Digestive and Liver Disease
Volume 38, Issue 10 , Pages 717-723, October 2006

Irritable bowel syndrome: The burden and unmet needs in Europe

  • E.M.M. Quigley

      Affiliations

    • Alimentary Pharmabiotic Centre, Department of Medicine, National University of Ireland, Cork University Hospital, Wilton, Cork, Ireland
    • Corresponding Author InformationCorresponding author. Tel.: +353 21 490 1228; fax: +353 21 490 1228.
    • ,
  • P. Bytzer

      Affiliations

    • Department of Medical Gastroenterology, Glostrup University Hospital, Copenhagen, Denmark
    • ,
  • R. Jones

      Affiliations

    • GKT Department of General Practice and Primary Care, King's College, London, UK
    • ,
  • F. Mearin

      Affiliations

    • Institute of Functional and Motor Digestive Disorders, Centro Médico Teknon, Barcelona, Spain

Received 8 January 2006; accepted 10 May 2006.

Article Outline

Abstract 

Irritable bowel syndrome affects approximately 10–15% of the European population, although prevalence rates vary depending on the classification used and the country surveyed. This may be due to differences in patterns of medical care and diagnosis of the condition. Up to 70% of individuals with irritable bowel syndrome may not have been formally diagnosed. The disorder affects 1.5–3 times as many women as men and poses a significant economic burden in Europe, estimated at €700–€1600 per person per year. It also reduces quality of life and is associated with psychological distress, disturbed work and sleep, and sexual dysfunction. It is a chronic disorder, which affects many individuals for more than 10 years. Most patients are managed in primary care, although some are referred to gastroenterologists and other specialists. Patients with irritable bowel syndrome undergo more abdomino-pelvic surgery than the general population. We propose that a positive diagnosis of the condition may avoid the delay in diagnosis many patients experience. We conclude that, in Europe, there are significant unmet needs including lack of familiarity with irritable bowel syndrome, difficulties in diagnosis and lack of effective treatments for the multiple symptoms of the disorder. The development of pan-European guidelines for irritable bowel syndrome will benefit patients with this condition in Europe.

Keywords: Europe, Healthcare burden, Irritable bowel syndrome, Quality of life

 

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1. Introduction 

Irritable bowel syndrome (IBS) is a common sensory and motility disorder of the gastrointestinal (GI) tract, affecting approximately 10–15% of the Western population. However, only one third to two thirds of sufferers consult a physician depending on the severity of their symptoms [1], [2]. Patients with IBS experience chronic, episodic abdominal pain/discomfort, bloating and constipation and/or diarrhoea. IBS can be classified according to the patient's predominant bowel symptom: IBS with constipation (IBS-C), IBS with diarrhoea (IBS-D) and IBS with alternating constipation and diarrhoea (IBS-A). According to community-based US data, the prevalence of these subtypes is similar, with each accounting for approximately one third of the total [3], [4]. However, the distribution of these subtypes will differ depending on the specific population evaluated, the criteria used to define each subtype and the geographic location [5]. Although the pathophysiology of IBS is still incompletely understood, the onset of IBS symptoms has been linked to defects in the availability and signalling of serotonin (5-HT) in the GI tract. Blocking or activating key serotonin receptors has been shown to alleviate many of the symptoms of IBS-C and IBS-D. These observations have led us to the development of drugs specifically designed to modulate serotonin receptors in order to target the multiple symptoms experienced by IBS sufferers. A growing body of evidence has also linked acute episodes of gastroenteritis to the subsequent development of IBS (termed ‘post-infective IBS’) [6], [7]. However, currently it is unclear whether post-infective IBS constitutes a distinct IBS sub-group with a unique pathogenesis. More studies are needed to further understand the pathophysiology of post-infective IBS, particularly within the United States, as most studies to date have focussed on the prevalence of the condition in Europe.

IBS is associated with a substantial burden of illness, measured by its prevalence, morbidity and associated costs. Sufferers have impaired quality of life (QoL), increased rates of absenteeism from work and high levels of healthcare utilisation compared with non-sufferers [8]. Recent studies of IBS have improved our understanding of the high prevalence of this disorder and the substantial socioeconomic burden that arises due to direct and indirect costs. However, currently in the European Union (EU), there are no effective and well tolerated pharmacological therapies that treat the multiple symptoms of IBS [9], [10], [11]. This review focuses on the burden of illness associated with IBS in the EU and highlights the current unmet needs of both patients and physicians.

