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Weight Loss Supplements—The Good, The Bad, The Ugly

Weight Loss Supplements—The Good, The Bad, The Ugly

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Weight Loss Supplements—The Good, The Bad, The Ugly

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  1. Weight Loss Supplements—The Good, The Bad, The Ugly Thad J. Barkdull, MAJ, MC Fellow, Sports Medicine Tri-Services National Capital Consortium Fellowship Fort Belvoir, Virginia Adapted from presentation by Rodney Gonzalez, MD

  2. Outline • Obesity Biostatistics • General Supplement Information • DSHEA of 1994 • Specific Weight Loss Supplements • Summary of Recommendations

  3. Obesity • Obesity in America (2000): • Estimated 30.5% of adults were obese (BMI > 30) • Estimated 15.5% of adolescents overweight (BMI 20-30)

  4. Obesity * from www.obesityinamerica.org a website for The Endocrine Society and The Hormone Foundation

  5. Obesity * from www.obesityinamerica.org a website for The Endocrine Society and The Hormone Foundation

  6. Obesity * from www.obesityinamerica.org a website for The Endocrine Society and The Hormone Foundation

  7. Obesity * from www.obesityinamerica.org a website for The Endocrine Society and The Hormone Foundation

  8. Obesity * from www.obesityinamerica.org a website for The Endocrine Society and The Hormone Foundation

  9. Obesity • Federal Trade Commission, Sep 2002: • U.S. Surgeon General said that overweight and obesity afflicted 6 out of every 10 Americans • Second leading cause of preventable death (after smoking) – 300,000 deaths/yr • Costs: Direct/indirect estimated to exceed $100 BILLION/year

  10. Supplements • In 2001, one study showed 53% of American adults use vitamins, supplements or minerals • Survey in 1998 found: • 7% of adults have used OTC weight-loss supplements • Greatest percentage in young, obese women (28%)

  11. Supplements • In 2000, consumers spent $34.7 billion on weight loss products and programs • In 2001, weight loss supplements had retail sales estimated at $1.3 BILLION • Metabolife 356 (ephedra containing) was the top selling at $70 million, increase of 127% over 2000 sales

  12. Supplements Dietary Supplement Establishments * from Dietary Supplement Strategic Plan Cost Out (Report to Congress) by the US FDA, Center for Food Safety and Applied Nutrition, May 29, 2002.

  13. Supplements Dietary Supplement Sales (1994 to 2000) * from Dietary Supplement Strategic Plan Cost Out (Report to Congress) by the US FDA, Center for Food Safety and Applied Nutrition, May 29, 2002.

  14. Supplements Dietary Supplement Estimated Sales Breakdown * from Dietary Supplement Strategic Plan Cost Out (Report to Congress) by the US FDA, Center for Food Safety and Applied Nutrition, May 29, 2002.

  15. Supplements In 2005, retail sales within the U.S. consumer packaged goods health and wellness industry reached $79 billion Functional/Fortified Foods & Beverages: $29.4 billion (26% growth)Vitamins, Minerals, Herbal & Dietary Supplements: $19.6 billion (3% growth)Organic Foods/Beverages: $12.8 billion (17% growth)Natural Foods/Beverages: $12.4 billion (11% growthNatural/Organic Personal Care: $4.9 billion (22% growth) * from Natural Marketing Institute, Feb 28, 2006.

  16. Supplements • Marketed as “natural” • May be interpreted as being safe and efficacious • Adoption of good manufacturing practices by supplement makers is not mandatory • Quality (absence of contamination and accuracy of labeling) may be variable and uncertain

  17. Dieter’s Cleanse is a 14-day cleanse program. [Weight Loss]. Proper cleansing of the digestive tract allows for better elimination of waste and improved absorption of nutrients from the food you eat. Bowel Detox provides key nutrients for digestive and intestinal systemic function and balance.Master Gland Formula strengthens the glands throughout the body that produce hormones essential for total body health. Hormones influence balance and harmony in all body systems. Enviro-Detox helps cleanse the daily accumulation of toxins from the body and is designed to provide ongoing support to the body’s natural cleansing functions. From www.natureshealthypeople.com Liver Cleanse Formula nourishes and strengthens the liver, the primary organ for filtering toxic waste. LBS II supports the production of digestive enzymes and bile to promote healthy colonic bacteria. GTF Chromium processed foods have little or no chromium; without chromium cells resist insulin and do not absorb the glucose necessary for energy. The liver also uses chromium to manufacture fatty acids, lecithin, cholesterol, and lipoproteins. SF (Vital Nutrition, Weight Management) supports the body with adaptogenic herbs for balance. Designed to support the body’s weight-management mechanisms, with added benefits for the Urinary and Digestive Systems. Higher quantities of nutrients are required during balancing required for weight management.*

