Biomedical subjects
S Müller-Lissner
Publications and source records attributed to S Müller-Lissner.
A randomised controlled trial assessing the efficacy and safety of repeated tegaserod therapy in women with irritable bowel syndrome with constipation.
BACKGROUND: It has been proposed that treatments for irritable bowel syndrome with constipation (IBS-C) should provide rapid symptomatic relief, be intermittent, and effective upon repeated use. AIMS: To evaluate the efficacy and safety of tegaserod on IBS symptoms, and its impact on quality of life and health economic measures. PATIENTS: Women (> or = 18 years of age) with IBS-C according to the Rome II criteria. METHODS: Prospective, double blind, placebo controlled, randomised trial. Women with IBS-C either received tegaserod 6 mg twice daily or placebo for one month. Patients with at least a partial response entered a treatment free interval. Upon symptom recurrence, tegaserod treated patients were re-randomised to tegaserod or placebo for an additional month. Primary efficacy variables were response (overall IBS symptoms and abdominal discomfort/pain) to first and repeated treatment. Analysis was by intention to treat. RESULTS: 2660 patients and 1191 patients were randomised for first and repeated treatment respectively. Tegaserod was superior to placebo for each primary efficacy variable (first treatment: 33.7% v 24.2% responders respectively for relief of IBS symptoms and 31.3% v 22.1% for relief of abdominal discomfort/pain; repeated treatment: 44.9% v 28.7%, and 42.4% v 27.1%, all p < 0.0001). Tegaserod was superior to placebo for every secondary efficacy variable (relief of abdominal discomfort/pain, bloating and constipation; stool frequency and consistency). A response to tegaserod was observed within the first treatment week. Tegaserod produced greater satisfaction, work productivity, and improved quality of life than placebo (p < 0.05). CONCLUSION: Tegaserod provides rapid and sustained relief of IBS-C symptoms both during first and repeated treatment.
Tegaserod is effective in the initial and retreatment of irritable bowel syndrome with constipation.
BACKGROUND: Symptoms of irritable bowel syndrome are often cyclical and thus may require repeated rather than continuous therapy. Tegaserod is effective and well-tolerated for irritable bowel syndrome with constipation but data on retreatment are lacking. AIM: To assess whether tegaserod retreatment is as efficacious and well-tolerated as initial treatment in a primary care setting. METHODS: This open-label trial was designed to evaluate the effectiveness of tegaserod under real-life conditions. Irritable bowel syndrome with constipation patients received tegaserod 6 mg b.d. for 12 weeks; response was assessed at weeks 4 and 12. Responders (those achieving satisfactory relief for at least 2 of the previous 4 weeks) at weeks 4 and/or 12 entered an 8-week withdrawal period where symptom recurrence was assessed. Patients experiencing recurrence could receive tegaserod 6 mg b.d. for another 4 weeks (retreatment phase) and on completion, could choose to continue tegaserod in a 6-month extension study. RESULTS: A total of 513 patients received initial treatment with tegaserod; 85.0% (436 of 513) responded. 403 responders entered the withdrawal period; symptoms recurred in 83.9% (338 of 403) after a mean of 38 days. Of the 307 patients who subsequently entered retreatment 89.3% (274 of 307) responded. Among patients entering the retreatment period, 269 (87.6%) had responded within the first 4 weeks of initial treatment. Of these, 243 (90.3%) responded to tegaserod retreatment. Adverse events were infrequent and similar during 4 weeks of the initial treatment period (11.1%) and on retreatment (10.4%). The extension study, completed by 188 of 232 (81.0%) patients, demonstrated good long-term tolerability of tegaserod. CONCLUSIONS: Irritable bowel syndrome with constipation patients can be successfully treated, and retreated, with tegaserod 6 mg b.d. Tegaserod was well-tolerated during initial and retreatment periods.
[Consensus conference of the DGVS on gastroesophageal reflux].
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[Topic complex II: Diagnosis].
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Contemporary understanding and management of reflux and constipation in the general population and pregnancy: a consensus meeting.
