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. 2025 Feb 15;24(1):e156425.
doi: 10.5812/ijpr-156425. eCollection 2025 Jan-Dec.

Assessment of the Efficacy and Safety of Sublingual Melatonin on Symptom Severity, Quality of Life, and Sleep Disorders in Patients with Irritable Bowel Syndrome

Shabnam Shahrokh  1 , Niloofar Namazi  2 , Mohammad Abbasinazari  2 , Ali Abazarikia  2 , Amir Sadeghi  1 , Arash Mahboubi  3
Affiliations

Assessment of the Efficacy and Safety of Sublingual Melatonin on Symptom Severity, Quality of Life, and Sleep Disorders in Patients with Irritable Bowel Syndrome

Shabnam Shahrokh et al. Iran J Pharm Res. .

Abstract

Background: Previous studies have demonstrated the efficacy of melatonin in alleviating symptoms of irritable bowel syndrome (IBS) and improving quality of life (QoL).

Objectives: Due to its superior bioavailability, this trial was designed to compare the effects of sublingual melatonin (SL melatonin) with a placebo in alleviating IBS symptoms, enhancing QoL, and addressing sleep disorders.

Methods: The IBS patients were randomly assigned to receive either 3 mg of SL melatonin or a matching placebo for eight weeks. Participants completed the IBS symptom severity score (IBS-SSS), IBS-quality of life 34 items (IBS-QoL 34), and Pittsburgh Sleep Quality Index (PSQI) questionnaires immediately before and after the study period.

Results: A total of 76 patients completed the trial over six months. The results indicated that the severity of IBS symptoms and QoL scores were significantly better in the SL melatonin group compared to the placebo group (P = 0.032 and P = 0.045, respectively). No participants withdrew from the trial due to serious side effects in either the SL melatonin or placebo groups.

Conclusions: Sublingual melatonin may be administered to IBS patients as a complementary treatment to alleviate symptoms and improve QoL.

Keywords: IBS; Melatonin; Sublingual Tablet; Trial.

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Conflict of interest statement

The authors declared no conflict of interests.

Figures

Figure 1.
Figure 1.. Flowchart of the study
Figure 2.
Figure 2.. Irritable bowel syndrome quality of life-34 (IBS-QoL34) before and after intervention in two arms
Figure 3.
Figure 3.. Pittsburgh Sleep Quality Index (PSQI) scores before and after intervention in two arms
See this image and copyright information in PMC

References

    1. Simren M, Tornblom H, Palsson OS, Whitehead WE. Management of the multiple symptoms of irritable bowel syndrome. Lancet Gastroenterol Hepatol. 2017;2(2):112–22. doi: 10.1016/S2468-1253(16)30116-9. - DOI - PubMed
    1. Camilleri M. Diagnosis and Treatment of Irritable Bowel Syndrome: A Review. JAMA. 2021;325(9):865–77. doi: 10.1001/jama.2020.22532. - DOI - PubMed
    1. Shapiro JM, Deutsch JK. Complementary and Alternative Medicine Therapies for Irritable Bowel Syndrome. Gastroenterol Clin North Am. 2021;50(3):671–88. doi: 10.1016/j.gtc.2021.03.009. - DOI - PubMed
    1. Chen CQ, Fichna J, Bashashati M, Li YY, Storr M. Distribution, function and physiological role of melatonin in the lower gut. World J Gastroenterol. 2011;17(34):3888–98. doi: 10.3748/wjg.v17.i34.3888. - DOI - PMC - PubMed
    1. Chen KH, Zeng BY, Zeng BS, Sun CK, Cheng YS, Su KP, et al. The efficacy of exogenous melatonin supplement in ameliorating irritable bowel syndrome severity: A meta-analysis of randomized controlled trials. J Formos Med Assoc. 2023;122(3):276–85. doi: 10.1016/j.jfma.2022.10.001. - DOI - PubMed

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