Stephen Ezeji Stephen Ezeji-Okoy

Okoy

Chair, VHA VHA CO FAC on 

C on 
Overview 

 CAM in US and VA CAM and Pain  Evidence for CAM Summation 

DefinitionsDefinitions 

 Complementary and Alternative Medicine - A gr

medical and health care systems, p , ractices, and produ

presently considered to be part of conventional medic

 Complementary Medicine - Used in conjunction wit

conventional medicine

 Alternative Medicine - Used in place of conventiona

medicine medicine 

 Integrative Medicine - Combination of mainstream 

therapies for which there is some high quality scientific 
•

State of CAM in US CAM in US 

2007 National Health Interview Survey 2007 National Health Interview Survey 

 29,266 households; 75,764 persons; 23,393 adults  38% of adults in US (83 million) use some form of CAM  $33.9 B in out-of-pocket expenditure 

 $11.9 B CAM practitioners  $14.8 B non-vitamin, non-mineral, natural products  $7.2 B other CAM (yoga, tai chi, qi gong, homeopathic medicine, relaxat

 11.2% of total out-of-pocket expenditures on healthcare  2/3 of expenditures are on self-care  CAM practitioner cost is 25% of what spent on physicians Compared with prior survey 10 years earlier Compared with prior survey 10 years earlier 

 Increase in self-care and decline in visits to practitioners (50% decline) 

 Biggest decline: visits to energy healer and practitioners of relaxation  Acupuncture saw 3-fold increase in visits 

Nahin RL, Barnes PM, Stussman BJ, and Bloom B. Costs of Complementary an

Medicine (CAM) and Frequency of Visits to CAM Practitioners: United StaNational health statistics reports; no 18. Hyattsville, MD: National Center f
Does CAM Fit Into V Does CAM Fit Into VACar Care

 CAM’s focus on wellness, disease prevention, and hea

promotion is consistent with VA’s approach to care

 There is a possible benefit in management of chronic 

There is a possible benefit in management of chronic and promotion of health and wellness 

 CAM is not explicitly part of the Uniform Benefits Pac

(UBP)/Medical Benefits Package (UBP)/Medical Benefits Package 

 VA has increasing focus on providing evidence-based

medicine

 Lack of high quality research/evidence for many CAM prac

prac

 Many CAM practices lack: 

 Standardized educational accrediting bodies  State regulation/licensure State regulation/licensure  Certifying bodies 
CAM Offered by VV A 

 Use is widespread - Healthcare Analysis and Informa

Group (HAIG) Study on CAM Utilization in VHA 2002

 84% of VA facilities provide some form of CAM  Most common offered modalities: 

 Acupuncture, biofeedback, chiropractic care, guided image

hypnotherapy meditation music therapy progressive relaxhypnotherapy, meditation, music therapy, progressive relaxstress management 

 Most provided by conventionally trained practitioners 

 Integrated into treatment plans Integrated into treatment plans  Wide variation in process used to credential privilege prov Limited oversight in training, experience, certification, and 

CAM providers 

 Limited utilization of scientific evidence to support use of CAM 

its safety and efficacy 
Reason CAM Modalities Of eason CAM Modalities Of

Promotes Patient Adjunctive Proven Provider Reflects Have Consistent Promotes Cult

83% 80% 78% 

73% 

70% 65%80% 90% 

N=12

55% 

46% 

35% 

29% 28

30% 40% 50% 60% 

0% 

10% 20% 

wellness preference to chronic clinical request facility' s provider(s) with cost 

disease effectiveness mission who PACT model savings 

management volunteer 

their 

expertise 

CAM and Chronic Pain 

 Pain affect 100 million Americans 

 More than cancer, diabetes, CAD, and stroke combined 

 E ti t d t f h lth f Estimated cost of health care ranges from $560 - $63

$63

annually 

 Most common typ e of chronic pain is low back pain (2

Statistics survey)

