Psychosocial Treatments for Multiple Unexplained Physical Symptoms: A Review of the Literature
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Transcript of Psychosocial Treatments for Multiple Unexplained Physical Symptoms: A Review of the Literature
REVIEW
Psychosocial Treatments for Multiple Unexplained Physical Symptoms: A Reviewof the LiteratureLESLEY A. ALLEN, PHD, JAVIER I. ESCOBAR, MD, PAUL M. LEHRER, PHD, MICHAEL A. GARA, PHD, AND
ROBERT L. WOOLFOLK, PHD
Objective: Patients presenting with multiple medically unexplained physical symptoms, termed polysymptomaticsomatizers, often incur excessive healthcare charges and fail to respond to standard medical treatment. The presentarticle reviews the literature assessing the efficacy of psychosocial treatments for polysymptomatic somatizers.Methods: Relevant articles were identified by scanning Medline and PsychLit. Thirty-four randomized, controlledstudies were located. Whenever possible results from each study were transformed into effect sizes. An analysis ofthe efficacy of the psychotherapeutic approaches is provided. Results: Various psychosocial interventions havebeen investigated with polysymptomatic somatizers. Although the majority of studies suggest psychosocial treat-ments benefit this population, the literature is tarnished by methodological shortcomings. Effect sizes are modestat best. Long-term improvement has been demonstrated in fewer than one-quarter of the trials. Conclusions:Although seemingly beneficial, psychosocial treatments have not yet been shown to have a lasting and clinicallymeaningful influence on the physical complaints of polysymptomatic somatizers. Key words: somatization, irrita-ble bowel syndrome, chronic fatigue syndrome, fibromyalgia, treatment.
CBT � cognitive behavior therapy; CFS � chronicfatigue syndrome; DSM-IV � Diagnostic and Statisti-cal Manual of Mental Disorders, fourth edition; EMG� electromyographic; IBS � irritable bowel syndrome.
INTRODUCTION
Patients presenting with multiple medically unex-plained physical symptoms, termed polysymptomaticsomatizers, provide significant challenges to health-care providers. These patients’ physical symptomstend to be chronic and refractory to treatment (1, 2).Typically, polysymptomatic somatizers are dissatis-fied with the medical services they receive and repeat-edly change physicians (3). They incur excessivehealthcare bills, which reflect their overuse of diagnos-tic procedures, hospitalizations, and surgeries (4, 5). Inaddition, these patients present a theoretical challengein that the sources of their discomfort and their patho-
physiology remain unclear. Because of standard med-ical care’s limited success in treating somatizers, alter-native treatments have been developed for them.
Psychosocial treatments for somatic problemshave been reviewed elsewhere (6 –9). Most reviewsfocus on a single functional somatic syndrome, suchas irritable bowel syndrome (IBS) (6), or address oneunexplained symptom category, such as headaches(7) or dysmenorrhea (8). Alternatively, the most re-cent review examines the efficacy of only one formof treatment, cognitive behavior therapy (CBT), forpatients with either a single unexplained physicalsymptom or a single functional somatic syndrome(9). To date, no review has produced a comprehen-sive comparison of all psychosocial treatments forpolysymptomatic somatizing patients.
Accordingly, the present review aims to provide ananalysis of the relative efficacy of psychosocial treat-ments for polysymptomatic somatization with anemphasis on functional somatic syndromes and so-matization disorder. We focus on polysymptomaticsomatizers because patients experiencing multipleunexplained physical symptoms are not clearlycomparable to those experiencing just one unex-plained physical symptom. Research suggests thatthe number of unexplained physical symptoms re-ported correlates positively with the patient’s degreeof psychopathology and physical impairment (10).Polysymptomatic somatizers may not respond totreatment in exactly the way monosymptomatic so-matizers do. Also, individual syndrome reviews mayresult in conclusions that are narrow and specific to
From the Department of Psychiatry (L.A.A., J.I.E., P.M.L., M.A.G.),Robert Wood Johnson Medical School–University of Medicine andDentistry of New Jersey, Piscataway, New Jersey; and Department ofPsychology (R.L.W.), Rutgers University, New Brunswick, New Jersey.
Address reprint requests to: Lesley A. Allen, PhD, Department ofPsychiatry, RWJMS–UMDNJ, 671 Hoes Lane, Piscataway, NJ 08854.Email: [email protected]
Received for publication March 1, 2001; revision received November26, 2001.
DOI: 10.1097/01.PSY.0000024231.11538.8F
939Psychosomatic Medicine 64:939–950 (2002)
0033-3174/02/6406-0939Copyright © 2002 by the American Psychosomatic Society
that syndrome without allowing conclusions to becompared and contrasted across syndromes.
Overview of Polysymptomatic Somatizers
According to the Diagnostic and Statistical Manualof Mental Disorders (DSM-IV), somatization disorder ischaracterized by a lifetime history of at least four un-explained pain symptoms, two unexplained nonpaingastrointestinal symptoms, one unexplained sexualsymptom, and one pseudoneurological symptom (11).Although somatization disorder is classified as a dis-tinct disorder in DSM-IV, it has been argued that som-atization disorder represents the extreme end of a so-matization continuum (10, 12). Research suggests thatpatients experiencing multiple unexplained physicalsymptoms that fail to meet all DSM-IV criteria forsomatization disorder have similar characteristics tothose diagnosed with full somatization disorder (10,12, 13).
