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
 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
 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
 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
 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
 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.
 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
 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.
 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
 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)
 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)
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?
Clinical HA Trials 1980’s + 1990’s
 16 trials of true vs. sham acupuncture - generally
very small trials: n range from 10 to 52, most <30
 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

 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
 Best High Quality RCT’s
ART - Migraine Germany n=302 True vs. sham acupuncture
2005 vs. wait list

ART - Tension Germany n=270 True vs. sham acupuncture

2005 vs. wait list

NHS trial - Mixed England n=401 True acupuncture

2004 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
 Largest High Quality RCT’s
ART - Migraine Germany n=302 True vs. sham acupuncture
2005 vs. wait list

HA days / month
p<.001

Linde: JAMA 2005 - PMID 15870415

 Largest High Quality RCT’s
ART - Tension HA’s Germany n=270 True vs. sham acupuncture
2005 vs. wait list

HA days / month
p<.001

Melchart: BMJ 2005 - PMID 16055451

 Largest High Quality RCT’s
NHS trial - Mixed England n=401 True acupuncture x 3 mos
2004 vs. “usual care”

Weekly HA score
p=.0002

Vickers: BMJ 2004 - PMID 15023828

 Acupuncture for OA
 Large positive RCT in the Annals (Berman, 2004)
 Diverse group of pts (n=570), 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 2004:141:901

Improvement in Pain
Scores P=.003

Ann Intern Med 2004:141:901

Acupuncture for Other
Conditions
 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.
Opioids Ergot alkaloids Willow bark
- salicylates

Caffeine
 Herbs & Supplements: Best Evidence
(Most evidence is for Migraine
Headaches)
 Herbal medicines
 Feverfew
 Butterbur
 Supplements
 Riboflavin (vit B2)
 Coenzyme Q10
 Feverfew
(Tanacetum parthenium)
 Daisy family (asteraceae)
 Ragweed, marigold,
chrysanthemum, echinacea
 Traditionally for HA, fever,
arthritis, menstrual
irregularities…
 1980’s: gained popularity in
Great Britain as a migraine HA
remedy (chew on leaves)
 Feverfew Studies
for 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 NEGATIVE STUDY
(3 doses) (+ subset freq HAs)
Deiner 2005 170 4 mo Extract MIG-99  HA freq
 Feverfew SEs
 Mouth ulcerations (fresh leaves)
 Mild GI
 Affects platelet activity in vitro
 Allergic rxns
 Abortions in cattle
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
 Butterbur evidence
(from Germany)
DBRCTs n duration preparation results

Grossman 2000 60 3 mo. Petadolex®  # attacks

50 mg BID
Lipton 2004 245 4 mo. Petadolex® 75 mg BID
75, 50 mg BID  # attacks

 Petadolex®
 German standardized proprietary extract of root
 Extract process reduces hepatotoxic/carcinogenic
pyrrolizidine alkaloids to < limit of detection (0.01 ppm)
 Butterbur SEs
 Petadolex® - GI
(burping)
 C/I
 Raw herb
(pyrrolizidine alkaloids)
 Liver disease,
pregnancy/lactation
 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
>50%: 59%
vs. 15%
Maizels 2004 49 3 mo. Vit B2 400 mg Negative study
Feverfew 100 mg > 50%: 44%
Mag 300 mg vs 42%
Placebo=25mg B2
 Coenzyme Q10
 Also critical for mitochondrial fxn

DBRCT n duration preparation results

Sandor 2005 42 3 mo. 100 mg TID  # attacks

>50%:
48% vs. 14%
 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) > 25 mg
 Coenzyme Q10 300 mg/dy
 Magnesium? (diarrhea)
 Avoid:
 Butterbur raw herb - toxic
 Feverfew extracts - less effective?
 Glucosamine & Chondroitin
 Europe: Researched
since the 1960s
 and used for
osteoarthritis for
decades
 US: “The Arthritis
Cure” in 1997--->
 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

Glucosamine Chondroitin Glucosamine Celebrex

Placebo +
500mg tid 400mg tid Chondroitin 200mg qd

 Well matched; withdrawal rate equal; good compliance;

ITT
 All patients, mild pain, mod-severe pain
 GAIT Trial
 Primary outcome = >20% reduction in WOMAC* Score
 (secondary outcomes = similar results)
All subjects Mod-Severe
Placebo 60% 54%
Glucosamine 64% 66%
Chondroitin 65% 61%
Glucosamine +
Chondroitin
67% P=0.09 79% P<0.01

Celebrex 70% P<0.01 69% P=0.06

* WOMAC = Western Ontario and McMaster Universities Osteoarthritis Index
 Adverse Effects & Cost
 Both products very well tolerated
 Mild GI (dyspepsia, D, C) = placebo
 Shellfish allergy?
 No known drug interactions
 Cost: ~ $20-40/month
 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 G&C are “disease
modifying” agents
 Mixed quality of products always a problem
 www.ConsumerLab.com
INFORMATION RESOURCES
••ConsumerLab.co
ConsumerLab.co
mm
 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
 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