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

[Sly Saint]

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

 

[bobbler]

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:

Melatonin is a hormone secreted by the pineal gland with a photoperiodic pattern that regulates the circadian rhythm. Furthermore, melatonin is also found in the GI tract, 400 times more than the secreted amount of the pineal gland, which is mostly synthesized in enterochromaffin cells [4, 12]. Mozaffari et al. [4] conducted a systematic review on the effects of melatonin in the GI tract and IBS; and concluded that melatonin has anxiolytic, anti-inflammatory, anti-oxidative, and motility regulatory effects. In addition, they concluded that melatonin concentrations are disturbed in IBS patients so melatonin deficiency may be an influential factor in the pathogenesis of IBS. They suggested that exogenous melatonin may benefit these patients by reducing abdominal pain and improving overall IBS symptom scores due to its potential to regulate GI motility.

 

[Dolphin]

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).

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).

 

[Hutan]

I'm so used to reading dodgy methods I was cynical when reading their description of placebo-controlled etc so had a look.

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:

The most important limitation of our trial was not classifying the sub-types of IBS (IBS-C or IBS-D), which probably affected the results of the "Frequency of defecations per week" parameter. Adherence to the trial was evaluated based on the patient's statements so that all patients stated that they adhered to the trial, and no patients were excluded from the trial for this reason. Another limitation was using questionnaires to evaluate the parameters because some patients may not be accurate enough or even exaggerate when answering the questions; so, using other methods, such as polysomnography, could give more accurate data instead of a questionnaire to determine sleep disorders. For a definite conclusion as well as the optimal drug dose, patients who benefit the most from this treatment, and long-term effects of melatonin, it is recommended conduct more trials with a larger sample size in which patients are classified into IBS subtypes, in a more extended period of trial using objective methods than questionaries.

Can anyone find a reason to doubt this result?