Review Article Qigong and Fibromyalgia: Randomized ...Review Article Qigong and Fibromyalgia: Randomized Controlled Trials and Beyond JanaSawynok 1 andMaryLynch 2 DepartmentofPharmacology,DalhousieUniversity,P.O.Box,H

Review ArticleQigong and Fibromyalgia: Randomized ControlledTrials and Beyond

Jana Sawynok1 and Mary Lynch2

1 Department of Pharmacology, Dalhousie University, P.O. Box 15000, Halifax, NS, Canada B3H 4R22Departments of Anesthesia, Psychiatry, and Pharmacology, Dickson Centre, QEII Health Sciences Centre,5820 University Avenue, Halifax, NS, Canada B3H 1V7

Correspondence should be addressed to Jana Sawynok; [email protected]

Received 17 March 2014; Accepted 25 June 2014; Published 12 November 2014

Academic Editor: Martin Offenbaecher

Copyright © 2014 J. Sawynok and M. Lynch. This is an open access article distributed under the Creative Commons AttributionLicense, which permits unrestricted use, distribution, and reproduction in any medium, provided the original work is properlycited.

Introduction. Qigong is currently considered as meditative movement, mindful exercise, or complementary exercise and is beingexplored for relief of symptoms in fibromyalgia. Aim. This narrative review summarizes randomized controlled trials, as well asadditional studies, of qigong published to the end of 2013 and discusses relevant methodological issues. Results. Controlled trialsindicate regular qigong practice (daily, 6–8 weeks) produces improvements in core domains for fibromyalgia (pain, sleep, impact,and physical and mental function) that are maintained at 4–6 months compared to wait-list subjects or baselines. Comparisonswith active controls show little difference, but compared to baseline there are significant and comparable effects in both groups.Open-label studies provide information that supports benefit but remain exploratory. An extension trial and case studies involvingextended practice (daily, 6–12 months) indicate marked benefits but are limited by the number of participants. Benefit appears tobe related to amount of practice. Conclusions. There is considerable potential for qigong to be a useful complementary practice forthe management of fibromyalgia. However, there are unique methodological challenges, and exploration of its clinical potentialwill need to focus on pragmatic issues and consider a spectrum of trial designs. Mechanistic considerations need to consider bothsystem-wide and more specific effects.

1. Introduction

Fibromyalgia (FM) is characterized by widespread pain andmultiple somatic symptoms. In the 1990s, the AmericanCollege of Rheumatology (ACR) provided criteria involvingpresence of allodynia (tender point examination) and othersymptoms including fatigue, sleep disruption, and gastroin-testinal symptoms [1]. A recent PubMed search indicated 361English language articles with “fibromyalgia” as a keywordin the 20-year period prior to the 1990 ACR criteria beingpublished, and 3844 articles in the 20-year period followingpublication attesting to growing recognition of the condition[2]. In 2010, modified criteria were developed to addressthe issue of tender points, associated symptoms, and theobservation that FMmight represent an extreme end of a paincontinuum; updated criteria include a chronic widespreadpain index and symptom severity scale for cognitive symp-toms, sleep disturbance, fatigue, and somatic symptoms [3].

The prevalence of FM is 0.5–5% while that of chronicwidespread pain is 10–20% [2, 4]. FM is a challengingcondition, both for those who experience it and for thosewho treat it [5, 6]. Longitudinal benefits are modest despiteuse of currently approved drugs [7, 8]. Mechanisms involvedin FM include central sensitization, altered central pain pro-cessing, impaired endogenous pain regulation mechanisms,and disturbances in the hypothalamus-pituitary-adrenal axis,the autonomic nervous system, and peripheral tissues [2, 4].Current treatment guidelines emphasize patient education,pharmacological and nonpharmacological approaches, andtreatment of comorbid conditions [5, 9, 10].

Qigong (Chi Kung, Chi Gong) refers to cultivation(practice, discipline) of qi (life energy, energetic essence)and has a long history in China, extending thousands ofyears, as a health and wellness practice [11–13]. Many formsof qigong have developed, reflecting particular contexts fordevelopment (martial arts, health practice, and spiritual

Hindawi Publishing CorporationEvidence-Based Complementary and Alternative MedicineVolume 2014, Article ID 379715, 14 pageshttp://dx.doi.org/10.1155/2014/379715

2 Evidence-Based Complementary and Alternative Medicine

practice). The modern history of qigong began in China inthe 1950s; western interest grew in the 1960s and has furtheraccelerated in recent decades. As a self-practice, internalqigong involves dynamic (movement) and static (quiescent)elements and involves regulation of movement, breath, andawareness. When highly developed by skilled practitioners,qigong can be applied as external qigong, whereby thepractitioner directs energy (using hand movements, focusedattention) towards an individual to improve the flow ofqi. In the past decade, qigong has been characterized as“mindful exercise” [14] or “meditative movement” [15], andthese conceptualizations are useful for considering qigong inrelation to other practices such as mindfulness, meditation,and conventional exercise.

There have been several recent (published 2012-2013) sys-tematic reviews and meta-analyses of randomized controlledtrials (RCTs) of qigong for fibromyalgia. Some considerqigong as a distinct entity [16, 17] while others considerit as a “meditative movement therapy” or “complementaryand alternative exercise” whereby qigong, tai chi, and yogaare clustered together [18, 19]. There also have been reviewsof qigong in the even broader context of complementaryand alternative therapies [20, 21]. These overviews reachdifferent conclusions regarding the potential of qigong forfibromyalgia, ranging from cautious (may be useful, butemphasize the limited quality of trials and methodologicalchallenges) [16, 17] to indicating itmay be a useful componentof multimodal treatment [18, 19] and even to proposing arational usage algorithm (for complementary therapies ingeneral) [21].

In addition to RCTs, there is an increasing recognitionof the need for pragmatic or effectiveness trials to provideinformation for improving the management of chronic pain[22]. Furthermore, multiple diverse trial designs need to beconsidered for exploring the effectiveness of complementaryand alternative medicine (CAM) modalities [23–26]. Severaltrial variations are now available and provide additionalinsight into potential benefits of qigong. The purpose of thepresent narrative review paper is to describe (1) evidencefor efficacy of qigong in FM (RCTs, reviews, and others)published to the end of 2013 and to discuss (2) the relationshipbetween practice and outcomes, (3) methodological issuesthat require attention, and (4) potentialmechanisms of actionof qigong.

2. RCTS of Qigong for Fibromyalgia

There are 7 RCTs of qigong for FM published to the endof 2013 (Table 1). Six of these trials involved adults (𝑁 =367, mean age 45–57 years, and mean FM duration 5–15years) and one involved children and adolescents (𝑁 = 30,mean age 13 years). Three RCTs involved qigong instructionand daily home-practice over 6–8 weeks and monitoredadherence to practice [27–29]. One trial over 7 weeks didnot appear to require home-practice for the qigong groupbut did for the comparator group [30]. Two RCTs over 8–12 weeks involved weekly group sessions where qigong was

part of a multimodal session (with meditation, body aware-ness, and education) and no home-practice was performed[31, 32].

