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Impact Report
The Challenges of Diagnosis and Treatment

Diagnostic Guidelines for IBS Are Used Inconsistently
Currently, ROME II criteria, primarily implemented in epidemiologic and clinical research studies, provide guidance on identifying appropriate patients for irritable bowel syndrome (IBS) clinical trials.44 The ROME III criteria are under development (www.romecriteria.org) and represent ongoing efforts to refine this definition. Additionally, the evidence-based medicine consensus on IBS published by the American College of Gastroenterology (ACG) provides a practical symptom-based approach to IBS diagnosis using criteria outlined by ROME. The evidence reviewed supports the fact that, when followed, a symptom-based approach is reliable: IBS patients who do not have alarm symptoms (such as recurring fever, family history of colon cancer) are not more likely than people without IBS to develop most organic (structural) diseases.9

Despite the current recommendations for a step-wise, symptom-based approach to making a positive IBS diagnosis45,46 (compared with conducting exhaustive tests to exclude other possible causes), physicians generally do not use the diagnostic criteria consistently and often struggle to make a diagnosis in everyday clinical practice.

Patients with IBS often endure symptoms for months or years before consulting a health care provider. In the Gastrointestinal (GI) Sufferer Study, women reported that about 1.9 years elapsed from the time their symptoms began to the time they visited a health care professional. After reporting their symptoms, almost 10 months (0.8 years) passed before they received an official diagnosis. This may in part be due to patients’ symptoms initially not being recognized as a serious medical condition, or this may be due to the overlapping nature of the symptoms associated with other GI disorders. In total, 2.7 years elapsed from the emergence of IBS symptoms to the delivery of a formal IBS diagnosis (Fig. 12).

On average, 2.7 years elapse from the time women with IBS notice symptoms to the time they receive an official IBS diagnosis (GI Sufferer Study: women only; all IBS subtypes).

This underscores the need for an aggressive and comprehensive professional and patient education effort reinforcing the availability and utility of a symptom-based approach to simplify IBS diagnosis.

After Diagnosis, Women with IBS Encounter Significant Barriers to Obtaining Effective Treatment
Although patients hope their symptoms will be relieved once a formal diagnosis of IBS is made, their expectations are often left unmet. Frustrated by persisting symptoms after trying various medications, women with IBS often find themselves switching health care providers in their continual quest for relief.42

Women in the GI Sufferer Study commonly described difficulty gaining adequate relief of symptoms. More than one quarter of patients consulted 3 to 4 physicians for their condition (Fig.13). More than three quarters reported seeing more than 1 physician for their IBS symptoms.

Figure 13. Women typically consult more than 1 physician regarding IBS symptoms (GI Sufferer Study: women only; all IBS subtypes).

IBS patients frequently consult alternative medicine providers to help them manage their symptoms. For example, a recently conducted survey of 96 patients with IBS (67 women, 29 men) evaluated the use of alternative medicine for IBS symptoms.13 Findings revealed that 16% of survey responders had consulted an alternative medicine practitioner such as a homeopath, herbalist, osteopath, or acupuncturist. This shows that the actual number of health care professionals from whom IBS patients seek help may be underestimated.

Women with IBS Try Many Treatment Options in Their Search for Relief
The incomplete relief achieved with treatment options often drives IBS patients to attempt to self-manage their condition. Commonly used GI medications, such as laxatives/fiber supplements and antidiarrheals, are generally indicated for disease states other than IBS and are prescribed to treat a single symptom such as constipation or diarrhea.47 The ROME II criteria and the ACG consensus on IBS stress that the goal of IBS therapy is improvement in global IBS symptoms, including abdominal pain/discomfort, bloating, and altered bowel habits. They reinforce the concept that treating the bowel habit alone without addressing other symptoms is a suboptimal approach.9

Collectively, respondents to the International Foundation for Functional Gastrointestinal Disorders (IFFGD) survey reported using a total of 281 different treatments to control IBS symptoms including dietary and herbal supplements as well as prescription and overthe- counter (OTC) medications. Prescription drugs were used by 90% of people with IBS; OTC laxatives and OTC antidiarrheals were taken by 79% and 65% of survey respondents, respectively.25

In the GI Sufferer Study, women with IBS with constipation took a remarkable variety of medications—including prescription and OTC laxatives/fiber supplements, anti-anxiety agents, and antidepressants—to help alleviate their symptoms. An average of 1.9 prescription and OTC medications were used in the previous 12 months (by both the women and men surveyed). The sheer variety of agents strongly suggests that no single agent relieves the multiple symptoms of IBS. Women surveyed also reported using numerous nondrug approaches such as relaxation techniques and natural remedies. Most commonly, they used OTC medications (66%) and dietary modifications (60%) (Fig. 14).

