Transcript Non-traditional Medical Therapies

Complementary and
Alternative Medicine
(CAM) Therapies in
OB/GYN
Special Acknowledgement to
Dr. Michael Evers
Jenna Beckham
Goals of this Lecture
• Describe some common non-traditional medical
therapies used for obstetrical and gynecological
conditions
• Discuss what current evidence says about these
therapies
• Identify potential benefits and harms associated
with commonly used herbal supplements
• To encourage you to include questions about nontraditional therapies when taking a history from a
new patient
Why should you care?
• The 2007 National Health Interview Survey (NHIS),
showed that approximately 38% of adults use CAM
• Women tend to use CAM more than men
• The use of herbal medicines has increased from 12.1%
to 18.6% (1997 to 2002)
• According to a 2007 government survey, Americans
spent $33.9 billion out-of-pocket on CAM during the
previous year
• Potential benefits and potential interactions with
traditional medicines
Altern Ther Helath Med,11(1), Jan/Feb 2005, 42-49; JAMA, 280(18), Nov 11, 1998, 1569-1575
Nahin, RL, Barnes PM, Stussman BJ, and Bloom B. Costs of Complementary and Alternative Medicine (CAM) and Frequency of Visits to CAM Practitioners: United
States, 2007. National health statistics reports; no 18. Hyattsville, MD: National Center for Health Statistics. 2009.
The National Center for Complementary and Alternative Medicine http://nccam.nih.gov/
What Does ACOG have to say?
Committee Opinion #227 (November 1997) acknowledges
seven categories of Complementary and Alternative
Medicine (CAM):
1. Mind-body interventions--yoga, meditation, t’ai chi, support
groups and biofeedback
2. Alternative systems of medical practice--Traditional Chinese
Medicine (TCM), homeopathy, chiropractic, acupuncture and
Native-American medicine
3. Pharmacologic and biologic treatments--folk medicine, medicinal
plants
4. Herbal medicine--the use of botanicals with pharmacologic
activity
5. Diet and Nutrition--the use of nutritional supplements or vitamins
as well as the use of specific diets to obtain health
6. Manual healing methods--massage, chiropractic manipulation
and biofield therapeutics
7. Bioelectromagnetic applications--magnets, nerve stimulation
Definitions
Diet supplement--product (other than tobacco) that is
intended to supplement the diet containing one or more
of the dietary ingredients listed here: vitamin, mineral,
an herb or other botanical, an amino acid, a dietary
supplement used by humans to supplement the diet by
increasing the total dietary intake, or a concentrate,
metabolite, constituent, extract or combination of any
ingredient described above
DSHEA--Dietary Supplement Health and Education Act,
passed in October, 1994; allowed for labeling and selling
of dietary supplements with little to no oversight by the
FDA
Clin Obstet Gynecol, 44(4), Dec. 2001, 780-788
Definitions
Allopathy--A therapeutic system in which disease is
treated by producing a second condition that is
incompatible with or antagonistic to the first.
Conventional medicine in the United States.
Definitions
Homeopathy--System of therapy developed by Samuel
Hahnemann based on the “law of similia”, from the
aphorism, simila similibus curantur (likes are cured by
likes), which holds that a medicinal substance that can
evoke certain symptoms in healthy individuals may be
effective in the treatment of illnesses having symptoms
closely resembling those produced by the substance
Therapy mediated through the potentiation of substances
which are prepared with serial dilutions, often to the point
in which no molecules of the active substance is
detectable
Flourished during the 1800’s when patients often did better
than those treated with blood letting, emetics and other
treatments.
Definitions
Acupuncture:
• 2,000 acupuncture points on the body
• Connected via 12 main and 8 secondary pathways
(Meridians)
• Meridians connect energy, qi (“chee”), between the
surface of the body and the internal organs
• Qi regulates spiritual, emotional, mental and
physical balance
• Qi is influenced by the opposing forces of yin and
yang
• When yin and yang are balanced, they work with the
natural flow of qi to keep the body healthy
• The placement of needles in the acupuncture points
helps to keep the flow of qi unblocked.
