Academic Journal
A randomized, double-blind, placebo-controlled study to assess efficacy of mirtazapine for the treatment of diarrhea predominant irritable bowel syndrome
| Title: | A randomized, double-blind, placebo-controlled study to assess efficacy of mirtazapine for the treatment of diarrhea predominant irritable bowel syndrome |
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| Authors: | Alireza Khalilian, Davoud Ahmadimoghaddam, Shiva Saki, Younes Mohammadi, Maryam Mehrpooya |
| Source: | BioPsychoSocial Medicine, Vol 15, Iss 1, Pp 1-12 (2021) |
| Publisher Information: | BMC, 2021. |
| Publication Year: | 2021 |
| Collection: | LCC:Neurosciences. Biological psychiatry. Neuropsychiatry |
| Subject Terms: | Irritable bowel syndrome, Diarrhea, 5-hydroxytryptamine, Mirtazapine, Neurosciences. Biological psychiatry. Neuropsychiatry, RC321-571 |
| More Details: | Abstract Background 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). 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. Methods From 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. Results All 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). Conclusions Overall, 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 registration Trial registration: Registration number at Iranian Registry of Clinical Trials: IRCT20120215009014N311 . Registration date: 2019-10-21. |
| Document Type: | article |
| File Description: | electronic resource |
| Language: | English |
| ISSN: | 1751-0759 04473973 |
| Relation: | https://doaj.org/toc/1751-0759 |
| DOI: | 10.1186/s13030-021-00205-2 |
| Access URL: | https://doaj.org/article/fca61a7b76c04473973f9333d1c059cb |
| Accession Number: | edsdoj.fca61a7b76c04473973f9333d1c059cb |
| Database: | Directory of Open Access Journals |
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| ISSN: | 17510759 04473973 |
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| DOI: | 10.1186/s13030-021-00205-2 |
| Published in: | BioPsychoSocial Medicine |
| Language: | English |