Background: Besides hot-flushes, sleep disturbances increase around menopause, impacting on the
quality of life. When hormone replacement therapy is contraindicated, it is necessary to provide alternative treatments.
Objectives: This study aimed to observe the effects of an herbal remedy from pollen extracts and soy isoflavones
for menopausal complaints, particularly on sleep disorders.
Methods: A six-month prospective observational study was performed in women in natural menopause suffering
from menopausal symptoms and sleep disturbances. Three groups were compared: 57 women receiving two tablets/
day containing herbal remedy from pollen extracts (group A), 60 women receiving one tablet/day containing
isoflavones 60 mg (group B), 47 women not receiving any treatment (group C). At 3 (T3) and 6 months (T6), the
daily number of hot-flushes, Kupperman index for menopausal symptoms, the Pittsburgh Sleep Quality Index
(PSQI) test were assessed.
Results: Both groups A and B showed a significant improvement of hot flushes (p<0.001) and Kuppermann Index
(p<0.001) from T0 to T3 and from T0 to T6. No significant differences between treatment groups were found
at T3, while at T6 group A showed greater decrease of daily hot flashes and better improvement of Kupperman
Index as compared to group B (respectively, -48.8% versus -18.4% and -24.4% versus -15.4%; p<0.001). Improvement
of global sleep quality was more evident in the pollen treated group compared to isoflavones group at
both three (-24.7% versus -9.3%, p<0.001) and six (-52.9% vs -4.0%; p<0.001) months, mainly for the scores
related to subjective sleep quality, sleep latency and habitual sleep efficiency.
Conclusion: Non-hormonal treatments can effectively be used in symptomatic menopausal women: among these,
after six months of treatment, pollen extracts might achieve a better improvement of hot flushes, sleep disturbances
and menopause-related symptoms than soy isoflavones. Herbal remedy from pollen extracts is mainly
effective when the quality of sleep is the most disturbing complaint.