Diagnostic criteria for the irritable
bowel syndrome
Johann Hammer a and Nicholas
J. Talley
bA,
Australia
-
The Rome criteria for IBS
-
Are the Rome criteria valid?
-
Studies comparing gastrointestinal
symptoms in IBS and organic diseases
-
Studies using factor
analysis
-
Overview of the Rome diagnostic
criteria
-
Abdominal pain or discomfort plus altered
defecation
-
Abdominal pain or discomfort relieved
by defecation
-
Abdominal pain associated with a change
in the frequency or consistency of stool
-
Altered stool frequency
-
Altered stool form
-
Altered stool passage
-
Passage of mucus
-
Bloating and visible
distension
-
Criticisms of the Rome
criteria
-
Can the Rome criteria be
simplified?
-
Conclusion
-
References and Notes
Abstract
The Rome criteria represent a consensus viewpoint based on currently available
data, but their development certainly does not establish that the content
is truly indicative of a specific disease process. There is a limit to the
repertoire of gastrointestinal symptoms; because of the low specificity of
symptoms, it is understandable that symptoms alone are unlikely to be accurate
enough. However, in the absence of a reproducible and accepted biological
marker, symptoms currently remain the primary means of identifying and recruiting
patients for research. All diagnostic criteria will continue to be controversial
until the pathophysiology of irritable bowel syndrome (IBS) is better understood
and treatment more appropriately targeted to relevant disturbances. The aim
of this review is to present the current Rome criteria and critically evaluate
the arguments for and against the individual components being included as
part of the criteria.
There have been three Rome working team reports on diagnostic criteria for
the irritable bowel syndrome (IBS). The first report in 1988
1 was subsequently
modified when a second Rome working team proposed a classification for all
of the functional gastrointestinal disorders.
2
A further update of the Rome
definition was published in 1992. 3,3a
3,3a Another consensus conference took
place in Rome in June 1998 with the aim to refine the current diagnostic
criteria. These were published only recently. The aim of this review is to
present the original Rome criteria and critically evaluate the arguments
for and against the individual components being included as part of the
criteria.
The Rome criteria for IBS
The Rome criteria 3,3a
3,3a are summarized in an accompanying
article. The Rome I criteria (1992) recommend the diagnosis of IBS only in
the presence of the main diagnostic criteria, that is, abdominal pain or
discomfort associated with chronic altered bowel habit and two or
more of the supportive criteria. In contrast, the Rome II working team (1998)
recommends that the diagnosis of IBS be based on the presence of two of the
three main diagnostic criteria alone. The supportive criteria may then be
used to further classify IBS into diarrhea-predominant or
constipation-predominant.
The Rome Criteria for Irritable Bowel Syndrome:
-
Abdominal Pain/Discomfort Relieved by
Defecation
-
Abdominal Pain/Discomfort Associated with Change in Stool
Frequency
-
Abdominal Pain/Discomfort Associated with Change in Stool
Consistency
-
Altered Stool Frequency; Altered
Stool Form; Altered Stool Passage;
Passage of Mucus;
-
Bloating or Feeling of
Distension
The Manning Criteria for Irritable Bowel Syndrome:
-
• Pain relieved by defecation
-
• Looser stools at onset of
pain
-
• More frequent bowel movements at onset of
pain
-
• Abdominal distension
(visible)
-
• Mucus per
rectum
-
• Feeling of incomplete rectal
emptying
Are the Rome criteria valid?
Validity refers to the property that diagnostic criteria measure what they
purport to measure. Two different research approaches have been taken to
validate gastrointestinal symptoms in IBS. One set of studies has evaluated
the discriminatory value of gastrointestinal symptoms in IBS versus health
and organic disease. These studies compared gastrointestinal symptoms in
patients identified as having IBS with patients who were diagnosed to have
organic gastrointestinal diseases ( Table
1 ). Although none of the available studies
measured the validity of the Rome criteria, all used the gastrointestinal
symptoms either described by Manning et al
4 or Kruis et al
5 on which the Rome criteria are based.
Another set of studies have attempted to establish whether gastrointestinal
symptoms constitute a true ''syndrome of IBS''; they have applied factor
analysis, a statistical method used to determine whether there are symptoms
that distinctly group together in the population and are consistent with
the Rome criteria
| Table 1. Results of Studies Comparing Gastrointestinal
Symptoms in Irritable Bowel Syndrome (IBS) and Organic Diseases |
|
|
No study has attempted to determine whether the Rome criteria are of value
in discriminating IBS from organic disease. Indeed, the literature on the
discriminatory value of gastrointestinal symptoms in organic colonic disease
is very limited. The available literature suggests that the Manning criteria
can discriminate IBS from health or upper gastrointestinal tract conditions
but does not provide convincing evidence that the criteria can discriminate
IBS from organic disease of the colon. This should not be interpreted to
mean that the symptoms comprising the criteria for IBS are invalid; rather,
it suggests that they are not specific for IBS.
