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GASTROENTEROLOGY 1991;100:450-457

A Controlled

Trial

Treatment

for

the

of Psychological
Irritable

Bowel

Syndrome
ELSPETH
and

GUTHRIE,

BARBARA

Departments

FRANCIS

CREED,

DAVID

DAWSON,

TOMENSON

of Psychiatry

and Gastroenterology,

Manchester

Royal Infirmary,

Manchester,

England

One hundred two patients with irritable bowel


syndrome were studied in a controlled trial of
psychological treatment involving psychotherapy,
relaxation, and standard medical treatment compared with standard medical treatment alone. Patients were only selected if their symptoms had not
improved with standard medical treatment over the
previous 6 months. At 3 months, the treatment group
showed significantly greater improvement than the
controls on both gastroenterologists' and patients'
ratings of diarrhea and abdominal pain, but constipation changed little. Good prognostic factors included overt psychiatric symptoms and intermittent
pain exacerbated by stress, whereas those with
constant abdominal pain were helped little by this
treatment. This study has demonstrated that psychological treatment is feasible and effective in two
thirds of those patients with irritable bowel syndrome who do not respond to standard medical
treatment.
T

he rationale for considering psychological treatment in the irritable bowel syndrome (IES) comes

from several areas of research. First, many authors


have considered psychological factors to be implicated in the etiology oflES (1). Second, approximately
half oflES clinic attenders have diagnosable psychiatric illness by research criteria (2-5). Third, the onset
of the condition is often associated with life-threatening events similar to those that precipitate depression
or self-poisoning (6). Fourth, there is some evidence
that psychological treatment might help those patients whose symptoms do not respond to "standard"
medical treatment and are at risk of becoming chronic
sufferers and clinic attenders (7,8).
However, the efficacy of psychological treatment in
IES and its clinical indications are less than clear
(9,10). Patients in previous controlled trials have

either been self-selected for hypnosis (11) or have not


included patients with previous surgery to the gastrointestinal tract, with psychiatric disorder or with a
disability pension (12)-the patients for whom gastroenterologists mostly need further treatments. Hypnosis is least helpful for patients over 50 years of age,
those with atypical IBS, and those with psychiatric
symptoms (13), but precise indications have not been
defined.
The aim of this study was to assessthe feasibility
and efficacy of psychological treatment in a conseoutive series of clinic attenders with IBS unresponsive to
standard medical treatment (7). Since Klein criticized
many previous reports of IBS treatment studies on
methodological grounds (10), this paper will address
those aspects of method necessary for a clear interpretation including details of the study design, the
subjects included, the measuresof efficacy, the ability
to generalize findings, and statistical issues.
The study was a randomized controlled trial comparing active psychological treatment in addition to
standard medical treatment with continued medical
treatment alone. It was intended to recruit the maximum number of subjects into the study who fulfilled
the inclusion criteria to avoid the bias of some
previous samples.
The study period was 3 months with a follow-up 1
year after the end of treatment. However, many of the
control subjects were left with troublesome bowel
symptoms and mood disturbances after 3 months, so
it was not thought ethical to leave them untreated for
a further year. Instead they were offered active psychological treatment. This carried the advantage that the

February

1991

PSYCHOLOGICAL

Methods
Included

and Study Design

Patients were recruited into the study if they had IBS


diagnosed as symptoms of abdominal pain, abdominal
distention, and an abnormal bowel habit associated with
normal hematology, serum biochemistry, rectal biopsy, and
colonoscopy or contrast radiology. Subjects were only
included if they had experienced these symptoms for over 1
year and they had attended the gastroenterology clinic for
over 6 months without improvement
on bulking agents
and/or antispasmodic therapy.
All such patients were asked if they would take part in a
study "to examine how psychological symptoms relate to
bowel symptoms." The study was explained initially by the
gastroenterologist (D.D.) but the psychiatrist (E.G.) was also
present in the gastroenterology clinic and immediately took
the patient to another room where the study was explained
in detail. Thereafter, the patient was randomized
and
attended the psychiatric department for detailed assessment.
The study design is shown in Figure 1.

