Gut, 1988, 29, 342-345
`
`Symptoms and stool patterns in patients with
`ulcerative colitis
`
`S S C RAO, C D HOLDSWORTH, AND N W READ
`
`From the Gastrointestinal Unit, Royal Hallamshire Hospital, Sheffield
`
`SUMMARY The prevalence Of symptoms and stool patterns was assessed prospectively in 96 patients
`with ulcerative colitis subdivided according to the extent and activity of the disease. Increased
`frequency of defecation (83%), urgency (85%), a feeling of incomplete evacuation (78%) and
`tenesmus (63%) were the most frequent symptoms experienced by patients with active colitis. All
`were significantly more common (p<0.001) in patients with active than quiescent colitis and their
`prevalence was similar in those with total and distal colitis, indicating that these symptoms are
`related to an inflamed and irritable distal colon. Twenty seven per cent of patients with active colitis
`voided hard stools indicative of constipation, however, and this was more common in active, than
`quiescent colitis (p<0.05). This feature is probably secondary to faecal stasis in the proximal colon,
`and an apt description of the bowel disturbance in ulcerative colitis, irrespective of the extent of
`disease is that the colon suffers from proximal constipation and distal irritability.
`
`For a condition in which change of bowel habit is a
`major manifestation, there is a surprising dearth of
`objective data on bowel symptoms in ulcerative
`colitis, and this is reflected by the very inadequate
`and poorly referenced accounts in many standard
`textbooks of medicine and gastroenterology.
`Although it is often assumed that the patient with
`active colitis usually has diarrhoea, there are no
`systematic studies of stool weight and frequency.
`Constipation has been mentioned in some clinical
`accounts'-5 but many descriptions have ignored this
`symptom." In a small series, Engel' observed that
`44% of colitics were constipated at the time of
`presentation, and in a larger retrospective enquiry,
`constipation was reported by 20% of patients.' The
`concept of faecal stasis in colitis was extended by
`Lennard-Jones et al,910 and in a retrospective case
`record analysis it was estimated that 15% of colitics
`exhibited this feature." During the course of physio-
`logical studies of patients with ulcerative colitis, we
`observed that transit through the small intestine and
`proximal colon was paradoxically slow,12 and this
`reinforced our own clinical impression that constipa-
`tion is a frequent problem. In order to understand the
`nature of the bowel disturbance in patients with
`ulcerative colitis, we set out to systematically docu-
`Address for correspondence: Dr C D Holdsworth, FRCP, Consultant
`Physician, Floor J, Royal Hallamshire Hospital, Sheffield SIO 2JF.
`Received for publication 24 August 1987.
`
`ment the prevalence of symptoms and stool patterns
`in three patients.
`
`Methods
`
`PATIENTS
`One hundred and ten assessments were carried out in
`96 patients with histologically proven ulcerative
`colitis. The clinical details are shown in the Table.
`The disease was judged to be active, if sigmoido-
`scopic appearance and histology of a biopsy of rectal
`mucosa showed evidence of active inflammation and
`the severity of colitis was categorised in accordance
`with Truelove and Witts criteria." The extent of the
`disease was assessed by radiology and sigmoidoscopy
`and was termed distal if it did not extend proximal to
`the splenic flexure. Sixty patients had active colitis
`and 50 had quiescent colitis and 14 were assessed
`during active and quiescent phases of their disease.
`Of patients with distal colitis, four with active disease
`and three with quiescent disease had proctitis only.
`Of the 26 patients with active total colitis, five had
`mild colitis, 10 moderately severe colitis and 11
`severe colitis. Of the 34 patients with active distal
`colitis, 12 had mild colitis, 16 moderately severe
`colitis and six severe colitis.
