Audience Question Audience Question

How many are: 

Mental health clinicians?Non-mental health clinicians?Researchers?Trainees (graduate students, interns, fellows, etc)?

How many use: 

Complementary and alternative Medicine (CAM) thcli

nical practice

?

CAM therapies personally?
Evidence Evidence -based Synthesis Program based Synthesis Program

Efficacy of Complementary and 

Alternative Medicine Therapies f

Posttraumatic Stress Disorder

Jennifer L. Strauss, PhD

John W. Williams, Jr., MD

Evidence-based Synthesis Program (ESP) Cen

Durham Veterans Affairs Healthcare System

Durham NC Durham, NC

February 29, 2012 February 29, 2012 
Evidence Evidence -based Synthesis Program based Synthesis Program

Acknowledgements

Co-Investigators: 

Remy Coeytaux, MD, PhD

Jennifer McDuffie, PhD Jennifer McDuffie, PhD

Research Assistant: 

Avishek Nagi MS Avishek Nagi, MS 

Medical Editor: 

Li Wi MA Liz Wing, MA

This project was nominated by the Office of Researc

Development, Department of Veteran Affairs
Disclosure

• This report is based on research conducted by the ED h VA M l C D h NC Durham VA Medi cal Center, Durham, NC • Funded by the De partment of Veterans Affairs and HSR&D RCD-II award to Dr. Strauss • The findings in this document are those of the autho

The findings in this document are those of the autho

not necessarily represent the views of the DepartmenVeterans Affairs. 

• No investigators have any affiliations or financial invthat conflict with material presented in this report that conflict with material presented in this report 
-

Evidence-based Synthesis Program 

(ESP) P O i (ESP): Program Overview

• Sponsored by VA Office of R&D and HSR&D • Established to provide timely, accurate reports on health

identified by VA staff to improve the healthcare of Vetera

• Builds on expertise already in place at the Evidence Builds on expertise already in place at the Evidence -bas

bas

Center (EPC) designated by Agency for Healthcare ResQuality (AHRQ). Four of these EPCs are also ESP Cen

o Durham VA Medical Center o VA Greater Los Angeles Health Care System o Portland VA Medical Center Portland VA Medical Center o Minneapolis VA Medical Center 
t t

p g p p p

Evidence-based Synthesis Program 

(ESP) P O i (ESP): Program Overview

• Each Center provides ≥ 3 evidence syntheses per ye

important clinical practice topics relevant to Veteran

to: 

o Develop clinical policies informed by evidence o Implement effective services to improve patient oo Support VA clinical practice guidelines and perfo

measures 

o Guide the direction for future research to addres

clinical knowledge 

• Topic nomi ti na onprocess facilit ated b y ESP C oordi 

Center (Portland) through online process: 

http://www.hsrd.research.va.gov/publications/esp/TopicNomina
Evidence-based Synthesis Program 

(ESP) P O i (ESP): 

Program 

Overv

iew

ESPs work with stakeholders to meet their needs throu• Technical Advisory Panel 

(TAP

) 

o Recruited for each topic to provide content expero Guides topic development, refines the key quest

reviews data and draft report eviews data and draft report 

• External Peer Reviewers & Policy Partners 

o Review and comment on draft report 

o All reviewer comments are addressed in the fina

(often later published in peer-reviewed journal) 

• Final reports posted on VA HSR&D website and diss

Final reports posted on VA HSR&D website and diss

widely through the VA 

http://www.hsrd.research.va.gov/publications/esp/repor
Efficacy of Com plementaryand 

Alternative Medicine Therapies f

Posttraumatic Stress Disorder

Published August 2011 

Full-length report available on ESP website: length report available on ESP website: 

http://www.hsrd.research.va.gov/publications/esp/rep
Background: PTSD Background: PTSD

Posttraumatic Stress Disorder (PTSD) 

• A t t l di Among mos

t common men

t

al disor

ders 

• Often chronic • Associated with significant adverse consequences: 

