Irritable Bowel Syndrome: Klosterhalfen S

Enck P, Klosterhalfen S, Zipfel S, Martens U. · No affiliation provided · J Psychosom Res. · Pubmed #18501255 No free full text.

This publication has no abstract.

Musial F, Klosterhalfen S, Enck P. · Department of Internal Medicine, Integrative and Complementary Medicine, Kliniken Essen-Mitte, Knappschafts-Krankenhaus, Am Deimelsberg 34a, Essen 45276, Germany. · World J Gastroenterol. · Pubmed #17659688 links to  free full text

Abstract: Over the last several years there has been a growing interest in placebo, not only as an inert control in clinical trials, but also in the placebo effect as a group effect as well as a reaction in individual subjects. Methodological factors such as regression to the mean and natural history of the disease play a role in the evaluation of a possible placebo effect. In this report, we discuss several factors including Pavlovian conditioning, beliefs outcome, expectations, and other factors as potential mediators of the placebo response. Placebo effects are common in gastrointestinal diseases and there seems to be no clear difference between placebo effects in functional gastrointestinal diseases (functional dyspepsia and irritable bowel syndrome) and organic gastrointestinal disease (duodenal ulcer and inflammatory bowel disease).

Enck P, Martens U, Klosterhalfen S. · University Hospitals Tubingen, Department of Internal Medicine VI, Psychosomatic Medicine and Psychotherapy, Osianderstrasse 5, Tubingen 72076, Germany. · World J Gastroenterol. · Pubmed #17659685 links to  free full text

Abstract: Research on gut-brain interactions has increased over the last decade and has brought about a number of new topics beyond "classical" subjects, such as "stress" and "personality", which have dominated the psychosomatic literature on gastrointestinal disorders over the past century. These novel topics include brain imaging of intestinal functions, placebo responses in gastroenterology, learning of gastrointestinal symptoms, quality of life in patients with intestinal complaints, and psychotherapy and familial aggregation of functional intestinal disorders. Currently, these new topics appear with a frequency of 1% to 3% in leading gastroenterological journals, either as data presentation or review papers. Increasing focus underlines the importance of enhancing our understanding on how the psyche and the brain communicate in order to better meet the needs of our patients.

Enck P, Klosterhalfen S. · Department of Internal Medicine VI/Psychosomatics, University Hospitals Tuebingen, Tuebingen, Germany. · Neurogastroenterol Motil. · Pubmed #15916619 No free full text.

Abstract: The nature and determinants of the placebo response are widely unknown, as are the underlying psychological and biological mechanisms. High placebo response rates in functional bowel disorders (functional dyspepsia, irritable bowel syndrome) are similar to those in non-intestinal diseases (depression, pain, Parkinson's disease) and not too dissimilar to other organic gastrointestinal diseases (duodenal ulcer, inflammatory bowel diseases). Methodological reasons (regression to the mean, shift in signal detection through manipulation of expectations) and psycho-biological mechanisms (Pavlovian conditioning of biological processes) are proposed to explain a large component of the response variance in clinical trials. Psychobiological mechanisms of the placebo response in functional and organic diseases can also be identified in brain function studies (such as imaging).

Enck P, Zimmermann K, Rusch K, Schwiertz A, Klosterhalfen S, Frick JS. · Psychosomatic Medicine and Psychotherapy, University Hospital Tübingen, Frondsbergstr. 23, 72076 Tübingen. · Z Gastroenterol. · Pubmed #19606407 No free full text.

Abstract: BACKGROUND: The composition of the fecal mircoflora and its changes on ageing have rarely been investigated in large samples of both patients and volunteers. METHODS: We analysed the fecal flora by conventional microbiological testing (Kyberstatus, Institute of Microecology, Herborn, Germany) of stool samples from 35 292 adults (age: 46.3 +/- 0.08 [18 to 96] years, 9564 males, 24 784 females; remaining = missing data) with different intestinal and non-intestinal diagnoses for total colony-forming units (CFU) (per g stool) as well as relative abundance of Bifidobacteria, Bacteroides spp., Escherichia coli, Enterococcus spp., and Lactobacillus spp. with respect to age, gender, and clinical data available (e. g., stool consistency and pH). RESULTS: The total CFU was stable and showed no age- or gender-related changes. Individual bacterial species constantly and significantly increased with age (E. coli, Enterococci spp.), or decreased at higher age (Bacteroides spp.), or were stable throughout the life span (Lactobacilli, Bifidobacteria). Gastrointestinal diagnoses (Crohn's disease, n = 198; ulcerative colitis, n = 515; irritable bowel syndrome, n = 7765; other GI diagnoses, n = 10 478) tended to exhibit some specificity of the bacterial profile, and when GI diagnoses were excluded, the age-related bacterial profile of the remaining group (n = 15 619, m:f = 4197:11 422) was not different. CONCLUSION: Conventional microbiological investigations of the fecal microbiota showed both bacteria-specific as well as a general pattern of ageing of the colonic microbiota, with the last decades (more than 60 years) demonstrating the most profound changes. It remains to be shown whether these changes reflect direct changes of the gut microbiota, the mucosal innate immunity, or indirect consequences of age-related altered nutrition.

