使用褪黑素治疗肠易激综合征:随机安慰剂对照临床试验的系统回顾

D. S. Mironov, I. A. Spirin, T. N. Trubeckaya, N. S. Shitova, V. A. Postoev
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摘要

简介肠易激综合征(IBS)是最常见的胃肠道功能性疾病之一,严重影响患者的生活质量。目前,治疗这种疾病只能使用对症药物。虽然使用褪黑素可被视为一种病因疗法,但其疗效尚未得到确证。这篇随机安慰剂对照临床试验的系统性综述回顾了褪黑素对肠易激综合征患者疗效评估的现有数据。材料和研究方法。在 PubMed、ScienceDirect、ClinicalTrials.gov、Cochrane Library、eLibrary、medRxiv 和 International Clinical Trials Registry Platform 等数据库中搜索并筛选了自发表至 2022 年 10 月 30 日期间的出版物。结果符合纳入标准的有四项随机安慰剂对照试验,共有 155 人参加,这些试验均纳入了随后的分析。所有调查都显示,腹胀的频率和严重程度都有显著降低,其他肠道症状也有减轻的趋势。有两项试验报告称患者的生活质量有所改善,不过其中一项研究发现这些变化在统计学上并不显著,另一项研究也没有对这些变化进行评估。本综述表明,在绝大多数已发表的 RCT 中,褪黑素可降低肠易激综合征症状的频率和严重程度,从而有效治疗肠易激综合征。由于临床试验的数量和样本量较少,而且方法质量不高,因此我们无法就褪黑激素对改善肠易激综合征患者生活质量的贡献得出任何肯定的结论。要确认褪黑素在治疗肠易激综合征患者方面的重要性,还需要进行更大规模的研究,以评估褪黑素以不同剂量使用时的疗效和安全性。
本文章由计算机程序翻译,如有差异,请以英文原文为准。
The use of melatonin in the treatment of irritable bowel syndrome: a systematic review of randomized placebo-controlled clinical trials
Introduction. One of the most prevalent functional disorders of the gastrointestinal system, irritable bowel syndrome (IBS), significantly affects patients’ quality of life. At the moment, only symptomatic drugs are used to treat this disorder. Although using melatonin can be thought of as a form of pathogenetic therapy, its efficacy has not yet been conclusively demonstrated. This systematic review of randomized placebo controlled clinical trials reviews current data on the evaluation of the efficacy of melatonin in patients with IBS. Material and research methods. The search and selection of publications was carried out in the PubMed, ScienceDirect, ClinicalTrials.gov, Cochrane Library, eLibrary, medRxiv and International Clinical Trials Registry Platform databases from their publication until October 30, 2022. Results. The inclusion criteria were met by four randomized placebo-controlled trials, totaling 155 participants, and these trials were included in the subsequent analysis. All investigations revealed a considerable reduction in the frequency and severity of bloating, as well as a tendency for other intestinal symptoms to regress. Two trials reported an improvement in patients’ quality of life, albeit one of the studies did not find these changes to be statistically significant, and the other did not assess them. This review demonstrates that melatonin is effective in treating IBS by lowering the frequency and severity of the condition’s symptoms in the vast majority of published RCTs. The poor number and sample size of clinical trials, along with their inadequate methodological quality, prevent us from drawing any firm conclusions about the contribution of melatonin to the improvement of IBS patients’ quality of life. To confirm melatonin’s significance in the treatment of IBS patients, larger studies are required to assess its efficacy and safety when used in various doses.
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