Community Health amp 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 ID: 636569
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Slide1
Herbs and Supplements
Reetu Grewal, MD
Community Health & Family Medicine
UF Health JacksonvilleSlide2
No DisclosuresSlide3
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
Codeine (Poppy--
Papaver
somniferum
)
Digoxin (Foxglove--Digitalis
purpurea
)
Salicylic Acid (Willow bark--Salix
purpurea
)
Taxol
(Pacific yew--
Taxus
brevifolia
)Slide4
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 USSlide5
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 statusSlide6
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)Slide7
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 FDASlide8
Safety
USP United States
Pharmacopial
Convention
A scientific nonprofit organization that sets standards for the identity, 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 proceduresSlide9
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
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: GISlide10
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 benefitSlide11
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/daySlide12
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 seasonSlide13
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, 2012Slide14
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 effectivenessSlide15
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
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 effectSlide16
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 symptomsSlide17
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
sxMethodological problems noted within the trials included lack of standardized symptom scores and short study durationsSlide18
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 PSASlide19
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 LetterSlide20
Questions???Slide21
References
www.uptodate.com
Briggs JP
,
Killen J
.
Perspectives on complementary and alternative medicine research.
JAMA.
2013 Aug 21;310(7):691-2.
www.USP.org
Linde
K,
Berner
MM,
Kriston
L. St. John’s
wort
for major
depression.
Cochrane
Database
Syst
Rev
. 2008;(4):CD000448
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.
Hemilä
H,
Chalker
E. Vitamin C for preventing and treating the common cold.
Cochrane Database of Systematic Reviews
2013, Issue 1
Singh M, Das RR. Zinc for the common cold.
Cochrane Database of Systematic Reviews
2013, Issue 6.
Cohen HA,
Rozen
J, Kristal H, et al. Effect of honey on nocturnal cough and sleep quality: a double-blind, randomized, placebo-controlled study. Pediatrics. 2012; 130(3): 465-471.
Schmidt M, Thomsen M, U Schmidt. Suitability of Ivy Extract for the Treatment of
Paediatric
Cough.
Phytother
Res. 2012 26:1942-1947.Slide22
References
Roongroj
Bhidayasiri
, Stanley
Fahn
, William J. Weiner, et
al
American
Academy of Neurology Report of the Guideline Development Subcommittee of the Evidence-based guideline: Treatment of tardive syndromes:
Neurology
2013;81;463-469
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
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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
Urology
Volume
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):291-300Slide23
References
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.
Marcoff
L, Thompson PD. The role
ofcoenzyme
Q10 in statin-associated
myopathy.A
systematic review.
J Am
CollCardiol
. 2007; 49:2231-7
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.
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.
Leach MJ, Kumar S. Cinnamon for diabetes mellitus.
Cochrane Database
Syst
Rev.
2012 Sep 12;9