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

Systematic review : knowledge and educational needs of patients with irritable bowel syndrome

Educational programs have been used as a control condition in trials on psychological therapies for irritable bowel syndrome (IBS). An optimal control condition should have all logistic features of the experimental intervention, except the active component, but also have basic therapeutic benefit for the patient. The aim of the present study is to systematically determine patients' educational needs on the basis of the (mis) conceptions that they have of their disease and their reported desire for information to optimize the control intervention in IBS research. A systematic review of studies on the knowledge and educational needs of IBS patients in terms of their condition was performed. Studies published as full text in the English language in peer-reviewed journals and that included adult IBS patients diagnosed according to the Manning or Rome I, II, or III criteria were selected. Eight studies involving 2132 patients were included. When focusing on misconceptions of patients, the most prevalent are that IBS is caused by dietary factors, food allergies and intolerance (37-90%), heredity (52%), or a lack of digestive enzymes (52%); IBS is a form of colitis (43%); and will last a lifetime (31-54%), develop into cancer (15-49%), or worsens with age (48%). Patients are 'unhappy' with their level of knowledge or feel poorly informed (65%). They want information about the diagnostic process, which foods to avoid (63%), causes (62%), coping strategies (59%), new medications (55%), course (52%), and the role of psychological factors (51%). IBS patients do have a large variety of educational needs. Educational programs optimally addressing these needs can be used adequately as a placebo control condition in research on psychological interventions. Copyright (C) 2015 Wolters Kluwer Health, Inc. All rights reserved

Multidisciplinaire richtlijn prikkelbaredarmsyndroom.

The multidisciplinary guideline 'Diagnostics and treatment of irritable bowel syndrome (IBS)' provides the basis for a properly coordinated collaboration between the patient suffering from IBS and all healthcare providers involved in his or her treatment, such as the general practitioner, gastroenterologist, internist, occupational-health physician, dietitian and psychologist. The diagnosis 'IBS' is often made in accordance with diagnostic criteria, such as the Rome III criteria, but a somatic condition needs to be excluded first. If there are no indications for this, additional diagnostic tests are not necessary. Management of the condition consists primarily of advice on life-style plus non-pharmacological interventions, in addition to explaining the condition and providing information. Drug treatment is rarely indicated. If the IBS symptoms have a significant impact on quality of life and patients do not respond to the measures taken in accordance with this general policy, there are three options for psychotherapeutic treatment. When the symptoms result in absenteeism or other work-related problems, the doctor can advise the patient to contact the occupational-health physician and to search for specific solutions in consultation with the employer. When individual advice is required or if the patient's diet is not well-balanced, a referral to the dietitian will follow

Comparison of medical costs generated by IBS patients in primary and secondary care in the Netherlands

Background: Irritable Bowel Syndrome (IBS) is a functional somatic syndrome characterized by patterns of persistent bodily complaints for which a thorough diagnostic workup does not reveal adequate explanatory structural pathology. Detailed insight into disease-specific health-care costs is critical because it co-determines the societal impact of the disease, enables the assessment of cost-effectiveness of existing and new treatments, and facilitates choices in treatment policy. In the present study the aim was, to compare the costs and magnitude of healthcare consumption for patients diagnosed with Irritable Bowel Syndrome (IBS) in primary and secondary care, compare these costs with the average health care expenditure for patients without IBS and describe these costs in further detail. Methods: Reimbursement data for patients diagnosed with IBS by a general practitioner (GP) or specialist between 2006 and 2009 were extracted from a healthcare insurance company and compared to an age and gender matched control group of patients without IBS. Using a case-control design, direct medical costs for GP consultations, specialist care and medication prescriptions were calculated. Results: Data of 326 primary care and 9274 secondary care IBS patients were included in the analysis. For primary care patients, the mean total annual health care costs for the three years after diagnosis compared to the three years before diagnosis, increased with 486 Euro after IBS was diagnosed, whereas for secondary care patients, these costs increased with 2328 Euro. Total health care costs remained higher in the three years after the initial diagnosis when the patient is treated in secondary care, compared to primary care. This increase was significant for hospital specialist costs and medications, but not for GP contacts. For controls, there was no significant difference in mean total annual health costs in the three years before and the three years after the diagnosis and also no significant difference in cost increases between both primary-and secondary-care control patients. Conclusion: Total healthcare costs per patient substantially increase after a diagnosis of IBS and IBS related costs are significantly higher when patients are treated in secondary-care compared to primary-care. IBS patients should be treated in primary-care where possible, not only because guidelines recommend this from a quality of care viewpoint, but also to optimize use of health care resources. Referral should be restricted to those patients with alarm symptoms, with ill-matching symptoms, or other cases of diagnostic uncertainty