Pud Dorit, Aamar Suhail, Schiff-Keren Bareket, Sheinfeld Roee, Brill Silviu, Robinson Dror, Fogelman Yaakov, Habib George, Sharon Haggai, Amital Howard, Boltyansky Boris, Haroutounian Simon, Eisenberg Elon
Faculty of Social Welfare and Health Sciences, University of Haifa, Haifa, Israel.
Hadassah-Hebrew University Medical Center, Jerusalem, Israel.
Pain Rep. 2024 Apr 26;9(2):e1143. doi: 10.1097/PR9.0000000000001143. eCollection 2024 Apr.
The use of medicinal cannabis for managing pain expands, although its efficacy and safety have not been fully established through randomized controlled trials.
This structured, prospective questionnaire-based cohort was aimed to assess long-term effectiveness and safety of cannabis oil extracts in patients with chronic pain.
Adult Israeli patients licensed to use cannabis oil extracts for chronic pain were followed prospectively for 6 months. The primary outcome measure was change from baseline in average weekly pain intensity, and secondary outcomes were changes in related symptoms and quality of life, recorded before treatment initiation and 1, 3, and 6 months thereafter. Generalized linear mixed model was used to analyze changes over time. In addition, "responders" (≥30% reduction in weekly pain at any time point) were identified.
The study included 218 patients at baseline, and 188, 154, and 131 at 1, 3, and 6 months, respectively. At 6 months, the mean daily doses of cannabidiol and Δ9-tetrahydrocannabinol were 22.4 ± 24.0 mg and 20.8 ± 30.1 mg, respectively. Pain decreased from 7.9 ± 1.7 at baseline to 6.6 ± 2.2 at 6 months ((3,450) = 26.22, < 0.0001). Most secondary parameters also significantly improved. Of the 218 participants, 24% were "responders" but could not be identified by baseline parameters. "Responders" exhibited higher improvement in secondary outcomes. Adverse events were common but mostly nonserious.
This prospective cohort demonstrated a modest overall long-term improvement in chronic pain and related symptoms and a reasonable safety profile with the use of relatively low doses of individually titrated Δ9-tetrahydrocannabinol and cannabidiol.
药用大麻用于疼痛管理的情况日益增多，尽管其疗效和安全性尚未通过随机对照试验得到充分证实。
这项基于结构化、前瞻性问卷调查的队列研究旨在评估大麻油提取物对慢性疼痛患者的长期有效性和安全性。
对获得使用大麻油提取物治疗慢性疼痛许可的成年以色列患者进行了为期6个月的前瞻性随访。主要结局指标是平均每周疼痛强度相对于基线的变化，次要结局指标是相关症状和生活质量的变化，分别在治疗开始前以及之后的1、3和6个月进行记录。采用广义线性混合模型分析随时间的变化。此外，还确定了“反应者”（在任何时间点每周疼痛减轻≥30%）。
该研究基线时纳入了218名患者，1、3和6个月时分别为188名、154名和131名。在6个月时，大麻二酚和Δ9 - 四氢大麻酚的平均日剂量分别为22.4±24.0毫克和20.8±30.1毫克。疼痛程度从基线时的7.9±1.7降至6个月时的6.6±2.2（(3,450)=26.22，<0.0001）。大多数次要参数也有显著改善。在218名参与者中，24%为“反应者”，但无法通过基线参数识别。“反应者”在次要结局方面有更高的改善。不良事件很常见，但大多不严重。
这项前瞻性队列研究表明，使用相对低剂量的个体化滴定的Δ9 - 四氢大麻酚和大麻二酚，慢性疼痛及相关症状总体上有适度的长期改善，且安全性合理。
