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In a randomized trial of 67 women with osteopenia or stable osteoporosis, those assigned Pycnogenol® reported better bodily-pain scores than placebo after three months. The study was small, pain was a quality-of-life measure, and its later phase cannot show whether continued use caused further benefit.
A randomized trial of 67 women with osteopenia or stable osteoporosis found that participants taking French maritime pine bark extract reported better bodily-pain scores than those taking placebo after three months. The study, published in Frontiers in Nutrition, measured quality of life and safety; it does not establish that the supplement treats bone loss or prevents fractures.
Researchers assigned 33 participants to Pycnogenol®, a branded extract of French maritime pine bark, and 34 to placebo. The extract group took 100 milligrams twice daily for the first three months. After that, participants in both groups received the extract for another three months, creating an active-treatment extension rather than a continuing placebo comparison.
At three months, scores in the bodily-pain domain of the SF-36v2 were significantly better in the extract group than in the placebo group, including after adjustment for starting scores. Higher scores on that measure represent better reported health status, including less bodily pain. The researchers also found higher vitality scores in the extract group at three months, but that between-group difference was not maintained at six months.
Four participants initially assigned to the extract and three assigned to placebo withdrew during the six-month study. Researchers reported two mild events considered possibly related to treatment: dizziness in one extract-group participant and vomiting in one placebo-group participant. Both participants discontinued. The report said there were no moderate or serious adverse events and no clinically relevant laboratory abnormalities. These findings describe this trial and do not establish safety with longer use.
Pain Scores, Not Bone Outcomes
Pain and energy can affect daily functioning and quality of life for people living with low bone density, so the reported difference may be relevant to patients and clinicians considering supportive care. However, the result is a change in a self-reported quality-of-life score, not evidence that the supplement repaired bone, reduced fracture risk, or replaced established osteoporosis treatment.
The trial was also small and single-center, and its quality-of-life measures were secondary or exploratory outcomes. The study was powered for bone-turnover markers, which were reported separately. A larger trial designed around pain and daily functioning would be needed to test whether the observed difference is reliable and meaningful to patients.
French maritime pine bark extract supplement
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How the Trial Was Designed
The study enrolled adults who met German guideline criteria for osteopenia or osteoporosis, based on fracture risk and bone-density measurements from dual-energy X-ray absorptiometry. It excluded people taking ongoing anti-osteoporosis medication, those with recent osteoporotic fractures, and those taking other nutritional supplements, subject to specified exceptions. The trial therefore does not directly establish how the extract performs alongside standard osteoporosis medicines.
At the three in-person visits, researchers assessed health-related quality of life and monitored blood counts, liver and kidney function, inflammation, and markers of mineral metabolism, including calcium, phosphate, parathyroid hormone, and vitamin D. Earlier evidence cited in the report included preclinical findings and clinical studies in other settings, but the authors said direct clinical evidence on this extract in people with osteopenia or osteoporosis had been lacking.
“The trial evaluated quality of life and safety in women with osteopenia and stable osteoporosis.”
— The study authors, as reported by News-Medical
Limits of the Six-Month Evidence
The study does not show whether the pain-score difference would persist with longer use, or whether it would appear in a larger or more diverse group. Since both groups received Pycnogenol® during months four through six, the six-month comparison between them cannot establish an additional treatment effect against placebo. It also cannot determine whether any benefit came from the extract itself beyond the first three-month comparison.
The source report does not provide the size of the pain-score difference in a way that establishes how noticeable it was to participants in everyday life. Nor does this quality-of-life analysis establish an effect on bone density, fractures, or the need for standard care. Longer-term safety also remains uncertain; the study followed participants for six months.
Further Trials Needed
The study authors said the trial was powered for bone-turnover markers reported separately. The source material does not identify a planned follow-up study or a date for further results. Researchers would need longer, larger placebo-controlled trials focused on patient-reported pain and functional outcomes to confirm the finding and assess how long any effect lasts.
For now, the result is preliminary evidence about reported pain scores, not a recommendation to use the extract. People considering supplements while managing low bone density should discuss them with a qualified health professional, particularly because this trial excluded most participants receiving ongoing anti-osteoporosis medication.
Key Questions
What did the trial find about pain?
After three months, women assigned Pycnogenol® had significantly better bodily-pain scores than women assigned placebo on the SF-36v2 questionnaire. The result reflects reported quality of life, not proof that the supplement treats osteoporosis.
How many women took part?
Sixty-seven women were randomized: 33 to the extract group and 34 to placebo. Seven participants withdrew during the six-month study.
Did the study show that the extract prevents fractures?
No. The reported finding concerned bodily-pain scores. This study did not establish that Pycnogenol® prevents fractures or improves bone density.
Was the supplement reported as safe?
The researchers reported two mild events considered possibly treatment-related, one in each group, and no moderate or serious adverse events or clinically relevant laboratory abnormalities. A six-month study cannot establish long-term safety.
Can the six-month results confirm continued benefit?
No. After the first three months, participants in both groups received the extract. Without a placebo group in the extension phase, the six-month comparison cannot isolate an additional effect of treatment.
Source: rss
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