Comparison of the Effects of Vitagnus, Soy, and Vitagnus-soy Capsules on Premenstrual Syndrome in University Students: A Randomized Clinical Trial

Document Type : Original Article

Authors

1 Student Research Committee, School of Nursing and Midwifery, Mashhad University of Medical Sciences, Mashhad, Iran;

2 Global and Women’s Health, Planetary Health Division, School of Public Health and Preventive Medicine, Faculty of Medicine, Nursing and Health Sciences Monash University, Melbourne, Australia;

3 Nursing and Midwifery Care Research Center, Mashhad University of Medical Sciences, Mashhad, Iran;

4 Pharmacological Research Center of Medicinal Plants, Mashhad University of Medical Sciences, Mashhad, Iran;

5 Department of Biostatistics, School of Heath, Mashhad University of Medical Sciences, Mashhad, Iran;

6 Medical Toxicology Research Center, Mashhad University of Medical Sciences, Mashhad, Iran

Abstract

Background: Premenstrual syndrome (PMS) is a common disease that negatively impacts women’s quality of life. This study aimed to compare the effects of the Vitagnus, soy, and Vitagnus-soy combination on PMS in students.
Methods: This triple-blind, three-arm clinical trial was conducted on 108 students with PMS living in the dormitory of Mashhad University of Medical Sciences from September 2022 to October 2023. Eligible participants diagnosed with moderate to severe PMS over two menstrual cycles, using the Calendar of Premenstrual Experiences form, were randomly assigned to one of three groups. Each participant took one daily capsule of Vitagnus (N=36), Soy (N=36), or a Vitagnus-soy combination (N=36) for two menstrual cycles. The data were analyzed using the ANOVA test (or Kruskal-Wallis test) with post-hoc tests based on Tukey (or Bonferroni correction), Chi-square test (or Fisher’s exact method), and Wilcoxon test analysis (or paired t-test) in SPSS software version 26 with the significance level of P<0.05.
Results: In all three groups, PMS symptoms significantly reduced after the intervention (P<0.001). The Vitagnus-soy combination was more effective than either Soy or Vitagnus group in decreasing psychological (P<0.001) and total PMS symptoms (P<0.001). Vitagnus-soy combination had no statistically significant difference in decreasing physical PMS symptoms compared to Soy (P>0.999), but it was more effective than Vitagnus (P<0.001).
Conclusion: The Vitagnus-soy combination was more effective in alleviating PMS psychological and total symptoms than using either Soy or Vitagnus alone, making it a recommended option for reducing PMS symptoms.
Trial Registration Number: IRCT2022072005514N1

Highlights

Roya Partovi Golshan (Google Scholar) (PubMed)

Maryam Moradi (Google Scholar) (PubMed)

