Rotman-Pikielny Pnina, Ness-Abramof Rosane, Charach Gideon, Roitman Alexander, Zissin Rivka, Levy Yair
a Department of Medicine E , Meir Medical Center , Kfar Saba , Israel.
J Am Coll Nutr. 2014;33(1):55-62. doi: 10.1080/07315724.2014.870008.
DBCare® (Ace Continental Exports Inc., London, UK) is a traditional Indian herbal food supplement marketed as an antidiabetes remedy. This study evaluated the efficacy and safety of DBCare in patients with inadequately controlled type 2 diabetes mellitus (T2DM) despite oral hypoglycemic treatment.
A 12-week randomized double-blind placebo-controlled trial was conducted. Patients with T2DM on oral hypoglycemic agents with HbA1C > 7.0% were randomized to receive DBCare or placebo tablets.
Thirty-five patients (20 male/15 female; mean age 61.2 ± 7.6 years), with a mean baseline HbA1C of 7.9% ± 0.6%, received DBCare (N = 18) or placebo (N = 17). During the study period, HbA1C declined 0.4 ± 0.7% in the DBCare® group and 0.2% ± 0.8% in the placebo group (p = 0.806). No significant changes occurred in fasting plasma glucose, lipid profile, or homeostasis model assessment throughout the study or in body mass index, waist circumference, or blood pressure values. Hypoglycemic episodes (glucose < 70 mg/dL) were more frequent in the treatment group (7 vs 1, p = 0.043), necessitating a decrease in other hypoglycemic medications in 2 patients. DBCare was generally well tolerated, with mild side effects that were not different from those of the placebo group.
This preliminary study did not demonstrate that DBCare was efficacious in improving glycemic control in inadequately controlled patients with T2DM on oral hypoglycemics. A trend toward improved glycemic control was noted in the DBCare group, which correlates with more frequent hypoglycemic episodes. Further studies are needed to elucidate DBCare's hypoglycemic effect in patients with T2DM in general and in specific clinical settings, such as HbA1C ≥ 8%, short (≤10-year) duration of diabetes, or young age in particular.
DBCare®（英国伦敦Ace Continental Exports公司）是一种作为抗糖尿病疗法销售的传统印度草药食品补充剂。本研究评估了DBCare对尽管接受口服降糖治疗但血糖控制不佳的2型糖尿病（T2DM）患者的疗效和安全性。
进行了一项为期12周的随机双盲安慰剂对照试验。口服降糖药且糖化血红蛋白（HbA1C）>7.0%的T2DM患者被随机分配接受DBCare或安慰剂片。
35例患者（20例男性/15例女性；平均年龄61.2±7.6岁），平均基线HbA1C为7.9%±0.6%，接受了DBCare（n = 18）或安慰剂（n = 17）。在研究期间，DBCare®组的HbA1C下降了0.4±0.7%，安慰剂组下降了0.2%±0.8%（p = 0.806）。在整个研究过程中，空腹血糖、血脂谱或稳态模型评估以及体重指数、腰围或血压值均未发生显著变化。低血糖发作（血糖<70mg/dL）在治疗组中更频繁（7次对1次，p = 0.043），2例患者需要减少其他降糖药物剂量。DBCare总体耐受性良好，轻微副作用与安慰剂组无差异。
这项初步研究未证明DBCare对口服降糖药治疗血糖控制不佳的T2DM患者改善血糖控制有效。DBCare组有血糖控制改善的趋势，这与更频繁的低血糖发作相关。需要进一步研究以阐明DBCare对一般T2DM患者以及特定临床情况（如HbA1C≥8%、糖尿病病程短（≤10年）或特别是年轻患者）的降糖作用。