Assessments

Treatments

Assessments were performed at the start of the study


and after 3 months.
The gastroenterologist rated the severity of each of the
following symptoms: abdominal discomfort, abdominal distention, diarrhea, and constipation.
Each symptom was
rated on a four-point scale of severity: 0, none; 1, mild; 2,
moderate; and 3, severe. The sum of these scores was taken
as an overall measure of severity. Because severe diarrhea
and severe constipation were virtually mutually exclusive,
the effective maximum was 9.

All patients had received standard medical treatment in the gastroenterology clinic over the previous 6
months. The most common was a combination of a bulking
agent and an antispasmodic drug. For the purposes of the
trial, such treatment was continued unchanged. Active
treatment involved an initial long interview (2 hours or
more) during which bowel and psychiatric symptoms were
assessed and the patients' feelings about their illness and
any emotional problems were explored. This dynamic
psychotherapy
continued during a further six follow-up

1st
Interview

53

TREATMENT
x-x-x-x-x
\
-46-

CONTROL
0-0-0-0-0\

49
\

1
year
43

Drop-outs:

(6
months)

3
months

Drop-outs:

Figure 1. Design of study indicating numbers followed up


and control subjects receiving treatment.

OF IBS

The patients recorded the overall severity of their symptoms on a linear analogue scale (0, no symptoms; 100, worst
possible symptoms). They also rated the severity of each
abdominal symptom on the same four-point scale as the
gastroenterologist (0, none; 3, severe) and how much these
symptoms limited their lives when severe. Site(s) of pain
were indicated on a diagram of the abdomen.
Throughout the 3-month period, each patient kept a daily
chart of his or her bowel symptoms under four headings:
pain severity, frequency and consistency of bowel motions,
and bloating. For each separate symptom the daily scores
were added over 2-week periods yielding 6 scores for each
symptom over the 12 weeks of the study. In this way it could
be observed whether all symptoms changed equally with
treatment, or whether some symptoms changed more than
others.
The psychiatrist assessedthe patient's mental state using
the psychiatric assessmentscale (14), the Hamilton depression rating scale (15), and the clinical anxiety scale (16).
These interviews were audio taped by E.G., but rated by
another psychiatrist who was blind to the subject's group
(E.C.).
A follow-up assessment was performed at 1 year. This
was similar to the previous assessments with two exceptions: the gastroenterologist could not rate the patient's
symptoms because some of the patients had been discharged from the clinic by this time, and lack of resources
meant only a single follow-up visit was possible so patients
were not asked to complete a bowel diary at this time. An
overall assessmentof change was made by each patient on a
five-point scale (mucq better, better, no different, worse, or
much worse.) ,

number of subjects who had received psychological


treatment was nearly doubled so the factors related to
outcome could be studied more reliably. The results
for these subjects have been examined in the section
concerned with predictors of outcome, but the study
should not be viewed as a crossover trial as the
"carry-over effect" of psychological treatment study is
inevitable in making such a design impossible (10).

Subjects

TREATMENT

43
2

--)
\

33

TREATMENT
x-x-x-x-x

33

30

\
10

better

10

452

GUTHRIE ET AL.

GASTROENTEROLOGY

interviews using the conversational model of Hobson (17).


In addition, each patient received a relaxation tape to use on
a regular basis at home. No psychotropic medication was
prescribed.
Patients in the control group were seen for the initial and
3-month assessments, but the psychiatrist did not engage
them in a long initial interview about emotional problems.
The patients attended on three occasions (at 2, 4, and 8
weeks) simply to discuss their daily bowel charts.
The results of the study are presented first as baseline
comparisons to indicate any differences between treatment
and control groups at the start of the trial and also to
indicate whether the sample was similar to other studies of
IBS treatments. Next, the changes in bowel symptoms and
psychiatric symptoms during the 3 months of the trial are
demonstrated. Finally, the factors related to improvement
are presented.
Statistical comparisons between groups have been made
using the Mann-Whitney
U test and the x2 test. Correlations
between different measures of change used Spearman's
rank correlation coefficient. A discriminant function analysis was used to determine the variables that best predicted
outcome, and an analysis of covariance was used to examine whether improvement
in bowel symptoms could be
accounted for by change in psychiatric symptoms. Because
nonparametric statistics were used throughout, the results
are shown as median and range. Ethical permission was
obtained from the Central Manchester Health Authority
Ethical Committee.

