Alternative Medicine. In 1997, 42% of US adults reported using. one or more forms of alternative medicine. $27 billion out of pocket dollars spent on …
The Terror Within: Americans Fight Obesity with Diet and Supplements
Debra Sullivan PhD, RD
Department of Dietetics and Nutrition University of Kansas Medical Center
It is estimated that approximately 38 of women and 24 of men are trying to lose weight at any point in time
Critical Reviews in Food Science and Nutrition2001;411: 1-28
Alternative Medicine
In 1997, 42 of US adults reported using one or more forms of alternative medicine 27 billion out of pocket dollars spent on alternative medicine in 1997 Less than 40 of the alternative therapies were disclosed to a physician
Eisenberg DM et al JAMA 280:1569, 1988
Dietary Supplement Popularity
Lifestyle changes to lose weight are difficult More readily available, less expensive Perpetuation of the myth that natural equals safe
Product X: Guaranteed to Help You Lose Weight
Product X
1
Who Uses Dietary Supplements?
According to the Behavioral Risk Factor Surveillance System, a randomized digit telephone survey conducted in
1998 in 5 states: 7 of respondents reported nonprescription weight loss product use Young, obese women 284 Normal-weight women 79 Prescription weight loss users 338
Alternative Medicine?
There is no alternative medicine There is only scientifically proven, evidence-based medicine supported by solid data or unproven medicine, for which scientific evidence is lacking Fontanarosa Lundberg JAMA 1998
Presentation Overview
Ø Ø Ø Ø Ø Ø Ø Ephedra Ma Huang Hydroxycitrate Conjugated Linoleic Acid Pyruvate Chitosan Chromium Picolinate Carnitine
Product X
Ø How It Works Ø Testimonials Ø Guarantee Ø Order Now
Ephedra Ma Huang
Reported to have stimulant effects and when used in combination with caffeine, may decrease weight through thermogenesis and reduced appetite In 1999, it is estimated that 12 million individuals were using ephedra products Metabolife, Diet Fuel, Herbal Ecstasy, etc
Ephedra Testimonials
Ø Boozer et al, 2001 n 67 overweight subjects Metabolife x 8 weeks 30 fat
diet
exercise Results: Significant greater weight loss in EC group: 4034 vs 0824 kg Significant difference in heart rate; BP different at 6 weeks, but not at other time points No significant differences in ECG Attrition 23 EC, 0 placebo
How It Works
ØStructurally similar to amphetamines, induces SNS effects
2
Ephedra Testimonials Meta-analysis
Shekelle et al, 2003
Promotes modest short-term weight loss 09 kg/month more than placebo No data regarding long-term weight loss available No studies over 6 -months Safety data from 50 trials revealed a 22 to 36-fold increase in odds of psychiatric, gastric, and cardiac side effects
Ephedra Safety Controversy
A study by Bent and colleagues reported that products containing ephedra accounted for 64 of all reported adverse effects from herbs even though they represented less than 1 of total herbal product sales
Ephedra Side Effects
Ø
CAUTION Negative side effects Mild: nervousness, dizziness, tremor, heart rate and BP,
headache, GI distress Severe: chest pain, MI, hepatitis, stroke, seizures, psychosis and death
Ephedra Side Effects
ØFDA received 140 adverse event reports
from 6/1/97 to 3/31/99
ü22 Events Attributable to Ephedra ü38 Events Supportive ü72 Events Insufficient Data ü8 Events Not evaluated
Ephedra Drug Interactions
Ø Cardiac glycosides or halothane arrhythmias Ø Guanethidine: enhancement of sympathomimetic effect Ø MAO inhibitors: greatly raise sympathomimetic action of ephedra
Ephedra Ma Huang WARNING
Not intended for use by anyone under the age of 18 Do not use this product if you are pregnant or nursing Consult a health care professional before using this product if you have heart disease, thyroid disease, diabetes, high blood pressure, depression or other psychiatric condition, glaucoma, difficulty in urinating, prostate enlargement, or seizure disorder, if you are using a monoamine oxidase inhibitor MAOI or any other prescription drug, or you are using an over-the-counter drug
containing ephedrine, pseudoephedrine or phenylpropanolamine
3
Ephedra WARNING
Continued
Ephedra Ma Huang
SERVING LIMIT Products are not to contain in excess of 25mg of total ephedrine alkaloids per serving; usage instructions should limit daily consumption to 100mg of total ephedrine alkaloids
Exceeding recommended serving will not improve results and may cause serious adverse health effects Discontinue use and call a health care professional immediately if you experience rapid heartbeat, dizziness, severe headache, shortness of breath, or other similar symptoms
Ephedra Safety
NIH commissioned the RAND Corporation study to evaluate the safety and efficacy of supplements containing ephedra
ØStudy reviewed 16,000 adverse events 21 sentinel events 4 Heart attack, 9 Stroke, 1 Seizure, 5 psychiatric cases, 2 Death
RAND Study Conclusions
Limited evidence of an effect on short-term weight loss Minimal evidence of an effect on performance enhancement Associated with higher
risks of mild to moderate side effects
Ephedra Ma Huang
Order Now ?
