HERBS AND SUPPLEMENTS
REETU GREWAL, MD
COMMUNITY HEALTH & FAMILY MEDICINE
UF HEALTH JACKSONVILLE
NO DISCLOSURES
INTRODUCTION
• Plants have been used for medicinal purposes for thousands of years
• Saw palmetto was used for urinary symptoms in men from Egypt in the 15th century BC
• Hippocrates documented the use of St. John's wort for mood ailments in the 5th century
BC
• Many conventional medications are derived from plant species
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Codeine (Poppy--Papaver somniferum)
Digoxin (Foxglove--Digitalis purpurea)
Salicylic Acid (Willow bark--Salix purpurea)
Taxol (Pacific yew--Taxus brevifolia)
INTRODUCTION
Data from the 2007 National Health Interview Survey show
about 40% of US residents integrate 1 or more of these
unconventional health practices into their personal health
care, spending about $34 billion per year out of pocket
Useage worldwide is much higher than in the US
PATIENTS WHO USE HERBS/SUPPLEMENTS
• Female gender
• Higher education
• Higher household income
• Western region of residence
• Hispanic or non-hispanic minorities
• Individuals who had more positive self-reported health status
QUALITY
• Plant species used (multiple strains of Echinacea)
• Plant part used
• Harvesting and storing
• Processing (drying, alcohol extraction, pressing out juice)
• Purity (heavy metals, toxins)
SAFETY
• Herb-Drug Interactions
• St Johns Wort inhibits CYP450
• Grapefruit Juice inhibits CYP450
• No Herbs if on Warfarin
• Lack of Evidence, Poor Quality Studies
• Not regulated by the FDA
• Regulation is based on the Dietary Supplement Health and Education Act
(DSHEA) of 1994
• This act was passed to make natural medicine available to the population
at a faster rate then if they went through the rigorous testing of the FDA
SAFETY
• USP United States Pharmacopial Convention
• A scientific nonprofit organization that sets standards for the identity,
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strength, quality, and purity of medicines, food ingredients, and dietary
supplements manufactured, distributed and consumed worldwide, 900 +
volunteer experts
Contains the ingredients listed on the label, in the declared potency and
amounts.
Does not contain harmful levels of specified contaminants.
Will break down and release into the body within a specified amount of time
Has been made according to FDA current Good Manufacturing Practices
using sanitary and well-controlled procedures
GLUCOSAMINE AND CHONDROITIN
• #1 Supplement sold in the US
• Produced by the body
• Most studies are relatively short duration
• GAIT Trial (DBPCT) 600+ pts
• Initial trial 24 weeks, evaluated G (500 mg TID), CS (400 mg TID), and together
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vs celecoxib (200 mg Q day) and placebo
• Results looked promising for G and CS together for moderate to severe
arthritis
Continued study for 2 years
• No significant improvement
• Side effect: GI
PROBIOTICS
• Most common are Lactobacillus and Bifidobacteria, in powders, capsules, yogurts,
suppositories
• No reviews for claims other than diarrhea (boosting immunity)
• Prevention of Antibiotic Associated Diarrhea
• 2012 Meta-analysis; RDBPCTs; 34 studies, 4K pts
• Tx all infections RR 0.53, NNT 8
• Tx H pylori infection RR 0.36, NNT 5
• Prevention of C diff associated diarrhea
• RCTs of adults and peds patients, Meta-analysis of 20 trials, ~ 4K pts, any strain, any dose
• 13 of the trials were lacking data on C difficile outcomes
• Moderate quality evidence suggest benefit
ZINC
• Inhibits rhinovirus in vitro
• Lozenges, Tablets, Liquid; Previously sold as intranasal swabs
• Side effects: nausea, vomiting, metallic taste
• Cochrane Review: 1966-2013; Prevention and treatment
• RDBPCT using Zn at least 5 days for tx or >5 months for prevention
• 16 therapeutic trials: 1400 pts; significant effect on duration of cold if started within 24 hours, no
effect on severity, need to take >75 mg/day
