Overview of Complementary and Alternative Medicine (CAM) and Its Role in Caring for Veterans with Post-Deployment Health Concerns - PowerPoint PPT Presentation

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Overview of Complementary and Alternative Medicine (CAM) and Its Role in Caring for Veterans with Post-Deployment Health Concerns

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Title: Overview of Complementary and Alternative Medicine (CAM) and Its Role in Caring for Veterans with Post-Deployment Health Concerns


1
Overview of Complementary and Alternative
Medicine (CAM) and Its Role in Caring for
Veterans with Post-Deployment Health Concerns
  • An-Fu Hsiao, MD, PHD
  • September 15, 2010
  • WRIISC Caring for Veterans with Post-Deployment
    Health Concerns

2
Overview
  • Introduction of Complementary and Alternative
    Medicine (CAM)
  • Philosophical discussion about Evidence-Based
    approach
  • Literature review of the efficacy of acupuncture
    and herbs/supplements for treatment of
    headaches and osteoarthritis

3
Popularity of Complementary and Alternative
Medicine (CAM) in General Population
  • CAM Is defined as a group of therapies that are
    not taught in conventional medical school or are
    outside of mainstream, conventional medicine
  • Total 1997 out-of-pocket expenditures related to
    CAM were estimated at 27 billion
  • 42 of general population used at least one type
    of CAM within past 12 months

4
Popularity of Complementary and Alternative
Medicine (CAM) in Veterans
  • Headaches and osteoarthritis are common health
    concerns for post-deployment Veterans
  • Estimated that 30 to 50 of Veterans used CAM
  • OEF/OIF, female, and younger Veterans are more
    likely to use CAM and their use will increase in
    the future

5
CAM vs. Integrative Medicine
  • CAM and Integrative Medicine are two different
    paradigms
  • Integrative Medicine can be defined as
    integrating best elements of conventional
    medicine and CAM and combining them into a safer
    and more effective model of healing
  • Our talk will focused on CAM because there is
    little high-quality research and data on
    integrative medicine

6
Potential Barriers to Integration of CAM with
Conventional Treatments
  • Lack of knowledge on the effectiveness and safety
    of CAM treatments.
  • Lack of know-how in referring to high-quality CAM
    practitioners.
  • Turf battles between physicians and CAM
    practitioners.

7
Lack of Safe and Effective Conventional Medical
Treatment for Headaches and Osteoarthritis
  • The treatment goals for headaches and
    osteoarthritis focus on controlling pain and
    improving health-related quality of life.
  • Pharmacological therapies include NSAIDS, COX-2
    inhibitors, topical analgesics, opioid
    analgesics, and intra-articular steroid and
    hyaluronate injections.
  • These treatments are expensive
  • May cause dangerous side effects

8
Not All CAM Modalities Are Created Equal
  • Some CAM modalities are evidence-based, while
    others are based on anecdotes and tradition.
  • Some CAM modalities may have adverse effects.
  • Some CAM modalities may cause adverse herb-drug
    interactions.

9
Is Randomized Controlled Trial the Best Research
Design to Evaluate the Efficacy of CAM?
  • Randomized Controlled Trial (RCT) is considered
    the gold standard and the strongest research
    design in evaluating efficacy of conventional
    treatment
  • RCT may not be the best way to evaluate the
    efficacy of CAM because they are individualized,
    multi-components, and difficult to double blind

10
Is It Fair to Require CAM Use to Be
Evidence-Based?
  • Is it fair to ask CAM to be held at such high
    standard when only 20-25 of conventional
    medicine is evidence-based?
  • Lack adequate funding to support CAM research
    (NCCAM budget is 100 million and NIH budget is
    24 billion)

11
Acupuncture
  • One part of the ancient, rich system of
    Traditional Chinese Med, generally combined w/
    Chinese herbs
  • Yin-Yang - opposing forces in the body. Goal of
    acupuncture is to restore their balance.
  • Qi - Life energy. Runs along channels
    (meridians). Acupuncture relieves blockages,
    improves flow
  • Overarching goal rebalance, redistribute
    Yin-Yang and allow Qi to flow more
    freely.
  • Western Acup needles only (without Chinese
    herbs)

12
Acupuncture Hair-thin, solid, needles safe, sterile, disposable. Not painful. Patients often describe tingling warmth.
Chinese Herbs Centuries-old formulas. Usually 6-12 herbs mixed together. Exact formulas individualized, which makes it harder to study. Question Do studies of Western acupuncture miss efficacy of the whole TCM system?
13
Clinical HA Trials 1980s 1990s
  • 16 trials of true vs. sham acupuncture -
    generally very small trials n range from 10 to
    52, most lt30
  • Almost all had serious methodological problems
  • 8 trials had positive results, 8 statistically
    negative
  • Summary data likely skewed to falsely positive by
    missing negative trials (publication bias)
  • Conclusion possible benefit, data extremely weak