Table 1. Characteristics

of the Sample

Sex
Median age (yr)
No. of years since first episode of
IBS
Duration of current symptoms
(yr)
Duration of current outpatient
attendance (mo)
Number of outpatient appointments last year
Time off work in last year (wk)
No. of previous consultants
No. of hospital admissions
Previous gastrointestinal
operations:
Appendectomy
Laparotomy
Site of pain
Both LIF and RIF
Left iliac fossa

'reatment

Control

group

group

8 M/45
49

NS

(21-75)

5 (1-20)

3.5 (1-12)

NS

2 (1-10)

2.5 (1-12)

NS

15 (7-49)

15 (9-50)

NS

4 (2-6)

4 (2-7)

3 (0-20)

4 (0-52)

2 (1-4)

2 (1-5)

1 (0-5)

1 (0-6)

NS
NS
NS
NS

NS

26

22

21

19

30

30

Right iliac fossa

Central/generalized
Epigastric

NOTE. Figures are median and range unless otherwise


up < 0.05.

stated.

Table 2. Improvement

Vol. 100. No.2

Scoresjor Each Symptom


Treatment
(n = 53)

Gastroenterologist's
rating
Abdominal discomfort
Abdominal distention
Diarrhea
Constipation
Patients' own rating
Abdominal pain
Distention
Diarrhea
~ Con.stipation

Control
(n

19)

1(-11o3)

o (-2

to

3)

0(-1103)

O ( -1

to

3)

1 (-1

1o 2)

O (-1

to 2)

NS
b

0 (-1

to 2)

O (-1

to

2)

NS

to 4)

O(-1to3)

1.5

(-1

1 (-1

to

3)

O(-1to2)

1 (-1

to

3)

O (-1

to

2)

O (-1

to

2)

0 (-1

to

2)

NS

NOTE. The median improvement


scores (i.e.. change between
initial and 3-month scores) are shown with range and significance
of difference between treatment and control group.
"P < 0.01. hp < 0.05. ,p < 0.001 (Mann-Whitney).

Results
One hundred fifteen consecutive patients were
approached in the gastrointestinal clinic. Eleven were
excluded. 5 had severe depression with suicidal ideas
requiring immediate antidepressant medication,
4
refused treatment, and 2 could not speak English.
Two other patients were later withdrawn
when it
became clear that they had organic pathology: chronic
pancreatitis and chronic inflammatory bowel disease.
Of the 102 patients with IBS in this study, 53 were
in the treatment group and 49 in the control group.
Thirteen patients dropped out-7
from the treatment
group and 6 from the control group. Data were
collected at 3 months for all but two of these dropouts.
The data for dropouts have been included in the
results that indicate the overall efficacy of treatment,
but have been excluded from later analyses concerning which patients responded best to the active
treatment (18).

Baseline Measures
The patients were typical of patients with IBS
in other series (Table 1). Because the clinic is at a
major teaching hospital receiving tertiary referrals
from throughout the region, over 40% of the subjects
were seeing their third consultant gastroenterologist.
A similar proportion had been admitted to the hospital at least twice for investigation, and nearly half had
had abdominal operations, mostly for removal of a
normal appendix. In terms of psychiatric disorder ,
just under half could be given a DSM III psychiatric
diagnosis of major depression (30%) or anxiety states
(18%) (19).
At the beginning of the study, there were no
significant differences between treatment and control

February

1991

PSYCHOLOGICAL

0.8...

453

3.01
2.0~
1.00-

0.6J
0.4,

I
0-

BEFORE

Figure 2. Median scores for treatment (.) and control (0) groups
before and after treatment. Abdominal symptoms (A) limiting
effect
of illness (8), and severity ofsymptoms on linear analogue scale (D)
rated by the patient; severity of
symptoms rated by gastroenterologist (C). In all measures, significant improvement
of treatment
group
compared
with
control
group at p < 0.05.

OF IBS

5.04.0-

1.0-

0.2~

TREATMENT

AFTER

BEFORE

AFTER

BEFORE

AFTER

8
6
4
2
BEFORE

@0

groups for age, social class, marital status, severity or


duration of IBS, and proportion
with psychiatric
diagnosis, but there were more men in the control
group (8 vs. 17, X2 = 4.29, p < 0.05) than women.

