Galen Goertzen PharmD Group Health Cooperative Disclosures No conflicts of interest or commercial affiliations Free of commercial bias Includes unlabeled uses for ALL discussed natural medicines ID: 775303
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Slide1
Nutritional and Weight Loss Supplements
Galen Goertzen, PharmD
Group Health Cooperative
Slide2Disclosures
No conflicts of interest or commercial affiliations
Free of commercial bias
Includes unlabeled uses for ALL discussed natural medicines
Slide3Objectives
Discuss the process by which dietary supplements reach the US market and the FDA’s role in that process
Provide brief overview of most common dietary supplements used by adults in the U.S.
Discuss the evidence for efficacy and safety for the various dietary and weight loss supplements
Identify evidence-based natural medicine resources for clinicians and members.
Slide4Background
Use of herbal products has increased by nearly 400% during the last decade.
There appears to be an implicit belief that, because herbal remedies are natural, they are safe.
The FDA does not regulate herbs for content and safety.
Dietary Supplement and Nonprescription Drug Consumer Protection Act serious adverse event reporting – effective on products labeled after December 22, 2007 (enforcement begins 1/1/2010).
Slide5Who is doing it?U.S. CAM Patient Demographics
38% of adults 41% of adults aged 60-69 1 in 9 children 42.8% women 55.4% of people with higher levels of education - Masters, doctorate or professional 60% of pregnant and breast-feeding women
2007 Statistics on CAM Use in the United States, http://nccam.nih.gov/news/camstats/2007/
60-70% do NOT disclose this information to their doctors
Slide6Slide7What’s the concern?
Not all Dietary Supplements are Created Equal
Slide8What’s the concern?Differences in Regulatory Standards
Drugs vs. Supplements: Different Regulatory Standards Rx DrugsSupplementsProof of SafetyRequiredNot required*Proof of EffectivenessRequiredNot requiredPost-marketing SurveillanceRequiredNot required**Good Manufacturing Practices (GMPs)Pharmaceutical GMPsFood GMPs***Disease Treatment ClaimsAllowedNot allowed
* Premarket notification is required for "new dietary ingredients" which have not been previously marketed. However, proof of safety is not required.
** Starting in 2007 dietary supplement manufacturers are required to report adverse event information that they receive to the FDA.
*** Dietary supplement GMPs are in development by the FDA
Slide9What’s the concern?Safety and other concerns
Toxicity – may be inherently unsafe when orally ingested i.e. ephedra, aristolochic acid
Adulterants – contamination, particularly with imported products – i.e. Man Up Now and Vigor-25 contain sulfoaildenafil
Dosage variability – active ingredients may vary wildly between different products – i.e. hoodia
Risks to special populations – what is effect in pregnancy, children, kidney disease
Economic risks – May be considerably more expensive than FDA approved products on market – Airborne, Red Yeast Rice vs. lovastatin
Slide10What’s the concern?Drug-Supplement Interactions
The POTENTIAL for interactions is huge.
We know that drug-supplement interactions do in FACT occur based on case reports and some clinical studies.
1. Pharmacokinetic
These interactions occur when absorption, distribution, metabolism, or elimination (ADME) of a drug is altered.
Calcium: quinolone antibiotics, tetracycline, bisphoshonates, levothyroxine
St. John’s wort: CYP3A4 substrates
2. Pharmacodynamic
interactions can often be predicted based on the pharmacology of a drug and supplement. These interactions can occur when the pharmacological effects of two products are additive or oppositional.
Kava: Hepatotoxic drugs
Ginkgo: Antiplatelet drugs
Slide11What’s the Concern?Fad ingredients particularly susceptible to adulteration and fraud
Products for “Sexual enhancement” - > 80 FDA actions
Claim to work in minutes or hours or have long-lasting effects up to 24-72 hours
Weight Loss products - >70 FDA actions
“Bodybuilding” products - > 80 FDA actions
Claim to be legal alternative to anabolic steroids
Watch particularly for products marketed in foreign language or through mass e-mails
Are the claims too good to be true???