 Low back pain is the number 1 cause of disability wor

(Gl b l B d f Di 2010 (Global Burden of Disease 2010 - L t) ance 

 Up to 40% of patients with chronic pain may use a CA

modality

NCCAM: Scientific Evidence on CAM f

 Low Back Pain 



Promi is ng

 E

E



vidence

 Massage, Spinal Manipulation, Progressive Relaxation, Yoga 

 Limited/Mixed/No Evidence 

 Prolotherapy, Herbal Remedies 

 Arthritis 

 Promising Evidence 

 Acupuncture

 Limited/Mixed/No Evidence Limited/Mixed/No Evidence 

 Glucosamine/Chondroitin, Gamma Linolenic Acid, Herbal Remedies 

 Headache 

 Promising Evidence 

 Acupuncture, Spinal Manipulation 

 Limited/Mixed/No Evidence 

 Feverfew 

 Neck Pain Neck Pain 

 Limited/Mixed/No Evidence 

 Acupuncture, Spinal Manipulation 
Review of of Evidence f Evidence f or Some CAM r Some CAM 

ModalitiesModalities ModalitiesModalities Used for Pain 

 Acupuncture  Massage  MBSR  Music  Tai Chi  Yoga 

VA TT AP: Acupuncture P: Acupuncture 

 2007 Review 

 RCTs and Qualitative and Quantitative synthesis of 

 Levels of Evidence to Support Use 

 Effective (USPSTF equivalent B) 

 P t d tl i Post op dental pain 

 Promising (USPSTF equivalent C) 

 Migraine, LBP, Fibromyalgia, OA Knee, Tennis Elbow, Lab

 Inconclusive (USPSTF equivalent I) 

 Carpel tunnel

 Inconclusive/Ineffective (USPSTF equivalent I/D)

 Post Herpetic Neuralgia 
Cherkin D, PhD; Karen J. Sherman K, e

Randomized Trial Comparing Acupuncture, Sim

Acupuncture, and Usual Care for Chronic Lo

Pain: Arch Intern Med. 2009;169(9):85
AcupuncturAcupuncture and Lo and Lo w Back 

w Back 

 Back 

pain leadin

g reason to visit acu

puncturist 

 Randomized to: 

 Individual acupuncture  Standard acupuncture  Simulated acupuncture  Usual care acupuncture 

 638 patients with CLBP 

 Age 18-70  < 3-month duration 

 Evaluated with disability questionnaire 

 Assessed at 8, 26, and 52 weeks  10 treatments over 7 weeks 

 2x/wk x 3 weeks; weekly x 4 weeks 
Results 

 Statistically significant improvement in dysfunction scor

acupuncture groups compared to usual care (p<0.001

 Seen at 8 weeks persisted through 26 and 52 weeks Seen at 8 weeks persisted through 26 and 52 weeks  No difference between acupuncture groups 

 Statistical improvements in symptoms in acupuncture g

weeks, but not at 26 and 52 weeks 

 Use of medication decreased significantly in acupunct

 Persisted through 52 weeks Persisted through 52 weeks 
ConclusionsConclusions 

 Acupuncture is effective in the treatment of CLBP Site of needling is unimportant 

Furlan A, Brosseau L, Imamura M, Irvin E: Mass

Low 

–back Pain: A Systematic Review w

Framework of the Cochrane Collaborative Back 

Group: Spine 2002;27:189
Studies 

 8 studies 8 studies 

 RCT/quasi randomized trials/controlled clinical trials  Had at least one of four outcome measures: pain, return to w

subj ti h f t f ti l t t bjective change of symptoms, functional status 

 Short term effects – immediate post intervention  Long term – > 3 mo post intervention 

 Adults >18  Non specific LBP: acute < 4weeks;subacute 4-12;chron

weeks 

 Aim: 

 Primary: effectiveness of massage vs. placebo; other medical  Secondary: effectiveness of different types of massage, mass

other treatments 
Results 

 Massage: 

 Better than sham laser, acupuncture, self care (education) for 

and function and function 

 Equal to spinal manipulation  Effects noted to last up to 52 weeks  M b ff h TENS May be ll ess effective than TENS 

 Massage + education + exercise 

 Better than exercise alone  Better than massage only in short term for pain 

 Acupuncture massage better than classic massage for 

f ti unc on 
ConclusionsConclusions 

 Limited – moderate strength of evidence  Evidence too poor to make assessment in acute LBP  Appears beneficial for sub acute and chronic LBP 

