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									Alternative Therapies
Safety, Efficacy, Liability, and Rational Use

Victor S. Sierpina, MD
Associate Professor Principal Investigator, CAM Education Project Grant UTMB, Family Medicine Department

Learning Objectives

• Utilize a rational approach to advising patients about alternative therapies • Describe liability issues in this area • Describe some common, safe, and effective alternative therapies • Access useful resources for patient care and professional education

Evidence Based Curriculum in Alternative Therapies

• UTMB received a 5 year grant for $1.5 million to develop a core curriculum in AT • Focus on evidence, communication, life-long learning skills as well as clinical skills in CAM • Target audiences: medical, nursing, allied health students, house staff • Faculty and community preceptors/CME

Which of the following are recommended by the AHA for CV risk reduction?
A. B. C. D. E. Olive oil, margarine, trans-fatty acids Canola and flaxseed oil Fish oil and eating fish weekly Mediterranean diet Vitamin E

Ans. B, C, (D)
Harper, Beyond the Mediterranean Diet: the Role of Omega-3 Fatty Acids in the Prevention of CAD, Prev Cardiol, 2003

In a patient with colon polyps, which of the following should you recommend?
A. B. C. D. Fiber Broccoli Folic acid Aspirin

Ans. A, B, C, D

A patient with a high homocysteine level may respond to which of the following?
A. B. C. D. Nitrates Vioxx Vitamins B6, B12, and folic acid Vitamin E

Ans. C
Hu F, Willett W. Optimal diets for prevention of coronary heart disease. JAMA. 2002;288:2569-2578 {Systematic review}
Schnyder et al. JAMA. 2002;288:973-979 Rimm et al. JAMA. 1998;279:359-364

Which of the following is true about Glucosamine Sulfate?
A. Increased incidence of GI bleeding B. Increased blood glucose levels in Type II diabetics C. Proven additive effect with chondroitin D. Structural and symptomatic improvement of OA demonstrated in meta-analysis
Ans. D
Richy, et al. Structural and symptomatic efficacy of glucosamine and chondroitin in knee osteoarthritis: a comprehensive meta-analysis. Arch Int Med, 2003.

Safety First

• Primum non nocere

“It is more important to know what sort of patient has a disease than what disease a patient has.”
- Sir William Osler

Patient Approach

• • • •

Communication Answer questions Advise Promote proven and safe therapies

Create an open climate for discussion

• Most patients won’t bring up their use of alternative therapies • Ignoring their requests for information may make you seem both uninformed and uncaring • Global approvals and disapprovals are not helpful for patients seeking specific advice

What to do when they ask you a question

• Don’t be afraid to say you don’t know the answer….BUT will look it up • Be open and respectful • Inquire why the patient is interested in this approach • Discuss standard of care approaches and explore options/preferences

Safety first

• Review literature and online resources for what is known about product or therapy • Be aware of drug-herb and drug-supplement interactions • Know the training and credentials of alternative practitioners you refer to

Perspectives on Safety

• The Institute of Medicine reported that standard medical treatment results in >225,000 iatrogenic deaths per year • JAMA meta-analysis reported adverse drug reactions in 6.7% of hospitalized patients • Kellogg Foundation reported a 3.7% medical error rate • Wolfe et al estimated 103,000 serious GI complications and 16,500 deaths related to NSAID use

“You medical people will have more lives to answer for in the other world than even we generals.”
--Napoleon Bonaparte

Safety issues in CAM

• • • •

Labeling/mislabeling Misrepresentation Misdiagnosis Substitution for appropriate therapy • Interaction between CAM and conventional medicine

• Double-dosing • Adverse events reporting • Unreliable, nonstandardized diagnostic procedures and laboratories • Training/Credentialing of providers

Product safety issues

• Contamination • Potency, purity, and bioavailability • Dosing levels uncertain

• Allergies • Direct toxicity • Herbal remedies and surgery • Overdosing of nutraceuticals

Some safe CAM modalities

• • • • •

Acupuncture Chiropractic Homeopathy Massage Despite standardization concerns, herbs and supplements are generally safer than many prescription drugs

A hierarchy of decision making in the use of CAM therapy
1) Evidence supports safety and efficacy 2) Evidence supports safety;efficacy is inconclusive 3) Evidence supports efficacy; safety is inconclusive 4) Evidence indicates serious risk or inefficacy
Cohen M, Eisenberg D. Potential physician malpractice liability associated with complementary and integrative medicine therapies. Ann Intern Med. 2002;136(8):596-603.

