Could an extract from French maritime pine bark make everyday life easier for women with thinning bones? Researchers investigated its effects on pain, energy levels, and safety in a six-month clinical trial.
Study: Quality of life and safety of a dietary intervention with French maritime pine bark extract (Pycnogenol®) in women with osteoporotic bone loss: a randomized, placebo-controlled double-blind study – Part II. Image Credit: luchschenF / Shutterstock
A recent study in the journal Frontiers in Nutrition evaluated the effects of Pycnogenol® supplementation on quality of life, pain, vitality, and safety in women with osteopenia and stable osteoporosis.
Current Evidence in Pycnogenol® Bone Health Research
Osteoporosis and osteopenia are prevalent metabolic bone disorders characterized by reduced bone mass and compromised bone microarchitecture, resulting in increased susceptibility to fractures. Osteoporosis, in particular, poses a significant public health burden in aging populations because of its association with morbidity, loss of mobility, increased mortality, and reduced quality of life.
While antiresorptive and osteoanabolic agents remain the cornerstone of osteoporosis management, there is growing interest in adjunctive options, such as plant-derived dietary supplements, that may modulate bone turnover, reduce inflammation, and improve antioxidant status. Pycnogenol®, a standardized extract from French maritime pine bark, is rich in oligomeric procyanidins and polyphenols and has shown strong antioxidant and anti-inflammatory properties in preclinical models.
In animal studies, Pycnogenol® has been shown to modulate bone turnover, reduce bone loss, and improve bone strength. More than 160 clinical trials with over 12,000 participants report a favorable safety profile, but long-term safety remains uncertain because most studies last less than six months. In addition, no clinical studies have directly assessed the impact of Pycnogenol® on bone health, quality of life, or long-term safety in osteopenia or osteoporosis.
Impact of Pycnogenol® on Quality of Life and Safety in Osteopenia and Osteoporosis
The current single-center, randomized, double-blind, placebo-controlled trial enrolled participants with osteopenia or osteoporosis between October 2021 and January 2024. The study utilized a two-arm parallel design: three months of Pycnogenol® (100 mg twice daily) or matching placebo, followed by a three-month active-treatment extension phase in which all participants received Pycnogenol®.
Participants attended five visits: baseline, 3 months, and 6 months on-site; telephone follow-ups at weeks 6 and 18. Baseline assessments included clinical evaluation, quality-of-life questionnaires, including the Quality of Life Questionnaire of the International Osteoporosis Foundation (QUALEFFO-41) and the 36-Item Short Form Health Survey Version 2 (SF-36v2), and a nutrition questionnaire.
Inclusion criteria were based on German national guidelines and included adults aged 18 or older who met criteria for osteopenia or osteoporosis, as assessed by fracture risk and dual-energy X-ray absorptiometry (DXA) measurements. Exclusion criteria included ongoing antiosteoporotic medication, recent osteoporotic fractures, and concurrent nutritional supplements, with specified exceptions for some patients who could not or chose not to receive indicated osteoporosis medication.
At the three on-site visits, the researchers monitored blood counts, liver and kidney function, inflammation, and markers of mineral metabolism, including calcium, phosphate, parathyroid hormone, and vitamin D. Health-related quality of life was assessed. These measures were secondary or exploratory outcomes; the trial was powered for bone turnover markers reported separately.
Pycnogenol® Associated With Better Bodily Pain and Vitality Scores
Following eligibility screening, 67 female patients were enrolled and randomized to receive either Pycnogenol® (33 participants) or placebo (34 participants). The study flowchart recorded four withdrawals from the initial Pycnogenol® group and three from the initial placebo group across six months. Baseline characteristics were comparable. The mean age was 60.7 years in the Pycnogenol® group and 63.1 years in the placebo group. The mean body mass index was 24.8 kg/m² in the Pycnogenol® group and 24.2 kg/m² in the placebo group.