 Improves symptoms and function  Effects are long lastin g 

 Acupuncture massage may be better than classic mass

-

Grossman P, Niemann L et al. Mindfulness-base

reduction and health benefits reduction and health benefits A meta . A meta analysis: Jou

Psychosomatic Research 2004;57
Studies 

 Published and unpublished studies from 12/2001 

 Interventions were taught

 Quantit ative outcome measures 64 studies but only 20 were of acceptable quality t  Total of 1605 subjects Total of 1605 subjects  Diagnoses: Fibromyalgia, cancer, CAD, depression, chr

anxiety, obesity, binge eating, and coping with stress 

 Outcomes: Does MBSR improve health related dimensi

chronically ill and how large are the benefits and is fustudy warranted study warranted 
Results

 Studies with control groups

# # Mean 95% CI P

studies Subjects Effect

Size

(twotailed)

Mental

H lth

10 771 0.54 0.39‐

68

< .0001

Health 0.68PhysicalHealth

5 203 0.53 0.23‐

0.81

<.0004
5

Results (cont.)sults (cont.) 

 Observational Studies – pre and post comparisons of 

and mental health variables

*significant heterogeneity in subjects *significant heterogeneity in subjects 

#studies

#Subjects

MeanEffect

95% CI P

studies Subjects Effect

Size

MentalHealth *

18 894 0.5 0.43‐

0.56

<.0001

PhysicalHealth

9 566 0.42 0.34‐

0.50

<.0001
ConclusionsConclusions 

 Suggests usefulness of MBSR in a broad range of chro

disorders

 Mi df l t i i h bilit t ith 

Mindfulness training may enhance ability to cope with 

distress and disability as well as in more serious condi

 Studies only ev aluated immediate post-intervention pe

Long term effects are unknown

 Further study is needed 
-

Cramer H, Haller H, Lauche R, Do

Mindfulness-based stress reduction for low bac

A systematic review. BMC Complementary and Alte

Medicine 2012, 
Studies 

 Only RCTs included – wait list control (2) education pro Main outcome measures – pain intensity, back related  3 RCT -117 patients 

 2 RCTs older adults > or = 65, chronic LBP > 3 mo 

 8 weeks MBSR + education 

 1 RCT patients of any age with failed back surgery syndrome 

 8 weeks MBSR + education + mindful meditation + yoga 
Results 

 MBSR vs. wait list control 

 Non-specific LBP 

 No significant difference in pain intensity or disability No significant difference in pain intensity or disability  Significant difference seen for improving physical functioni

acceptance 

 Failed back syndrome 

 Significant improvement in pain intensity and disability, pa

acceptance, medication intake, and sleep quality 

 MBSR vs. health education MBSR vs. health education 

 Non-specific LBP 

 No significant difference in pain intensity or disability No group differences at 4 month follow No group differences at 4 month follow-up 
ConclusionsConclusions 

 More research is needed  Limited evidence that MBSR can provide short term re Yoga may be crucial to the intervention’s success 

 Trial that showed improvement in pain and disability included 

 No evidence for long term effects of MBSR No evidence for long term effects of MBSR 

Cepeda M, Carr D, Lau J, Alvarez H: Music for pai

Cochrane Database of Systematic Reviews 2006 Cochrane Database of Systematic Reviews 2006 

, 

Art. No. : CD0

DOI:10.1002/14651858.CD00484
Studies 

 51 RCTs  Effect of music on acute, chronic, neuropathic, cancer p

experi ti en al pai

i

n 

 Children and adults  1867 subjects, 1796 controls 1867 subjects, 1796 controls  Combined trials with clinical homogeniety  Compared music to no music, pharmacologic or nonpharmacologic intervention Looked for:

 D i i i i Decrease in pain intensity scores  Opioid requirements 
Results 

 Due to heterogeniety of studies only able to evaluate 

acute pain 

 Decrease ii n opiate use amongst th d t 

ose exposed to mu

 1 mg over 2 hours; 5.7 mg in 24 hours 

 Acute post op pain – significant improvement amongst 

exposed to music

 decrease of 0.5 units on 0-10 scale 
ConclusionConclusion 

 Listening to music decreases pain intensity scores and o Magnitude of benefit is small  Clinical importance is unclear 

