The effect of the Cyclodynon drug on sexual function in patients with infertility and menstrual disorders
Artymuk N.V., Zotova O.A.
Objective: To compare the effect of the drug made from the extract of Vitex agnus-castus and cyclic vitamin therapy on the sexual function of patients with menstrual disorders and infertility.
Materials and methods: This was an open, exploratory, comparative randomized clinical study. It included 104 women aged 23 to 36 years with anovulatory infertility and menstrual disorders. The patients were divided into two groups: the women of group 1 (n=52) received a drug made from a standardized extract of Vitex agnus-castus (Cyclodynon drug in the form of film-coated tablets) at a dose of one tablet once a day for four months; the patients of group II (n=52) received cyclic vitamin therapy (Cyclovita dietary supplement) at a dose of one tablet once a day in the follicular phase of the menstrual cycle and two tablets once a day in the luteal phase of the menstrual cycle for four months. In addition to medical treatment, individual psychotherapy was prescribed in both groups. Before the treatment and four months after the start of the treatment, the patients were interviewed using the questionnaires of the Female Sexual Function Index (FSFI) and the Hospital Anxiety and Depression Scale (HADS).
Results: Sexual dysfunction was detected before the treatment in 30/52 (58%) patients in group I and in 32/52 (62%) patients in group II (p=0.089). The number of patients with subclinical and clinical anxiety before the treatment was 12/52 (23%) and 7/52 (13%) women in groups I and II (p=0.255); the number of patients with depression was 6/52 (12%) and 2/52 (4%), respectively (p=0.380). After the treatment, the average FSFI value increased in both groups; however, the difference of average values (Δ) in group I proved to be greater than in group II, namely 0.85 (0.53;1.16) and 0.53 (0.3;0.76), respectively. The assessment of anxiety values in group I showed a statistically significant improvement from 5.23 (3.13) to 4.48 (2.14) points according to the HADS scale, Δ (95% CI) was -0.75 (-1.3; -0.2).
Conclusion: Taking Vitex agnus-castus by patients with menstrual disorders and infertility leads to an improvement in their sexual function. Additional extensive research in this area is needed.
Authors’ contribution: Artymuk N.V., Zotova O.A. – developing the concept and design of the study, collecting and processing the material, writing the text, editing.
Conflicts of interest: Authors declare lack of the possible conflicts of interests.
Funding: The study was conducted without sponsorship.
Ethical Approval: The study was approved by the Ethical Review Board of the Kemerovo State Medical University, Ministry of Health of Russia.
Patient Consent for Publication: The patients provided an informed consent for the publication of their data.
Authors' Data Sharing Statement: The data supporting the findings of this study are available on request from the corresponding author after approval from the principal investigator.
For citation: Artymuk N.V., Zotova O.A. The effect of the Cyclodynon drug on sexual function in patients with infertility and menstrual disorders.
Akusherstvo i Ginekologiya/Obstetrics and Gynecology. 2023; (11): 158-168 (in Russian)
https://dx.doi.org/10.18565/aig.2023.193
Keywords
female sexual dysfunction
Female Sexual Function Index
anxiety
depression
infertility
menstrual disorder
Cyclodynon
Vitex agnus-castus
standardized extract of the dried fruits of Vitex agnus-castus
BNO 1095
References
- Nappi R.E., Tiranini L., Martini E., Bosoni D., Righi A., Cucinella L. Medical treatment of female sexual dysfunction. Urol. Clin. North Am. 2022;49(2):299-307. https://dx.doi.org/10.1016/j.ucl.2022.02.001.
- Erdős C., Kelemen O., Pócs D., Horváth E., Dudás N., Papp A., Paulik E. Female sexual dysfunction in association with sexual history, sexual abuse and satisfaction: a cross-sectional study in hungary. J. Clin. Med. 2023;12(3):1112. https://dx.doi.org/10.3390/jcm12031112.
- American College of Obstetricians and Gynecologists' Committee on Practice Bulletins-Gynecology. Female sexual dysfunction: ACOG Practice Bulletin Clinical Management Guidelines for Obstetrician-Gynecologists, Number 213. Obstet. Gynecol. 2019;134(1):e1-e18. https://dx.doi.org/10.1097/AOG.0000000000003324.
- Latif E.Z., Diamond M.P. Arriving at the diagnosis of female sexual dysfunction. Fertil. Steril. 2013;100(4):898-904. https://dx.doi.org/10.1016/j.fertnstert.2013.08.006.
