a randomised controlled trial on hypnotherapy for irritable bowel syndrome design and methodological challenges (the imagine study)肠易激综合征的随机对照试验在催眠疗法设计和方法论的挑战(想象的研究).pdfVIP

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2017-09-11 发布于上海
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a randomised controlled trial on hypnotherapy for irritable bowel syndrome design and methodological challenges (the imagine study)肠易激综合征的随机对照试验在催眠疗法设计和方法论的挑战(想象的研究).pdf

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a randomised controlled trial on hypnotherapy for irritable bowel syndrome design and methodological challenges (the imagine study)肠易激综合征的随机对照试验在催眠疗法设计和方法论的挑战(想象的研究)

Flik et al. BMC Gastroenterology 2011, 11:137 /1471-230X/11/137 STUDY PROTOCOL Open Access A Randomised Controlled Trial on hypnotherapy for Irritable Bowel Syndrome: design and methodological challenges (the IMAGINE study) 1* 2 3 4 5 6 Carla E Flik , Yanda R van Rood , Wijnand Laan , André JPM Smout , Bas LAM Weusten , Peter J Whorwell and Niek J de Wit7 Abstract Background: 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. Methods/Design: 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 re