Effect of Amitriptyline and Escitalopram on Functional Dyspepsia: A Multicenter, Randomized Controlled Study.
Effect of Amitriptyline and Escitalopram on Functional Dyspepsia: A Multicenter, Randomized Controlled Study.
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DOI：
10.1053/j.gastro.2015.04.020
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发表时间：
2015-08
期刊：
影响因子：
29.4
通讯作者：
Zinsmeister AR
中科院分区：
文献类型：
--
作者：
Talley NJ;Locke GR;Saito YA;Almazar AE;Bouras EP;Howden CW;Lacy BE;DiBaise JK;Prather CM;Abraham BP;El-Serag HB;Moayyedi P;Herrick LM;Szarka LA;Camilleri M;Hamilton FA;Schleck CD;Tilkes KE;Zinsmeister AR
抗抑郁药通常用于治疗功能性消化不良（FD），这是一种以上腹部症状为特征的常见疾病，包括不适或餐后饱腹感。然而，很少有证据表明这些药物对FD患者的疗效。我们进行了一项随机、双盲、安慰剂对照试验，以评估抗抑郁治疗对FD患者症状、胃排空（GE）和进餐诱导饱腹感的影响。我们在北美的8个地点进行了一项研究，这些患者符合FD的Rome II标准，没有抑郁症或使用抗抑郁药。受试者（n=292，年龄44±15岁，75%为女性，70%为运动障碍样FD， 30%为溃疡样FD）被随机分为安慰剂组、阿米替林50 mg组或艾司西酞普兰10 mg组，疗程10周。主要终点是在最后10周（共12周）中FD症状缓解≥5周。次要终点包括GE时间、营养饮料试验中的最大耐受量和fd相关的生活质量。39名安慰剂组（40%）、51名阿米替林组（53%）和37名艾司西酞普兰组（38%）报告了充分的缓解反应（P= 0.05，在治疗后，根据包括所有受试者的基线平衡因素进行了调整）。溃疡样FD患者给予阿米替林的报告充分缓解的可能性是给予安慰剂的3倍以上（优势比为3.1；95%可信区间为1.1-9.0）。在任何一组中，阿米替林和艾司西酞普兰在10周后都没有影响GE或饮食诱导的饱腹感。与正常GE受试者相比，延迟GE受试者报告充分缓解的可能性较小（优势比为0.4；95%可信区间为0.2-0.8）。两种抗抑郁药都提高了整体生活质量。阿米替林，而非艾司西酞普兰，似乎对一些FD患者有益，尤其是那些溃疡样（疼痛）FD患者。迟发性GE患者对这些药物没有反应。
Anti-depressants are frequently prescribed to treat functional dyspepsia (FD), a common disorder characterized by upper abdominal symptoms, including discomfort or post-prandial fullness. However, there is little evidence for the efficacy of these drugs in patients with FD. We performed a randomized, double-blind, placebo-controlled trial to evaluate the effects of anti-depressant therapy effects on symptoms, gastric emptying (GE), and mealinduced satiety in patients with FD. We performed a study at 8 North American sites of patients who met the Rome II criteria for FD and did not have depression or use anti-depressants. Subjects (n=292; 44±15 y old, 75% female, 70% with dysmotility-like FD, and 30% with ulcer-like FD) were randomly assigned to groups given placebo, 50 mg amitriptyline, or 10 mg escitalopram for 10 weeks. The primary endpoint was adequate relief of FD symptoms for ≥5 weeks of the last 10 weeks (out of 12). Secondary endpoints included GE time, maximum tolerated volume in a nutrient drink test, and FD-related quality of life. An adequate relief response was reported by 39 subjects given placebo (40%), 51 given amitriptyline (53%), and 37 given escitalopram (38%) (P=.05, following treatment, adjusted for baseline balancing factors including all subjects). Subjects with ulcer-like FD given amitriptyline were more than 3-fold more likely to report adequate relief than those given placebo (odds ratio=3.1; 95% confidence interval, 1.1–9.0). Neither amitriptyline nor escitalopram appeared to affect GE or meal-induced satiety after the 10 week period in any group. Subjects with delayed GE were less likely to report adequate relief than subjects with normal GE (odds ratio=0.4; 95% confidence interval, 0.2–0.8). Both anti-depressants improved overall quality-of-life. Amitriptyline, but not escitalopram, appears to benefit some patients with FD— particularly those with ulcer-like (painful) FD. Patients with delayed GE do not respond to these drugs.