Liability Issues

• • • • • • •

Documentation Documentation Documentation Referral Control Limited damages Informed consent

Liability Issues

• Texas Board of Medical Examiners position • Standard of care issues • ―Two schools of thought‖ defense— respectable minority within profession would consider this tx • Duty to inform and avoid misrepresentation

Efficacy

• • • •

Assessing evidence for alternative therapies Peer-reviewed literature Textbooks On-line and other electronic resources

National Institutes of Health: National Center for Complementary & Alternative Medicine (NCCAM)
•Biologically-based Therapies •Mind-Body Therapies •Manual Therapies •Alternative Systems of Care •Bioenergetic Medicine

Research on Acupuncture

• NIH Consensus Statement 1997 • Effects on nausea in pregnancy
– Smith C, Crowther C, Beilby, J. Acupuncture to Treat Nausea and Vomiting in Early Pregnancy: A Randomized Controlled Trial. Birth Issues in Perinatal Care 2002;29(1):1-9

Efficacy of acupuncture

Best evidence is for: • Post operative nausea secondary to anesthesia • Nausea from chemotherapy • Nausea of pregnancy • Dental pain

Acupuncture may be effective but not limited to the following conditions
• • • • • • Back pain Fibromyalgia Carpal tunnel Arthritis Neuralgia Stroke rehabilitation • • • • Epicondylitis Menstrual cramps Asthma Tension and migraine headaches • Addiction

American Heart Association Recommendations


Healthy individuals should take two servings of fish(salmon, sardines, tuna, mackerel, trout) weekly along with flaxseed, canola, and soybean oil  Patients with CHD should consume higher doses, 1 g/d of EPA + DHA, which may require fish oil supplementation • Utilize complex carbohydrates, higher in fiber and lower in glycemic load to reduce risk of CHD
AHA Recommendations: Intake of omega-3 fatty acids. Women’s Health in Primary Care. 2003.6(1): 25-26 (Consensus opinion) Hu F, Willett W.Optimal diets for prevention of coronary heart disease. JAMA. 2002;288:2569-2578 {Systematic review}

How intake of Omega-3 Fatty Acids is helpful
• Stabilization of atherosclerotic plaques • Reduction of inflammation by mediation prostaglandin synthesis pathway • Improved ratio of omega-3 to omega 6 FA reduces arachidonic acid and pro-inflammatory, proplatelet aggregatory cytokines (4:1 vs 25:1) • Enhances PGE1 and PGE 3 and less inflammatory leukotrienes(see diagram)
Thies F, et al. Association of n-3 polyunsaturated fatty acids with stability of atherosclerotic plaque: RCT, Lancet, 2003;361:477-85 Harper, Beyond the Mediterranean Diet: the Role of Omega-3 Fatty Acids in the Prevention of CAD, Prev Cardiol, 2003;6(3):134-46

St. John’s Wort: Dose 300 mg tid std extract (0.3%), 3-4 ml tid
tincture

• Jarsin/Lichter Pharma • Quanterra Emotional Balance/Warner Lambert • Perika/Nature’s Way • Movana/Pharmaton

Recent Studies on SJW
Recent study at Duke comparing SJW with SSRI’s: neither sertraline nor SJW was better than placebo(RCT)* SJW not effective in major depression, (RCT)**
*Davidson JRT, Gadde KM, et al. JAMA 2002;287;1807-1814 **Shelton et al. JAMA. 2001;285:1978-1986

WATCH OUT: Drug Interactions with SJW

SSRI’s General anesthetics Benzodiazepines

 Retrovirals  Digoxin  Cyclosporine

OCP’s

Glucosamine for Osteoarthritis

• 1500mg a day well supported as an analgesic • No GI side effects • Theoretical risk of altering insulin sensitivity not clinically demonstrated • ? effect on b/p • May protect and even help regenerate cartilage

Recent Studies on Glucosamine
• Richy, et al. Structural and symptomatic efficacy of glucosamine and chondroitin in knee osteoarthritis: a comprehensive meta-analysis. Arch Int Med, 2003 • McAlindon, TE, et al. Glucosamine and chondroitin for treatment of osteoarthritis: a systematic quality assessment and meta-analysis. JAMA 283(11): 1483-84. Feb 2000 • RPC study showed reduction in cartilage loss and symptoms of OA over a 3 yr period in 106 pts (Reginster, Jan 2001 Lancet)

My Favorite Therapies

• • • • •

Saw palmetto 320 mg/d--BPH Ginkgo 120-240 mg/d—memory Horse chestnut 60 mg bid—varicose veins Echinacea 300 mg tid—colds and flu Black cohosh/soy 40-80 mg/d—menopausal symptoms

My Favorite Therapies

• Relaxation therapies/mind-body medicine— multiple conditions • Tai chi and yoga exercise • Magnets for pain

My Favorite Therapies

• Anti-oxidants Vitamins C (1 gram/d), E 800 IU/d), high intakes (5-9 servings/d) of fruits and vegetables—vascular dz, aging, wound healing, immune support • Chromium 400 mcg/d—diabetes • Coenzyme Q 10 50-100 mg/d—with statins, gingivitis, hypertension • Zinc 15-45mg/d—wound healing, prostate health • Glucosamine sulfate 1500 mg/d—arthritis

Once a day to keep the doctor away

• Low levels of anti-oxidant vitamins (A, C, E) may increase risk of several chronic diseases • Most people do not consume optimal intake of all vitamins by diet alone
Fletcher R, Fairfield K. Vitamins for chronic disease prevention in adults—clinical applications. JAMA. 2002;287:3127-3129 (Review)