• psychiatric comorbidities (e.g., comorbid depres• substance abuse • suicidalit

y 

• impaired functioning • decreased quality of life • increased rates of medical morbidities health ris

increased rates of medical morbidities, health ris

and health service use 

• Estimated lifetime prevalence in US = 7% 
Background: PTSD Background: PTSD

PTSD in Veterans 

• I d i Increased incid V ence among 

Ve

terans 

• PTSD is the mental disorder most commonly associ

combat and other military traumas (sexual assault, M

• OEF/OIF/OND VA users = 22% dia

gnosed PTSD (Se

• Witnessing sharp increase in VA mental health servi

both OEF/OIF/OND and Vietnam-era Veterans 

• As VA strives to anticipate and serve the treatment n

growing Veteran 

p

opulation, identifyin

g and impleme

effective PTSD treatments remains a critical priority 
Background: Current Treatments Background: Current Treatments

Current First-Line, Evidence-Based Treatments (VA/DoD C

Guideline for Management of PTSD, Oct 2010) 

• 

Traumafocuse

d cognitive 

b

e

havioral psyc

h th o erapies 

• theoretically grounded in CBT • multi-component, PTSD specific (+ anxiety mgmt/psy

• prolonged exposure cognitive processing therapy EM

prolonged exposure, cognitive processing therapy, EM

• overlap with CAM (e.g., relaxation strategies prior to e

• Stress inoculation training 

• theoretically grounded in CBT • “toolkit” approach of skills to “inoculate” against stress • overlap with CAM (breathing relaxation, muscle relax

• Pharmacotherapies 

• SSRIs (paroxetine, sertraline) and SNRIs (vanlafaxin
t t

Background: Current Treatments Background: Current Treatments

Summary • Mounting pp empirical support for current EBTs, and strong 

clinical research community to refine and optimize these 

• Yet, each is associated with limitations and potential bar

dissemination and uptake 

Primary Limitations of Current Evidence-Based Treatm

• Access • Specialized provider training/frequent contact • Suitability • Side effects (meds) • Stigma of seeking mental health specialty care 
Background: CAM Overview Background: CAM Overview

Complementary and alternative medicine (CAM): includ

therapies not considered standard to the practice of 

US. 

NIH National Center for Complementary and Alternative 

(NCCAM) classification of CAM therapies: 

o Mind-bod

y medicine 

(e.

g., meditation, acu

puncture, relaxa

o Manipulative and body-based practices (e.g., chiropractic, o Other alternative practices (e.g., energy therapy) o Natural products (e.g., supplements; not included in curreo Whole medical systems (e.g., 

Aruyvedic; not included in c

o Imperfect classification system (e.g., biofeedback con

conventional and CAM) 

o

for many, mechanisms o

f action poorly understood 
t t t 

Background: Rationale for CAM Background: Rationale for CAM

Rationale for an Evidence-based Synthesis of CAM T

f PTSD for PTSD: 

o Patient preferences: CAM interventions widely used by M

Patient preferences: CAM interventions widely used by M

(including Veterans) 

o Considered minimally invasive/low anticipated risk of adveo If efficacious, could increase the breadth of PTSD treatme

o first line treatments? o adjunctive? 

o Numerous stakeholders have expressed strong interest in 

th id b f lt ti h the evidence base for alternative approaches to treatmen
Background: Rationale for CAM Background: Rationale for CAM
Methods: Overview Methods: Overview

Q: What’s so systematic about a syst

evidence review? evidence review? 

A: Pretty much everything.... 

1. Topic development 2. 

S

ystematic searches of literature 

3. Study selection 4. Data abstraction Data abstraction 5. Quality assessment 6. Data synthesis synthesis 7. Peer review 
Methods: Key Questions Methods: Key Questions

• Key Question 1: In adults with PTSD, are mind-body C

therapies more efficacious than control for PTSD sympto

h lth ea -rel t d lit f lif ? la

t

e

d quality of lif

e? 

• Key Question 2: In adults with PTSD, are manipulative 

based CAM therapies more efficacious than control for Psymptoms and health-related quality of life? 

• Key Question 3: In adults with PTSD, are CAM therapi

movement-based and energy therapies more efficacious 

for PSTD symptoms and health for PSTD symptoms and health 

-related quality of life? related quality of life? 