AFTER

ment group, which did not reach statistical significance. There was no significant difference regarding
consistency of stools (no. of days stools were watery
or loose, stringy or like pellets).
Results for males and females are presented separately in Table 3. It can be seen that a similar trend is

Gastroenterologists's Assessment
The total severity score of bowel symptoms
was similar in the treatment and control groups at the
start of the trial (median 5, range 2-8 in each case),
but had significantly improved in the treatment group
at 3 months: treatment group, median 2 (range, 0-8);
controls, median 5 (range 0-8); (P < 0.01). When
analyzed for each sex separately, the same pattern
emerged for men and women but only for the latter
were the numbers adequate for the differences to be
statistically
significant. There were significant improvements for the individual symptoms of abdominal discomfort and diarrhea, whereas abdominal distention and constipation did not change significantly
(Table 2).

TOTAL

PLAIN

SGORE

No

OF OAYS

ON WHICH

STOOL

FORMEO

.-.
A

/\
..,
-2 0

/
..:;:.:;:.
2 .6

, ,
.10

;;
o

No

OF OAYS

BOWELS

THAN

5 TIMES

OPEN

8 8
o o

1
12 TIME (WEEKS)
8
o

MORE

26

Patient's Assessments
The patients' own rating of their symptoms at
the initial and 3-month assessments are shown in
Table 2 and Figure 2. The results for the daily
recording of four symptoms on the bowel charts are
shown in Figure 3. These charts showed significant
improvements for the treatment group in abdominal
pain, diarrhea recorded as both number of days
bowels opened five times or more, and number of days
on which stools were formed. The bowel charts
indicated an improvement in bloating for the treat-

2.-

/0\

:\

2220-

'.-.

'",

.~-v

1.161.1..-

',..."...
I , .I
.'"'
-2 0 2 ...'0

10-

"

.'

I
,2 TIME IWEEKSI
~
o
~

,
-2

,
0

,
2

.,

..
0 .2

TIME

IWEEKS)

8
o
~

Figure 3. Median scores for treatment and control groups on


bowel charts showing change over 12 weeks of study. Each score
represents the mean of the previous 2 weeks' scores.

454

GASTROENTEROLOGY

GUTHRIE ET AL.

Table 3. Improvement

Scores by Sex Expressed as Mean and Range (Parameters Used in Figure 2)

Male
Patient ratings
Abdominal symptoms
Limiting effect of illness
Severity of symptoms on linear analogue scale

0,26 ( -0.21

Female
Patient ratings
Abdominal symptoms
Limiting effect of illness
Severity of symptoms on linear analogue scale

0 ( -2

to

(n

O (-2

5)

(n

44)

0.4 ( -0.26

to
=

NS

5)
31)

0.11 (-0.1410

to 1.38)

1.47)

0(-61011)
5(01091)

4(-2to21)
53.5 (0 to 100)

Gastroenterologist's rating
Severity of symptoms

NS
NS
NS

0.16 (0 to 0.42)
0(-3 to 16)
10.5 (0 to 95)

to 1.05)

2(-lto6)
66 (0 to 100)

Gastroenterologist's rating
Severity of symptoms

p < 0.05, hp < 0.001,

Vol. 100, No.2

Q(-3to7)

2(-2t08)

cp < 0.01,

recorded in both sexes, with the exception of the


gastroenterologist's rating; the numbers were too small
for men to reach statistical significance.

in

psychological

bowel

led

to

an

improvement

in

Predictors of Outcome

Psychiatrist's Assessments
Figure 4 shows that the treatment group improved significantly more than the control group with
regard to anxiety and depression. The improvements
in bowel symptoms were significantly correlated with
these changes in psychiatric symptom scores (Table
4). In view of the high correlations, an analysis of
covariance was performed to determine whether the
change in bowel scores remained significant after
adjusting for group differences in the psychological
variables. For both depression (Hamilton Rating Scale
for Depression) and anxiety (Clinical Anxiety Scale),
the covariate effect of the psychological variable was
significant: once this was accounted for, no significant difference remained between the treatment and
control groups with respect to the bowel symptom
scores. When the situation was reversed and the
psychological variables were analyzed using the bowel
symptom scores as covariate, the effects of treatment
all remained significant suggesting that improvement

status

symptomatology.