The term functional somatic syndrome is used todescribe groups of co-occurring symptoms that aremedically unexplained. Many functional somatic syn-dromes involve only one unexplained symptom, suchas jaw or chest pain. The three functional somaticsyndromes whose criteria require multiple unex-plained symptoms are IBS, chronic fatigue syndrome(CFS), and fibromyalgia. IBS is characterized by per-sistent abdominal pain along with altered bowel habitsand abdominal distension that cannot be explained byorganic pathology (14). A diagnosis of CFS is given forunexplained fatigue, lasting at least 6 months, thatcauses at least a 50% reduction in activity. Concomi-tant symptoms include memory impairment, sorethroat, tender lymph nodes, muscle pain, joint pain,headache, nonrestorative sleep, and postexertional fa-tigue (15). Fibromyalgia is characterized by chronicwidespread pain and multiple tender points that haveno known biological basis and are often accompaniedby nonrestorative sleep, fatigue, and malaise (16).
Despite the different physical complaints demarcat-ing the functional somatic syndromes described above,similar clinical, behavioral, demographic, and physio-logical characteristics are observed in each syndrome(17–19). Like somatization disorder patients, individ-uals diagnosed with one of these syndromes are morelikely to use healthcare services, report functional im-pairment, and suffer from psychopathology than areeither healthy or medically ill subjects (5, 14–27). Theoverwhelming majority of CFS, fibromyalgia, and so-matization disorder patients are female (12, 28, 29).The same pathophysiologic dysregulation and blunt-ing of the central nervous system’s response to stressmay be present in all of these syndromes (30). Finally,
many patients diagnosed with one of the functionalsyndromes meet diagnostic criteria for one or more ofthe other functional syndromes, resulting in multisys-tem comorbid functional syndromes (19, 31–34). As awhole, research suggests there is substantial overlapamong the functional somatic syndromes and somati-zation disorder (35). In fact, Wessely et al. (18) haveencouraged investigators not to distinguish among thefunctional somatic syndromes but instead to examinethem as a single classification of patients.
Because the illness behavior, psychopathology, andphysical complaints of the polysymptomatic somaticdisorders resemble each other, their treatments will bereviewed together. Integrating the findings from theseareas of literature may unearth the consistencies andinconsistencies as well as the merits and shortcomingsof the literature. The review aims to identify futuredirections for treating this difficult population.
Overview of the Rationales for PsychosocialTreatment Interventions
Psychodynamic theory has proposed that unex-plained physical symptoms are produced to protectthe somatizer from traumatic, frightening, and/or de-pressing emotional experiences. If an individual failsto process a trauma adequately, it is hypothesized, theoriginal affect later may be converted into physicalsymptoms (36). Short-term, dynamically orientedtreatments for somatizers focus on the stress and emo-tional distress associated with physical symptoms.
Psychophysiologists have described several mecha-nisms that produce somatic symptoms in the absence oforganic pathology (37, 38). These mechanisms includeoveractivity/dysregulation of the autonomic nervous sys-tem, smooth muscle contractions, endocrine overactiv-ity, and hyperventilation. Miscellaneous techniques,directed at reducing somatizers’ physiological arousaland physical discomfort, have been studied withincontrolled experimental designs, including hypno-therapy, progressive muscle relaxation, electromyo-graphic (EMG) biofeedback, autogenic training, andmultifaceted relaxation training programs.
The cognitive-behavioral model of somatization em-phasizes the interaction of physiology, cognition, emo-tion, behavior, and environment (39). Specifically, anindividual’s interpretation of physical sensations maybring on heightened awareness of bodily sensations,increased emotional distress, and self-defeating behav-ior (such as avoiding activities), all of which mayexacerbate the physical symptoms. In turn, the envi-ronment, including family, friends, and physicians,may respond in ways that reinforce the individual’ssomatic distress. Short-term CBT has been used with
L. A. ALLEN et al.
940 Psychosomatic Medicine 64:939–950 (2002)
somatizers to alter dysfunctional cognitive processesand behavior. These treatments typically include re-laxation training.
Some investigators have focused on either the cog-nitive or the behavioral component of CBT. Cognitivetherapy teaches patients to identify associations be-tween thoughts and physical symptoms and to modifydysfunctional beliefs. Relaxation and other behavioraltechniques are not included in cognitive therapy. Be-havior therapy for somatic complaints uses methodsfor pain management and for increasing avoided activ-ities based on operant conditioning.
Finally, exercise treatments have been developedfor somatizers in accordance with evidence suggestingthat exercise improves mood, pain thresholds, andsleep (40, 41). One theory explaining the benefits ofexercise proposes that exercise produces increases inserum levels of �-endorphin-like immunoreactivity,adrenocorticotropic hormone, prolactin, and growthhormone (42).
METHODS
Sample
Relevant articles were located with a computer search of Medlineand PsychLit from 1966 through January 2001. The following key-words were searched: unexplained physical symptoms, somatiza-tion, somatoform, psychogenic, functional somatic syndrome, irri-table bowel, fibromyalgia, and chronic fatigue. These terms werecross-referenced with the keywords: treatment, therapy, and out-come. To ensure a comprehensive review of the literature, the ref-erence lists of the articles generated from the above search wereexamined. Finally, we searched the Cochrane Library with theseterms (43).
Studies were included in the review if they compared any psy-chosocial intervention with a comparison control intervention in thetreatment of multiple unexplained physical symptoms. Clinical tri-als with patients suffering from single-symptom unexplained disor-ders, such as tension headaches or dysmenorrhea, were excludedfrom the review. Also excluded from the review were studies withmixed samples, that is, samples that comprised both single-symp-tom and polysymptomatic disorders. Only randomized experiments
were included. Studies that were unpublished or published in anon-English language were excluded. These inclusion criteria pro-duced 34 studies.
Estimating Treatment Effects
Whenever possible results were transformed into Cohen’s d asthe measure of treatment effect size. Cohen’s d provides a standard-ized estimate of the mean differences among treatment groups (44).When group means, standard deviations, and sample sizes wereunavailable, the statistical procedures described by Glass et al. (45)were used to estimate effect sizes.