Two mild, possibly treatment-related adverse events occurred: one case of dizziness in the Pycnogenol® group and one case of vomiting in the placebo group, both leading to discontinuation. The researchers reported no moderate or serious adverse events or clinically relevant laboratory abnormalities.
In the bodily pain domain of SF-36v2, scores improved significantly in the Pycnogenol® group compared to placebo after 3 months, including after adjustment for baseline values. Higher SF-36v2 scores indicate better health status, including less bodily pain. At six months, scores remained higher in the continuously treated group than in those who switched from placebo, when both groups received the supplement. The later comparison cannot establish an additional treatment effect because neither group continued on placebo.
Vitality scores were significantly higher in the Pycnogenol® group than in the placebo group after 3 months, but this difference was not maintained at 6 months. The improvement from baseline within the Pycnogenol® group alone was not statistically significant. Other quality-of-life domains did not change over time. Apparent differences in areas such as household responsibilities, mental function, and emotional role functioning reflected baseline disparities or measurement limitations rather than treatment effects.
The osteoporosis-specific QUALEFFO-41 questionnaire did not show an overall quality-of-life benefit. The QUALEFFO-41 total score, where lower values indicate better quality of life, did not differ significantly between groups and remained stable. QUALEFFO-41 pain scores were initially lower in the Pycnogenol® group. After 6 months, pain scores were significantly lower in those who received Pycnogenol® throughout the study than in those who switched from placebo, but this was a descriptive comparison of treatment durations, not a continued placebo-controlled test. The within-group reduction in pain scores was not statistically significant.
The Physical Component Summary (PCS) and Mental Component Summary (MCS) scores from SF-36v2 could not be determined because of missing data. The pain and vitality domains of SF-36v2 were strongly correlated with QUALEFFO-41 scores. Incomplete questionnaires were more common in the continuously treated group at later visits, which may have influenced the reported improvements.
Laboratory testing found no major safety signal during the six-month observation period. Serum calcium, alkaline phosphatase, and vitamin D levels remained stable in both groups, with no significant changes over time. Serum phosphate declined significantly after 6 months of continuous Pycnogenol® treatment (from 1.20 to 1.12 mmol/L) and remained unchanged in the placebo group during its initial three months, with little change after switching treatment. Serum phosphate was positively correlated with CTX-1**, a marker of bone resorption. Parathyroid hormone and iFGF-23 concentrations remained stable, and the apparent three-month difference in parathyroid hormone was not significant after baseline adjustment. The assessed laboratory markers generally remained within their reference ranges. The phosphate decline was small, and its implications for fracture risk remain uncertain.
Liver enzyme levels (AST, ALT) were stable in both groups. GGT decreased significantly after 6 months in participants who switched from placebo to Pycnogenol®, but overall, no significant differences were observed between groups. The authors considered this small decrease unlikely to be clinically meaningful. Renal function and blood counts remained unchanged, with no significant differences between groups. CRP levels were consistently higher in the Pycnogenol® group at baseline and throughout the study, but did not change over time and showed no significant difference after baseline adjustment.
Conclusions
Pycnogenol® supplementation was generally well tolerated over six months and was associated with improvements in specific bodily pain and vitality measures, but did not significantly improve overall disease-specific quality of life in women with osteopenia or stable osteoporosis.
The study has several limitations, including a relatively small sample size, a short intervention period, and no long-term follow-up. Missing questionnaire responses, particularly in the continuously treated group, may have introduced selection bias. The study was not powered to detect quality-of-life effects, and the analysis did not adjust for multiple testing across outcomes. The findings may not apply to men, patients with progressive osteoporosis, or those receiving antiosteoporotic medication.
Future research should include larger, more diverse cohorts, longer observation periods, and investigations into underlying mechanisms. Continued studies are needed to confirm the reported pain and vitality findings, assess long-term safety, and determine whether supplementation affects bone density or fracture risk.
Funding: The study received an educational grant from Horphag Research, which supplied the supplement and placebo. The authors reported that the funder had no role in the design, data collection, analysis, interpretation, or reporting of the trial.
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