Two RCTs (𝑁 = 57, 𝑁 = 100) involving qigong(7-8 weeks, daily home practice) compared outcomes towait-list subjects and reported significant benefits in pain,impact, sleep, physical and mental function, and quality oflife following the intervention and at 4–6months of follow-up[27, 29]. Post-intervention standard mean differences (SMD,or Cohen’s d, is the difference between means divided by thepooled standard deviation (M1−M2)/√[𝜎

1

2+ 𝜎2

2]; values of

≥ 0.2 are small, ≥ 0.5 aremedium, and ≥ 0.8 are of large effectsizes) across these domains were 0.44–0.73 [27] and 0.71–1.16 [29] compared to the wait-list group. At follow-up, therewas some drift but significant effects were maintained (SMDs0.2–0.7 in [27]; 0.52–0.72 in [29]). A smaller RCT (𝑁 = 14)of qigong (7 weeks, daily home practice) compared qigongto sham exercise and reported significant postinterventionbenefits in the qigong group but not the sham exercise group(effect sizes 0.99–1.98), but there was no follow-up [28]. OneRCT (𝑁 = 30) compared qigong (QG) to another movementand body awareness method (Rességuier method, RM) andcompared two groups in which these methods were usedsequentially for 7 weeks (RM + QG,QG + RM). The first 7weeks of this trial represents a comparative trial of QG versusRM. In both groups, there were significant and comparablepostintervention improvements in pain, impact, mood, andfunction following the first intervention; addition of thesecond intervention did not lead to further improvement,but benefits were maintained at 6-7 months [30]. SMDscompared to baseline ranged from 0.7 to 1.5 postinterventionand at follow-up.

Two earlier RCTs (𝑁 = 128, 𝑁 = 38) of qigonginvolved weekly sessions (8–12 weeks, but no home practice)in which qigong was part of a multimodal approach; bothnoted no differences in pain or impact compared to thecomparison group (education support, normal daily activity)[31, 32]. There were beneficial changes across time in boththe intervention and the control groups in one study [31], butfew differences in the other [32]. The RCT in children andadolescents (𝑁 = 30) compared qigong to aerobic exercise(3 sessions/week) and monitored many aspects of physicalfunction and functional outcomes; benefits were reportedin both groups, but the aerobics group performed better onseveral measures [33].

3. Other Trials of Qigong for Fibromyalgia

Additional information on the effects of qigong for FM isavailable from other trials that use heterogeneous approaches(Table 2). Three pilot studies examined qigong (all useddifferent forms) in an open-label manner over 3–9 weekswith follow-up to 3–6 months. Creamer et al. [34] (𝑁 =28) included qigong as one component of a multimodalintervention (weekly for 8 weeks, no home practice) andobserved significant improvements in many areas that weremaintained over time (4–6 months); however, it is notpossible to discern an effect of qigong in this study due to the

Evidence-Based Complementary and Alternative Medicine 3

Table1:Summaryof

rand

omized

controlledtrials(RCT

s)of

qigong

forfi

brom

yalgia.C

ontro

lgroup

sinclude

passive(normalactiv

ities,w

ait-list)a

ndactiv

egrou

ps(edu

catio

n,aerobic

exercise,sham

exercise,and

otherinterventions).

Stud

yParticipants,

study

features

Interventio

n,du

ratio

n,measures

Outcomes

Betweengrou

pcomparis

ons,except

where

indicated

(1)A

stinetal.2003[31]

𝑁=128;Q

G+MM𝑁=64

CG(edu

catio

nsupp

ort)𝑁=64

Meanage:47.7yrs

MeanFM

duratio

n:5.0y

rsAttrition

:50(39%

)by8w

ks,61(48%)

by16wks,and

67(49%

)by24

wks

Note:Th

e1stcontrolledstu

dyof

QG

forfi

brom

yalgia.

Interventio

n:QG(D

ance

ofPh

oenix),

mindfulnessmeditatio

n(M

M);

2.5h

rtotal(Q

G=60

min),weeklygrou

psession

Duration:

8wks

Measures:BL

,8wks;4

and6m

osF-UP

Post-in

terventio

nFo

llow-

upFIQ

NS

NS

Totalm

yalgicscore

NS

NS

SF-36pain

NS

NS

6min

walktest

NS

NS

Depression(BDI)

NS

NS

Note:(1)D

ueto

high

attrition

,onlythosec

ompletingthee

ntire

protocolwerea

nalysed.(2)

With

in-group

comparis

onsa

t8wks

and4and6m

osindicatethatbo

thgrou

pshadsig

nificant

improvem

entsover

timeinFIQ,totalmyalgicscore,SF-36pain,and

depressio

n;effectswerem

anifest

at8w

ksandmaintainedto

24wks.

(2)M

annerkorpi

andArndo

w2004

[32]

𝑁=38;Q

G+BA𝑁=19

CG(normalactiv

ities)𝑁=17

Meanage:45

yrs

MeanFM

duratio

n:10yrs

Attrition

:14(39%

)

Interventio

n:QG(styleno

treported),

body

awareness(BA

)therapy;

1.5hr

total(QG=20

min),weeklygrou

psession

Duration:

3mos

(14sessions)

Measures:BL

,3mos

Note:Participantsweree

ncou

ragedto

practicea

thom

e,bu

tnon

eregularly

perfo

rmed

homee

xercise

s.

Post-in

terventio

nBA

RS𝑃<0.05

FIQ

NS

Handg

riptest

NS

Chairtest

NS

Note:(1)D

ueto

attrition

,only12

+10

participated

inpo

st-testou

tcom

es.(2)

With

in-group

BARS

analysisindicatedsig

nificantchanges

intre

atmentg

roup

butn

otcontrolgroup

;with

in-group

FIQ

totalscore

analysisindicatessignificantchanges

incontrolgroup

butn

ottre

atmentg

roup

.

(3)S

teph

ense

tal.2008

[33]

𝑁=30;Q

G𝑁=16

CG(aerob

icexercise)𝑁=14

Meanage:13.3yrs

Attrition

:6(20%

)Note:Th

e1stcontrolledtrialofQ

Gas

exercise

interventio

nin

child

renand

adolescentsw

ithFM

.

Interventio

n:QGexercises(18

postu

res,

styleno

treported)

versus

aerobic

exercise;30m

inof

practic

ein1g

roup

session+2ho

mes

essio

nseach

week

Duration:

3mos

Measures:BL

,3mos

Note:Ad

herencem

onito

redby

heartrate

mon

itorsanddiaryentries(no

tedas

60–70%

)

Post-in

terventio

n,therew

eres

ignificantimprovem

entsin

physicalfunctio

n,functio

nalcapacity,

QOL,andfatig

uein

thea

erob

icsg

roup

.Aerob

icfunctio

n,tend

erpo

intcou

nt,pain,

andsymptom

severityim

proved

similarly

inbo

thgrou

ps;the

aerobics

grou

pperfo

rmed

bette

rinseveralm

easures

comparedto

theQ

Ggrou

p.Note:(1)Th

estudy

addressedbo

thph

ysicalfitnessandclinicalsym

ptom

sand

mon

itoredmultip

leou

tcom

es.(2)

Intent-to

-treatanalysis

was

used.


Table1:Con

tinued.