Figure 14. Women with IBS with constipation used a variety of IBS treatments during a 12-month period (GI Sufferer Study: women only; IBS with constipation).

Patients with IBS with Constipation Are Generally Dissatisfied with Treatment
IBS patients were largely dissatisfied with the effectiveness of agents in alleviating their symptoms. In the IFFGD survey, fewer than one third of participants reported that they were satisfied with these medications or remedies. Dissatisfaction related primarily to lack of efficacy. Figure 15 depicts the percentages of IBS patients (current medication users) rating prescription and OTC medications as ineffective or somewhat effective.25

Many IBS patients are dissatisfied with the relief achieved with OTC or prescription medications. Percentages refer to efficacy ratings by current medication users, discussed on page 20 of full report (IFFGD survey: women and men [women-only data were not available]; all IBS subtypes).

In the IBS Medications Side Effects Study, the majority of patients were either not satisfied or somewhat satisfied with the symptom relief achieved with available prescription and OTC medications (Fig. 16). Patients gave particularly low satisfaction scores to products commonly used to treat IBS with constipation, including OTC laxatives/fiber supplements, prescription laxatives, and OTC stool softeners. While many patients find relief of individual symptoms from available medications, the data demonstrate that patients with IBS with constipation still have a need for relief of multiple symptoms.

Patients with IBS with constipation vary in their satisfaction ratings for prescription and OTC medications (IBS Medications Side Effects Study: women and men [women-only data were not available]; IBS with constipation).

Adverse effects of medications commonly contribute to patients’ dissatisfaction with therapy. Although most therapeutic options have positive benefits for some patients with IBS, they typically only relieve individual symptoms or are used to treat only one subtype of IBS. Further, some medications taken to relieve a single symptom can be associated with adverse effects that aggravate or mimic existing IBS symptoms. For example, while fiber products can be effective for treating IBS-related constipation, for some people a diet high in fiber (>20 g/day) can worsen or can cause bloating or gas.8 Tricyclic antidepressants and antispasmodics can make symptoms worse in those with constipation because of the anticholinergic side effects.9

Sixty-two percent of IFFGD survey respondents taking prescription drugs reported adverse effects of their medication. Almost half of these patients (45%) viewed the medicationrelated adverse effects as moderate or severe. Surveyed prescription drug users reported at least one of the following adverse effects: constipation, gas, cramps, bloating, nausea, change, weakness, dizziness, drowsiness, dry mouth, weight change, headache, or drive.25 Some of these medication-related adverse effects mirror IBS symptoms.

In the IBS Medications Side Effects Study, many of the IBS patients with constipation experienced adverse effects from medications, including abdominal cramping, bloating, drowsiness, and dizziness. For example, approximately 60% of survey respondents taking OTC laxatives (n = 112), prescription laxatives (n = 59), or prescription antidepressants (n = 87) and close to 70% of patients taking prescription anti-anxiety medications (n = 88) experienced adverse effects. Additionally, nearly 40% of respondents taking OTC fiber supplements (n = 263) and 50% of patients taking prescription antispasmodics (n = 189) also reported adverse effects. Most of the survey respondents considered these adverse effects to be mild or moderate. A limitation of these findings is the fact that the degree to which these reported adverse effects were truly caused by the medications could not be assessed.



Foreword
Preface
Introduction
Patient and Physician Surveys
The Physical Impact of IBS
IBS and Quality of Life
The Economic Impact of IBS
The Challenges of Diagnosis and Treatment
Bridging the Gap Between Patients and Physicians: A Prerequisite for Progress
Educational Needs: Many Gaps
Conclusion
Appendix
References
Adivsory Panel
About the Society for Women’s Health Research
Board of Directors
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