`
`SYMPTOM QUESTIONNAIRE
`All patients completed a symptom questionnaire in
`342
`
`MYLAN EXHIBIT - 1048
`Mylan Pharmaceuticals, Inc. v. Bausch Health Ireland, Ltd. - IPR2022-00722
`
`

`

`Symptoms and stool patterns in patients with ulcerative colitis
`
`343
`
`Table 1 Clinical details and the prevalence of stool patterns and bowel symptoms, in patients with ulcerative colitis,
`subdivided according to the extent and activity of disease
`
`Studied (n)
`Men/women
`Age (years)*
`Duration of colitis (years)*
`Daily stool frequency*
`Nocturnal defecation
`
`Predominant stool consistency
`Unformed
`Formed
`Hard
`
`Symptoms
`Urgency
`Incomplete evacuation
`Tenesmus
`Pain
`Anal soreness
`Incontinence
`
`Total colitis
`
`Active
`
`26
`10/16
`48(19-76)
`7 (0.5-21)
`5 (4-9)t
`21 (81%)t
`
`17 (65%)t
`4 (15%)t
`5 (19%)
`
`24 (92%)t
`20 (77%)t
`18 (69%)t
`12 (46%)t
`13 (50%)t
`8 (31%)t
`
`Quiescent
`
`19
`9/10
`50 (20-79)
`8(0.6-22)
`2 (1-3)
`0
`
`3 (16%)
`15 (79%)
`1 (5%) NS
`
`2(11%)
`3 (16%)
`2(11%)
`2(11%)
`2(11%)
`0
`
`Distal colitis
`
`Active
`
`34
`19/15
`46(20-79)
`6 (0.4-22)
`4 (2-6)f
`19(56%)1
`
`15 (44%)#
`8 (23%)$
`11(33%)§
`
`27 (79%)#
`27 (79%)t
`20 (59%)t
`18 (53%)$
`11(32%)1
`6 (18% )*
`
`Quiescent
`
`31
`13/18
`48(20-80)
`8 (0.6-23)
`1 (1-3)
`0
`
`2 (7%)
`26 (84%)
`3 (9%)
`
`5 (16%)
`6(19%)
`3 (10%)
`5 (16%)
`2 (6%)
`0
`
`*=data expressed as median (range); t =significantly different from quiescent total colitis (p<0.01); #=significantly different from quiescent
`distal colitis (p<0.01); §=significantly different from quiescent distal colitis (p<0.05); NS= not significant.
`
`which they indicated the presence or absence of six
`symptoms related
`to defecation. These were:
`(1) urgency (an irresistible and urgent desire to
`defecate), (2) feeling of incomplete evacuation (a
`strong and persistent desire to evacuate after defeca-
`tion), (3) tenesmus (continual inclination to evacuate
`bowels accompanied by painful straining), (4) pain
`(lower abdominal or rectal pain, with or without any
`relation to defecation), (5) perianal soreness (intense
`discomfort or itching of the perianal skin), (6) faecal
`incontinence (inability to control defecation volun-
`tarily resulting in leakage of motions and/or soiling of
`garments). A clear explanation of each symptom was
`provided at the time of the interview.
`In addition, all patients were asked if their stools
`were predominantly loose, formed or hard, if they
`were associated with blood and mucus, and if they
`had to wake up at night to defecate. Their average
`daily bowel frequency was also recorded.
`
`STATISTICAL ANALYSIS
`The differences in the stool consistency and in
`the prevalence of symptoms between active and
`quiescent disease were analysed using x2 tests. Data
`on stool frequency were compared by Wilcoxon's
`rank-sum tests.
`
`Results
`
`PREVALENCE OF SYMPTOMS
`The prevalence of the six bowel symptoms in patients
`
`with ulcerative colitis is shown in the Table. Patients
`with active disease exhibited a higher prevalence
`of urgency, a feeling of incomplete evacuation,
`tenesmus, pain, anal soreness and faecal incontin-
`ence, compared with patients with quiescent colitis.
`The prevalence of these symptoms did not vary
`significantly with the extent of the disease (Table).
`Fourteen patients (women =12, men = two) with
`active colitis reported faecal incontinence. All except
`two (one woman, one man) were over 60 years of
`age.
`
`STOOL PATTERNS
`As would be expected, the frequency of defecation
`was higher in patients with active than quiescent
`colitis, irrespective of the extent of the disease
`(Table). Eighty three per cent of patients with active
`colitis were defecating more than three times a day.
`No patient with quiescent colitis experienced this
`degree of stool frequency. Nocturnal defecation was
`reported by 81% of patients with active total colitis
`and 56% of patients with active distal colitis, but by
`none of the patients with quiescent colitis. There
`was no significant difference in the prevalence of
`nocturnal defecation between patients with total and
`distal colitis.
