Low-Dose Cannabidiol Is Safe but Not Effective in the Treatment for Crohn's Disease, a Randomized Controlled Trial
Low-Dose Cannabidiol Is Safe but Not Effective in the Treatment for Crohn's Disease, a Randomized Controlled Trial
复制标题
DOI：
10.1007/s10620-017-4540-z
复制
发表时间：
2017-06-01
影响因子：
3.1
通讯作者：
Konikoff, Fred M.
中科院分区：
文献类型：
--
作者：
Naftali, Timna;Mechulam, Refael;Konikoff, Fred M.
大麻二酚（CBD）是一种抗炎大麻素，在IBD小鼠模型中显示有益。由于缺乏中枢效应，大麻二酚是治疗炎症性疾病的一个有吸引力的选择。在一项随机安慰剂对照试验中评估大麻二酚对克罗恩病的影响。20例年龄在18-75岁，克罗恩病活动性指数（CDAI）为200的患者随机接受口服（10mg） CBD或安慰剂，每日两次。患者对类固醇（11例）、硫嘌呤（14例）或TNF拮抗剂（11例）的标准治疗无反应。在治疗期间8周和治疗后2周评估疾病活动性和实验室参数。其他医疗服务保持不变。在招募的20名患者中，有19人完成了这项研究。平均年龄39±15岁，男性11例。CBD组和安慰剂组在大麻二酚摄入前的平均CDAI分别为337 +/- 108和308 +/- 96 （p = NS）。治疗8周后，CBD组和安慰剂组的指数分别为220 +/- 122和216 +/- 121 （p = NS）。血红蛋白、白蛋白、肾功能和肝功能检查保持不变。未观察到任何副作用。在这项中度活动性克罗恩病的研究中，CBD是安全的，但没有有益的作用。这可能是由于CBD对克罗恩病缺乏效果，但也可能是由于CBD剂量小，研究中的患者数量少，或者缺乏与其他大麻素的必要协同作用。nct01037322。
Cannabidiol (CBD) is an anti-inflammatory cannabinoid shown to be beneficial in a mouse model of IBD. Lacking any central effect, cannabidiol is an attractive option for treating inflammatory diseases.To assess the effects of cannabidiol on Crohn's disease in a randomized placebo-controlled trial.Twenty patients aged 18-75 years with a Crohn's disease activity index (CDAI) > 200 were randomized to receive oral (10 mg) CBD or placebo twice daily. Patients did not respond to standard treatment with steroids (11 patients), thiopurines (14), or TNF antagonists (11). Disease activity and laboratory parameters were assessed during 8 weeks of treatment and 2 weeks thereafter. Other medical treatment remained unchanged.Of 20 patients recruited 19 completed the study. Their mean age was 39 +/- 15, and 11 were males. The average CDAI before cannabidiol consumption was 337 +/- 108 and 308 +/- 96 (p = NS) in the CBD and placebo groups, respectively. After 8 weeks of treatment, the index was 220 +/- 122 and 216 +/- 121 in the CBD and placebo groups, respectively (p = NS). Hemoglobin, albumin, and kidney and liver function tests remained unchanged. No side effects were observed.In this study of moderately active Crohn's disease, CBD was safe but had no beneficial effects. This could be due to lack of effect of CBD on Crohn's disease, but could also be due to the small dose of CBD, the small number of patients in the study, or the lack of the necessary synergism with other cannabinoids. Further investigation is warranted.NCT01037322.