Slide12What’s the concern? $2.5B Spent, No Alternative Med Cures
Ten years ago the government set out to test herbal and other alternative health remedies to find the ones that work. No better than PLACEBO in big studies funded by the NIH National Center for Complementary and Alternative Medicines.Echinacea for colds. Ginkgo biloba for memory. Glucosamine and chondroitin for arthritis.Black cohosh for menopausal. Saw palmetto for prostate health. Shark cartilage for cancer. The lone exception: ginger capsules may help chemotherapy nausea.Studying herbals is tough because they are not standardized as prescription drugs are required to be.
http://nccam.nih.gov/
Slide13Evidence based information
Complementary & Alternative Medicine Databases
Natural Medicines Comprehensive Database
Natural Standard -
AAFP recommended resource
ConsumerLab.com - A Quality "Watchdog" for Herbal and Dietary Supplements
CAM on PubMed
http://nccam.nih.gov/research/camonpubmed/
Cochrane Database – search in reviews by topic and select
Complementary Medicine Field
http://www.cochrane.org
Natural Medicines Watch
™
Slide14How to help patients select a natural supplement
Step #1: Safety Assessment
Safety Rating: Likely Safe to Unsafe
Step #2: Effectiveness Assessment
Effective to Likely Ineffective
Slide15Bring Safety and Efficacy Together
Developed by Natural Medicines Comprehensive Database
Slide16How to help patients select a natural supplement
Step #3: Product Quality AssessmentLook for the USP-Verified MarkUSP standards are enforceable by the FDA. The mark represents that USP has rigorously tested and verified the supplement to assure the following:What's on the label is in fact in the bottle.The supplement does not contain harmful levels of contaminants. The supplement will break down and release ingredients in the body.The supplement has been made under good manufacturing practices.
Practice Pearl –
National Vitamin Company is USP verified for disintegration and dissolution standards. They maintain Pharmaceutical Standards of GMP and are in compliance with Pharmacopeia standards for measuring identity, strength, quality, and purity of active ingredients.
Slide17USP Dietary Supplement Verification Program
Comprehensive laboratory testing of supplements against USP standardsThorough manufacturing and quality control document reviewOn-site manufacturing facility audit for compliance with USP standards and FDA current Good Manufacturing PracticesRandom off the shelf testing to confirm that products continue to meet USP standards
Slide18What patients are taking
Slide19Fish Oilomega-3 fatty acids eicosapentaenoic acid (EPA) and docosahexaenoic acid (DHA)
EffectiveHypertriglyceridemia. Fish oil from supplements or from dietary sources can reduce triglyceride levels by 20% to 50%Lovaza is FDA approved as adjunct to diet therapy in the treatment of hypertriglyceridemia at 4g/day – no evidence of increased effectivenessLikely effectiveCardiovascular disease. Consuming fish oil from dietary sources (fish), two servings of fatty fish/week, seems to reduce the risk of developing cardiovascular disease (primary prevention)
AdultsLikely safe when used orally and appropriately. Doses of 3 grams per day and less can be safely used by most people. Possibly unsafe in large amounts. Doses greater than 3 grams per day can inhibit blood coagulation and potentially increase the risk of bleeding and might also suppress immune response. Pregnancy and lactationLikely safe ChildrenPossibly safe
Consider recommending in adults
Slide20Echinaceaechinacea angustifolia; echinacea pallida; echinacea purpurea
AdultsLikely safe when used orally, short-term. Several formulations of echinacea have been used safely in trials lasting up to 12 weeks.Pregnancy: possibly safe when used orally, short-term. Lactation: insufficient reliable information available; avoid using. ChildrenPossibly safe when used orally, short-term; might increase the risk of rash in some children.