  18. Ingredients:BOWEL DETOXVitamin A (beta-carotene) 534 IUVitamin C (ascorbic acid) 20 mg Vitamin E (d-alpha tocopherol) 4 IU Zinc (gluconate) 2 mg Selenium (amino acid chelate) 10.6 mcgBetaine HCl 16 mgBile Salts 16 mg Pancreatin 72 mgPepsin 16 mg Other Ingredients: Psyllium hulls (Plantago ovata), Algin (from brown seaweed), Cascara Sagrada bark (Rhamnus purshiana), Bentonite clay, Apple pectin, Marshmallow root (Althaea officinalis), Parthenium root (Parthenium integrifolium), Charcoal, Ginger rhizome (Zingiber officinale), Sodium copper chlorophyllin, gelatin, and water.

  19. MASTER GLAND FORMULA Vitamin A (beta-carotene) 900 IU Vitamin C (ascorbic acid) 60 mg Vitamin E (d-alpha tocopherol) 14 IU Pantothenic Acid (d-calcium pantothenate) 24 mg Zinc (gluconate) 6 mg Manganese (amino acid chelate) 1 mg Potassium (citrate) 20 mg Lecithin 25 mg Other Ingredients: Licorice root (Glycyrrhiza glabra), Alfalfa aerial parts (Medicago sativa), Asparagus stem (Asparagus officinalis), Black Walnut hulls (Juglans nigra), Kelp leaves and stem (Ascophyllum nodosum and Laminaria digitata), Parsley leaves (Petroselinum crispum), Parthenium root (Parthenium integrifolium), Thyme herb (Thymus vulgaris), Asparagus stem (Asparagus officinalis), Dandelion root (Taraxacum officinale), Dong Quai root (Angelica polymorpha), Lemon bioflavonoids, Schizandra fruit (Schisandra chinensis), Eleuthero root (Eleutherococcus senticosus), Marshmallow root (Althaea officinalis), Uva Ursi leaf (Arctostaphylos uva ursi) gelatin, and water.

  20. ENVIRO-DETOX Proprietary blend 501 mg Burdock Root (Arctium lappa)Dandelion Root (Taraxacum officinale)Fenugreek Seed (Trigonella foenum-graecum)Ginger Rhizome (Zingiber officinale)Marshmallow Root (Althaea officinalis)PepsinRed Clover Flowers (Trifolium pratense)Sarsaparilla Root (Smilax officinalis)Yellow Dock Root (Rumex crispus)Echinacea Root (Echinacea purpurea)Lactospores (Lactobacillus sporogenes)Cascara Sagrada Bark (Rhamnus purshiana)Milk Thistle Seed Concentrate (Silybum marianum) LIVER CLEANSE FORMULAAmount Per CapsuleProprietary blend 450 mg Red Beet Root (Beta vulgaris)Dandelion Root (Taraxacum officinale)Parsley Leaves (Petroselinum crispum)Horsetail Stems and Strobilus (Equisetum arvense)Yellow Dock Root (Rumex crispus)Black Cohosh Root (Cimicifuga racemosa)Birch Leaves (Betula pendula)Blessed Thistle Aerial Parts (Cnicus benedictus)Angelica Root (Angelica archangelica)Chamomile Flowers (Matricaria recutita)Gentian Root (Gentiana lutea)Golden Rod Aerial Parts (Solidago virgaurea)LBS II Amount Per 3 CapsulesProprietary blend 1,275 mg Cascara Sagrada Bark (Rhamnus purshiana)Buckthorn Bark (Rhamnus frangula)Licorice Root (Glycyrrhiza glabra)Capsicum Fruit (Capsicum annuum)Ginger Rhizome (Zingiber officinale)Oregon Grape Root (Berberis aquifolium)Turkey Rhubarb Root (Rheum officinale)Couch Grass Rhizome (Agropyron repens)Red Clover Tops (Trifolium pratense)

