Chung Hyun Tae, Ra Ri Cha, Jung-Hwan Oh, Tae-Guen Gweon, Jong Kyu Park, Ki Bae Bang, Kyung Ho Song, Cheal Wung Huh, Ju Yup Lee, Cheol Min Shin, Jong Wook Kim, Young Hoon Youn, Joong Goo Kwon
{"title":"临床试验:功能性消化不良患者服用控释莫沙必利和去甲替林的疗效:一项多中心、双安慰剂、双盲、随机对照、平行临床研究。","authors":"Chung Hyun Tae, Ra Ri Cha, Jung-Hwan Oh, Tae-Guen Gweon, Jong Kyu Park, Ki Bae Bang, Kyung Ho Song, Cheal Wung Huh, Ju Yup Lee, Cheol Min Shin, Jong Wook Kim, Young Hoon Youn, Joong Goo Kwon","doi":"10.5056/jnm23147","DOIUrl":null,"url":null,"abstract":"<p><strong>Background/aims: </strong>Prokinetic agents and neuromodulators are among the treatment options for functional dyspepsia (FD), but their comparative efficacy is unclear. We aimed to compare the efficacy of mosapride controlled-release (CR) and nortriptyline in patients with FD after 4 weeks of treatment.</p><p><strong>Methods: </strong>Participants with FD were randomly assigned (1:1) to receive mosapride CR (mosapride CR 15 mg and nortriptyline placebo) or nortriptyline (mosapride CR placebo and nortriptyline 10 mg) in double-placebo, double-blinded, randomized controlled, parallel clinical study. The primary endpoint was defined as the proportion of patients with overall dyspepsia improvement after 4 weeks treatment. The secondary endpoints were changes in individual symptom scores, anxiety, depression, and quality of life.</p><p><strong>Results: </strong>One hundred nine participants were recruited and assessed for eligibility, and 54 in the mosapride CR group and 50 in the nortriptyline group were included in the modified intention-to-treat protocol. The rate of overall dyspepsia improvement was similar between groups (53.7% vs 54.0%, <i>P</i> = 0.976). There was no difference in the efficacy of mosapride CR and nortriptyline in a subgroup analysis by FD subtype (59.3% vs 52.5% in postprandial distress syndrome, <i>P</i> = 0.615; 44.4% vs 40.0% in epigastric pain syndrome, <i>P</i> = > 0.999; 50.0% vs 59.1% in overlap, <i>P</i> = 0.565; respectively). Both treatments significantly improved anxiety, depression, and quality of life from baseline.</p><p><strong>Conclusion: </strong>Mosapride CR and nortriptyline showed similar efficacy in patients with FD regardless of the subtype. Both treatments could be equally helpful for improving quality of life and psychological well-being while also relieving dyspepsia.</p>","PeriodicalId":16543,"journal":{"name":"Journal of Neurogastroenterology and Motility","volume":null,"pages":null},"PeriodicalIF":3.3000,"publicationDate":"2024-01-30","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC10774802/pdf/","citationCount":"0","resultStr":"{\"title\":\"Clinical Trial: Efficacy of Mosapride Controlled-release and Nortriptyline in Patients With Functional Dyspepsia: A Multicenter, Double-placebo, Double-blinded, Randomized Controlled, Parallel Clinical Study.\",\"authors\":\"Chung Hyun Tae, Ra Ri Cha, Jung-Hwan Oh, Tae-Guen Gweon, Jong Kyu Park, Ki Bae Bang, Kyung Ho Song, Cheal Wung Huh, Ju Yup Lee, Cheol Min Shin, Jong Wook Kim, Young Hoon Youn, Joong Goo Kwon\",\"doi\":\"10.5056/jnm23147\",\"DOIUrl\":null,\"url\":null,\"abstract\":\"<p><strong>Background/aims: </strong>Prokinetic agents and neuromodulators are among the treatment options for functional dyspepsia (FD), but their comparative efficacy is unclear. We aimed to compare the efficacy of mosapride controlled-release (CR) and nortriptyline in patients with FD after 4 weeks of treatment.</p><p><strong>Methods: </strong>Participants with FD were randomly assigned (1:1) to receive mosapride CR (mosapride CR 15 mg and nortriptyline placebo) or nortriptyline (mosapride CR placebo and nortriptyline 10 mg) in double-placebo, double-blinded, randomized controlled, parallel clinical study. The primary endpoint was defined as the proportion of patients with overall dyspepsia improvement after 4 weeks treatment. The secondary endpoints were changes in individual symptom scores, anxiety, depression, and quality of life.