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- Engsbro, A L, et al.
(författare)
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Short-term stability of subtypes in the irritable bowel syndrome: prospective evaluation using the Rome III classification.
- 2012
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Ingår i: Alimentary pharmacology & therapeutics. - : Wiley. - 1365-2036 .- 0269-2813. ; 35:3, s. 350-9
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Tidskriftsartikel (refereegranskat)abstract
- Background In irritable bowel syndrome (IBS) subtyping is used in research and clinical practice. Knowledge of subtype stability is needed for proper design of trials and treatment strategies. Aims To evaluate the stability of Rome III IBS subtypes over time and to determine the optimal time period for prospective, diary-based subtyping. Methods Rome III IBS patients aged 18-70years enrolled in two identical, randomised, placebo-controlled trials of probiotics, were included. No difference was found on stool pattern, thus patients were analysed as one group. Patients scored defaecations according to Bristol Stool Form Scale for 10weeks. IBS subtypes were determined for all 1- and 2-week periods. Subtype distribution and stool pattern over time were determined. The proportions of patients having the same subtype all weeks (stable patients) or having a predominant subtype (same subtype ≥60% of time) were determined. Results A total of 126 patients, mean age 46±15years, 72% women were included. Subtype distribution was similar over time with IBS with constipation, IBS with diarrhoea and IBS unsubtyped constituting one-third of the population each. Even though only 18-35% had the same subtype all weeks, the majority of patients had the same subtype for ≥60% of time (82-98%). Sixty-nine per cent had the same predominant and baseline subtypes. Two-week data increased the proportion of stable patients, of patients with a predominant subtype, and of patients who had similar baseline and predominant subtype. Conclusions Most IBS patients change subtype over time. However, an underlying stool pattern stability was demonstrated in the majority of patients. To increase stability, we recommend 2-week data for IBS subtyping.
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- Engsbro, A. L., et al.
(författare)
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The Rome II and Rome III criteria identify the same subtype-populations in irritable bowel syndrome: agreement depends on the method used for symptom report
- 2012
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Ingår i: Neurogastroenterology and Motility. - : Wiley. - 1350-1925. ; 24:7
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Tidskriftsartikel (refereegranskat)abstract
- Background For comparing trials using different classifications for irritable bowel syndrome (IBS) subtypes, it is important to know whether these identify the same sub-populations. Our aim was to determine the agreement between Rome II and Rome III subtypes, and to explore whether agreement depends on the symptom reporting method. Methods Rome II IBS patients from two identical, randomized placebo-controlled trials of probiotics were included. Retrospective subtypes were based on the Rome II questionnaire. Prospective subtypes were based on diary cards for 2 weeks of run-in. Agreement was determined between: (i) retrospective Rome II and Rome III, (ii) prospective Rome II and Rome III, (iii) retrospective Rome II and prospectively Rome III, (iv) retrospective and prospective Rome II, and (v) retrospective and prospective Rome III. Key Results A total of 126 patients, 72% women, mean age 46 +/- 15 years, were included. The agreement between subtypes using the same symptom reporting method was: (i) 90.3% (? = 0.85) for retrospective subtypes, and (ii) 84% (? = 0.76) for prospective subtypes. The agreement between subtypes using different symptom reporting methods was, (iii) 49% (? = 0.23) for retrospective Rome II and prospective Rome III, (iv) 51% (? = 0.26) for Rome II subtypes, and (v) 41% (? = 0.25) for Rome III subtypes. Conclusions & Inferences Agreement between Rome II and Rome III subtypes is good to very good when using the same symptom reporting method. When mixing methods, agreement is only fair even within the same classification. This has implications for comparison of trials using different symptom reporting methods for subtyping.
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- Hellström, Per M., 1954-, et al.
(författare)
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Clinical trial : The glucagon-like peptide-1 analogue ROSE-010 for management of acute pain in patients with irritable bowel syndrome
- 2009
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Ingår i: Alimentary Pharmacology and Therapeutics. - : Wiley. - 0269-2813 .- 1365-2036. ; 29:2, s. 198-206
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Tidskriftsartikel (refereegranskat)abstract
- BACKGROUND: There is currently no treatment available to manage acute pain attacks in IBS patients regardless of subtype. AIMS: To evaluate efficacy and safety of the GLP-1 analogue ROSE-010 in patients with irritable bowel syndrome (IBS) through a randomized, double-blind, placebo-controlled study. METHODS: Eligible patients (n = 166) meeting Rome II criteria were randomly assigned to receive single subcutaneous injections of ROSE-010 100 microg, 300 microg and placebo in a cross-over design. Safety was assessed from spontaneously reported adverse events and measurement of vital signs. Patient-rated pain relief and intensity were measured on a 100-mm visual analogue scale. The primary efficacy variable was proportion of patients with >50% maximum total pain relief response from 10 to 60 min after treatment. Secondary endpoints included the maximum summed pain intensity difference, time to meaningful pain relief and patient ratings of satisfaction with treatment. RESULTS: Twice as many patients were responders in the primary efficacy endpoint after both ROSE-010 injections compared to placebo (24%P = 0.011, 23%P = 0.005, and 12% after 300 microg, 100 microg and placebo injections, respectively). Similar results were obtained for the proportion of patients with total pain intensity response. Times to meaningful and total pain relief were shorter for both doses of ROSE-010 compared with placebo. Compared with placebo, more patients (P < 0.05) were satisfied with ROSE-010 and considered ROSE-010 better than previous IBS medications used. CONCLUSION: ROSE-010 was well tolerated and provided fast and effective relief of acute pain attacks on demand in IBS patients.
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