Natural Medicines... Help or Hype?

Transcription

1 Disclosure Statement Natural Medicines... Help or Hype? Angela M. Hill, Pharm.D., PP Professor, hair, & Assoc. Dean of linical Affairs University of South Florida I, do not have a vested interest in or affiliation with any corporate organization offering financial support or grant money for this continuing education program, or any affiliation with an organization whose philosophy could potentially bias my presentation. Learning Objectives for pharmacists and nurses Explain various natural medicine practices; Describe the regulatory measures for natural medicine practices; Identify the most commonly used natural medicines utilized by the aging patient; Demonstrate key counseling points that pharmacists can utilize in educating aging gp patients about natural medicines; Identify resources that pharmacists can use to enhance their knowledge about natural medicines; Discuss strategies for pharmacists to minimize adverse reactions from the combined use of allopathic and natural medications; and Describe the impact of access to care on the utilization of natural medicines in the aging patient. Learning objectives for pharmacy technicians Explain various natural medicine practices; describe the regulatory measures for natural medicine practices. Identify the most commonly used natural medicines utilized by the aging patient. Describe the impact of access to care on the utilization of natural medicines in the aging patient. 1

2 Traditional hinese Ayurveda Homeopathy Types of Herbals What is the name of the legislation that regulates herbal medicines? The Dietary Supplement Health Education Act (DSHEA) What was the benefit of DHSEA? DSHEA specifically reaffirmed the status of dietary supplements as a category of food and created a specific definition for dietary supplements. DSHEA provided FDA with additional enforcement authority, including the ability to remove from the market ktproducts the agency deems unsafe through: h 1) an imminent hazard clause which permits FDA to immediately remove a product it considers to present an immediate safety concern and 2) a significant or unreasonable risk clause that allows removal of a product considered to pose an unacceptable risk of illness or injury. Has DSHEA been revisited? Dietary Supplement and Nonprescription Drug onsumer Protection Act was signed into law by President ush on December 22, The law requires manufacturers to notify the FDA of all serious adverse events associated with an over the counter drug or a dietary supplement that they receive. 2

3 Marketing of Natural Products Examples Data on efficacy is not required for the products to be marketed. annot make claims to treat, cure or diagnose disease. annot state treat cancer an make structure function claims. an state strengthens immune function Attempts at Quality ontrol with Herbal Products USP has a Dietary Supplementation Verification Program NSF verifies contents onsumer Lb Labs puts a seal of approval on products with accurate labeling NPA verifies labeling and product contents Precautions with use of Herbals: Pregnancy Surgery leeders Sweeteners ytochrome influencing herbals Herbs unfit for human consumption Kavaism Herbs affecting Lactation Dosing Medications that can chelate with vitamins 3

4 Herbals most commonly used in Aging Patients Saw Palmetto Ginkgo Huperzine A lack cohosh Glucosamine Ginseng Fish Oils Ginger Melatonin Echinacea Red Yeast Rice Soy What do I need to know specifically about the herbals? Popular use ommon side effects Interactions with allopathic medications Precautions What AM I Used For? lack ohosh at s law Devil s law Echinacea Feverfew Fenugreek Feverfew Ginseng Gingko Glucosamine/hondroitin Huperzine A Kava Kava Milk Thistle Shark s artiledge Saw Palmetto St. John s wort Melatonin Red Yeast Rice SAMe Valerian Root What allopathic medications may interact with the following herbals? lack ohosh at s law Devil s law Echinacea Feverfew Fenugreek Feverfew Ginseng Gingko Glucosamine/hondroitin Huperzine A Kava Kava Milk Thistle Shark s artiledge Saw Palmetto St. John s wort Melatonin Red Yeast Rice SAMe Valerian Root 4

5 ommon Allopathic Drug Herbal Interactions St. John s wort St. John s wort interacts with: SSRIs serotonin syndrome yclosporine reduction in plasma levels Theophylline decreased plasma levels Digoxin decreased bioavailability Indinavir* decreased therapeutic effect Warfarin* decreased therapeutic effect * these drugs are metabolized by cytochrome P450 pathway which is altered by St. John s wort EHINAEA Echinacea interacts with: Immunosuppressants Medications metabolized by cytochrome P450 Glucosamine Glucosamine interacts with: Anticoagulants elevation in INR Hypoglycemic agents decrease effectiveness, increased dblood glucose Insulin increased blood glucose 5