Follow label warnings and consult physician Use modest dose with caution for short term
Hydroxycitrate
Ø How It Works
Garcinia Cambogia, a natural fruit acid from brindleberry rind In vitro, HCA inhibits ATP-citrate, rate limiting step of de novo long chain fatty acid synthesis In vivo animal data suggest the effect is time and dose dependent
4
Hydroxycitrate Testimonials
Westerterp-Plantenga et al, 2001 6-wk cross-over trial n24 Consumed 100ml tomato juice with 300mg HCA or 100 ml tomato juice placebo 3 times/day for two weeks Results: 24-hour energy intake ? 15-30 p 005 compared to placebo Snacking decreased significantly Produced 05 kg weight loss
Hydroxycitrate Testimonials
Kriketos et al, 1999 n10 men
EE
Dose: 3g/d x 3 days Results: No effect on substrate metabolism or Dose: 12 g/d x 12 weeks 1200 kcal diet Results: Significantly more wt loss in HCA
group 3731kg vs 2429kg
Mattes
Bormann, 2000 n89 females
Hydroxycitrate
Ø Guarantee
No strong supportive data of HCA alone No side effects noted thus far, but safety issues unknown
Conjugated Linoleic Acid
Ø Proposed Action
Helps reduce fat and promotes lean mass gains
Ø How It Works
Group of isomers of linoleic acid containing double bonds
Ø Order Now Ø NO Wait and see
Ø Diet sources dairy beef
Conjugated Linoleic Acid
Animal studies mice, pigs, dogs, chicks demonstrate weight loss and increased LBM Changes linked to increased lipolysis in adipose and oxidation in both adipocytes and skeletal muscle Pariza et al, 1997, Park et al, 1999
Conjugated Linoleic Acid Testimonials
Atkinson et al, 1999 Ø Dose: 27 g/day x 6 months Ø Results: No difference in body composition Vessby Smedman, 1999 Ø Dose: 42 g/day x 12 weeks Ø Results: significant body fat mass
5
Conjugated Linoleic Acid Testimonials
Blankson et al, 2000 n60 ØDose:17, 34, 51 or 68 g/day x 12 weeks ØResults: Significant decrease in FM at
doses 34 g and 68 g/day ØNo difference in LBM, BMI, or safety
Conjugated Linoleic Acid
Ø Testimonials - Humans
Ø Zambell et al, 2000 metabolic ward, n 17F Dose: 39 g/d CLA or Placebo sunflower oil x 64 d Ø Results: No difference in body weight or composition No difference in energy expenditure or fat oxidation No adverse effects noted
Conjugated Linoleic Acid
Kamphuis et al, 2003 n 54 13-week study with CLA supplementation following weight loss in overweight subjects Followed VLC diet for 3 weeks Dose: 18 g CLA or placebo/day low dose; or 36 g CLA or placebo per day high dose Results: CLA did not affect body weight regain ?regain of fat-free mass, ? RMR Did not result in improved body weight maintenance following weight loss
Conjugated Linoleic Acid
Larsen et al, 2003 Review of safety and efficacy of 13 randomized, short-term 6 month human trials Effective at weight loss in animal models but similar results not found in human trials Isomer t10,c12 may produce liver
hypertrophy and insulin resistance via a redistribution of fat deposition Decreases fat content of human milk
Conjugated Linoleic Acid
Ø Guarantee ü Inconclusive data ü Appears beneficial in animal models but mixed results in human trials More trials currently underway Ø Order Now Ø No Wait and see
Pyruvate
Ø How It Works 3-carbon metabolite of glycolysis Ø Claims: Promotes fat and weight loss, increased muscle mass, and increased endurance all without diet or exercise
6
Pyruvate
Ø Testimonials 5 human studies examined effect on weight loss ØResults: Significant weight loss in all studies ØComments/Concerns Short 3-6 weeks only 2 laboratories Often used pyruvate dihydroxyacetone
Pyruvate
Ø Comments/Concerns - continued Large doses: 6g 53g 2 studies pyruvate isocalorically substituted for CHO in VLCD 1 refeeding study with pyruvate at 20 of energy Weight loss relatively small, 08-13 kg
Pyruvate
Ø Guarantee Limited quality data, yet existing data suggest very large
doses are effective at producing small effects on weight Requires further study No studies on safety Ø Order Now Ø No Wait and see, but doubtful Ø How It Works
Chitosan
Chitosan is an amino polysaccharide derived from the powdered shells of marine crustaceans Proposed to bind to dietary fat, preventing digestion and storage
Ø Claims
Marketed as fat blockers or fat trappers Reported to block up to 120 g dietary fat/day
Chitosan Testimonials
Gades et al, 2002 n 7 healthy males Dose: High fat intake 120 g/day for 12 days; 525 g/day chitosan Results: Did not increase fecal fat content, and thus, did not block fat absorption Stern et al, 2000 n 7 healthy males Dose: 135 g dietary fat/day x 6 days; 12 g Chitosan 15 capsules Fat Trapper Results: No difference in fecal fat content
