Department of Medicine and Biochemistry, University of Puerto Rico School of Medicine, Medical Sciences Campus, San Juan, Puerto Rico; University of Puerto Rico Comprehensive Cancer Center, University of Puerto Rico, San Juan, Puerto Rico.
Department of Medicine, The Johns Hopkins University School of Medicine, Baltimore, Maryland.
Gastroenterology. 2018 Sep;155(3):668-673. doi: 10.1053/j.gastro.2018.05.031. Epub 2018 May 23.
BACKGROUND & AIMS: Familial adenomatous polyposis is an autosomal dominant disorder characterized by the development of hundreds of colorectal adenomas and eventually colorectal cancer. Oral administration of the spice curcumin has been followed by regression of polyps in patients with this disorder. We performed a double-blinded randomized trial to determine the safety and efficacy of curcumin in patients with familial adenomatous polyposis.
This study included 44 patients with familial adenomatous polyposis (18-85 years old) who had not undergone colectomy or had undergone colectomy with ileorectal anastomosis or ileal anal pouches, had at least 5 intestinal adenomatous polyps, and had enrolled in Puerto Rico or the United States from September 2011 through November 2016. Patients were randomly assigned (1:1) to groups given 100% pure curcumin (1,500 mg orally, twice per day) or identical-appearing placebo capsules for 12 months. The number and size of lower gastrointestinal tract polyps were evaluated every 4 months for 1 year. The primary outcome was the number of polyps in the curcumin and placebo groups at 12 months or at the time of withdrawal from the study according to the intention-to-treat principle.
After 1 year of treatment, the average rate of compliance was 83% in the curcumin group and 91% in the placebo group. After 12 weeks, there was no significant difference in the mean number of polyps between the placebo group (18.6; 95% CI, 9.3-27.8) and the curcumin group (22.6; 95% CI, 12.1-33.1; P = .58). We found no significant difference in mean polyp size between the curcumin group (2.3 mm; 95% CI, 1.8-2.8) and the placebo group (2.1 mm; 95% CI, 1.5-2.7; P = .76). Adverse events were few, with no significant differences between groups.
In a double-blinded randomized trial of patients with familial adenomatous polyposis, we found no difference in the mean number or size of lower intestinal tract adenomas between patients given curcumin 3,000 mg/day and those given placebo for 12 weeks. Clinicaltrials.gov ID NCT00641147.
家族性腺瘤性息肉病是一种常染色体显性遗传疾病，其特征是数百个结直肠腺瘤的发展，最终导致结直肠癌。对这种疾病患者进行香料姜黄素的口服给药后，息肉出现了消退。我们进行了一项双盲随机试验，以确定姜黄素在家族性腺瘤性息肉病患者中的安全性和疗效。
本研究纳入了 44 名家族性腺瘤性息肉病患者（18-85 岁），这些患者未接受结肠切除术，或接受了结肠切除术联合回肠直肠吻合术或回肠肛门袋，至少有 5 个肠腺瘤性息肉，并于 2011 年 9 月至 2016 年 11 月期间在波多黎各或美国入组。患者按照 1:1 的比例随机分配（双盲），分别给予 100%纯姜黄素（每天口服 1500mg，分两次）或外观相同的安慰剂胶囊，疗程为 12 个月。每 4 个月评估一次下消化道息肉的数量和大小，为期 1 年。主要结局是根据意向治疗原则，在 12 个月或研究退出时，姜黄素组和安慰剂组的息肉数量。
治疗 1 年后，姜黄素组的平均依从率为 83%，安慰剂组为 91%。在 12 周后，安慰剂组（18.6；95%置信区间，9.3-27.8）和姜黄素组（22.6；95%置信区间，12.1-33.1；P=.58）之间的平均息肉数量无显著差异。我们发现姜黄素组（2.3 毫米；95%置信区间，1.8-2.8）和安慰剂组（2.1 毫米；95%置信区间，1.5-2.7；P=.76）之间的平均息肉大小无显著差异。不良事件较少，两组之间无显著差异。
在一项家族性腺瘤性息肉病患者的双盲随机试验中，我们发现每天给予 3000 毫克姜黄素的患者与给予安慰剂的患者相比，在 12 周内下消化道腺瘤的平均数量或大小没有差异。Clinicaltrials.gov 注册号 NCT00641147。