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2. Burden of illness 

2.1. The prevalence of IBS 

IBS affects hundreds of thousands of people across Europe, although there is wide variation in the reported prevalence between individual countries (4.0% in France [12], 5.8% in the Netherlands [13], 12.1% in Spain [14], 12.5% in Germany [15], 16.7% in the UK [16] and 28.0% in Croatia [17]). Two extensive community surveys were conducted in the United States and Europe to determine the prevalence, symptom pattern and impact of IBS. Results from the US survey revealed that 14.1% of the population had current symptoms of IBS [4], and this compares with a slightly lower European prevalence of 9.6% [8]. The two surveys that produced these data used similar study methodology, but there were marked differences between the sizes of the study populations’ surveyed. In the US survey, approximately 5000 individuals were screened, compared with more than 40,000 individuals in the European study. Comparisons of prevalence rates between studies can be difficult, as the different IBS diagnostic criteria that are often used [18] can influence the reported prevalence of IBS [19]. For example, the Rome II criteria [20] are more stringent than either the Manning [21] or Rome I criteria [22]. However, even when the same diagnostic criteria are applied, variations in IBS prevalence between individual countries persist, as demonstrated by the Hungin studies discussed earlier [4], [8] (Fig. 1). This may, in part, reflect differences in the healthcare-seeking behaviour of IBS sufferers and in the willingness of physicians to diagnose IBS in different countries [8]. Physician and patient awareness of IBS may also differ between countries.

IBS is reported approximately twice as frequently in women as in men, irrespective of the criteria used to define IBS, with female:male ratios ranging from 1.5:1 to 3.0:1 [16], [17], [23], [24]. This may be due partly to gender differences in healthcare-seeking behaviour and perception of IBS symptoms, and may also be contributed to by the observation that women are more likely to enrol in clinical trials than men [23]. Among IBS patients, pain-related symptoms are similar in men and women, but the passage of mucus, a feeling of incomplete evacuation and distension are less common in men. A lower rate of reporting of these symptoms in clinical studies may account for the apparently lower prevalence of IBS in men and may contribute to the reduced reliability of diagnostic criteria to detect IBS in men [25]. Symptoms of IBS are also more common in younger (under 55 years) than in older patients (55 years or over) [8].

2.2. The economic burden of IBS 

The economic impact of IBS is substantial [26]. IBS is associated with significant healthcare costs for both patients and healthcare providers. IBS patients meeting the Rome II criteria report a higher level of medical resource utilisation and poorer QoL than those exclusively meeting Rome I criteria [2], [27]. This is unsurprising given the greater disease severity implied by these updated criteria. Studies in the United States have shown that the severity of abdominal pain/discomfort is a significant predictor of healthcare use and costs for IBS sufferers compared with individuals without IBS [28].

Analyses of the economic burden of IBS include direct costs (physician visits, diagnostic testing, investigations, medical treatment, hospitalisations and prescription medications) and indirect costs (reduced productivity and loss of earnings due to illness). The annual direct and indirect costs of GI motility and sensory disorders in the eight most industrialised countries have been estimated to exceed US$ 40 billion, with indirect costs accounting for two thirds of the total [29].

However, the absolute economic burden of IBS is unknown, mostly due to insufficient data on a variety of indirect costs, as well as those intangible costs (pain, suffering and reduced QoL) that cannot be readily estimated, and the substantial number of undiagnosed IBS sufferers [30]. A study comparing the economic burden of IBS in four European countries (UK, Germany, Switzerland and Portugal) reported a substantial annual impact on medical resource use (approximately €700–€1600) [31] (Fig. 2). Although annual direct costs between countries were similar, there were substantial differences in indirect costs, largely due to variations in the number of illness-related days off work [31]. Direct comparison of the cost of IBS between the United States and Europe are difficult due to differences in healthcare funding. However, a study by Hahn et al. [32] revealed many similarities between healthcare resource use in the United States and UK. For example, hospitalisation rates and the number of visits to doctors surgeries and emergency rooms were similar in both the United States and UK, with only the number of visits to hospital outpatient clinics found to be significantly different between the two countries (mean utilisation determined to be 1.6 in the UK versus 0.9 in the United States, p<0.05). In addition, indirect effects of IBS on resource use were also similar between the two countries, with approximately 10% of patients citing IBS as the reason for dramatic changes in their working schedules and also their need to work from home.

