GASTROENTEROLOGY 1991;100:450-457

A Controlled Trial of PsychologicalTreatment for the Irritable Bowel

Syndrome

ELSPETH GUTHRIE, FRANCIS CREED, DAVID DAWSON,

and BARBARA TOMENSONDepartments of Psychiatry and Gastroenterology, Manchester Royal Infirmary, Manchester,England

One hundred two patients with irritable bowelsyndrome were studied in a controlled trial ofpsychological treatment involving psychotherapy,relaxation, and standard medical treatment com-pared with standard medical treatment alone. Pa-tients were only selected if their symptoms had notimproved with standard medical treatment over theprevious 6 months. At 3 months, the treatment groupshowed significantly greater improvement than thecontrols on both gastroenterologists' and patients'ratings of diarrhea and abdominal pain, but consti-pation changed little. Good prognostic factors in-cluded overt psychiatric symptoms and intermittentpain exacerbated by stress, whereas those withconstant abdominal pain were helped little by thistreatment. This study has demonstrated that psycho-logical treatment is feasible and effective in twothirds of those patients with irritable bowel syn-drome who do not respond to standard medicaltreatment.

either been self-selected for hypnosis (11) or have notincluded patients with previous surgery to the gas-trointestinal tract, with psychiatric disorder or with adisability pension ( 12 )-the patients for whom gastro-enterologists mostly need further treatments. Hypno-sis is least helpful for patients over 50 years of age,those with atypical IBS, and those with psychiatricsymptoms (13), but precise indications have not beendefined.

The aim of this study was to assess the feasibilityand efficacy of psychological treatment in a conseou-tive series of clinic attenders with IBS unresponsive tostandard medical treatment (7). Since Klein criticizedmany previous reports of IBS treatment studies onmethodological grounds (10), this paper will addressthose aspects of method necessary for a clear interpre-tation including details of the study design, thesubjects included, the measures of efficacy, the abilityto generalize findings, and statistical issues.

The study was a randomized controlled trial com-paring active psychological treatment in addition tostandard medical treatment with continued medicaltreatment alone. It was intended to recruit the maxi-mum number of subjects into the study who fulfilledthe inclusion criteria to avoid the bias of someprevious samples.

The study period was 3 months with a follow-up 1year after the end of treatment. However, many of thecontrol subjects were left with troublesome bowelsymptoms and mood disturbances after 3 months, soit was not thought ethical to leave them untreated fora further year. Instead they were offered active psycho-logical treatment. This carried the advantage that the

T he rationale for considering psychological treat-ment in the irritable bowel syndrome (IES) comes

from several areas of research. First, many authorshave considered psychological factors to be impli-cated in the etiology oflES (1). Second, approximatelyhalf oflES clinic attenders have diagnosable psychiat-ric illness by research criteria (2-5). Third, the onsetof the condition is often associated with life-threaten-ing events similar to those that precipitate depressionor self-poisoning (6). Fourth, there is some evidencethat psychological treatment might help those pa-tients whose symptoms do not respond to "standard"medical treatment and are at risk of becoming chronicsufferers and clinic attenders (7,8).

However, the efficacy of psychological treatment inIES and its clinical indications are less than clear(9, 10). Patients in previous controlled trials have

PSYCHOLOGICAL TREATMENT OF IBSFebruary 1991

number of subjects who had received psychologicaltreatment was nearly doubled so the factors related tooutcome could be studied more reliably. The resultsfor these subjects have been examined in the sectionconcerned with predictors of outcome, but the studyshould not be viewed as a crossover trial as the"carry-over effect" of psychological treatment study isinevitable in making such a design impossible (10).

The patients recorded the overall severity of their symp-toms on a linear analogue scale (0, no symptoms; 100, worstpossible symptoms). They also rated the severity of eachabdominal symptom on the same four-point scale as thegastroenterologist (0, none; 3, severe) and how much thesesymptoms limited their lives when severe. Site(s) of painwere indicated on a diagram of the abdomen.