Vitamin E

• High risk CV pts. had ―no apparent effect‖ from Vit E in an RCT. No significant adverse events -Yusuf et al.
NEJM, 2000;342:154-60

• Preventive effect suggested in several cohort studies of both men and women -Stampfer & Rimm NEJM, 1993; 328:
1444-1456

• Vit E reduced risk of non-fatal MI but not of cardiovascular mortality -Stephens, et al. Cambridge Heart
Antioxidant Study (CHAOS). Lancet. 1996; 347:781-786

Bio-identical Hormones

• Hormones that are identical to those produced in the human body (may be synthetically produced)
– Estrone, estradiol, estriol (Ortho-Est,Estrace, Estraderm, Climara) – Progesterone (ProGest, Fem-Gest, Progonol) – Testosterone – DHEA

Natural Progesterones

• Mexican Wild Yam—plant based hormones similar to progesterone • Not bioavailable nor convertible to progesterone in the body • Must add UPS Progesterone to topical cream to be effective

Compounding Pharmacies

• Compounding pharmacies: Bi-Est, Tri-Est, Micronized Progesterone, testosterone • Family Pharmacy, La Porte, TX • International Academy of Compounding Pharmacies, Sugarland, TX: 800-927-4227; www.iacprx.com… • Women’s International Pharmacy, Madison, WI; 800-279-5708 www.womensinternational.com…

Basics of Menopausal Care
• • • • • Regular exercise, weight bearing Social support Meditation, relaxation, sleep Quit smoking/alcohol Dietary phytoestrogens
– Soy – Celery, fennel, parsley – Nuts, seeds – Flaxseed

Bio-identical HRT

• Bi-Est (80% estriol/20%estradiol)1.25-5 mg qd (may divide in bid dosing) • Tri-Est (80% estriol/10%estradiol/10%estrone) 1.25-5.0 mg qd (may divide bid) • Micronized progesterone (Prometrium) 100200 mg qd • Progesterone cream (Pro-Gest)20-40 mg/d

Phytoestrogens

• Soy • Black Cohosh

• • • • • •

Dong Quai Red Clover Chaste Berry Tree Licorice Evening Primrose Oil Ginseng

Conclusions

• Jury still out on safety of HRT • Bio-identical HRT has not been evaluated in clinical trials • Are risks of HRT due to the hormones, their metabolites, methods of administration?

Conclusions

• Botanical medicines useful to treat menopausal sx • ? Effect on osteoporosis, CV dz • Progesterone alone may tx both menopausal sx and osteoporosis (controversial for osteoporosis when used alone)

BOTTOM LINE

– HRT for menopausal sx is likely safe for up to 4-5 yrs – Longer use (10-15 yrs) may create increased risk for some women – Don’t HRT as CV tx or preventive – Individualize risk/benefit ratio and choice for each pt.

Some Useful Referrals
• Acupuncture • Massage Therapy • Biofeedback • Hypnosis

• Chiropractic
• Osteopathic manipulation

• Cognitive behavioral therapy

―Four P’s‖

1) 2) 3) 4)

Protect Partnership Permit Promote proven practices

Jonas W. Advising patients on the use of complementary and alternative medicine. Appl Psychopysiol Biofeedback. 2001; 26(3): 205-14.

Advising patients about CAM

• • • • •

Ask Be willing to listen and learn Communicate and collaborate Diagnose! Explain and explore preferences, efficacy, safety

More mistakes in medicine are made by those who do not care than those who do not know.
Allen Gregg

Integrative Healthcare: Complementary and Alternative Therapies for the Whole Person

By: Victor S. Sierpina, MD FA Davis Philadelphia, 2001 B&N.com Amazon.com

Murray M, Pizzorno J. Encyclopedia of Natural Medicine. Rocklin, CA: Prima. 1998.

References

• Alternative Therapies in Health and Medicine. Published by the Innovision Communications, 800899-1712; bimonthly peer reviewed journal.

Print Resources

• Natural Medicines Comprehensive Database. Compiled by the Editors of Prescriber’s Letter and Pharmacist’s Letter • Ernst E. The Desktop Guide to Complementary and Alternative Medicine--an evidence-based approach. Mosby, 2001. • PDR Herbal and Nutritional Supplement editions. 2002, 2003

http://cam.utmb.edu

Electronic Resources

• Natural Medicines Comprehensive Database http://www.naturaldatabase.com/pda
• HealthNotes OnLine. http://healthnotes.com… • epocrates.com

More Databases and Websites

• CAM on PubMed—peer referenced articles http://www.nlm.nih.gov/nccam/camonpubmed.html…. • InfoPoems Clinical Awareness System—synopsized data, 30 second answers http://www.InfoPOEMS.com… • Consumerlab—assessment of product quality www.consumerlab.com…. • Boston Children’s Hospital—CAM use in children www.holistickids.org… • Longwood Herbal Taskforce—herbal monographs http://www.mcp.edu/herbal….

http://cam.utmb.edu


								
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