</p><p><strong>Results: </strong>One hundred nine participants were recruited and assessed for eligibility, and 54 in the mosapride CR group and 50 in the nortriptyline group were included in the modified intention-to-treat protocol. The rate of overall dyspepsia improvement was similar between groups (53.7% vs 54.0%, <i>P</i> = 0.976). There was no difference in the efficacy of mosapride CR and nortriptyline in a subgroup analysis by FD subtype (59.3% vs 52.5% in postprandial distress syndrome, <i>P</i> = 0.615; 44.4% vs 40.0% in epigastric pain syndrome, <i>P</i> = > 0.999; 50.0% vs 59.1% in overlap, <i>P</i> = 0.565; respectively). Both treatments significantly improved anxiety, depression, and quality of life from baseline.</p><p><strong>Conclusion: </strong>Mosapride CR and nortriptyline showed similar efficacy in patients with FD regardless of the subtype. 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引用次数: 0
摘要
背景/目的:促动力药和神经调节剂是功能性消化不良(FD)的治疗选择之一,但它们的疗效比较尚不明确。我们旨在比较莫沙必利控释片(CR)和去甲替林在治疗 FD 患者 4 周后的疗效:在双安慰剂、双盲、随机对照、平行临床研究中,FD患者被随机分配(1:1)接受莫沙必利控释片(莫沙必利控释片15毫克和去甲替林安慰剂)或去甲替林(莫沙必利控释片安慰剂和去甲替林10毫克)治疗。主要终点定义为治疗4周后总体消化不良症状得到改善的患者比例。次要终点是个体症状评分、焦虑、抑郁和生活质量的变化:共招募并评估了 199 名参与者,其中 54 名莫沙必利 CR 组患者和 50 名去甲替林组患者被纳入修改后的意向治疗方案。两组总体消化不良改善率相似(53.7% vs 54.0%,P = 0.976)。在按消化不良亚型进行的亚组分析中,莫沙必利CR和去甲替林的疗效没有差异(分别为餐后不适综合征59.3% vs 52.5%,P = 0.615;上腹痛综合征44.4% vs 40.0%,P = > 0.999;重叠期50.0% vs 59.1%,P = 0.565)。与基线相比,两种疗法都能明显改善焦虑、抑郁和生活质量:结论:莫沙必利CR和去甲替林对FD患者具有相似的疗效,无论其属于哪种亚型。这两种治疗方法同样有助于改善生活质量和心理健康,同时还能缓解消化不良。
Clinical Trial: Efficacy of Mosapride Controlled-release and Nortriptyline in Patients With Functional Dyspepsia: A Multicenter, Double-placebo, Double-blinded, Randomized Controlled, Parallel Clinical Study.
Background/aims: Prokinetic agents and neuromodulators are among the treatment options for functional dyspepsia (FD), but their comparative efficacy is unclear. We aimed to compare the efficacy of mosapride controlled-release (CR) and nortriptyline in patients with FD after 4 weeks of treatment.
Methods: Participants with FD were randomly assigned (1:1) to receive mosapride CR (mosapride CR 15 mg and nortriptyline placebo) or nortriptyline (mosapride CR placebo and nortriptyline 10 mg) in double-placebo, double-blinded, randomized controlled, parallel clinical study. The primary endpoint was defined as the proportion of patients with overall dyspepsia improvement after 4 weeks treatment. The secondary endpoints were changes in individual symptom scores, anxiety, depression, and quality of life.
Results: One hundred nine participants were recruited and assessed for eligibility, and 54 in the mosapride CR group and 50 in the nortriptyline group were included in the modified intention-to-treat protocol. The rate of overall dyspepsia improvement was similar between groups (53.7% vs 54.0%, P = 0.976). There was no difference in the efficacy of mosapride CR and nortriptyline in a subgroup analysis by FD subtype (59.3% vs 52.5% in postprandial distress syndrome, P = 0.615; 44.4% vs 40.0% in epigastric pain syndrome, P = > 0.999; 50.0% vs 59.1% in overlap, P = 0.565; respectively). Both treatments significantly improved anxiety, depression, and quality of life from baseline.
Conclusion: Mosapride CR and nortriptyline showed similar efficacy in patients with FD regardless of the subtype. Both treatments could be equally helpful for improving quality of life and psychological well-being while also relieving dyspepsia.
期刊介绍:
Journal of Neurogastroenterology and Motility (J Neurogastroenterol Motil) is a joint official journal of the Korean Society of Neurogastroenterology and Motility, the Thai Neurogastroenterology and Motility Society, the Japanese Society of Neurogastroenterology and Motility, the Indian Motility and Functional Disease Association, the Chinese Society of Gastrointestinal Motility, the South East Asia Gastro-Neuro Motility Association, the Taiwan Neurogastroenterology and Motility Society and the Asian Neurogastroenterology and Motility Association, launched in January 2010 after the title change from the Korean Journal of Neurogastroenterology and Motility, published from 1994 to 2009.