For the patients who had completed the psychological treatment after 3 months, those who had and
had not improved according to the gastroenterologist's assessment were compared (Table 5). The gastroenterologist considered that the patients who described constant pain (i.e., without
discernible
episodes) did not improve, whereas those who recognized that their pain was exacerbated by stress did
improve and those who had a diagnosis of anxiety/
depression improved more than those without.
A discriminant
function analysis confirmed this
result for all 70 patients who had received psychological treatment by 6 months (the original treatment
group plus the subjects in the control group who later
received active psychological
treatment). The best
predictors of a good outcome were presence of anxiety
or depression, absence of constant pain, short duration of present symptoms, and few sites of abdominal
pain.

February

PSYCHOLOGICAL

1991

Table 4. Correlation Coefficients Demonstrating


Relationship Between Change in Psychiatric
."vmDtnm.c; nnr/ Chanflf! in Rf)wel.')'vmntnms

Table 6. Results

The results of the follow-up interviews are


shown in Table 6 and Figure 5. According to the
patients' self-reports, the improvement noted after the
psychological treatment period is maintained at 1
year in most cases, both for the original treatment
group and the control subjects who later received
treatment. The controls who remitted spontaneously
during the first 3 months (and therefore were not
offered treatment) had mild symptoms at the outset
but had mostly relapsed during the subsequent year.
The dropouts did not improve.
Following
psychological
treatment there was a
highly significant reduction in the number of outpatient visits to the gastrointestinal
clinic: median 4
(range, 2-7) in the year before the trial to median 1
(range, 0-6) in the year following
the treatment
(x2 = 75.2,df=
7,? < 0.001).

Discussion
This study
necessary

fulfilled
most of Klein's stringent
for a satisfactory
treatment
trial in

Table 5. Comparison of Those in the Treatment Group Who


Did and Did Not Improve
Improved
In = 31)
Number of males
Age over 50 years
Anxiety/depression
Median no. of years since
first IBS
Median no. of years current
symptoms
Constant pain
Pain exacerbated by stress
Median no. of weeks off \vork
Confined to bed at worst

No improvement
(n = 12)
2

15

20

4.5

20

NS
NS

NS

2
2

6.5

NOTE. Results only for those who completed treatment period


ap < 0.05 (X' text), "p < 0.01 (Mann-Whitney).
'P < 0.05.

Interviews

OF IBS

455

at 1 Year

No. of patients
--

Follow-up at 1 Year

criteria

ofFollow-up

TREATMENT

NS

IBS (10). The study included over 100 patients.


Separate measures were used to assess change in
pain, distention, and bowel disturbance as well as
global and psychiatric measures. Baseline comparisons were made, the statistical comparison included
all but two of the dropouts (18), and some assessment
was r:nade at 1 year follow-up.
The first limitation of the study was the absence of
precise criteria for defining IBS. Such criteria have
subsequently been produced (20) and would have
formed useful entry criteria to ensure a homogeneous
sample. But we have calculated in retrospect that 72
of the patients' would have fulfilled these criteria and
their outcome was no different from the remainder .
Selection of patients according to nonresponse to 6
months of "standard" treatment in the clinic had
some merits. First, these patients represent the patients presenting most difficulty to the gastroenterologist, so time-consuming
psychological treatment is
most likely to be cost-effective (9). Second, these
patients have relatively stable symptoms (7) thus
reducing the chance of a marked placebo response
(10). The 20% spontaneous response rate in the
control group affected those with milder symptoms
and probably represents the effect of a single assessment interview plus daily recording of bowel habit
(12). This slight improvement
of patients in the
control group refutes the suggestion that they felt
deprived of a treatment during the initial 3-month
trial period.
Th~ second of Klein's criteria, which was not
possible to maintain throughout this trial, was doubleblind assessments. In a psychological treatment trial
it is impossible for the patient to be ignorant of the
group (treatment or control) to which she belongs. But
we are reasonably confident that the gastroenterologist did remain .'blind" while making his 3-month
assessment because even the control subjects made
frequent visits to the psychiatrist for consideration of
their bowel charts. No objective measures of bowel
motility were used (21) because of the difficulty we

456

GASTROENTEROLOGY

GUTHRIE ET AL.