Who uses CAM?
“Why Patients Use Alternative Medicine: Results
of a National Study,” JAMA, 1998; 279: 15481553
1500 random surveys were sent out, 69% response
rate (1035)
Three Theories:
1. Dissatisfaction with conventional treatment
2. Need for personal control over treatment options
and decisions over health care decisions
3. Philosophical congruence with patient’s
worldview, spiritual/religious philosophy or beliefs
regarding health and illness
Who uses CAM?
More educated (50% with graduate degrees as
opposed to 31% of those with high school diploma
or less)
Those with holistic philosophy of health (“The health
of my body, mind, and spirit are related, and
whoever cares for my health should take that into
account”)
Had a transforming experience (“I’ve had a
transformational experience that causes me to
view the world differently than before”)
Being dissatisfied with conventional medicine not
predictive
Who uses CAM?
Defined their health status as poorer than non-users of
CAM
Specific conditions such as anxiety, back problems,
chronic pain or urinary tract problems were predictive
of using CAM
Only 4% of people relied solely on CAM for therapy
Highest rates of use in groups aged 35-49 (42%) and
50-64 (44%)
Acupuncture
A part of Traditional
Chinese Medicine (TCM)
36 States have state
licensure for acupuncture
9-12 million visits to
acupuncturists take place
in the United States
Acupuncture needles are
regulated by the FDA as
medical devices
Clin Obstet Gynecol, 44(4), Dec. 2001, 801-813; Anat Record, 262, 2002, 257-265
Acupuncture
• Each of 12 primary
meridians associated with
and named for a specific
organ
• Organs represent more
than just the anatomic
structures
• Approximately 360
acupuncture points lie
along meridians
• Endorphins and cortisol
are released with point
stimulation
Clin Obstet Gynecol, 44(4), Dec. 2001, 801-813; Anat Record, 262,
2002, 257-265
www.scienceandsociety.co.uk
Acupuncture’s uses for OB/GYNs
Nausea and Vomiting:
Revolves around acupuncture or
acupressure at site P6 (Neiguan point)
Sea-Band (Sea Band International,
Greensboro, N.C.)
Acupuncture’s uses for OB/GYNs
Nausea and Vomiting:
Multiple smaller studies have shown decreased
levels of nausea and vomiting in the first
trimester pregnancy, chemotherapy, motion
and in the postoperative period
The most methodologically sound of these
studies involved 161 women in three groups
(treatment, control, placebo) for 8 days
All three groups reported significant decrease in
nausea and vomiting, but there was no
difference among treatment vs. placebo
Am J Obstet Gynecol, 174(2), Feb. 1996, 708-715; Obstetrics & Gynecology, 2001;97:184-188
Acupuncture’s uses for OB/GYNs
Nausea and Vomiting:
187 women over 21 days with nerve stimulation at P6 with
ReliefBand (Woodside Biomedical, Carlsbad, CA.) or sham
device
Self-reporting scores for N/V decreased significantly
Study group gained more weight (2.9 lbs vs. 1.2, P=0.003)
No significant change in medication use between groups
Obstetrics & Gynecology, 2003;102:129-135
Acupuncture’s uses for OB/GYNs
Induction of Labor:
Study from Vienna took 45 women at 40 weeks and
administered treatment every other day for up to 10 days.
Study group had statistical significant cervical shortening
and interval to delivery (5.0 vs. 7.9 days)
Two studies in Norway had mixed conclusions on use of a
single acupuncture treatment after confirmation of SROM
At UNC we took 56 nulliparous women at 39+4 weeks or
beyond and half received 3 daily treatments. Study group
was more likely to labor spontaneously and less likely to
need a C/S
Rabl M, et. al., Wien Klin Wochenshr, 113, 2001, 942-946; J. Mat-Fetal & Neonatal Med Aug. 2006; 19(8), 465-70; Acta
Obstetricia et Gynecologica, 85, 2006, 1348-1353, Acta Obstetricia et Gynecologica, 86, 2007, 1447-1452
Acupuncture is not without potential risks
Infections:
One-hundred twenty-six cases of Hepatitis B have
been linked to acupuncture
Evidence for Hepatitis C infection in Japan
A few reported cases of HIV infection as well
Subacute bacterial endocarditis
Trauma:
Thirty two cases of Pneumothorax have been reported
Cardiac tamponade
Pain, 71(1997), 123-126
HERBS, DIETARY SUPPLEMENTS
AND YOUR PATIENTS
• Use of dietary supplements is common among the
U.S. adult population.
