第二阶段随机对照试验比较传统的泰国基于大麻的药物与lorazepam治疗失眠治疗
Thavatchai Kamoltham1, Suwadee Chokchaisiri2, Chawalit Yongram2
1Department of Cannabis Health Sciences, College of Allied Health Sciences, Suan Sunandha Rajabhat University, Samut Songkhram, 75000, Thailand. thavatchai.ka@ssru.ac.th.
一种基于大麻的泰国草药配方显示,在慢性失眠方面,它的疗效与洛拉泽巴姆无差. 这种传统药物是改善睡眠质量的耐受性良好的短期替代品.
科学领域:
- 草药是一种草药.
- 临床研究 临床研究
- 睡眠科学 睡眠科学
背景情况:
- 泰国传统的基于大麻的多草药配方在泰国被合法承认用于治疗用途.
- 支持其用于治疗失眠的临床证据有限.
研究的目的:
- 在慢性失眠患者中,将泰国大麻基草药配方与洛拉泽帕姆的疗效和安全性进行比较.
- 评估草药配方作为慢性失眠的潜在短期替代方案.
主要方法:
- 第二阶段随机,双盲,主动控制的非劣势试验.
- 100名患有慢性失眠的参与者被随机分配给草药配方或洛拉泽帕姆4周.
- 通过匹兹堡睡眠质量指数 (PSQI) 评估睡眠质量;在第4周评估非劣势性.
主要成果:
- 82名参与者完成了这项研究;这两种治疗都显著改善了睡眠质量.
- 草药配方证明与洛拉泽巴姆无劣 (PSQI平均差异 -1.34,95% CI: -2.99至0.31).
- 在两组中都观察到可比的安全概况,生活质量和压力方面的改善.
结论:
- 泰国基于大麻的草药配方在治疗慢性失眠的有效性方面与洛拉泽不逊色.
- 草药配方被很好地容忍,可以被认为是短期的替代品.
- 支持对睡眠障碍的传统草药进一步调查.
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