Stud

yParticipants,

study

features

Interventio

n,du

ratio

n,measures

Outcomes

Betweengrou

pcomparis

ons,except

where

indicated

(4)H

aakandScott2

008[27]

𝑁=57;Q

G𝑁=29

CG(w

ait-list)𝑁=27

Meanage:53.3yrs

MeanFM

duratio

n:15.4yrs

Attrition

:1(2%)

Note:At

thee

ndof

thew

ait-list

interval,

subjectsreceived

QGtraining

and

constituted

adelayed

training

coho

rt.

Interventio

n:QG(H

eHua

Qigon

g)11.5hrsinstructio

ns/practiceo

ver7

wks;

encouraged

topractic

eath

ome(2×

20min/day);subjectsalso

had2external

QGsessions

Duration:

7wks

Measures:BL

,8wks,4

mos

F-UP

Note:At

postinterventio

n,the

combinatio

ngrou

phadhigh

compliance

with

93%repo

rtingregu

lar(3–6days/w

k)or

daily

practic

e.At

4mos

F-UP,65%

weres

tillpracticingand90%of

thoseo

nar

egular-dailybasis.

Betw

een-grou

pWith

in-group

Pvalues

Pain

(VNS)

Coh

en’sd

Pre-po

stPre-F-UP

Intensity

0.63

<0.001

<0.05

Inconvenience

0.73

<0.01

<0.05

Con

trolofp

ain

0.61

<0.01

NS

Sleep(V

NS)

Resto

ratio

n0.44

<0.001

<0.01

Quality

NS

<0.001

<0.01

Psycho

logical

STAI(anxiety)

0.66

<0.05

<0.01

BDI(depressio

n)0.69

<0.01

<0.001

QOLtotal

0.55

<0.001

<0.01

QOLpsycho

logical

0.52

<0.001

<0.001

QOLph

ysical

NS

<0.01

<0.001

Note:(1)M

anybetween-grou

peffectsizes

follo

wingtheinterventionareinthem

oderate-to-la

rge

range(0.5–0.8).(2)

Com

binatio

ngrou

pdatarepo

rtsp

ostin

terventio

nandlonger-te

rmou

tcom

esfor

𝑁=56subjects.

(3)W

hilebenefitsa

resustainedover

time,SM

Dsa

tfollow-upcomparedto

BLrange

from

0.2to

0.7.

(5)L

iuetal.2012[28]

𝑁=14;Q

G𝑁=8

CG(sham

exercise)𝑁=6

Meanage:56.5yrs

MeanFM

duratio

n:9.4

yrs

Attrition

:12.5%

(2/8)ininterventio

ngrou

pNote:Th

isistheo

nlystu

dyto

uses

ham

exercise

asac

omparis

on.

Interventio

n:QG(Liu

ZiJueQ

igon

g,“Six

Healin

gSoun

ds”),2

training

sessions,

weeklygrou

psessions

(45–60

min),daily

home-practice(2×15–20m

in,m

orning

andevening).Sham

hadthes

ame

movem

ents,

butn

omeditatio

nor

healing

soun

ds.

Duration:

6wks

Measures:BL

,6wks

Note:Participantsaskedto

keep

diaryof

home-practice.Com

pliancew

asmod

erately

high

(75–85%daily,77–79%

grou

psessions).

Pre-po

stQG

Pre-po

stSh

amSF-M

PQ(pain)

↓44

%(𝑃<0.0125)↓10%(N

S)MFI

(fatig

ue)

↓25%(𝑃<0.0125)↓6%

(NS)

PSQI(sle

ep)

↓37%(𝑃<0.0125)↓10%(N

S)FIQ(im

pact)

↓44

%(𝑃<0.0125)↓12%(N

S)Note:(1)B

etween-grou

pCoh

en’sdforp

ain,

fatig

ue,sleep,and

impactwas

1.56,1.5

8,0.99,and

1.98,

respectiv

ely.(2)

Trialislim

itedby

thes

mallsam

ples

izea

ndlack

offollo

w-updata.


Table1:Con

tinued.

Stud

yParticipants,

study

features

Interventio

n,du

ratio

n,measures

Outcomes

Betweengrou

pcomparis

ons,except

where

indicated

(6)L

ynch

etal.2012[29]

𝑁=100;Q

G𝑁=53

CG(w

ait-list)𝑁=47

Meanage:52

yrs

MeanFM

duratio

n:9.6

yrs

Attrition

:12%

(12/100)

at6m

os;29%

(12/42)d

elayed

interventio

ngrou

pNote:(1)Th

elargestQGforF

Mtrialto

date.(2)

Atthee

ndof

thew

ait-list

interval,sub

jectsreceivedQGtraining

andconstituted

adelayed

training

coho

rt.

Interventio

n:QG(C

haoyiF

anhu

anQigon

g,CF

Q);3half-daytraining

sessions

(4hrse

ach);w

eekly

review

/practices

essio

n(60m

in);daily

home-practice(45

mins)

Duration:

8wks

Measures:BL

,8wks,4

and6m

osF-UP

Note:(1)C

ompliancew

ithpractic

ewas

repo

rted

asaveragew

eeklypractic

etim

eat8w

ksandat4and6m

osF-UPs.(2)

Fora

llwho

completed

the6

-mon

thtrial,

85%(62/73)p

racticed≥3hrs/weekand

52%(38/73)≥

5hrs/weekat8w

ks.

Post-Q

G4m

oF-UP

6moF-UP

NRS

(pain)

imm<0.001

0.01

<0.05

del

0.01

0.005

<0.05

FIQ(im

pact)

imm<0.001

0.003

0.007

del<0.001

0.01

0.05

PSQI(sle

ep)

imm

0.001

<0.001

0.003

del

0.00

9NS∗

NS∗

SF-36ph

ysical

imm<0.001

<0.001

0.00

4del

<0.01

<0.001

0.01

SF-36mental

imm

0.002

NS

NS

del

0.00

4NS

NS∗

Note:(1)Ind

ividualQ

Ggrou

ps(im

m,del)sho

wed

good

reprod

ucibilitywhencomparedto

wait-list.

(2)∗𝑃<0.01in

combinatio

ngrou

panalysis.

(3)C

ombinatio

ngrou

pdatarepo

rtsp

ost-intervention

andfollo

w-updataforthe𝑁=73who

completed

thetria

lto6mon

ths;itinclu

desp

artic

ipantsfro

mbo

ththeimmediateandthed

elayed

interventio

ngrou

ps.(4)

Com

binatio

ngrou

pSM

Dvalues

comparedto

wait-list

are0

.81(0.67,0.56atF-UP)

forp

ain,

1.16(0.63,0.57

atF-UP)

forimpact,0.71

(0.60,0.52

atF-UP)

forsleep,0.80(0.72,0.56

atF-UP)

forp

hysic

alfunctio

n,and0.79

(0.23,0.49

atF-UP)

form

entalfun

ction.

(5)Inthe𝑁=38perp

rotocolgroup

(practiced≥5h

rs/w

eekat8w

k),

SMDvalues

versus

wait-list

arep

ain1.17(0.96,0.93

atF-UP),impact1.6

7(0.88,0.88

atF-UP),sleep

1.04(0.97,0.71

atF-UP),physic

alfunctio

n0.95

(0.93,0.79

atF-UP),and

mentalfun

ction1.0

7(0.39

,0.62

atF-UP).