Enck P, Zimmermann K, Menke G, Klosterhalfen S. · Internal Medicine VI, University Medical Hospital, Tübingen, Germany. · Z Gastroenterol. · Pubmed #19197823 No free full text.

Abstract: BACKGROUND: Therapy trials with bacterial compounds in irritable bowel syndrome (IBS) have produced conflicting results and, so far, an E.-coli preparation has not been used. METHODS: Two hundred and ninety-eight patients with lower abdominal symptoms diagnosed as IBS were treated for 8 weeks by the compound Symbioflor-2 (Symbiopharm GmbH, Herborn, Germany), an Escherichia coli product (N = 148), or placebo (n = 150) in a double-blinded, randomized fashion. Patients were seen weekly by the physician, who assessed the presence of core IBS symptoms. Both an abdominal pain score (APS) as well as a general symptom score (GSS) were used as primary endpoints. Responders had to have complete absence of IBS core symptoms at > or = 1 visit during treatment. RESULTS: The responder rate in GSS to the drug was 27 / 148 (18.2 %) in comparison to placebo with 7 / 150 (4.67 %) (p = 0.000397). The improvement in APS was 28 / 148 (18.9 %) and 10 / 150 (6.67 %) for placebo (p = 0.001649). The response was reached from visit 3 onwards with both medication and placebo. Post-hoc analysis revealed no significant differences in efficacy of the drug between the gender and different age groups. CONCLUSION: Treatment of IBS with the probiotic Symbioflor-2 is effective and superior to placebo in reducing typical symptoms of IBS patients seen by general practitioners and by gastroenterologists.

Enck P, Zimmermann K, Menke G, Müller-Lissner S, Martens U, Klosterhalfen S. · Department of Internal Medicine VI, University Hospital of Tübingen, Tübingen, Germany. · Neurogastroenterol Motil. · Pubmed #18565142 No free full text.

Abstract: Therapy trials with bacterial compounds in irritable bowel syndrome (IBS) have produced conflicting results. This study was performed in 1988 and 1989, and was re-analysed according to current IBS standards. Two hundred ninety-seven patients with lower abdominal symptoms diagnosed as IBS were treated for 8 weeks by the compound ProSymbioflor((R)) (Symbiopharm GmbH, Herborn, Germany), an autolysate of cells and cell fragments of Enterococcus faecalis and Escherichia coli, or placebo in a double-blinded, randomized fashion. Patients were seen weekly by the physician, who assessed the presence of core IBS symptoms. Responders had at least a 50% decrease in global symptom score (GSS) and in abdominal pain score (APS) reports at >/=1 visit during treatment. The responder rate in GSS to the drug was 102/149 (68.5%) in comparison to placebo with 56/148 (37.8%) (P < 0.001), the improvement in APS was 108/149 (72.5%) and 66/148 (44.6%) respectively (P = 0.001). The number-needed-to-treat was 3.27 for GSS and 3.59 for the APS report. Kaplan-Meier analysis revealed a mean response time of 4-5 weeks for active treatment and more than 8 weeks for placebo (P < 0.0001). Treatment of IBS with the bacterial lysate ProSymbioflor is effective and superior to placebo in reducing typical symptoms of IBS patients seen by general practitioners.

Enck P, Kowalski A, Martens U, Klosterhalfen S. · Department of Psychosomatic Medicine and Psychotherapy, University Hospitals Tübingen, Tübingen. Germany. · Eur J Gastroenterol Hepatol. · Pubmed #17099374 No free full text.

