BackgroundInternational guidelines recommend contrasting initial treatment strategies for functional dyspepsia (FD).AimsTo evaluate the efficacy and safety of treatment according to subtypes, compared with empirical proton pump inhibitor (PPI), in the initial treatment of FD.MethodsWe performed a single‐blinded, randomised controlled trial of adults with FD. In the intervention group (treatment according to subtype), patients were categorised into epigastric pain syndrome (treatment esomeprazole); postprandial distress syndrome (PDS; treatment itopride) and overlap (treatment itopride, maintain, add/or switch to esomeprazole at week 4). The control group received esomeprazole only. The primary efficacy outcome was the assessment of global symptom improvement (primary end point: best two points from the 7‐point Likert scale) over 8 weeks. Secondary outcomes included assessment of the change in nine individual upper gastrointestinal symptoms, quality of life (Short‐Form Nepean Dyspepsia Index) and adverse events.ResultsWe randomised 180 patients (median age: 50; 68.7% female 56.7% PDS) 1:1 into intervention and control arms. The percentage of patients achieving the primary efficacy outcome were 74.4% and 72.2%, respectively (p = 0.74). The improvement of individual symptoms in both groups were similar. The SF‐NDI improved after treatment in both groups (p < 0.001) but there was no significant difference in the degree of change between groups. Rates of adverse events between groups were similar at week 8.ConclusionInitial treatment of FD according to subtype was not more effective than empirical PPI alone for up to 8 weeks. Further multicentre studies, with a larger sample size, are recommended to validate these findings.Trial Registration: ClinicalTrials.gov identifier: NCT04918017

中文翻译：

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临床试验：与经验性质子泵抑制剂相比，根据亚型治疗功能性消化不良


背景国际指南推荐了对功能性消化不良 （FD） 的对比初始治疗策略。目的评价根据亚型与经验质子泵抑制剂 （PPI） 相比，在 FD 初始治疗中的有效性和安全性。方法我们对成人 FD 患者进行了一项单盲、随机对照试验。在干预组 （根据亚型治疗） 中，患者被分为上腹痛综合征 （治疗埃索美拉唑）;餐后窘迫综合征 （PDS;治疗 itopride） 和重叠 （治疗 itopride、维持、添加/或第 4 周改用埃索美拉唑）。对照组仅接受埃索美拉唑。主要疗效结局是 8 周内整体症状改善的评估 （主要终点：7 分李克特量表中最好的两分）。次要结局包括评估 9 个个体上消化道症状的变化、生活质量 （Short-Form Nepean Dyspepsia Index） 和不良事件。结果我们将 180 例患者 （中位年龄： 50;68.7% 女性 56.7% PDS） 1：1 随机分配到干预组和对照组。达到主要疗效结果的患者百分比分别为 74.4% 和 72.2% （p = 0.74）。两组个体症状的改善相似。两组治疗后 SF-NDI 均有所改善 （p < 0.001），但组间变化程度无显著差异。第 8 周时两组之间的不良事件发生率相似.结论根据亚型对 FD 进行初始治疗并不比单独经验性 PPI 更有效，持续长达 8 周。建议进行进一步的多中心研究，使用更大的样本量来验证这些发现。试验注册：ClinicalTrials。gov 标识符：NCT04918017