Vortioxetine Effects on Quality of Life of Irritable Bowel Syndrome Patients: A Randomized, Double-Blind, Placebo-Controlled Trial Publisher Pubmed



Seddighnia A¹ ; Tadayon Najafabadi B¹ ; Ghamari K¹ ; Noorbala AA² ; Ebrahimi Daryani N³ ; Kashani L⁴ ; Akhondzadeh S¹ Show Affiliations
Source: Journal of Clinical Pharmacy and Therapeutics Published:2020

Abstract

What is known and objective: Irritable bowel syndrome (IBS) is a functional gastrointestinal disease causing a substantial productivity loss with no definite treatment. Our study investigates the effects of vortioxetine vs placebo in enhancing the IBS patients' quality of life. Methods: In a double-blinded, placebo-controlled, randomized trial, adults with IBS, according to the ROME IV criteria, were randomized to placebo and vortioxetine for 6 weeks. Participants were visited every two weeks to fill IBS quality of life, hospital anxiety and depression scale, and adverse effect questionnaires. Results: Eighty patients were randomized, and seventy-two finished the trial. Baseline characteristics of groups were similar. Both placebo and vortioxetine significantly increased the quality of life during course of the study (both P-values <.001), whereas vortioxetine demonstrated a greater increase (P-value <.001). According to the analysis of covariances, this enhancement was irrespective of depression or anxiety score changes (P-value =.002). Adverse effect profile was similar between the groups and can increase IBS patients' quality of life superior to placebo. Vortioxetine effects in our study were observed irrespective of the depression and anxiety levels. © 2019 John Wiley & Sons Ltd