Women's health update.

Pine Bark Extract (Pycnogenol) and Osteoarthritis of the Knee

Cisar P, Jany R, Waczulikova I, et al. Effect of pine bark extract (Pycnogenol) on symptoms of knee osteoarthritis. Phytotherapy Research 2008;22:1087-1092.

The purpose of this study was to evaluate the effects of Pycnogenol in reducing symptoms of osteoarthritis (OA) in a double-blind, placebo-controlled, randomized trial. One hundred patients older than 25 were suffering from mild OA (stage I or II) in at least one knee and mild to moderate pain for at least 3 months prior to the study, and/or morning knee stiffness and/or knee crepitus.

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The main outcome criteria were reduction of symptoms of OA using the Western Ontario and McMaster (WOMAC) Osteoarthritis Index scores and reduction of pain using a visual analogue scale (VAS). The secondary outcome was a decrease in the use of analgesics. Study subjects were randomly assigned to Pycnogenol 50 mg t.i.d. or placebo (14 men and 36 women in the Pycnogenol group, and 18 men and 32 women in the placebo group). Patients were allowed to continue with their current medication (NSAIDs or analgesics) and to change medication as needed, but were required to report dosage or frequency changes at each visit. Patients were evaluated at baseline, 3 months, and 4 weeks after completing the treatment. The WOMAC questionnaire for pain, stiffness, and daily activities was completed by the patient every 2 weeks during the study, whereas the VAS for pain was filled in by each patient weekly.

Results: The WOMAC-A score, summarizing pain scores, improved significantly in the Pycnogenol group (p = 0.0004) over the time of the study. The statistical difference for pain reduction compared to baseline in the Pycnogenol group was evident after weeks 8, 12 and 14 (p < 0.001). The difference between treatment group and placebo was near statistical significance at week 8 (p = 0.08).

The WOMAC-B score, analyzing stiffness, showed statistically significant improvement (p = 0.01) in the Pycnogenol groups versus baseline after weeks 8,12, and 14. Statistically significant differences between treatment group and placebo group were observed at weeks 8 and 12 (p < 0.05).

The WOMAC score in regard to the ability to perform daily activities improved significantly versus baseline in the Pycnogenol group at weeks 8,12, and 14 (p < 0.01). The change in the placebo group was not significant, and the difference between the Pycnogenol and placebo groups was not significant.

Pain scores by VAS were somewhat higher in the placebo group than the Pycnogenol group at baseline, although this difference was not significant. After treatment for 4 weeks, the treatment group reported less pain when compared to placebo, and pain continued to diminish until month 3. The correlation of decreased pain over time was statistically significant (p < 0.04) for the Pycnogenol group, but poor for the placebo group (p < 0.17). Only a marginal significance was seen between Pycnogenol versus placebo at weeks 4 (p = 0.08) and 8 (p = 0.07).

Patients in the Pycnogenol group were able to reduce their use of analgesics or NSAIDs at a higher percentage than those in the placebo group. Ten percent of placebo group patients had to increase their dose of analgesics, whereas no higher doses were needed in the Pycnogenol group.

Commentary: I'm encouraged to see this study and am looking forward to using this in patients with milder to moderate OA symptoms, especially of the knees. Pycnogenol is a special standardized extract from the bark of the French maritime pine. It is composed of polyphenols, several phenolic acids, catechins, taxifolin, and procyanidins. In laboratory research, Pycnogenol selectively inhibits matrix metalloproteinases (MMPs). MMPs are one of the inflammatory responses in arthritic joints induced by interleukin-1. The matrix-degrading activity contributes to the loss of cartilage and is associated with chronic inflammation. Other in vitro research has shown that Pycnogenol inhibits other inflammatory cells and specifically inhibits COX1 and COX2. The observation of these previously observed anti-inflammatory effects, as a background to the current study, contributes a body of information that enables us to have another viable alternative treatment in early OA of the knee, as well as an approach to reducing the use of analgesics and NSAIDs in pain management.

