Division of Otolaryngology Head and Neck Surgery, Stony Brook University Medical Center, Stony Brook, New York 11794-8191, USA.
Otolaryngol Head Neck Surg. 2012 Apr;146(4):524-32. doi: 10.1177/0194599812436933. Epub 2012 Feb 3.
To perform a systematic literature review that evaluates the impact of proton pump inhibitor treatment of gastroesophageal reflux disease on sleep disturbance-related outcomes.
PubMed, Web of Science, and Cochrane databases were searched from 1989 (when omeprazole became available) to present; additional references gleaned from citations.
The search strategy identified all randomized placebo-controlled clinical trials published in English; both proton pump inhibitor use and outcome measures of sleep disturbance were reported for esophageal reflux disease patients. Using a preestablished systematic review protocol and data extraction format, 4 coauthors independently reviewed all articles.
The original search identified 20 articles; 9 were not directly relevant, and 3 were not placebo controlled. Sample sizes varied from 15 to 642; mean age was 47.4 ± 4.56 years; mean body mass index was 29.4 ± 2.9; the proportion of women varied widely across studies. Esomeprazole was studied most frequently. More than 50% of publications permitted rescue antacids. Two studies reported polysomnography outcomes, without statistically significant improvement. All studies reported non-polysomnography outcomes; 7 identified statistically significant improvements demonstrating drug treatment superiority over placebo.
The existing evidence supports the use of proton pump inhibitors as a treatment for esophageal reflux disease to improve quality-of-life sleep disturbance-related outcomes. Given the wide variability in proton pump inhibitor treatments and sleep disturbance-related outcomes reported, however, study-specific results cannot be directly compared or aggregated. This conclusion appears robust not only for 7 of 8 studies included but also for the 3 highest quality studies.
系统评价质子泵抑制剂治疗胃食管反流病对睡眠障碍相关结局的影响。
从 1989 年(奥美拉唑上市时)到现在,检索了 PubMed、Web of Science 和 Cochrane 数据库;从引文获取了额外的参考文献。
搜索策略确定了所有以英文发表的随机安慰剂对照临床试验;报告了质子泵抑制剂的使用情况和食管反流病患者的睡眠障碍结局测量。使用预先制定的系统评价方案和数据提取格式,4 位合著者独立审查了所有文章。
最初的搜索确定了 20 篇文章;9 篇不直接相关,3 篇不是安慰剂对照。样本量从 15 到 642 不等;平均年龄为 47.4 ± 4.56 岁;平均体重指数为 29.4 ± 2.9;女性比例在不同研究中差异很大。埃索美拉唑研究最多。超过 50%的出版物允许使用救急抗酸剂。两项研究报告了多导睡眠图结果,但没有统计学上的显著改善。所有研究都报告了非多导睡眠图结果;7 项研究表明药物治疗优于安慰剂,具有统计学意义的改善。
现有证据支持质子泵抑制剂作为治疗食管反流病的一种方法,以改善与睡眠质量相关的生活质量。然而,鉴于质子泵抑制剂治疗和睡眠障碍相关结局的广泛变异性,研究特定的结果不能直接比较或汇总。这一结论不仅适用于 8 项研究中的 7 项,也适用于 3 项质量最高的研究。