Nonhormonal adjustment of stress-associated menstrual cycle disorders: data of MONARCH trial on the use of Mabelle Cycle complex

Aim. To evaluate the efficacy and safety of using the complex herbal preparation Mabell Cycle in the treatment of stress-dependent menstrual disorders. Materials and methods. Prospective, open-label, non-interventional study was conducted with 80 patients aged 18–31 years (mean age 24.41±2.95 years) with stress-dependent menstrual disorders. The participants were ratio into two groups: the main group (n=40) received Mabelle Cycle (active ingredients: Trifolium pratense (red clover) extract, Vitex agnus-castus extract, Angelica sinensis root extract, Griffonia simplicifolia extract, D,L-phenylalanine, iron) at a dose of 2 tablets daily for 3 months, while the control group (n=40) received non-drug therapy (consultation with a psychologist, physiotherapy) following the same regimen. The duration of therapy was 3 months. Efficacy was assessed by menstrual cycle restoration, dynamics of premenstrual syndrome symptoms, and MEDI-Q questionnaire indicators. Safety assessent was based on the incidence of adverse reactions. Study design: prospective, open-label, non-interventional. Results. The Mabell Cycle group showed progressive restoration of the menstrual cycle: 22.5%, 50.0%, and 62.5% of patients over three months of therapy compared to 7.5%, 17.5%, and 27.5% in the control group, respectively. Statistically significant differences were detected from the second month of therapy (p=0.008). The Mabell Cycle group showed significant reduction in mood lability (from 45.0% to 7.5%, p=0.015), mastalgia (from 40.0% to 10.0%, p=0.008), complete resolution of depressive symptoms (p<0.001), and improvement in five out of six evaluated psychoemotional parameters versus three in the control group. The total MEDI-Q score in the Mabell Cycle group decreased from 58.00 to 33.00 (p=0.001), achieving significant intergroup differences by the end of the study (p=0.001). Conclusion. The multitarget phytocomplex Mabell Сycle demonstrates high efficacy and safety in restoring the menstrual cycle in stress-dependent disorders. The use of a phytocomplex for 3 months provides significant improvement in cycle regularity, reduction in the severity of psychoemotional and somatic symptoms, and enhancement of patients' quality of life. The results obtained allow recommending the phytocomplex Mabell Cycle for inclusion in clinical protocols for managing patients with stress-dependent menstrual disorders. © 2025 Elsevier B.V., All rights reserved.