Gastroenterology and Hepatology, Mayo Clinic, Rochester, Minnesota.
Biomedical Statistics and Informatics, Mayo Clinic, Rochester, Minnesota.
Clin Gastroenterol Hepatol. 2018 Mar;16(3):401-406.e2. doi: 10.1016/j.cgh.2017.10.021. Epub 2017 Dec 1.
BACKGROUND & AIMS: Tricyclic antidepressants are effective in reducing symptoms of functional dyspepsia (FD). We performed a post hoc analysis of data from a previous randomized clinical trial to determine whether the benefits of an antidepressant on gastrointestinal symptoms in patients with FD were mediated by improving sleep or reducing anxiety. We explored the relationships between psychological measures, quality of sleep, and relief of symptoms.
We analyzed data from a multicenter, double-blind trial that evaluated the efficacy of antidepressants on symptoms of FD, from October 2006 through October 2012. Patients (n = 292) were randomly assigned to groups given 50 mg amitriptyline, 10 mg escitalopram, or placebo for 12 weeks. During the study, participants completed the following validated psychological questionnaires: Symptom Check List 90, Symptom Somatic Checklist, Hospital Anxiety Depression Scale, Profile of Mood States, State Trait Anxiety Inventory, and Pittsburgh Sleep Quality Index at baseline and 12 weeks following treatment.
Baseline scores for the psychological and sleep measures were similar among groups; after 12 weeks there were no significant differences in scores among groups. Baseline mean global Pittsburgh Sleep Quality Index scores indicated poor sleep quality in all groups at baseline and after 12 weeks. Overall, antidepressants affected sleep duration scores: patients given amitriptyline had lower (better) scores than patients given placebo or escitalopram (P = .019). In all groups, responders had decreased anxiety and improvements in some sleep components.
In a post hoc analysis of data from a clinical trial that evaluated the effects of antidepressants in patients with FD, amitriptyline was found to reduce symptoms of FD, but its mechanism is unlikely to involve reductions in psychological distress. The drug may modestly improve sleep. Clinicaltrials.gov no: NCT00248651.
三环类抗抑郁药可有效缓解功能性消化不良（FD）的症状。我们对先前一项随机临床试验的数据进行了事后分析，以确定抗抑郁药治疗 FD 患者胃肠症状的益处是否通过改善睡眠或减轻焦虑来介导。我们探讨了心理测量指标、睡眠质量和症状缓解之间的关系。
我们分析了 2006 年 10 月至 2012 年 10 月进行的一项多中心、双盲试验的数据，该试验评估了抗抑郁药对 FD 症状的疗效。患者（n=292）被随机分为阿米替林 50mg 组、艾司西酞普兰 10mg 组或安慰剂组，治疗 12 周。在研究期间，参与者在基线和治疗 12 周后完成了以下经过验证的心理问卷：症状清单 90、症状躯体检查表、医院焦虑抑郁量表、心境状态问卷、状态特质焦虑量表和匹兹堡睡眠质量指数。
基线时，各组的心理和睡眠测量评分相似；治疗 12 周后，各组评分无显著差异。基线时，所有组的匹兹堡睡眠质量指数总分均表明基线和 12 周后睡眠质量较差。总体而言，抗抑郁药影响睡眠持续时间评分：与安慰剂或艾司西酞普兰相比，给予阿米替林的患者评分较低（更好）（P=0.019）。在所有组中，应答者的焦虑减轻，一些睡眠成分得到改善。
在评估抗抑郁药治疗 FD 患者效果的临床试验数据的事后分析中，发现阿米替林可减轻 FD 症状，但机制不太可能涉及减轻心理困扰。该药物可能适度改善睡眠。Clinicaltrials.gov 编号：NCT00248651。