6 Garlic Garlic interacts with: Anticoagulants elevation in INR Estrogen/progesterone decrease unbound sex hormones Ginkgo Ginkgo biloba interacts with: Anticoagulants (i.e. warfarin) spontaneous hemorrhage Anticonvulsants (i.e. trazadone) coma, decrease seizure threshold Aspirin/salicylates spontaneous hemorrhage Other NSAIDs Huperzine A Side Effects GI Upset holinergic Toxicity ( Higher than recommended doses) Drug Interactions Acetylcholinesterase Inhibitors Impact of the herbals on blood glucose There are some herbals that decrease blood glucose such as: ittermelon, Fenugreek, Garlic, Gynemna Sylvestre, Nettle, Sage, Ginseng, hromium and Vanadium There are herbals that increase blood glucose such as: Devil`s law, Ginseng, Stinging, Nettle, Licorice, Rosemary, Ma Huang and Korela 6

7 Impact on herbals on thyroid function There are some herbals that affect thyroid function such as: Kelp (synergizes thyroid supplementation) and Horseraddish (may decrease thyroid function) Herbal Allergy Precautions Feverfew: member of the Asteraceae family hamomile: member of the Asteraceae family Other members: Ragwood, Yarrow Glucosamine/hondroitin: Shellfish Photosensitivity reactions can occur from St. John s wort ase A is an 73 y.o. female who had bilateral knee replacements last year, and has rheumatoid arthritis, hypertension, and hypercholesterolemia. She takes amlodipine, elebrex, lovastatin, and a multivitamin. She wants to use the osamin DS product how would you advise this patient? Fish OIls Fish oils interacts with: Antihypertensives greater reduction in P Elevations in INR 7

8 ase MS is a 69 y.o. who is taking Losartan, Vitamin E, baby aspirin, elexa, and potassium chloride, and furosemide. She recently started taking fish oils. How would you counsel this patient? What is your opinion about natural products? Are they help or hype? Key to Grades lack ohosh Grade A D F Scientific Evidence Strong Evidence for this use Good scientific evidence for this use Unclear scientific evidence for this use Fair scientific evidence against this use (It may not work) Strong scientific against this use (it likely does not work) Natural Standard Herb & Supplement Guide: An Evidence ased Reference opyright 2010 by Mosby, Inc. Randomized controlled trials have been conducted in menopausal women Results are inconclusive with regards to efficacy in treating hot flashes. Open label uncontrolled trials have provided supporting data in terms of efficacy and safety of black ohosh. Further randomized controlled trials are needed to establish efficacy 8

9 Evidence for lack cohosh lack ohosh reast ancer Menopausal Symptoms Arthritis Pain Migraine Help or Hype Gingko iloba: linical Trials Gingko Most clinical trials used products containing: 24 25% flavone glycosides 5 6% terpenoids linical trialsshouldshould modest memory improvement. Many products available to consumers do not contain these concentrations. Side Effects GI upset Allergic skin reactions Seizures ( when consumed in large amounts) Warnings/ Precautions Gingko should be discontinued at least 3 days before surgery. 9

10 Evidence for ginkgo Ginkgo iloba Medical Disorder Dementia (Multiinfarct & Alzheimer s Type) erebral Insufficiency Acute Hemorrhoidal Attacks Age Associated Memory Impairment Altitude (Mountain) Sickness Asthma ardiovascular Disease laudication (painful Legs from logged arteries) hemotherapy Side Effects hronic Venous Insufficiency Memory Enhancement (In Health People) Grading A A Help or Hype ase LK is a 59 y.o. female who still has hot flashes. She has taken premarin/provera for the past 10 years, and is concerned about the risks of cancer associated with these hormones. She asks you about using dong quai, soy, or evening primrose oil to address the flashes. How would you counsel this patient? Soy Evidence suggests that it may be useful for the reduction of menopausal symptoms. In a DP trial 45% of women who consumed 60grams daily of soy protein isolate had a reduction in hot flashes. Not all studies have shown benefit. 10