Overview of the Rome diagnostic criteria
Abdominal pain
or discomfort plus altered defecation
The current Rome criteria require that abdominal pain and disturbed
defecation must both be present for the diagnosis to be made.
3 This differs from an earlier version of
the Rome criteria, which allowed bowel disturbance without pain to constitute
IBS. 1 The change represents a conservative
approach, as there is currently widespread agreement that abdominal pain
is a sine qua non of IBS. The change also reflects the view of the Rome Committee
that patients with functional diarrhea and functional constipation (where
IBS criteria are not fulfilled) represent distinct conditions, a viewpoint
that itself is controversial. The current Rome criteria do not give a specific
definition of abdominal pain or discomfort, and thus the criteria may be
subject to personal interpretation.
Abdominal pain
or discomfort relieved by defecation
This symptom represents one of the key items identified by Manning
et al. 4 They showed that 81% of IBS patients
had pain relief by defecation compared with only 30% with organic disease.
Subsequent studies have consistently shown that pain relieved by defecation
occurs less frequently in IBS but was significantly associated with the syndrome.
[6] [7]
[8] [9]
[10] However, any colonic pain may be
relieved by defecation. Indeed, in inflammatory bowel disease this occurs
as frequently as it does in IBS.
11
Abdominal pain
associated with a change in the frequency or consistency of
stool
A change in stool frequency or consistency, or both, represents separate
diagnostic criteria in the current Rome classification. Manning et al
4 showed that looser stools at pain onset
and more frequent stools at pain onset were both strongly associated with
IBS, and this has been confirmed by other clinical and factor analysis studies.
[6] [7]
[8] [9]
[10]
[11]
[12]
[13]
[14] However, the Rome criteria do not
only specify a diarrhea-predominant change but also include a constipation
type change (i.e., less frequent or harder stools). Heaton et al have identified
that changes in stool form, reflecting both slow and fast mouth-to-caecum
transit times, have a link to IBS. 22
Certainly, there is a strong clinical impression that when patients report
erratic bowel habit, they frequently are experiencing looser or more frequent
stools initially, which is then followed by a period with no bowel movements
or harder stools. However, the diagnostic value of a constipation type change
is unclear, as the studies that have evaluated this change have failed to
identify the symptoms as having any clear discriminatory value.
19,23
19,23 It could therefore be argued that
the Rome criteria should be modified
accordingly.
Altered stool
frequency
An increase or decrease in stool frequency is one of the Rome criteria.
The definition of altered frequency for research purposes was based on the
95% confidence limits around normal stool frequency reported in the general
population. 24 As less than 5% of people
have more than three bowel movements a day or less than three bowel movements
a week, this was considered a suitable research criterion cut-off. As no
better definition has been offered from research studies to date, this seems
reasonable. However, changes in stool frequency do not discriminate between
IBS and inflammatory bowel disease.
11
Altered stool
form
Loose or watery stools, or lumpy or hard stools, do occur in patients
with IBS and may be reported to occur alternately. Observable changes in
stool form have been linked to IBS. 22
There is a correlation of stool form and mouth-to-anus transit time,
25 as well as colonic transit time.
26 Looser stools were also identified
in one study to add additional discriminatory power to the original six Manning
symptom criteria.
6
Altered stool
passage
Straining, urgency, or feelings of incomplete evacuation are included
as one of the Rome criteria. Feelings of incomplete rectal emptying have
been confirmed to occur more frequently in IBS than in organic disease.
11 Urgency frequently accompanies other
diarrhea type symptoms in IBS and for this reason was included. However,
both urgency and straining remain more controversial inclusions, as these
symptoms have not been identified to be of discriminatory value to
date.
Passage of
mucus
Mucus per rectum may be an underestimated symptom in clinical practice.
If patients are specifically asked, up to 60% with IBS will report this
occurring. 8,11
8,11 This symptom has been shown to be
of discriminatory value in IBS versus organic disease but probably does not
discriminate from colonic diseases, such as inflammatory bowel disease.
11
Bloating and
visible distension
In the original study by Manning et al,
4 visible abdominal distension was an indicator
of IBS, but bloating alone was not. Abdominal distension was also more common
in IBS patients when compared with inflammatory bowel disease.