Table1:Con

tinued.

Stud

yParticipants,

study

features

Interventio

n,du

ratio

n,measures

Outcomes

Betweengrou

pcomparis

ons,except

where

indicated

(7)M

addaliBo

ngietal.2012

[30]

𝑁=30(RM

+QG𝑁=15;Q

G+RM

𝑁=15)

CG(RM

over

thefi

rst7

weeks)

Meanage:57.3yrs

MeanFM

duratio

n:7.2

Attrition

:0%on

cetraining

commenced

(but

8/38

with

drew

follo

wing

rand

omization)

Note:(1)C

omparativ

etria

lbetween

twoactiv

emetho

dsconsidered

as“m

ind-bo

dy”p

ractices.B

othgrou

psrepresentp

otentia

llyactiv

einterventio

ns.

(2)Initia

l7weeks

iscomparis

ontrial;

ther

emaind

erof

study

represents

acrossover

trialbut

canalso

beconsidered

anadd-on

trial.

Group

1:RM

+QG

Group

2:QG+RM

7wks

(1wkbreak)

+7w

ks2sessions/w

eekforw

ks1–3

1sessio

n/weekforw

ks4–

7(to

tal10sessions,45–60

mins)

RM:hom

eexercise

of30

min/day

durin

ginterventio

nDuration:

15wks,F-U

P12wks

after

completingthe2

ndmetho

dMeasures:BL

,7wks

(T1),15w

ks(T2),

27wkF-UP

Note:(1)D

etaileddescrip

tionof

QGand

RMprovided

(QGsty

leno

tspecified).

(2)R

Mpractic

eddaily

for3

0mins,bu

tthiswas

notspecifiedforQ

G.

Pre-po

stPvalues

(with

ingrou

p)Group

1:RM

+QG

Afte

rRM

Afte

rQG

F-UP

FIQ

<0.001

<0.001

<0.001

HAQ

<0.001

<0.001

<0.001

NRS

(pain)

<0.001

<0.001

<0.001

RPS(pain)

<0.001

<0.001

<0.001

NRS

(sleep)

NS

NS

NS

HADS-A

<0.001

<0.001

<0.001

HADS-D

NS

<0.001

<0.001

SF-36PC

S<0.001

<0.001

<0.001

SF-36MCS

NS

NS

NS

Group

2:QG

+RM

Afte

rQG

Afte

rRM

F-UP

FIQ

<0.05

<0.001

<0.05

HAQ

<0.001

<0.001

<0.001

NRS

(pain)

<0.001

<0.001

<0.001

RPS(pain)

<0.001

<0.001

<0.001

NRS

(sleep)

NS

<0.05

NS

HADS-A

<0.001

<0.001

<0.001

HADS-D

<0.001

<0.001

<0.001

SF-36PC

S<0.05

<0.001

<0.001

SF-36MCS

NS

NS

NS

Note:(1)Q

GandRM

prod

ucec

omparableb

enefitscomparedto

BLover

arange

ofou

tcom

eswhen

appliedas

aninitialinterventio

n.Whenthey

areimplem

entedas

asequentialintervention,

most

outcom

esaren

otdifferent

from

thee

ndof

thefi

rstintervention.

(2)E

ffectsa

regenerally

maintained

inthefollow-upintervalto

6mos.(3)

SMDvalues

forF

IQ,H

AQ,R

PS,H

ADS-A,H

ADS-D,and

SF-36

PCSgenerally

rangefrom

0.7to

1.5in

both

grou

ps(8wks–6

mos).

BA,bod

yaw

areness;BA

RS,bod

yaw

arenessratingscale;BD

I,Be

ckDepressionInventory;BL

,baseline;C

G,con

trolorc

omparis

ongrou

p;del,delayedinterventio

ngrou

p;FIQ,fibrom

yalgiaim

pactqu

estio

nnaire;

FM,fi

brom

yalgia;F

-UP,

follo

w-up;

HADS,

HospitalA

nxiety

andDepressionScale(A-anx

iety,D

-depression);H

AQ,h

ealth

assessmentq

uestion

naire

;hrs,h

ours;imm,immediate

interventio

ngrou

p;MFI,

Multid

imensio

nalF

atigue

Inventory;

MM,m

indfulness

meditatio

n;mos,m

onths;NRS

,num

ericalratin

gscale;NS,

nonsignificant(𝑃>0.05);PS

QI,Pittsbu

rghSleepQualityIndex;

QG,q

igon

ggrou

p;QOL,

quality

oflife;RM

,Rességuierm

etho

d;RP

SRe

gion

alPain

Scale;SF-36,shortform-36(M

CSmentalcom

ponent

summary,PC

Sph

ysicalcompo

nent

summary);SF-MPQ

,sho

rtform

-McG

illpain

questio

nnaire;

SMD,stand

ardmeandifference;ST

AI,StateA

nxietyInventory;T1,treatment1;T

2,tre

atment2

;VNS,visualnu

mericalscale;wks,w

eeks;yrs,years.

Evidence-Based Complementary and Alternative Medicine 7Ta

ble2:Summaryof

otherstudies

ofqigong

forfi

brom

yalgia.

Stud

yParticipants,

features

Interventio

n,du

ratio

nOutcomes

(1)C

ream

eretal.200

0[34]

Pilotstudy,opentrial𝑁=28

Meanage:47.9yrs

Attrition

:8/28(29%

)did

notcom

plete

5/8sessions

Note:(1)N

ocontrolgroup

.(2)D

atafollowinginterventio

nwas

also

repo

rted

bySing

hetal.(1998)[35]

Attend

ance

at8weeklysessions

(2.5hrs

each),with

educationaland

cogn

itive/behaviouralcompo

nent

(30m

in),relaxatio

n/meditatio

n(60m

in),

qigong

(60m

in,form

notspecified)

Duration:

8weeks

Measures:BL

,8wks,4

mos

F-UP,6m

osF-UP

Sign

ificant

(𝑃<0.05)improvem

entsin

FIQ,sleep,patient

glob

al,R

ANDHealth

Survey

(physic

alfunctio

n,energy,emotionalfun

ction,

socialfunctio

n,andpain),

coping

,depression,andfunctio

nfollo

wingtheintervention.Be

nefitsw

ereg

enerally

maintainedat4and6mon

thsfrom

BL.

Note:(1)Intent-to-tre

atanalysisof

results.(2)

Due

tomultip

leinterventio

nsdu

ring

thew

eeklysession,

itisno

tpossib

leto

ascribee

ffectsspecificallyto

qigong

.

(2)C

henetal.200

6[36]


Meanage:49.8yrs

MeanFM

duratio

n:6.2y

rsAttrition

:3/13

(23%

)dropp

edou

tafte

r1–3sessions;datafor𝑁=10analysed

postinterventio

n;𝑁=8returned

for

3mos

F-UP

Note:Nocontrolgroup

.

