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Non traditional Medical Therapies


									Complementary and
Alternative Medicine
(CAM) Therapies in

    Special Acknowledgement to
         Dr. Michael Evers
          Jenna Beckham
            Goals of this Lecture

• Describe some common non-traditional medical
  therapies used for obstetrical and gynecological
• Discuss what current evidence says about these
• Identify potential benefits and harms associated
  with commonly used herbal supplements
• To encourage you to include questions about non-
  traditional 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
   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
4. Herbal medicine--the use of botanicals with pharmacologic
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

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

                                     Clin Obstet Gynecol, 44(4), Dec. 2001, 780-788

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.
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
Flourished during the 1800’s when patients often did better
   than those treated with blood letting, emetics and other
• 2,000 acupuncture points on the body
• Connected via 12 main and 8 secondary pathways
• 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
• 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: 1548-
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
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
                Who uses CAM?
Defined their health status as poorer than non-users of
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%)
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

• Each of 12 primary
  meridians associated with
  and named for a specific
• Organs represent more
  than just the anatomic
• Approximately 360
  acupuncture points lie
  along meridians
• Endorphins and cortisol
  are released with point
Clin Obstet Gynecol, 44(4), Dec. 2001, 801-813; Anat Record, 262,
2002, 257-265                                             
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
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
      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
      Thirty two cases of Pneumothorax have been reported

      Cardiac tamponade
                                           Pain, 71(1997), 123-126
       • 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

       • 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

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
        Digoxin—From foxglove
        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,
Areas of Concern with Herbal Medicines

Toxic effects

Dangerous interactions with other

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

Used today primarily for treatment of menopausal

We really do not know the mechanism of action in black

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
 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

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
   regimen, shows
little potential as an
  important therapy
       for relief of

                              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
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
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

                                       MEDSURG Nursing, 17(1), Feb. 2008, 52-54
St. John’s Wort Drug Interactions
          Increases             Decreases
         Potency of:            Potency of:
•   SSRIs              •   HIV medications
•   Triptans           •   TCAs
•   Barbituates        •   Cyclosporine
•   Alcohol            •   Estrogen
•   Narcotics          •   Digoxin
•   Fenfluramine       •   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
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
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
Marketed as an immunity booster and to help lower
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

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,
             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).

 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
• The National Library of Medicine
• The National Center for Complementary and
  Alternative Medicine
• The NIH Office of Dietary Supplements
• Quackwatch
• To report an adverse event with a supplement
• Natural Standard database

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