Outcome measures of primary interest were those assessing in-tensity and frequency of physical symptoms. Because many studiesexamined changes in psychological and functional symptoms aswell, effect sizes were calculated for each of these domains. Withinthese domains (ie, physical distress, psychological distress, andfunctional impairment), investigators often used multiple measuresto examine outcomes. Effect sizes for each domain represent themean effect size for the aggregated outcome measures within thatdomain.
RESULTS
Treatments for Somatization Disorder
Two groups of investigators have examined the ef-fect of psychotherapy on patients with diverse unex-plained physical symptoms (see Table 1). One study,using patients diagnosed with full somatization disor-der, demonstrated that group psychotherapy reducedphysical functioning and mental health complaintsmore than did standard medical care (46). The grouptreatment, which appeared to lack a theoretical basis,“aimed to enhance emotional expression, peer sup-port, and coping skills.” The second trial, studyingpatients experiencing five or more unexplained phys-ical symptoms, showed that individual CBT coincidedwith greater reductions in somatic complaints andphysician visits than did standard medical care (47).
TABLE 1. Psychosocial Treatments for Somatization
N Dropouts PopulationTreatmentCondition
ControlCondition(s)
Results
Kashner et al., 1995 (46) 70 Not reported Somatization disorderpatients referredfrom internists andadvertisements
Group therapy (82-hour sessions)
Standard medicalcare
Treatment group had greaterimprovements in physicalfunctioning,*a mentalhealth***a
Sumathipala et al., 2000 (47) 68 T: 30%C: 38%
Primary care patientswith �5unexplainedphysical symptoms
CBT (6-1⁄2 hoursessions)
Standard medicalcare
Treatment group had greaterreductions in healthcarevisits,*a physicalcomplaints***a
a Intent-to-treat analysis performed.* p � .05; ** p � .01; *** p � .001.
TREATMENTS FOR MEDICALLY UNEXPLAINED SYMPTOMS
941Psychosomatic Medicine 64:939–950 (2002)
Treatments for Irritable Bowel Syndrome
Various psychosocial interventions for IBS havebeen examined in controlled trials. Table 2 summa-rizes each of them.
Four different therapeutic approaches have ap-peared more efficacious in reducing bowel symptomsthan did the control intervention to which they werecompared. Short-term dynamic therapy, hypnother-apy, progressive muscle relaxation, and cognitive ther-apy each seemed to reduce IBS symptoms (48–54). Inthese studies dynamic therapy, hypnotherapy, andprogressive muscle relaxation were conducted indi-vidually, whereas cognitive therapy was conductedeither individually (52, 53) or in a group format (54).
CBT has had mixed results in seven different con-trolled trials with IBS sufferers (55–61). Three trialsshowed CBT, administered individually, relievedbowel symptoms more effectively than did either stan-dard medical care (55) or a waiting list (56, 57). In afourth study, CBT administered as a group treatmentresulted in greater improvements in IBS symptomsthan did a waiting list control condition (58). Threeother investigations found no difference between indi-vidual CBT and a control condition (59–61).
Only one study examined the efficacy of purelybehavioral methods for IBS. In this study Corney et al.(62) compared a combination of bowel retraining, op-erant pain management techniques, and increasing ac-tivity levels to the standard medical treatment of bulk-ing agents, antispasmodics, and laxatives. By the endof treatment, no differences were observed betweenthe experimental and control groups in their reportingof IBS symptoms.
Treatments for Chronic Fatigue Syndrome
Psychosocial interventions, specifically CBT andexercise programs, have had mixed results in con-trolled trials with CFS patients (see Table 3). In onestudy CBT was no more effective than the controltreatment (63), whereas in two other studies CBT re-duced fatigue significantly more than the control treat-ments did (64, 65). Another trial found that a gradedexercise program resulted in greater improvements infatigue, functioning, and general health than did arelaxation/flexibility intervention (66). In a study com-paring graded exercise, fluoxetine (a selective seroto-nin reuptake inhibitor), graded exercise plus fluox-etine, and a no-treatment control, neither exercise norfluoxetine was associated with improvements in fa-tigue (67).
Treatments for Fibromyalgia
Numerous interventions for fibromyalgia have beensubjected to empirical investigation (see Table 4).
Three trials compared the efficacy of a standardrelaxation intervention to an alternative treatment.Hypnotherapy and EMG biofeedback each resulted ingreater reductions in discomfort than did physicaltherapy (68) or false biofeedback (69), respectively.The third study, examining the effects of progressivemuscle relaxation and hydrogalvanic baths, showedno difference between the two treatments; participantsin each condition reported some pain relief (70).
The impact of exercise on fibromyalgia symptom-atology has been examined by four groups of investi-gators. Two trials showed a thrice per week exercisegroup resulted in greater reductions in objective mea-sures of tenderness than did a thrice per week flexibil-ity training (71) or relaxation program (72). A thirdstudy evaluated the effects of four different interven-tions, specifically an exercise group, a relaxationgroup, a combined exercise/relaxation group, and aneducation/control group (73). In this study the exerciseand exercise/relaxation groups experienced greaterimprovements in physical functioning than did thecontrol group. Despite there being no differencesamong the four groups’ myalgia scores or self-reportsof pain, all three treatment groups manifested greaterdecreases in tenderness than the control group did(73). The fourth trial failed to demonstrate reductionsin self-reported pain from an exercise treatment rela-tive to a no-treatment control condition (74).