Externalqigong

therapyappliedfor5

–7sessions

(45m

ins)over

3wks;m

onthly

maintenance

session

Interventio

ndu

ratio

n:3we

eks

Measures:BL

,3wks,1moF-UP,3m

osF-UP

Sign

ificant

improvem

entsin

impact(FIQ

),depressio

n(BDI),pain(M

PQ,V

AS),

andanxietyfollowingtheintervention.Ch

angesw

erem

aintainedat1and

3mon

ths,

althou

ghtherew

assomer

ebou

nd.P

re-postSMDvalues

were1.1–

1.9at3w

ks,

0.7–1.7

atthe1

moF-UP,and0.8–1.4

atthe3

mos

F-UP.Sleep(PSQ

I)scores

were

notsignificantly

improved.

Note:Tw

ocasesh

adsuch

dram

aticandpersistentb

enefitfollowingtre

atmentthat

they

werec

onsid

ered

“cured.”Individu

alou

tcom

esforF

IQ,tenderp

oints,MPQ

,andBD

Iare

presentedandindicateminim

alpo

st-tre

atmentsym

ptom

olog

y.

(3)L

ynch

etal.200

9[37]


Meanage:51.1yrs

MeanFM

duratio

n:12.0yrs

Attrition

:21(91%)com

pleted

4wks,14

(61%

)9wks,13(52%

)3mos,and

12(52%

)6m

os.

Note:Nocontrolgroup

.

Twohalf-day(4

hrs)qigong

training

sessions

(level1

CFQ),weekly

review

/practices

essio

n(90m

in),daily

home-practice(45

min).

Interventio

ndu

ratio

n:9w

ksMeasures:BL

,9wks,3

mos

F-UP,6m

osF-UP

Note:(1)L

evel1C

FQconsistso

fmovem

ents.

(2)N

omeasure

ofho

me-practicew

asinclu

ded.

Sign

ificant

improvem

entsin

pain

(NRS

),im

pact(FIQ

),andph

ysicalfunctio

n(SF-36),either

followingtre

atmento

ratF

-UP.

Note:(1)A

nalysis

cond

uctedon𝑁=12who

completed

the6

-mon

thtrial.(2)

Pre-po

stSM

Dvalues

forp

ain,im

pact,and

physicalfunctio

nwere0

.6–0

.9follo

wing

theinterventionandatfollo

w-up.

(4)S

awyn

oketal.2013[38]

Case

repo

rts,𝑁=2

Age:#1=

45yrs,#2

=57

yrs

FMdu

ratio

n:#1

=10yrs,#2

=20

yrs

Note:(1)B

othcasesh

adextensive

symptom

olog

y(pain,

distu

rbed

sleep,

andmultip

leothersym

ptom

s)thathad

progressed

over

time.(2)B

othhad

previouslytriedmanyothertherapies

(pharm

acological,n

ondrug

,complem

entary

metho

ds)b

utremained

symptom

atic.

Extensiveq

igon

gpractice(levels1and

2CF

Q).Bo

thattend

edan

initial8-day

worksho

pin

2008

andsubsequently

practic

eddaily

fora

nextend

edinterval

(≥1h

rfor

6mos);on

eund

ertook

repeat

training

/practices

essio

ns.In2009

and

2010,bothattend

edadditio

nalw

orksho

ps(8–10days)a

ndcontinuedextensived

aily

practic

e(1.5

–3hrs/d

ay)attim

es.

Note:(1)L

evel1C

FQconsistso

fmovem

ents,

whilelevel2

CFQconsistso

fmeditativ

epractice.(2)Th

eseind

ividuals

undertoo

kextensivea

mou

ntso

fself-practic

eofq

igon

g.Motivationto

engage

andcontinue

camefrom

initial

health

benefitse

xperienced.

Case

1:initially,

lesspain,tensio

n,anxiety;over

next

fewmon

thso

ther

treatments

ceased

(antidepressant,massage,chiropractic)a

ndresumed

eatin

gfood

sthatshe

was

allergicto;blood

pressure

norm

alized.1yr

F-UP:

allm

edications

and

supp

lementshadceased;too

thandjawpain

resolved;sleep

improved.3

yrF-UP:

nobo

dy-w

idep

ainsin

ce1yra

fterstarting;pain

occasio

naland

localized;tensio

nheadachesg

one;cogn

ition

,sleep,fatigue,m

ood,skin,and

circulationallimproved;

employmentresum

ed.

Case

2:initially,

improved

energy

andbladdera

ndbo

welfunctio

n;by

6mos,vast

improvem

entinpain

andothersym

ptom

s.1+

yrF-UP:

improvem

entinvisio

nat

8mos;resum

edfull-tim

ework.3+

yrF-UP:

resumed

eatin

gfood

sthatshe

was

allergicto

stopp

edtaking

supp

lements,

amitriptylin

e;resumed

herlife.

Note:(1)O

nlyqu

alitativ

ecom

mentsarea

vailable.(2)Th

erange

ofsymptom

sthat

resolvew

ithextend

edqigong

practic

eiso

fpartic

ular

interest.


Table2:Con

tinued.

Stud

yParticipants,

features

Interventio

n,du

ratio

nOutcomes

(5)S

awyn

oketal.2013[39]

Extensiontrial,𝑁=20

Sometria

lcom

pletersfrom

RCT[29]

participated

ina6

-mon

thextension

phase.

Meanage:53

yrs

MeanFM

duratio

n:11.5yrs

(extracted

from

RCT)

Attrition

:7/20(35%

)with

drew

Note:(1)F

orthosec

ompletingthistrial,

5/13

(38%

)had

voluntarily

undertaken

additio

nalqigon

gtraining

priortothe

extensionph

ase.(2)B

othqu

antitative

andqu

alitativ

eoutcomes

were

recorded.

Twohalf-day(4

hrs)qigong

sessions

(level2

CFQ),weeklyreview

/practice

session(60m

in),daily

home-practice

(60m

in)for

8wks.H

ome-practic

emixof

levels1and

2CF

Q.

Duration:

8wks

Measures:BL

,8wks,4

mos

F-UP,6m

osF-UP

Note:(1)L

evel2CF

Qconsistso

fmeditatio

ninstructions.(2)

Practic

etim

esself-repo

rted

at8w

ksand4and

6mos

(viachecklist

oftim

es).

Qua

ntita

tivem

easures:Fo

r𝑁=13extensiontrialcom

pleters,therew

ere

significantreductio

nsin

pain

(NRS

)and

impact(FIQ

)and

improvem

entsin

sleep

(PSQ

I)andph

ysicalfunctio

n(SF-36

physical)com

paredto

baselin

e.Similar

quantitativec

hanges

observed

inthosew

hohadvoluntarily

undertaken

additio

nal

training

(𝑁=5)a

ndthosew

hohadno

t(𝑁=8).Th

eformer

hadmild

erbaselin

esymptom

ologythan

thelatter.

