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Open AccessArticle

A Double-Blind Randomized Placebo-Controlled Study Assessing the Safety, Tolerability and Efficacy of a Herbal Medicine Containing Pycnogenol Combined with Papain and Aloe vera in the Prevention and Management of Pre-Diabetes

1
Sydney Medical School, Faculty of Medicine and Health, The University of Sydney, Sydney NSW 2006, Australia
2
Medlab Clinical, Sydney NSW 2015, Australia
3
WriteSource Medical Pty Ltd., Lane Cove NSW 2066, Australia
4
School of Medical Science, University of New South Wales (UNSW), Sydney NSW 2052, Australia
5
Facility of Science, Health, Education and Engineering, University of the Sunshine Coast, Sippy Downs QLD 4556, Australia
*
Author to whom correspondence should be addressed.
Medicines 2020, 7(4), 22; https://doi.org/10.3390/medicines7040022
Received: 30 March 2020 / Revised: 18 April 2020 / Accepted: 20 April 2020 / Published: 22 April 2020
Background: Herbal medicines present attractive options to patients with chronic diseases. Undertaking clinical studies with patients presenting with symptomless pre-T2D can lead to significant limitations. Methods: A 12-week randomized double-blind placebo-controlled clinical study was conducted that investigated the safety and efficacy of an herbal formulation administered orally for the treatment of pre-type 2 diabetes (pre-T2D). Results: A numerically greater proportion of subjects in the interventional arm had impaired fasting glucose (IFG) at week 12 compared to the control arm (71.0% vs. 69.0%, p = 0.75). Fewer participants had impaired glucose tolerance (IGT) at 12 weeks in the intervention arm compared to the control arm (unadjusted 58.3% vs. 66.7%, p = 0.65; adjusting for baseline IGT, p = 0.266). In a subgroup analysis, subjects with a baseline fasting plasma glucose (FPG) level in the range of 6.1–6.9 mmol/L demonstrated a non-significant lower proportion of IFG at week 12 in the intervention arm compared to the control arm (60.0% vs. 41.7% p = 0.343). Total blood cholesterol and triglyceride levels remained unchanged from baseline to week 12 in both treatment groups. Conclusions: This study suggests that a polyherbal medicine was not effective for reducing the metabolic markers associated with pre-T2D over a 12-week period. Therefore, larger studies with well-defined endpoints and of longer duration are warranted. View Full-Text
Keywords: pre-diabetes; pycnogenol; papain; Aloe vera; impaired fasting glucose; fasting plasma glucose pre-diabetes; pycnogenol; papain; Aloe vera; impaired fasting glucose; fasting plasma glucose
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MDPI and ACS Style

Vitetta, L.; Butcher, B.; Dal Forno, S.; Vitetta, G.; Nikov, T.; Hall, S.; Steels, E. A Double-Blind Randomized Placebo-Controlled Study Assessing the Safety, Tolerability and Efficacy of a Herbal Medicine Containing Pycnogenol Combined with Papain and Aloe vera in the Prevention and Management of Pre-Diabetes. Medicines 2020, 7, 22. https://doi.org/10.3390/medicines7040022

AMA Style

Vitetta L, Butcher B, Dal Forno S, Vitetta G, Nikov T, Hall S, Steels E. A Double-Blind Randomized Placebo-Controlled Study Assessing the Safety, Tolerability and Efficacy of a Herbal Medicine Containing Pycnogenol Combined with Papain and Aloe vera in the Prevention and Management of Pre-Diabetes. Medicines. 2020; 7(4):22. https://doi.org/10.3390/medicines7040022

Chicago/Turabian Style

Vitetta, Luis; Butcher, Belinda; Dal Forno, Serena; Vitetta, Gemma; Nikov, Tessa; Hall, Sean; Steels, Elizabeth. 2020. "A Double-Blind Randomized Placebo-Controlled Study Assessing the Safety, Tolerability and Efficacy of a Herbal Medicine Containing Pycnogenol Combined with Papain and Aloe vera in the Prevention and Management of Pre-Diabetes" Medicines 7, no. 4: 22. https://doi.org/10.3390/medicines7040022

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