In IBS patients, symptom severity correlates positively with both the total number of consultations (general practitioners and gastroenterologists) and the number of medications taken [33]. IBS patients frequently use a variety of over-the-counter and alternative therapies [34]. Consequently, they may incur expenses not usually accounted for in IBS-related cost analyses and may be exposed to an increased risk of experiencing adverse events by taking multiple medications [34]. Studies in France [35] and Germany [36] have shown that the main direct cost components of IBS are medical investigations (39%) and hospitalisations (22%). These costs may, in part, relate to the difficulties faced by many physicians in diagnosing IBS and the lack of effective agents to treat the multiple symptoms of IBS. The highest medical costs are associated with patients of older age, patients with severe pain and those with a deterioration in their QoL. The total impact of IBS, in terms of demand for physician time and healthcare costs (diagnostic tests and medications), is similar to that of well recognised conditions such as asthma and migraine [37].

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3. IBS: the burden on the patient 

IBS has a considerable negative impact on sufferers’ lives. It is associated with psychological distress, disturbance of work and sleep, and sexual dysfunction [8] (Fig. 3). Overall, IBS impairs QoL to a similar degree as other episodic, chronic disorders, with some specific health-related aspects being lower in IBS patients than in patients with gastro-oesophageal reflux disease [38], asthma and migraine [39] (Fig. 4). A study comparing QoL impairment in patients from the United States and Europe found that patients in Europe experienced significantly poorer QoL than patients in the United States [32]. Patients in Europe experienced significantly more sleep disturbances, lower energy, difficulties in daily life due to physical health and impaired sexual relations due to their disease compared with patients in the United States. A linear relationship has been observed between patient QoL and IBS symptom severity, with the most severe symptoms resulting in poorer QoL [40]. However, similarly severe IBS symptoms have been reported in both patient groups [41].

IBS is a chronic condition, and many patients experience symptoms for more than 10 years [42]. Although clinical diagnostic criteria are available, an estimated 70% of IBS sufferers are not formally diagnosed [8] (Fig. 1). This may represent patients’ reluctance to visit physicians about their IBS symptoms. Indeed, over one third of individuals with undiagnosed IBS do not consult a physician, stating that their symptoms are not serious enough to obtain medical help, or that they have learnt to live with their condition [8]. Individuals who formally seek medical care for IBS may report more severe symptoms (e.g. abdominal pain and visible abdominal distension) than non-consulters [43], may exhibit greater psychological disturbance (anxiety, depression and sleep disturbances) [44], [45] and have a poorer QoL compared with non-consulters.

Of those IBS sufferers who have obtained a formal diagnosis, the majority are seen by primary care physicians and less frequently by gastroenterologists [8]. Most IBS patients referred to secondary care in Europe have IBS-C, although IBS patients in the UK are more frequently referred because of IBS-D [46].

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4. IBS: the challenge for physicians 

Despite the fact that many IBS sufferers remain undiagnosed, IBS still accounts for a substantial proportion of primary care and gastroenterological consultations [24], [47]. Although most data on the burden that IBS places on physicians is derived from the United States [26], [30], [48], studies in Europe show that a substantial proportion of patients with IBS (28%) consult gastroenterologists about their symptoms [8]. A similar survey conducted in the United States found that 64% of patients in the US consulted a gastroenterologist. It is possible that differences in the accessibility of healthcare resources (nationalised health services such as the NHS in the UK may encourage more people to seek help for their IBS symptoms) could account for the differences in healthcare utilisation between Europe and the United States. IBS sufferers are often referred to gynaecology and surgical outpatient clinics and are more likely to undergo abdomino-pelvic surgery, such as cholecystectomy, appendectomy or hysterectomy [49]. In addition, IBS patients in primary care often report co-morbid conditions (e.g. mood disorder, health anxiety, neuroticism, adverse life events and reduced QoL) more frequently than non-IBS patients, further increasing the demand for healthcare resources [50].