» >40% used supplements in 1988–1994
» >50% in 2003–2006
• Patients do not stop their herbal supplements during
pregnancy
• Among the 53% of adults >50 yrs using CAM, 58%
reported that they have ever discussed CAM with a
healthcare provider
• 61% said “it wasn’t important for my doctor to know,”
60% said “the doctor never asked.”
AARP, NCCAM. Complementary and Alternative Medicine: What People Aged 50 and Older Discuss With Their Health Care Providers. Consumer Survey Report; April 13, 2010
Gache, J et al. Dietary Supplement Use Among U.S. Adults Has Increased Since NHANES III (1988–1994) . NCHS Data Brief. April 2011:61.
JAMA 2002;287:37-344, Am J Obs GYN 2003;188(4):1039-1045, Ann Intern Med 2001;135:344
What are Herbal Medicines?
Herbal forms of medications are often dietary supplements
They are in the form of tablets or capsules, bulk herbs, oils, teas or
tinctures (alcohol extracted concentrates added to liquid)
Soup, potato chips or beverages that contain herbal ingredients are
not dietary supplements, they are foods and regulated by the FDA
There is no standardization as to concentration of “herbal
medicines,” or whether it is a raw botanical component or a
distillation.
Herbs themselves often have multiple ingredients which may have
biologic effect, so it is difficult to tell which ingredient is producing an
effect, if any
Clin Obstet Gynecol 44(4), Dec. 2001 780-788, ACOG Practice Bulletin, No. 28, June 2001
Herbal Medicines
About 30-40% of our drugs are grown in plant-form or
are photochemicals made in a laboratory
Well known drugs today were first discovered in plants
Atropine—Belladona
Codeine—Poppy
Digoxin—From foxglove
Ephedrine—Ephedra
Salicylic acid—Willow bark
Scolpolamine—Jimson weed
Quinine—From Cinchona bark
Taxol—Pacific yew
Vincristine—Madagascar periwinkle
BMJ 319, Oct. 16, 1999, 1050-1053; Clin Obstet Gynecol, 44(4), Dec. 2001, 853-863, www.uptodate.com
IF IT IS “NATURAL” IT MUST
BE SAFE, RIGHT?
Areas of Concern with Herbal Medicines
Toxic effects
Dangerous interactions with other
medications
Discontinuing known and effective
conventional therapies
What are Herbal Supplements used for?
• Generalized “Health”
• Menopausal symptoms
• Mood Disorders
• Weight Loss
Most Common Herbal Products Being Used
•
•
•
•
•
•
•
•
Echinacea (40.3%)
Ginseng (24.1%)
Ginkgo Biloba (21.1%)
Garlic (19.9%)
St. John’s wort (12.0%)
Peppermint (11.8%)
Ginger (11.7%)
Soy (9.4%)
Barnes, Complementary and alternative medicine use among adults, Advance Data from Vital Statistics,
US Dept of Health and Human Services, Rockville, MD 2004
Black Cohosh
(Actaea [Cimicifuga] racemosa, black snakeroot)
Traditionally used by Native Americans for gynecologic
conditions
Used today primarily for treatment of menopausal
symptoms
We really do not know the mechanism of action in black
cohosh
We do know that Black Cohosh is not estrogenic as it has
no impact on the vaginal cell status, LH, FSH, estradiol,
prolactin or endometrial thickness in comparison to
baseline
Ann Intern Med 137(10), Nov. 19, 2002: 805-813, Menopause 10(4); 2003:299-313; Menopause 15(1); 2008, 51-58
Black Cohosh
There are small studies that imply that it decreases the
intensity of vasomotor symptoms for menopausal women
Most studies performed with black cohosh for menopausal
symptoms did not last longer than 6 months
Most studies have been done in Germany where black
cohosh is approved for treatment of symptoms of the
climacteric
Almost all studies done on black cohosh is the formulation
Remifemin, distributed by GlaxoSmithKline in the US
Clin Obstet Gynecol 44(4), Dec. 2001, 853-863, Ann Intern Med 137(10), Nov 19, 2002, 805-813, Menopause 10(4);2003: 299-313,
Obstetrics & Gynecology 2006;107:247-255.