Throughout the 3-month period, each patient kept a dailychart 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 scoreswere added over 2-week periods yielding 6 scores for eachsymptom over the 12 weeks of the study. In this way it couldbe observed whether all symptoms changed equally withtreatment, or whether some symptoms changed more thanothers.

The psychiatrist assessed the patient's mental state usingthe psychiatric assessment scale (14), the Hamilton depres-sion rating scale (15), and the clinical anxiety scale (16).These interviews were audio taped by E.G., but rated byanother psychiatrist who was blind to the subject's group(E.C.).

A follow-up assessment was performed at 1 year. Thiswas similar to the previous assessments with two excep-tions: the gastroenterologist could not rate the patient'ssymptoms because some of the patients had been dis-charged from the clinic by this time, and lack of resourcesmeant only a single follow-up visit was possible so patientswere not asked to complete a bowel diary at this time. Anoverall assessment of change was made by each patient on afive-point scale (mucq better, better, no different, worse, ormuch worse.) ,

Methods

Subjects Included and Study DesignPatients were recruited into the study if they had IBS

diagnosed as symptoms of abdominal pain, abdominaldistention, and an abnormal bowel habit associated withnormal hematology, serum biochemistry, rectal biopsy, andcolonoscopy or contrast radiology. Subjects were onlyincluded if they had experienced these symptoms for over 1year and they had attended the gastroenterology clinic forover 6 months without improvement on bulking agentsand/or antispasmodic therapy.

All such patients were asked if they would take part in astudy "to examine how psychological symptoms relate tobowel symptoms." The study was explained initially by thegastroenterologist (D.D.) but the psychiatrist (E.G.) was alsopresent in the gastroenterology clinic and immediately tookthe patient to another room where the study was explainedin detail. Thereafter, the patient was randomized andattended the psychiatric department for detailed assess-ment.

The study design is shown in Figure 1.

Treatments

All patients had received standard medical treat-ment in the gastroenterology clinic over the previous 6months. The most common was a combination of a bulkingagent and an antispasmodic drug. For the purposes of thetrial, such treatment was continued unchanged. Activetreatment involved an initial long interview (2 hours ormore) during which bowel and psychiatric symptoms wereassessed and the patients' feelings about their illness andany emotional problems were explored. This dynamicpsychotherapy continued during a further six follow-up

Assessments

Assessments were performed at the start of the studyand after 3 months.

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

3months

1stInterview

1year

(6months)

TREATMENT53 x-x-x-x-x -46- \ \ 43

Drop-outs: 3 4

CONTROL TREATMENT49 0-0-0-0-0- 43 --) 33 x-x-x-x-x 33

\ \ \Figure 1. Design of study in-dicating numbers followed upand control subjects receiv-ing treatment.

30

Drop-outs: 4 2 \10 better 10

452 GUTHRIE ET AL. GASTROENTEROLOGY Vol. 100. No.2

Table 2. Improvement Scoresjor Each SymptomControl

(n = 19)Treatment

(n = 53)

Gastroenterologist's ratingAbdominal discomfortAbdominal distentionDiarrheaConstipation

Patients' own ratingAbdominal painDistentionDiarrheaCon.stipation

~

1(-11o3)0(-1103)1 (-1 1o 2)0 (-1 to 2)

o (-2 to 3)O ( -1 to 3)O (-1 to 2)O (-1 to 2)

NSb

NS

1.5 (-1 to 4)1 (-1 to 3)1 (-1 to 3)O (-1 to 2)

O(-1to3)O(-1to2)O (-1 to 2)0 (-1 to 2) NS

NOTE. The median improvement scores (i.e.. change betweeninitial and 3-month scores) are shown with range and significanceof difference between treatment and control group."P < 0.01. hp < 0.05. ,p < 0.001 (Mann-Whitney).

interviews using the conversational model of Hobson (17).In addition, each patient received a relaxation tape to use ona regular basis at home. No psychotropic medication wasprescribed.