Qua

litativer

espo

nses:Th

esew

erec

onsid

ered

separatelyfor𝑁=5and𝑁=8

subgroup

s.Narrativ

ecom

mentsno

tedbenefitsinpain,sleep,physic

alandmental

functio

n,andqu

ality

oflifea

sassessedin

quantitativem

easuresinthe𝑁=5

subgroup

;com

mentswerem

oretem

peredforthe𝑁=8subgroup

.Therew

erea

lsohealth

benefitsinothera

reas

(food

allergies,chem

icalsensitivitie

s,asthma,

migraines,blood

pressure,and

visio

n)in

the𝑁=5subgroup

;severaldiscon

tinued

medications

(form

igraine,asthma,sle

ep,and

pain);additio

nalbenefitsweren

otno

tedby

the𝑁=8subgroup

.Note:(1)Th

e𝑁=5subgroup

repo

rted

theh

ighestho

me-practicetim

esat8w

ks(∼60

min/day),andthiswas

maintainedto

6mos.Th

e𝑁=8subgroup

hadlower

home-practicetim

esat8w

ks(∼40

min/day),andthisfadedover

time

(∼20

min/day).(2)F

orsomeinthe𝑁=5subgroup

,open-endedcomments

indicatedho

me-practic

etim

esof

10–15h

rs/w

eekatsomes

tages.

(6)S

awyn

okandLynch2014

[40]

Retro

spectiv

equalitativea

nalysis

of𝑁=73commentsby

participantswho

completed

theR

CT[29].

Note:Analysis

considered

(a)n

arrativ

ecom

mentsof

extensiontrial

completersv

ersusn

oncompletersa

nd(b)

them

aticcommentsby

thosew

hopractic

edperp

rotocol,minim

ally,

oran

interm

ediateam

ount.

Noadditio

nalqigon

gpractic

e.Re

trospectiv

eanalysis

ofinitial6-

mon

thexperie

ncew

ithpractic

eoflevel1C

FQ.

Postho

ccon

siderationclu

steredarou

nd(a)m

otivation/perseverance

and(b)

amou

ntof

practic

e.Note:Perp

rotocolpractice:>5h

rs/w

kMinim

alpractic

e:<3h

rs/w

kInterm

ediatepractic

e:>3<5h

rs/w

k

Narrativ

ecom

ments:Th

erew

asad

ifference

ininitialqigong

experie

nces

bythose

who

completed

thee

xtensio

ntrial(𝑁=13)v

ersustho

sewho

didno

tcom

pletethe

extension(𝑁=7),with

morefavou

rableh

ealth

effectsrepo

rted

bycompleters.

Com

mentsrecapitulateq

uantitativ

emeasuresb

utalso

covero

ther

areas.

Them

aticcomments:Th

erew

asac

lear

differenceincommentson

pain,sleep,and

quality

oflife,by

thosew

hopractic

edperp

rotocolversustho

sewho

practic

edminim

ally,

andtheser

eflectq

uantitativ

edifferencesb

etweenthetwogrou

ps.Th

ose

who

practic

edan

interm

ediateam

ount

also

hadpo

sitivec

ommentson

experie

nces,

butthere

was

adifference

intone

(morem

oderated)com

paredto

thosew

hopractic

edperp

rotocol.

BDI,Be

ckDepressionInventory;BL

,baseline;CF

Q,C

haoyiF

anhu

anQigon

g;FIQ,fi

brom

yalgiaim

pactqu

estio

nnaire;F

M,fi

brom

yalgia;F-U

P,follo

w-up;hrs,ho

urs;mo,mon

th;m

in,m

inute;MPQ

McG

illpain

questio

nnaire;N

RS,N

umericalRa

tingScale;PS

QI,Pittsbu

rghSleepQualityIndex;RC

T,rand

omized

controlledtrial;SF-36,

ShortF

orm-36;

SMD,stand

ardmeandifference;VA

S,VisualAnalogScale;wk(s),

week(s);yrs,years.


multimodal nature of the intervention (included educational,cognitive/behavioural, and relaxation/meditation elements,all of which potentially contribute to benefit). Chen et al. [36](𝑁 = 13) used external qigong (5–7 sessions over 3 weeks)and observed significant pre-post intervention improvements(SMDs 0.7–1.9) that were maintained at follow-up. Twoparticipants in this study had such marked reductions insymptoms that they were considered “cured” by the interven-tion, and their end symptomology was minimal. Lynch et al.[37] (𝑁 = 23) examined qigong practice over 9 weeks withdaily home-practice and follow-up to 6 months; significantimprovements in several areas were observed over time. Thelatter trial informed the conduct of a larger RCT (Table 1(6)).Attrition in the three pilot studies over 3–9 weeks was 23–39%.

Information on the effects of extended practice of qigongis available from case studies and an extension trial (Tables2(4) and 2(5)). There are qualitative case reports of indi-viduals (𝑁 = 2) who engage in extended qigong practice(≥1 hr/day) over longer periods of time (1-2 years) in acommunity setting which indicate marked reductions inFM symptoms (pain, sleep disturbance, impact, mood, andquality of life), as well as health improvements in other areas(allergies, vision, skin, and circulation) [38]. There is anothercase of extended qigong practice in a community settingprovidingmarked health benefits in several areas [41]. Effectsof long-term practice of qigong in FM also were addressedin an extension trial in which 𝑁 = 20 who had completedan earlier controlled trial went on to a further 6-monthphase (total practice ≥ 1 year) [39]. 𝑁 = 13 completed theextension, and their outcomes indicate that extended qigongpractice resulted in significant gains in core FM areas (pain,impact, sleep, and physical function and mental function) inquantitative assessments. In the 𝑁 = 5 subgroup who hadpreviously voluntarily undertaken additional practice priorto the extension and who practiced the most during theextension trial, end symptomology was mild, and qualitativecomments indicated additional health benefits (food aller-gies, chemical sensitivities, asthma, migraines, blood pres-sure, and vision; some discontinued several medications).The other 𝑁 = 8 who completed the extension phase hadsimilar improvements in pain, impact, sleep, and physicaland mental function in quantitative scores, but their endsymptomology was higher (as were baselines). In addition,their qualitative comments were clearly more moderate intone, and there was little mention of health benefits in otherareas. It appears that a subgroupof individuals benefits greatlyfrom extended qigong practice, with respect to both FMand other symptoms. The amount of practice undertaken bythese individuals would be difficult to study in a prospectivemanner, and extension trial methodology is a useful andpractical consideration for documenting effects. A qualitativepost hoc analysis of comments of RCT participants whocompleted or did not complete the extension trial, andconsidered in relation to amount of practice, reveals thatinitial favourable experiences with the practice predispose tocontinued practice and better outcomes (Table 2(6)).

4. Methodological Issues

Qigong is a complex practice involving regulation of move-ment, breath, and attention, and methodological issuesrelated to qigong studies have been considered recently [42].Some of these relate to general experimental design (e.g.,sample size, description of practice, blinding, and controls),while others relate to factors that are specific to qigong (e.g.,diversity of interventions, differing doses and duration, andmixture of active factors). Tai chi research issues share manyof these features [43, 44]. Methodological issues particularlyrelevant to qigong and FM are summarized in Table 3.

The following considerations relate to studies of qigongfor FM summarized in Tables 1 and 2.

(1) Plurality of Forms. Studies are from several geographiclocations (United States, Canada, Sweden, and Italy) andreflect different forms that are available locally. There isconsiderable heterogeneity in the amount of details providedas to the nature of practice in these studies. There are nocomparative trials of different forms of qigong for FM, andit is not clear whether all forms of qigong would necessarilyproduce the same results.