• Key Question 4: For treatments evaluated in Key Ques

that lack randomized controlled trials is there evidence fthat lack randomized controlled trials, is there evidence fstudy designs that suggests the potential for treatment e
t

Analytic Framework Analytic Framework

KQ4 Other prospective 

study designs 

when no published 

RCTs available 

Manipulative and 

body based Mind-body 

Randomized controlled trials: KQs 1−3 

Movement-based 

body-based and energy 

therapies* therapies* 

KQ2 KQ3

and energy 

therapies* 

KQ1 

Ad 

KQs 1-3 

Pi O 

Adverse 

effects 

Primary Outcomes 

• PTSD symptoms • Health-related quality of 

life 

Secondary Outcomes 

• Patient satisfaction • Treatment adherence 

Comparators 

Usual care, 

empirically-based treatments 

Population 

Adults with PTSD 

Treatment adherence 

• Functional status 
Methods: Search Strategy Methods: Search Strategy

Databases: English-language publications in MEDLINE, EP INFO PsycINFO, C l ti I d t N i d Alli d H lth 

Cumulative In

dex 

to 

Nursing and Alli

ed 

Health 

(CINAHL), Cochrane Controlled Trials Registry, and the PuInternational Literature on Traumatic Stress (PILOTS) data(targeted search for relaxation studies) 

Search terms: Included terms for CAM thera

pies, PTSD, a

randomized controlled trials (RCTs) 

Supplemental searches: Supplemental searches: Bibliographies of individual rese

Bibliographies of individual rese

review papers; used the PubMed broad “therapy filter” to idprospective studies when RCTs were not identified; Clinica

progress/completed unpublished studies) progress/completed, unpublished studies) 
Methods: Inclusion Criteria Methods: Inclusion Criteria

Study design: • RCTs for KQs 1-3 • Non

-RCT prospective studies when no RCTs identified RCT, prospective studies when no RCTs identified 

Population: Adults > 19 yrs w/PTSD by DSM criteria, vali

severity measures, or cli

nical diagnosis; in acu

te-p

hase 

tre

Interventions: Mind-body, manipulative or body-based, mb d th i base

d, or energy therapies 

Comparators: Any control condition (including no treatmeOutcomes: PTSD diagnosis and symptom severity, social 

patient satisfaction, quality of life reported 

≥ 6 weeks post i

Setting: Community, outpatient mental health or general m
Methods: Exclusion Methods: Exclusion Criteria

• Non-English language publication 3⁄4 Studies not conducted in Westernized countries • Patient populations with psychosis, acute suicidality, or substa• Studies that included a CAM therapy in both intervention and c3⁄4 Interventions commonly considered standard therapy (e.g., bio

relaxation skills training as part of CBT) 

• PTSD as a comorbid rather than primary diagnosis • Intervention used in a continuation or maintenance phase of tr3⁄4 Relaxation: excluded if control arm and/or description of interv

components unclear (e.g., components unclear (e.g., 

“3 relaxation skills taught 3 relaxation skills taught ) ”

)
Methods: Quality Assessment Methods: Quality Assessment

Assessment of risk of bias: applied quality criteria describefor Healthcare and Research Quality (AHRQ) Methods GuEffectiveness and Comparative Effectiveness Reviews Data abstraction: for RCTs, data abstracted on adequacy o

randomization and allocation concealment, comparability obaseline, blinding, completeness of followup and differentiafollowup, whether incomplete data were addressed appropvalidit

y of outcome measures , com

pleteness of outcomes r

conflict of interest 

Assigned quality score of Good, Fair, or Poor to individ
Methods: Data Synthesis Methods: Data Synthesis

Criticall

y anal

yzed studies: characteristics, methods, 

Qualitative synthesis 

•Gestalt of findings for each Key Question Gestalt of findings for each Key Question 

Quantitative synthesis 

•Could not perform quantitative meta Could not perform quantitative meta

-analyses analyses 

•When evidence sufficient, computed Standardized MeDifference (SMD) using Hedges g Difference (SMD) using Hedges g •SMD allows comparisons across studies (different mesame outcome) 
Methods: Methods: “Grading Grading ” of Evidence of Evidence

Rating the Body of Evidence

GRADE Working Grou p criteria for assessing overall body • High—Further research unlikely to change confidence i

effect 

• Moderate—Further research likely to have an importan

confidence in the estimate of effect and may change thconfidence in the estimate of effect, and may change th

