The study, funded by Shionogi SRL, the Italian operating subsidiary of Japanese company Shionogi & Co., investigated the effect of Femal Osteo, a Shionogi supplement containing 320 mg of PCP, 25 mcg of vitamin D3, 10 mg of vitamin E, 180 mcg of vitamin K2 and 1.4 mg of vitamin B6.
The researchers in Italy divided the patients into two groups based on their treatment choice after receiving medical advice. Group A took Femal Osteo, and Group B chose not to take any pharmacological treatment for vasomotor symptoms. The researchers observed improvements in symptoms, along with reduced markers of bone turnover after three months of supplementation.
“The availability of a supplement as an alternative to estroprogestins or anti-resorptive drugs that could globally help improve women’s quality of life may be extremely useful during the transitional period from pre- to postmenopause and even beyond, when HRT is not the treatment of choice,” they wrote.
Pollen extract may ease hot flashes through brain signaling
Hot flashes are among the most common symptoms of perimenopause, along with sleep problems and mood changes. Previous research has found that PCP may reduce hot flashes, sleep problems and mood symptoms in menopausal women. The researchers noted that PCP may work by influencing serotonin, GABA and dopamine signalling in the brain, which could influence temperature regulation, sleep and mood.
Furthermore, nutrients such as vitamin D, calcium and vitamin K2 are well researched for their potential role in preventing bone loss. The researchers of the new study suggested that they could potentially complement other ingredients for menopause support.
“The objective of this retrospective observational study is to evaluate the efficacy of a combination therapy consisting of PCP associated with vitD and vitK2 on menopausal symptoms and the main parameters of bone metabolism,” they wrote.
Fewer hot flashes and lower bone turnover
The researchers assessed clinical data from 45 women stored in participating gynecological clinics’ databases in Italy between May and November 2025.
All women were aged 45–60 with menopausal symptoms, 22 of whom took supplementation, while the other 23 participants chose not to.
The researchers measured several blood markers at the start of the study and after three months. These included follicle-stimulating hormone (FSH), luteinizing hormone (LH), estradiol (E2), vitamin D (25OHD), parathyroid hormone (PTH), calcium and phosphorus. They also measured markers of bone turnover: C-terminal telopeptide of type I collagen (CTX), which reflects bone breakdown, and osteocalcin (OC), which reflects bone formation. They also measured bone mineral density and calculated trabecular bone score (TBS).
All participants completed the Menopause-Specific Quality of Life (MENQOL) questionnaire at baseline and after three months. The questionnaire covered 29 menopause-related symptoms and asked participants to rate how much each symptom affects them. The symptoms were grouped into four areas: vasomotor, psychosocial, physical and sexual.
Results showed that vitamin D levels increased significantly in Group A, rising by 63.0% after three months, while no significant change occurred in Group B.
Blood levels of calcium, phosphorus and PTH did not change significantly in either group after three months, and osteocalcin, a marker of bone formation, did not change significantly in either group. However, CTX, a marker of bone resorption, fell by 29.3% in Group A after three months.
Women in Group A also reported significantly fewer hot flashes after three months, while no reduction occurred in the control group. Furthermore, MENQOL scores improved significantly in Group A in three areas: physical symptoms decreased by 40.3%, psychosocial symptoms by 50.0%, and vasomotor symptoms by 57.9%. The control group again showed no significant improvement in MENQOL scores.
“To our knowledge, although retrospective, this is the first study reporting the efficacy of a compound composed of PCP, vitD, and vitK2 compared with controls,” the researchers noted.
“Our evaluation showed that this supplement could be useful not only to treat climacteric syndrome, but it could also help prevent bone deterioration associated with menopause, potentially counteracting increased bone turnover.
“It should be noted that bone loss, as well as vasomotor symptoms, may begin many years before the final cessation of menstruation, when irregular menses may occur.”
They noted that future studies should use larger, randomized controlled trial methods with placebo groups and longer follow-up periods to confirm whether the combination of PCP, vitamin D and vitamin K2 genuinely improves menopausal symptoms and helps preserve bone health.
Journal: Nutrients; doi: 10.3390/nu18162734; “Beneficial Effects of Purified Cytoplasm of Pollen Associated with Vitamin D and Vitamin K2 on Menopausal Symptoms and Bone Health.” Authors: Capozzi, A. et al.