(2) Components of Practice.The recent designation of qigongas “meditative movement” and “mindful exercise” has beenuseful in terms of identifying core elements (deconstruction),using recognizable language to define instructions (opera-tionalization), and providing relevant comparisons (qigongversus other movements or meditative practices); these facil-itate the design, conduct, and interpretation of clinical trialsinto qigong.

(3) Amount of Practice. Table 1 summarizes RCTs thatexamined qigong over 6–8 weeks and involve regular/dailyhome-practice and follow-up to 6 months (Tables 1(4)–1(7)).These trials uniformly report significant benefits in core FMdomains (pain, sleep, impact, physical and mental function,and quality of life) compared to wait-list and/or significantand sustained improvements over time compared to baseline.Trials involving weekly sessions whereby qigong was partof a mixed session noted little difference or ambiguousresults and are difficult to interpret specifically in relation toqigong (Tables 1(1) and 1(2)). One trial performed a post hocanalysis in relation to amount of qigong practice and notedsignificant differences in outcomes between those who prac-ticed daily and those who practiced minimally (Table 1(6)).Table 2 provides further insight, noting case studies andextension trial participants who engage in extensive practiceand reportmarkedly improved health outcomes. Collectively,this information indicates that benefit is related to amountof practice. However, with increased practice time comesincreased attrition, and the number who engaged in extendedpractice is limited. The factors that predispose to suchextended practice are not clear, but post hoc analysis of thequalitative information from a RCT does indicate that goodexperiences over the initial 8 weeks of practice predispose tocontinued practice and better outcomes (Table 2(6)).


Table 3: Methodological issues relating to qigong studies for fibromyalgia.

Issue Comments

(1) Plurality of forms

(i) Qigong has a long history and is part of traditional Chinese medicine; many forms have evolved;different contexts (martial arts, health benefits, and spiritual development) emphasize different elements.(ii) Qigong is used either generically to refer to collective practices with common elements or specificallyto refer to a particular form of practice.

(2) Components of practice

(i) Qigong consists of movement, breath instruction, and mental/mind components.(ii) Qigong is now characterized as “meditative movement” and “mindful exercise,” recognizing a uniqueform of movement.(iii) Qigong movements emphasize softness, looseness, flowing, and relaxation; this differs from theemphasis on muscular strength or flexibility or aerobic capacity that is part of other exercise regimens.

(3) Amount of practice

(i) Internal qigong involves self-practice, while external qigong involves highly skilled practitioners; mostFM studies use self-practice.(ii) Minimal amounts of practice required (threshold for effect) and relationship of amount of practice tooutcomes (practice-response relationship) are important.(iii) Threshold requirements can be explored in RCTs where the amount of practice is specified, andadherence to practice is monitored.(iv) The practice-response relationship can be explored in a prospective or retrospective manner withinRCTs. However, as the amount of practice increases, there is increased attrition, and retrospective analysesare limited by self-selection.(v) Observational studies of those who engage in extended practice in a controlled setting, or voluntarilyin a community setting, provide important information relating to the health potential of qigong.

(4) Effectiveness of practiceNot all practice time is equally effective. Movements can take time to learn, and nuances of execution canmatter. With mental instructions, it can be a challenge to determine parameters that reflect effectiveengagement.

(5) Control/comparatorgroup

(i) Some trials strive to isolate an active component of an intervention, to delineate “specific” from“nonspecific” factors.(ii) With complex interventions, many elements (specific, nonspecific) can be contributive, and isolatingspecific components can be a challenge.(iii) Control/comparison groups for FM trials can consist of (1) wait-list subjects; (2) sham group (someelements of practice engaged, e.g., movement without mental instruction); (3) education/social supportgroup; (4) active comparator group (e.g., qigong compared to exercise or meditation).

(6) Multiple trial designs

(i) RCTs involve controlled settings, defined inclusion-exclusion criteria, predetermined primary andsecondary outcomes, and comparison to placebo or comparator groups, and provide information that isrelevant to the regulatory approval process.(ii) Pragmatic trials provide “in situ” information, include more heterogeneous patient groups, compareoutcomes to usual care or standards of care, include long-term follow-ups, and provide information that isrelevant to clinical practice.(iii) Qualitative research provides further valuable insights.(iv) It is impossible to blind qigong practice, and multiple trial designs are needed to explore efficacy.

(7) Participants, subgroups

(i) FM involves widespread pain and multiple somatic symptoms (disturbances in sleep, mood, and otherfunctions) and can differ in terms of chronicity (duration) and additional symptomology (part of FM orcomorbidity).(ii) Post hoc analyses based on demographics or chronicity are possible in larger trials.(iii) Prospective subgroups based on psychological characteristics, motivation, locus of control, andattitudes towards complementary and alternative therapies need to be considered.

(8) Outcomes

(i) FM outcomes can be considered in the context of chronic pain or as condition-specific outcomes.(ii) Comparisons can be between groups (compared to control or comparator) or within groups(compared to baseline).(iii) With the latter approach, it is possible to consider outcomes in relation to those considered to beclinically significant, which have been defined by clinicians and patients.(iv) For a condition with multiple symptoms, an intervention that provides benefits in multiple coredomains (pain, sleep, mood, impact, and quality of life) will be of particular relevance for clinical practice.

(4) Effectiveness of Practice. Not all practice time is equallyeffectivewithmeditative practices, and it can be a challenge toaddress this component. A meditative movement inventory[45] has been designed but is not validated or widely used.Themindfulness and body awareness literatures face a similar

challenge and also are developing measures to address thisissue [46, 47].

(5) Control or Comparison Group. RCTs in Table 1 usea variety of control groups, and each has its merits and


limitations. It is important to distinguish between a groupwhere the intent is to utilize a sham (presumed inert) pro-cedure which lacks the active component and a group wherethe intent is to compare effects of qigong to another activegroup. With the latter approach, there may not be a differ-ence between qigong and active comparators in between-group analyses. However, within-group analysis compared tobaseline for both groups can be assessed and considered inrelation to benchmark clinical outcomes, and this provides afurther valuable perspective.

(6) Multiple Trial Designs. RCTs and pragmatic trials forchronic pain have unique strengths and limitations andinform different contexts (regulatory processes, clinical care)[22]. Both approaches provide information on qigong forFM (Tables 1 and 2). Mixed-methods research that includesqualitative information is of further value, especially withextended practice.

(7) Participants. The mean age of adult participants inqigong for FM trials ranges from 42 to 57 years and themean FM duration ranges from 5 to 15 years, and theseare typical of FM trials in general. One trial conducted apost hoc analysis of those with FM duration above andbelow the median of 9 years and observed no differencesin pain and impact with qigong [29]. There is the potentialto explore subgroups in a prospective manner in relationto factors relevant to self-practice (e.g., locus of control,motivation, and psychological characteristics). Furthermore,with a practice that is less familiar than other practices(exercise, meditation, and yoga), it may be important todetermine attitudes towards complementary and alternativetherapies and especially in relation to extended practice.

