Trial reportBMC gastroenterology2023
The effect of melatonin on irritable bowel syndrome patients with and without sleep disorders: a randomized double-blinded placebo-controlled trial study.
Trial report in BMC gastroenterology, 2023. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 14 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
14 citing papers in PubMed, 18 citations in OpenAlex.
- Article
- Multi-strain synbiotic and lifestyle modifications on patients with metabolic dysfunction-associated steatotic liver disease (MASLD): a randomized double-blinded placebo-controlled trial.European journal of medical research · 2026Article
- Melatonin alleviates diarrhea and visceral hypersensitivity in rats with diarrhea-predominant irritable bowel syndrome by modulating of the TLR4/MyD88/NF-κB pathway.BMC gastroenterology · 2025Article
- Melatonin's anti-inflammatory and antioxidant effects in gallstone disease: A narrative review.World journal of hepatology · 2025Review
- Therapeutic Potential of Melatonin in Functional Dyspepsia.The Korean journal of helicobacter and upper gastrointestinal research · 2025Article
- Natural Products for the Treatment of Irritable Bowel Syndrome.Gastroenterology & hepatology · 2025Article
- HowMedicina (Kaunas, Lithuania) · 2025Review
- Unravelling behavioural contributions to IBS risk: evidence from univariate and multivariate Mendelian randomisation.Journal of global health · 2025Article
- Article
- Night shift work increases the risk of developing irritable bowel syndrome: a prospective cohort study in the UK Biobank.Frontiers in public health · 2025Article
- Mind-Body Interventions for Comorbid Sleep and Gastrointestinal Concerns.Current sleep medicine reports · 2025Review
- Melatonin's Impact on Wound Healing.Antioxidants (Basel, Switzerland) · 2024Review
- Article
- Melatonin Alleviates Intestinal Barrier Damaging Effects Induced by Polyethylene Microplastics in Albino Rats.International journal of molecular sciences · 2023Article
Corrections and comments
PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.
Authors and funding
6 authors at 1 institution in 1 country.
Funding
No grant is acknowledged in the PubMed record.
Abstract
backgroundIrritable bowel syndrome (IBS) is one of the world's most common gastrointestinal (GI) disorders, and current treatments do not meet patients' demands. This study aimed to investigate melatonin's therapeutic effects on IBS score, GI symptoms, quality of life, and sleep parameters in both groups of IBS patients with and without sleep disorders.
methodsIn this randomized double-blinded placebo-controlled trial study, 136 patients with a diagnosis of IBS based on ROME IV criteria were enrolled and then divided into two groups respecting having sleep disorders or not. Patients of each group were randomized in a 1:1 ratio to receive melatonin 6 mg daily (3 mg fasting and 3 mg at bedtime) for 2 months (8 weeks). Blocked randomization was used in this process. All patients were evaluated both at the beginning and the end of the trial regarding IBS score, GI symptoms, quality of life, and sleep parameters through valid questionnaires.
resultsIn both groups of patients with and without sleep disorders, a significant improvement was observed in IBS score and GI symptoms, including the severity and the frequency of abdominal pain, the severity of abdominal bloating, satisfaction with bowel habits, disease's impact on patient's life, and stool consistency; however, there was no significant improvement in the frequency of defecations per week. In patients with sleep disorders, significant improvement in sleep parameters, including subjective sleep quality, sleep latency, sleep duration, sleep efficiency, and daytime dysfunction, was observed, while in patients without sleep disorders, there was no significant improvement in sleep parameters. In addition, quality-of-life improvement was observed in a significant number of melatonin recipients compared to placebo in both groups of patients.
conclusionMelatonin can be considered an effective treatment for improving IBS score, GI symptoms, and quality of life in IBS patients with and without sleep disorders. It is also effective to improve sleep parameters in IBS patients with sleep disorders.
trial registrationThis study has been registered to the Iranian Registry of Clinical Trials (IRCT) with the approval number IRCT20220104053626N2 on the date of 13/02/2022.
Indexed as
Identifiers
What OpenQuestion holds
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.