A randomised controlled trial on hypnotherapy for irritable bowel syndrome: design and methodological challenges (the IMAGINE study)

<p>Abstract</p> <p>Background</p> <p>Irritable Bowel Syndrome (IBS) is a common gastro-intestinal disorder in primary and secondary care, characterised by abdominal pain, discomfort, altered bowel habits and/or symptoms of bloating and distension. In general the efficacy of drug therapies is poor. Hypnotherapy as well as Cognitive Behaviour Therapy and short Psychodynamic Therapy appear to be useful options for patients with refractory IBS in secondary care and are cost-effective, but the evidence is still limited. The IMAGINE-study is therefore designed to assess the overall benefit of hypnotherapy in IBS as well as comparing the efficacy of individual versus group hypnotherapy in treating this condition.</p> <p>Methods/Design</p> <p>The design is a randomised placebo-controlled trial. The study group consists of 354 primary care and secondary care patients (aged 18-65) with IBS (Rome-III criteria). Patients will be randomly allocated to either 6 sessions of individual hypnotherapy, 6 sessions of group hypnotherapy or 6 sessions of educational supportive therapy in a group (placebo), with a follow up of 9 months post treatment for all patients. Ten hospitals and four primary care psychological practices in different parts of The Netherlands will collaborate in this study. The primary efficacy parameter is the responder rate for adequate relief of IBS symptoms. Secondary efficacy parameters are changes in the IBS symptom severity, quality of life, cognitions, psychological complaints, self-efficacy as well as direct and indirect costs of the condition. Hypnotherapy is expected to be more effective than the control therapy, and group hypnotherapy is expected not to be inferior to individual hypnotherapy.</p> <p>Discussion</p> <p>If hypnotherapy is effective and if there is no difference in efficacy between individual and group hypnotherapy, this group form of treatment could be offered to more IBS patients, at lower costs.</p> <p>Trial registration number</p> <p>ISRCTN: <a href="http://www.controlled-trials.com/ISRCTN22888906">ISRCTN22888906</a></p

The Effect of Bifidobacterium on Reducing Symptomatic Abdominal Pain in Patients with Irritable Bowel Syndrome: A Systematic Review

Probiotics, specifically Bifidobacteria, may improve abdominal pain in patients with irritable bowel syndrome (IBS); however, results from randomised controlled trials (RCTs) are conflicting. Here, we systematically reviewed the efficacy of Bifidobacteria on abdominal pain in IBS. We searched MEDLINE, EMBASE and the Cochrane Controlled Trials Register from inception to 20 May 2019, without language or date restrictions. The search strategy comprised of the combination of three concepts: supplementation, abdominal pain, and IBS. Inclusion criteria included double-blind placebo-controlled RCTs featuring Bifidobacteria supplementation in Rome-diagnosed IBS patients. A total of 8 RCTs involving a total of 1045 patients with Rome diagnosed IBS were included. The dose of total Bifidobacteria ranged from 106 to > 1011 cfu (colony-forming unit) and duration of supplementation ranged between 2 and 8 weeks. Bifidobacteria was delivered through either intake of fermented milk products, encapsulation or via a malted milk beverage, with all studies assessing abdominal pain via a visual analogue Likert scale. From the studies included, 50% (n = 4) of studies found a statistically significant improvement in abdominal pain following Bifidobacteria supplementation compared to placebo, 38% (n = 3) of studies found non-significant improvements and 12% (n = 1) showed a statistically significant dose-response effect of improvement. The evidence shows a heterogeneity of effect for Bifidobacteria dependent upon strain, dosage and delivery method. While not all studies demonstrate significant improvements in abdominal pain, none of the selected studies reported an increase in pain or other adverse effects

A candidate probiotic with unfavourable effects in subjects with irritable bowel syndrome: a randomised controlled trial

