A meta-analysis of the placebo response in complementary and alternative medicine trials of irritable bowel syndrome.

Among patients with irritable bowel syndrome (IBS) enrolled in clinical trials of conventional medical therapy, the placebo response rate is high. IBS patients also frequently use complementary and alternative medicine (CAM), which may act through an 'enhanced placebo effect'. The purpose of this study was to estimate the magnitude of the placebo response rate in CAM trials for IBS and to identify factors that influence this response. We performed a systematic review and meta-analysis of randomized, placebo-controlled clinical trials of CAM therapies for IBS identified from MEDLINE/EMBASE/PsychLIT databases from 1970 to 2006. Placebo and active treatment response rates for global symptom improvement were assessed. Nineteen studies met the inclusion criteria. The pooled estimate of the placebo response rate was 42.6% (95% confidence interval, 38.0-46.5%). Significant heterogeneity existed across trials (range 15.0-72.2%, P < 0.00001). Higher placebo response rates correlated with a longer duration of treatment (r = 0.455, P = 0.05) and a greater number of office visits (r = 0.633, P = 0.03). Among IBS patients in CAM trials, the placebo response rate is high. That this rate is similar in magnitude to that seen in conventional medicine trials suggests that the placebo response is independent of the type of therapy used and that it is not particularly 'enhanced' in CAM trials.

Development and pilot testing of an integrated, web-based self-management program for irritable bowel syndrome (IBS).

BACKGROUND: Although essential, many medical practices are unable to adequately support irritable bowel syndrome (IBS) patient self-management. Web-based programs can help overcome these barriers. METHODS: We developed, assessed, and refined an integrated IBS self-management program (IBS Self-care). We then conducted a 12-week pilot test to assess program utilization, evaluate its association with patients' self-efficacy and quality of life, and collect qualitative feedback to improve the program. KEY RESULTS: 40 subjects with generally mild IBS were recruited via the Internet to participate in a 12-week pilot study. Subjects found the website easy to use (93%) and personally relevant (95%), and 90% would recommend it to a friend. Self-rated IBS knowledge increased from an average of 47.1 on a 100-point VAS scale (SD 22.1) at baseline to 77.4 (SD: 12.4) at week 12 (p < 0.0001). There were no significant changes in patient self-efficacy (Patient Activation Measure) or quality of life (IBS -Quality of Life Scale). CONCLUSIONS & INFERENCES: The IBS Self-Care program was well received by users who after 12 weeks reported improved knowledge about IBS, but no significant changes in self-efficacy or quality of life. If applied to the right population, this low cost solution can overcome some of the deficiencies of medical care and empower individuals to better manage their own IBS.

Systematic review: self-management support interventions for irritable bowel syndrome.

BACKGROUND: Irritable bowel syndrome is an extremely common and costly condition. Because there is no cure, patients must be supported to manage their own condition. AIM: To assess systematically the interventions used to support irritable bowel syndrome patient self-management. METHODS: A search of PubMed, EMBASE, CINAHL and PsycINFO was performed to identify all studies that involved self-management support interventions for irritable bowel syndrome. Studies that compared the self-management-related intervention to a control group were included. RESULTS: Eleven studies that involved a total of 1657 patients were included. For nearly all studies, the intervention was associated with statistically significant benefits. However, across studies there was significant heterogeneity in terms of sample size, diagnostic criteria, study setting, study design, primary outcome, statistical analyses and study quality. Therefore, individual study results could not be statistically combined. CONCLUSIONS: Many self-management support interventions appear benefit patients with irritable bowel syndrome. However, studies were limited by methodological flaws. Furthermore, feasibility in 'real world' clinical practice is uncertain. Thus, practical self-management interventions that can be applied across various clinical settings should be developed, and then tested in well-designed clinical trials.

The development and validation of a new coeliac disease quality of life survey (CD-QOL).

BACKGROUND: Previous studies on coeliac disease (CD)-related quality of life (QOL) have been limited by their use of a 'generic' rather than coeliac disease-specific assessment instruments. AIM: To develop and psychometrically validate a new coeliac disease-specific instrument, the CD-QOL. METHODS: Through a series of focus groups, we elicited items from patients that related to the specific nature of their disease and its impact on their basic needs. Through expert review, cognitive debriefing with patients and pilot testing, a scale was developed, refined and administered to 387 patients on a gluten-free diet from both community-based support groups and a tertiary care referral centre. Finally, a formal validation study was conducted to assess the psychometric properties of the CD-QOL. RESULTS: The final CD-QOL has 20 items across four clinically relevant subscales (Limitations, Dysphoria, Health Concerns, and Inadequate Treatment). The CD-QOL has high internal consistency, reliability, and psychometric validation indicates both convergent and discriminate validity. CONCLUSIONS: The CD-QOL is a reliable and valid measure of coeliac disease related QOL. As a new disease-specific instrument, it is likely to be a useful tool for evaluating patients with this disorder.