Melchart et al. Cochrane Reviews 2001 PMID
11279710
14
Clinical HA Trials 2000-2008
  • In the past 8 years there have been 16 more
    trials
  • Three of these trials have been much larger and
    of much higher quality than those which came
    before
  • All 3 used sound, careful, reliable methodology
  • These trials create a new, quite robust, evidence
    in assessing the efficacy of acupuncture for HA
    in more than 900 patients

15
Best High Quality RCTs
ART - Migraine Germany 2005 n302 True vs. sham acupuncture vs. wait list
ART - Tension Germany 2005 n270 True vs. sham acupuncture vs. wait list
NHS trial - Mixed England 2004 n401 True acupuncture vs. usual care
Sham superficial / minimal needling of random
non-acupuncture points
Linde JAMA 2005 - PMID 15870415 Melchart BMJ
2005 - PMID 16055451 Vickers BMJ 2004 - PMID
15023828
16
Largest High Quality RCTs
ART - Migraine Germany 2005 n302 True vs. sham acupuncture vs. wait list
HA days / month
plt.001
Linde JAMA 2005 - PMID 15870415
17
Largest High Quality RCTs
ART - Tension HAs Germany 2005 n270 True vs. sham acupuncture vs. wait list
HA days / month
plt.001
Melchart BMJ 2005 - PMID 16055451
18
Largest High Quality RCTs
NHS trial - Mixed England 2004 n401 True acupuncture x 3 mos vs. usual care
Weekly HA score
p.0002
Vickers BMJ 2004 - PMID 15023828
19
Acupuncture for OA
  • Large positive RCT in the Annals (Berman, 2004)
  • Diverse group of pts (n570), very few exclusions
  • Patients were randomized into three arms
    1) true acup 2) sham acup 3)
    control - educ only
  • Elaborate sham acup. Survey showed successful
    blinding (equal guessed they got sham in
    both arms)
  • 2 months of full treatment, followed for 6 months

Berman. Ann Intern Med 2004141901
20
Improvement in Pain Scores
P.003
Ann Intern Med 2004141901
21
Acupuncture for Other Conditions
22
Take Home Points Acupuncture
  • There is strong evidence to show that acupuncture
    is effective for treatment of headaches and
    osteoarthritis.
  • For soldiers and Veterans who have headache,
    acupuncture is an effective adjunctive therapy
    for conventional medical treatment.

23

Opioids
Ergot alkaloids
Willow bark - salicylates
Caffeine
24
Herbs Supplements Best Evidence(Most evidence
is for Migraine Headaches)
  • Herbal medicines
  • Feverfew
  • Butterbur
  • Supplements
  • Riboflavin (vit B2)
  • Coenzyme Q10

25
Feverfew(Tanacetum parthenium)
  • Daisy family (asteraceae)
  • Ragweed, marigold, chrysanthemum, echinacea
  • Traditionally for HA, fever, arthritis, menstrual
    irregularities
  • 1980s gained popularity in Great Britain as a
    migraine HA remedy (chew on leaves)

26
Feverfew Studiesfor migraine prophylaxis
(non-U.S.)
DBRCTs n duration preparation results
Johnson 1985 17 6 mo Dried leaf ? HA freq, N/V
Murphy 1988 59 4 mo Dried leaf cap ? HA freq, , N/V
Abstract 1994 20 NEGATIVE STUDY
De Weerdt 1996 50 4 mo Extract NEGATIVE STUDY
Palevitch 1997 57 2 mo Leaf capsule ? HA pain, N/V
Pfaffenrath 2002 147 3 mo Extract MIG-99 (3 doses) NEGATIVE STUDY ( subset freq HAs)
Deiner 2005 170 4 mo Extract MIG-99 ? HA freq
27
Feverfew SEs
  • Mouth ulcerations (fresh leaves)
  • Mild GI
  • Affects platelet activity in vitro
  • Allergic rxns
  • Abortions in cattle

28
Butterbur (Petasites hybridus - sweet coltsfoot)
  • Daisy family (asteraceae)
  • Ragweed, marigolds, chrysanthemum, echinacea
  • Traditionally for F, cough, GI/GU cramps,
    dysmenorrhea
  • Affects PGs, LTs, histamine receptor
  • RCT evidence for allergic rhinitis cetirizine
    (Zyrtec)
  • Also studied for migraine prevention, after
    anecdotal reports

