Onyeakazi Uzunma M, Columb Malachy O, Rosalind Adam, Kanakarajan Saravanakumar, Galley Helen F
School of Medicine, Medical Sciences and Nutrition, University of Aberdeen, Aberdeen, UK.
Manchester University Hospitals NHS Foundation Trust, Wythenshawe, UK.
Br J Anaesth. 2024 Apr;132(4):725-734. doi: 10.1016/j.bja.2024.01.012. Epub 2024 Feb 14.
Sleep disturbance is a major issue for patients with chronic pain. Melatonin has been shown to improve symptoms of fibromyalgia, but its efficacy in other chronic non-malignant pain conditions is not fully known. Hence, we determined the effect of melatonin in patients with severe noncancer chronic pain.
This was a randomised double-blinded crossover trial of modified-release melatonin as Circadin™ compared with placebo. Sixty male and female subjects with chronic severe pain were randomised to receive either 2 mg of Circadin™ or placebo before sleep for 6 weeks, followed by a >4 week washout, then crossing over to the other treatment. Sleep disturbance, quality, and latency were measured using three different validated sleep assessment tools. The primary outcome measure was self-reported sleep disturbance after 6 weeks of treatment. Adverse events were also recorded.
Sleep disturbance after 6 weeks was not significantly altered by melatonin treatment, but differences between melatonin and placebo treatment periods after 3 weeks were seen: sleep disturbance (P=0.014), latency (P=0.04), overall sleep quality (P=0.004), and effect of pain on sleep (P=0.032). Pain intensity scores improved during both treatment periods (both P<0.001). There were no differences in adverse events between treatment periods.
Circadin™ treatment did not improve sleep disturbance in patients with severe chronic pain compared with placebo at 6 weeks, but there were consistent improvements in aspects of sleep in the shorter term. Given its favourable safety profile, it could be beneficial for some patients with chronic pain.
ISRCTN12861060.
睡眠障碍是慢性疼痛患者的一个主要问题。褪黑素已被证明可改善纤维肌痛症状，但其在其他慢性非恶性疼痛病症中的疗效尚不完全清楚。因此，我们确定了褪黑素对重度非癌性慢性疼痛患者的影响。
这是一项将缓释褪黑素（Circadin™）与安慰剂进行对比的随机双盲交叉试验。60名患有慢性重度疼痛的男性和女性受试者被随机分为两组，一组在睡前服用2毫克Circadin™，另一组服用安慰剂，为期6周，随后进行超过4周的洗脱期，然后交叉接受另一种治疗。使用三种经过验证的睡眠评估工具来测量睡眠障碍、质量和潜伏期。主要结局指标是治疗6周后自我报告的睡眠障碍情况。同时记录不良事件。
褪黑素治疗6周后，睡眠障碍没有显著改变，但在3周后，褪黑素治疗期和安慰剂治疗期之间出现了差异：睡眠障碍（P = 0.014）、潜伏期（P = 0.04）、总体睡眠质量（P = 0.004）以及疼痛对睡眠的影响（P = 0.032）。在两个治疗期内，疼痛强度评分均有所改善（均P < 0.001）。治疗期之间不良事件没有差异。
与安慰剂相比，Circadin™治疗在6周时并未改善重度慢性疼痛患者的睡眠障碍，但在短期内睡眠的各个方面有持续改善。鉴于其良好的安全性，它可能对一些慢性疼痛患者有益。
ISRCTN12861060。
