Department of Gastroenterology and Hepatology, Meir Medical Center and Sackler Faculty of Medicine, Tel Aviv University, Kfar Saba, Israel.
Clin Gastroenterol Hepatol. 2013 Oct;11(10):1276-1280.e1. doi: 10.1016/j.cgh.2013.04.034. Epub 2013 May 4.
BACKGROUND & AIMS: The marijuana plant Cannabis sativa has been reported to produce beneficial effects for patients with inflammatory bowel diseases, but this has not been investigated in controlled trials. We performed a prospective trial to determine whether cannabis can induce remission in patients with Crohn's disease.
We studied 21 patients (mean age, 40 ± 14 y; 13 men) with Crohn's Disease Activity Index (CDAI) scores greater than 200 who did not respond to therapy with steroids, immunomodulators, or anti-tumor necrosis factor-α agents. Patients were assigned randomly to groups given cannabis, twice daily, in the form of cigarettes containing 115 mg of Δ9-tetrahydrocannabinol (THC) or placebo containing cannabis flowers from which the THC had been extracted. Disease activity and laboratory tests were assessed during 8 weeks of treatment and 2 weeks thereafter.
Complete remission (CDAI score, <150) was achieved by 5 of 11 subjects in the cannabis group (45%) and 1 of 10 in the placebo group (10%; P = .43). A clinical response (decrease in CDAI score of >100) was observed in 10 of 11 subjects in the cannabis group (90%; from 330 ± 105 to 152 ± 109) and 4 of 10 in the placebo group (40%; from 373 ± 94 to 306 ± 143; P = .028). Three patients in the cannabis group were weaned from steroid dependency. Subjects receiving cannabis reported improved appetite and sleep, with no significant side effects.
Although the primary end point of the study (induction of remission) was not achieved, a short course (8 weeks) of THC-rich cannabis produced significant clinical, steroid-free benefits to 10 of 11 patients with active Crohn's disease, compared with placebo, without side effects. Further studies, with larger patient groups and a nonsmoking mode of intake, are warranted. ClinicalTrials.gov, NCT01040910.
大麻植物大麻已被报道对炎症性肠病患者有有益的影响，但这尚未在对照试验中进行研究。我们进行了一项前瞻性试验，以确定大麻是否可以诱导克罗恩病患者缓解。
我们研究了 21 名（平均年龄 40 ± 14 岁；男性 13 名）克罗恩病活动指数（CDAI）评分大于 200 的患者，这些患者对类固醇、免疫调节剂或抗肿瘤坏死因子-α 药物治疗无反应。患者被随机分为两组，每天两次给予含有 115 毫克 Δ9-四氢大麻酚（THC）的香烟或含有已提取 THC 的大麻花的安慰剂。在 8 周的治疗和之后的 2 周内评估疾病活动和实验室检查。
大麻组 11 名受试者中有 5 名（45%）达到完全缓解（CDAI 评分<150），安慰剂组 10 名受试者中有 1 名（10%）（P =.43）。11 名接受大麻的受试者中有 10 名（90%）出现临床反应（CDAI 评分下降>100），而安慰剂组中有 4 名（40%）（从 330 ± 105 降至 152 ± 109；P =.028）。大麻组中有 3 名患者从类固醇依赖中逐渐减少。接受大麻的受试者报告说食欲和睡眠改善，没有明显的副作用。
尽管该研究的主要终点（诱导缓解）未达到，但与安慰剂相比，富含 THC 的大麻短期（8 周）治疗可使 11 名活动性克罗恩病患者中的 10 名患者获得显著的临床、无类固醇益处，且无副作用。需要进一步的研究，纳入更大的患者群体和非吸烟摄入方式。ClinicalTrials.gov，NCT01040910。