Patients in the control group were seen for the initial and3-month assessments, but the psychiatrist did not engagethem in a long initial interview about emotional problems.The patients attended on three occasions (at 2, 4, and 8weeks) simply to discuss their daily bowel charts.

The results of the study are presented first as baselinecomparisons to indicate any differences between treatmentand control groups at the start of the trial and also toindicate whether the sample was similar to other studies ofIBS treatments. Next, the changes in bowel symptoms andpsychiatric symptoms during the 3 months of the trial aredemonstrated. Finally, the factors related to improvementare presented.

Statistical comparisons between groups have been madeusing the Mann-Whitney U test and the x2 test. Correlationsbetween different measures of change used Spearman'srank correlation coefficient. A discriminant function analy-sis was used to determine the variables that best predictedoutcome, and an analysis of covariance was used to exam-ine whether improvement in bowel symptoms could beaccounted for by change in psychiatric symptoms. Becausenonparametric statistics were used throughout, the resultsare shown as median and range. Ethical permission wasobtained from the Central Manchester Health AuthorityEthical Committee.

Results

One hundred fifteen consecutive patients wereapproached in the gastrointestinal clinic. Eleven wereexcluded. 5 had severe depression with suicidal ideasrequiring immediate antidepressant medication, 4refused treatment, and 2 could not speak English.Two other patients were later withdrawn when itbecame clear that they had organic pathology: chronicpancreatitis and chronic inflammatory bowel disease.

Of the 102 patients with IBS in this study, 53 werein the treatment group and 49 in the control group.Thirteen patients dropped out-7 from the treatmentgroup and 6 from the control group. Data werecollected at 3 months for all but two of these dropouts.The data for dropouts have been included in theresults that indicate the overall efficacy of treatment,but have been excluded from later analyses concern-ing which patients responded best to the activetreatment (18).

Table 1. Characteristics of the Sample

'reatmentgroup

Controlgroup

NS8 M/45 F

49 (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)3 (0-20)2 (1-4)1 (0-5)

4 (2-7)4 (0-52)2 (1-5)1 (0-6)

NSNSNSNS

2621

5

2219

3

NS

308491

302791

SexMedian age (yr)No. of years since first episode of

IBSDuration of current symptoms

(yr)Duration of current outpatient

attendance (mo)Number of outpatient appoint-

ments last yearTime off work in last year (wk)No. of previous consultantsNo. of hospital admissionsPrevious gastrointestinal

operations:AppendectomyLaparotomy

Site of painBoth LIF and RIFLeft iliac fossaRight iliac fossaCentral/generalizedEpigastric

Baseline Measures

The patients were typical of patients with IBSin other series (Table 1). Because the clinic is at amajor teaching hospital receiving tertiary referralsfrom throughout the region, over 40% of the subjectswere seeing their third consultant gastroenterologist.A similar proportion had been admitted to the hospi-tal at least twice for investigation, and nearly half hadhad abdominal operations, mostly for removal of anormal appendix. In terms of psychiatric disorder ,just under half could be given a DSM III psychiatricdiagnosis of major depression (30%) or anxiety states(18%) (19).

At the beginning of the study, there were nosignificant differences between treatment and control

NOTE. Figures are median and range unless otherwise stated.up < 0.05.

February 1991 PSYCHOLOGICAL TREATMENT OF IBS 453

5.0-4.0-

3.012.0~1.0-

0-

@BEFORE AFTERBEFORE AFTER

Figure 2. Median scores for treat-ment (.) and control (0) groupsbefore and after treatment. Abdom-inal symptoms (A) limiting effectof illness (8), and severity ofsymp-toms on linear analogue scale (D)rated by the patient; severity ofsymptoms rated by gastroenterolo-gist (C). In all measures, signifi-cant improvement of treatmentgroup compared with controlgroup at p < 0.05.

