Prospective observational study to evaluate the efficacy and safety of the pollen extract Sérélys^® in the management of women with menopausal symptoms

Abstract

Safety concerns or contraindications to the use of hormones have resulted in a rise of the use of herbal medicinal products for the management of menopausal symptoms. The pollen extract Sérélys^® represents, due to its ingredients and mode of action, a new and innovative alternative for the management of these symptoms. The aim of the present study was to demonstrate the efficacy and safety of Sérélys^®. A prospective, open, observational, and multicentre study was performed on 104 menopausal women. The patients received over 3 months the pollen extract Sérélys^® containing the extracts PI82 and GC Fem in a dosage of twice 160 mg extract and 5 mg vitamin E. Using a validated menopausal rating score, the improvement of menopausal symptoms was recorded. A significant decrease of different menopausal symptoms was observed between the starting point of the study and after 12 weeks (p < .0001). Hot flashes were reduced by 48.5%, sleep disturbance by 50.1%, depressive mood by 51.2%, irritability by 47.9%, fatigue by 47.8%, vaginal dryness by 39.63% and muscles and joint pain by 27.4%. The pollen extract Sérélys^® reduced significant menopausal symptoms showing a very low side effect profile.

摘要

出于安全考虑或对激素使用的禁忌, 越来越多的人使用草药产品来治疗更年期症状。由于Serelys^®成分和作用方式, 为这些症状的管理提供了一种全新的和革命性的选择。本研究的目的是证明药物Serelys^®的有效性和安全性。对104名更年期妇女进行了前瞻性、开放性、观察性和多中心研究。患者接受含PI82和GC Fem的花粉提取物（Serelys^®）3个月的治疗, 每片药物含160 mg提取物和5 mg维生素E, 每天2次。采用经过验证的更年期等级评分, 记录更年期症状的改善情况。从研究开始到12周后, 观察到不同的更年期症状显著缓解(p < .0001)。与用药前相比, 潮热评分下降48.5%, 睡眠障碍50.1%, 抑郁情绪51.2%, 易怒47.9%, 疲劳47.8%, 阴道干涩39.63%, 肌肉和关节痛27.4%。Serelys^®明显缓解的更年期症状, 并显示出非常低的副作用。

The Chinese abstracts are translated by Prof. Dr. Xiangyan Ruan and her team: Beijing Obstetrics and Gynecology Hospital, Capital Medical University, Beijing 100026, China.

Keywords:

• Pollen extract
• menopause
• non-estrogenic activity

Disclosure statement

Manule Sailer and Pedro-Antonio Regidor are employees of Exeltis Healthcare. Thomas Fait has no conflict of interest.