Derosa Giuseppe, D'Angelo Angela, Bonaventura Aldo, Bianchi Lucio, Romano Davide, Maffioli Pamela
University of Pavia, Department of Internal Medicine and Therapeutics, Fondazione IRCCS Policlinico S. Matteo, P.le C. Golgi, 2 - 27100 Pavia, Italy.
Expert Opin Biol Ther. 2013 Apr;13(4):475-82. doi: 10.1517/14712598.2013.776037. Epub 2013 Feb 27.
To evaluate the efficacy as antihypercholesterolemic agent of berberine in patients with low cardiovascular risk.
144 Caucasian subjects were enrolled. After a 6-month run-in period following diet and practicing physical activity, patients were randomized to take placebo or berberine 500 mg twice a day, for 3 months, in a double-blind, placebo-controlled design. Berberine and placebo were then interrupted for 2 months (washout period), and all patients continued with only diet and physical activity. At the end of the washout period, patients restarted berberine or placebo twice a day for further 3 months. Anthropometric and metabolic parameters were assessed during the run-in period, at randomization, before and after the washout period.
A decrease of body weight and BMI was observed after the run-in period. Berberine reduced total cholesterol, triglycerides and LDL cholesterol and increased HDL cholesterol after 3 months from randomization and compared with placebo. After the washout period, lipid profile worsened; afterward, when berberine was reintroduced, lipid profile improved again both compared with the washout period, and with placebo.
Berberine is effective and safe to mildly improve lipid profile in subjects with low risk for cardiovascular disease.
评估小檗碱对心血管疾病低风险患者作为抗高胆固醇血症药物的疗效。
招募了144名白种人受试者。在经过6个月的饮食和体育锻炼导入期后，患者被随机分配接受安慰剂或小檗碱，每天两次，每次500毫克，为期3个月，采用双盲、安慰剂对照设计。然后小檗碱和安慰剂中断服用2个月（洗脱期），所有患者仅继续进行饮食和体育锻炼。在洗脱期结束时，患者重新开始每天两次服用小檗碱或安慰剂，再持续3个月。在导入期、随机分组时、洗脱期前后评估人体测量和代谢参数。
导入期后观察到体重和BMI下降。与安慰剂相比，随机分组3个月后，小檗碱降低了总胆固醇、甘油三酯和低密度脂蛋白胆固醇，并提高了高密度脂蛋白胆固醇。洗脱期后，血脂状况恶化；之后，重新引入小檗碱时，与洗脱期相比以及与安慰剂相比，血脂状况再次改善。
小檗碱对于轻度改善心血管疾病低风险受试者的血脂状况是有效且安全的。
