Assessment of the Efficacy of a Food Supplement in Subjects Complaining Primary Dysmenorrhea - the Triangirl-feel Good Study

Author(s): Rita Mocciaro, Amelia Spina, Maite Pérez-Hernández, Roser de Castellar-Sansó

Background:

Primary dysmenorrhea, characterized by painful abdominal cramping before and during menstruation without pelvic pathology, significantly affects quality of life (QoL). First-line treatments, such as non-steroidal anti-inflammatory drugs and hormonal contraceptives, have suboptimal efficacy and tolerability in some patients, increasing interest in alternative therapies like dietary supplements.

Objective:

This study assessed the effectiveness and safety of a dietary supplement combining palmitoylethanolamide, ginger root extract, and fennel seed extract in alleviating primary dysmenorrhea symptoms.

Methods:

56 women (18–30 years) were randomized into two regimens: the maintenance regimen (supplement taken three days before and two days into menstruation) and the rescue regimen (taken at pain onset). Pain intensity was measured using the Visual Analogue Scale (VAS), and QoL was assessed with the Quality-of-Life Enjoyment and Satisfaction Questionnaire - Short Form (Q-LES-Q-SF) questionnaire. The study spanned four menstrual cycles, with one cycle serving as a control group that did not undergo any treatment, and three cycles undergoing treatment. The researchers measured outcomes over the course of three menstrual cycles. In addition, adherence to treatment and the presence of any adverse effects were closely monitored.

Results:

Both regimens effectively reduced pain, with a greater and sustained effect observed in the maintenance group. By the third and fourth cycles, VAS scores decreased from 6 to 2 in both groups, with a more pronounced QoL improvement in the maintenance group (22.8% vs. 19.5%). The supplement reduced analgesic use and was well tolerated, with no reported adverse effects.

Conclusion:

The dietary supplement effectively alleviated primary dysmenorrhea symptoms and improved QoL, particularly with the maintenance regimen. These findings support the potential of dietary supplements as safe, non-pharmacological options for managing menstrual pain.