29
Butterbur evidence(from Germany)
DBRCTs n duration preparation results
Grossman 2000 60 3 mo. Petadolex 50 mg BID ? attacks
Lipton 2004 245 4 mo. Petadolex 75, 50 mg BID 75 mg BID ? attacks
  • Petadolex
  • German standardized proprietary extract of root
  • Extract process reduces hepatotoxic/carcinogenic
    pyrrolizidine alkaloids to lt limit of detection
    (0.01 ppm)

30
Butterbur SEs
  • Petadolex - GI (burping)
  • C/I
  • Raw herb (pyrrolizidine alkaloids)
  • Liver disease, pregnancy/lactation

31
Riboflavin (vit B2)
  • Mitochondrial electron transport dysfxn
    migraines
  • Riboflavin is utilized by mitochondria

DBRCTs n duration preparation results
Schoenen 1998 55 3 mo. 400 mg/dy ? attacks gt50? 59 vs. 15
Maizels 2004 49 3 mo. Vit B2 400 mg Feverfew 100 mg Mag 300 mg Placebo25mg B2 Negative study gt 50? 44 vs 42
32
Coenzyme Q10
  • Also critical for mitochondrial fxn

DBRCT n duration preparation results
Sandor 2005 42 3 mo. 100 mg TID ? attacks gt50? 48 vs. 14
33
Supplement Recommendation for Migraine Prevention?
  • Standardized butterbur extract
  • e.g. Petadolex 75 mg BID
  • Combination product containing
  • Feverfew leaf 100 mg/dy
  • Riboflavin (Vit B2) gt 25 mg
  • Coenzyme Q10 300 mg/dy
  • Magnesium? (diarrhea)
  • Avoid
  • Butterbur raw herb - toxic
  • Feverfew extracts - less effective?

34
Glucosamine Chondroitin
  • Europe Researched since the 1960s
  • and used for osteoarthritis for decades
  • US The Arthritis Cure in 1997---gt

35
GAIT Trial
  • Glucosamine/chondroitin Arthritis Intervention
    Trial
  • NIH funded, rigorous DBRCT (NEJM Feb. 23,
    2006)
  • 1583 pts followed for 6 months, in 16 US centers
  • Symptomatic knee OA
  • Well matched withdrawal rate equal good
    compliance ITT
  • All patients, mild pain, mod-severe pain

Placebo Glucosamine 500mg tid Chondroitin 400mg tid Glucosamine Chondroitin Celebrex 200mg qd
36
GAIT Trial
  • Primary outcome gt20 reduction in WOMAC Score
  • (secondary outcomes similar results)

All subjects Mod-Severe
Placebo 60 54
Glucosamine 64 66
Chondroitin 65 61
Glucosamine Chondroitin 67 P0.09 79 Plt0.01
Celebrex 70 Plt0.01 69 P0.06
WOMAC Western Ontario and McMaster
Universities Osteoarthritis Index
37
Adverse Effects Cost
  • Both products very well tolerated
  • Mild GI (dyspepsia, D, C) placebo
  • Shellfish allergy?
  • No known drug interactions
  • Cost 20-40/month

38
Take Home Points Supplements and Herbs
  • Appear to have analgesic activity for OA
  • Both safe and well-tolerated
  • Slow onset of action (2 month trial)
  • Combination preferred GAIT
  • Best for pts with mod-severe pain GAIT
  • Some evidence GC are disease modifying agents
  • Mixed quality of products always a problem
  • www.ConsumerLab.com

39
INFORMATION RESOURCES
  • ConsumerLab.com

40
Discussion
  • Veterans with post-deployment health concerns,
    such as headaches and osteoarthritis, are
    commonly using CAM as an adjunctive therapy with
    conventional medical treatment
  • There is strong evidence to support the use of
    acupuncture as an adjunctive therapy for
    treatment of headaches and osteoarthritis.
  • There is preliminary evidence to support use of
    feverfew and butterbur for treatment of headaches
    and glucosamine and chondroitin for treatment of
    osteoarthritis

41
Policy Implications for VHA and DOD
  • Clinicians need to openly inquire Veterans about
    their CAM use to help them successfully integrate
    CAM with their conventional treatment.
  • VHA and DOD need to establish guideline for CAM
    use and credentialing and privileging standards
    for CAM practitioners
  • VHA and DOD need to allocate more resources to
    deliver CAM modalities, provide educational
    training for clinicians, and conduct research
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