Keywords

References


1.    Siminiuc R, Ţurcanu D. Impact of nutritional diet therapy on premenstrual syndrome. Frontiers in Nutrition. 2023;10:1079417.
2.    Taylor HS, Pal L, Sell E. Speroff’s Clinical Gynecologic Endocrinology and Infertility. 9th ed. Philadelphia: Lippincott Williams & Wilkins; 2019.
3.    Ranjbaran M, Samani RO, Almasi-Hashiani A, et al. Prevalence of premenstrual syndrome in Iran: A systematic review and meta-analysis. International Journal of Reproductive Biomedicine. 2017;15:679-86.
4.    Simsek Kucukkelepce D, Unver H, Nacar G, Tashan ST. The effects of acupressure and yoga for coping with premenstrual syndromes on premenstrual symptoms and quality of life. Complementary Therapies in Clinical Practice. 2021;42:101282.
5.    Sohrabi N, Kashanian M, Seyed Ghafoori S, Kazem Malakouti S. Retracted: Evaluation of the effect of omega-3 fatty acids in the treatment of premenstrual syndrome: A pilot trial. Complementary Therapies in Medicine. 2023;72:102919.
6.    Ebrahimi Azmoudeh B, Habibian M, Askari B. The Effectiveness of the Combination of Cinnamon and Ginger with Exercise Training in the Treatment of Dysmenorrhea and Premenstrual Syndrome. Iran Journal of Nursing. 2019;32:68-81. [In Persian]
7.    Mousavi P, Zaheri H, Najar S, Afshari P. The effect of Vitagnus on physical and emotional symptoms of premenstrual syndrome: a randomized clinical trial. Journal of Clinical Nursing and Midwifery. 2015;4:68-76. [In Persian]
8.    Nazemi M, Hassani A, Kalalian Moghaddam H. Effect of Taking Soybean Supplement and Regular Aerobic Exercise in Water on Mental and Physical Symptoms of Premenstrual Syndrome among Female Students. Journal of Knowledge & Health. 2014;9:58. [In Persian]
9.    Pakgohar M, Moradi M, Jamshidi A, Mehran A. Assessment of Vitex agnus- castus L. Extract Effect on Treatment of Premenstrual Syndrome. Journal of Medicinal Plants. 2009;8:98-107. [In Persian]
10.    Kalhor M, Yuseflo S, Kaveii B, et al. Effect of Yarrow (Achillea millefolium L.) Extract on Premenstrual Syndrome in Female Students Living in Dormitory of Qazvin University of Medical Sciences. Journal of Medicinal Plants. 2019;18:52-63. [In Persian]
11.    Souto EB, Durazzo A, Nazhand A, et al. Vitex agnus-castus L.: Main Features and Nutraceutical Perspectives. Forests. 2020;11:761.
12.    Gudipally PR, Sharma GK. Premenstrual Syndrome. Treasure Island (FL): StatPearls Publishing; 2023.
13.    Verkaik S, Kamperman AM, van Westrhenen R, Schulte PFJS. The treatment of premenstrual syndrome with preparations of Vitex agnus castus: a systematic review and meta-analysis. American Journal of Obstetrics and Gynecology. 2017;217:150-66.
14.    Mendes C, Fonseca AMdF, Alves MS, et al. Narrative review of Vitex agnus-castus in symptoms in Gynecology. Revista da Associação Médica Brasileira (1992). 2022;68:716-9.
15.    Heskes AM, Sundram TCM, Boughton BA, et al. Biosynthesis of bioactive diterpenoids in the medicinal plant Vitex agnus‐castus. The Plant Journal. 2018;93:943-58.
16.    Song C, Xue L. Roles of the µ-opioid receptor and its related signaling pathways in the pathogenesis of premenstrual syndrome liver-qi stagnation. Experimental and Therapeutic Medicine. 2017;13:3130-6.
17.    Dalil Heirati SF, KaboudMehri R, Mojab F, et al. Effect of Vitex agnus-castus plant on sexual function in women of reproductive age. The Iranian Journal of Obstetrics, Gynecology and Infertility. 2020;23:62-74. [In Persian]
18.    Puglia LT, Lowry J, Tamagno G. Vitex agnus castus effects on hyperprolactinaemia. Frontiers in Endocrinology (Lausanne). 2023;14:1269781.
19.    Kim IS, Yang WS, Kim CH. Beneficial effects of soybean-derived bioactive peptides. International Journal of Molecular Sciences. 2021;22:8570.
20.    Rizzo G, Baroni L. Soy, Soy Foods and Their Role in Vegetarian Diets. Nutrients. 2018;10:43.
21.    Perfecto A, Rodriguez-Ramiro I, Rodriguez-Celma J, et al. Pea ferritin stability under gastric pH conditions determines the mechanism of iron uptake in Caco-2 cells. The Journal of Nutrition. 2018;148:1229-35.