The efficacy of group CBT, but not individual CBT,for fibromyalgia has been assessed in three trials. Twotrials comparing a CBT/education group with a discus-sion/education group found no differences in paincomplaints or functioning between the two treatmentconditions (75, 76). The third trial, comparing the ef-ficacy of a group CBT to that of an autogenic traininggroup, also showed no differences between the condi-tions at posttreatment. However, 4 months later theCBT participants reported a greater reduction in painintensity than the relaxation participants did (77).
Finally, two groups of investigators have comparedthe efficacy of stress management interventions withexercise treatments. One study examined an exercisegroup, a stress management group, and standard med-ical care. Just after treatment, both the stress manage-ment and exercise participants reported greater reduc-tions in tenderness than the control participants. Theinvestigators found no differences between the stressmanagement and exercise groups just after treatmentnor 4 years later (78). In another study, participantswere randomly assigned to a stress management pro-
L. A. ALLEN et al.
942 Psychosomatic Medicine 64:939–950 (2002)
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%SM
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anD
ulm
enet
al.,
1996
(58)
47T:
0%C
:0%
Inte
rnal
med
icin
epa
tient
s1.
Gro
upC
BT
(82-
hour
sess
ions
)1.
Wai
ting
list
(WL)
Trea
tmen
tgr
oup
repo
rted
grea
ter
impr
ovem
ent
inse
veri
tyan
ddu
ratio
nof
stom
ach
pain
**Po
sttr
eatm
ent
effe
ctsi
zefo
rIB
S:d
�0.
39N
odi
ffere
nce
betw
een
grou
pson
psyc
hiat
ric
sym
ptom
s44
%C
BT
vs.
11%
WL
had
CSI
b
Vol
lmer
and
Bla
ncha
rd,
1998
(54)
32T1
:0%
T2:
0%C
:0%
Ref
erra
lsfr
omM
Ds
and
adve
rtis
emen
ts
1.G
roup
CT
(10
90-m
inut
ese
ssio
ns)
2.In
divi
dual
CT
(10
1-ho
urse
ssio
ns)
1.W
aitin
glis
t/sym
ptom
mon
itori
ng(W
L)B
oth
trea
tmen
tgr
oups
repo
rted
grea
ter
impr
ovem
ent
inIB
Ssy
mpt
oms
than
WL*
*N
odi
ffere
nce
betw
een
grou
pan
din
divi
dual
CT
64%
grou
pC
Tvs
.55
%in
divi
dual
CT
vs.
10%
WL
had
CSI
b
CB
T�
cogn
itiv
ebe
hav
iora
lth
erap
y;C
SI
�cl
inic
ally
sign
ific
ant
imp
rove
men
t;IB
S�
irri
tabl
ebo
wel
syn
dro
me;
PR
M�
pro
gres
sive
mu
scle
rela
xati
on.
aIn
ten
t-to
-tre
atan
alys
isp
erfo
rmed
.b
CS
Iw
asin
dic
ated
byat
leas
ta
50%
red
uct
ion
inIB
Ssy
mp
tom
sbe
twee
nba
seli
ne
and
the
pos
ttre
atm
ent
orfo
llow
-up
asse
ssm
ent.
*p
�.0
5;**
p�
.01;
***
p�
.001
.
TREATMENTS FOR MEDICALLY UNEXPLAINED SYMPTOMS
943Psychosomatic Medicine 64:939–950 (2002)
TA
BL
E3.
Psy
chos
ocia
lT
reat
men
tsfo
rC
hro
nic
Fat
igu
eS
ynd
rom
e
ND
ropo
uts
Popu
latio
nTr
eatm
ent
Con
ditio
nC
ontr
olC
ondi
tion(
s)R
esul
ts
CB
Ttr
eatm
ent
tria
lsLl
oyd
etal
.,19
93(6
3)90
T1:
0%T2
:0%
C1:
5%C
2:4%
Not
repo
rted
1.C
BT
�pl
aceb
o(6
sess
ions
)2.
CB
T�
dial
yzab
lele
ukoc
yte
1.St
anda
rdm
edic
alca
re�
plac
ebo
med
icat
ion
2.St
anda
rdm
edic
alca
re�
dial
yzab
lele
ukoc
yte
Post
trea
tmen
t:no
diffe
renc
esam
ong
the
4gr
oups
3-m
onth
follo
w-u
p:no
diffe
renc
esam
ong
the
4gr
oups
Shar
peet
al.,
1996
(64)
60T:
0%C
:0%
Infe
ctio
usdi
seas
ecl
inic
patie
nts
1.C
BT
(16
sess
ions
)1.
Stan
dard
med
ical
care
Post
trea
tmen
t:23
%C
BT
vs.
7%co
ntro
lha
dC
SIb
infa
tigue
a
8-m
onth
follo
w-u
p:73
%C
BT
vs.
23%
had
CSI
bin
fatig
uea
Dea
leet
al.,
1997
(65)
60T:
10%
C:
13%
Ref
erre
dfr
ompr
imar
yM
Ds
and
spec
ialis
ts1.
CB
T(1
3se
ssio
ns)
1.R
elax
atio
ntr
aini
ng(R
T)(1
0se
ssio
ns)
Post
trea
tmen
t:C
BT
mor
eef
fect
ive
than
RTa
Effe
ctsi
zefo
rfa
tigue
:d
�0.
46Ef
fect
size
for
func
tioni
ng:
d�
0.69
Effe
ctsi
zefo
rem
otio
nal
dist
ress
:d
�0.
496-
mon
thfo
llow
-up:
CB
Tm
ore
effe
ctiv
eth
anR
Ta
Effe
ctsi
zefo
rfa
tigue
:d
�0.
90Ef
fect
size
for
func
tioni
ng:
d�
1.13
Effe
ctsi
zefo
rem
otio
nal
dist
ress
:d
�0.
26Ex
erci
setr
eatm
ent
tria
lsFu
lche
ran
dW
hite
,19
97(6
6)66
T:12
%C
:9%
CFS
clin
icpa
tient
s1.