<p>Abstract</p> <p>Background</p> <p>Some probiotics have shown efficacy for patients with irritable bowel syndrome (IBS). <it>Lactobacillus (L.) plantarum </it>MF1298 was found to have the best <it>in vitro </it>probiotic properties of 22 strains of lactobacilli. The aim of this study was to investigate the symptomatic effect of <it>L. plantarum </it>MF1298 in subjects with IBS. Primary outcome was treatment preference and secondary outcomes were number of weeks with satisfactory relief of symptoms and IBS sum score.</p> <p>Methods</p> <p>The design was a randomised double blind placebo-controlled crossover trial. 16 subjects with IBS underwent two three-week periods of daily intake of one capsule of 10¹⁰CFU <it>L. plantarum </it>MF 1298 or placebo separated by a four-week washout period.</p> <p>Results</p> <p>Thirteen participants (81%; 95% CI 57% to 93%; <it>P </it>= 0.012) preferred placebo to <it>L. plantarum </it>MF1298 treatment. The mean (SD) number of weeks with satisfactory relief of symptoms in the periods with <it>L. plantarum </it>MF1298 and placebo were 0.50 (0.89) and 1.44 (1.26), respectively (<it>P </it>= 0.006). IBS sum score was 6.44 (1.81) in the period with <it>L. plantarum </it>MF1298 treatment compared with 5.35 (1.77) in the period with placebo (<it>P </it>= 0.010). With a clinically significant difference in the IBS sum score of 2 in disfavour of active treatment, the number needed to harm was 3.7, 95% CI 2.3 to 10.9.</p> <p>Conclusions</p> <p>This trial shows for the first time an unfavourable effect on symptoms in subjects with IBS after intake of a potential probiotic.</p> <p>The trial registration number</p> <p>Clinical trials NCT00355810.</p

Tactile massage and hypnosis as a health promotion for nurses in emergency care-a qualitative study

<p>Abstract</p> <p>Background</p> <p>This study explores nursing personnel's experiences and perceptions of receiving tactile massage and hypnosis during a personnel health promotion project. Nursing in a short term emergency ward environment can be emotionally and physically exhausting due to the stressful work environment and the high dependency patient care. A health promotion project integrating tactile massage and hypnosis with conventional physical activities was therefore introduced for nursing personnel working in this setting at a large university hospital in Sweden.</p> <p>Methods</p> <p>Four semi-structured focus group discussions were conducted with volunteer nursing personnel participants after the health promotion project had been completed. There were 16 participants in the focus groups and there were 57 in the health promotion intervention. The discussions were transcribed verbatim and analysed with qualitative content analysis.</p> <p>Results</p> <p>The findings indicated that tactile massage and hypnosis may contribute to reduced levels of stress and pain and increase work ability for some nursing personnel. The sense of well-being obtained in relation to health promotion intervention with tactile massage and hypnosis seemed to have positive implications for both work and leisure. Self-awareness, contentment and self-control may be contributing factors related to engaging in tactile massage and hypnosis that might help nursing personnel understand their patients and colleagues and helped them deal with difficult situations that occurred during their working hours.</p> <p>Conclusion</p> <p>The findings indicate that the integration of tactile massage and hypnosis in personnel health promotion may be valuable stress management options in addition to conventional physical activities.</p

The clinical overlap between functional dyspepsia and irritable bowel syndrome based on Rome III criteria

<p>Abstract</p> <p>Background</p> <p>Epidemiological studies suggest considerable overlap between functional dyspepsia (FD) and irritable bowel syndrome (IBS). To date, no surveys have been performed to investigate the clinical overlap between these two disorders using Rome III criteria. Our aim was to investigate the prevalence and risk factors for the overlap of FD and IBS based on Rome III criteria in a large clinical sample.</p> <p>Methods</p> <p>Consecutive patients at the general gastroenterology outpatient clinic were requested to complete a self-report questionnaire. FD and IBS were defined by Rome III criteria.</p> <p>Results</p> <p>Questionnaires were returned by 3014 patients (52.8% female, 89% response rate). FD-IBS overlap was observed in 5.0% of the patients, while 15.2% and 10.9% of the patients were classified as FD alone and IBS alone, respectively. Compared with non-IBS patients, the odds ratio of having FD among IBS patients was 2.09 (95% CI: 1.68–2.59). Patients with FD-IBS overlap had higher severity scores for the postprandial fullness symptom (2.35 ± 1.49 vs. 1.72 ± 1.59, P < 0.001) and overall FD symptom (6.65 ± 2.88 vs. 5.82 ± 2.76, P = 0.002) than those with FD alone. The only independent risk factor for FD-IBS overlap vs. FD alone was the presence of postprandial fullness symptom (OR 2.67, 95% CI: 1.34–5.31).</p> <p>Conclusion</p> <p>Clinical overlap of FD and IBS according to Rome III criteria is very common. One risk factor for FD-IBS overlap is the presence of postprandial fullness symptom. This study provides clues for future pathophysiological studies of FD and IBS.</p

The role of a probiotics mixture in the treatment of childhood constipation: a pilot study

