The adjunctive role of metformin in patients with mild to moderate ulcerative colitis: a randomized controlled study.

IF 4.4 2区 医学 Q1 PHARMACOLOGY & PHARMACY
Frontiers in Pharmacology Pub Date : 2025-03-19 eCollection Date: 2025-01-01 DOI:10.3389/fphar.2025.1507009
Ammena Y Binsaleh, Sahar M El-Haggar, Sahar K Hegazy, Maha M Maher, Monir M Bahgat, Thanaa A Elmasry, Sarah Alrubia, Amsha S Alsegiani, Mamdouh Eldesoqui, Mostafa M Bahaa
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引用次数: 0

Abstract

Background: Metformin, hypoglycemic medication, is recognized for its diverse properties and its capacity to influence the inflammatory pathways. Medications with anti-inflammatory and anti-oxidative characteristics have been demonstrated to be able to elicit and sustain remission in ulcerative colitis (UC), chronic inflammatory disorder of the bowel. Studies in both preclinical and clinical settings have looked into the several metabolic pathways via which metformin protects against UC.

Aim: To assess efficacy of metformin as adjunctive therapy in patients with mild to moderate UC.

Methods: This clinical research was double-blinded, randomized, controlled, and involved 60 patients with mild to moderate UC. The participants were randomly assigned to one of two groups (n = 30). The control group was given 1 g of mesalamine three times a day (t.i.d.) for a period of 6 months (mesalamine group). The metformin group was given 500 mg of metformin twice daily and 1 g of mesalamine t. i.d. For a period of 6 months. Patients with UC were assessed by a gastroenterologist using the disease activity index (DAI) both at the beginning of treatment and 6 months thereafter. To evaluate the drug's biological efficacy, measurements of fecal calprotectin, serum C-reactive protein (CRP), interleukin 10 (IL-10), and nitric oxide (NO) were taken both before and after treatment.

Study outcomes: Decrease in DAI and change in the level of measured serum and fecal markers.

Results: The metformin group displayed a statistical reduction in DAI (p = 0.0001), serum CRP (p = 0.019), NO (p = 0.04), and fecal calprotectin (p = 0.027), as well as a significant increase in IL-10 (p = 0.04) when compared to the mesalamine group. There was a significant direct correlation between DAI and calprotectin (p < 0.0001, r = 0.551), and between DAI and CRP (p < 0.0001, r = 0.794). There was a significant negative correlation between DAI and IL-10 (p = 0.0003, r = 0.371).

Conclusion: Metformin may be an effective adjunct drug in management of patients with mild to moderate UC by decreasing DAI and other inflammatory markers that were involved in the pathogenesis of UC.

Clinical trial registration: identifier NCT05553704.

二甲双胍在轻度至中度溃疡性结肠炎患者中的辅助作用:一项随机对照研究。
背景:二甲双胍是一种降糖药物,因其多种特性和影响炎症途径的能力而被公认。具有抗炎和抗氧化特性的药物已被证明能够引起并维持溃疡性结肠炎(UC)的缓解,这是肠道的慢性炎症性疾病。临床前和临床环境的研究都研究了二甲双胍预防UC的几种代谢途径。目的:评价二甲双胍辅助治疗轻至中度UC的疗效。方法:本临床研究采用双盲、随机、对照的方法,纳入60例轻中度UC患者。参与者被随机分为两组(n = 30)。对照组给予美沙拉胺1 g,每日3次(t.i.d),连续6个月(美沙拉胺组)。二甲双胍组患者给予二甲双胍500 mg,每日2次,美沙拉明1 g,每日1次,疗程6个月。UC患者在治疗开始时和治疗后6个月由胃肠病学家使用疾病活动指数(DAI)进行评估。为评价药物的生物学疗效,治疗前后分别测定患者粪便钙保护蛋白、血清c反应蛋白(CRP)、白细胞介素10 (IL-10)、一氧化氮(NO)含量。研究结果:DAI降低,血清和粪便标志物水平改变。结果:与美沙拉明组相比,二甲双胍组DAI (p = 0.0001)、血清CRP (p = 0.019)、NO (p = 0.04)、粪便钙保护蛋白(p = 0.027)均有统计学意义降低,IL-10显著升高(p = 0.04)。DAI与钙保护蛋白(p < 0.0001, r = 0.551)、DAI与CRP (p < 0.0001, r = 0.794)有显著的直接相关性。DAI与IL-10呈显著负相关(p = 0.0003, r = 0.371)。结论:二甲双胍可降低DAI及其他参与UC发病机制的炎症标志物,是治疗轻中度UC患者的有效辅助药物。临床试验注册:标识符NCT05553704。
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来源期刊
Frontiers in Pharmacology
Frontiers in Pharmacology PHARMACOLOGY & PHARMACY-
CiteScore
7.80
自引率
8.90%
发文量
5163
审稿时长
14 weeks
期刊介绍: Frontiers in Pharmacology is a leading journal in its field, publishing rigorously peer-reviewed research across disciplines, including basic and clinical pharmacology, medicinal chemistry, pharmacy and toxicology. Field Chief Editor Heike Wulff at UC Davis is supported by an outstanding Editorial Board of international researchers. This multidisciplinary open-access journal is at the forefront of disseminating and communicating scientific knowledge and impactful discoveries to researchers, academics, clinicians and the public worldwide.
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