Title: Overview of Complementary and Alternative Medicine (CAM) and Its Role in Caring for Veterans with Post-Deployment Health Concerns
1Overview 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
2Overview
- 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
3Popularity 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
4Popularity 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
5CAM 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
6Potential 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.
7Lack 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
8Not 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.
9Is 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
10Is 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)
11Acupuncture
- 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)
12Acupuncture 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?
13Clinical 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
14Clinical 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
15Best 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
16Largest 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
17Largest 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
18Largest 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
19Acupuncture 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
20Improvement in Pain Scores
P.003
Ann Intern Med 2004141901
21Acupuncture for Other Conditions
22Take 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
24Herbs Supplements Best Evidence(Most evidence
is for Migraine Headaches)
- Herbal medicines
- Feverfew
- Butterbur
- Supplements
- Riboflavin (vit B2)
- Coenzyme Q10
25Feverfew(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)
26Feverfew 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
27Feverfew SEs
- Mouth ulcerations (fresh leaves)
- Mild GI
- Affects platelet activity in vitro
- Allergic rxns
- Abortions in cattle
28Butterbur (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
29Butterbur 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)
30Butterbur SEs
- Petadolex - GI (burping)
- C/I
- Raw herb (pyrrolizidine alkaloids)
- Liver disease, pregnancy/lactation
31Riboflavin (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
32Coenzyme Q10
- Also critical for mitochondrial fxn
DBRCT n duration preparation results
Sandor 2005 42 3 mo. 100 mg TID ? attacks gt50? 48 vs. 14
33Supplement 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?
34Glucosamine Chondroitin
- Europe Researched since the 1960s
- and used for osteoarthritis for decades
- US The Arthritis Cure in 1997---gt
35GAIT 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
36GAIT 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
37Adverse Effects Cost
- Both products very well tolerated
- Mild GI (dyspepsia, D, C) placebo
- Shellfish allergy?
- No known drug interactions
- Cost 20-40/month
38Take 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
39INFORMATION RESOURCES
40Discussion
- 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
41Policy 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