The randomised, placebo-controlled, double-blind trial measured the efficacy of continuous ingestion of OLL2809 for managing menstrual symptoms in 80 healthy adult women over three menstrual cycles.
The authors from the division of research and development, Meiji Co. In Japan conclude: “OLL2809 may contribute to enhancing the quality of life of women."
Menstruation, the natural physiological process that occurs in women of reproductive age, can present significant health challenges for women as a result of short-term fluctuations or unstable levels of female hormones.
Recent research has shown that premenstrual symptoms affect approximately half of women worldwide, and women have reported that have been unable to perform all their regular daily activities during their menstrual period.
Premenstrual symptoms are reportedly responsible for a productivity loss of 72%, and the authors therefore note that “menstrual-related symptoms are a critical concern not only for women but also for society.”
Despite extensive research, the authors explain that many uncertainties remain in understanding the cause of premenstrual syndrome (PMS), one of the common menstrual-related symptoms.
They note: “No known relationship exists between PMS and organic abnormalities or abnormalities in ovarian hormone secretion. Consequently, there are currently no clinically applicable biomarkers for diagnosis.”
Lactobacillus paragasseri OLL2809 is a probiotic shown to have immunomodulatory effects, and previous clinical trials conducted on patients with endometriosis demonstrated its effectiveness in reducing menstrual pain.
Other research has shown that OLL2809 administration can alter the gut microbiota and ameliorate stress-induced depression-like behaviors.
Stress has been recognised as a major causative factor for menstrual-related symptoms, and as recent evidence has shed light on the role of gut microbiota in PMS, the authors of the new study suggest: “OLL2809 has the potential to alleviate menstrual-related symptoms, particularly psychological ones.”
The participants, all aged 25–40 years who experienced premenstrual and menstrual symptoms, were randomly assigned to either the OLL2809 or placebo group (n = 40 each) and ingested tablets containing OLL2809 or placebo for three menstrual cycles.
The active tablets were composed of dried OLL2809 powder (100 mg per two tablets, equivalent to approximately 1 × 1010 bacterial cells), maltitol, cellulose, calcium carboxymethyl cellulose, calcium stearate, and silicon dioxide.
The placebo tablets contained lyophilised OLL2809 culture medium powder and dextrin instead of OLL2809 powder.
The efficacy of OLL2809 on premenstrual and menstrual symptoms was evaluated by a 46-item self-administered questionnaire designed to assess and treat premenstrual and menstrual symptoms.
The 46 items were categorised into eight sub factors: (1) pain, (2) water retention, (3) autonomic reactions, (4) negative affect, (5) concentration, (6) behavioural change, (7) arousal, and (8) control.
Results showed that the OLL2809 group exhibited a significantly greater change in premenstrual ‘arousal’ scores on the menstrual distress questionnaire compared to the placebo group after the three menstrual cycles.
Specifically, changes in the ‘activity’ sub factor were significantly higher in the OLL2809 group than in the placebo group.
Additionally, the OLL2809 group reported significantly lower premenstrual irritability on the visual analog scale than the placebo group.
The authors do however note: “Given the absence of objective biomarkers for menstrual symptoms, the mechanism of action of OLL2809 remains unclear based on the current results.
“We speculate that this lack of clarity may be related to the stress response of the HPA axis.
“However, further investigation is necessary to elucidate how OLL2809 ingestion improves premenstrual psychological symptoms."
“Lactobacillus paragasseri OLL2809 Improves Premenstrual Psychological Symptoms in Healthy Women: A Randomized, Double-Blind, Placebo-Controlled Study.”
Authors: Asako Sato, Akika Fukawa-Nagira and Toshihiro Sashihara