Reports of “satisfactory relief” by IBS patients receiving usual medical care are confounded by baseline symptom severity and do not accurately reflect symptom improvement (original) (raw)
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Adequate relief in a treatment trial with IBS patients: a prospective assessment
The American journal …, 2009
BackgroundAdequate relief of IBS symptoms (IBS-AR) has been used as a primary endpoint in many randomized controlled trials of IBS and is considered by the Rome III Committee to be an acceptable primary endpoint. However, controversy exists on whether baseline severity confounds the effect of this treatment patient outcome.AimsIn a randomized controlled treatment trial (1) to compare subjective report of IBS-AR to global assessment of improvement (IBS-GAI), change in IBS symptom severity scale (IBS-SSS) and IBS Quality of Life (IBS-QOL); (2) to explore whether initial IBS symptom severity influences the sensitivity of these outcome measures; (3) to determine whether psychological symptoms influence the sensitivity of these measures.Methods289 adult IBS patients were recruited to a treatment trial. Baseline IBS-SSS scores were used to classify IBS severity as mild (<150), moderate (150-300), or severe (>300). Questionnaires were completed at baseline and after 3 weeks of treatment with sham acupuncture or waitlist control.ResultsIBS baseline severity significantly affected the proportion of patients who reported IBS-AR at 3 weeks (mild, 70%; moderate, 49.7%; severe, 38.8%) (p<0.05). However, once the patients who reported IBS-AR at baseline (28.0%) were excluded from the analysis, baseline severity no longer affected the proportion of patients reporting IBS-AR. Baseline severity did not have a significant of effect patients reporting moderate or significant improvement on the IBS-GAI (mild, 30%; moderate, 25.3%; severe, 18.8%) (p=NS). Psychological symptoms had no significant correlations with responders after adjusting for baseline severity.ConclusionsThese data suggest that IBS-AR as an endpoint is confounded with initial IBS symptom severity as measured by baseline reporting of adequate relief. The confounding effects of adequate relief can be eliminated if patients who report adequate relief at screening are excluded from study participation.
Carolina Digital Repository (University of North Carolina at Chapel Hill), 2009
Background-While clinicians generally make treatment decisions in IBS related to the type of symptoms, other factors such as the perceived severity and the risks patients are willing to tolerate for effective treatment are also important to consider. These factors are not fully understood. Objective-To describe among patients with IBS their symptoms and severity, quality of life and health status, medications taken, and the risk that they would take to continue medications for optimal relief. Methods-Adult patients diagnosed with IBS who accessed the websites of the International Foundation for Functional GI Disorders (IFFGD) or the UNC Center for Functional GI Disorders filled out questionnaires to address the study aims. Results-The 1,966 respondents (83% female, 91% Caucasian, 78% USA/Canada) reported impaired health status: restricting on average 73 days of activity in a year, having poor HRQOL particularly with dietary restrictions, mood disturbance and interference with daily activity, and 35% reported their symptoms as severe defined primarily as pain, bowel difficulties, bloating and eating/ dietary restrictions). These symptoms were reported in some combination by over 90%, and 35.1% endorsed all 4 items. To receive a treatment that would make them symptom free, patients would give up 25% of their remaining life (average 15 years) and 14% would risk a 1/1000 chance of death. Most of the medications being taken were for pain relief and 18% were taking narcotics. Complementary and alternative treatments were used by 37%.
International Survey of Patients With IBS
Journal of Clinical Gastroenterology, 2009
Background-While clinicians generally make treatment decisions in IBS related to the type of symptoms, other factors such as the perceived severity and the risks patients are willing to tolerate for effective treatment are also important to consider. These factors are not fully understood.
Diagnosis and management of IBS
Nature Reviews Gastroenterology & Hepatology, 2010
| IBS is a common gastrointestinal condition characterized by chronic or recurrent abdominal pain associated with altered bowel habits. IBS is considered a functional bowel disorder (that is, not defined by structural or biochemical abnormalities) and is diagnosed using symptom-based criteria. Limited and judicious use of diagnostic testing is recommended, particularly in patients with typical symptoms of IBS without alarm signs and symptoms. Management of IBS is based on a multifactorial approach and includes establishment of an effective patient-provider relationship, education, reassurance, dietary alterations, pharmacotherapy, behavioral and psychological treatment. Patient-centered care is recommended, in which management is focused on the patient's most bothersome and impactful symptoms, their preferences and previous experiences with treatment, and addressing factors associated with the onset and exacerbation of symptoms. Pharmacotherapy is typically targeted against the predominant symptom. This Review discusses the current evidence-based recommendations for the diagnosis and management of IBS. An improved understanding of the recommended diagnostic and therapeutic approaches for IBS will lead to greater patient satisfaction, as well as reduced health-care costs.