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Medical diagnosis generally requires observed anatomical or physiological abnormalities. Description of the illness and criteria for its diagnosis follow naturally. Recognized symptoms can then be attributed to the observation, and a diagnosis predictably follows. In the case of the functional disorders, such a process is impossible. As there are no observed defects, we only know of the existence of these disorders through the words of our patients. Hence there can be no animal model. Parrots may talk, but are not likely to discuss their bowels. The need to define these disorders of unknown pathology represents a major paradigm shift, a substantial change in thinking for doctors whose training concentrates on basic science and palpable evidence. As more than half of the gut disorders encountered by gastroenterologists and primary care doctors are functional, we must face the reality that scientific evidence to explain these disorders does not exist, and develop alternative methods to identify disease.
For too long, functional diseases have been described by what they are not, rather than as real entities. Yet they are real enough to our patients. Not only does this exclusive approach fail to provide the patient with the dignity of a diagnosis, but it also generates needless tests and consultations. The fruitless pursuit of an anatomical cause renders functional disorders diagnoses of exclusion. Their very numbers and cost demand a more positive approach.
There are many references to gut dysfunction in the ancient and early European literature. However, the first credible English language descriptions of irritable bowel syndrome (IBS) appeared in the early 19th century. One such description of the IBS in 1818 drew attention to the three cardinal symptoms of IBS; abdominal pain, “derangement of. . .digestion” and “flatulence.”1 A few years later, Howship described a “spasmodic stricture” of the colon reflecting the enduring, but still unsubstantiated belief that functional gut disorders are somehow the product of gut spasm.2 Mid century brought more sophisticated treatises (and very unsophisticated cures such as purging and “electrogalvanism”). In 1849, Cumming asks incredulously: “the bowels are at one time constipated and at another lax in the same person. . .how the disease has two such different symptoms I do not propose to explain.”3 Were Dr Cumming to return to a modern consensus meeting, he would discover that this enigma remains unexplained! Cumming’s treatise contained one other comment in line with modern thinking about IBS, “One can tell, without more minute examination what the nature of the complaint is.” The authors of this supplement agree with Cumming’s notion of a positive diagnosis, even though many doctors persist in recognizing IBS and the other functional gut disorders only after the patient has undergone extensive investigation.
Medicine’s understanding of the IBS progressed little during the next 120 years. Indeed, it may have lost ground! In Edwardian times, functional disorders were considered diseases of the wealthy. In fact, only the affluent could afford to be the patients of the Harley Street doctors who published their observations in the medical literature.4 Through the writings of Metchnikoff and Arbuthnot Lane, constipation became associated with uncleanness.5 The quaint notion of “autointoxication” resulting from colon contents prompted an urge to purge that persists to this day. In the 1920s and 1930s pejorative descriptors such as “psychogenic,” “neurogenic,” and “The Abdominal Woman”6 did little to help patients with functional gut disorders. Proctalgia fugax was long thought to be a disease of young professional men, because only doctors had the temerity to describe their symptoms in letters to the editor of theLancet.7 Use of terms such as “spastic colitis” and “hyperacidity” inferred etiologies that do not exist for these disorders.5
The first systematic attempt to bring discipline to this area was a 1962 retrospective review of patients with IBS seen at Oxford by Chaudhary and Truelove.8 From this experience, the authors were able to report many of the features that we recognize as those of the IBS (or the irritable colon syndrome as they termed it). They even separated IBS from what we now call functional diarrhea, and noted that one quarter of their patients’ complaints began with an enteric infection. Their report ushered in a new era, and scientific publications on functional disorders increased rapidly thereafter (fig1).
