Liver and Gastrointestinal Diseases Research Center, Tabriz University of Medical Sciences, Tabriz, Iran.
BMC Gastroenterol. 2023 Apr 25;23(1):135. doi: 10.1186/s12876-023-02760-0.
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.
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.
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.
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.
This study has been registered to the Iranian Registry of Clinical Trials (IRCT) with the approval number IRCT20220104053626N2 on the date of 13/02/2022.
肠易激综合征（IBS）是世界上最常见的胃肠道（GI）疾病之一，目前的治疗方法无法满足患者的需求。本研究旨在探讨褪黑素对伴有和不伴有睡眠障碍的 IBS 患者的 IBS 评分、GI 症状、生活质量和睡眠参数的治疗效果。
在这项随机双盲安慰剂对照试验研究中，根据罗马 IV 标准诊断为 IBS 的 136 名患者被纳入研究，并随后根据是否存在睡眠障碍分为两组。每组患者按 1:1 的比例随机分为两组，分别接受褪黑素 6mg/天（空腹 3mg，睡前 3mg）治疗 2 个月（8 周）。在这个过程中使用了分组随机化。所有患者在试验开始和结束时都通过有效问卷评估 IBS 评分、GI 症状、生活质量和睡眠参数。
在伴有和不伴有睡眠障碍的两组患者中，IBS 评分和 GI 症状均显著改善，包括腹痛严重程度和频率、腹胀严重程度、对排便习惯的满意度、疾病对患者生活的影响以及粪便稠度；然而，每周排便频率无显著改善。在有睡眠障碍的患者中，睡眠参数包括主观睡眠质量、入睡潜伏期、睡眠时间、睡眠效率和日间功能障碍均显著改善，而在无睡眠障碍的患者中，睡眠参数无显著改善。此外，与安慰剂相比，在两组患者中，接受褪黑素治疗的患者生活质量显著改善。
褪黑素可被视为改善伴有和不伴有睡眠障碍的 IBS 患者 IBS 评分、GI 症状和生活质量的有效治疗方法。它对改善伴有睡眠障碍的 IBS 患者的睡眠参数也有效。
本研究于 2022 年 2 月 13 日在伊朗临床试验注册中心（IRCT）注册，注册号为 IRCT20220104053626N2。
