Department of Nutrition, University of California Davis, 3150B Meyer Hall, Davis, CA 95616, USA.
J Med Food. 2013 Jun;16(6):529-37. doi: 10.1089/jmf.2012.0178.
The clinical effects and tolerability of a novel herbal formulation comprising the extracts of Sphaeranthus indicus and Garcinia mangostana were assessed in two similarly designed randomized, double-blind, placebo-controlled, clinical trials in 100 human subjects with a body mass index (BMI) between 30 and 40 kg/m². Participants were randomized into two groups receiving either 400 mg of herbal blend twice daily or two identical placebo capsules. All subjects received three meals (2000 kcal/day) throughout the study and walked 5 days a week for 30 min. The primary outcome was reduction in body weight. Secondary outcomes were reduction in BMI and in waist and hip circumference. Serum glycemic, lipid, and adiponectin levels were also measured. Ninety-five subjects completed the trials, and data from these two studies were pooled and analyzed. At study conclusion (8 weeks), statistically significant reductions in body weight (5.2 kg; P<.0001), BMI (2.2 kg/m²; P<.0001), as well as waist (11.9 cm; P<.0001) and hip circumferences (6.3 cm; P=.0001) were observed in the herbal group compared with placebo. An increase in serum adiponectin concentration was also found in the herbal group versus placebo (P=.0008) at study conclusion along with reductions in fasting blood glucose (12.2%, P=.01), cholesterol (13.8%, P=.002), and triglyceride (41.6%, P<.0001) concentrations. No changes were seen across organ function panels, multiple vital signs, and no major adverse events were reported. The minor adverse events were equally distributed between the two groups. Our findings suggest that the herbal blend appears to be a well-tolerated and effective ingredient for weight management.
评估了一种由 Sphaeranthus indicus 和 Garcinia mangostana 的提取物组成的新型草药配方在两项类似设计的随机、双盲、安慰剂对照临床试验中的临床效果和耐受性，共纳入了 100 名体重指数（BMI）在 30 至 40kg/m²之间的人体受试者。参与者随机分为两组，分别每天接受 400mg 草药混合物两次或服用两个相同的安慰剂胶囊。所有受试者在整个研究期间接受三餐（每天 2000 卡路里），每周步行 5 天，每次 30 分钟。主要终点是体重减轻。次要终点是 BMI 以及腰围和臀围的减少。还测量了血清血糖、血脂和脂联素水平。95 名受试者完成了试验，将这两项研究的数据合并并进行了分析。在研究结束时（8 周），与安慰剂组相比，草药组的体重（5.2kg；P<.0001）、BMI（2.2kg/m²；P<.0001）以及腰围（11.9cm；P<.0001）和臀围（6.3cm；P=.0001）显著降低。在研究结束时，还发现与安慰剂组相比，草药组的血清脂联素浓度增加（P=.0008），空腹血糖（12.2%；P=.01）、胆固醇（13.8%；P=.002）和甘油三酯（41.6%；P<.0001）浓度降低。各器官功能面板、多项生命体征均未见变化，未报告重大不良事件。轻微不良事件在两组间分布均匀。我们的研究结果表明，该草药混合物似乎是一种耐受良好且有效的体重管理成分。