11 Evidence of SOy Dong Quai Medical Disorder Dietary Source of Protein High holesterol Diarrhea (in infants and children) Menopausal Symptoms reast ancer Prevention ardiovascular Disease ardiac Ischemia Grading A A Help or Hype Dong Quai Evidence for dong quai Traditional hinese Medicine that is used with other herbal products for gynecological problems. Studies do not shown a benefit over placebo. Possesses anticoagulant, vasodilatory and antispasmodic effects. Avoid in patients taking warfarin or those who are at increased risk of bleeding. Medical Disorder Amenorrhea Angina Pectoris/oronary Artery Disease Arthritis Dysmenorrhea Glomerulonephritis Idiopathic Thrombocytopenic Purpura Menstrual Migraine Headache Nerve Pain Pulmonary Hypertension Menopausal Symptoms Grading D 11

12 Help or Hype Evening primrose Evening Primrose Oil Made from the seeds of the primrose plant. No evidence of therapeutic benefit. ontains linolenic acid which is considered heart healthy and may increase prostaglandin synthesis and suppresses inflammation. At high doses may contribute to an increase in bleeding risk. Evidence for Evening primrose St. John s wort Medical Disorder Atopic Dermatitis reast ancer reast Pain/reast ysts ronchitis Menopause (Flushing/one Metabolism) Premenstrual Symptoms Diabetes Grading D D Help or Hype 12

13 Efficacy of St. John s Wort A meta analysis of 23 randomized trials of SJW showed that it was superior to placebo;however, many of the studies had significant flaws in theirdesign. Linde K et al. MJ 1996;313: Efficacy of St. John s Wort In 3 studies, 63.9% responded to SJW compared to 58.5% with imipramine, maprotiline, or amitriptyline Emanuel et al. J Pharm Prac 2001;14(6): Evidence for st. john s wort SAM e Medical Disorder Depressive Disorder (Mild to Moderate) Anxiety Disorder Atopic Dermatitis Depressive Disorder (Severe) Obsessive ompulsive Disorder Perimenopausal Symptoms Seasonal Affective Disorder HIV Social Phobia Grading A D D Help or Hype 13

14 SAM e echinacea Most clinical trials have compared to placebo or tricyclic antidepressants and have found SAMe to be equally efficacious to TAs. These trials were very short (4 weeks) and limit the ability to state that SAMe has equivalent antidepressant effects as TAs. Help or Hype Echinacea Echinacea Not a lot of strong evidence to support its use in treating colds. Some studies suggest that echinacea improves cold symptoms and decreases the duration of symptoms by 1 3 days. HOWEVER, some studies have shown no benefit. Meta analysis suggests that echinacea might be more effective than placebo. Research to date is incomplete and inconclusive. No consensus regarding the most effective or most appropriate dose or formulation. Side Effects Allergic reactions Exacerbations of autoimmune disorders. Drug Interactions Immunosuppressants E. angustifolia inhibits 3A4 pathway. 14

15 Help or Hype Saw palmetto ase MT is a 73 y.o. male who has an elevated PSA despite the use of Flomax and Hytrin. He asks you about the use of Saw Palmetto instead of theprescription medications. How would you respond to this gentleman? Saw Palmetto Evidence for Saw palmetto linical trials have demonstrated that Saw Palmetto improves symptoms in men with mild to moderate symptoms. RD trial found that Saw Palmetto 320 mg daily was as effective as finasteride and it does not reduce PSA levels. ompared to alpha blockers it is not as effective at improving symptoms. Medical Disorder Enlarged Prostate (PH) Male Pattern Hair Loss Prostate ancer Prostatis/hronic Pelvic Pain Underactive ladder Grading A 15

