肠易激综合征初级保健患者的饮食或药物治疗：DOMINO 研究 - 一项由比利时医疗保健知识中心（KCE 试验计划）和罗马基金会研究所在的支持下进行的随机试验。

Diet or medication in primary care patients with IBS: the DOMINO study - a randomised trial supported by the Belgian Health Care Knowledge Centre (KCE Trials Programme) and the Rome Foundation Research Institute.

机构信息

Department of Gastroenterology, KU Leuven University Hospitals Leuven, Leuven, Belgium.

TARGID (Translational Research Center for Gastrointestinal Disorders), KU Leuven, Leuven, Belgium.

出版信息

Gut. 2022 Nov;71(11):2226-2232. doi: 10.1136/gutjnl-2021-325821. Epub 2022 Apr 28.

DOI:10.1136/gutjnl-2021-325821

PMID:35483886

原文链接:https://pmc.ncbi.nlm.nih.gov/articles/PMC9554021/

Abstract

BACKGROUND

In Europe, IBS is commonly treated with musculotropic spasmolytics (eg, otilonium bromide, OB). In tertiary care, a low fermentable oligosaccharides, disaccharides, monosaccharides and polyols (FODMAP) diet provides significant improvement. Yet, dietary treatment remains to be explored in primary care. We evaluated the effect of a smartphone FODMAP-lowering diet application versus OB on symptoms in primary care IBS.

METHODS

IBS patients, recruited by primary care physicians, were randomised to 8 weeks of OB (40 mg three times a day) or diet and followed for 24 weeks. We compared IBS Symptom Severity Score and the proportion of responders (improvement ≥50 points) in all patients and the subgroup fulfilling Rome IV criteria (Rome+). We also evaluated treatment efficacy, quality of life, anxiety, depression, somatic symptom severity (Patient Health Questionnaire (PHQ15, PHQ9)) and treatment adherence and analysed predictors of response.

RESULTS

459 primary care IBS patients (41±15 years, 76% female, 70% Rome+) were randomised. The responder rate after 8 weeks was significantly higher with diet compared with OB (71% (155/218) vs 61% (133/217), p=0.03) and more pronounced in Rome+ (77% (118/153) vs 62% (98/158), p=0.004). Patients allocated to diet (199/212) were 94% adherent compared with 73% with OB (148/202) (p<0.001). The significantly higher response rate with diet was already observed after 4 weeks (62% (132/213) vs 51% (110/215), p=0.02) and a high symptom response persisted during follow-up. Predictors of response were female gender (OR=2.08, p=0.04) for diet and PHQ15 (OR=1.10, p=0.02) for OB.

CONCLUSION

In primary care IBS patients, a FODMAP-lowering diet application was superior to a spasmolytic agent in improving IBS symptoms. A FODMAP-lowering diet should be considered the first-line treatment for IBS in primary care.

TRIAL REGISTRATION NUMBER

NCT04270487.

摘要

背景

在欧洲，肠易激综合征通常采用肌动力痉挛药物（如溴奥亭）治疗。在三级医疗机构中，低发酵寡糖、双糖、单糖和多元醇（FODMAP）饮食可显著改善症状。然而，在初级保健中，饮食治疗仍有待探索。我们评估了智能手机 FODMAP 降低饮食应用与奥亭溴铵（OB）对初级保健 IBS 患者症状的影响。

方法

通过初级保健医生招募 IBS 患者，随机分为 OB（40mg 每日三次）或饮食治疗 8 周，并随访 24 周。我们比较了所有患者和符合罗马 IV 标准（Rome+）的亚组中 IBS 症状严重程度评分和应答者比例（改善≥50 分）。我们还评估了治疗效果、生活质量、焦虑、抑郁、躯体症状严重程度（患者健康问卷（PHQ15、PHQ9））和治疗依从性，并分析了应答的预测因素。

结果

共纳入 459 例初级保健 IBS 患者（41±15 岁，76%为女性，70%符合 Rome+标准）。8 周后，饮食治疗的应答率显著高于 OB（71%（155/218）比 61%（133/217），p=0.03），在 Rome+患者中更为明显（77%（118/153）比 62%（98/158），p=0.004）。接受饮食治疗的患者（199/212）的依从率为 94%，而接受 OB 治疗的患者（148/202）的依从率为 73%（p<0.001）。饮食治疗的高应答率在 4 周时就已经观察到（62%（132/213）比 51%（110/215），p=0.02），且在随访期间持续存在。应答的预测因素是女性（饮食治疗 OR=2.08，p=0.04）和 PHQ15（OB 治疗 OR=1.10，p=0.02）。