  21. GTF CHROMIUMChromium (chromium amino acid chelate,chromium nicotinate) 500 mcg Proprietary blend 472 mg Alfalfa Aerial Parts (Medicago sativa)Horsetail Stems and Strobilus (Equisetum arvense) Red Clover Flowers (Trifolium pratense) Yarrow Flower (Achillea millefolium) Other Ingredients: Magnesium stearate (vegetable), gelatin, and water. SFProprietary blend 900 mgChickweed Aerial Parts (Stellaria media)Cascara Sagrada Bark (Rhamnus purshiana)Licorice Root (Glycyrrhiza glabra)Safflower Flowers (Carthamus tinctorius)Black Walnut Hulls (Juglans nigra)Parthenium Root (Parthenium integrifolium)Gotu Kola Aerial Parts (Hydrocotyle asiatica)Hawthorn Berries (Crataegus oxyacantha)Papaya Fruit (Carica papaya)Fennel Seed (Foeniculum vulgare)Dandelion Root (Taraxacum officinale)

  22. Dietary Supplement & Health Education Act -1994DSHEA

  23. DSHEA of 1994 • Congressional Intent: • Limit impediments to marketing and promoting dietary supplements • Provide a wide availability of supplements to the consumer • Enhance information available to the consumers

  24. DSHEA of 1994 • Defined dietary supplements • Provisions for safety, marketing and good manufacturing practices • Provisions for ingredient and nutrient labeling • Provisions for use of health claims

  25. DSHEA of 1994 • Definitions of a supplement: “… a product (other than tobacco) intended to supplement the diet that bears or contains one or more of the following dietary ingredients …” [21 U.S.C. § 321(ff)(1)] vitamin mineral herb or other botanical amino acid a dietary substance for use by man to supplement the diet by increasing the total intake a concentrate, metabolite, constituent, extract or combination of any ingredient described above

  26. DSHEA of 1994 • Safe, unless proven unsafe by FDA • Not required to show bioequivalence • Can state that a product does something beneficial, but cannot make a medical claim • Must also have: “This statement has not been evaluated by the Food and Drug Administration. This product is not intended to diagnose, treat, cure, or prevent any disease.”

  27. Label Requirements * from www.cfsan.fda.gov/~acrobat/fdsuppla.pdf

  28. DSHEA of 1994 • Congressional Intent: • Limit impediments to marketing and promoting dietary supplements • Provide a wide availability of supplements to the consumer • Enhance information available to the consumers

  29. DSHEA of 1994 • Manufacturers Application: • Allow them to formulate and release supplements without research • Provide many different supplement types and combinations without research • Tell consumers what they want them to know about a product $$$

  30. Weight Loss Supplements • FTC Sep 2002 Reports: • Nearly 40% of sampled adds made at least one representation that almost certainly is false • 55% of the ads made at least one representation that is very likely to be false or lacks adequate substantiation • Between 1992 and 2001, frequency of weight loss advertisements in magazines doubled • Type of advertisement sifted from meal replacement in 1992 (57%) to dietary supplements (66%) in 2001

  31. Weight Loss Supplements “People do not want to make lifestyle changes. They are looking for the quick fix.”

  32. Weight Loss Supplements • Google: weight loss supplements • 54,800,000 • MD Consult: weight loss supplements • 1,378 Journals/MEDLINE • 1 Reference Book • 17 Current Practice • 41 Practice Guidelines • 139 Patient Handouts * Pop-up add from www.foxnews.com

  33. Our natural weight loss pills will surely make you a winner in the battle to lose weight. Now that the Ephedra ban has been overturned you have even more choices. Combined with a reduced calorie diet and a sensible exercise program you’re certain to meet your weight loss goals with the help of our natural weight loss pills. Click Here To View Ephedra Diet PillsClick Here To View Ephedra Free Diet Pills

  34. Weight Loss Supplements Eating good all the time just isn’t fun or practical! Cheaters Relief When you give into your desires, Cheaters Relief will help relieve the guilt while inhibiting the fats, carbs, and calories! Cheaters Relief will help you keep your shape, muscle tone, and definition when eating good just isn’t an option! * from www.supplements101.com

  35. Weight Loss Supplements • Should ask a patient about supplements: • “Have you tried, or considered trying, special diets, exercise programs, diet pills, herbs, or vitamins for weight loss?” • “Do you take any over the counter medications, including vitamins and supplements?”

