Department of Plastic Surgery, University of Virginia, Charlottesville, VA.
School of Medicine, University of Virginia, Charlottesville, VA.
J Hand Surg Am. 2022 Jul;47(7):611-620. doi: 10.1016/j.jhsa.2022.03.002. Epub 2022 May 28.
Since the passage of the Agricultural Improvement Act of 2018, hand surgeons have increasingly encountered patients seeking counseling on over-the-counter, topical cannabidiol (CBD) for the treatment of pain. To this end, we designed a human clinical trial to investigate the therapeutic potential of CBD for the treatment of pain associated with thumb basal joint arthritis.
Following Food and Drug Administration and institutional approval, a phase 1 skin test was completed with 10 healthy participants monitored for 1 week after twice-daily application of 1 mL of topical CBD (6.2 mg/mL) with shea butter. After no adverse events were identified, we proceeded with a phase 2, double-blinded, randomized controlled trial. Eighteen participants with symptomatic thumb basal joint arthritis were randomized to 2 weeks of twice-daily treatment with CBD (6.2 mg/mL CBD with shea butter) or shea butter alone, followed by a 1-week washout period and then crossover for 2 weeks with the other treatment. Safety data and physical examination measurements were obtained at baseline and after completion of each treatment arm.
Cannabidiol treatment resulted in improvements from baseline among patient-reported outcome measures, including Visual Analog Scale pain; Disabilities of the Arm, Shoulder, and Hand; and Single Assessment Numeric Evaluation scores, compared to the control arm during the study period. There were similar physical parameters identified with range of motion, grip, and pinch strength.
In this single-center, randomized controlled trial, topical CBD treatment demonstrated significant improvements in thumb basal joint arthritis-related pain and disability without adverse events.
TYPE OF STUDY/LEVEL OF EVIDENCE: Therapeutic II.
自 2018 年《农业改进法案》通过以来，手外科医生越来越多地遇到寻求咨询的患者，他们希望使用非处方、局部使用的大麻二酚（CBD）来治疗疼痛。为此，我们设计了一项人体临床试验，以研究 CBD 治疗拇指基底关节关节炎相关疼痛的治疗潜力。
在获得食品和药物管理局以及机构批准后，10 名健康参与者完成了为期 1 周的 1 毫升局部 CBD（6.2mg/mL）与乳木果油的两次每日应用的 1 期皮肤测试，在没有发现不良事件后，我们进行了 2 期、双盲、随机对照试验。18 名有症状的拇指基底关节关节炎患者随机分为两组，分别接受 2 周的每日两次 CBD（含乳木果油的 6.2mg/mL CBD）或乳木果油单独治疗，然后进行 1 周的洗脱期，然后交叉接受另一种治疗 2 周。在基线和每个治疗臂完成后，均获得安全性数据和体格检查测量值。
与对照组相比，CBD 治疗组在研究期间的患者报告结果测量值（包括视觉模拟评分疼痛、上肢、肩部和手残疾和单一评估数字评估评分）中从基线开始出现改善。还确定了类似的运动范围、握力和捏力等物理参数。
在这项单中心、随机对照试验中，局部 CBD 治疗在拇指基底关节关节炎相关疼痛和残疾方面显示出显著改善，且无不良反应。
研究类型/证据水平：治疗 II 级。