`Ninety six per cent of patients with active colitis
`passed blood and mucus in their stools every day. In
`contrast only 8% of patients with quiescent disease
`occasionally passed blood and 12% occasionally
`passed mucus in their stools.
`
`

`

`344
`
`Rao, Holdsworth, and Read
`
`Although the proportion of stools which were
`unformed was significantly higher in patients with
`active than quiescent colitis (Table), many patients
`with active disease passed formed or hard stools.
`A higher proportion of patients with active colitis
`(27%) than quiescent colitis (8%) reported that their
`stools were hard (p<0.05), and this was true in both
`distal colitis and total colitis, although in the case of
`total colitis this did not reach statistical significance
`(Table). Two of four patients with active proctitis and
`one of three with quiescent proctitis voided hard
`stools. The hard stools of active colitis were always
`accompanied by blood and mucus and were associ-
`ated with symptoms of tenesmus and a feeling of
`incomplete evacuation.
`
`Discussion
`
`Although most patients with active colitis had
`increased stool frequency and were voiding blood
`and mucus in their stools, the results of stool
`consistency were surprising. Twenty eight of 60
`(47%) patients with active colitis reported they were
`passing formed stools and in as many as 16 (27%)
`patients, the stools were hard. This shows that liquid
`diarrhoea is by no means a constant feature of active
`colitis. Instead, the passage of hard stools suggests
`that by this criterion at least a sizeable proportion of
`colitics are constipated. The observation that the
`passage of hard stools was more common in patients
`with active than quiescent colitis suggests that in
`some patients hard stools are an index of disease
`activity. The existence of constipation in ulcerative
`colitis is supported by previous observations'-s"" but
`the frequency with which this occurs and its relation-
`ship to the extent and activity of inflammation has
`never been assessed prospectively. A large survey of
`450 patients published recently, has reported that
`only 3.5% of patients with colitis have constipation at
`the time of presentation.14 In this survey, the patients
`were asked to record their bowel habit as `normal',
``diarrhoea', or `constipation'. This form of assess-
`ment is unlikely to provide a clear picture, as most
`patients with colitis are often distracted by the
`frequent passage of blood and mucus.° If frequency
`of defecation is the sole criterion used, then the
`occurrence of constipation will be overlooked.
`The prevalence of important symptoms related to
`defecation has hitherto not been documented in
`patients with colitis. An urgent desire to defecate and
`a feeling of incomplete evacuation were reported by
`80-90% of patients with active colitis and by 10-15%
`of patients with quiescent colitis. Tenesmus was
`reported by 63% of patients indicating that painful
`straining during evacuation is an important and
`frequent manifestation of active colitis. The preval-
`
`ence of these and other symptoms assessed were
`similar in patients with total and distal colitis,
`suggesting that they are related to an inflamed distal
`colon. Tests of anorectal function have shown that
`the rectum in patients with active colitis is hyper-
`sensitive's (unpublished data), poorly compliant'
`and reacts excessively to intraluminal distension
`(unpublished data); features that could explain the
`symptoms of urgency and increased frequency of
`defecation.
`The occurrence of nocturnal defecation and faecal
`incontinence invariably suggests active disease, as
`they were absent in patients with quiescent colitis.
`Eleven of 14 patients with incontinence were
`elderly women, and this group of the population has
`been shown
`to be particularly susceptible to
`incontinence."
`Symptoms of increased bowel frequency, pain
`relieved by defecation, a feeling of incomplete
`evacuation and passage of mucus have been reported
`to favour a positive diagnosis of irritable bowel
`syndrome.'9 As these symptoms are commonly
`present in colitics, we agree with others2' that it is not
`possible to distinguish patients with functional bowel
`disturbance from those with organic bowel disease on
`the basis of these symptoms alone.
`We have recently shown that patients with active
`colitis void small volume stools frequently, and have
`stasis in the proximal colon and rapid transit through
`the rectosigmoid region, irrespective of the extent of
`colitis.12 Our present study shows how these changes
`in colonic function may be related to the symptoms of
`active disease, the proximal colonic stasis causing
`hard stools, and the irritable distal colon causing
`the more widely recognised frequent defecation,
`urgency, tenesmus, and a feeling of incomplete
`evacuation.
`
`Dr S S C Rao is supported by a grant from the Special
`Trustees of the Former United Sheffield Hospitals.
`
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`
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