- Prabhu S.S., Hegde S., Sareen S. Female sexual dysfunction: a potential minefield. Indian J. Sex Transm. Dis. AIDS. 2022;43(2):128-34. https://dx.doi.org/10.4103/ijstd.IJSTD_82_20.
- Clayton A.H., Valladares Juarez E.M. Female sexual dysfunction. Med. Clin. North Am. 2019;103(4):681-98. https://dx.doi.org/10.1016/j.mcna.2019.02.008.
- Imprialos K.P., Koutsampasopoulos K., Katsimardou A., Bouloukou S., Theodoulidis I., Themistoklis M., Doumas M. Female sexual dysfunction: a problem hidden in the shadows. Curr. Pharm. Des. 2021;27(36):3762-74. https://dx.doi.org/10.2174/1381612827666210719104950.
- Palacios S., Castaño R., Grazziotin A. Epidemiology of female sexual dysfunction. Maturitas. 2009;63(2):119-23. https://dx.doi.org/10.1016/j.maturitas.2009.04.002.
- Артымук Н.В., Хапачева С.Ю. Распространенность симптомов дисфункции тазового дна у женщин репродуктивного возраста. Акушерство и гинекология. 2018; 9: 99-105. [Artymuk N.V., Khapacheva S.Yu. The prevalence of pelvic floor dysfunction symptoms in reproductive-aged women. Obstetrics and Gynecology. 2018; (9): 99-105. (in Russian)]. https://dx.doi.org/10.18565/aig.2018.9.99-105
- Артымук Н.В., Сурина М.Н., Аталян А.В., Эль-Джефут М., Некрасова Е.В. Новая коронавирусная инфекция и сексуальная функция женщин. Фундаментальная и клиническая медицина. 2021; 6(1): 32-40. [Artymuk N.V., Surina M.N., Atalyan A.V., El-Jefut M., Nekrasova E.V. New coronavirus infection and sexual function of women. Fundamental and clinical medicine. 2021;6(1):32-40. (in Russian)]. https://dx.doi.org/10.23946/2500-0764-2021-6-1-32-40.
- Starc A., Trampuš M., Pavan Jukić D., Rotim C., Jukić T., Polona Mivšek A. Infertility and sexual dysfunctions: a systematic literature review. Acta Clin. Croat. 2019;58(3):508-15. https://doi.org/10.20471/acc.2019.58.03.15.
- Okobi O.E. A systemic review on the association between infertility and sexual dysfunction among women utilizing female sexual function index as a measuring tool. Cureus. 2021;13(6): e16006. https://dx.doi.org/10.7759/cureus.16006.
- Facchin F., Somigliana E., Busnelli A., Catavorello A., Barbara G., Vercellini P. Infertility-related distress and female sexual function during assisted reproduction. Hum. Reprod. 2019;34(6):1065-73. https://dx.doi.org/10.1093/humrep/dez046.
- Weinberger J.M., Houman J., Caron A.T., Anger J. Female sexual dysfunction: a systematic review of outcomes across various treatment modalities. Sex Med. Rev. 2019 ;7(2):223-50. https://dx.doi.org/10.1016/j.sxmr.2017.12.004.
- Weinberger J.M., Houman J., Caron A.T., Patel D.N., Baskin A.S., Ackerman A.L., Eilber K.S., Anger J.T. Female sexual dysfunction and the placebo effect: a Meta-analysis. Obstet. Gynecol. 2018;132(2):453-58. https://dx.doi.org/10.1097/AOG.0000000000002733.
- Уварова Е.В. Эффективность и безопасность применения растительного лекарственного препарата Циклодинон® для лечения нарушений менструального цикла у девочек-подростков: обзор опыта клинического применения. Репродуктивное здоровье детей и подростков. 2021; 17(2): 51-64. [Uvarova E.V. Effectiveness and safety of herbal medicinal product Cyclodynone® in treatment of menstrual irregularities in adolescent girls: a review of clinical usage. Pediatric and Adolescent Reproductive Health. 2021; 17(2): 51-64. (in Russian)]. https://dx.doi.org/10.33029/1816-2134-2021-172-51-64.
- Heirati S.F.D., Ozgoli G., KabodMehri R., Mojab F., Sahranavard S., Nasiri M. The 4-month effect of Vitex agnus-castus plant on sexual function of women of reproductive age: а clinical trial. J. Educ. Health Promot. 2021;10:294. https://dx.doi.org/10.4103/jehp.jehp_63_21.