8

64

2

@0BEFORE AFTER BEFORE AFTER

groups for age, social class, marital status, severity orduration of IBS, and proportion with psychiatricdiagnosis, but there were more men in the controlgroup (8 vs. 17, X2 = 4.29, p < 0.05) than women.

ment group, which did not reach statistical signifi-cance. There was no significant difference regardingconsistency of stools (no. of days stools were wateryor loose, stringy or like pellets).

Results for males and females are presented sepa-rately in Table 3. It can be seen that a similar trend is

Gastroenterologists's Assessment

The total severity score of bowel symptomswas similar in the treatment and control groups at thestart of the trial (median 5, range 2-8 in each case),but had significantly improved in the treatment groupat 3 months: treatment group, median 2 (range, 0-8);controls, median 5 (range 0-8); (P < 0.01). Whenanalyzed for each sex separately, the same patternemerged for men and women but only for the latterwere the numbers adequate for the differences to bestatistically significant. There were significant im-provements for the individual symptoms of abdomi-nal discomfort and diarrhea, whereas abdominal dis-tention and constipation did not change significantly(Table 2).

TOTAL PLAIN SGORE No OF OAYS ON WHICH STOOL FORMEO

.-.

A

/\ /.., ..:;:.:;:. , , 1

-2 0 2 .6 .10 12 TIME (WEEKS);; 8 8 8o o o o

No OF OAYS BOWELS OPEN MORETHAN 5 TIMES

26

2.-

22-

20-

1.-

16-

1.-

1..-

10-

:\'",

/0\Patient's Assessments

The patients' own rating of their symptoms atthe initial and 3-month assessments are shown inTable 2 and Figure 2. The results for the dailyrecording of four symptoms on the bowel charts areshown in Figure 3. These charts showed significantimprovements for the treatment group in abdominalpain, diarrhea recorded as both number of daysbowels opened five times or more, and number of dayson which stools were formed. The bowel chartsindicated an improvement in bloating for the treat-

.~-v'.-.

',..."... "

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

~ 8o o~ ~

.'

, , , ., , ..

-2 0 2 0 .2 TIME IWEEKS)

Figure 3. Median scores for treatment and control groups onbowel charts showing change over 12 weeks of study. Each scorerepresents the mean of the previous 2 weeks' scores.

1.0-0.8...

0.6J0.4,

0.2~I

0-

GASTROENTEROLOGY Vol. 100, No.2454 GUTHRIE ET AL.

Table 3. Improvement Scores by Sex Expressed as Mean and Range (Parameters Used in Figure 2)

NSNSNS

0,26 ( -0.21 to 1.05)2(-lto6)

66 (0 to 100)

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

10.5 (0 to 95)

NS0 ( -2 to 5)(n = 44)

O (-2 to 5)

(n = 31)

0.11 (-0.1410 1.47)0(-61011)5(01091)

0.4 ( -0.26 to 1.38)4(-2to21)

53.5 (0 to 100)

MalePatient ratings

Abdominal symptomsLimiting effect of illnessSeverity of symptoms on linear analogue scale

Gastroenterologist's ratingSeverity of symptoms

FemalePatient ratings

Abdominal symptomsLimiting effect of illnessSeverity of symptoms on linear analogue scale

Gastroenterologist's ratingSeverity of symptoms Q(-3to7)2(-2t08)

p < 0.05, hp < 0.001, cp < 0.01,

recorded in both sexes, with the exception of thegastroenterologist's rating; the numbers were too smallfor men to reach statistical significance.

in psychological status led to an improvement inbowel symptomatology.

Predictors of OutcomeFor the patients who had completed the psycho-

logical treatment after 3 months, those who had andhad not improved according to the gastroenterolo-gist's assessment were compared (Table 5). The gastro-enterologist considered that the patients who de-scribed constant pain (i.e., without discernibleepisodes) did not improve, whereas those who recog-nized that their pain was exacerbated by stress didimprove and those who had a diagnosis of anxiety/depression improved more than those without.

