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Integrative Medicine in OB/GYN, highlights

UCSF Obstetrics and Gynecology UpdateOctober 26th, 2016By Sanjay Reddy, MDDirector Inpatient Integrative Medicine, UCSF

Disclosures• I have nothing to disclose

Goals of Session• Brief overview of Integrative Medicine/CAM

• Review resources for herb/supplement reference

• Sampling of evidence for different modalities

What is CAM?

• CAM (Complementary and Alternative Medicine) is a group of diverse medical and health care systems, practices, and products that are not generally considered part of conventional medicine.

http://nccam.nih.gov/health/whatiscam

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Integrative Medicine Big Overview• Biologically based therapies (fish oil, kava)• Whole systems (TCM, homeopathy)• Mind-body medicine (MBSR, biofeedback)• Manual Medicine (osetopathy, massage)• Energy Medicine (reiki, healing touch)

• Useful organization, but many cross overs

2012 NHIS Highlights• 33.2% of U.S. adults used complementary health approaches.

• Most common approach was natural products • (dietary supplements other than vitamins and minerals).

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Botanical Medicine• Old as people (probably)

• In the United States, the use of botanicals has increased significantly over the past two decades.

• In the USA annual total cost of more than $4 billion!

Herbal Usage• 2012 National Health Institute Survey:

• 23.6% of American adults have used herbs/dietary supplements

• A lot of our patients use them, less talk about it1• Recent study of oncologists showed less than half discuss

herbs with their patients

Lee RT et al. National survey of US oncologists' knowledge, attitudes, and practice patterns regarding herb and supplement use by patients with cancer. J Clin Oncol 2014; 32: 4095-4101 [PMID: 25403205 DOI: 10.1200/JCO.2014.55.8676]

Dietary Supplement and Health Education Act ‘94

• Classifies vitamins, minerals, botanicals, and amino acids as nutritional or dietary supplements

• Supplements can be marketed without proof of safety or efficacy

• No claims allowed to treat or cure

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Act ’94 continued• Manufacturers can make "structure and

function" claims • Ex. Black cohosh can be marketed to support women’s

health but not to treat hot flashes.

• FDA must first prove that a botanical preparation unsafe!• Opposite of medications

Safety Concerns• Adulterated like crazy

• Heavy Metals• Pesticides• Poisons• Prescription drugs• Things I don’t even know about…

How to Advise Patients• There’s a lot of adulterated products

• Discuss with their providers what they are taking

• Review tested products/quality

• In general, few botanicals have been studied for safety in pregnancy

Resources for Clinicians• Resources for busy clinicians at UCSF:

• Natural Medicines Comprehensive Database (www.naturaldatabase.com) and Natural Standard (www.naturalstandard.com).

• Third-party testing: www.consumerlab.com• 2-3$/mo, consumer products

• University of Maryland and Sloan:• https://umm.edu/health/medical/altmed/treatment/herbal-

medicine• https://www.mskcc.org/cancer-care/treatments/symptom-

management/integrative-medicine/herbs/search

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Purported Ginseng UsesGood evidence in humans

• Cancer Related Fatigue• Glucose lowering• Cognitive function (early

data)• Decreasing URI/colds

(some evidence)

Not so good• Prevent Cancer• Athletic Performance• Immune Stimulation

(animal studies +)• Strength and stamina

American GinsengPanax Quinquefolius• Asian Ginseng is Panax Ginseng, less human evidence

• Like Asian ginseng has ginsenosides• Exact mechanism of action unknown

• More calming than Asian ginseng

• Nourishes Yin

Ginseng and Cancer Fatigue• 364 patients from 40 institutions• >4 on Cancer Related Fatigue (CRF)

• (0 being none and 10 “as bad as it can be”) for at least 1mo prior to study

• Excluded steroids, opiates, current ginseng or other fatigue agents

• Showed American Ginseng 2000mg daily led to a significant difference in 8 weeks for CRF scores.

Barton et al. Wisconsin Ginseng (Panax quinquefolius) to Improve Cancer-Related Fatigue: A Randomized, Double-Blind Trial, N07C2. J Natl Cancer Inst. 2013 Aug 21; 105(16): 1230–1238.

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Ginseng Interactions• Can induce CYP3A4

• Can antagonize Warfarin’s effects and reduce effectiveness

Ma Huang- Ephedra sinica• TCM: typically very low dose with multiple other

herbs to treat asthma and very safe

• Sold for weight loss in massive doses, often with caffeine

• Contains ephedrine and pseudoephedrine

• 2004: banned in USA due to severe and fatal reactions: including hypertension, myocardial infarction, and stroke.