- Neijenhuijs K.I., Hooghiemstra N., Holtmaat K., Aaronson N.K., Groenvold M., Holzner B. et al. The female sexual function index (FSFI) - a systematic review of measurement properties. J. Sex Med. 2019;16(5):640-60. https://dx.doi.org/10.1016/j.jsxm.2019.03.001.
- Zigmond A.S., Snaith R.P. The hospital anxiety and depression scale. Acta Psychiatr. Scand. 1983;67(6):361-70.https://dx.doi.org/10.1111/j.1600-0447.1983.tb09716.x.
- Julious S.A. Sample sizes for clinical trials with normal data. Stat. Med. 2004; 23(12): 1921-86. https://dx.doi.org/10.1002/sim.1783.
- Стеняева Н.Н., Хритинин Д.Ф., Чаусов А.А. Гинекологические заболевания как предикторы женской сексуальной дисфункции. Гинекология. 2021; 23(2):149-54. [Stenyaeva N.N., Chritinin D.F., Chausov A.A. Gynecological diseases as predictors of female sexual dysfunction. Gynecology. 2021;23(2): 149-54. (in Russian)]. https://dx.doi.org/10.26442/20795696.2021.2.200784.
- Drugs and Lactation Database (LactMed®) [Internet]. Bethesda (MD): National Institute of Child Health and Human Development; 2006. Available from: https://www.ncbi.nlm.nih.gov/sites/books/NBK501922/toc/
- LiverTox: Clinical and Research Information on Drug-Induced Liver Injury [Internet]. Bethesda (MD): National Institute of Diabetes and Digestive and Kidney Diseases; 2012.
- Soleymanzadeh F., Mahmoodi M., Shahidi S. Effect of Vitex agnus-castus ethanolic extract on sex hormones in streptozotocin-induced diabetic rats. J. Family Reprod. Health. 2020;14(2):102-5. https://dx.doi.org/10.18502/jfrh.v14i2.4352.
- Hafizi S., Abbassian A., Tabarrai M. The effect of Jazar supplement on quality of life and sexual function in postmenopausal women: a double-blind, randomized, placebo-controlled trial. Evid. Based Complement. Alternat. Med. 2021;2021: 8854182. https://dx.doi.org/10.1155/2021/8854182.
- Koliji T., Keshavarz Z., Mojab F., Nasiri M., Zare E. Comparison of Cinnamon and Vitex on improving sexual function in postmenopausal women: a triple-blind randomized clinical trial. Jundishapur J. Nat. Pharm. Prod. 2022;17(4):e128406. https://doi.org/10.5812/jjnpp-128406.
- Manouchehri A., Abbaszadeh S., Ahmadi M., Nejad F.K., Bahmani M., Dastyar N. Polycystic ovaries and herbal remedies: a systematic review. JBRA Assist. Reprod. 2023;27(1):85-91. https://dx.doi.org/10.5935/1518-0557.20220024.
- Rafieian-Kopaei M., Movahedi M. Systematic review of premenstrual, postmenstrual and infertility disorders of Vitex Agnus Castus. Electron. Physician. 2017;9(1):3685-9. https://dx.doi.org/10.19082/3685.
- Heskes A.M., Sundram T.C.M., Boughton B.A., Jensen N.B., Hansen N.L., Crocoll C. et al. Biosynthesis of bioactive diterpenoids in the medicinal plant Vitex agnus-castus. Plant. J. 2018;93(5):943-58. hhttps://dx.doi.org/10.1111/tpj.13822.
- Бурчаков Д.И., Ших Е.В. Витекс священный: от античных легенд к нейрофизиологии дофаминергического ответа на стрессовые стимулы. Женская клиника. 2020; 1: 17-23. [Burchakov D.I., Shikh E.V. Vitex agnus castus: from the antique legends to neurophysiology of dopaminergic stress response. Women's Clinic. 2020; (1): 17-23. (in Russian)].
Received 15.08.2023
Accepted 17.11.2023
About the Authors
Natalya V. Artymuk, Dr. Med. Sci., Professor, Head of the Department of Obstetrics and Gynecology named after Professor G.A. Ushakova, Kemerovo State Medical University, Ministry of Health of the Russian Federation, +7(960)923-33-55, artymuk@gmail.com, https://orcid.org/0000-0001-7014-6492,650056, Russia, Kemerovo, Voroshilova str., 22a.
Olga A. Zotova, Ph.D., obstetrician-gynecologist, Kuzbass Regional Clinical Hospital named after S.V. Belyaev, https://orcid.org/0000-0002-4991-5354,
650066, Russia, Kemerovo, Octyabrsky pr., 22a.
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