Casa di Cura Villa Igea, Modena, Italy.
Department of General Surgery and Surgical Specialties, University of Modena and Reggio Emilia Medical School, Surgical Clinic, Modena, Italy.
Clin Ter. 2022 Feb 7;173(1):91-96. doi: 10.7417/CT.2022.2399.
Our main aim was to investigate the short-term thera-peutic effects, safety/tolerability of natural compound, composed of melatonin (1,5 mg) and cannabis extracts (2.5 mg CBD) in patients with sleep disorders.
In this spontaneous, anecdotal, retrospective, "compas-sionate-use," observational, open-label study, 20 patients (age 43-96 years) were appealed to our "Second Opinion Medical Consulting Net-work" (Modena, Italy), because of a variable pattern of sleep disorders and anxiety and were instructed to take sublingually the compound (20 drops) overnight for 3 months of treatment. Tolerability and adverse effects were assessed monthly during the treatment period through direct contact (email or telephone) or visit if required.
PSQUI and HAM-A scores evidenced reduction in mood alterations, including anxiety, panic, paranoia, depression (P < 0.03), in pain (P < 0.02) and good general health perceptions.
These data suggest that the formula CBD-melatonin could be competitive with the classic hypnotic synthetic drugs, the antioxidant activity of melatonin offers a further benefit to the brain network, restoring the biological clock functions, while CBD, redu-cing chronic pain perception, helps to complete the neuromuscular relaxation and to relieve anxiety fulfilling a very balanced sensation of wellbeing during the sleep.
我们的主要目的是研究由褪黑素(1.5 毫克)和大麻素提取物(2.5 毫克 CBD)组成的天然化合物在睡眠障碍患者中的短期治疗效果、安全性/耐受性。
在这项自发的、轶事的、回顾性的、“同情使用”、观察性的、开放标签研究中,由于睡眠障碍和焦虑的模式不同,20 名年龄在 43-96 岁的患者向我们的“第二意见医学咨询网络”(意大利摩德纳)寻求帮助,并被指示在夜间服用舌下含服该化合物(20 滴),治疗期为 3 个月。在治疗期间,通过直接联系(电子邮件或电话)或需要时进行访问,每月评估耐受性和不良反应。
PSQUI 和 HAM-A 评分显示,情绪改变包括焦虑、恐慌、偏执、抑郁(P < 0.03)、疼痛(P < 0.02)和良好的总体健康感知得到改善。
这些数据表明,CBD-褪黑素配方可能与经典的催眠合成药物具有竞争力,褪黑素的抗氧化活性为大脑网络提供了额外的益处,恢复生物时钟功能,而 CBD 降低慢性疼痛感知,有助于完成神经肌肉放松,缓解焦虑,在睡眠期间产生非常平衡的幸福感。