Black Cohosh
Herbal Alternatives for Menopause Trial (HALT)
--One-year RCT with 351 women
--Five arms
Black Cohosh (80)
Multibotanical that contains Black Cohosh (76)
Multibotanical that contains Black Cohosh plus
dietary soy counseling (79)
Hormone therapy [Estrogen +/- progesterone] (32)
Placebo (84)
Ann Int Med, 145(12), Dec. 19, 2006, 869-879
Black Cohosh
Herbal Alternatives for Menopause Trial (HALT)
“Black cohosh
used in isolation, or
as part of a
multibotanical
regimen, shows
little potential as an
important therapy
for relief of
vasomotor
symptoms.”
Ann Int Med, 145(12), Dec. 19, 2006, 869-879
Black Cohosh
Biggest side-effect is gastric discomfort.
There have been multiple (about 50) reported cases of
hepatoxicity…though no known mechanism to explain it
Regulatory agencies in Australia, Canada and the
European Union warn about hepatoxicity
US Pharmacopeia states black cohosh should have
cautionary statement on label
Menopause, 15(4), 2008, 628-638
Black Cohosh is NOT Blue Cohosh
Blue Cohosh (Caulophyllum thalictroides) has a very different
therapeutic profile
Both are sometimes referred to as “Squaw root”
Blue Cohosh is a vasoconstrictor with mild uterine effects.
Sometimes used to induce labor
Case reports of abruption and neonate seizures linked to
Blue Cohosh
St. John’s Wort
(Hypericum perforatum)
Named after St. John the Baptist’s birthday (6/24) when it typically
blooms
Multiple RCTs show that it is better than placebo for MILD to
MODERATE depression
Other RCTs show that it is as effective as prescription
antidepressants with fewer side effects
NO better than placebo for MAJOR depression
Side effects include mild HA, gastric upset, dizziness, fatigue and
photosensitivity
MAJOR concern for herb-drug interaction
Ann Intern Med 2002;136:42-35, Linda K et al Cochrane Database Systematic Review 2005;CD000448
St. John’s Wort
• Induces the CYP3A4 isozyme of the P-450 system
• CYP3A4 isozyme is responsible for metabolizing more
than 50% of all prescription drugs
• Induces the p-glycoprotein transport system in cell
membranes
MEDSURG Nursing, 17(1), Feb. 2008, 52-54
St. John’s Wort Drug Interactions
•
•
•
•
•
•
Increases
Potency of:
SSRIs
Triptans
Barbituates
Alcohol
Narcotics
Fenfluramine
•
•
•
•
•
•
•
Decreases
Potency of:
HIV medications
TCAs
Cyclosporine
Estrogen
Digoxin
Theophylline
Warfarin
Red Clover
Source of isoflavones and marketed as a soy
alternative for dealing with menopausal symptoms
Three RCT show equivocal results at best, often
with groups in the placebo and treatment arm
both having a large drop in symptoms
No serious real side effects
Menopause 11(1);2004:11-33, Ann Intern Med 137(10), Nov 19, 2002, 805-813
Evening Primrose Oil
Touted for premenstrual syndrome and
postmenopausal symptoms
A potent source of gamma linolenic acid (GLA), a
type of omega-3 essential fatty acid
One well done placebo controlled trial exists looking
at 56 women with at least 3 hot flashes a day
Evening Primrose Oil did not perform better than
placebo
The Evening Primrose plant also produces
substances that have anticoagulant effects
Menopause 11(1);2004:11-33, Ann Intern Med 137(10), Nov 19, 2002, 805-813, ACOG Practice Bulletin No. 28, June 2001
Dong Quai
Traditionally used in TCM for all gynecologic conditions
Often prepared as a tonic and used in conjunction with other