Abstract: OBJECTIVES: We wished to determine the value of an open-access internet questionnaire for assessment of upper and lower gastrointestinal symptoms and health-related quality of life. METHODS: Between January 2002 and June 2005, a symptom scale for upper gastrointestinal and lower gastrointestinal symptoms was placed on a genuine website (www.gesundheits-umfrage.de) and linked to the website of the German irritable bowel syndrome patient group (www.Reizdarmselbsthilfe.de). Patients were asked to report gastrointestinal symptoms that had occurred during the last month. Patients who finished this symptoms questionnaire and acknowledged more than two of a total of eight upper gastrointestinal symptoms and/or more than two of 16 lower gastrointestinal symptoms were immediately offered the assessment of their health-related quality of life by a validated general quality of life scale--the patient general well-being inventory--a 22-item scale with six subscales (anxiety, depression, general well-being, self-control, health, and vitality) and a global scale. Total patient general well-being inventory scores and subscale values were correlated to upper gastrointestinal and lower gastrointestinal symptom scores including the Rome I definition of the irritable bowel syndrome, and to social variables. RESULTS: Five thousand two hundred and fifty-six individuals completed symptom assessment. Out of these, 4431 had three or more upper gastrointestinal symptoms, the mean number of upper gastrointestinal symptoms reported was 3.2+/-2.0; 4456 had three or more lower gastrointestinal symptoms (mean: 10.3+/-3.3), and 3187 met the Rome I criteria for irritable bowel syndrome. A total of 3316 individuals completed the patient general well-being inventory assessment (1156 men, 2160 women, mean age: 37.7+/-12.3 years). Upper gastrointestinal, lower gastrointestinal, and total symptom score were higher in women than in men (P < 0.001), and significantly correlated to the global quality of life assessment. Family status affected the symptom scores (higher in singles) and quality of life scores (lower in people living in partnership for health, but higher for vitality and depression). Age correlated negatively with upper gastrointestinal, lower gastrointestinal, and with total symptom scores as well as with some patient general well-being inventory scores. CONCLUSION: Symptom and quality of life assessment using an open internet questionnaire is feasible and generates data which are, in large, comparable to those from other sources of assessment, despite the fact that the population addressed is, on average, moderately younger than previously studied cohorts.

Enck P, Klosterhalfen S, Kruis W. · Medizinische Klinik VI: Psychosomatische Medizin und Psychotherapie, Universitätsklinikum Tübingen. · Dtsch Med Wochenschr. · Pubmed #16123895 No free full text.

Abstract: BACKGROUND AND OBJECTIVE: The determinants of the placebo effect are not well established. Goal of this study was to explore likely predictive factors in an already published data set. METHODS: We re-analysed data from a study in 120 patients with the irritable bowel syndrome (IBS) that were randomly assigned to three arms of the study to receive (double-blind) either a drug (mebeverin) (n = 40) or placebo (n = 40), or (in an open trial) dietary treatment (fibre) (n = 40) for up to 16 week. Treatment was conducted by 3 different doctors (A, B, C) with 44, 27, and 18 patients, resp. A fourth group (n = 31) was treated by different varying physicians. Symptoms were assessed every 4 weeks, and the degree of patient compliance and the number of drop-outs, the number of patients improved/not improved (in %), symptom severity (Kruis Score) at enrolment, and age and gender as covariates were included into the analysis. RESULTS: Drop-out rate was 30 % for placebo, 30 % for mebeverin, and 15 % for the diet. For the patients remaining in the study, average compliance was 75 % with placebo, but 89 % for the drug and 82 % for the diet. Response rates were 39 % for placebo, but 20 % for the drug; response rate for the diet (open trial) was 43 % under all doctors. Response rates for drug and placebo combined were 32 % for doctor A (female,43 years), but 19 % for doctors B and C together (both males, 32 and 40 years)); this effect was not significant. Placebo responders were more often women (47 %) than men (28 %), while age effects were only found with dietary treatment: responders were younger. Placebo responders had an overall lower Kruis Score than non-responders (45 vs 52 points), but this was also true for drug (52 vs. 62 points) and diet responders (56 vs 68 points). CONCLUSION: The major factors contributing to the placebo response are the treating physician (gender, training), and the patients gender (female). Patients with lower Kruis score (more likely non-functionally disordered) may be prone to higher (placebo) response rates.