Chitosan Testimonials
Ø Pittler et al, 1999 n 34 overweight adults Normal ad lib diet Dose: 4 capsules chitosan or placebo x 28 days Results: No difference in body weight, serum lipoproteins or
fat soluble vitamins
7
Chitosan
Ø Guarantee In the absence of a low energy diet, evidence does not support that chitosan is effective at producing weight loss
Chromium Picolinate
Ø How It Works Chromium is essential element required for normal carbohydrate and lipid metabolism Ø Often sold for weight loss, particularly for obese people in danger of developing diabetes Ø Proposed Action ?Satiety ?Energy expenditure through thermogenesis
ØRisks
Some malabsorption of essential nutrients is possible Safety has not been rigorously tested Ø Order Now NO
Chromium Picolinate
ØTestimonials
Majority of data from exercising subjects 7 of 10 studies showed no effect Non-exercising subjects Amato et al, 2000 Healthy, older subjects n19; 1g/day Cr x 8 weeks Result: No difference in body composition, blood lipids or glucose
Chromium Picolinate
Ø Guarantee Ø Insufficient quality evidence that Cr alone is effective for weight loss Ø Risks ü Possible tissue accumulation and damage to
DNA ü Case reports of kidney damage and liver dysfunction after chronic ingestion of large doses of chromium Ø Order Now NO
Carnitine
Ø How It Works 3-hydroxy,4-N-trimethylaminobutyric acid Carnitine is required for long chain fatty acids to enter the mitochondria for oxidation Ø Proposed Action: ? the rate that the liver metabolizes fat
Carnitine
ØSources
Endogenous: produced in body from methionine lysine Diet: red meat and dairy foods
8
Carnitine
Ø Testimonials - Limited data regarding weight loss ü Effect on Carnitine Content and Fat Oxidation
Carnitine
Ø Testimonials continued Weight loss 1 RCT n36 women 2 g BID x 8 weeks No Difference in Body Composition 5/18 Carnitine Group stopped due to nausea and diarrhea
No evidence supplements muscle carnitine
content Arenas et al, 1991; Vukovich et al, 1994
No documented increase in lipid oxidation
Colombani et al, 1995; Decom baz et al, 1993
Bioavailability of oral supplements only 5-10
Carnitine
Ø Guarantee üNo
Justification to use as weight loss supplement üLarge oral doses may cause diarrhea or fishy odor Ø Order Now NO
Combinations
Ø Most products contain combinations of products Ø Ephedra caffeine appears effective Ø Effectiveness of other combinations unknown Ø Safety of combinations unknown Ø Safety with Rx drugs unknown
Combinations - Examples
Vitamin E Magnesium Chelate Zinc Chelate Chromium Picolinate Guarana Concentrate seed 40 mg caffeine Ma Huang Concentrate 12 mg naturally occurring ephedrines Bee Pollen Ginseng root Ginger root Lecithin Bovine Complex Damiana leaf Sarsaparilla root Golden Seal Nettles leaf Gotu Kola aerial part Spirulina Algae Royal Jelly
Cautious Conclusions
Ø Limited quality data available ü No single product has adequate supportive data ü Ephedra caffeine appears effective Use modest dose with caution NOAEL 90 mg/d ü Hydroxycitrate CLA may hold promise ü Pyruvate is doubtful ü Chitosan, Creatine, Carnitine are not
effective
9
Cautious Conclusions
Ø Unknown content of doses in herb preparations Ø Unknown herb-drug interactions Ø Individual susceptibilities
Alternative Medicine?
There is no alternative medicine There is only scientifically proven, evidence-based medicine supported by solid data or unproven medicine, for which scientific evidence is lacking Fontanarosa Lundberg JAMA 1998
Alternative Medicine?
Using Fontanarosa Lundbergs definition, At this point all current weight loss products are still unproven medicine, for which scientific evidence is lacking
Reviews
Dyck DJ: Can J Appl Physiol 25:495-523, 2000 Allison DB, Fontaine KR, Heshka S, Mentore JL, Heymsfield SB: Crit Rev Food Sci Nutr 41:1-28, 2001 Egger G, Cameron-Smith D, Stanton R: Med J Aust 171:604-608, 1999
Caffeine Comparison Chart
Beverage Serving Size
1 cup 1 cup 1 cup 1 cup 1 oz 1 oz 12 oz can Varies
Ephedra Comparison Chart
Product Serving Size Ephedra Alkaloid Dose 500 mg 2-15 mg
Caffeine Dose/Serving
60-150
mg 20-50mg 2-5 mg 6 mg 6 mg 35 mg 40 mg 25-50 mg per gram
Coffee Tea loose or bags Decaffeinated Coffee Hot Cocoa Milk Chocolate Baking Chocolate Cola drinks Guarna
Herb capsule Ephedra Herb Tea OTC Asthma tablet Rx Asthma tablet Pseudoephedrine
1 cup 10-15 mg 1 tablet 24 mg 1 tablet 25 mg Childs dose 30 mg
Pseudoephedrine HCl
Adult dose 60 mg
Pseudoephedrine HCl
12 hour dose
120mg
Pseudoephedrine HCl
10
Product X
Product X
11
Source:bcbsok.com
