Pycnogenol, Papain, and Aloe Vera for the Management of Pre-Diabetes

by | Jul 28, 2020 | 2020, Aloe Vera, Diabetes, Pycnogenol

Written by Angeline A. De Leon, Staff Writer. Twelve weeks of supplementation with a polyherbal blend of pycnogenol, papain, and aloe vera was not effective in the management of pre-type-two diabetes.

Pre-diabetes is characterized by elevated levels of fasting plasma glucose (FPG) beyond the normal range but below that of the diabetic range 1, with diagnosis based on an FPG level between 6.1 and 6.9 moll/L 2. Pre-diagnosis increases the risk of developing both type 2 diabetes and cardiovascular disease (CVD) 3, and for patients at the pre-clinical stage, proper management of blood glucose and insulin sensitivity is critical 4. In this respect, several natural products have demonstrated notable therapeutic value. For one, pycnogenol, an extract of French maritime bark, shows the ability to improve cardiometabolic risk factors, including blood pressure, FPG, plasma triglycerides, and endothelial function, in patients with type 2 diabetes 5. Similar effects have been observed with pycnogenol supplementation in patients with confirmed diagnoses of hypertension 6. Papaya fruit also appears to exert significant metabolic benefits for diabetes and obesity 7, and epidemiological evidence suggests that aloe vera may possess significant cardioprotective effects, as well 8. In a 2020 study 9 in Medicines, researchers sought to explore the efficacy of a nutraceutical product combining pycnogenol, papain (derived from papaya), and aloe vera in the management of pre-type 2 diabetes.

A total of 117 participants (mean age = 62.4 years) with impaired FPG (between 5.5 and 6.9 mmol/L) and a body mass index of 25 kg/m2 or more were enrolled in a randomized, double-blind, placebo-controlled, parallel-arm trial. Subjects were randomized to receive 50 mL of the herbal formulation (containing 130 mg pycnogenol, 120 mg papain, and 87.5 mg aloe vera) or matching placebo daily for 12 weeks. FPG was tested at baseline, Week 4, Week 8, and Week 12. Participants also completed an oral glucose tolerance test (OGTT) and provided blood samples, which were analyzed for serum insulin, insulin resistance/sensitivity, markers of oxidative stress (high-sensitivity C-reactive protein, hs-CRP), and lipid profile at baseline and at Week 12.

Results of the trial did not show that the polyherbal medicine used in the current study was effective in improving metabolic markers of pre-diabetes. At 12 weeks, participants in the active treatment arm showed a trend for lower FPG, compared to controls, however, this difference was non-significant (p = 0.16). A subgroup analysis of participants with a baseline FPG between 6.1 and 6.9 mmol/L showed a trend for a lower proportion of subjects with impaired glucose tolerance (IGT) in the polyherbal group vs. control after 12 weeks, but this trend, similarly, was non-significant (58.3% vs. 66.7%, p = 0.65). Fasting insulin levels were found to be statistically significantly higher in the placebo vs. treatment group (+7.5 mU/L, p = 0.039) by the end of the study, however, no significant differences were observed for total cholesterol or triglyceride levels nor for any of the other anthropometric or metabolic measures assessed.

Although results indicate that treatment was safe and well-tolerated, findings from the current study do not support the efficacy of an herbal formulation containing pycnogenol, papain, and aloe vera for improving metabolic/glycemic markers of pre-diabetes. A number of study limitations should be considered regarding the null findings of the study. Although there was evidence indicative of an improvement in FPG for the treatment group vs. control in a subgroup analysis, this trend was non-significant, potentially owing to the fact that the study was not sufficiently powered for such a comparison (power = 15%). Investigators also employed a relatively short treatment duration and a wide FPG range. It is possible that a longer study period would reveal significant clinical changes associated with supplementation or that supplementation in conjunction with other lifestyle changes like exercise could improve metabolic parameters. Further research is needed to explore these possibilities and to verify the changes associated with a polyherbal medicine at the intestinal microbiome level.

Source: Vitetta L, Butcher B, Dal Forno S, et al. A double-blind randomized placebo-controlled study assessing the safety, tolerability, and efficacy of an herbal medicine containing pycnogenol combined with papain and aloe vera in the prevention and management of pre-diabetes. Medicines. 2020; 7: 22. DOI: 10.3390/medicine7040022.

© 2020 by the authors. Licensee MDPI, Basel, Switzerland. This article is an open access article distributed under the terms and conditions of the Creative Commons Attribution (CC BY) license (http://creativecommons.org/licenses/by/4.0/).

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Posted July 28, 2020.

Angeline A. De Leon, MA, graduated from the University of Illinois at Urbana-Champaign in 2010, completing a bachelor’s degree in psychology, with a concentration in neuroscience. She received her master’s degree from The Ohio State University in 2013, where she studied clinical neuroscience within an integrative health program. Her specialized area of research involves the complementary use of neuroimaging and neuropsychology-based methodologies to examine how lifestyle factors, such as physical activity and meditation, can influence brain plasticity and enhance overall connectivity.

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