• Low—Further research very likely to have an important 

confidence in the estimate of effect, and may change th

• Insufficient—Evidence on an outcome is absent or too 

sparse, or inconsistent to estimate an effect 
Peer Review Peer Review

• Draft reviewed bytechnical experts and 

leadership 

• Reviewer comments addressed, incorpo

into final report, and listed in App endix
Literature Flow

(RCT mind-body CAM) 6 trials + 4 companion studies 

(RCT manipulative and 

body based CAM) 

1 trial + 1 companion studies 

Search results = 1776 references Excluded = 1738 references 

Excluded at the title/abstract level 

Pulled for full text review = 38 references 

Excluded = 29 references Population not PTSD = 10 Setting not of interest = 2 Intervention not complementary medIntervention not complementary medComparator not appropriate = 1 Not Westernized culture = 1 Language not English = 1 Included = 9 trials and 5 companion studies* Not primary data = 3 

companion studies 

KQ 1 (RCT mind body CAM) 

KQ 2 (RCT manipulative and 

KQ 3 (RCT movement/energy (RCT movement/energy ­based CAM) 0 trials/ companion studies 

K(n2 st
Results: ? Results: 

?

Drum roll please..... Drum roll please.....
Results: Key Question #1 Results: Key Question #1

Key Question 1: In adults with PTSD, are mind-body CAM 

more efficacious than control for PTSD symptoms and heaquality of life? 

• Mind-BodyThera

pies: acu

p ,y uncture, meditation, y

o

g

a, 

breathing exercises, guided imagery, hypnotherapy, prelaxation, and tai chi 

• 6 published RCTs 

• 2 meditation (1 fair, 1 poor)

• 1 acupuncture (1 good) 1 acupuncture (1 good) • 3 relaxation (3 poor) 

• 16 bli h d / i t i l (Cli i lT i l 16 unpubli

s

h

ed 

/ongoing 

t

rials 

(Cli

nicalT

rials.gov

) 
Results: Summary of Study 

Charac

teri KQ#1stics: KQ#1

St duy I t ti In

tervention vs. compara

t

or 

RCTs of mind-body interventions: KQ 1 Bormann et al., 2008 (n = 29) 

Mantram repetition vs. usual care 

Brooks and Scarano, 1985 

( ) n = 25)

Transcendental meditation vs. psychothera

Echeburúa et al., 1996 (n = 20) 

Progressive muscle relaxation vs. cognitivtherapy 

Hollifield et al, 2007 (n = 84) 

Acupuncture vs. group cognitive behavioravs. waitlist 

Vaughan et al Vaughan et al., 1994 (n = 36) 

Applied muscle relaxation vs image habituApplied muscle relaxation vs. image habitu

training vs. eye movement desensitization reprocessing (EMDR) 

Watson et al., 1997 (n = 90) 

Sim

p le relaxation instruction vs. relaxation 

+ deep breathing vs. relaxation instruction breathing and thermal biofeedback 
Results: ClinicalTrials.gov Results: ClinicalTrials.gov

Intervention

Type

Completed

RCTs

(n=7)

Ongoing

RCTs

(n=8)

U

Acupuncture

2

2 

Emotional Emotional freedom freedom techniques techniques

1

1 

Guided imagery

1

1 

Mind‐bod

y skills ‐ 1 

Mindfulness‐basedstress reduction

2 ‐ 

Mindfulness meditation ‐ 1 Relaxation ‐ 1 

Yoga

1

1
a u at e a d based e a es a a 

Results: Key Question #2 Results: Key Question #2

Key Question 2: In adults with PTSD, are manipulative and 

CAM therapies more efficacious than control for PTSD symhealth-related quality of life? 

• Manipulative and Body-based Therapies: spinal man

massage 

• 1 massage (1 poor quality) 1 massage (1 poor quality) 

• 0 unpublished /ongoing trials (ClinicalTrials.gov) 
oe et ased e a es e de a s e e 

t

Results: Key Question #3 Results: Key Question #3

• Key Question 3: In adults with PTSD, are CAM therapies 

movement-based and energy therapies more efficacious t

for PSTD symptoms and health-related quality of life? 

