| Interventions |
Fluoxetine was selected based on previous research showing its anti-inflammatory properties in humans, and in relation to IBD based on findings of studies examining animal models of colitis. Previous human studies have recommended a dose of 20mg daily (which is considered a low therapeutic dose when used in the treatment of depression) and the length of study to be at least 3 to 8 weeks in order to show fluoxetine's efficacy. However, the present study was concerned with the longitudinal efficacy of fluoxetine as an agent modifying the course of IBD and psychological parameters, and thus treatment was provided for 12 months with the dose of 20mg daily administered orally. A Generic Health brand of fluoxetine was purchased from the RAH pharmacy and the placebo was an inactive tablet produced by Pharmaceutical Packaging Professionals as recommended by the same pharmacy. Treatment with fluoxetine is currently not part of standard practice in gastroenterology, however, in our case-note audit we demonstrated that a life-time use of antidepressants in our IBD patients is approx. 30% and thus many patients would have been exposed to antidepressants, including fluoxetine. In the audit, we did not identify any major adverse-events related to the use of antidepressants in IBD and the interview we conducted with IBD patients currently taking antidepressants demonstrated their acceptance by this population. |