(8) Outcomes. FM outcomes can align with general IMM-PACT guidelines for chronic pain and FM-specific OMER-ACTguidelines [48, 49]. Between-group analysis of outcomesprovides a statistical measure of effectiveness, but not neces-sarily a clinical assessment of effectiveness. Effect size analysis(standard mean difference, Cohen’s d) provides an indicationof whether an effect is small (≥ 0.2), medium (≥ 0.5), orlarge (≥ 0.8). Changes that constitute clinically importantoutcomes for pain (30–35% reduction from baseline) [50,51] and impact (14% reduction from baseline) [52] havebeen determined and provide further benchmarks. Theseinterpreted and benchmark parameters are of particularimportance for within-group analyses.

5. Mechanisms of Qigong

Mechanistic considerations for qigong can be global (system-wide) or specific (focus on cellular, molecular, or chemicalmediators). Within a traditional framework, there is a qi-matrix which interacts dynamically with physiological sys-tems; qigong practice smooths and strengthens the circu-lation of qi within this system, and unrestricted qi flowleads to health and longevity [11, 12]. Contemporary languagefor this concept is coherence and resonance within a living

system matrix which allows for self-organization in a com-plex system leading to integrated function [11, 53]. Qigonghas also been characterized as a complex biopsychosocialactivity [12, 14, 54]. Within this framework, psychologicalfactors (e.g., cognitive/behavioral, social interactions) andphysiological factors (e.g., cardiovascular fitness, autonomicnervous system regulation, central neurotransmitter systems,neuroendocrine, and stress hormone systems) contributeto mind/body integration and a state of health. A furtherconceptualization considers qigong as a complex interventioninvolving somatic regulatory systems and neurohormonaland neurotransmitter mediators; it considers movements inrelation to metabolic expenditure, rhythm, and posture andreflects on interoception, imagery, and neuroplastic changes[42]. The latter acknowledges that a shortcoming of this areaof investigation is a lack of taxonomy of components withinrecognizable categories.

Additional studies examine effects of qigong on specificfunctional parameters and biomarkers. An analysis of 26trials published from 1997 to 2006 indicates that qigong haseffects on immune function (white blood cells, lymphocytes),cardiovascular function (cardiac kinetics, blood pressure),and respiratory function (capacity, exchange) [55]. Otherreviews note effects of qigong on biomarkers of stress,inflammation, and immune function [56, 57]. Such studiesare limited by the multiple forms of practice in individualstudies, variable durations of practice, and variable linkageswith clinical outcomes.

Some recent intriguing studies demonstrate thatextended qigong practice can lead to changes at a molecularlevel. Thus, there is a report that extensive qigong practice(1-2 hrs daily, for at least a year) leads to altered expressionof 250 genes in neutrophils compared to healthy controls,with changes characterized by enhanced immunity, down-regulation of cellular metabolism, and alteration in apoptoticgenes in favor of resolution of inflammation [58]. However,that study was small and did not include functional effects.Another report on a therapeutic regimen of qigong (twice-weekly group practice for 5 weeks, daily home-practice for12 weeks) compared to a wait-list control group reportedsignificant beneficial effects in chronic fatigue syndrome(which exhibits overlap with FM [59, 60]) and demonstrateda significant increase in telomerase activity after 4 months ofpractice [61]. It will be important for future studies of qigongto examine functional outcomes and biomarkers particularlyrelevant to those conditions. It will also be important toconsider the amount of practice time in a systematic mannerin relation to these events.

6. Summary and Perspective

Complementary therapies represent a diverse group of ther-apies and practices and there are attempts being made tofind their place in treatment of FM [20, 21]. Evidence-basedguidelines from different countries differ in recommenda-tions relating to complementary therapies [62]. The currentreview focuses on qigong, considers RCTs as well as otherstudies, and provides an additional perspective beyond asingular focus on RCTs. Certain themes are emerging.


(1) The Magnitude and Duration of Benefit Is Significant.Regular self-practice (particularly daily) for 6–8 weeks leadsto effect sizes of 0.5–0.8 and beyond for pain, sleep, impact,and physical and mental function, and benefits are main-tained at follow-up at 4–6 months [27–30]. These effectsare manifest when compared to wait-list subjects and/orbaselines, and effects are consistently moderate-to-large overa range of core domains for FM. Other body awarenessregimens practiced diligently (daily, for 7 weeks) producesimilar effects to qigong [30]. While there can be concernover whether effects of qigong are specific or nonspecific, andthis is relevant to regulatory and mechanistic considerations,the observation most relevant to clinical care is magnitudeof post-intervention effects that are sustained over time. Themagnitude of other nonpharmacological approaches can besimilar to qigong, while pharmacological effects are generallymodest [10, 63–65]. This emphasizes the need to more fullyexplore nonpharmacological modalities for FM.

(2) The Amount of Qigong Practice Matters. There has beenlimited systematic assessment of the relationship of outcomesto amount of qigong practice, but several observations arerelevant. Thus (a) RCTs that utilize limited amounts ofqigong practice (weekly session) report more limited andambiguous outcomes compared to those that engage inregular practice (6–8 weeks, daily practice); (b) outcomes arerelated to amount of practice within a trial (minimal practiceversus daily practice); (c) extended practice (≥1 hr/day, ≥6–12 months) leads to marked health benefits in FM and otherareas. Practice time and compliance will be important toconsider in future controlled trials and in systematic reviewsand meta-analyses of qigong.

(3) There Is a Need for Additional Exploration of Qigong.The literature on qigong for FM is limited by the smallnumber of RCTs and heterogeneity of qigong styles and studydesigns, but the magnitude, scope, and duration of beneficialeffects in core domains of FM with regular qigong practiceare intriguing and the practice merits further attention. Thebenefits of extended qigong practice are particularly notable,but there are few such reports. There is a particular needto further explore extended qigong practice in observationaltrials, both as extension trials to RCTs, and in those whopractice in a community setting. Thus, a recent review ofFM guidelines from several countries concluded by noting“FM cannot be cured by any therapy” [62] yet extendedqigong practice has produced marked health benefits inFM in a subset of individuals, and their experiences canprovide valuable insights. It is impossible to blind qigongpractice, so it will be important to examine intact systems ofpractice. Additional studies need tomake direct comparisonsto other practices (exercise, othermovements, andmeditativemethods) and with drug regimens, psychological methods(e.g., cognitive/behavioural therapy), and even combinationsof such approaches (multimodal therapy). They also needto examine components of practice (deconstruct elements,work towards a more uniform and recognizable taxonomy)and address mechanistic substrates (at systems, cellular andmolecular levels). Finally, barriers to the practice of qigong

need to be identified (e.g., nature of instruction, concep-tualization, language, optimal training regimes, motivatingfactors, and subgroup factors) as these can impact on ourunderstanding of the health potential of this practice.

Conflict of Interests

Neither author has any affiliation that could be considered aconflict of interest in relation to the content of this paper.

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Review Article Qigong and Fibromyalgia: Randomized ...Review Article Qigong and Fibromyalgia: Randomized Controlled Trials and Beyond JanaSawynok 1 andMaryLynch 2 DepartmentofPharmacology,DalhousieUniversity,P.O.Box,H