Hall A, Maher C, Latimer J, Ferreira M: The effective

Tai Chi for chronic musculoskeletal pain cond

systematic review and meta-analysis. Arthr

Rheumatism 2009 (61): 7
Studies 

 7 RCTs  321 participants  Osteoarthritis (5) RA (1) Tension headache (1)  Styles of Tai Chi used – Yang (42%), Sun (42%), Wu ( Evaluate effectiveness of Tai Chi in: 

 Decreasing pain  Decreasing disability  Improving physical function  Improving quality of life 
Results 

 Self reported pain (7/7) 

 P l oo ed eff

f

fect of Tai Chi – reduction of 10.1points on 0 Ch f 10 0 -100 

(P<0.05)

 Self reported disability (6/7) 

 Pooled effect of Tai Chi – reduction of 9.6 points on 0-100 sc

(P<0.05) 

 Physical performance (3/7) Physical performance (3/7) 

 Reporting scales to heterogeneous to pool  2/3 used 50 ft walk 

 0.4 second reduction seen with Tai Chi (not statistically sign

 Quality of life (4/7) 

 Results to heterogeneous to pool  Trend to positive effects overall physical health, tension levels

in OA 
ConclusionsConclusions 

 Small positive effect on short term self assessed pain a

disability

 Cli i l i ifi f d f i t i l Clinical significance of degree of improvement is uncle Group exercise, low cost, social rather than clinical set

increase significance of small improvement 

Wren A, Wright M, Carson J, Keefe F: Yoga for pe

pain: New findings and directions for an ancient p

2010 International Association for the Study of Pa

(2011) 477 
Studies 

 13 RCTs  Pain population 

 CTS -1 OA h d 1, OA hand -1 CLBP 1, CLBP – 6 Fib l i 6, Fibromyalgia – 1, H di l 

Hemodialy

Chronic Pancreatitis -1, Migraine -1, Breast cancer survivor 

 Subjects 

 Primarily white, middle aged, higher socioeconomic women 

 Interventions – Iyengar-based Hatha yoga (2), Iyenge

Viniyoga Viniyoga (1), Hatha (2) Modified (2), Modified Hatha (1) Yoga of (1), Yoga of awareness (2), Modified yoga program (1), Integrated approach to yoga therapy (1) 
Results 

 CTS – improvement in pain and grip strength  OA hand – improvement in pain and range of motion  CLBP – improvements in pain, medication usage (5); no 

significant difference (1)

 Fibromyalgia – improvement in pain, vigor, acceptance H di l i Hemodialysis – i i i f i l d improvements in pain, fatigue, sleep d Breast cancer survivors – improvements in pain, sleep 

disturbance, vigor, hot flashes ,g 

 Chronic pancreatitis – improvements in quality of life, 

and stress

 Migraine – improvements in pain, frequency and inten

medication usage, anxiety, depression
ConclusionsConclusions 

 Suggests yoga may have promise in persistent pain co Similar results despite varying styles of yoga intervent Populations studied fairly homogenous with moderate 

due to pain 

 Unclear applicability in more diverse populations Unclear applicability in more diverse populations 

 Further research needed 

Implications for VA 

 Insufficient evidence to make CAM is part of medical 

package 

 E id d t t f CAM i Evidence does not support use of CAM as a primary

intervention

 May be useful as an adjunct measure 

 Most promising interventions are Acupuncture, Yoga, a

Massage

 Could be provided by existing CAM providers Could be provided by existing CAM providers  Further work needed to create occupational class for CAM pr
Next Stepsxt Steps 

 Growing interest to provide acupuncture services in VA 

 Intent: Make acupuncture services available to Veterans by w

physicians, chiropractors, and/or licensed acupuncturists physicians, chiropractors, and/or licensed acupuncturists 

 Memo prepared for USH requesting: 

 Assistant Sec for HRA allows for establishment of the occupat The development of qualification standards under this author

 Document providing statutory justification being finaliz

 Request the establishment of Hybrid T Request the establishment of Hybrid T-38 status to LAc. 

 Pure T-38 would require legislation