High frequency of spin bias in controlled trials of cannabis derivatives and their synthetic analogues: a Meta-epidemiologic study.

Abstract

OBJECTIVE\nTo investigate the frequency and perform a qualitative analysis of spin bias in publications of controlled trials assessing the therapeutic use of cannabis derivatives and their synthetic analogues.\n\n\nSTUDY DESIGN AND SETTING\nMeta-epidemiologic study carried out at the Universidade Federal de São Paulo, Brazil.\n\n\nRESULTS\n65 publications with at least one efficacy primary outcome were considered. The results analysis for the primary outcome indicated statistically significant effects in 44.6% (29/65) of the publications, and 70.7% (45/65) of the conclusions were considered favorable to the intervention. Among the 36 publications that found statistically non-significant results for the primary outcome, 44.4% (16/36) presented conclusions favorable to or recommending the intervention, which represents spin bias according to the definition adopted in this study. Qualitative analysis of the 16 studies with spin bias showed selective outcomes reporting (elevating secondary outcomes that had positive results or reporting only subgroup results), deviations from the planned statistical analysis, and failure to consider or report uncertainty in the estimates of treatment effects.\n\n\nCONCLUSION\nThe frequency of spin bias among publications of controlled trials with statistically non-significant results assessing the therapeutic use of cannabis derivatives and their synthetic analogues reached 44.4%. When not observed by readers, such deviation can lead to misconduct in clinical practice through the adoption of interventions that are not effective or whose effectiveness is uncertain.