<p>Abstract</p> <p>Background</p> <p>Inconsistent data exist about the efficacy of probiotics in the treatment of constipation. Several studies in adults with constipation showed positive effects of probiotics on constipation. Inconsistent data exist regarding the effect of a single probiotic strain in constipated children. The aim of this pilot study was to determine the effect of a mixture of probiotics containing bifidobacteria and lactobacilli in the treatment of childhood constipation.</p> <p>Methods</p> <p>Children aged 4–16 years with constipation as defined by the Rome III criteria were eligible for the study. During a 4 week period, children received a daily mix of 4 × 10⁹colony forming units of a probiotic mixture (<it>Ecologic</it>^®<it>Relief</it>) containing Bifidobacteria (B.) bifidum, B. infantis, B. longum, Lactobacilli (L.) casei, L. plantarum and L. rhamnosus. Primary outcome measures were frequency of bowel movements (BMs) per week and stool consistency. Secondary outcome measures were number of faecal incontinence episodes per week, abdominal pain and side effects.</p> <p>Results</p> <p>Twenty children, 50% male, median age 8 (range 4–16) were included.</p> <p>The frequency of BMs per week increased from 2.0 (1.0–5.0) to 4.2 (0.0–16.0) in week 2 (p = 0.10) and 3.8 (2.1–7.0) in week 4 (p = 0.13). In 12 children presenting with <3 BMs/week, BMs per week increased significantly from 1.0 (0.0–2.0) to 3.0 (0.0–7.0) in week 2 (p = 0.01) and 3.0 (0.0–10.0) in week 4 (p = 0.01). The stool consistency was reported as hard in 7 children at baseline, in 4 children at week 2 (p = 0.23) and in 6 children after 4 weeks of treatment (p = 1.00). A significant decrease in number of faecal incontinence episodes per week was found in the entire group: 4.0 (0.0–35.0) to 1.5 (0.0–14.0) in week 2 (p = 0.01) and 0.3 (0.0–7.0) in week 4 (p = 0.001). The presence of abdominal pain decreased significantly from 45% to 25% in week 2 (p = 0.04) and 20% at week 4 (p = 0.006). No side effects were reported.</p> <p>Conclusion</p> <p>This pilot study shows that a mixture of probiotics, has positive effects on symptoms of constipation. To confirm these findings, a large randomised placebo controlled trial is required.</p

Low Densities of Serotonin and Peptide YY Cells in the Colon of Patients with Irritable Bowel Syndrome

Background The gut hormones are important in regulating gastrointestinal motility. Disturbances in gastrointestinal motility have been reported in patients with irritable bowel syndrome (IBS). Reduced endocrine cell density, as revealed by chromogranin A, has been reported in the colon of IBS patients. Aims To investigate a possible abnormality in the colonic endocrine cells of IBS patients. Methods A total of 41 patients with IBS according to Rome Criteria III and 20 controls were included in the study. Biopsies from the right and left colon were obtained from both patients and controls during colonoscopy. The biopsies were immunostained for serotonin, peptide YY (PYY), pancreatic polypeptide (PP), entroglucagon, and somatostatin cells. Cell densities were quantified by computerized image analysis. Results Serotonin and PYY cell densities were reduced in the colon of IBS patients. PP, entroglucagon, and somatostatin- immunoreactive cells were too few to enable reliable quantification

Commensal-Induced Regulatory T Cells Mediate Protection against Pathogen-Stimulated NF-κB Activation

Host defence against infection requires a range of innate and adaptive immune responses that may lead to tissue damage. Such immune-mediated pathologies can be controlled with appropriate T regulatory (Treg) activity. The aim of the present study was to determine the influence of gut microbiota composition on Treg cellular activity and NF-κB activation associated with infection. Mice consumed the commensal microbe Bifidobacterium infantis 35624 followed by infection with Salmonella typhimurium or injection with LPS. In vivo NF-κB activation was quantified using biophotonic imaging. CD4+CD25+Foxp3+ T cell phenotypes and cytokine levels were assessed using flow cytometry while CD4+ T cells were isolated using magnetic beads for adoptive transfer to naïve animals. In vivo imaging revealed profound inhibition of infection and LPS induced NF-κB activity that preceded a reduction in S. typhimurium numbers and murine sickness behaviour scores in B. infantis–fed mice. In addition, pro-inflammatory cytokine secretion, T cell proliferation, and dendritic cell co-stimulatory molecule expression were significantly reduced. In contrast, CD4+CD25+Foxp3+ T cell numbers were significantly increased in the mucosa and spleen of mice fed B. infantis. Adoptive transfer of CD4+CD25+ T cells transferred the NF-κB inhibitory activity. Consumption of a single commensal micro-organism drives the generation and function of Treg cells which control excessive NF-κB activation in vivo. These cellular interactions provide the basis for a more complete understanding of the commensal-host-pathogen trilogue that contribute to host homeostatic mechanisms underpinning protection against aberrant activation of the innate immune system in response to a translocating pathogen or systemic LPS