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The effect of melatonin on irritable bowel syndrome patients with and without sleep disorders: a randomized double-blinded..trial, 2023,Dinevari et al

Discussion in ''Conditions related to ME/CFS' news and research' started by Sly Saint, Apr 26, 2023.

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  1. Sly Saint

    Sly Saint Senior Member (Voting Rights)

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    The effect of melatonin on irritable bowel syndrome patients with and without sleep disorders: a randomized double-blinded placebo-controlled trial study
    2023 Dinevari et al

    Abstract
    Background
    Irritable 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.

    Methods
    In 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.

    Results
    In 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.

    Conclusion
    Melatonin 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.

    https://bmcgastroenterol.biomedcentral.com/articles/10.1186/s12876-023-02760-0
     
    Last edited by a moderator: Apr 26, 2023
    Sly Saint, Apr 26, 2023
    #1
    Binkie4, Peter Trewhitt, Hutan and 5 others like this.
  2. bobbler

    bobbler Senior Member (Voting Rights)

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    I'm so used to reading dodgy methods I was cynical when reading their description of placebo-controlled etc so had a look. But it does seem they divided each group equally etc. And that when looking at the figures for the IBS stuff it did seem to have an effect just as much on those without sleep disorders as those with.

    I don't know what the power situation is regarding the numbers for this one, but it is interesting. It wouldn't be the first time that a drug had a second usage that it works for.

    I found the following interesting in the discussion:

     
    bobbler, Apr 26, 2023
    #2
    Binkie4, Peter Trewhitt, alktipping and 3 others like this.
  3. Dolphin

    Dolphin Senior Member (Voting Rights)

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    I hope someone does a trial of a lower dose. Not sure how comfortable I would be taking that dosage (though I’m no melatonin expert).
     
    Dolphin, Apr 26, 2023
    #3
    Binkie4, Peter Trewhitt, alktipping and 2 others like this.
  4. Hutan

    Hutan Moderator Staff Member

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    Yes, this study looks ok to me too, written well, designed well, clear and consistent benefits.

    Iranian research. A supplier is mentioned as providing the melatonin and placebo tablets, but there are no conflicts of interest declared by the researchers. Even if they did have a connection with a supplement company, melatonin is a widely available supplement, so there is less of an incentive for the researchers to fiddle the results. I mean, it's not creating demand for a proprietary mixture for a company with a monopoly on the supply.

    I've been dubious about melatonin, especially because a South Australian professor of animal physiology, who knows about use of melatonin in animal production systems to affect reproduction expressed very strong concerns about melatonin being used in young humans. But, this study makes me rethink my doubt a bit (although I still would not want to give it to young people).

    The Limitations section seemed well thought through:
    Can anyone find a reason to doubt this result?
     
    Hutan, Apr 26, 2023
    #4
    Binkie4, Peter Trewhitt, RedFox and 4 others like this.

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