Temple University, Philadelphia, Pennsylvania.
Johns Hopkins University, Baltimore, Maryland.
JAMA. 2013 Dec 25;310(24):2640-9. doi: 10.1001/jama.2013.282833.
IMPORTANCE: Gastroparesis remains a challenging syndrome to manage, with few effective treatments and a lack of rigorously controlled trials. Tricyclic antidepressants are often used to treat refractory symptoms of nausea, vomiting, and abdominal pain. Evidence from well-designed studies for this use is lacking. OBJECTIVE: To determine whether treatment with nortriptyline results in symptomatic improvement in patients with idiopathic gastroparesis. DESIGN, SETTING, AND PARTICIPANTS: The NORIG (Nortriptyline for Idiopathic Gastroparesis) trial, a 15-week multicenter, parallel-group, placebo-controlled, double-masked, randomized clinical trial from the National Institute of Diabetes and Digestive and Kidney Diseases Gastroparesis Clinical Research Consortium (GpCRC), comparing nortriptyline with placebo for symptomatic relief in idiopathic gastroparesis. One hundred thirty patients with idiopathic gastroparesis were enrolled between March 2009 and June 2012 at 7 US academic medical centers. Patient follow-up was completed in October 2012. Inclusion criteria included delayed gastric emptying and moderate to severe symptom scores using the Gastroparesis Cardinal Symptom Index (GCSI). INTERVENTIONS Nortriptyline vs placebo. Study drug dose was increased at 3-week intervals (10, 25, 50, 75 mg) up to 75 mg at 12 weeks. MAIN OUTCOMES AND MEASURES: The primary outcome measure of symptomatic improvement was a decrease from the patient's baseline GCSI score of at least 50% on 2 consecutive 3-week GCSI assessments during 15 weeks of treatment. RESULTS: The primary symptomatic improvement outcome did not differ between 65 patients randomized to nortriptyline vs 65 patients randomized to placebo: 15 (23% [95% CI, 14%-35%]) in the nortriptyline group vs 14 (21% [95% CI, 12%-34%]) in the placebo group (P = .86). Treatment was stopped more often in the nortriptyline group (19 [29% {95% CI, 19%-42%}]) than in the placebo group (6 [9%] {95% CI, 3%-19%}]) (P = .007), but numbers of adverse events were not different (27 [95% CI, 18-39] vs 28 [95% CI, 19-40]) (P = .89). CONCLUSIONS AND RELEVANCE: Among patients with idiopathic gastroparesis, the use of nortriptyline compared with placebo for 15 weeks did not result in improvement in overall symptoms. These findings do not support the use of nortriptyline for idiopathic gastroparesis. TRIAL REGISTRATION: clinicaltrials.gov Identifier: NCT00765895.
重要性：胃轻瘫仍然是一种具有挑战性的综合征，治疗方法有限，且缺乏严格控制的试验。三环类抗抑郁药通常用于治疗恶心、呕吐和腹痛的难治性症状。缺乏对此类用途的精心设计研究的证据。 目的：确定曲普坦治疗特发性胃轻瘫患者是否会导致症状改善。 设计、地点和参与者：国家糖尿病、消化和肾脏疾病胃轻瘫临床研究联盟（GpCRC）的 NORIG（曲普坦治疗特发性胃轻瘫）试验是一项为期 15 周的多中心、平行组、安慰剂对照、双盲、随机临床试验，比较曲普坦与安慰剂在特发性胃轻瘫中缓解症状的疗效。2009 年 3 月至 2012 年 6 月，在美国 7 家学术医疗中心共纳入 130 名特发性胃轻瘫患者。2012 年 10 月完成了患者随访。纳入标准包括胃排空延迟和使用胃轻瘫关键症状指数（GCSI）评估的中度至重度症状评分。 干预措施：曲普坦与安慰剂。研究药物剂量每 3 周增加一次（10、25、50、75 mg），12 周时增加至 75 mg。 主要结果和测量：症状改善的主要终点是在 15 周的治疗期间，患者的基线 GCSI 评分连续两次连续 3 周的 GCSI 评估降低至少 50%。 结果：接受曲普坦治疗的 65 例患者与接受安慰剂治疗的 65 例患者的主要症状改善结局无差异：曲普坦组 15 例（23%[95%CI，14%-35%]），安慰剂组 14 例（21%[95%CI，12%-34%]）（P=0.86）。曲普坦组停药率（29%[95%CI，19%-42%]）高于安慰剂组（9%[95%CI，3%-19%]）（P=0.007），但不良事件发生率无差异（27[95%CI，18-39] vs 28[95%CI，19-40]）（P=0.89）。 结论和相关性：在特发性胃轻瘫患者中，与安慰剂相比，使用曲普坦治疗 15 周并未导致总体症状改善。这些发现不支持使用曲普坦治疗特发性胃轻瘫。 试验注册：clinicaltrials.gov 标识符：NCT00765895。
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