The Effect of Ramelteon on Heartburn Symptoms of Patients With Gastroesophageal Reflux Disease and Chronic Insomnia A Pilot Study
The Effect of Ramelteon on Heartburn Symptoms of Patients With Gastroesophageal Reflux Disease and Chronic Insomnia A Pilot Study
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DOI：
10.1097/mcg.0000000000000322
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发表时间：
2016-02-01
影响因子：
2.9
通讯作者：
Dickman, Ram
中科院分区：
文献类型：
--
作者：
Jha, Lokesh K.;Fass, Ronnie;Dickman, Ram
背景：胃食管反流病（GERD）与睡眠存在双向关系。研究表明，抗反流治疗可以改善伴有夜间反流的胃食管反流患者的睡眠质量。材料与方法：纳入胃灼热和/或反流3次/周、失眠3个月的患者。采用人口统计学、胃食管反流症状评估量表、Epworth嗜睡量表、柏林睡眠呼吸暂停、匹兹堡睡眠质量指数和失眠严重程度指数问卷对患者进行基线评估。受试者接受上颌内窥镜检查，随后进行pH值测试。随后，在一项双盲安慰剂对照试验中，受试者被随机分组，在睡前服用8毫克拉美替恩或安慰剂，持续4周。在治疗的最后一周，受试者完成每日胃食管反流症状和睡眠日记，并进行活动记录。结果：16例患者完成了研究，每组8例（平均年龄和M/F分别为48.5 vs 57.8 y, 8/0 vs 6/2）。与接受安慰剂的患者相比，接受拉美替恩的患者在白天胃灼热（-42%比-29%）、夜间胃灼热（-42%比- 78%）、24小时胃灼热（-42%比-3%）和24小时胃酸反流（-26%比- 19%）方面的症状评分有统计学意义上的降低
Background:There is a bidirectional relationship between gastroesophageal reflux disease (GERD) and sleep. It has been demonstrated that antireflux treatment can improve sleep quality in GERD patients with nighttime reflux.Materials and Methods:Patients with heartburn and/or regurgitation 3 times/week and insomnia for 3 months were included. Patients were assessed at baseline with the demographic, GERD symptom assessment scale, Epworth sleepiness scale, Berlin sleep apnea, Pittsburgh sleep quality index, and the Insomnia severity index questionnaires. Subjects underwent an upper endoscopy followed by pH testing. Subsequently, subjects were randomized, in a double-blind, placebo-controlled trial, to receive either ramelteon 8 mg or placebo before bedtime for 4 weeks. During the last week of treatment, subjects completed a daily GERD symptom and sleep diary and underwent actigraphy.Results:Sixteen patients completed the study, 8 in each arm (mean age and M/F were 48.5 vs. 57.8 y, and 8/0 vs. 6/2, respectively). Patients who received ramelteon demonstrated a statistically significant decrease in symptom score as compared with those who received placebo for daytime heartburn (-42% vs. -29%), nighttime heartburn (-42% vs. 78%), 24-hour heartburn (-42% vs. -3%), and 24-hour acid regurgitation (-26% vs. 19%) (all P