH Consensus Conference on Acupuncture • 1997 • First large trial of CAM therapy, St. John’s Wort for depression • 1998 • National Center for Complementary & Alternative Medicine (NCCAM) established • First full scale article in JAMA on herbal medicine • “Trends in alternative medicine use in the United States, 1990-1997: results of a follow-up national survey” • Office of Cancer Complementary and Alternative Medicine (OCCAM)

10. CAM becomes “legit” • 2001 • CAM on PubMed (NCCAM and NLM) • 2004 • Effectiveness of acupuncture as adjunctive therapy in osteoarthritis of the knee: a randomized, controlled trial • 2007 • FDA Issues Dietary Supplements Final Rule • FDA Draft of Evidence-Based Review System for Scientific Evaluation of Health Claims

11. Impact of CAM • CDC Report (2004)* • 36% of adults used some form of CAM • 55% CAM + conventional treatments • 26% used CAM because a medical professional suggested it • $36-47 billion on CAM therapies in 1997 • $5 billion on herbal remedies • Alternative Therapies (2007)+ • Nearly 1 in 5 of U.S. population use herbal medicine (more than half did not disclose this information to their physicians) *Barnes PM, et al. Complementary and alternative medicine use among adults: United States 2002; CDC +Gardiner P, et al. Factors Associated with Herbal Therapy Use By Adults in the United States. Alternative Therapies in Health and Medicine. 2007 Mar-Apr

12. Who Uses Herbal Medicine?* • Largely non-Hispanic white • 35-54 years old • Self-perceived health status excellent, very good or good • Majority use both herbal and prescription • Female • Higher education levels • Have medical insurance • Visited health professional in the last 6 months * Gardiner P, et al.

13. 2004* Back pain or problem Head or chest cold Neck pain or problem Joint pain or stiffness Anxiety/depression Arthritis, gout, lupus or fibromyalgia Stomach or intestinal illness Severe headache or migraine Recurring Pain Insomnia 2007+ Head or chest cold Musculoskeletal conditions (back, neck, arthritis, gout, lupus, fibromyalgia) Stomach or intestinal illness Anxiety/depression Insomnia Severe headache/migraine Menopause Cholesterol Recurring pain Diseases and Conditions* *Barnes PM, et al. +Gardiner P, et al.

14. Top CAM Therapies* • Prayer • Natural products, dietary supplements • Deep breathing exercises • Meditation • Chiropractic • Yoga • Massage • Diets *Barnes PM, et al.

15. 2004* Echinacea Ginseng Ginkgo biloba Garlic Glucosamine St. John’s wort Peppermint Fish oil/Omega 3 Ginger Soy 2007+ Echinacea Ginseng Ginkgo biloba Garlic St. John’s wort Peppermint Ginger Soy Ragweed Kava kava Top 10 Supplements *Barnes PM, et al. +Gardiner P, et al.

16. Categorization of Therapies* • Whole Medical Systems • Biologically Based Practices • Energy Medicine • Manipulative and Body-Based Practices • Mind-Body Medicine *National Center of Complementary and Alternative Therapy

17. Whole Medical Systems • Complete systems of theory and practice that evolved independently from conventional medicine • Traditional systems of medicine that are practiced by individual cultures throughout the world • Includes acupuncture, traditional Chinese medicine, Ayurvedic medicine, homeopathy, naturopathy *National Center of Complementary and Alternative Therapy

18. Biologically Based Practices • Includes: botanicals, animal-derived extracts, vitamins, minerals, fatty acids, amino acids, proteins, whole diets, and functional foods • Dietary supplements are a subset of biologically based practices *National Center of Complementary and Alternative Therapy

19. Biologically Based - Supplements • What is a supplement? • Regulated by FDA http://www.fda.gov • no requirements for FDA testing • manufacturers responsible for ensuring product safety • label requirements • safety alerts: http://www.cfsan.fda.gov/~dms/ds-warn.html

20. Energy Medicine • Veritable - energy that can be measured • Includes sound, visible light, magnetism • Putative – energy that has yet to be measured • human beings are infused with a subtle form of energy • Includes qi (ki in Japanese); doshas; prana, homeopathic resonance *National Center of Complementary and Alternative Therapy

21. Energy Medicine - Acupuncture • Few complications • Scientific evidence? • post chemotherapy management of nausea • pain relief • NIH Consensus Statement (1997) • http://consensus.nih.gov/1997/1997Acupuncture107html.htm

22. Manipulative and Body-Based • Structures and systems of the body, including the bones and joints, the soft tissues, and the circulatory and lymphatic systems • Includes chiropractic manipulation, massage therapy, reflexology, rolfing, Alexander technique,Feldenkrais method *National Center of Complementary and Alternative Therapy

23. Mind-Body Medicine • Interactions among the brain, mind, body, and behavior • The ways in which emotional, mental, social, spiritual, and behavioral factors can directly affect health • Includes relaxation, hypnosis, visual imagery, meditation, yoga, biofeedback, tai chi, group support, and spirituality *National Center of Complementary and Alternative Therapy

24. CAM Therapies In 1992, “complementary therapies” introduced in MeSH

25. Avoiding Bad Science • The “One Product Does It All” claim http://www.emuoilcanada.com/ • Personal Testimonials http://www.getslimslippers.com/ • Quick Fixes/Cures http://www.cure-your-asthma.com • The “No Risk Money Back Guarantee” http://www.bodycatalyst.com/colon_cleanse.html • The “Natural” claim http://www.amtrueman.com/products.html

