Department of Gastroenterology, Medical University, Lodz, Poland.
J Physiol Pharmacol. 2011 Jun;62(3):327-34.
Ulcerative colitis (UC) is a chronic disease characterized by the variable clinical picture with the inflammatory changes which can involve the whole colon or its distal part. The current treatments for UC are mostly nonspecific, not always effective, and often accompanied by serious side effects. Therefore, there is a considerable interest in finding alternative and more tolerable treatments for this serious disease. Several lines of experimental studies have shown that melatonin (MEL) regulates the extensive gut immune system and exerts antiinflammatory and immunomodulatory effects suggesting its beneficial action in UC by reducing and controlling inflammation. The study aimed at evaluating the effect of MEL on the activity of inflammatory process and sustaining the remission in patients with UC. It comprised 60 patients with left-sided UC, divided in two equal groups of 30 patients each (38 women and 22 men, aged 26-49 years), similar in both groups, who were in clinical remission for the last 12 months. Patients, during a next period of 12 months, were given mesalazine in daily doses 2 x 1.0 g and melatonin 5 mg daily at bedtime (group I) or placebo (group II). All the patients on MEL adjuvant treatment remained in remission during 12 months of observation with The Mayo Clinic Disease Activity Index (MCDAI) values 1.50±0.51 at the beginning and 2.75±1.86 points after 12 months. In the placebo group significantly higher MCDAI values were observed than in patients on MEL after 6, 9 and 12 months. At the inclusion MCDAI was 1.61±0.68 points and at the end of observation it reached the value of 5.10±2.22 points. In MEL group CRP level remained within the normal range during the course of the study (from 3.49±1.40 to 4.17±2.10 mg/dl). Whereas in the placebo group from the end of the third month the steady rise in CRP blood concentration was noted from 3.85±1.29 to 13.13±6.08 mg/dl. Parallelly to CRP rise a significant decrease in hemoglobin concentration in blood from 12.05±0.69 to 10.93±0.81 g/dl was observed in patients receiving placebo and the values significantly differed between the groups after 3 (p<0.05), 6, 9 and 12 months (p<0.01). The level of anxiety and the intensity of depression in patients on adjuvant MEL decreased during the study but there were no statistical differences noted between the groups. The results of the study allowed drawing the conclusion that adjuvant melatonin therapy may help in sustaining remission in patients with UC.
溃疡性结肠炎（UC）是一种慢性疾病，其特征为临床表现多变，炎症改变可累及整个结肠或其远端部分。目前 UC 的治疗大多是非特异性的，并不总是有效，而且常常伴有严重的副作用。因此，人们对寻找这种严重疾病的替代和更耐受的治疗方法产生了相当大的兴趣。几项实验研究表明，褪黑素（MEL）调节广泛的肠道免疫系统，并发挥抗炎和免疫调节作用，提示其通过减轻和控制炎症对 UC 具有有益作用。本研究旨在评估 MEL 对炎症过程活性的影响，并维持 UC 患者的缓解期。它包括 60 名左侧 UC 患者，分为两组，每组 30 名患者（38 名女性和 22 名男性，年龄 26-49 岁），两组患者在过去 12 个月内均处于缓解期。在接下来的 12 个月中，患者每天服用美沙拉嗪 2x1.0g 和褪黑素 5mg（I 组）或安慰剂（II 组）。所有接受 MEL 辅助治疗的患者在使用 Mayo 临床疾病活动指数（MCDAI）评估时，在 12 个月的观察期内仍处于缓解期，数值为 1.50±0.51，而在 12 个月后数值为 2.75±1.86。在安慰剂组中，与 MEL 组相比，在第 6、9 和 12 个月时观察到的 MCDAI 值明显更高。在纳入时，MCDAI 值为 1.61±0.68 点，在观察结束时达到 5.10±2.22 点。在 MEL 组中，C 反应蛋白（CRP）水平在研究过程中一直保持在正常范围内（从 3.49±1.40 到 4.17±2.10mg/dl）。而在安慰剂组中，从第三个月开始，CRP 血液浓度稳步上升，从 3.85±1.29 到 13.13±6.08mg/dl。与 CRP 升高平行的是，接受安慰剂的患者血液中血红蛋白浓度显著下降，从 12.05±0.69 到 10.93±0.81g/dl，在第 3、6、9 和 12 个月时两组之间的差异具有统计学意义（p<0.05）。在接受辅助 MEL 治疗的患者中，焦虑程度和抑郁强度在研究过程中下降，但两组之间无统计学差异。研究结果表明，辅助褪黑素治疗可能有助于维持 UC 患者的缓解期。