herbs
Increases uterine volume and weight in ovariectomized rats
Only one RCT has been done. It shows no benefit with hot
flashes over placebo
Has coumarin-like properties and its root contains Safrole, an
oil that is a known carcinogen
Menopause 11(1);2004:11-33, Ann Intern Med 137(10), Nov 19, 2002, 805-813, ACOG Practice Bulletin No. 28, June 2001
Ginseng
Marketed as an immunity booster and to help lower
weight
Many different types of Ginseng (Chinese, American,
Siberian) with different effects and VERY different
concentrations between brands
Minimal if any effect on menopausal symptoms and
no effect on FSH, estradiol levels, endometrial
thickness and vaginal pH
Side effects include insomnia, diarrhea, nausea,
vomiting and headaches
Interacts with warfarin and will lower INR
Menopause 11(1);2004:11-33, Arch Intern Med 158(20), Nov 9, 1998, 2192-2199, 2200-2211, Ann Intern Med 2002;136:42-53
Herbs you should know
Gingko—Used for memory and dementia treatment. Inhibits
platelet-activating factor, should not be used with patients
on NSAIDs, warfarin or heparin
Ginger—Used for nausea and vomiting in pregnancy. As
good as Vitamin B6. Inhibitor of thromboxane synthetase
which prolongs bleeding time, should use with caution
while on warfarin
May be important to discontinue these prior to procedures
and surgeries.
Ann Intern Med 2002;136:42-35, Obstetrics & Gynecology 2004;103(4):639-645
Herbs you should know
Bitter Orange—(Citrus aurantium, green orange).
Marketed for weight loss. Works just like ephedera,
can theoretically cause hypertension, stroke and other
cardiac problems. Only 1 RCT which showed no
benefit.
Garlic—Marketed for lowering cholesterol and to help
with hypertension. Nausa/vomitting, diarrhea, contact
dermatitis, inhibition of iodine uptake, decreases
platelet aggregation and increases INR in patients on
warfarin. Wide range of concentrations. May be important
to discontinue use prior to procedures and surgeries
Amer J Cardiol 2004;94:1359, Arch Intern Med 158(20), Nov 9, 1998, 2192-2199, 2200-2211, www.consumerlabs.com
Herbs you should know
Echinacea—Often used to treat the common cold. Herbal
products usually draw from closely related species, E.
pururea, E. pallida or E. angustifolia. Two NIH studies
have shown no benefit for shortening cold or flu symptoms.
May be helpful in URI’s. GI side effects are most common,
but can cause mild to severe reactions in those allergic.
People with allergies to other plants in the daisy family are
more susceptible (ragweed, daisy, marigolds).
http://nccam.nih.gov/health/echinacea/
In Review
• There are all types of CAM out there
• As insurance begins to pay for CAM, you may be asked for
a referral
• “Some” evidence that Black Cohosh, St. John’s Wort and
acupuncture work for certain conditions
• Remember the concept of “do no harm”
• Ask your patients what other therapies they are using,
especially before an upcoming surgery
Resources
• The National Library of Medicine
http://www.ncbi.nlm.nih.gov/PubMed/
• The National Center for Complementary and
Alternative Medicine http://nccam.nih.gov/
• The NIH Office of Dietary Supplements
http://ods.od.nih.gov/
• Quackwatch http://www.quackwatch.com
• To report an adverse event with a supplement
http://www.fda.gov/medwatch
• Natural Standard database
www.naturalstandard.com