BACKGROUND: Gastro-oesophageal reflux disease (GERD) and constipation have a major impact on public health; however, the wide variety of treatment options presents difficulties for recommending therapy. Lack of definitive guidelines in pharmacy and general practice medicine further exacerbates the decision dilemma. AIMS: To address these issues, a panel of experts discussed the principles and practice of treating GERD and constipation in the general population and in pregnancy, with the aim of developing respective treatment guidelines. RESULTS: The panel recommended antacids 'on-demand' as the first-line over-the-counter treatment in reflux, and as rescue medication for immediate relief when reflux breaks through with proton pump inhibitors. Calcium/magnesium-based antacids were recommended as the treatment of choice for pregnant women because of their good safety profile. In constipation, current data do not distinguish a hierarchy between polyethylene glycol (PEG)-based laxatives and other first-line treatments, although limitations are associated with stimulant- and bulk-forming laxatives. Where data are available, PEG is superior to lactulose in terms of efficacy. In pregnancy, PEG-based laxatives meet the criteria for the ideal treatment. CONCLUSIONS: The experts developed algorithms that present healthcare professionals with clear treatment options and management strategies for GERD and constipation in pharmacy and general practice medicine.
[Adhesions to explain abdominal complaints: a concept to adhere to?].
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Role of alimentation in irritable bowel syndrome.
BACKGROUND: Different food items are made responsible for irritable bowel syndrome (IBS) symptoms, but the physiopathology of IBS remains unclear. AIMS: During a meeting in Nice, France, experts of the European Working Team of the IBiS Club discussed selected data regarding the relationships between alimentation, food items (including fibers) and IBS symptoms. METHODS/RESULTS: Food allergy remains a difficult diagnosis, but medical and general history, presence of general symptoms such as skin rash, and hypersensitivity tests may help in achieving a positive diagnosis. On the other hand, food intolerance is more confusing because of the subjectivity of the relationship between ingestion of certain foods and the appearance of clinical symptoms. Different food items which are commonly implicated in adverse reactions mimicking IBS were found to be stimulants for the gut, suggesting that patients with predominant diarrhea IBS have to be carefully questioned about consumption of different kinds of food (i.e., coffee, alcohol, chewing gum, soft drinks) and not only on lactose ingestion. Gas production is discussed on the basis of retention of intestinal gas as well as on malabsorption of fermentable substrates. The role of a large amount of this kind of substrate reaching the colon is suggested as a potential mechanism of IBS-type symptoms in overeating patients. Regarding the role of fiber in IBS, the expert group concluded that fibers are not inert substances and that they could trigger pain or bloating in some IBS patients. CONCLUSION: Despite numerous reviews on this subject, it is very difficult to give general dietary advice to IBS patients, but dieteticians may have a positive role in managing such patients.
[An experimental evaluation of a hospital's internal clinical guideline system. Randomized, controlled crossover pilot study on the efficacy of Intranet-based guidelines for General Internal Medicine at the Park Clinic Weissenssee in Berlin]].
Randomised, controlled crossover pilot study on the efficacy of Intranet-based guidelines for General Internal Medicine at the Park-Klinik Weissensee in Berlin. As part of the evaluation programme for the intranet-based internal guideline system at the Park-Klinik Weissensee in Berlin, an experimental randomised, controlled trial was conducted in which 12 medical students in their final year were asked to solve 10 clinical vignettes each. A number of written and electronic sources of medical information was available. In addition, the students were allowed to use the internal guideline system for one half of the vignettes in a crossover fashion. There was a sample size-related non-significant trend in favour of the guideline system concerning the primary endpoint "time to right solution" (mean 2.8 min; 95% CI -1.6 to 7.3). A per-protocol-analysis revealed a great variability in the actual use of the guidelines available. There was an inverse "dose-response relationship" between the intensity of guideline usage and the endpoint.
The rise and fall in primary liver cancer mortality in Italy.
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[Endoscopic plastic surgery at the cardia].
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Potential pitfalls in the differential diagnosis of irritable bowel syndrome.
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Nongastrointestinal disorders in the irritable bowel syndrome.
A large proportion of irritable bowel syndrome (IBS) patients also complain of other functional disorders, such as headache, noncardiac chest pain, low back pain, and dysuria. Some of these features, particularly headache, may have a negative influence on the outcome of IBS. In a large proportion of female IBS patients, sexual intercourse triggers the symptoms, and frequently IBS symptoms exacerbate during menses. These gynecological-type symptoms often mislead the patients to the gynecological clinic, which may imply unnecessary investigations and inappropriate treatments. The diagnostic criteria of the fibromyalgia syndrome include IBS, and hence, the apparent relationship of both syndromes is difficult to analyze. On the other hand, no convincing evidence has been produced to date to sustain an association between IBS and the chronic fatigue syndrome.