  36. Increase energy expenditure Modulate carbohydrate metabolism Increase satiety Increase fat oxidation or reduce fat synthesis Block dietary fat absorption Increase water elimination Enhance mood Other miscellaneous or unspecified Weight Loss Supplements

  37. Weight Loss Supplements Ephedra Alkaloids and Caffeine Compounds • Increase energy expenditure • Ephedra • Bitter orange • Guarana • Caffeine • Country mallow • Yerba Maté

  38. Weight Loss Supplements Ephedra Alkaloids and Caffeine Compounds • Shekelle, et al. reported in 2003 a meta-analysis of RCTs showing ephedra had a weight loss of 2lb more per month compared to placebo • However, they also showed they had a 2.2 to 3.6-fold increase in adverse events (psychiatric, autonomic, cardiovascular and gastrointestinal symptoms)

  39. Weight Loss Supplements Ephedra Alkaloids and Caffeine Compounds • FDA MedWatch: • 87 reports of ephedra adverse events between June 97 and March 99 • HTN, arrhythmias, MI, stroke and seizures • 10 events led to death • 13 others yielded permanent disability • 9 of the 23 were at the recommended doses in individuals without cardiovascular risk factors

  40. Weight Loss Supplements Ephedra Alkaloids and Caffeine Compounds • Ephedra comprised 0.8% of dietary supplement sales in 2001 • However, in 2001, they were responsible for 64% of all herb-related adverse events reported to the U.S. Poison Control Centers • Bitter orange and country mallow and other ephedra-like substances are in the “Ephdra-free” weight loss supplements

  41. Weight Loss Supplements Ephedra Alkaloids and Caffeine Compounds “Some products, especially those containing stimulants, can cause short-term weight loss. (Likewise, amputation of an extremity can cause weight loss.) But the risk outweighs the benefit.” - Scott GN, et al. Problems with Weight Loss Products. Pharmacist’s Letter/Prescriber’s Letter 2006;22:1-3.

  42. Weight Loss Supplements Ephedra Alkaloids and Caffeine Compounds • The Good: • They work • The Bad: • They have many adverse events • The Ugly: • They can kill • Ephedra sales banned by the FDA in April 2004

  43. Ephedra Ban Ruled Invalid • Ephedra Diet PillsOn April 13, 2005 the 2004 Final Rule issued by the FDA banning Ephedra was overturned by a Federal Judge (Case No. 2:04CV409 TC).  An appeal was filed on June 13, 2005 however it will take some time for this case to be decided.

  44. Weight Loss Supplements Chromium and Ginseng • Modulate carbohydrate metabolism • Chromium • Ginseng

  45. Weight Loss Supplements Chromium and Ginseng • Chromium is thought to play a role in carbohydrate and lipid metabolism • Chromium deficiency is associated with hyperglycemia, hyper-insulinemia, hypertriglyceridemia and low HDL • Three (small) RCTs of chromium supplements showed no difference in weight loss when compared to placebo

  46. Weight Loss Supplements Chromium and Ginseng • No adverse events at recommended dose of chromium, but rhabdomyolysis and renal failure have been reported at super-therapeutic doses (1000mcg vs 200 to 400mcg)

  47. Weight Loss Supplements Chromium and Ginseng • Ginseng has preliminary data suggesting that it may improve glucose tolerance • No RCTs in humans have shown greater weight loss with ginseng when compared to placebo

  48. Weight Loss Supplements Chromium and Ginseng • The Good: • They may be safe • The Bad: • No good RCTs to show efficacy • The Ugly: • Potential renal failure

  49. Weight Loss Supplements Glucomannan, Psyllium, and Guar Gum • Increases satiety • Guar gum • Glucomannan • Psyllium