Possibly EffectiveCommon cold. Taking some echinacea preparations seems to modestly reduce symptom severity and duration, possibly by about 10% to 30%Vaginal candidiasis. Taking echinacea orally in combination with a topical antifungal cream seems to be effective for preventing recurrent vaginal yeast infection.Product ConcernsEchinacea products are frequently mislabeled or may contain no Echinacea. Echinacea products have been commonly adulterated. Some have been contaminated with selenium, arsenic, and lead.
Don’t recommend this product
Slide21Glucosamine SULFATE & Chondroitin SULFATE
Adults
Likely safe when used orally. Glucosamine has been used safely in multiple clinical trials lasting from 4 weeks to 3 years. Chondroitin sulfate has been used safely in studies lasting from 2 months to 6 years.
Possibly safe when used IM short-term. Glucosamine sulfate in combination with chondroitin sulfate, shark cartilage, and camphor appears to be safe when applied topically on an as-needed basis for up to eight weeks.Pregnancy and Lactation: Insufficient reliable information available; avoid using.
OsteoarthritisLikely EffectiveClinical trials show that glucosamine sulfate orally significantly improves symptoms of pain and functionality compared to placebo in patients with osteoarthritis of the knee in studies up to 3 years.Note: There is conflicting evidence about the effectiveness of glucosamine HCl.Possibly effective Clinical research on the effectiveness of chondroitin sulfate is inconsistent.Combination products of glucosamine plus chondroitin are probably effective, but there is no reliable evidence that it is better than glucosamine alone.
Consider recommending in adults
Don’t recommend these products
Slide22L-Methylfolate (Deplin)
Dietary folate is a mixture of different forms of folate – converted to L-methylfolate enzymatically
Compared to folic acid in pregnancy and heart disease – slightly more bioavailable but with continued use there is no difference in blood levels
Safety appears to be equivalent to folic acid – avoid high dose use in elderly (just like folic acid) due to possible increased cancer risk
No need to recommend
Slide23Nausea TreatmentsPyridoxine (B6) and Ginger
Pyridoxine: ACOG considers pyridoxine a first line option for N/V of pregnancy - however, it should not be used long-term or without medical supervision25 mg every 8 hours better than placebo Lower doses also help for nauseaDoxylamine added when patients don't respond to pyridoxine aloneGinger: 250 mg four times daily better than placebo and comparable to vitamin B6. Takes approximately 3 days to see benefit.Chemotherapy related nausea: Contradictory evidence of effectiveness for CINV. PONV: 1 gram one hour prior to surgery seems to reduce the incidence of 24-hour postoperative nausea and vomiting
AdultsBoth likely safe when used orally.Pyridoxine is possibly safe in amounts exceeding the recommended dietary allowance and possibly unsafe in doses exceeding 1000 mg daily or total doses of 1000 grams (neuropathy).Pregnancy: Pyridoxine is likely safe; but possibly unsafe when used in excessive doses. There is some concern that high-dose maternal pyridoxine can cause neonatal seizures.Ginger is possibly safe in pregnancyChildren: Pyridoxine is likely safe
Consider recommending
Slide24Summary of Select Supplements in Adults*
Safety/EfficacyLikely SafePossibly SafeInsufficient EvidencePossibly UnsafeLikely UnsafeUnsafeEffectiveFish OilLikely EffectiveCo-Enzyme Q10Ginger Glucosamine SulfatePyridoxinePossibly EffectiveChondroitin SulfateFlaxseedEchinaceaGarlicGinkgoSiberian GinsengAmerican GinsengPanax GinsengInsufficient EvidenceGlucosamine HClPossibly Ineffective
Consider recommending this product.
Don't recommend using this product.
Recommend against using this product.
*Listed are the best efficacy and safety ratings for each product, different doses and uses may have different ratings.