• Movement-Based Therapies: Feldenkrais method, Ale

technique, Pilates, Rolfing Structural Integration, and TPsychophysical Integration 

• Energy Therapies: magnet therapy, light therapy, qi go

healing touch 

• 0 RCTs • 0 unpublished /ongoing trials (ClinicalT ir als.gov)
o a do o e s ud es

Results: Key Question #4 Results: Key Question #4

• Key Question 4: For treatments evaluated in Key Questi

lack randomized controlled trials, is there evidence from o

designs that suggests the potential for treatment efficacy? 

• 2 n

onr

a

ndomized, p spec ed, 

p

rospective 

s

tudies

• no quality rating • Both multimodal therapies that incorporated CAM 

(hypnotherapy guided imagery relaxation) (hypnotherapy, guided imagery, relaxation) 

• 2 unpublished /ongoing nonrandomized trials (Clinical

both examine yoga interventions both examine yoga interventions 
Results: Summary of Study 

Charac

teri KQ#2&4 i

stics: KQ#2&4

RCT of manipulative and body-based interventions: KQ 2 Price, 2006 (n = 8) 

Body-oriented therapy (massage) vs. wa

Non-RCT of CAM therapies for PTSD: KQ 4 Abramowitz and Lichtenber

g, 2010 

Prospective cohort (n = 36) 

H

ypnotherapeutic olfactor

y conditioning 

H kossac and B t ll Bentall, 1996 R l ti d i l ki th ti di i Case series (n =5) 

R

elaxation an

d visual kinesth

etic dissocia

Note: No studies were found that were applicable to KQ#3 
Results: ClinicalTrials.gov

(N O i St di ) (No Ongoing Studies)

• Alexander technique• Craniosacral therapy therapy • Energy field work • Feldenkrais Feldenkrais • Magnet therapy 

• Pilates 

• Reiki • Tai chi • Therapeutic t

Therapeutic t

• Trager therap
- -

Summary of Evidence: KQ #1 

Mi dn -B d Th i Body Therapies 

DOMAINS PERTAINING TO STRENGTH OF 

EVIDENCE 

MAGNITUDE OF 

STRENGTH O

Number of 

studies (subjects) 

Risk of bias: Risk of bias: design/quality Consistency Directness Precision 

PTSD symptoms: EffePTSD symptoms: Effe

CI) 

KQ 1: Meditation vs. usual care Low SOE 1 (29) RCT/Fair N/A Direct Imprecise SMDb : -0 32 . ( -1 42 . to 0 

to 0

SDM: -0.70 (-1.06 to 0

KQ 1: Meditation vs. active treatment Insufficient SOE 1 (25) RCT/Poor RCT/Poor N/A Direct Imprecise Imprecise Not estimated Not estimated KQ 1: Acupuncture vs. control Moderate SOE 1 (84) RCT/Good N/A Direct Imprecise Imprecise SMD: -0.92 (-1.51 to -0KQ 1: Acupuncture vs. group CBT Low SOE 1 (84) RCT/Good N/A Direct Imprecise SMD: -0.35 (-0.91 to 0

aA negative SMD indicates a greater effect for the CAM therapy bSMD: standardized mean difference; Hedge’s g for continuous outcomes 
Summary of Evidence: KQ #1 

Mi dn

d

-B d Th i B

o

dy Therap

ies 

DOMAINS PERTAINING TO STRENGTH OF 

EVIDENCE 

MAGNITUDE OF 

STRENGTH O

Number of 

studies (subjects) 

Risk of bias: Risk of bias: design/quality Consistency Directness Precision 

PTSD symptoms: EffePTSD symptoms: Effe

CI) 

KQ 1: Relaxation vs. control Insufficient SOE 1 (90) RCT/Poor N/A Direct Imprecise Not estimated KQ 1: Relaxation vs. other active treatment Insufficient SOE 2 (56) RCT/Fair to Poor Consistent Consistent Direct Imprecise Imprecise SMD: 0.41 (-0.42 to 1.2

SMD: 0.79 (-0.13 to 1.7

KQ 2: Massage vs. control Insufficient SOE 1 (8) RCT/Fair N/A Direct Imprecise Not estimated KQ 3: Movement-based and energy therapies vs. control Insufficient SOE None N/A N/A N/A N/A N/A 

