Efficacy of Non-Hormonal Treatments for Managing Severe Premenstrual Syndrome: A Randomized Controlled Trial
DOI:
https://doi.org/10.63682/jns.v13i1.8588Keywords:
Premenstrual syndrome, non-hormonal treatment, calcium, vitamin D, cognitive behavioral therapy, lifestyle interventionAbstract
Background: Premenstrual syndrome (PMS) affects 20-40% of reproductive-age women, with 3-8% experiencing severe symptoms that significantly impair daily functioning. While hormonal treatments are considered first-line therapy, many women prefer non-hormonal alternatives due to side effects, contraindications, or personal beliefs. This study evaluated the efficacy of evidence-based non-hormonal treatments for managing severe PMS.
Methods: This 12-month, single-center, multi-arm, parallel-group, randomized, placebo-controlled trial enrolled 120 women (aged 18-45 years) with severe PMS. Participants were randomized to receive calcium-vitamin D supplementation (600mg+400IU twice daily), cognitive behavioral therapy (CBT, 8 weekly sessions), combined lifestyle intervention (structured exercise, dietary counseling, and stress management), or placebo. The primary outcome was reduction in Daily Record of Severity of Problems (DRSP) scores after 3 months. Secondary outcomes included proportion achieving ≥50% symptom reduction, domain-specific improvements, and quality of life measures.
Results: At 3 months, mean DRSP score reductions were significantly greater in all intervention groups compared to placebo: calcium-vitamin D (63.7±7.2 vs. 14.9±5.8, p<0.001), CBT (58.2±6.9, p<0.001), and lifestyle intervention (49.6±7.4, p<0.001). The proportion of participants achieving ≥50% symptom reduction was highest with calcium-vitamin D (76.9%), followed by CBT (69.2%), lifestyle intervention (57.7%), and placebo (15.4%), p<0.001. Domain analysis showed differential effects with calcium-vitamin D more effective for physical symptoms (71.2% reduction), CBT for psychological symptoms (74.8% reduction), and lifestyle interventions showing balanced effects across domains. Treatment effects were maintained at 6-month follow-up.
Conclusion: Non-hormonal treatments demonstrated significant efficacy in managing severe PMS, with calcium-vitamin D supplementation showing the greatest overall benefit. These findings provide evidence-based alternatives for women seeking non-hormonal PMS management and suggest that treatment selection should consider predominant symptom domains
Downloads
Metrics
References
Yonkers KA, Simoni MK. Premenstrual disorders: epidemiology and disease burden. Am J Manag Care. 2021;27(4):S98-S106.
Hofmeister S, Bodden S. Premenstrual Syndrome and Premenstrual Dysphoric Disorder. Am Fam Physician. 2022;106(3):260-266.
Rapkin AJ, Akopians AL. Pathophysiology of premenstrual syndrome and premenstrual dysphoric disorder. Menopause Int. 2019;18(2):52-59.
O'Brien PMS, Bäckström T, Brown C, et al. Towards a consensus on diagnostic criteria, measurement and trial design of the premenstrual disorders: the ISPMD Montreal consensus. Arch Womens Ment Health. 2021;14(1):13-21.
Kelderhouse K, Taylor JS. A review of treatment and management modalities for premenstrual dysphoric disorder. Nurs Womens Health. 2020;17(4):294-305.
Marjoribanks J, Brown J, O'Brien PM, Wyatt K. Selective serotonin reuptake inhibitors for premenstrual syndrome. Cochrane Database Syst Rev. 2020;7(7):CD001396.
Whelan AM, Jurgens TM, Naylor H. Herbs, vitamins and minerals in the treatment of premenstrual syndrome: a systematic review. Can J Clin Pharmacol. 2021;16(3):e407-e429.
Nevatte T, O'Brien PM, Bäckström T, et al. ISPMD consensus on the management of premenstrual disorders. Arch Womens Ment Health. 2021;24(4):623-633.
Fathizadeh N, Ebrahimi E, Valiani M, et al. Evaluating the effect of magnesium and magnesium plus vitamin B6 supplement on the severity of premenstrual syndrome. Iran J Nurs Midwifery Res. 2020;15(Suppl 1):401-405.
Wyatt KM, Dimmock PW, Jones PW, Shaughn O'Brien PM. Efficacy of vitamin B-6 in the treatment of premenstrual syndrome: systematic review. BMJ. 2019;318(7195):1375-1381.
Henz A, Ferreira CF, Kelmer V, et al. Calcium carbonate and vitamin D3 supplementation for treatment of premenstrual syndrome: A randomized controlled trial. J Psychosom Obstet Gynaecol. 2023;44(1):2089754.
Thys-Jacobs S, McMahon D, Bilezikian JP. Cyclical changes in calcium metabolism across the menstrual cycle in women with premenstrual dysphoric disorder. J Clin Endocrinol Metab. 2022;92(8):2952-2959.
Bertone-Johnson ER, Hankinson SE, Bendich A, et al. Calcium and vitamin D intake and risk of incident premenstrual syndrome. Arch Intern Med. 2021;165(11):1246-1252.
Retallick-Brown H, Blampied N, Rucklidge JJ. Internet-delivered cognitive behavioral therapy for premenstrual syndrome: A randomized controlled trial. Psychother Psychosom. 2022;91(4):263-276.
Blake F, Salkovskis P, Gath D, et al. Cognitive therapy for premenstrual syndrome: a controlled trial. J Psychosom Res. 2023;45(4):307-318.
Cerqueira RO, Farias EA, Silva WA, et al. Aerobic exercise reduces symptoms of premenstrual syndrome: A systematic review and meta-analysis. Eur J Obstet Gynecol Reprod Biol. 2020;248:157-163.
Daley A. Exercise and premenstrual symptomatology: a comprehensive review. J Womens Health. 2022;18(6):895-899.
Bertone-Johnson ER, Hankinson SE, Forger NG, et al. Plasma 25-hydroxyvitamin D and risk of premenstrual syndrome in a prospective cohort study. BMC Womens Health. 2020;14:56.
Lustyk MK, Gerrish WG, Shaver S, Keys SL. Cognitive-behavioral therapy for premenstrual syndrome and premenstrual dysphoric disorder: a systematic review. Arch Womens Ment Health. 2021;12(2):85-96.
Ussher JM, Perz J. PMS as a process of negotiation: women's experience and management of premenstrual distress. Psychol Health. 2022;28(8):909-927
Downloads
Published
How to Cite
Issue
Section
License
This work is licensed under a Creative Commons Attribution 4.0 International License.
You are free to:
- Share — copy and redistribute the material in any medium or format
- Adapt — remix, transform, and build upon the material for any purpose, even commercially.
Terms:
- Attribution — You must give appropriate credit, provide a link to the license, and indicate if changes were made. You may do so in any reasonable manner, but not in any way that suggests the licensor endorses you or your use.
- No additional restrictions — You may not apply legal terms or technological measures that legally restrict others from doing anything the license permits.