11 The Rome criteria broadened this approach
based on the clinical impression that bloating is a frequent symptom that
accompanies other IBS complaints. The discriminant value of bloating without
visible distension is, however, uncertain.
In addition to continuing uncertainty about the value of the individual symptom
items, a number of potential criticisms of the current criteria need to be
considered. First, there has been some confusion regarding which of the Rome
criteria should be applied. In particular, the change to requiring abdominal
pain be present remains controversial; whether IBS can exist in the absence
of abdominal pain is unsettled. However, the current criteria are conservative.
This is consistent with one of the major goals of the Rome criteria, which
is to reduce patient heterogeneity in order to enhance the prospects for
identifying relevant pathophysiologic disturbances and efficacious
therapies.
The Rome criteria do impose constraints including the percentage of time
that a symptom needs to be experienced to be considered as diagnostic. Although
these are arbitrary, the limits were chosen to reflect those individuals
who were at least two standard deviations above the normal mean. This again
represents a conservative approach; more appropriate cut-offs may become
apparent as further knowledge of the epidemiology and natural history of
IBS accumulates.
The criteria could also be criticized because they are not all inclusive
and other primary diagnostic symptoms might be considered. For example, it
has been suggested that postprandial pain or postprandial urgency or diarrhea
are symptoms that should be included as part of the definition based on clinical
impressions. Lower abdominal tenderness and lower abdominal bloating is also
often seen in clinical practice in patients with IBS. The value of changing
the criteria accordingly will depend on data accumulating that this is
appropriate, but factor analysis studies do not in general support these
additional symptom items. [14]
[15]
[16]
[17]
[18]
[19]
[20]
[21]
The time frame defined as at least 3 months of continual or recurrent symptoms
is arbitrary and may be confusing. For example, one could interpret the time
frame to mean either a temporally contiguous period of symptoms lasting at
least 3 months or a total, but not necessarily contiguous, period of 3 months.
Definitions of continual or recurrent have not been provided by the Rome
Committees, and if inappropriately interpreted, this may lead to noncomparable
patients being enrolled in clinical studies.
It is also unknown whether the Rome criteria have the same diagnostic value
in men as in women. 27 The diagnostic
value of the Manning criteria, for example, has been shown in one study to
be of no value in men, 28 and women were
twice as likely to fulfill the Rome criteria
29 or the Manning criteria
30 in random population samples. Talley
et al 6 noted that the Manning criteria
were most useful in young women. In contrast, Poynard et al
7 did not observe any difference in the
sensitivity and specificity of the Manning criteria in men and women. In
a study of 156 patients with IBS, 31 mucus,
feeling of incomplete evacuation, abdominal distension, and scybala were
reported significantly more frequently by women than by men with IBS, although
pain relieved by defecation and pain associated with a change in stool frequency
and stool consistency were similar in both sexes.
31 Why gastrointestinal symptoms may have
different predictive values in men and women remains to be determined.
27
In a recent report of a population-based study in a Swedish municipality,
the diagnostic agreement for IBS, defined according to Manning (abdominal
pain plus greater than or equal to two of six symptoms in the definition),
Rome (modified), and a simple (Swedish) definition (any abdominal pain or
discomfort combined with self-reported diarrhea and/or constipation), was
analyzed. 32
The overall agreement of the Swedish definition for the identification of
IBS compared with the standard IBS definitions was 96% (Rome vs Swedish)
and 90% (Manning vs Swedish), respectively. The overall agreement between
the Manning criteria and the Rome criteria was 94%. Thus, based on this report,
it may be possible to greatly simplify the definition of IBS for epidemiologic
studies and in clinical practice.
The Rome criteria represent a consensus viewpoint based on currently available
data, but their development certainly does not establish that the content
is truly indicative of a specific disease process. The validity of the Rome
criteria in discriminating IBS from organic disease has not been determined.
There is a limit to the repertoire of gastrointestinal symptoms; because
of the low specificity of symptoms, it is understandable that symptoms alone
are unlikely to be accurate enough. However, in the absence of a reproducible
and accepted biological marker, symptoms currently remain the primary means
of identifying and recruiting patients for research. Certainly, the Rome
criteria have standardized the field and promoted clinical research. Their
development has been welcomed by regulatory agencies and the pharmaceutical
industry despite the criticisms that have been engendered. All diagnostic
criteria will continue to be controversial until the pathophysiology of IBS
is better understood and treatment more appropriately targeted to relevant
disturbances.
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