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Mindfulness Based Stress Reduction

• Structured 8wk program, 28h total

• Secular, based on Buddhist traditions

• Deliberate, sustained, nonjudgmental attention • enhance self-awareness • change maladaptive thinking• increase the capacity for skillful response• reduce suffering

MBSR Studies• Over 350 and counting, particularly effective for:

• Anxiety• Depression• Stress• “Cancer-related symptoms”

• mood disturbance• anxiety• stress• quality of life

Gotink RA. Standardisedmindfulness-based interventions in healthcare: an overview of systematic reviews and meta-analyses of RCTs. PLoS One. 2015 Apr 16;10(4)

Mindfulness-Based Childbirth• …and Parenting (MBCP)• 3h/wk for 9 wks, plus 7h silent retreat day and a reunion class• Pilot study of 27 women, third trimester

• Statistically significant pre to post-test: • + mindfulness and positive affect• -pregnancy anxiety, depression, and negative affect

• Qualitative with majority reporting benefits of mindfulness perinatally and early parenting

Duncan LG, Bardacke N. Mindfulness-Based Childbirth and Parenting Education: Promoting Family Mindfulness During the Perinatal Period. J Child Fam Stud. 2010 Apr;19(2):190-202.

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“Yes, I definitely am aware of trying to be in the moment and that each moment, good or bad, will pass. When I got really worried about the birth, I would just breathe to stop my mind from going allsorts of bad places. And in postpartum, I have tried to use the practice to deal with stressful situations whether it be a crying baby or just accepting my new role as a mother who doesn’t have much time for herself. Being mindful is always at the back of my mind, no matter what I am doing, even if it isn’t a formal practice.”

Variable Pre-MBCP level: M(SD)

Post-MBCP level: M(SD)

Mean change (SD)

t-value p-value Effect size, Cohen’sd

Perceived stress (PSS)

26.41 (6.73) 24.11 (4.99) −2.30 (6.13) −1.95 .062 .40

Pregnancy anxiety

2.49 (.58) 2.09 (.41) −0.39 (.32) −6.36 <.0001 .81

Depression (CES-D)

1.63 (.45) 1.48 (.34) −0.15 (.30) −2.59 .016 .38

Mindfulness 3.14 (.44) 3.44 (.38) 0.30 (.27) 5.66 <.0001 .74

Attention/Awareness

3.10 (.44) 3.25 (.35) 0.16 (.42) 1.95 .062 .38

Nonjudging 3.50 (.57) 3.78 (.60) 0.28 (.36) 4.13 .0003 .49

Nonreactivity 2.85 (.59) 3.31 (.51) 0.46 (.45) 5.35 <.0001 .85

Positive affect (PANAS)

3.30 (.70) 3.58 (.69) 0.28 (.60) 2.4 .024 .41

Negative affect (PANAS)

2.03 (.58) 1.83 (.47) −0.20 (.31) −3.35 .003 .39

Positive affect (DES)

3.64 (.67) 3.91 (.69) 0.27 (.56) 2.47 .020 .40

Negative affect (DES)

1.97 (.50) 1.83 (.50) −0.14 (.36) −2.04 .051 .29

Yoga in Pregnancy• What are the effects of an integrated yoga practice and guided

yogic relaxation in pregnancy on perceived stress and measure autonomic response?

• 122 women recruited between 18-20wk in Bangalore, randomized to yoga and deep relaxation or standard prenatal exercises for 1h/d. 45/group completed.

• Yoga intervention decreased perceived stress compared to control with consistent changes in heart rate variability.

Satyapriya et al. Effect of integrated yoga on stress and heart rate variability in pregnant women. Int J Gynaecol Obstet. 2009 Mar;104(3):218-22.

Yoga and Pregnancy, Results

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Acupuncture• Part of larger system of Chinese Medicine

• Use of needles to access energetic meridians throughout the body

• Alterations in energy flow cause disharmony

• Disharmony�Disease

Western Proposed Mechanisms• Acupuncture points unique, Connective Tissue

communication1,2:• Denser innervation, tightly packed connective tissue,

different receptor distribution• Central opiate receptors (varying types) mediate analgesic

effect3• Spinal and supraspinal neurotransmitter release; Narcan

can block effects• Local inflammatory mediators4

1. Langevin et al. Biomechanical response to acupuncture needling in humans J Appl Physiol, 91 (2001), pp. 2471–24782. Abraham et al. TRPV1 expression in acupuncture points: Response to electroacupuncture stimulation

(2011) Journal of Chemical Neuroanatomy, 41 (3) , pp. 129-1363. Han, JS. Acupuncture Analgesia: Areas of consensus and controversy. Pain. 2011 Mar;152(3 Suppl):S41-8. doi: 10.1016/j.pain.2010.10.014. Leung, L. Neurophysiologic Basis of Acupuncture Induced Analgesia- Un Updated Review. J Acupunct Meridian Stud. 2012 Dec;5(6):261-70. doi:

10.1016/j.jams.2012.07.017. Epub 2012 Aug 22.

Langevin HM et al. Mechanical signaling through connective tissue: a mechanism for the therapeutic effect of acupuncture. FASEB J. 2001 Oct;15(12):2275-82.

