Abstract
BackgroundAmple evidence indicates the efficacy of serotonin type 3 (5-HT3) receptor antagonists in the treatment of patients with diarrhea-predominant irritable bowel syndrome (IBS-D). Mirtazapine is an atypical antidepressant with a well-known 5-HT3 receptor antagonist property. This study, therefore, was undertaken to investigate whether compared to placebo, mirtazapine would be efficacious and safe in the treatment of patients with IBS-D.MethodsFrom November 2019 until July 2020, 67 patients meeting Rome IV criteria for IBS-D were randomized in a double-blind fashion into either the mirtazapine treatment group (n = 34) or the placebo treatment group (n = 33). Patients started with mirtazapine 15 mg/day at bedtime for one-week; after which the dose was increased to 30 mg/day for an additional 7-week. Outcomes included changes in the total IBS symptom severity score (IBS-SSS), Hospital anxiety and depression scale score (HADS), and IBS Quality of Life. Additionally, changes in the diary-based symptoms scores including pain, urgency of defecation, bloating, stool frequency, and stool consistency based on the 7-point Bristol Stool Form Scale (BSFS), and a number of days per week with pain, urgency, diarrhea, or bloating, once during the 1-week run-in period, and once during the last week of treatment were recorded.ResultsAll analyses were performed on an Intention-to-Treat (ITT) analysis data set. The results showed compared to placebo, mirtazapine is more efficacious in decreasing the severity of IBS symptoms (P-value = 0.002). Further, at the end of the treatment period, all diary-derived symptoms except bloating showed significantly more improvement in the mirtazapine-treated subjects compared to the placebo-treated subjects. While was well-tolerated, mirtazapine also significantly improved the patients’ quality of life (P-value = 0.04) and anxiety symptoms (P-value = 0.005).ConclusionsOverall, mirtazapine seems to have a potential benefit in the treatment of patients with IBS-D, particularly those with concomitant psychological symptoms. However, further studies are warranted to determine whether these findings are replicated.Trial registrationTrial registration: Registration number at Iranian Registry of Clinical Trials: IRCT20120215009014N311. Registration date: 2019-10-21.
Highlights
Ample evidence indicates the efficacy of serotonin type 3 (5-HT3) receptor antagonists in the treatment of patients with diarrhea-predominant irritable bowel syndrome (IBS-D)
A number of pharmacological treatments are available for the treatment of Irritable bowel syndrome (IBS), most of the currently available drugs focus on alleviating symptoms rather than targeting the underlying pathophysiology
Study design This was an 8-week double blind, randomized, placebocontrolled study that from November 2019 until July 2020 was conducted in a gastroenterology clinic, at a tertiary referral hospital, affiliated to Hamadan University of Medical Sciences, Hamadan, Iran, to evaluate the efficacy of mirtazapine in the treatment of IBS-D
Summary
Ample evidence indicates the efficacy of serotonin type 3 (5-HT3) receptor antagonists in the treatment of patients with diarrhea-predominant irritable bowel syndrome (IBS-D). Irritable bowel syndrome (IBS) is the most common functional gastrointestinal disorder with a relapsing/ remitting course. It is a symptom-based condition defined by abdominal pain and discomfort in association with altered bowel habits, with no identifiable cause [1]. It approximately affects 7–18% of the population worldwide and is more common in women than men [2]. It is believed that the benefits of antidepressants in IBS treatment are not limited only to their anxiolytic and antidepressants effects. There is a need for alternative effective pharmacological treatment for IBS
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