112,578 research outputs found
The stomach and obesity: the missing link, at last?
No full textLink between gastri function and obesit
Unfulfilled Wishes by Gastric Electrical Stimulation.
No full textUnfulfilled Wishes by Gastric Electrical Stimulatio
Review article: Linaclotide for the management of irritable bowel syndrome with constipation
No full textBACKGROUND:
Irritable bowel syndrome with constipation (IBS-C) represents a significant burden to patients and healthcare systems due to its prevalence and lack of successful symptomatic resolution with established treatment options. Linaclotide 290 μg has recently been approved by the European Medicines Agency (EMA) for moderate-to-severe IBS-C and by the US Food and Drug Administration for IBS-C (290 μg dose) and for chronic constipation (145 μg dose).
AIM:
To summarise data leading to the approval of linaclotide for IBS-C, with focus on EMA-pre-specified outcome measures.
METHODS:
Literature search of a peer-review database (PubMed) and review of congress abstracts on linaclotide preclinical and clinical trial data in IBS-C.
RESULTS:
Preclinical studies suggest that the guanylate cyclase C agonist (GCCA) linaclotide acts through elevation of cyclic guanosine monophosphate (cGMP) levels, leading to accelerated gastrointestinal (GI) transit through increased fluid secretion and reduced visceral hypersensitivity. Clinical trial data demonstrate that linaclotide improves abdominal symptoms (pain, bloating) and bowel symptoms (constipation) compared with placebo in patients with IBS-C. The most frequent side effect, diarrhoea, results from the therapeutic action of linaclotide. Linaclotide acts locally in the GI tract with minimal systemic exposure, resulting in low oral bioavailability and thus a low risk of relevant systemic adverse effects.
CONCLUSION:
Linaclotide, a first-in-class GCCA, is a promising new drug with a novel, dual mechanism of action that, unlike more well-established agents, can relieve the abdominal pain, bloating and constipation associated with IBS-C and has a low propensity for systemic side effects
Dried plum vs psyllium
No full textDried plums vs. psyllium; comment on
Randomised clinical trial: dried plums (prunes) vs. psyllium for constipation
Review article: adherence to Rome criteria in therapeutic trials in functional dyspepsia.
No full textBACKGROUND:
The Rome criteria are currently required by health authorities for the inclusion of patients affected by functional dyspepsia in therapeutic trials. However, the degree of adherence to these criteria has not been formally verified.
AIM:
To review adherence to the Rome criteria for inclusion criteria, outcome measures and endpoints in therapeutic trials on functional dyspepsia and the potential impact on the conclusions that can be drawn from these studies.
METHODS:
A total of 1818 articles were screened. Fifty-eight trials claiming to include adults affected by functional dyspepsia as defined by the Rome criteria published as full articles in English between 2000 and 2013 were considered.
RESULTS:
Lack of full adherence to the Rome criteria of inclusion criteria was found in 54% of the studies, due to inclusion of patients with symptoms not reported in the Rome criteria or definitions of dyspeptic symptom that varied from those proposed by the Rome criteria. Ninety-five per cent of clinical trials adopted therapeutic outcome measures that were not adherent to the Rome criteria, using questionnaires that did not include all dyspeptic symptoms or including symptoms other than those proposed by the Rome criteria.
CONCLUSIONS:
Stringent criteria have not been adopted for inclusion criteria and outcome measures in the vast majority of published studies on functional dyspepsia that claim to have been carried out according to the Rome criteria. Appropriate questionnaires should be developed to promote adherence to internationally accepted definitions of the syndrome in future studies
ReQuest-- the challenge of quantifying both esophageal and extra-esophageal manifestations of GERD.
No full textGastroesophageal reflux disease (GERD) is highly prevalent in Western countries. It is characterized by esophageal and extra-esophageal symptoms (both typical and atypical) as well as by a number of potential complications. As the majority of patients have normal gross endoscopic findings, the assessments of symptom severity and quality of life, as well as the patients' response to treatment have become increasingly important. Self-assessed symptom questionnaires are now key instruments in clinical trials. An ideal GERD symptom questionnaire, suitable as a primary end-point for clinical trials, should: (1) be sensitive in patients with GERD, (2) cover frequency and intensity of typical and atypical GERD symptoms, (3) be multidimensional (cover all symptom dimensions), (4) have proven psychometric properties (validity, reliability and responsiveness), (5) be practical and economical, (6) be self-assessed, (7) use 'word pictures' which are easy to understand for patients, (8) respond rapidly to changes (responsiveness in short-time intervals), (9) be used daily to assess changes during and after therapy, and (10) be valid in different languages for international use. A literature review revealed five evaluative scales that met some of the above characteristics, but none fulfilled all of them. Therefore, a new evaluative tool for the assessment of GERD symptoms and their response to therapy is needed. The Reflux Questionnaire (ReQuest) is a self-assessed questionnaire developed and validated to assess the effect of treatment on the spectrum of GERD-related symptoms. Initially, GERD symptoms were identified on the basis of available literature, knowledge from previous clinical trials, experienced physicians, and patient interviews. An overall of 67 typical and atypical symptom descriptions were grouped into six different dimensions of GERD (acid complaints, upper abdominal/stomach complaints, lower abdominal/digestive complaints, nausea, sleep disturbances, other complaints). To these six dimensions a seventh, general well-being was added. Each dimension was tested by questions for frequency and intensity (except general well-being, for which only the intensity was determined). Thereafter, ReQuest was translated into different languages and tested in mother tongue patient focus groups. ReQuest psychometric properties (test-retest reliability, internal consistency, construct validity, responsiveness) were validated in two clinical trials of erosive GERD and endoscopic negative (en) GERD. In the first open, multicenter study, ReQuest was assessed in 430 patients with erosive GERD grade A-D. Patients with GERD grade A were treated with pantoprazole 20 mg od whereas those with GERD grade B-D received 40 mg od. The second open, multicenter, multinational trial with pantoprazole 20mg od assessed the ReQuest in over 800 patients with endoscopic negative GERD. Furthermore, ReQuest was used to determine the 'normal' ranges of GERD symptoms in individuals without GERD evidence. Over 300 healthy volunteers took part in a 4-day evaluation by completing ReQuest on each of the four study-days, as well as GSRS and PGWB on day 1. Based on the 90% percentiles determined in this study, a 'normal' range was calculated for ReQuest and relative subscales. The study showed that even individuals without GERD evidence can experience mild GERD symptoms. The derived 'normal' ranges within the population can be used for classification of symptom relief. In conclusion, ReQuest proved to be a valid, reliable, and responsive tool for measuring both typical and atypical GERD symptoms, and to be particularly suitable for measuring daily symptom changes and identifying normalization of the clinical picture in therapeutic trials
Perspectives on irritable bowel syndrome: where have we been? Where are we now?
No full textIrritable bowel syndrome is a chronic functional disorder with a complex etiology and multiple overlapping symptoms. Irritable bowel syndrome is characterized by long-lasting abdominal pain or discomfort, abnormal bowel habits and typically inadequate response to many of the available therapies
Overlapping functional syndromes: a way forward for medical therapy?
No full textOverlapping functional syndrome
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