A Dietary Supplement of Vitamin B6 with Four Herbal Extracts Improves Sleep Disturbances and Anxiety Associated with the Menstrual Cycle and Menopause Transition: Results from an Exploratory Study

Abstract

Background:

Hormonal changes during the menstrual cycle and at menopause transition (MT) are associated with a broad spectrum of physical and psychological symptoms. Severe cases of premenstrual syndrome (PMS) and MT may require treatment. This study investigated the efficacy of a dietary supplement containing vitamin B6 and four plant extracts (Griffonia simplicifolia, Melissa officinalis, Valeriana officinalis, Rhodiola rosea), for the treatment of sleep disturbances and anxiety associated with PMS and MT.

Methods:

This exploratory, monocentric, prospective study enrolled women aged 18–70 years with symptoms of PMS or MT related sleep disturbances and anxiety. Participants received one tablet of the supplement twice daily, for 15–20 days. Perceived sleep disturbances and anxiety were assessed at baseline and the end of treatment using the Insomnia Severity Index (ISI) and the Hospital Anxiety and Depression Scale (HADS).

Results:

Thirty-two women were enrolled and completed the study (PMS, n = 18; MT, n = 14). The dietary supplement was associated with a 46.6% improvement in ISI score (from 20.39 to 10.87) and a 23.2% improvement in the HADS anxiety score (from 16.23 to 12.45) from baseline to the end of treatment. Improvements in both scores were observed in women with PMS and those with MT.

Conclusions:

The five component dietary supplement may be an option for the treatment of sleep disturbances and anxiety related to PMS and MT; its use should be further investigated in prospective, placebo-controlled studies with a sample of adequate size and an extended treatment/observation period.