• 2 preventive trials: insufficient data to make a recommendation
• Author’s Conclusion: Zinc is effective for treatment if started early, needs >75 mg/day
VITAMIN C
• Generally recommended dose of 1-3 gm/day
• Side effects: diarrhea
• Cochrane Review 2010-2012; Prevention and Treatment of Colds
• RCTs using greater than 0.2 gm/day
• Prevention Trials: 29 studies, >10K pts; Risk Ratio was 0.97 with vitamin C
• Treatment Trials Regular (daily) supplementation: 31 studies, ~10K pts; Adults showed
decrease in duration by 8%, children showed decrease of 18%; severity of sx was also
decreased
• Treatment Trials (therapeutic): 7 studies, no effect on duration or severity of symptoms
• Author’s Conclusion: Vitamin C is effective for treatment when taken daily
during season
HONEY
• Used as a treatment for cough
• DBPCRS of 300 children, ages 1-5, given 1 of 3 types of honey (10 gm) or
placebo in a single dose and compared to no medication the previous night
• Evaluated cough frequency, severity and sleep quality of parents and
children
• All interventions (placebo included) showed statistically significant
improvement in sx, however the honey tx groups had greater improvement
than placebo
• Author’s Conclusion: Honey may be an effective tx, more studies are needed
Pediatrics, 2012
CINNAMON
In animals attenuation of diabetes associated weight loss, reduction of fasting blood glucose,
LDL and HbA(1c) , increasing HDL cholesterol and increasing circulating insulin levels
½ tsp per day of raw cinnamon or 1-6 gm /day of cassia cinnamon (PL)
Conflicting Data of Evidence
J Clinical Nutrition review 2001-2011
Meta-analysis of 6 RCTs, from 40days-4 months, doses from 1-6 g/day
Decrease in HbA1c 0.09% statistically significant
Cochrane review up to 2011
10 RCT, 500+ pts, 4-16 weeks
High risk of bias in all trials (selection, attrition, blinding), poor quality
No evidence of effectiveness
SOY (ISOFLAVONES)
• Used for tx of menopausal symptoms
• Soy is a phytoestrogen, phenolic ring binds to estrogen receptor, are about
100-10K x weaker than endogenous estrogen
• Side effects: GI upset, taste intolerance
• Cochrane review, 1966-2004
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RPCT at least 4 weeks in duration, 25 trials, >2K pts, avg age 53
Soy foods/beverages/powders (11) Maybe beneficial but small trend
Soy Extracts (9) No Effect
Red Clover (5) No effect
COENZYME Q10 (UBIQUINONE)
• Important in muscle metabolism, decreased during statin therapy
• 2007 JACC Systematic Review
• Numerous studies show supplementation raises circulating levels of CoQ10
• Only 2 studies evaluating effect on myalgias, small and not well designed
• Not beneficial for myalgia treatment
• 2012 Systematic Review on tx of myalgias with statin use
• 3 RCTs; 2 of good quality , 1 poor
• 2 studies showed decrease in pain scores although not statistically significant, 1
study showed no difference
• Authors conclusion: may be beneficial for patients with mild symptoms
SAW PALMETTO (SERENOA REPENS)
• The proposed mechanisms of action include 5-alpha reductase inhibition,
intraprostatic androgen receptor blockage, and adrenergic receptor
antagonism.
• Mild GI side effects, URI
• Most common doseage is 160 mg BID
• 2002 Cochrane Review
• 21 trials ranging from 4-48 wks, 3K pts; nocturia reduced, improvement of sx
• Methodological problems noted within the trials included lack of standardized
symptom scores and short study durations
SAW PALMETTO
• STEP Trial (NIH funded)
• RPCT USP formulated product, 225 pts, 1 year study
• Used AUA scores for symptoms
• No difference in placebo vs. saw palmetto
• CAMUS Trial evaluated saw palmetto on psa
• Stepped therapy starting at 160 mg BID and increasing Q 6 months
• 300 patients, evaluated at 24, 48 and 72 weeks
• No effect on PSA
RESOURCES FOR PROVIDERS
• NIH National Center for Complementary and Alternative Medicine
• http://nccam.nih.gov/
• Medline Plus
• http://www.nlm.nih.gov/medlineplus/druginfo/herb_All.html
• Prescribers Letter
QUESTIONS???