22.    Belobrajdic DP, James-Martin G, Jones D, Tran CD. Soy and Gastrointestinal Health: A Review. Nutrients. 2023;15:1959.
23.    Khalid AR, Alshdaifat E, Sindiani A, Alkhatatbeh M. Severity of premenstrual symptoms among women with musculoskeletal pain: relation to vitamin D, calcium, and psychological symptoms. Journal of Medicine and Life. 2024;17:397-405.
24.    Mishra S, Elliott H, Marwaha R. Premenstrual Dysphoric Disorder. Treasure Island (FL): StatPearls Publishing; 2023.
25.    Kenda M, Glavač NK, Nagy M, et al. Herbal Products Used in Menopause and for Gynecological Disorders. Molecules. 2021;26:7421.
26.    Salkar K, Chotalia C, Salvi R. Premenstrual syndrome (PMS) and review of probable mode of action of a polyherbal medicine-prementrid. International Journal of Herbal Medicine. 2020;8:5-9.
27.    Abdi F, Ozgoli G, Rahnemaie FS. A systematic review of the role of vitamin D and calcium in premenstrual syndrome. Obstetrics & Gynecology Science. 2019;62:73-86.
28.    Shabani F, Zareian MA. Evaluation of the Synergism of Medicinal Effects of Chamomile and Ginger on Pain and Symptoms of Primary Dysmenorrhea: A Randomized Controlled Trial. Complementary Medicine Journal. 2020;9:3852-67. [In Persian]
29.    Salari R, Yousefi M, Ghorbanzadeh H, Jafarinejad Bajestani M. A Review of Medicinal Herbs With Estrogenic, Progesteronic, and Testosteronic Properties. The Iranian Journal of Obstetrics, Gynecology and Infertility. 2016;19:19-30. [In Persian]
30.    American Psychiatric Association. Diagnostic and statistical manual of mental disorders: DSM-5. 5th ed. Washington, DC: American Psychiatric Association; 2013.
31.    Lovibond PF, Lovibond SH. The structure of negative emotional states: comparison of the Depression Anxiety Stress Scales (DASS) with the Beck Depression and Anxiety Inventories. Behaviour Research and Therapy. 1995;33:335-43.
32.    Samani S, Joukar B. A Study on The Reliability and Validity of The Short Form of The Depression Anxiety Stress Scale (Dass-21). Journal of Social Sciences and Humanities of Shiraz University. 2007;26:65-77. [In Persian]
33.    Feuerstein M, Shaw WS. Measurement properties of the Calendar of Premenstrual Experience in patients with premenstrual syndrome. The Journal of Reproductive Medicine. 2002;47:279-89.
34.    Nourani Saadoldin S, Dadi Givshad R, Esmaily H, Sepehri Shamloo Z. Investigating The Impact of Life Skills Education on Symptoms Severity of Premenstrual Syndrome. Iranian Journal of Obstetrics, Gynecology and Infertility. 2013;16:1-11. [In Persian]
35.    Fähndrich E, Linden M. Reliability and validity of the Visual Analogue Scale (VAS). Pharmacopsychiatria. 1982;15:90-4.
36.    Rezvani Amin M, Siratinayer M, Abadi A, Moradyan T. Correlation between visual analogue scale and short form of McGill questionnaire in patients with chronic low back pain. Qom University of Medical Sciences Journal. 2012;6:31-4. [In Persian]
37.    Salm S, Rutz J, van den Akker M, et al. Current state of research on the clinical benefits of herbal medicines for non-life-threatening ailments. Frontiers in Pharmacology. 2023;14:1234701.
38.    Beidokhti H, Heidari M, Firozeh M. The Soy Bean Effect on The Premenstrual Syndrome Concerning Its Physical٬ Psycho and Behavioral Effects in Female Students of Semnan University Dormitory. Nursing and Midwifery Journal. 2013;11:316-24. [In Persian]
39.    Takeda T, Ueno T, Uchiyama S, Shiina M. Premenstrual symptoms interference and equol production status in Japanese collegiate athletes: A cross sectional study. Journal of Obstetrics and Gynaecology Research. 2018;44:488-94.
40.    Farahmand M, Ramezani Tehrani F, Saei Gharenaz M. The role of vitamins and minerals on the symptoms of premenstrual syndrome: A narrative review. The Iranian Journal of Obstetrics, Gynecology and Infertility. 2022;25:93-104. [In Persian]

Files

Share

How to cite

Statistics