*A negative SMD indicates a greater effect for the CAM therapy 
Summary

...and so, in plain English, what does 

that mean, exactly? 
Summary: Key Findings Summary: Key Findings

• Hi

ghest 

qualityevidence exists for acu

puncture 

• acupuncture > wait list control 

p (g p 

• but... strong conclusions cannot be reliably drawn on the 

single RCT (further study needed) 

• Greatest breadth of evidence exists for relaxation 

• generally associated with moderate improvement • but...all 3 studies (breathing, relaxation) are preliminary a

significant design flaws that limit interpretability; preliminafavor active comparators (further study needed) 

• acu

puncture ؐ active treatment (grou

p CBT vs individual 
Summary: Key Findings Summary: Key Findings

• Evidence in support of meditation is 

generallyp 

positive

• meditation > control (usual care) • meditation vs. active treatment ? • but... based on 2 preliminary studies on concentrative me

(further study needed) 

• Evidence in support of massage is positive but quite limited 

• 1 RCT with significant design flaws (further study needed) 

• Did not identify eligible RCTs of spinal manipulation, movemen

energy therapies (KQ 3) 

• Overall: studies rarely addressed the issue of adverse effects; 

Overall: studies rarely addressed the issue of adverse effects; 

(when reported) similar to current evidence-based approaches 
Limitations

• Limited to RCTs in peer-reviewed, English language journ

• No systematic search of the “gray literature” 3⁄4 Limited to CAM trials conducted in clinical, PTSD samples 3⁄4 Relaxation therapies: only included those presented as ac

treatment s (versus control) and d d (5 adequately describ ed (5 o

relevant studies excluded, which showed modest effects vcomparators) 

• Did not examine issues of symptom overlap, comorbidity 

traumatic brain injury, or other unique presentations that m

anticipated among OEF/OIF Veterans anticipated among OEF/OIF Veterans 

3⁄4 Did not examine “third-wave psychotherapies” (e.g., mind

cognitive therapy, acceptance and commitment therapy) cognitive therapy, acceptance and commitment therapy) 

• Scope of search excluded natural products (e.g., nutrition

supplements) 
Strengths

• Quality over quantity: highly structured, systematic eviden• Application of rigorous research methods relatively new to • Multidisciplinary team included expertise in: 

• research methods • internal medicine nternal medicine • clinical psychology • epidemiology • acupuncture research cupuncture research • integrative medicine 
Conclusions

• Current evidence base is very limited (7 RCTs, 2 prospec• Overall, published findings are positive Overall, published findings are positive • Research on CAM therapies for PTSD appears to be on t

suggested by the 16 pertinent RCTs we identified in Clinic

• Glass half empty: limitations of current evidence bases pr

drawing any strong conclusions at this point 

• Glass half full: there are numerous, important opportunitie

research in this area! 

• Q i i uestions remain: effi ff i f fficacy, effectiveness, safety, cost-effe

comparative effectiveness, mechanisms of action, dosingand contraindications, differential responses among subg
Conclusions

• CAM encompasses broad range of treatments, not all of w

hold the same promise for PTSD 

• The current absence of a strong signal pointing to any on

approach argues for investment in a set of adequately pow

evaluate most promising approaches evaluate most promising approaches 

• Good-quality early empirical evidence (e.g., acupunct• Sound theoretical rationale in absence of strong prelim

Sound theoretical rationale in absence of strong prelim

(meditation) 

• And/or promising data gleaned from bench sciences (

And/or promising data gleaned from bench sciences (

compelling animal models) 

• For those CAM approaches for which science and theory 

developed (e.g., energy therapies), smaller, exploratory pwould be a more prudent next step 
Final Thoughts Final Thoughts

This is a dynamic and growing field of inqThis is a dynamic and growing field of inq

Results of this review suggest that we can look fo

more comprehensive evidence base on CAM th

PTSD in the near future PTSD in the near future. 
Contact Information Contact Information

Questions? 

If you have further questions, 

feel free to contact: 

Jennifer Strauss 

Email: jennifer strauss@va gov Email: jennifer.strauss@va.gov 

Phone: 919/286-0411, ext. 5275 

The full, final report and cyberseminar presentation will be 

on the ESP website: 

http://www.hsrd.research.va.gov/publications/esp/