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Placebo Effect on the Health-related Quality of Life of Inflammatory Bowel Disease Patients: A Systematic Review With Meta-analysis

2018; Oxford University Press; Volume: 12; Issue: 10 Linguagem: Inglês

10.1093/ecco-jcc/jjy100

1876-4479

María Manuela Estevinho, Joana Afonso, Isadora Rosa, Paula Lago, Eunice Trindade, L Correia, Cláudia Camila Dias, Fernando Magro,

Gastrointestinal motility and disorders

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]. 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. 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. Herein we prove that placebo effect on HRQoL is meaningful, providing insights about implications for clinical trials' design and interpretation and for IBD management.