NIH ‘97 Report of Efficacy • Myofascial Pain• Headache• Dental Pain• Fibromyalgia• Tennis Elbow• Osteoarthritis• Menstrual Cramps

• Nausea• Asthma• Stroke Rehab• Addictions• Carpal Tunnel • Lower Back Pain

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Safety- Many studies• Sample study of German physicians:

• 140 hours of formal acupuncture training• Only 19%>350 hours of training• >95k people with >700k treatments: 6 Major Complications:

• Exacerbation of Depression • Acute HTN Crisis • Vasovagal reaction�LOC• Asthma attack�HTN and Angina • Pneumothorax x2

Melchart et al. Prospective investigation of adverse effects of acupuncture in 97 733 patients. Arch Intern Med.2004 Jan 12;164(1):104-5.

Date of download: 5/14/2013Copyright © 2012 American Medical

Association. All rights reserved.

From: Prospective Investigation of Adverse Effects of Acupuncture in 97 733 Patients

Arch Intern Med. 2004;164(1):104-105. doi:10.1001/archinte.164.1.104

Nonserious Adverse Events of Acupuncture Reported in 97 733 Patients

Figure Legend:

Post-Op Acupuncture- Nausea• Cochrane review of 59 studies from 2015

• P6 acupoint stimulation vs antiemetics for PONV.

• Conclusion: “To prevent PONV, the effect of PC6 acupoint stimulation is comparable to antiemetics.”

Lee A et al. Stimulation of the wrist acupuncture point PC6 for preventing postoperative nausea and vomiting. Cochrane Database SystRev. 11 (2015 Nov 2) CD003281

Pericardium 6

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Primary Dysmenorrhea• 3 Arms, avg 36yo 9.5y of symptoms, all received

acupuncture:• Acupuncture Now, 101 pts• Start in 3 Mo, 100 pts• Not Randomized 448 pts

• Improved pain and cost effectiveWitt CM et al. Acupuncture in patients with dysmenorrhea: A randomized study on clinical effectiveness and cost-effectiveness in usual care. Am J Obstet Gynecol 2008

American Journal of Obstetrics & Gynecology 2008 198, 166.e1-166.e8DOI: (10.1016/j.ajog.2007.07.041) Copyright © 2008 Mosby, Inc. Terms and Conditions

Pain changes over Time Acupressure for Dysmenorrhea • 36 women with dysmenorrhea from 4 dormitories

• Dorms divided into randomized acupressure and no acupressure, both could use ibuprofen as needed• -20min of acupressure to SP-6 intervention • 5min x2 alternating each leg: 6s on, 2s off, with thumb

• Change in pain and ibuprofen use recorded

Charandabi S et al. The effect of acupressure at the Sanyinjiao point (SP6) on primary dysmenorrhea in students resident in dormitories of Tabriz. Iran J Nurs Midwifery Res. 2011 Autumn; 16(4): 309–317.

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Spleen 6 Location

Comparing the average number of ibuprofen consumption after the treatment in intervention and control groups

Pregnancy Depression• 150 DSM IV MDD+ patients:

• 52 needles, 49 control needles*, 49 massage

• 12 sessions over 8 weeks

• Excluded: • other sig psych or psych tx, active SI, thyroid dz, drug use, uncontrolled dz or med depression, bed rest, no prenatal care

Manber R et al. Acupuncture for depression during pregnancy: a randomized controlled trial. Obstet Gynecol. 2010 Mar;115(3):511-20

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Electric-Stim in Labor• 180 Nulliparous from a Chinese Hospital:

• 37-42wks gestational age• plan vaginal delivery with singleton pregnancy• No known complications and fetal vertex• dilatation >3cm with regular contractions

• Randomized to 3 groups:• SP-6• EX-B2 T10-L3• Control

Dong C et al. Effects of electro-acupuncture on labor pain management. Arch Gynecol Obstet. 2015 Mar;291(3):531-6.

Labor and electro-stim, cont.• VAS recorded in last contraction before intervention, then

30, 60 and 120” after

• Change of >3 considered effective

• Significant differences in pain and duration of active phase of labor

• EX-B2 more effective than SP6

Dong C et al. Effects of electro-acupuncture on labor painmanagement. Arch Gynecol Obstet. 2015 Mar;291(3):531-6.

VAS Labor and Neonate Outcomes

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Safety, Pregnancy• 105 mixed studies

• Looked at adverse events (AE) and causality• No major reported attributable to acupuncture

Park J et al. The safety of acupuncture during pregnancy: a systematic review. Acupunct Med. 2014 Jun;32(3):257-66.

• 17 studies with reported AE• Acupuncture and Control similar

Clarkson CE et al. Adverse event reporting in studies of penetrating acupuncture during pregnancy: a systematic review. Acta Obstet Gynecol Scand. 2015 May;94(5):453-64.

Thank you!