REFERENCES
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www.uptodate.com
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Briggs JP, Killen J. Perspectives on complementary and alternative medicine research. JAMA. 2013
Aug 21;310(7):691-2.
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www.USP.org
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Linde K, Berner MM, Kriston L. St. John’s wort for major depression.Cochrane Database Syst Rev.
2008;(4):CD000448
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Linde K, Barrett B, Bauer R, Melchart D, Woelkart K. Echinacea for preventing and treating the common
cold. Cochrane Database of Systematic Reviews 2006, Issue 1.
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Hemilä H, Chalker E. Vitamin C for preventing and treating the common cold. Cochrane Database of
Systematic Reviews 2013, Issue 1
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Singh M, Das RR. Zinc for the common cold. Cochrane Database of Systematic Reviews 2013, Issue 6.
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Cohen HA, Rozen J, Kristal H, et al. Effect of honey on nocturnal cough and sleep quality: a doubleblind, randomized, placebo-controlled study. Pediatrics. 2012; 130(3): 465-471.
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Schmidt M, Thomsen M, U Schmidt. Suitability of Ivy Extract for the Treatment of Paediatric Cough.
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• Sawitzke AD, Shi H, Finco MF, et al. Clinical efficacy and safety over two years use of glucosamine, chondroitin sulfate, their
combination, celecoxib, or placebo taken to treat osteoarthritis of the knee: a GAIT report. Ann Rheum Dis. 2010; 69 (8) 1459-1464.
• Videlock EJ, Cremonini F. Meta-analysis: probiotics in antibiotic-associated diarrhea. Alimen Pharmacol Ther. 2012; 35(12): 13551369.
• Johnston BC, Ma SS, Goldenberg JZ, et al. Probiotics for the prevention of Clostridium difficile-associated diarrhea: a systematic
review and meta-analysis . Ann Intern Med. 2012 Dec 18;157(12):878-88.
• Videlock EJ, Cremonini F. Meta-analysis: probiotics in antibiotic-associated diarrhea. Aliment Pharmacol Ther 2012
• GL Andriole et. Al. The Effect of Increasing Doses of Saw Palmetto Fruit Extract on Serum Prostate Specific Antigen: Analysis of
the CAMUS Randomized Trial . The Journal of UrologyVolume 189, Issue 2, February 2013, Pages 486–492.
• Bent S, Kane C, Shinohara K, et al. Saw palmetto for benign prostatic hyperplasia. N Engl J Med 2006;354:557–66
• http://nccam.nih.gov/
• Reinhart KM, Woods JA.. . Strategies to preserve the use of statins in patients with previous muscular adverse effects. Am J
Health Syst Pharm. 2012 Feb 15;69(4):291-300
REFERENCES
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Reinhardt KM, Woods JA. Strategies to preserve the use of statins in patients with previous muscular
adverse effects. Am J Health-Syst Pharm. 2012; 69: 291-300.
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Marcoff L, Thompson PD. The role ofcoenzyme Q10 in statin-associated myopathy.A systematic review.
J Am CollCardiol. 2007; 49:2231-7
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Akilen R, Tsaiami A, Devendra D, Robinson N. Cinnamon in glycaemic control: Systematic review and
meta analysis. Clin Nutr. 2012 Oct;31(5):609-15.
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Ranasinghe P, Jayawardana R et al. Efficacy and safety of 'true' cinnamon (Cinnamomum zeylanicum)
as a pharmaceutical agent in diabetes: a systematic review and meta-analysis. Diabet Med. 2012
Dec;29(12):1480-92.
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Leach MJ, Kumar S. Cinnamon for diabetes mellitus. Cochrane Database Syst Rev. 2012 Sep 12;9