16 Panax Ginseng One small trial suggests that taking Ginseng 900 mg three times daily subjectively improves erection in men with ED. More evidence is necessary to determine benefit. Side Effects Insomnia Tachycardia Mastalgia Headache Palpitations Itchy Skin QT prolongation Lowers blood glucose Avoid in patients with cardiovascular conditions. Drug interactions Warfarin (decreased effect) Imunosuppressants ( increases immune function) MAOIs Ginseng ginseng ase Medical ondition Heart onditions High lood Sugar/Glucose Intolerance Immune System Enhancement Type 2 Diabetes ADHD Aplastic Anemia ancer hemotherapy Grading 8/13/2014 Hi Dr. Hill, Is there something natural that I can take for high holesterol? I was taking Simvastatin, 40 mgs. and it was giving me all sorts of body pains! My doctor suggested I stop for 1 or 2 months and have blood work done. Unfortunately, my new blood work came out: Lipid Panel holesterol Total 263 mg/dl HDL holesterol 68 mg/dl Triglycerides 111 mg/dl LDL holesterol 173 mg/dl (calc) Someone suggested Garlic tablets??!!! I would really like to do anything natural rather than have to take a medication again! Thank you for any suggestions you can give me. Thanks XXXX 16

17 Research Evidence for Red Yeast RIce Eighty elderly patients were randomized in a prospective, parallel group, single blind study in patients >75 years of age who were statin intolerant. They received to either nutraceutical combined pill (containing berberine 500mg, policosanol 10mg, red yeast rice 200mg, and astaxanthin 0.5mg). They were assessed after 3,6, and 12 months. Medical ondition High holesterol oronary Heart Disease Diabetes Grading A onclusion: There was a reduction in cholesterolemia and achieved acceptable plasma LDL levels in elderly hypercholesterolemic patients who were prevoiusly statin intolerant. Long term effects of Nutraceuticals (erberine, Red Yeast Rice, Policosanol) in Elderly Hypercholesterolemic Patients. Marazzi G, et al. Adv Ther 2011;28(12): ase Melatonin Mr. PT is a 74 y.o. male who tells you he has been having difficulty with his sleep. He asks you if he should use Tylenol PM or Melatonin. When you question him a bit further, you realize that he gets up for at least 3 bathroom breaks, and has difficulty resuming sleep. He also takes daytime naps. How would you counsel this patient? Hormone produced by the pineal gland form tryptophan Side effects: Hypotension Hyperglycemia y Mood disturbances sperm count T4 & T3, GH, LH, prolactin Seizures intraocular pressure 17

18 Evidence for Melatonin Herbal Products Not Recommended for Human onsumption Medical Disorder Jet Lag Delayed Sleep Syndrome Insomnia in the Elderly Sleep Disorders in hildren with Psychiatric Disorders Alzheimer s Disease (Sleep Disorders) ADHD enzodiazepine tapering Grading A orage alamus haparral oltsfoot omfrey Ephedra Germander Licorice Life Root Pokeroot Sassafras Who do you report problems with herbal products to? MedWatch 5600 Fishers Lane Rockville, Maryland Fax# FDA 0178 How do I counsel patients about Natural products? Encourage them to inform all healthcare professionals about the use of natural products. Advise them to avoid switching brands of natural products. Educate them about allopathic equivalents to natural products. Discourage use for addressing chronic conditions. 18

19 How do I counsel patients about Natural products? Discuss the potential side effects and precautions of the natural products. Advise consumer to only use products with contact information for the manufacturer. Eliminate multiple sources of natural products or vitamins. How do I counsel patients about Natural products? Realize that the term natural does not guarantee that a product is safe onsider the name of the manufacturer and distributor Ask the company about the conditions under which its products were made Do not exceed the recommended dosage Purchase herbs from reliable sources Store in cool, dry environment and discard after 1 year Stop taking the product if side effects are noted Involve a health professional who can monitor your progress with the natural remedy What s your opinion? Are natural products help or hype? Herbal Resources Physician s Desk Reference for Herbal Medicines Lawrence Review of Natural Products Natural Medicines omprehensive Database Alternative Health Watch Database The omplete German ommission E Monographs Facts & omparisons Guide to Popular Natural Products Natural Standard Herb & Supplement Guide. An Evidence ased Reference 19

20 What are some reputable sources for clinicians? The AltMedDex System The Review of Natural Products The Natural Pharmacist Natural Medicine Encyclopedia Office of Dietary Supplements, NIH Professional Handbook of omplimentary & Alternative Medicines Herbal Websites d5131.mull/d5131/mull 01.hml Questions? Angela M. Hill, Pharm.D., PP