GI
L
a
u
0)

1.0

E
a
""
0.
E
>0)

.a

.6

Figure 5. Total bowel symptom score (as medians) at start


of trial, at 3 or 6 months and

.-1
GI
~
a
m

0.0

-3

Vol. 100, No.2

9
Time

in

12

15

monthB

experienced in recording a clear and reproducible


record of intestinal motility at the pretrial assessment.
The consecutive nature of the sample should mean
that our results can be generalized to other clinic
populations of nonresponders, provided the psychological treatment can be offerred in an acceptable
manner. The sympathetic approach of the gastroenterologist was probably very important together with the
immediate availability of the research psychiatrist to
counteract patients' resistance to the suggestion of
psychological treatment.
The nature of our sample meant that it more closely
resembled "refractory" patients of Whorwell et al. (11)
than those of Svedlund (12), who excluded patients
with more serious IBS. But whereas Whorwell's patients were self-selected for hypnosis, the present
sample was a consecutive series of chronically ill
patients; this study has shown that the majority can
be engaged in this type of treatment if a psychiatrist
works closely with the gastroenterologist. Further
research is planned to assesswhether a briefer time in
psychotherapy can be effective.
The efficacy of this treatment was confined to
certain symptoms-diarrhea and abdominal pain were
much more responsive than constipation. These symptoms were those most responsive to desipramine
when used in a dose that reduced depression scores
(21). The patients with constant pain, as opposed to
intermittent, did poorly in this study: similar findings
have been reported with hypnotherapy (13).
Unlike other studies (13,22,23), the presence of
psychiatric symptoms was not a poor prognostic
indicator; rather it predicted a good outcome. Unlike
hypnotherapy, which used a "gut directed" hypnotic

16

l-year follow-upo --,


Dropouts; -,
treatment group;
00-00-00-00,
control subjects receiving treatment between 3
and 6 months; --,
control
subjects who spontaneously
remitted
during
the first 3
months
and therefore
received no treatment.

technique to modify gut function, our psychological


treatment was aimed at those emotional problems
frequently associated with the onset of IBS (6), most
commonly marital and other relationship problems.
The reduction of anxiety and depression testifies to its
effectiveness in this respect, and the close correlation
between improvement in psychiatric status and bowel
symptoms adds further weight to the suggestion that
anxiety and/or depression causes bowel dysfunction
in at least some patients with IBS.
Our sample of 102 patients with IBS unresponsive
to standard treatment was collected in one busy clinic
over a 21-month period. Because so many patients are
attending gastroenterology
clinics with functional
bowel complaints (24,25), it is essential to put this
treatment in perspective. Most patients with IBS do
not reach the gastroenterologist (26,27); 85% of those
who do so will be helped by the first line of treatment
and can be discharged within 6 months (7), but it is
only two thirds of the remainder who responded to
this psychiatric treatment. Further research must now
define the particular aspects of the psychological
treatment responsible for the improvement of patients
with IBS, and a satisfactory treatment has yet to be
found for those with constant abdominal pain.

References
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bowel syndrome. Gut 1987;28:1307-1318.
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gastrointestinal
illness: a medical and psychiatric study. Br J PsychoI1980;136:
276-283.
3. Craig TK. Brown GW. Goal frustrating
aspects of life event

February

PSYCHOLOGICAL

1991

stress in the aetiology of gastrointestinal

disorder. J Psychosom

Res 1984;28:411-421.
4. Ford MJ. Miller PMcC. Eastwood J. Eastwood MA. Life events.
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TREATMENT

OF IBS

457

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Received December 5, 1989. Accepted August 11, 1990.


Address requests for reprints to: EIspeth Guthrie, M.D.. Department of Psychiatry, Rawnsley Building, Manchester Royal Infirmary, Oxford Road, Manchester M13 9WL. England.
This research was performed with a grant from the North West
Regional Health Authority.
Reckitt and Colman also provided
support including the Fybogel.
The authors thank Dr. R. Holmes. Dr. T. Warnes. and Dr. I.
Braganza for allowing us to study patients under their care.

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