Slide25Weight Loss Supplements
Appetite suppression – hoodia, Fen-phen
Metabolism boosters – ephedrine, bitter orange, caffeine
Inhibition of nutrient absorption – orlistat (Xenical), barley, bean pod
Slide26Weight Loss Supplements
Hoodia – succulent from South Africa – difficult to find so often substituted with cactus no evidence that it is effective
Ephedrine (not ephedra) – similar to PPA – when combined with caffeine may lead to wt loss – also
↑risk of psychiatric symptoms, autonomic hyperactivity and palpitations
Chromium – small effect if any
Slide27Weight Loss Supplements
Bitter Orange –
linked to reports of ischemic stroke and cardiotoxicity including tachyarrhythmia, cardiac arrest, syncope, angina, MI, ventricular arrhythmia, and death in otherwise healthy patients
Conjugated linoleic acid (CLA) -
may increase lean body mass but not decrease total body weight – may be associated with insulin resistance
Slide28Summary of Select Weight Loss Supplements in Adults*
Safety/EfficacyLikely SafePossibly SafeInsufficient EvidencePossibly UnsafeLikely UnsafeEffectiveLikely EffectivePossibly Effective- Blond psyllium (for orlistat side effects)- Calcium- Conjugated linoleic acidEphedraInsufficient Evidence- Barley- Chromium- St John’s Wort- Bean pod- Chitosan- Glucomannan- Guggul- pyruvate Cha de bugre Hoodia- Usnea5 HTP Bitter orangeAristolochiaPossibly Ineffective- Guar gum Garcinia Inulin
Consider recommending this product.
Don't recommend using this product.
Recommend against using this product.
*Listed are the best efficacy and safety ratings for each product, different doses and uses may have different ratings recreated from Pharmacist’s Letter
Slide29HCG diet
Human Chorionic Gonadotropin given by IM injection or now sublingually in addition to 500-800 calorie diet
Shown to be no more effective than 500-800 calorie diet by itself
Promoted by Kevin Trudeau in his book, “The Weight Loss Cure “They” Don’t Want You to Know About.”
Slide30Patient Friendly Information
Fact sheets on dietary supplements from the National Institutes of Health: http://nccam.nih.gov/
Patient Handouts from Natural Medicines Database or Natural Standard
Slide31Summary
As with conventional drugs, careful consideration of the risk vs. benefit should be done before recommending natural medicines.
Products without clear benefit and safety should be avoided.
Products that are
likely safe and effective or likely effective
and are high quality (e.g. USP-Verified Mark) are appropriate to recommend.
Ask your patients specifically about herbal products
Find a good consultation source, whether it is a good database or a good pharmacist!
Slide32Slide33References
Winslow and Kroll. Herbs as medicines. Archives of Internal Medicine 1998;158:2192-99.
Fugh-Berman A. Herb-drug Interactions. Lancet 2000; 355:134-38.
Eisenberg DM, Davis RB, Ettner SL, et al. Trends in alternative medicine use in the United States, 1990-97. JAMA 1998; 280:1569-75.
MacKichan and Ruthman. AORN 2004;79:948-59.
Cole and Fetrow. Adulteration of dietary supplements. Am J Health-Syst Pharm 2003;60:1576-80.
De Smet, Herbal Remedies. New Eng J Med 2002.
Natural Database Online
http://www.naturaldatabase.com
. Last accessed September 2009.
Ang-Lee M et al. Herbal medicines and perioperative care. JAMA 2004;286:208-216.
Tesch, B.J. Herbs commonly used by women: an evidence based review. Disease-A-Month. Volume 48, Issue 10. October 2002.
Natural Standard Online
http://www.naturalstandard.com
.
Accessed September, 2009.
Pharmacist's Letter Natural Medicines Confusion in the Supplement Aisle: How to Help Consumers Select Dietary Supplements Volume 7, No. 33 Self Study Course #07033.
Hulisz, Darrell T.Top Herbal Products: Efficacy and Safety Concerns CME/CE. MedScape. Release Date: January 4, 2008
Barnes PM, Bloom B, Nahin R.
CDC National Health Statistics Report #12
. Complementary and Alternative Medicine Use Among Adults and Children: United States, 2007. December 10, 2008