26. Evaluating Web Sites • Accuracy • Authority • Bias • Currency • Coverage

27. Examining the Research • Observational Studies • a study that does not involve randomization but where available data are nonetheless analyzed to make treatment comparisons. Observational studies are subject to bias, which may render their conclusions less reliable than those obtained by well controlled randomized CLINICAL TRIALS. Still, they may be useful for hypothesis generation and defining the natural history of disease. • Clinical Trials/Studies • Types of Trials • Treatment • Prevention • Diagnostic • Screening • Quality of life • Phases • Phase I- test experimental drug/treatment on 20-80 people for the 1st time • Phase II- experimental drug/treatment on 100-300 people for effectiveness and safety • Phase III- experimental drug/treatment on 1,000-3,000 people to monitor side effects • Phase IV- post-marketing studies to garner more information on risk, benefits, and use

28. Examining the Research • Clinical Trials/Studies • Randomized: A method based on chance by which study participants are assigned to a treatment group. Randomization minimizes the differences among groups by equally distributing people with particular characteristics among all the trial arms. The researchers do not know which treatment is better. • Blind: A randomized trial is "Blind" if the participant is not told which arm of the trial he is on. A clinical trial is "Blind" if participants are unaware on whether they are in the experimental or control arm of the study; also called masked. • Double-blind: A clinical trial design in which neither the participating individuals nor the study staff knows which participants are receiving the experimental drug and which are receiving a placebo (or another therapy). Double-blind trials are thought to produce objective results, since the expectations of the doctor and the participant about the experimental drug do not affect the outcome; also called double-masked study.

29. Examining the Research • Bias • When a point of view prevents impartial judgment on issues relating to the subject of that point of view. In clinical studies, bias is controlled by blinding and randomization • ClinicalTrials.gov • Gov’t and private clinical studies involving humans • Developed under Federal mandate in 1997 • http://clinicaltrials.gov • Contains 51,509 trials conducted nationwide and in 153 countries • Receives over 20 million page hits per day • 34,000 daily visitors

30. Reviewing the Evidence • Evidence Based Medicine: “What evidence do we have to justify the treatment…” • MedlinePlus • Over 100 Herbal Supplements Monographs: Validated rating scales are used to evaluate the quality of available evidence. • Complimentary and Alternative Therapies • PubMed • CAM on PubMed used by researchers, CAM practitioners, health care providers, students, people with illnesses, their family and friends, advocacy organizations, and many others as a resource to find citations related to complementary and alternative medicine • there are over 506,149 citations in the CAM subset of PubMed (from 1966 forward) • National Center for Complementary and Alternative Medicine (NCCAM)

31. Frontline: Mainstreaming of CAM

32. So, Will Duct Tape Cure My Warts? • 2002 Study • Randomized control trial (duct tape vs. liquid nitrogen) • 51 out of 61 patients completed study • Ages 3-22 years • 85% of duct tape patients vs. 60% of cryotherapy had complete resolution of warts • 2007 Study • Double-blind randomized control trial (mole skin with duct tape vs. mole skin) • 80 out of 90 patients completed study • Median age 54 • Found no statistically significant difference in treatment

33. Links • Class Links • http://nnlm.gov/training/consumer/cam/cam-classlinks.html • Recommended Sites • http://nnlm.gov/training/consumer/cam/cam-recommend.doc • CAM on PubMed Workbook • http://nnlm.gov/training/consumer/cam/cam-pubmed.pdf • Website Evaluation Exercises • http://nnlm.gov/training/consumer/cam/cam-evalwebsites.doc • Class Exercises • http://nnlm.gov/training/consumer/cam/cam-exercises.doc

34. Bibliography • Barnes PM, Powell-Griner E, McFann K, Nahin RL. Complementary and alternative medicine use among adults: United States, 2002. Advance data from vital and health statistics; no 343. Hyattsville, Maryland: National Center for Health Statistics. 2004 http://nccam.nih.gov/news/report.pdf (free) • Gardiner P, Graham R, Legedza A, Ahn A, Eisenberg D, Phillips R. Factors Associated with Herbal Therapy Use By Adults in the United States. Alternative Therapies in Health and Medicine. 2007 Mar-Apr; 13 (2): 22-29. http://www.alternative-therapies.com/at/ • Focht D, Spicer C, Faircock M. Efficacy of Duct Tape vs Cryotherapy in the Treatment of Verruca Vulgaris (the Common Wart). Archives of Pediatrics & Adolescent Medicine. 2002; Oct; 156 (10): 971-974. http://archpedi.ama-assn.org/cgi/content/abstract/156/10/971 • Institute of Medicine Committee on the Use of Complementary and Alternative Medicine by the American Public. National Academies Press 2005 http://www.nap.edu/books/0309092701/html/ • Marbella AM, Harris MC, Diehr S, Ignace G, Ignace G. Use of Native American healers among Native American patients in an urban Native American health center. Arch Fam Med. 1998 Mar-Apr;7(2):182-5. http://archfami.ama-assn.org/cgi/content/full/7/2/182 (free) • Werner R, Askari S, Cham P, Kedrowski D, Liu A, Warshaw E. Duct Tape for the Treatment of Common Warts in Adults. Archives of Dermatology. 2007 Mar; 143: 309-313. http://archderm.ama-assn.org/cgi/content/abstract/143/3/309

35. Dana Abbey, MLSNational Network of Libraries of Medicine-MidContinental Region dana.abbey@uchsc.eduhttp://nnlm.gov/mcr/