The high level of healthcare utilisation may also be partly explained by patients often visiting several physicians before receiving a positive diagnosis of their IBS. IBS has traditionally been regarded as a ‘diagnosis of exclusion’ following extensive and often invasive medical testing to exclude other conditions that could present with similar symptoms, including life-threatening diseases such as colorectal cancer and inflammatory bowel disease. IBS diagnosis has also been shown to be based on a physician's own clinical judgement, established following specific experiences in a real-life clinical setting [8], [51]. Consequently, the diagnosis of IBS is often a challenge, and those unfamiliar with IBS may yield to patient pressure and refer them to a gastroenterologist and/or schedule invasive/exploratory tests.

The principle of positive diagnosis (considering IBS as a possible diagnosis from the initial consultation, rather than the conventional elimination-based diagnosis of IBS) has been supported by the American College of Gastroenterology [52] and the Consenso Latinoamericano [53] and was recently reviewed by Malagelada [54]. Using this approach, some diagnostic tests may be used to exclude certain diseases, such as colorectal cancer, inflammatory bowel disease and coeliac disease, in appropriate patient populations. These may include patients over the age of 50 years with new onset symptoms and patients of any age with ‘alarm features’ or a family history of GI cancer [52], [55], [56]. Alarm features can be identified through a review of the patient's medical history and the performance of a physical examination and some simple laboratory tests. They include recent weight loss, rectal bleeding, occult blood-positive stools, anaemia, persistent diarrhoea, severe constipation, fever, night-time symptoms, abnormal physical findings (such as an abdominal mass) and a family history of colorectal cancer, inflammatory bowel disease or coeliac disease [56].

Once a diagnosis of IBS has been confirmed, the management of this disorder may pose a further challenge to physicians. Patients with IBS deserve a clear explanation of their condition and may also require support for psychological issues. Although pharmacological treatments for IBS are available in the EU, robust clinical evidence of their efficacy and safety are lacking [9], [10], [11], [52]. Traditionally available therapies, such as antispasmodics, fibre and bulking agents, psychotropic agents [11], laxatives and antidiarrhoeals [57], are often unsatisfactory. They tend to focus on relieving a single symptom and can exacerbate existing symptoms. Non-pharmacological approaches to the management of IBS have also been studied and may prove effective. They include probiotics [58], [59], food elimination [60], behavioural therapy [61], hypnotherapy [62] and traditional Chinese medicine [63]. Physicians are, therefore, likely to see each IBS patient several times while attempting to find a satisfactory treatment regime. Depending on the physicians’ expectations, this may sometimes lead us to frustration at the lack of effective treatment options available and could potentially translate into a lack of enthusiasm when managing patients with IBS.

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5. Unmet needs of IBS 

A consideration of the burden of IBS on physicians and patients, as well as the economic impact, reveals several unmet needs. These are summarised in Table 1. Physicians and patients highlight similar issues: unfamiliarity with IBS as a medical condition, difficulty in making and obtaining a positive diagnosis and a lack of effective treatments.

Table 1. Unmet needs associated with IBS
Unmet needsSolutions
PatientsGreater awareness and understanding of IBS as a medical conditionPatient education schemes
Simple, non-invasive diagnostic proceduresDevelopment of an algorithm focussing on positive diagnosis
Affordable, readily available treatmentsContinued research and development into new treatments targeting multiple IBS symptoms

PhysiciansBetter understanding of IBS and its natural historyPhysician education programmes
Simple, effective diagnostic proceduresDevelopment of a practice-based algorithm
Treatment guidelinesDevelopment of pan-European treatment guidelines
Effective, well tolerated first-line treatmentContinued research and development into new treatments targeting multiple IBS symptoms

IBS sufferers who do not seek formal medical help are more likely to classify their symptoms as trivial compared with consulters [43]. There may also be a general lack of awareness of IBS as a distinct medical condition. Education programmes focussing on this disorder could raise awareness and encourage patients to consult physicians. If employers also implemented educational or incentive programmes, employees with IBS may be more productive at work, thus reducing costs due to absenteeism and presenteeism (impaired productivity at work) [48]. Such programmes have been shown to be successful in managing other long-term conditions, such as depression [64]. IBS sufferers report frustration in their ability to control symptoms, prevent episodes and identify triggers [65]. A greater understanding of IBS could help alleviate this frustration, with patients learning to cope by adjusting their lifestyle and thereby reducing the overall impact of IBS on sufferers’ daily lives.

