title: Efficacy and safety of the dietary supplement DBCare® in patients with type 2 diabetes mellitus and inadequate glycemic control.
abstract: OBJECTIVE
  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.
  
  
  METHODS
  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.
  
  
  RESULTS
  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.
  
  
  CONCLUSIONS
  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.
authors.affiliation: a Department of Medicine E , Meir Medical Center , Kfar Saba , Israel.
authors.forename: Pnina
authors.initials: P
authors.lastname: Rotman-Pikielny
authors.forename: Rosane
authors.initials: R
authors.lastname: Ness-Abramof
authors.forename: Gideon
authors.initials: G
authors.lastname: Charach
authors.forename: Alexander
authors.initials: A
authors.lastname: Roitman
authors.forename: Rivka
authors.initials: R
authors.lastname: Zissin
authors.forename: Yair
authors.initials: Y
authors.lastname: Levy
mesh_terms: D000368:Aged; D001786:Blood Glucose / Q000378:metabolism*; D015992:Body Mass Index; D003924:Diabetes Mellitus, Type 2 / Q000188:drug therapy*; D019587:Dietary Supplements; D004311:Double-Blind Method; D005260:Female; D006442:Glycated Hemoglobin / Q000378:metabolism*; D006801:Humans; D007004:Hypoglycemic Agents / Q000494:pharmacology / Q000627:therapeutic use*; D007194:India; D019684:Magnoliopsida; D008297:Male; D008875:Middle Aged; D008517:Phytotherapy; D028321:Plant Preparations / Q000494:pharmacology / Q000627:therapeutic use*; D010946:Plants, Medicinal; D016896:Treatment Outcome
chemical_list: D001786:Blood Glucose; D006442:Glycated Hemoglobin; D007004:Hypoglycemic Agents; D028321:Plant Preparations