| Abstract | 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. |
| Authors | Stanley H Hsia, Mohsen Bazargan, Mayer B Davidson
(Affiliation: Charles R. Drew University of Medicine and Science, Los Angeles, CA, USA.)
|
| Journal | Metabolism: clinical and experimental
(Metabolism)
Vol. 53
Issue 9
Pg. 1166-73
(Sep 2004)
ISSN: 0026-0495 United States |
| PMID | 15334379
(Publication Type: Clinical Trial, Journal Article, Randomized Controlled Trial, Research Support, U.S. Gov't, P.H.S.)
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| Chemical References |
- Blood Glucose
- Hemoglobin A, Glycosylated
- Hypoglycemic Agents
- Sulfonylurea Compounds
- Metformin
|
| Topics |
- Adult
- Blood Glucose
(metabolism)
- Diabetes Mellitus, Type 2
(drug therapy, physiopathology, therapy)
- Double-Blind Method
- Electrocardiography
- Female
- Glucose Tolerance Test
- Hemoglobin A, Glycosylated
(metabolism)
- Humans
- Hypoglycemic Agents
(adverse effects, therapeutic use)
- Male
- Medicine, Ayurvedic
- Metformin
(therapeutic use)
- Middle Aged
- Phytotherapy
(adverse effects)
- Quality of Life
- Sulfonylurea Compounds
(adverse effects, therapeutic use)
- Treatment Outcome
|
