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
What this study found
The polyherbal formulation did not meaningfully improve pre-diabetes markers over 12 weeks. In the full analysis set, impaired fasting glucose at week 12 was similar in the active and placebo groups (71% vs 69%, p = 0.75), and impaired glucose tolerance was also not different (27% vs 22%, p = 0.53). HbA1c at week 12 was 5.8 (0.4) vs 5.6 (0.6) (p = 0.15), and no adverse events were reported. Fasting insulin was 7.5 mU/L higher in placebo at 12 weeks (p = 0.039), but overall clinical efficacy was not demonstrated.
- Study & population
- Double-blind, randomized, placebo-controlled trial in adults with pre-diabetes at risk for type 2 diabetes, characterized by impaired fasting glucose and overweight or obesity.
- Intervention
- Oral polyherbal formulation taken 50 mL twice daily for 12 weeks, with each 50 mL dose containing pycnogenol 130 mg, papain 120 mg, and Aloe vera 87.5 mg.
- Key limitation
- The trial was short in duration, single-center, and relatively small, which limits power for modest effects and longer-term metabolic outcomes.
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Open PDFOriginal abstract
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.