Efficacy of Linaclotide in Functional Dyspepsia and Constipation-Predominant Irritable Bowel Syndrome Overlap: A Randomized Trial

IF 3.7 3区医学 Q2 GASTROENTEROLOGY & HEPATOLOGY

Journal of Gastroenterology and Hepatology Pub Date : 2025-03-13 DOI:10.1111/jgh.16925

Li Cheng, Qianqian Wang, Biyu Wu, Xiujuan Yan, Ping Xu, Hongyi Qiu, Shengliang Chen

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Abstract

Background and Aim

Linaclotide is effective in relieving constipation-predominant irritable bowel syndrome symptoms. However, few studies focus on the efficacy of linaclotide for overlapping symptoms of functional dyspepsia among irritable bowel syndrome patients. This study aimed to assess the efficacy of linaclotide compared with lactulose in patients with functional dyspepsia and constipation-predominant irritable bowel syndrome overlap.

Methods

Seventy-eight patient were randomized (2:1) to receive linaclotide 290 μg or lactulose 20 mL daily for 4 weeks. The primary endpoint was the overall treatment satisfaction for gastrointestinal symptom relief. The secondary endpoints included score changes in functional dyspepsia, constipation-predominant irritable bowel syndrome symptoms, and psychological status.

Results

Seventy-one patients (47 with linaclotide and 24 with lactulose) completed the study. A higher proportion of patients receiving linaclotide reported partial or complete relief of gastrointestinal symptoms compared with patients receiving lactulose (87.2% vs. 54.2%, p = 0.002). Dyspeptic symptoms (postprandial fullness/early satiety and bloating) and bowel symptoms (stool frequency, consistency, straining, sensation of complete evacuation, and lower abdominal discomfort) showed greater improvement in linaclotide-treated patients than in lactulose group (p < 0.05).

Conclusions

Linaclotide shows better efficacy for functional dyspepsia and constipation-predominant irritable bowel syndrome overlap compared with lactulose.

Trial Registration

ClinicalTrials.gov: NCT05134584

Abstract Image

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利那洛肽对功能性消化不良和便秘为主的肠易激综合征重叠的疗效：一项随机试验。

背景与目的：利那洛肽可有效缓解便秘为主的肠易激综合征症状。然而，很少有研究关注利那洛肽对肠易激综合征患者功能性消化不良重叠症状的疗效。本研究旨在评估利那洛肽与乳果糖在功能性消化不良和便秘为主的肠易激综合征重叠患者中的疗效。方法：78例患者随机（2:1）给予利那洛肽290 μg或乳果糖20 mL，每日4周。主要终点是胃肠道症状缓解的总体治疗满意度。次要终点包括功能性消化不良、便秘为主的肠易激综合征症状和心理状态的评分变化。结果：71例患者（47例使用利那洛肽，24例使用乳果糖）完成了研究。接受利那洛肽治疗的患者报告胃肠道症状部分或完全缓解的比例高于接受乳果糖治疗的患者（87.2% vs. 54.2%, p = 0.002）。与乳果糖组相比，利那洛肽组患者的消化不良症状（餐后饱腹/早饱和腹胀）和肠道症状（大便频率、一致性、紧张感、完全排空感和下腹部不适）均有较大改善(p)。结论：利那洛肽对功能性消化不良和便秘为主的肠易激综合征重叠的疗效优于乳果糖组。试验注册：ClinicalTrials.gov: NCT05134584。

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来源期刊

Journal of Gastroenterology and Hepatology 医学-胃肠肝病学

CiteScore

7.90

自引率

2.40%

发文量

326

审稿时长

2.3 months

期刊介绍： Journal of Gastroenterology and Hepatology is produced 12 times per year and publishes peer-reviewed original papers, reviews and editorials concerned with clinical practice and research in the fields of hepatology, gastroenterology and endoscopy. Papers cover the medical, radiological, pathological, biochemical, physiological and historical aspects of the subject areas. All submitted papers are reviewed by at least two referees expert in the field of the submitted paper.