Pycnogenol and Perimenopause Symptoms

Yang H-M, Liao M-F, Zhu S-Y, Liao M-N, Rohdewald P. A randomised, double-blind, placebo-controlled trial on the effect of Pycnogenol on the climacteric syndrome in perimenopausal women. Acta Obstetricia et Gynecologica. 2007;86:978-985.

In a double-blind study, Taiwanese perimenopausal women aged 45 to 55 were given either placebo or 100 mg of Pycnogenol twice daily for 6 months. One hundred fifty-five women received the Pycnogenol and seventy-five the placebo. The Women's Health Questionnaire with 36 items was used to evaluate the climacteric symptoms at baseline and at 1, 3, and 6 months.

Results: Blood pressure decreased similarly in both groups. HDL increased and LDL decreased significantly from baseline with Pycnogenol, but no significant differences were seen in HDL between the two groups; however, LDL was more significantly reduced in the Pycnogenol group. Perimenopause symptoms of depression, vasomotor symptoms, memory, anxiety, sexual function, and sleep all improved significantly (P < 0.001) with Pycnogenol as soon as 1 month after starting the treatment, in both severity and frequency. Most symptoms also improved with placebo, but not significantly.

Commentary: I was surprised to see this study, as I have never thought to use Pycnogenol in the treatment of perimenopause/menopause symptoms. The most common symptoms of perimenopause/menopause that I see in my practice are hot flashes, sweating, heart palpitations, fatigue, depression, decreased sexual function, insomnia, and cognitive impairment. It's imperative to have as many nonhormonal natural medicine options as possible, and making clinical decisions based on evidence-based therapies is extremely helpful, enhancing our ability to help more women, more of the time. I'm pleased to be able to add Pycnogenol to my list of choices and will look forward to hopefully positive results.

Pine bark extract and endometriosis

Kohama T, Herai K, Inoue M. Effect of French maritime pine bark extract on endometriosis as compared with leuprorelin acetate. J Reprod Med 2007;52(8):703-708.

Fifty-eight women were surgically diagnosed with endometriosis and then started on Pycnogenol within 6 months of the surgery after confirming regular menstruation and ovulation for three months. Women were randomized to receive either Pycnogenol 30 mg twice daily for 48 weeks or a gonadotropin-releasing hormone agonist (Gn-RHa), leuprorelin acetate depot, 3.75 mg IM six times every 4 weeks for 24 weeks. Patients were monitored at 4, 12, 24, and 48 weeks after treatment began.

Results: Both groups had similar symptoms before the treatments began: severe pain, pelvic tenderness, and pelvic indurations. After 4 weeks on Pycnogenol, patients slowly but steadily improved, reducing symptoms from severe to moderate. Overall, this group experienced a 33% reduction in symptoms of endometriosis. The leuprorelin group had a greater response within the treatment period, but relapsed after 24 weeks posttreatment. The Pycnogenol group maintained regular menses and normal estrogen levels during treatment; and, as expected, the leuprorelin group had suppressed menstruation and drastically lowered estrogen levels during treatment. In addition, five women in the trial taking Pycnogenol became pregnant.

Commentary: One of the most common causes of pelvic pain and infertility, endometriosis is a challenging problem for women and a complex problem to treat with natural medicine. New research shows multiple potential factors involved in the etiology and progression of the disease, including:

* retrograde menstruation

* metastasis

* genetics

* altered cellular immunity

* coelomic metaplasia 

* iatrogenesis 

* environmental factors

* increased inflammatory mediators

No single theory explains the development of endometriosis in all cases. More than likely, it is a combination of these postulated mechanisms with variable influences from case to case. Pine bark extract appears to offer meaningful symptom relief, and is likely contributing to improved local pelvic immune response and a decrease in inflammatory mediators produced by the endometriosis or causing the endometriosis, or both.

by Tori Hudson, ND

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