[Chronic constipation in the aged. Consensus conference of the German Society for Geriatrics].
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Symptomatic gastro-oesophageal reflux disease: double blind controlled study of intermittent treatment with omeprazole or ranitidine. The European Study Group.
OBJECTIVE: To assess intermittent treatment over 12 months in patients with symptomatic gastro-oesophageal reflux disease. DESIGN: Randomised, multicentre, double blind, controlled study. Patients with heartburn and normal endoscopy results or mild erosive changes received omeprazole 10 mg or 20 mg daily or ranitidine 150 mg twice daily for 2 weeks. Patients remaining symptomatic had omeprazole 10 mg or ranitidine dose doubled for another 2 weeks while omeprazole 20 mg was continued for 2 weeks. Patients who were symptomatic or mildly symptomatic were followed up for 12 months. Recurrences of moderate or severe heartburn during follow up were treated with the dose which was successful for initial symptom control. SETTING: Hospitals and primary care practices between 1994 and 1996. SUBJECTS: 677 patients with gastro-oesophageal reflux disease. MAIN OUTCOME MEASURES: Total time off active treatment, time to failure of intermittent treatment, and outcomes ranked from best to worst. RESULTS: 704 patients were randomised, 677 were eligible for analyses; 318 reached the end of the study with intermittent treatment without recourse to maintenance antisecretory drugs. The median number of days off active treatment during follow up was 142 for the entire study (281 for the 526 patients who reached a treatment related end point). Thus, about half the patients did not require treatment for at least 6 months, and this was similar in all three treatment groups. According to outcome, 378 (72%) patients were in the best outcome ranks (no relapse or one (or more) relapse but in remission until 12 months); 630 (93%) had three or fewer relapses in the intermittent treatment phase. Omeprazole 20 mg provided faster relief of heartburn. The results were similar in patients with erosive and non-erosive disease. CONCLUSIONS: Intermittent treatment is effective in managing symptoms of heartburn in half of patients with uncomplicated gastro-oesophageal reflux disease. It is simple and applicable in general practice, where most patients are seen.
Cost effectiveness of omeprazole and ranitidine in intermittent treatment of symptomatic gastro-oesophageal reflux disease.
OBJECTIVE: This 1-year study compared the cost effectiveness of omeprazole and ranitidine when used as initial therapy in an intermittent treatment strategy for the management of patients with symptomatic gastro-oesophageal reflux disease with or without erosive oesophagitis. DESIGN AND SETTING: A prospective health economic analysis was conducted alongside an international multicentre randomised, double-blind clinical study. The economic analysis was performed from a societal perspective. PATIENTS: A total of 704 patients in the UK, the Republic of Ireland, Germany, France, Italy and Spain were randomised to 1 of the 3 treatment groups. INTERVENTIONS: Patients were randomised to receive either omeprazole 20 mg once daily, omeprazole 10 mg once daily or ranitidine 150 mg twice daily. Initial treatment failure resulted in dose titration and drug switching from ranitidine to omeprazole, and subsequently open maintenance treatment. MAIN OUTCOME MEASURES AND RESULTS: The estimated mean direct medical costs (medication and number of visits and endoscopies) were found to be lower for both dosages of omeprazole than for ranitidine in all countries except Germany. However, none of the differences were statistically significant. The differences between omeprazole 10 mg and omeprazole 20 mg were small and nonsignificant. With regard to numbers of symptom-free days, both omeprazole 20 mg and omeprazole 10 mg were found to be more effective than ranitidine. However, none of the differences were statistically significant. CONCLUSIONS: Following a pragmatic interpretation, incorporating intermediate short term results, the results in this study give no support to the notion that a step-up approach, either as dose titration from omeprazole 10 mg to omeprazole 20 mg or as drug switching from ranitidine to omeprazole, will result in cost savings and thereby be cost effective.
[Diagnostic value of symptoms in gastroesophageal reflux].
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Classification, pharmacology, and side-effects of common laxatives.
No definition of the term laxative is satisfactory since their mode of actions affects multiple mechanisms, absorption/secretion and motor activity. Laxatives are very heterogeneous chemically. They act by either holding water inside the bowel lumen (dietary fibre, osmotic laxatives), by inhibition of water absorption or stimulation of secretion (stimulant laxatives), or by stimulation of colonic motility (stimulant laxatives, 5HT4 agonists). Most laxatives have side-effects but these are usually mild.