Effect of Pancreas Tonic (an ayurvedic herbal supplement) in type 2 diabetes mellitus.
Although there is widespread use of herbal dietary supplements that are believed to benefit type 2 diabetes mellitus, few have been proven to do so in properly designed randomized trials; their efficacy for intermediate-term glucose control remains unclear. Pancreas Tonic is a botanical mixture of traditional Indian Ayurvedic herbs currently available as a dietary supplement. We report the results of a single-center, randomized, double-blind, placebo-controlled 3-month trial of Pancreas Tonic in type 2 diabetic patients inadequately treated with diet/lifestyle or stable doses of sulfonylureas and/or metformin for at least 3 months. Patients with type 2 diabetes for >/= 1 year were entered into 2 strata of hemoglobin A(1c) (HbA(1c)) levels (stratum 1: 8.0% to 9.9%; stratum 2: 10.0% to 12.0%). All subjects began a 1-month single-blind placebo run-in phase, followed by randomization in a 2:1 ratio of active treatment: placebo, to 3 months of double-blind treatment with either Pancreas Tonic or matching placebo (2 capsules 3 times a day). Concurrent oral agents were continued unchanged throughout the study. The primary outcome was the change in HbA(1c) from randomization; results of each stratum were analyzed independently. The baseline characteristics of 36 subjects who completed the study were comparable between treatment groups. Nineteen subjects entered stratum 1 and 17 entered stratum 2. A statistically significant reduction of HbA(1c) from randomization to end-of-study was seen in the stratum 2 subjects (Pancreas Tonic: 10.1% +/- 1.0% to 8.8% +/- 1.9%, P =.004; placebo: 10.8% +/- 1.4% to 11.2% +/- 1.8%, not significant [NS]). No significant HbA(1c) reductions were seen in the stratum 1 subjects. There were no significant treatment-related differences in the fasting plasma glucose (FPG), lipids, body mass index (BMI), body composition, blood pressure, insulin sensitivity estimates using the minimal model, glucose and insulin responses to a meal challenge, quality of life, adverse events, or other safety indices between treatment groups. Pancreas Tonic was well tolerated. Treatment with Pancreas Tonic (2 capsules 3 times per day) for 3 months significantly improved glucose control in type 2 diabetic patients with HbA(1c) levels between 10.0% to 12.0%. This study represents the first properly designed, prospective intervention trial of therapy with an Ayurvedic herbal supplement for intermediate-term glucose control in type 2 diabetes.
Hsia
Stanley H
SH
Charles R. Drew University of Medicine and Science, Los Angeles, CA, USA.
Bazargan
Mohsen
M
Davidson
Mayer B
MB
D000328:Adult; D001786:Blood Glucose / Q000378:metabolism; D003924:Diabetes Mellitus, Type 2 / Q000188:drug therapy / Q000503:physiopathology / Q000628:therapy*; D004311:Double-Blind Method; D004562:Electrocardiography; D005260:Female; D005951:Glucose Tolerance Test; D006442:Glycated Hemoglobin / Q000378:metabolism; D006801:Humans; D007004:Hypoglycemic Agents / Q000009:adverse effects / Q000627:therapeutic use; D008297:Male; D008515:Medicine, Ayurvedic; D008687:Metformin / Q000627:therapeutic use; D008875:Middle Aged; D008517:Phytotherapy / Q000009:adverse effects; D011788:Quality of Life; D013453:Sulfonylurea Compounds / Q000009:adverse effects / Q000627:therapeutic use; D016896:Treatment Outcome
D001786:Blood Glucose; D006442:Glycated Hemoglobin; D007004:Hypoglycemic Agents; D008687:Metformin; D013453:Sulfonylurea Compounds