Efficacy of Mirtazapine in Patients With Functional Dyspepsia and Weight Loss
Efficacy of Mirtazapine in Patients With Functional Dyspepsia and Weight Loss
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DOI：
10.1016/j.cgh.2015.09.043
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发表时间：
2016-03-01
影响因子：
12.6
通讯作者：
Van Oudenhove, Lukas
中科院分区：
文献类型：
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作者：
Tack, Jan;Ly, Huynh Giao;Van Oudenhove, Lukas
背景与目的：功能性消化不良（FD）患者的一个子集表现为早期饱食和体重减轻，对此没有确定的治疗选择。我们调查了米氮平的疗效方法：我们进行了一项随机、安慰剂对照的初步试验，研究了34名FD患者，（29名女性;平均年龄，35.9 ± 2.3岁），体重减轻>原始体重的10%（平均减轻，12.4 ± 2.3 kg），无抑郁或焦虑。导入期后，患者以双盲方式随机分配至安慰剂组（n = 17）或米氮平组（n = 17），每天15 mg，持续8周。在2周基线和8周治疗期间，对受试者的消化不良症状严重程度、生活质量（基于Nehru消化不良指数）和胃肠道特异性焦虑进行评估;对他们进行营养激发试验并称重。数据分析采用线性混合模型，然后进行计划对比与自适应降压Bonferroni多重检验校正。在第4周和第8周，与第0周相比，米氮平显著降低了平均消化不良症状严重程度评分（分别为P = 0.003和P = 0.017）;安慰剂组没有显著降低（第4周和第8周P > 0.37）。米氮平和安慰剂之间相对于第0周的变化差异在第4周显示出效应量较大的趋势（P = 0.059），而在第8周则不显着（P = 0.55）。然而，米氮平组从第0周至第4周和第8周的早期饱食、生活质量、胃肠道特异性焦虑、体重和营养耐受性的改善显著大于安慰剂组（大多数具有较大的效应量）。在一项随机、安慰剂对照试验中，米氮平显著改善了早期饱食、生活质量、胃肠道特异性焦虑、营养耐受性，以及FD患者的体重减轻。ClinicalTrials.gov编号：NCT 01240096。
BACKGROUND & AIMS: A subset of patients with functional dyspepsia (FD) present with early satiation and weight loss, for which there are no established therapeutic options. We investigated the efficacy of mirtazapine (an antidepressant and antagonist of the histamine receptor H-1, the alpha(2) adrenergic receptor, and the serotonin receptors 5-HT2C and 5-HT-3) in patients with FD and weight loss.METHODS: We conducted a randomized, placebo-controlled pilot trial that studied 34 patients with FD (29 women; mean age, 35.9 +/- 2.3 years) with weight loss >10% of original body weight (mean loss, 12.4 +/- 2.3 kg) without depression or anxiety. After a run-in period, patients were randomly assigned to groups given placebo (n = 17) or mirtazapine 15 mg each day for 8 weeks (n = 17) in a double-blind manner. Subjects were evaluated during a 2-week baseline and 8-week treatment for dyspepsia symptom severity, quality of life (on the basis of the Nepean Dyspepsia Index), and gastrointestinal-specific anxiety; they were given a nutrient challenge test and weighed. Data were analyzed by using linear mixed models, followed by planned contrasts with adaptive step-down Bonferroni multiple testing correction.RESULTS: Two patients in each group dropped out. At weeks 4 and 8, mirtazapine significantly reduced mean dyspepsia symptom severity scores compared with week 0 (P = .003 and P = .017, respectively); there was no significant reduction in the placebo group (P > .37 for weeks 4 and 8). The difference in change from week 0 between mirtazapine and placebo showed a trend with a large effect size at week 4 (P = .059) that was not significant at week 8 (P = .55). However, improvements from week 0 to weeks 4 and 8 were significantly larger in the mirtazapine group than placebo group for early satiation, quality of life, gastrointestinal-specific anxiety, weight, and nutrient tolerance (mostly with large effect sizes).CONCLUSIONS: In a randomized, placebo-controlled trial, mirtazapine significantly improved early satiation, quality of life, gastrointestinal-specific anxiety, nutrient tolerance, and weight loss in patients with FD. ClinicalTrials.gov number: NCT01240096.