A discriminant function analysis confirmed thisresult for all 70 patients who had received psycholog-ical treatment by 6 months (the original treatmentgroup plus the subjects in the control group who laterreceived active psychological treatment). The bestpredictors of a good outcome were presence of anxietyor depression, absence of constant pain, short dura-tion of present symptoms, and few sites of abdominalpain.

Psychiatrist's AssessmentsFigure 4 shows that the treatment group im-

proved significantly more than the control group withregard to anxiety and depression. The improvementsin bowel symptoms were significantly correlated withthese changes in psychiatric symptom scores (Table4). In view of the high correlations, an analysis ofcovariance was performed to determine whether thechange in bowel scores remained significant afteradjusting for group differences in the psychologicalvariables. For both depression (Hamilton Rating Scalefor Depression) and anxiety (Clinical Anxiety Scale),the covariate effect of the psychological variable wassignificant: once this was accounted for, no signifi-cant difference remained between the treatment andcontrol groups with respect to the bowel symptomscores. When the situation was reversed and thepsychological variables were analyzed using the bowelsymptom scores as covariate, the effects of treatmentall remained significant suggesting that improvement

February 1991 PSYCHOLOGICAL TREATMENT OF IBS 455

Table 6. Results ofFollow-up Interviews at 1 YearTable 4. Correlation Coefficients DemonstratingRelationship Between Change in Psychiatric."vmDtnm.c; nnr/ Chanflf! in Rf)wel.')'vmntnms No. of patients

--

Follow-up at 1 Year

The results of the follow-up interviews areshown in Table 6 and Figure 5. According to thepatients' self-reports, the improvement noted after thepsychological treatment period is maintained at 1year in most cases, both for the original treatmentgroup and the control subjects who later receivedtreatment. The controls who remitted spontaneouslyduring the first 3 months (and therefore were notoffered treatment) had mild symptoms at the outsetbut had mostly relapsed during the subsequent year.The dropouts did not improve.

Following psychological treatment there was ahighly significant reduction in the number of outpa-tient 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 fulfilled most of Klein's stringentcriteria necessary for a satisfactory treatment trial in

Table 5. Comparison of Those in the Treatment Group WhoDid and Did Not Improve

Improved No improvementIn = 31) (n = 12)

NSNS

3

15

20

263

IBS (10). The study included over 100 patients.Separate measures were used to assess change inpain, distention, and bowel disturbance as well asglobal and psychiatric measures. Baseline compari-sons were made, the statistical comparison includedall but two of the dropouts (18), and some assessmentwas r:nade at 1 year follow-up.

The first limitation of the study was the absence ofprecise criteria for defining IBS. Such criteria havesubsequently been produced (20) and would haveformed useful entry criteria to ensure a homogeneoussample. But we have calculated in retrospect that 72of the patients' would have fulfilled these criteria andtheir outcome was no different from the remainder .

Selection of patients according to nonresponse to 6months of "standard" treatment in the clinic hadsome merits. First, these patients represent the pa-tients presenting most difficulty to the gastroenterolo-gist, so time-consuming psychological treatment ismost likely to be cost-effective (9). Second, thesepatients have relatively stable symptoms (7) thusreducing the chance of a marked placebo response(10). The 20% spontaneous response rate in thecontrol group affected those with milder symptomsand probably represents the effect of a single assess-ment interview plus daily recording of bowel habit(12). This slight improvement of patients in thecontrol group refutes the suggestion that they feltdeprived of a treatment during the initial 3-monthtrial period.

Th~ second of Klein's criteria, which was notpossible to maintain throughout this trial, was double-blind assessments. In a psychological treatment trialit is impossible for the patient to be ignorant of thegroup (treatment or control) to which she belongs. Butwe are reasonably confident that the gastroenterolo-gist did remain .'blind" while making his 3-monthassessment because even the control subjects madefrequent visits to the psychiatrist for consideration oftheir bowel charts. No objective measures of bowelmotility were used (21) because of the difficulty we

4 8 NS

4.5

8

2

6.5

4

~

7

20

2

7

Number of malesAge over 50 yearsAnxiety/depressionMedian no. of years since

first IBSMedian no. of years current

symptomsConstant painPain exacerbated by stressMedian no. of weeks off \vorkConfined to bed at worst NSNOTE. Results only for those who completed treatment periodap < 0.05 (X' text), "p < 0.01 (Mann-Whitney). 'P < 0.05.