The first attempt to classify all the functional gastrointestinal disorders appears in the index of my book The Irritable Gut, published in 1979.9 In 1978, led by Ken Heaton, Adrian Manning and I reported results obtained by questionnaire administered to Bristol outpatients with abdominal pain and disordered bowel habit.10 The six of 15 symptoms we found more common in the IBS than organic gut disease (as determined by a chart review a year later) are now known as the Manning Criteria. (see C. Functional bowel disorders and D. Functional abdominal pain in this supplement). In 1984, Kruis and colleagues from Germany reported a similar study.11 Their report recalls the three cardinal IBS symptoms of pain, bowel dysfunction, and flatulence mentioned by Powell in 1818. If all three were present, IBS was highly likely. Kruiset al stressed chronicity and other symptoms as well, but their major contribution was to quantitate the alarm symptoms that should alert the physician to organic disease. These two discriminant function studies in addition to epidemiologic data provided by Drossman12 and Whitehead13 are the basis of the Rome criteria.
The inspiration for the Rome criteria followed the 12th International Congress of Gastroenterology held in Lisbon in 1984. I chaired one of the earliest international symposia on the IBS, and my panel and the organizers of the Congress were astonished that despite untranslated presentations in three languages, the attendees far outstripped the capacity of the assigned room. One of the panel members was Professor Aldo Torsoli, an organizer of the next international congress to be held four years later in Rome. Over coffee in Portugal, we discussed the need for guidelines for the diagnosis and study of IBS. A working team was set up to produce such guidelines for the next congress.
Delighted at the opportunity to chair this working team, I corresponded with Doug Drossman (USA), Ken Heaton (UK), Gerhard Dotteval (Sweden), and Wolfgang Kruis (Germany) for two years. In 1987, we met in Rome to debate a draft proposal and reach consensus on definitions. The penultimate draft was sent to 16 noted colleagues in seven countries. Their comments and suggestions were considered by the working team, and the first Rome criteria were presented at the 13th Congress in Rome in 1988. They were published the following year.14
Following that Rome meeting, Doug Drossman, who was a member of the Rome Working Team, was invited by Professor Torsoli and Enrico Corazziari to set up another committee to look at subgroups of IBS. As a result of their discussions, the project was expanded to include all the functional gastrointestinal disorders. This working team, which included most of the editors of this supplement, met in Rome to classify the functional gastrointestinal disorders into 21 entities in five anatomical regions of the gut.15
Having achieved generous sponsorship, Dr Drossman organized a succession of working teams that further developed these criteria in the five anatomical regions (esophageal,16gastroduodenal,17 biliary,18 and anorectal19) and discussed topics related to functional gut disorders. In 1994, their collective work was updated and published in The Functional Gastrointestinal Disorders: Diagnosis, Pathophysiology and Treatment; A Multinational Consensus. 20
While this work is now known as Rome I, it includes the second rendition of the Rome IBS criteria. The new functional bowel working team published some revisions to the 1988 IBS criteria in 1992. Pain became a requisite for the diagnosis, and duration parameters were added.21
The Rome criteria have generated much energy and controversy. They are imperfect. Validation studies are difficult and rare. Those interested in the condition possess disparate viewpoints: epidemiologists, primary care physicians, consultants, researchers, psychologists, physiologists, third party payers, and of course, the patients themselves. Nevertheless, the criteria have gained such currency that they are the basis for entry into most research studies of functional gut disorders and have compelled an accurate description of entered patients in the remainder. They are the industry standard for entry into clinical drug trials, although they are sometimes modified to suit the characteristics of the product to be tested. They have given these disorders, particularly IBS, a profile. Patients can now be reassured they suffer from a legitimate disorder, not symptoms rendered imaginary by a negative test. The criteria have created a language with which the above-mentioned groups can communicate. The coming together of such disparate constituencies in a common effort is a major achievement, due in no small way to this systematic recognition of the functional gut disorders.
This supplement culminates a new three-year effort to update the Rome criteria and like Rome I, owes much to the energy and drive of Doug Drossman. The mechanics of this process are described elsewhere, but more than Rome I, the Rome II process is generously supported by industry, and has attracted the interest and participation of many people in several disciplines from around the world. There can be no better testimony to the stature that the Rome criteria have achieved. However, Rome II is not the end, or even the beginning of the end. It is, at best, the end of the beginning of what promises to be an ongoing process that may last as long as knowledge of the pathophysiology of functional gut disorders eludes us. Meanwhile, here is a great need to generate data that will sharpen the criteria and validate their use. Discussions have begun for Rome III.
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