ArticleBioPsychoSocial medicine2021
A randomized, double-blind, placebo-controlled study to assess efficacy of mirtazapine for the treatment of diarrhea predominant irritable bowel syndrome.
Article in BioPsychoSocial medicine, 2021. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 13 papers.
What it found
Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.
The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.
The trial behind it
Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.
Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.
Who cites it
13 citing papers in PubMed, 29 citations in OpenAlex.
- Trial
- Irritable Bowel Syndrome with Constipation: Diagnosis and Multisymptom Management Beyond Abdominal Pain and Bowel Movement Frequency: A Review.Advances in therapy · 2026Review
- Disorders of Gut-Brain Interaction in Eating Disorders: A Review of Management Approaches.Current psychiatry reports · 2026Review
- Mirtazapine for the treatment of irritable bowel syndrome: A systematic review.World journal of methodology · 2026Article
- Diagnosis and treatment of irritable bowel syndrome with diarrhea: Key clinical considerations.Journal of the American Association of Nurse Practitioners · 2026Article
- Placebo response variability on health-related quality of life outcomes in irritable bowel syndrome: an arm-based network meta-analysis.Quality of life research : an international journal of quality of life aspects of treatment, care and rehabilitation · 2025Review
- Impact of sedative and appetite-increasing properties on the apparent antidepressant efficacy of mirtazapine, selective serotonin reuptake inhibitors and amitriptyline: an item-based, patient-level meta-analysis.EClinicalMedicine · 2024Article
- Mirtazapine for gastrointestinal and neuropsychological symptoms in older adults with irritable bowel syndrome.Therapeutic advances in gastroenterology · 2024Review
- Review
- Antidepressants for pain management in adults with chronic pain: a network meta-analysis.The Cochrane database of systematic reviews · 2023Review
- Current perspectives on irritable bowel syndrome: a narrative review.The Journal of international medical research · 2022Review
- Irritable Bowel Syndrome, Depression, and Neurodegeneration: A Bidirectional Communication from Gut to Brain.Nutrients · 2021Review
- Antidepressants in irritable bowel syndrome: a systematic review and meta-analysis of randomized controlled trials.Annals of gastroenterologyArticle
Corrections and comments
PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.
Authors and funding
5 authors at 1 institution in 1 country.
Funding
Abstract
backgroundAmple evidence indicates the efficacy of serotonin type 3 (5-HT
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.
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Registered trials
Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.