Shabnam Shahrokh, Niloofar Namazi, Mohammad Abbasinazari, Ali Abazarikia, Amir Sadeghi, Arash Mahboubi
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引用次数: 0
摘要
背景：既往研究已证实褪黑素在缓解肠易激综合征（IBS）症状和改善生活质量（QoL）方面的疗效。目的：由于其优越的生物利用度，本试验旨在比较舌下褪黑素（SL褪黑素）与安慰剂在缓解肠易激综合征症状、提高生活质量和解决睡眠障碍方面的作用。方法：IBS患者被随机分配接受3毫克SL褪黑素或相匹配的安慰剂，为期8周。参与者在研究前后立即完成IBS症状严重程度评分（IBS- sss）， IBS-生活质量34项（IBS- qol 34）和匹兹堡睡眠质量指数（PSQI）问卷。结果：共有76名患者在6个月内完成了试验。结果显示，SL褪黑素组IBS症状严重程度和生活质量评分明显优于安慰剂组（P = 0.032和P = 0.045）。在SL褪黑素组或安慰剂组中，没有参与者因为严重的副作用而退出试验。结论：舌下褪黑素可作为IBS患者的辅助治疗，缓解症状，改善生活质量。
Assessment of the Efficacy and Safety of Sublingual Melatonin on Symptom Severity, Quality of Life, and Sleep Disorders in Patients with Irritable Bowel Syndrome.
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.
期刊介绍：
The Iranian Journal of Pharmaceutical Research (IJPR) is a peer-reviewed multi-disciplinary pharmaceutical publication, scheduled to appear quarterly and serve as a means for scientific information exchange in the international pharmaceutical forum. Specific scientific topics of interest to the journal include, but are not limited to: pharmaceutics, industrial pharmacy, pharmacognosy, toxicology, medicinal chemistry, novel analytical methods for drug characterization, computational and modeling approaches to drug design, bio-medical experience, clinical investigation, rational drug prescribing, pharmacoeconomics, biotechnology, nanotechnology, biopharmaceutics and physical pharmacy.
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