Educational initiatives focussed on IBS may also benefit physicians. By raising their general awareness of the condition and emphasising that IBS is a genuine disorder, physicians may be more likely to consider a positive diagnosis of IBS at the time of initial presentation. However, as existing diagnostic criteria have been primarily developed for clinical research and are not particularly user-friendly for the busy clinician [66], [67], [68], a practice-based diagnostic approach should also be developed in conjunction with physician education programmes. This would also directly benefit patients who are often frustrated when trying to obtain a medical diagnosis [65]. Although specific treatment guidelines for diagnosing and treating IBS have been produced in the United States [47], [52], limited clinical practice guidance focussing on management of IBS is currently available in Europe [69]. A survey of Italian general practitioners found that while most were capable of recognising the cardinal symptoms of IBS, few were familiar with the Rome II diagnostic criteria [70]. Further questioning revealed that general practitioners considered the Rome II criteria to be too complex and more relevant for use by secondary care practitioners and clinical researchers. The development of pan-European IBS treatment guidelines would benefit both physicians and their patients.

Dissatisfaction exists with treatments for IBS that are currently available in the EU, with fewer than 25% of patients reporting complete relief of any specific symptom [8], [34]. Patients in the EU need clinically effective treatments that relieve their multiple symptoms, but no such therapies for IBS are currently available. As discussed earlier in this review, serotonergic agents have been shown to improve multiple symptoms in IBS patients. The 5-HT4 receptor agonist, tegaserod, is currently licensed in the United States as a treatment for the multiple symptoms of IBS-C patients, however, despite attempts to gain approval, it is not currently licensed for use in the EU. Another serotonergic agent currently not available for use in the EU is alosetron (a 5-HT3 receptor antagonist). Alosetron has been shown to improve stool frequency and consistency in patients with IBS-D, but following safety concerns, was limited to use by patients in the United States with severe symptoms. Although some therapies such as tegaserod are licensed in the United States, they are not currently available in the EU. Therefore, in order to target this clearly defined, yet still unmet need in the EU, effective IBS therapies need to be approved in order for physicians to be able to prescribe to their patients. A recently published article discussed the differences between the current licensing policies of the European Medicines Agency (EMEA) and its US equivalent, the FDA [71]. This article concluded that while both policies are fundamentally comparable (in that they both require that all new drugs have proven efficacy and safety profiles), more stringent regulatory requirements exist in the EU. Briefly, these include the need to differentiate between symptomatic therapeutic agents and disease modifying agents, and the stipulation that pivotal IBS trials should be designed to incorporate specific criteria, such as repeated treatment cycles. In addition, in contrast to the United States, healthcare provision in the EU is primarily the responsibility of national governments. As such, the EMEA may seek reassurance that costs associated with a newly introduced drug (particularly if the target disease is prevalent chronic and not life threatening) will be off-set by the advantages of prescribing the drug to treat symptoms.

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6. Conclusions 

IBS affects approximately 10–15% of the Western population. It is associated with a considerable economic burden, and sufferers have an impaired QoL. Patients and physicians are likely to benefit from education programmes aimed at providing a better understanding of IBS. There is also a need for a simple, practical and reliable diagnostic approach that can be applied in everyday clinical practice, and which will encourage physicians to positively diagnose IBS [54]. The development of pan-European guidelines that include the latest diagnostic criteria and emerging management options would benefit physicians treating patients with IBS in the EU. Patients with IBS are currently limited to therapies that target only one symptom and need new first-line treatment options that can relieve multiple symptoms associated with IBS. Effective therapies for IBS are essential for the cost-effective management of this highly prevalent disorder.

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Conflict of interest statement 

None declared.

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Acknowledgements 

The authors would like to acknowledge the editorial support and contribution of ACUMED® to this manuscript. ACUMED's contribution and this research were funded by Novartis Pharma AG.

Grant support: This paper was funded by Novartis Pharma AG.

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PII: S1590-8658(06)00201-5

doi:10.1016/j.dld.2006.05.009

Digestive and Liver Disease
Volume 38, Issue 10 , Pages 717-723, October 2006

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