456 GUTHRIE ET AL. GASTROENTEROLOGY Vol. 100, No.2

1.0GILau0)Ea""

0.E>-0).-1GI~

am

.a

.6Figure 5. Total bowel symp-tom score (as medians) at startof trial, at 3 or 6 months andl-year follow-upo --, Drop-outs; -, treatment group;00-00-00-00, control subjects re-ceiving treatment between 3and 6 months; --, controlsubjects who spontaneouslyremitted during the first 3months and therefore re-ceived no treatment.

0.0-3 0 3 6 12 15 169

Time in monthB

technique to modify gut function, our psychologicaltreatment was aimed at those emotional problemsfrequently associated with the onset of IBS (6), mostcommonly marital and other relationship problems.The reduction of anxiety and depression testifies to itseffectiveness in this respect, and the close correlationbetween improvement in psychiatric status and bowelsymptoms adds further weight to the suggestion thatanxiety and/or depression causes bowel dysfunctionin at least some patients with IBS.

Our sample of 102 patients with IBS unresponsiveto standard treatment was collected in one busy clinicover a 21-month period. Because so many patients areattending gastroenterology clinics with functionalbowel complaints (24,25), it is essential to put thistreatment in perspective. Most patients with IBS donot reach the gastroenterologist (26,27); 85% of thosewho do so will be helped by the first line of treatmentand can be discharged within 6 months (7), but it isonly two thirds of the remainder who responded tothis psychiatric treatment. Further research must nowdefine the particular aspects of the psychologicaltreatment responsible for the improvement of patientswith IBS, and a satisfactory treatment has yet to befound for those with constant abdominal pain.

experienced in recording a clear and reproduciblerecord of intestinal motility at the pretrial assessment.

The consecutive nature of the sample should meanthat our results can be generalized to other clinicpopulations of nonresponders, provided the psycho-logical treatment can be offerred in an acceptablemanner. The sympathetic approach of the gastroenter-ologist was probably very important together with theimmediate availability of the research psychiatrist tocounteract patients' resistance to the suggestion ofpsychological treatment.

The nature of our sample meant that it more closelyresembled "refractory" patients of Whorwell et al. (11)than those of Svedlund (12), who excluded patientswith more serious IBS. But whereas Whorwell's pa-tients were self-selected for hypnosis, the presentsample was a consecutive series of chronically illpatients; this study has shown that the majority canbe engaged in this type of treatment if a psychiatristworks closely with the gastroenterologist. Furtherresearch is planned to assess whether a briefer time inpsychotherapy can be effective.

The efficacy of this treatment was confined tocertain symptoms-diarrhea and abdominal pain weremuch more responsive than constipation. These symp-toms were those most responsive to desipraminewhen used in a dose that reduced depression scores(21). The patients with constant pain, as opposed tointermittent, did poorly in this study: similar findingshave been reported with hypnotherapy (13).

Unlike other studies (13,22,23), the presence ofpsychiatric symptoms was not a poor prognosticindicator; rather it predicted a good outcome. Unlikehypnotherapy, which used a "gut directed" hypnotic

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PSYCHOLOGICAL TREATMENT OF IBS 457February 1991

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893.

Received December 5, 1989. Accepted August 11, 1990.Address requests for reprints to: EIspeth Guthrie, M.D.. Depart-

ment of Psychiatry, Rawnsley Building, Manchester Royal Infir-mary, Oxford Road, Manchester M13 9WL. England.

This research was performed with a grant from the North WestRegional Health Authority. Reckitt and Colman also providedsupport 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.