Wainstein Julio, Landau Zohar, Bar Dayan Yosefa, Jakubowicz Daniela, Grothe Torsten, Perrinjaquet-Moccetti Tania, Boaz Mona
1 Diabetes Unit, E. Wolfson Medical Center , Holon, Israel .
2 Frutarom Switzerland Ltd. , Wadenswil, Switzerland .
J Med Food. 2016 Feb;19(2):133-40. doi: 10.1089/jmf.2015.0090.
Purslane extract (PE) is derived from Portulaca oleracea L., a medicinal plant used in traditional medicine for its antidiabetic properties. This randomized, placebo-controlled clinical trial was designed to evaluate the efficacy and safety of PE in improving glucose control, blood pressure, and lipid profile in adults with type 2 diabetes mellitus (T2DM) treated with a single oral hypoglycemic agent at baseline. Subjects were randomized to treatment with three capsules of PE/day or a matched placebo. Change from baseline to the week 12 end-of-follow-up visit measures of glucose homeostasis, hemodynamics, and lipid profile was compared by treatment assignment. In addition, these measures were evaluated in a subgroup of "responders," defined as patients whose week 12 HbA1c was lower than baseline values, regardless of treatment assignment. This group was further assessed in subgroups of baseline oral hypoglycemic treatment. A total of 63 participants were treated with either PE (n = 31, 11 females, mean age 52.4 ± 7.9 years) or matched placebo (n = 32, 11 females, mean age 58.3 ± 10.8 years). In the total cohort, systolic blood pressure declined significantly more in the PE group than the placebo group: -7.5 ± 5.0 versus -0.01 ± 0.3 mmHg, P < .0001. In the responders' subgroup, HbA1c declined significantly more in the PE group than the placebo group: -0.8% ± 0.4% versus -0.6% ± 0.5%, P = .03. Few adverse events were reported. These were mild and did not differ by treatment assignment. PE appears to be a safe, adjunct treatment for T2DM, significantly reducing systolic blood pressure in the total cohort and HbA1c in the subgroup of responders.
马齿苋提取物(PE)源自马齿苋,这是一种传统医学中因其抗糖尿病特性而被使用的药用植物。这项随机、安慰剂对照的临床试验旨在评估PE对基线时接受单一口服降糖药治疗的2型糖尿病(T2DM)成年患者改善血糖控制、血压和血脂谱的疗效及安全性。受试者被随机分为接受每日3粒PE胶囊治疗组或匹配的安慰剂组。通过治疗分组比较从基线到随访第12周结束时葡萄糖稳态、血流动力学和血脂谱的变化。此外,在“反应者”亚组中评估这些指标,“反应者”定义为无论治疗分组如何,第12周糖化血红蛋白(HbA1c)低于基线值的患者。该组在基线口服降糖治疗亚组中进一步评估。共有63名参与者接受了PE治疗(n = 31,11名女性,平均年龄52.4±7.9岁)或匹配的安慰剂治疗(n = 32,11名女性,平均年龄58.3±10.8岁)。在整个队列中,PE组收缩压下降幅度显著大于安慰剂组:-7.5±5.0与-0.01±0.3 mmHg,P <.0001。在反应者亚组中,PE组HbA1c下降幅度显著大于安慰剂组:-0.8%±0.4%与-0.6%±0.5%,P = 0.03。报告的不良事件很少。这些不良事件较轻,且在治疗分组间无差异。PE似乎是一种安全的T2DM辅助治疗方法,可显著降低整个队列的收缩压以及反应者亚组的HbA1c。