Buckle Rachel L, Brown Lydia C, Aziz Imran
Academic Unit of Gastroenterology, Sheffield Teaching Hospitals NHS Foundation Trust, Sheffield, UK.
University of Sheffield, Sheffield, UK.
Neurogastroenterol Motil. 2024 Mar;36(3):e14733. doi: 10.1111/nmo.14733. Epub 2024 Jan 4.
BACKGROUND: Almost 80% of individuals with functional dyspepsia experience meal-related symptoms and are diagnosed with postprandial distress syndrome (PDS). However, studies evaluating dietary modifications in PDS are sparse. We performed a single-center randomized trial comparing reassurance and diagnostic explanation (RADE) with or without traditional dietary advice (TDA) in PDS. METHODS: Following a normal upper gastrointestinal endoscopy, individuals with PDS were randomized to a leaflet providing RADE ± TDA; the latter recommending small, regular meals and reducing the intake of caffeine/alcohol/fizzy drinks and high-fat/processed/spicy foods. Questionnaires were completed over 4 weeks, including self-reported adequate relief of dyspeptic symptoms, and the validated Leuven Postprandial Distress Scale (LPDS), Gastrointestinal Symptom Rating Scale, and Nepean Dyspepsia Index for quality of life. The primary endpoint(s) to define clinical response were (i) ≥50% adequate relief of dyspeptic symptoms and (ii) >0.5-point reduction in the PDS subscale of the LPDS (calculated as the mean scores for early satiety, postprandial fullness, and upper abdominal bloating). KEY RESULTS: Of the 53 patients with PDS, 27 were assigned RADE-alone and 26 to additional TDA. Baseline characteristics were similar between groups, with a mean age of 39 years, 70% female, 83% white British, and coexistent irritable bowel syndrome in 66%. The primary endpoints of (i) adequate relief of dyspeptic symptoms were met by 33% (n = 9) assigned RADE-alone versus 39% (n = 10) with TDA; p-value = 0.70, while (ii) a reduction of >0.5 points in the PDS subscale was met by 37% (n = 10) assigned RADE-alone versus 27% (n = 7) with TDA; p-value = 0.43. Response rates did not differ according to irritable bowel syndrome status. There were no significant between-group changes in the gastrointestinal symptom rating scale and dyspepsia quality of life. CONCLUSIONS & INFERENCES: This study of predominantly white British patients with PDS found the addition of TDA did not lead to significantly greater symptom reduction compared with RADE alone. Alternate dietary strategies should be explored in this cohort.
背景：近80%的功能性消化不良患者有与进餐相关的症状，被诊断为餐后不适综合征（PDS）。然而，评估PDS饮食调整的研究较少。我们进行了一项单中心随机试验，比较在PDS患者中给予安慰和诊断解释（RADE）加或不加传统饮食建议（TDA）的效果。 方法：在正常上消化道内镜检查后，PDS患者被随机分为接受提供RADE±TDA的宣传册组；TDA建议少食多餐，减少咖啡因/酒精/碳酸饮料以及高脂肪/加工/辛辣食物的摄入。在4周内完成问卷调查，包括自我报告的消化不良症状充分缓解情况，以及经过验证的鲁汶餐后不适量表（LPDS）、胃肠道症状评分量表和用于生活质量的内皮恩消化不良指数。定义临床反应的主要终点为：（i）消化不良症状充分缓解≥50%；（ii）LPDS的PDS子量表降低>0.5分（计算为早饱、餐后饱胀和上腹胀的平均得分）。 主要结果：53例PDS患者中，27例被分配至仅接受RADE组，26例被分配至接受额外TDA组。两组的基线特征相似，平均年龄39岁，70%为女性，83%为英国白人，66%同时患有肠易激综合征。主要终点方面，（i）仅接受RADE组中33%（n = 9）的患者消化不良症状得到充分缓解，接受TDA组为39%（n = 10）；p值 = 0.70；而（ii）仅接受RADE组中37%（n = 10）的患者PDS子量表降低>0.5分，接受TDA组为27%（n = 7）；p值 = 0.43。缓解率不因肠易激综合征状态而异。胃肠道症状评分量表和消化不良生活质量在组间无显著变化。 结论与推论：这项针对主要为英国白人PDS患者的研究发现，与仅接受RADE相比，添加TDA并未导致症状减轻更显著。应在该队列中探索其他饮食策略。
Neurogastroenterol Motil. 2015-8
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