Gra
ded
exer
cise
(1se
ssio
n/w
kfo
r12
wk)
1.Fl
exib
ility
/rel
axat
ion
(FR
)(1
sess
ion/
wk
for
12w
k)Po
sttr
eatm
ent:
exer
cise
mor
eef
fect
ive
than
FRa
Effe
ctsi
zefo
rfa
tigue
:d
�0.
73Ef
fect
size
for
func
tioni
ng:
d�
0.69
55%
exer
cise
vs.
27%
FRra
ted
them
selv
esas
muc
hor
very
muc
hbe
tter
Wea
rden
etal
.,19
98(6
7)13
4T1
:42
%T2
:32
%C
1:29
%C
2:15
%
Dep
artm
ent
ofM
edic
ine
patie
nts
1.G
rade
dex
erci
se�
fluox
etin
e2.
Gra
ded
exer
cise
�
plac
ebo
1.N
oex
erci
se�
fluox
etin
e2.
No
exer
cise
�pl
aceb
o
Post
trea
tmen
t:no
diffe
renc
esbe
twee
ngr
oups
onch
ange
infa
tigue
a
Bot
hex
erci
segr
oups
repo
rted
high
erfu
nctio
nal
wor
kca
paci
tyth
anth
eno
-exe
rcis
egr
oups
*a
aIn
ten
t-to
-tre
atan
alys
isp
erfo
rmed
.b
CS
I(c
lin
ical
lysi
gnif
ican
tim
pro
vem
ent)
was
ind
icat
edby
atle
ast
a50
%re
du
ctio
nin
fati
gue
betw
een
base
lin
ean
dth
ep
ostt
reat
men
tor
foll
ow-u
pas
sess
men
t.*
p�
.05.
L. A. ALLEN et al.
944 Psychosomatic Medicine 64:939–950 (2002)
TA
BL
E4.
Psy
chos
ocia
lT
reat
men
tsfo
rF
ibro
mya
lgia
ND
ropo
uts
Popu
latio
nTr
eatm
ent
Con
ditio
nC
ontr
olC
ondi
tion(
s)R
esul
ts
Rel
axat
ion
trea
tmen
ttr
ials
Haa
nen
etal
.,19
91(6
8)40
T:15
%C
:0%
Not
repo
rted
1.H
ypno
ther
apy
(8se
ssio
ns)
1.Ph
ysic
alth
erap
ygr
oup
mas
sage
�re
laxa
tion
Trea
tmen
tgr
oup
repo
rted
grea
ter
impr
ovem
ent
inpa
in,*
*a
psyc
hic
dist
ress
*a
No
diffe
renc
ebe
twee
ngr
oups
inTM
S3-
mon
thfo
llow
-up:
diffe
renc
esm
aint
aine
dFe
rrac
ciol
iet
al.,
1987
(69)
12T:
0%C
:0%
Rhe
umat
olog
ycl
inic
patie
nts
1.EM
Gbi
ofee
dbac
k(1
5se
ssio
ns)
1.Fa
lse
EMG
biof
eedb
ack
(15
sess
ions
)Tr
eatm
ent
grou
pha
dfe
wer
tend
erpo
ints
*an
dse
lf-re
port
edpa
in*
Mea
npo
sttr
eatm
ent
effe
ctsi
zefo
rpa
inan
dte
nder
ness
:d
�
4.01
Gun
ther
etal
.,19
94(7
0)26
T:0%
C:
8%R
heum
atol
ogy
clin
icpa
tient
s1.
Prog
ress
ive
mus
cle
rela
xatio
n(1
0se
ssio
ns)
1.H
ydro
galv
anic
bath
s(1
0tr
eatm
ents
)N
odi
ffere
nce
inse
lf-re
port
edpa
inB
oth
grou
psex
peri
ence
dre
duct
ions
inpa
inEx
erci
setr
eatm
ent
tria
lsM
cCai
net
al.,
1988
(71)
42T:
10%
C:
9%R
heum
atol
ogy
clin
icpa
tient
s1.
Fitn
ess
grou
p(E
X)
(3tim
es/w
kfo
r20
wk)
1.Fl
exib
ility
grou
p(F
LEX
)(3
times
/wk
for
20w
k)EX
had
grea
ter
impr
ovem
ent
inTM
S*67
%EX
vs.
15%
FLEX
had
CSI
bin
TMS
39%
EXvs
.10%
FLEX
had
�50
%de
crea
sein
self-
repo
rted
pain
No
diffe
renc
ebe
twee
ngr
oups
onps
ychi
atri
csy
mpt
oms
Mar
tinet
al.,
1996
(72)
60T:
40%
C:
33%
Ref
erre
dfr
omM
Ds
(rhe
umat
olog
yfa
mily
med
icin
e)an
dsu
ppor
tgr
oups
1.Ex
erci
segr
oup
(EX
)(3
times
/wk
for
6w
k)1.
Rel
axat
ion
grou
p(R
EL)
(3tim
es/w
kfo
r6
wk)
EXha
dgr
eate
rim
prov
emen
tin
TMS*
*Po
sttr
eatm
ent
effe
ctfo
rte
nder
poin
ts:
d�
0.92
No
diffe
renc
ebe
twee
ngr
oups
onse
lf-re
port
edpa
inB
ucke
lew
etal
.,19
98(7
3)10
9T1
:23
%T2
:13
%C
1:14
%C
2:10
%
Ref
erre
dfr
omM
Ds
(rhe
umat
olog
y,ps
ycho
logy
,ot
her)
1.Ex
erci
se�
biof
eedb
ack
(EX
B)
2.Ex
erci
seal
one
(EX
)1.
