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BACKGROUND: Despite the apparent high placebo response rate in randomized placebo-controlled trials (RCT) of patients with irritable bowel syndrome (IBS), little is known about the variability and predictors of this response.
OBJECTIVES: To describe the magnitude of response in placebo arms of IBS clinical trials and to identify which factors predict the variability of the placebo response.
METHODS: We performed a meta-analysis of published, English language, RCT with 20 or more IBS patients who were treated for at least 2 weeks. This analysis is limited to studies that assessed global response (improvement in overall symptoms). The variables considered as potential placebo modifiers were study design, study duration, use of a run-in phase, Jadad score, entry criteria, number of office visits, number of office visits/study duration, use of diagnostic testing, gender, age and type of medication studied.
FINDINGS: Forty-five placebo-controlled RCTs met the inclusion criteria. The placebo response ranged from 16.0 to 71.4% with a population-weighted average of 40.2%, 95% CI (35.9-44.4). Significant associations with lower placebo response rates were fulfillment of the Rome criteria for study entry (P=0.049) and an increased number of office visits (P=0.026).
CONCLUSIONS: Placebo effects in IBS clinical trials measuring a global outcome are highly variable. Entry criteria and number of office visits are significant predictors of the placebo response. More stringent entry criteria and an increased number of office visits appear to independently decrease the placebo response.
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<p>Psychotherapeutic interventions containing training in mindfulness meditation have been shown to help participants with a variety of somatic and psychological conditions. Mindfulness-based cognitive therapy (MBCT) is a meditation-based psychotherapeutic intervention designed to help reduce the risk of relapse of recurrent depression. There is encouraging early evidence from multi-centre randomized controlled trials. However, little is known of the process by which MBCT may bring therapeutic benefits. This study set out to explore participants' accounts of MBCT in the mental-health context. Seven participants were interviewed in two phases. Interview data from four participants were obtained in the weeks following MBCT. Grounded theory techniques were used to identify several categories that combine to describe the ways in which mental-health difficulties arose as well as their experiences of MBCT. Three further participants who have continued to practise MBCT were interviewed so as to further validate, elucidate and extend these categories. The theory suggested that the preconceptions and expectations of therapy are important influences on later experiences of MBCT. Important areas of therapeutic change ('coming to terms') were identified, including the development of mindfulness skills, an attitude of acceptance and 'living in the moment'. The development of mindfulness skills was seen to hold a key role in the development of change. Generalization of these skills to everyday life was seen as important, and several ways in which this happened, including the use of breathing spaces, were discussed. The study emphasized the role of continued skills practice for participants' therapeutic gains. In addition, several of the concepts and categories offered support to cognitive accounts of mood disorder and the role of MBCT in reducing relapse.</p>
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