Maria Manuela Estevinho1, Joana Afonso1, Isadora Rosa2, Paula Lago3, Eunice Trindade4, Luís Correia5, Cláudia Camila Dias6, Fernando Magro1,7. 1. Department of Pharmacology and Therapeutics, Faculty of Medicine of the University of Porto, Porto, Portugal. 2. Gastroenterology Department, Instituto Portugue^s de Oncologia de Lisboa, Lisboa, Portugal. 3. Gastroenterology Department, Centro Hospitalar do Porto, Porto, Portugal. 4. Department of Pediatrics, Centro Hospitalar São João, Porto, Portugal. 5. Department of Gastroenterology and Hepatology, Hospital de Santa Maria, University of Lisbon, Lisbon, Portugal. 6. Department of Community Medicine, Information and Decision in Health, Faculty of Medicine of the University of Porto, and Centre for Health Technology and Services Research, Porto, Portugal. 7. Department of Gastroenterology, Centro Hospitalar São João, Porto, Portugal.
Abstract
BACKGROUND AND AIMS: Placebo effect in health-related quality of life [HRQoL] of inflammatory bowel disease [IBD] patients has been poorly characterised. This systematic review and meta-analysis aimed to assess: i] mean improvements in IBDQ [Inflammatory Bowel Disease Questionnaire] and SF-36 [36-Item Short Form Health Survey] scores among placebo-treated IBD patients; and ii] the proportion of placebo-treated patients achieving IBDQ-defined response and remission and correspondent odds ratios [OR]. METHODS: Literature search was performed using four databases. Mean differences and ORs were computed using the random-effects model. Univariate and multivariate regressions were performed to evaluate the weight of different factors on the placebo effect. RESULTS: From the 328 identified records 26 were included in the study, comprising 2842 placebo-treated IBD patients. Pooled mean differences on IBDQ following placebo administration were above the clinically meaningful improvement [≥16 points] in ulcerative colitis [UC] patients during the induction regimen (17.67; 95% confidence interval [CI]: 12.90, 22.44) and during maintenance in both Crohn's disease [CD] [27.60; 95% CI: 14.29, 40.91] and UC patients [27.50; 95% CI: 18.73, 36.27]. The treatment regimen was the only significant variable in multivariate analysis, with lower placebo-related IBDQ improvements during induction. Maintenance trials' inclusion criteria were also relevant. The proportions of placebo-treated patients achieving IBDQ-defined response and remission were 0.42 [95% CI: 0.49, 0.56] and 0.31 [95% CI: 0.28, 0.34], respectively, with 0.49 and 0.40 the ORs for response and remission. Significant improvements were also observed on SF-36 score. CONCLUSIONS: Herein we prove that placebo effect on HRQoL is meaningful, providing insights about implications for clinical trials' design and interpretation and for IBD management.
BACKGROUND AND AIMS: Placebo effect in health-related quality of life [HRQoL] of inflammatory bowel disease [IBD] patients has been poorly characterised. This systematic review and meta-analysis aimed to assess: i] mean improvements in IBDQ [Inflammatory Bowel Disease Questionnaire] and SF-36 [36-Item Short Form Health Survey] scores among placebo-treated IBD patients; and ii] the proportion of placebo-treated patients achieving IBDQ-defined response and remission and correspondent odds ratios [OR]. METHODS: Literature search was performed using four databases. Mean differences and ORs were computed using the random-effects model. Univariate and multivariate regressions were performed to evaluate the weight of different factors on the placebo effect. RESULTS: From the 328 identified records 26 were included in the study, comprising 2842 placebo-treated IBD patients. Pooled mean differences on IBDQ following placebo administration were above the clinically meaningful improvement [≥16 points] in ulcerative colitis [UC] patients during the induction regimen (17.67; 95% confidence interval [CI]: 12.90, 22.44) and during maintenance in both Crohn's disease [CD] [27.60; 95% CI: 14.29, 40.91] and UC patients [27.50; 95% CI: 18.73, 36.27]. The treatment regimen was the only significant variable in multivariate analysis, with lower placebo-related IBDQ improvements during induction. Maintenance trials' inclusion criteria were also relevant. The proportions of placebo-treated patients achieving IBDQ-defined response and remission were 0.42 [95% CI: 0.49, 0.56] and 0.31 [95% CI: 0.28, 0.34], respectively, with 0.49 and 0.40 the ORs for response and remission. Significant improvements were also observed on SF-36 score. CONCLUSIONS: Herein we prove that placebo effect on HRQoL is meaningful, providing insights about implications for clinical trials' design and interpretation and for IBD management.
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