Bio
feed
back
alon
e(B
)2.
Educ
atio
ngr
oup
(ED
)N
odi
ffere
nces
amon
ggr
oups
onTM
S,se
lf-re
port
edpa
in,
orps
ychi
atri
csc
ales
EX,
B,
EXB
had
few
erte
nder
poin
tsth
anED
EXB
,EX
had
grea
ter
impr
ovem
ents
inph
ysic
alac
tivity
than
ED**
Men
gsho
elet
al.,
1992
(74)
35T:
39%
C:
18%
Ref
erre
dfr
ompa
tient
orga
niza
tion
1.A
erob
ics
grou
p(2
times
/wk
for
20w
k)1.
No
trea
tmen
tN
odi
ffere
nces
betw
een
grou
pson
self-
repo
rted
pain
CB
Ttr
eatm
ent
tria
lsV
laey
enet
al.,
1996
(75)
125
T:22
%C
1:23
%C
2:3%
Rhe
umat
olog
ycl
inic
patie
nts
1.C
BT/
educ
atio
n(1
2se
ssio
ns)
2.W
aitin
glis
t
1.Ed
ucat
ion/
disc
ussi
on(D
isc)
(12
sess
ions
)N
odi
ffere
nce
amon
ggr
oups
onse
lf-re
port
edpa
in,
activ
ityle
vel,
and
depr
essi
onD
isc
repo
rted
grea
ter
impr
ovem
ents
infe
arth
anC
BT*
*12
-mon
thfo
llow
-up:
nodi
ffere
nces
betw
een
CB
Tan
dD
isc
Nic
assi
oet
al.,
1997
(76)
86T:
25%
C:
8%R
heum
atol
ogy
clin
ican
dsu
ppor
tgr
oup
1.B
ehav
iora
lgr
oup
(10
sess
ions
)1.
Educ
atio
n/di
scus
sion
grou
p(1
0se
ssio
ns)
No
diffe
renc
esbe
twee
ngr
oups
onse
lf-re
port
edpa
in,
TMS,
func
tioni
ng,
orde
pres
sion
Kee
let
al.,
1998
(77)
32T:
13%
C:
19%
Rhe
umat
olog
ists
and
othe
rsp
ecia
lists
1.C
BT/
exer
cise
(1tim
e/w
kfo
r15
wk)
2.A
utog
enic
trai
ning
(15
wee
kly
sess
ions
)Po
sttr
eatm
ent:
nodi
ffere
nces
betw
een
grou
psin
self-
repo
rted
pain
4-m
onth
follo
w-u
p:C
BT
repo
rted
grea
ter
redu
ctio
nsin
pain
than
cont
rol
Follo
w-u
pef
fect
for
self-
repo
rted
pain
:d
�0.
35Ex
erci
seve
rsus
CB
Ttr
eatm
ent
tria
lsW
iger
set
al.,
1996
(78)
60T1
:20
%T2
:25
%C
:15
%
Ref
erre
dfr
ompa
tient
orga
niza
tion
and
phys
ical
med
icin
ecl
inic
1.A
erob
ics
grou
p(E
X)
(3tim
es/w
kfo
r14
wk)
2.St
ress
man
agem
ent
(SM
)
1.St
anda
rdm
edic
alca
reEX
and
SMha
dgr
eate
rre
duct
ion
inte
nder
ness
than
cont
rol*
*a
75%
EXvs
.47
%SM
vs.
12%
cont
rol
repo
rted
feel
ing
bette
ror
muc
hbe
tter
Effe
ctsi
zes
for
pain
:EX
vs.
cont
rol:
d�
0.67
SMvs
.co
ntro
l:d
�0.
684-
year
follo
w-u
p:no
diffe
renc
esbe
twee
nEX
and
SMB
urck
hard
tet
al.,
1994
(79)
99T1
:15
%T2
:10
%C
:14
%
Ref
erre
dfr
ompr
imar
yca
reph
ysic
ians
and
occu
patio
nal
heal
th
1.Fi
tnes
str
aini
ng(E
X)
(1tim
e/w
kfo
r6
wk)
2.St
ress
/edu
catio
ngr
oup
(ED
)
1.W
aitin
glis
tN
odi
ffere
nce
betw
een
any
grou
pson
self-
repo
rted
pain
EXan
dED
had
grea
ter
incr
ease
sin
qual
ityof
life*
and
self-
effic
acy
for
func
tioni
ng**
No
diffe
renc
esbe
twee
nEX
and
EDon
pain
,qu
ality
oflif
e,se
lf-ef
ficac
y
TM
S(t
otal
mya
lgic
scor
e)�
pai
nth
resh
old
acro
ssa
stan
dar
dse
tof
site
s.a
Inte
nt-
to-t
reat
anal
ysis
per
form
ed.
bC
SI
(cli
nic
ally
sign
ific
ant
imp
rove
men
t)w
asin
dic
ated
by�
10-k
g/cm
2im
pro
vem
ent
inT
MS
betw
een
base
lin
ean
dth
ep
ostt
reat
men
tor
foll
ow-u
pas
sess
men
t.*
p�
.05;
**p
�.0
1;**
*p
�.0
01.
TREATMENTS FOR MEDICALLY UNEXPLAINED SYMPTOMS
945Psychosomatic Medicine 64:939–950 (2002)
gram, a stress management plus exercise program, or awaiting list (79). Immediately after treatment, therewere no differences among any of the groups’ reportsof pain (79).
Aggregating the Studies
The majority of studies suggest that psychosocialinterventions provide some benefit to polysymptom-atic somatizers. Twenty-two of the 33 (67%) studies,using change in physical symptoms as the primaryoutcome measure, reported the treatment group im-proved significantly more than the control group did.Similarly, 8 of the 10 (80%) investigators, assessingefficacy with physical functioning scores, found theexperimental intervention outperformed the controlintervention. Eight of the 17 (47%) trials evaluating theimpact of treatment on psychological distress showedgreater improvement in the experimental group thanin the control group.
