Abstract：
BACKGROUND: Ulcerative colitis (UC) is a type of inflammatory bowel disease associated with persistent inflammation. Animal studies proved the efficacy of metformin in UC.
OBJECTIVE: To investigate the potential role of metformin and its protective pathways in patients with UC.
METHODS: This is a randomized, controlled, and double-blinded clinical trial that included 60 participants with mild to moderate UC and was divided randomly into two groups (n = 30). For 6 months, the mesalamine group received 1 g of mesalamine three times daily (t.i.d.). For six months, the metformin group received mesalamine 1 g t.i.d. and metformin 500 mg twice daily. A gastroenterologist evaluated patients at baseline and 6 months after starting the treatment in order to measure serum levels of zonulin, sphingosine 1 phosphate (S1P), interleukin-6 (IL-6), and tumor necrosis factor-alpha (TNF-α). Biopsies from the colon were used to measure gene expression of zonula occuldin-1 (ZO-1), signal transducer and activator of factor-3 (STAT-3), and intracellular adhesion molecule-1 (ICAM-1). The numeric pain rating scale (NRS) and partial Mayo score were also assessed for each patient.
RESULTS: When compared to the mesalamine group, the metformin group demonstrated a statistical decrease in serum IL-6, zonulin, TNF-α, SIP, gene expression of ICAM-1 and STAT-3, and a significant increase in colonic ZO-1 when compared to the mesalamine group. The metformin group also showed a significant decrease in NRS and partial Mayo score index in comparison with the mesalamine group.
CONCLUSIONS: Metformin may be a promising additional therapy for UC patients. Trial registration identifier: NCT05553704.
OBJECTIVE: To investigate the potential role of metformin and its protective pathways in patients with UC.
METHODS: This is a randomized, controlled, and double-blinded clinical trial that included 60 participants with mild to moderate UC and was divided randomly into two groups (n = 30). For 6 months, the mesalamine group received 1 g of mesalamine three times daily (t.i.d.). For six months, the metformin group received mesalamine 1 g t.i.d. and metformin 500 mg twice daily. A gastroenterologist evaluated patients at baseline and 6 months after starting the treatment in order to measure serum levels of zonulin, sphingosine 1 phosphate (S1P), interleukin-6 (IL-6), and tumor necrosis factor-alpha (TNF-α). Biopsies from the colon were used to measure gene expression of zonula occuldin-1 (ZO-1), signal transducer and activator of factor-3 (STAT-3), and intracellular adhesion molecule-1 (ICAM-1). The numeric pain rating scale (NRS) and partial Mayo score were also assessed for each patient.
RESULTS: When compared to the mesalamine group, the metformin group demonstrated a statistical decrease in serum IL-6, zonulin, TNF-α, SIP, gene expression of ICAM-1 and STAT-3, and a significant increase in colonic ZO-1 when compared to the mesalamine group. The metformin group also showed a significant decrease in NRS and partial Mayo score index in comparison with the mesalamine group.
CONCLUSIONS: Metformin may be a promising additional therapy for UC patients. Trial registration identifier: NCT05553704.
摘要：
背景：溃疡性结肠炎（UC）是一种与持续性炎症相关的炎症性肠病。动物研究证明二甲双胍在UC中的疗效。
目的：探讨二甲双胍及其保护途径在UC患者中的潜在作用。
方法：这是一个随机的，控制,和双盲临床试验,纳入60名轻度至中度UC患者,随机分为两组(n=30).6个月,美沙拉嗪组每天3次(t.i.d.)接受1g美沙拉嗪.六个月来,二甲双胍组每天两次接受1gt.i.d.和500mg二甲双胍.胃肠病学家在基线和开始治疗后6个月评估患者，以测量血清zonulin水平，鞘氨醇1磷酸（S1P），白细胞介素-6（IL-6），和肿瘤坏死因子-α(TNF-α)。来自结肠的活检被用来测量小带occardin-1（ZO-1）的基因表达，信号换能器和因子3的激活器（STAT-3），和细胞内粘附分子-1(ICAM-1)。还评估了每位患者的数字疼痛评定量表（NRS）和部分Mayo评分。
结果：与美沙拉嗪组相比，二甲双胍组显示血清IL-6，zonulin，TNF-α,SIP,ICAM-1和STAT-3的基因表达，与美沙拉嗪组相比，结肠ZO-1显着增加。与美沙拉嗪组相比，二甲双胍组的NRS和部分Mayo评分指数也显着降低。
结论：二甲双胍可能是UC患者的一种有希望的额外治疗方法。试用注册标识符:NCT05553704。
目的：探讨二甲双胍及其保护途径在UC患者中的潜在作用。
方法：这是一个随机的，控制,和双盲临床试验,纳入60名轻度至中度UC患者,随机分为两组(n=30).6个月,美沙拉嗪组每天3次(t.i.d.)接受1g美沙拉嗪.六个月来,二甲双胍组每天两次接受1gt.i.d.和500mg二甲双胍.胃肠病学家在基线和开始治疗后6个月评估患者，以测量血清zonulin水平，鞘氨醇1磷酸（S1P），白细胞介素-6（IL-6），和肿瘤坏死因子-α(TNF-α)。来自结肠的活检被用来测量小带occardin-1（ZO-1）的基因表达，信号换能器和因子3的激活器（STAT-3），和细胞内粘附分子-1(ICAM-1)。还评估了每位患者的数字疼痛评定量表（NRS）和部分Mayo评分。
结果：与美沙拉嗪组相比，二甲双胍组显示血清IL-6，zonulin，TNF-α,SIP,ICAM-1和STAT-3的基因表达，与美沙拉嗪组相比，结肠ZO-1显着增加。与美沙拉嗪组相比，二甲双胍组的NRS和部分Mayo评分指数也显着降低。
结论：二甲双胍可能是UC患者的一种有希望的额外治疗方法。试用注册标识符:NCT05553704。
