The CANBACK trial: a randomised, controlled clinical trial of oral cannabidiol for people presenting to the emergency department with acute low back pain
The CANBACK trial: a randomised, controlled clinical trial of oral cannabidiol for people presenting to the emergency department with acute low back pain
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DOI：
10.5694/mja2.51014
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发表时间：
2021-04-12
影响因子：
11.4
通讯作者：
Wong, Anselm
中科院分区：
文献类型：
--
作者：
Bebee, Bronwyn;Taylor, David M.;Wong, Anselm
目的：评估单剂量口服大麻二酚（CBD）作为急性腰痛急诊患者标准护理的辅助疗法的镇痛功效和安全性。设计：随机、双盲、安慰剂对照临床试验。地点：墨尔本奥斯汀医院三级急诊科。参与者：2018年5月21日至6月13日期间出现急性、非创伤性腰痛的患者2019.干预：100 名符合条件的患者被随机分配接受 400 毫克 CBD 或安慰剂，以及标准急诊科镇痛药物。主要结果指标：服用研究药物两小时后，根据口头数字疼痛量表进行疼痛评分（范围，0-10）。次要结局是住院时间、救援镇痛需求和不良事件。 结果：100 名参与者的中位年龄为 47 岁（IQR，34-60 岁）； 44 名是女性。 CBD 组（6.2 分；95% CI，5.5-6.9 分）和安慰剂组（5.8 分；95% CI，5.1-6.6 分；绝对差异，-0.3 分；95% CI，-1.3 至 0.6 分）两小时时的平均疼痛评分相似。 CBD 组的中位住院时间为 9.0 小时（IQR，7.4-12 小时），安慰剂组为 8.5 小时（IQR，6.5-21 小时）。两组在接受 CBD 或安慰剂前 4 小时和后 4 小时内使用羟考酮的情况相似，报告的副作用也相似。结论：CBD 作为缓解急诊科急性非创伤性腰痛的辅助药物并不优于安慰剂。
Objective: To assess the analgesic efficacy and safety of single-dose oral cannabidiol (CBD) as an adjunct to standard care for patients presenting to an emergency department with acute low back pain.Design: Randomised, double blinded, placebo-controlled clinical trial.Setting: The tertiary emergency department of Austin Hospital, Melbourne.Participants: Patients who presented with acute, non-traumatic low back pain between 21 May 2018 and 13 June 2019.Intervention: One hundred eligible patients were randomised to receiving 400 mg CBD or placebo in addition to standard emergency department analgesic medication.Main outcome measures: Pain score two hours after administration of study agent, on a verbal numerical pain scale (range, 0-10). Secondary outcomes were length of stay, need for rescue analgesia, and adverse events.Results: The median age of the 100 participants was 47 years (IQR, 34-60 years); 44 were women. Mean pain scores at two hours were similar for the CBD (6.2 points; 95% CI, 5.5-6.9 points) and placebo groups (5.8 points; 95% CI, 5.1-6.6 points; absolute difference, -0.3 points; 95% CI, -1.3 to 0.6 points). The median length of stay was 9.0 hours (IQR, 7.4-12 hours) for the CBD group and 8.5 hours (IQR, 6.5-21 hours) for the placebo group. Oxycodone use during the four hours preceding and the four hours after receiving CBD or placebo was similar for the two groups, as were reported side effects.Conclusion: CBD was not superior to placebo as an adjunct medication for relieving acute non-traumatic low back pain in the emergency department.