Multiple Fisher’s exact analyses were performed todetermine whether any of the following variables wasassociated with treatment outcome: patient’s diagnosis(IBS vs. CFS vs. fibromyalgia vs. somatization), type oftreatment (CBT vs. relaxation vs. exercise), format oftreatment (individual vs. group), and type of controlcondition (no or minimal treatment vs. attention-con-trol treatment). None of these analyses yielded signif-icant results. Of course, given the small effect sizes inthese analyses, none of the analyses had sufficientpower to reject the null hypothesis definitively. Forexample, the statistical power was only 11% for theanalysis of treatment outcome by type of controlcondition.
To calculate the magnitude of the interventions’impact, effect sizes were examined. Eleven studiesreported sufficient data to calculate effect sizes. Inthese studies, effect sizes ranged from 0.20 (for dy-namic therapy vs. standard medical care for IBS pa-tients) (49) to 4.01 (for EMG biofeedback vs. false EMGbiofeedback for fibromyalgia patients) (69). The meaneffect size for these 11 studies, weighted by samplesize, is 0.68.
The number of participants experiencing clinicallymeaningful improvement is often calculated to dem-onstrate a treatment’s effect on individual participants.Clinically significant change was defined a priori in 11studies, 9 of those addressing IBS. The percentage ofexperimental patients that achieved clinically signifi-cant change ranged from 44% to 80%, as comparedwith 25% to 55% of pseudotreatment patients and 0%to 32% of inactive control patients.
Follow-up assessments were conducted with bothtreatment and control participants in nine trials. Seven
of the nine studies showed treatment gains had beenmaintained or enhanced at the follow-up evaluation.The two studies resulting in no long-term differencesbetween treatment and control patients had alsoshown no differences at the posttreatment evaluation.The time frame of follow-up assessments ranged from3 to 12 months with a mean of 6.4 months.
Participants in the trials were usually treated intertiary care centers. Almost half of the studies (16 of34) accepted referrals only from specialists, such asgastroenterologists or rheumatologists. Three investi-gators (9%) treated primary care or internal medicinepatients; one investigator conducted treatment in theprimary care setting. The remaining studies eitherfailed to report their referral sources or recruited pa-tients from a variety of sources (ie, from various typesof physicians, advertisements, patient organizations,and support groups).
DISCUSSION
Our decision to aggregate the research on IBS, CFS,fibromyalgia, and somatization disorder may invitecontroversy. Many medical specialists, focusing on thebodily organ or system of their specialization, assumethese disorders have distinct pathophysiologicalcauses and distinguish among these syndromes. Otherinvestigators have suggested these syndromes beviewed as one disorder. Despite the disputes over thebiological mechanisms involved, all agree there is sig-nificant overlap in these patients’ behaviors, beliefsregarding their condition, and psychological function-ing (17–19). Polysymptomatic somatizers tend toadopt the sick role (80) by overutilizing health careand withdrawing from their activities. Assuming theirsymptoms are signs of a serious, disabling illness thatis likely to worsen, these individuals often think cat-astrophically about their health. Also, they frequentlysuffer from emotional disorders (17–19).
Grouping IBS, CFS, fibromyalgia, and somatizationdisorder into one category, termed polysymptomaticsomatization, has a number of implications. First, suchclassification highlights the importance of environ-mental, behavioral, and psychological factors. Second,this classification implies that a biopsychosocialmodel is superior to a biological model in the under-standing and treatment of these patients.
The theories underlying the interventions assessedin this review are predicated on a biopsychosocialmodel. Although each approach has its own distinctrationale, the similarities of the rationales and treat-ments should be noted. None of the theories nor theirassociated treatments is organ-specific. Instead, it isassumed that any one or more organs can be affected
L. A. ALLEN et al.
946 Psychosomatic Medicine 64:939–950 (2002)
by various psychosocial processes. Each interventionencourages the patient to make changes in thinkingand/or conduct.
On the whole, this review suggests psychosocialtreatments may be modestly effective in reducing thephysical discomfort and disability of polysymptomaticsomatizers. Benefits may last for at least 3 months aftertreatment has ended. No one intervention seems morepotent than the others. None of the syndromes seemsmore responsive to such interventions than the others.The conclusions must be tempered with a few caveats.First, because only one study has been published onfull somatization disorder, as defined in DSM, little isknown about treatment efficacy with this population.Second, methodological shortcomings are present inmuch of the literature, rendering all conclusions un-certain. These methodological weaknesses will be dis-cussed below.
A chief criticism of the literature is the paucity ofintent-to-treat analyses conducted. Often investigatorsexcluded premature withdrawals from the data analy-sis, resulting in biased findings. Nineteen studies re-ported either using intent-to-treat analyses or havingno premature withdrawals. Both of the somatizationand four (80%) of the CFS studies reported findingsusing intent-to-treat analyses. Only 3 of the 12 fibro-myalgia investigators handled premature withdrawalsproperly; one other fibromyalgia trial had no dropouts.Intent-to-treat analyses were not used in any of the IBStrials, of which 10 (67%) reported premature with-drawals. Thus, the effect sizes from the IBS and fibro-myalgia literature are debatable and may have beenoverestimated.
The mean effect size across studies was 0.68. Thiseffect size is based on data from only 11 trials, 3 ofwhich failed to use intent-to-treat analyses. Given thatdata from so few trials were included in this calcula-tion, interpretation is problematic. To raise additionalquestions about the effect size, only published studieshave been included in this review. If one assumes thatadditional studies on psychosocial interventions havenot been published because of their negative findings(ie, the file drawer effect), one must assume the trueeffect size to be lower than 0.68.
Even if a large effect size had been observed, thepractical utility of these treatments would still be un-certain. Large effect sizes convey little informationabout individuals’ responses to an intervention. Forinstance, it is possible for investigators using largesamples, for example, Svedlund et al. (49), to detect astatistical difference without achieving clinically sig-nificant change in any participant. Researchers havenot uniformly assessed whether psychosocial treat-ments have a clinically meaningful impact on individ-
ual subjects. Only one CFS, one fibromyalgia, and nosomatization studies examined clinical significance.The nine IBS studies assessing clinically meaningfulimprovement suggest the effect of the active treatmentwas modest relative to that of the control treatment.Changes in illness behavior, such as use of medicalservices and absenteeism from work, are other “clini-cally meaningful” measures of change that should alsobe reported in future studies.
Long-term follow-up assessments are critical in de-termining the efficacy of any intervention. The findingthat a substantial number of control participants expe-rienced improvements at the post-treatment evalua-tion (59–62, 70) implies that a placebo response mayhave occurred. Given that the benefits placebo re-sponders derive from treatment may disappear duringthe follow-up period, such follow-up may help distin-guish placebo treatments from active treatments. Also,practically effective treatments should be enduring intheir impact. If treated patients return to their formerlevels of functioning within a year of treatment, thevalue of these interventions is limited. Although mostof the reviewed trials reporting follow-up data supportthe long-term efficacy of psychosocial treatments, toooften follow-up data have been incomplete or nonex-istent. Only 26% of the trials reported long-term as-sessment data for both control and treated patients.
Despite the high rates of emotional distress experi-enced by polysymptomatic somatizers, the impact oftreatment on psychiatric symptoms has not been ade-quately addressed. Two investigators excluded partic-ipants who met DSM criteria for a psychiatric disorder(66, 76). Only half of the investigators measuredchanges in psychiatric symptoms as a secondary out-come variable. Although many trials showed that emo-tional and physical symptoms improved concurrently(48, 52, 53, 65), others reported no association betweenthe changed physical and emotional symptoms (49, 50,71). Additional research is needed to determinewhether psychiatric symptomatology mediates the re-lationship between psychosocial treatments and unex-plained physical symptoms. One review has alreadyconcluded that no such mediation exists for CBT. Ex-amining only CBT trials for somatizers, Kroenke andSwindle (9) found that psychiatric symptoms oftenfailed to benefit from CBT even when physical symp-toms did. The present review’s failure to show such aclear distinction between the impact of psychosocialtreatments on psychiatric, relative to physical, symp-toms may be attributable to the broader range of inter-ventions reviewed here.
Unexplained physical symptoms may be amelio-rated by many active or control treatments. The au-thors of the studies showing no difference between the
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experimental and control conditions noted that partic-ipants in both the experimental and control groupsimproved significantly over time (59–62, 70). Differ-ent psychosocial interventions seem to have similareffects on patients’ symptoms. Taken together, thesefindings suggest that none of the treatments alters spe-cific dysfunctions, but instead the treatments includesome common factor or factors that benefit these pa-tients. The active component(s) of treatment may bethe patient’s expectation of improvement, attentionfrom a healthcare provider, or encouragement to re-sume healthy functioning. Alternatively, it is possiblethat the treatments relieve feelings of helplessness,hopelessness, depression, and/or anxiety, which maypromote a reduction in physical discomfort. Futureresearch should explore the mechanism of change as-sociated with these treatments.
Few investigators examined the acceptability oftheir treatment to the general somatization population.Most trials were advertised for and conducted in ter-tiary care centers instead of in the primary care clinicswhere these patients typically are treated. The numberof patients screened and refusing treatment as well asthe number of missed treatment sessions frequentlywere not reported. Because most somatizing patientsattribute their discomfort to medical illnesses and seekmedical treatment, patients treated in psychiatric clin-ics may not adequately represent the population.Thus, the generalizability of the findings is uncertain.
Two previous reviews of psychosocial treatmentstudies have been conducted with patient populationsthat are similar to ours. After systematically evaluatingthe quality as well as the content of psychosocial treat-ment trials for IBS, Talley et al. (6) state that the effi-cacy of these treatments has not yet been establishedbecause of the literature’s methodological weaknesses.In a separate review summarizing only CBT trials withpatients diagnosed with one or more unexplainedphysical symptoms, Kroenke and Swindle (9) foundCBT to be effective in reducing physical discomfort.The discrepancies between these conclusions may be afunction of not only the populations and interventionsreviewed but also the authors’ criteria. Talley et al.’sreview (6) is somewhat more methodologically strin-gent than Kroenke and Swindle’s review (9) in that theformer found only one study that met their standard of“methodological acceptability.”
The present review suggests that psychosocial treat-ments, although seemingly beneficial, have not yetbeen shown to have a lasting and clinically meaningfulinfluence on the physical complaints of polysymptom-atic somatizers. To demonstrate unequivocal supportof a treatment, investigators should report effect sizesusing intent-to-treat analyses, the number of patients
experiencing clinically significant change, and long-term follow-up results. At present, the methodologi-cally sound studies suggest the interventions may lackpotency. Future research should assess the efficacy ofmore intensive treatments. No investigator examinedan intervention requiring more than 16 sessions, andmost interventions lasted only 6 to 12 sessions. Suchbrief treatment is in vogue as third-party payers limitcoverage of long-term treatment. Chronic somatic com-plaints, however, may require treatment of a durationlonger than 2 months.
This work was supported by Grants K08 MH01662and R01 MH60265 from the National Institute of Men-tal Health.
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