188
Views
0
CrossRef citations to date
0
Altmetric
Research Articles

Effects of the PREMEN-CALM® in the Management of the Premenstrual Syndrome: A Randomized, Double-Blind, Placebo-Controlled Pilot Study

, , & ORCID Icon

References

  • Abdollahi R, Abiri B, Sarbakhsh P, Kashanian M, Vafa M. 2019. The effect of vitamin D supplement consumption on premenstrual syndrome in vitamin D-deficient young girls: a randomized, double-blind, placebo-controlled clinical trial. Complement Med Res. 26(5):336–342. doi: 10.1159/000500016.
  • Ahmadi R, Mohammadzadeh-Moghadam H, Esmaeili R, Khajavi A, Ghahramany M, Salarbashi D, Bahramizadeh M, Elyasi S. 2023. Evaluation of a persian natural topical medicine based on sesame oil on mild-to-moderate outpatient coronavirus disease-19 patients: a randomized triple-blind placebo-controlled clinical trial. Trad Integr Med. 8(3):249–255.
  • American College of Obstetricians and Gynecologists. 2014. Guidelines for women’s health care: a resource manual. 4th ed. Washington, DC: American College of Obstetricians and Gynecologists; p. 608.
  • Anghelescu IG, Edwards D, Seifritz E, Kasper S. 2018. Stress management and the role of Rhodiola rosea: a review. Int J Psychiatry Clin Pract. 22(4):242–252. doi: 10.1080/13651501.2017.1417442.
  • Azizieh FY, Alyahya KO, Dingle K. 2017. Association of self-reported symptoms with serum levels of vitamin D and multivariate cytokine profile in healthy women. J Inflamm Res. 10:19–28. doi: 10.2147/JIR.S127892.
  • Bahrami A, Avan A, Sadeghnia HR, Esmaeili H, Tayefi M, Ghasemi F, Nejati Salehkhani F, Arabpour-Dahoue M, Rastgar-Moghadam A, Ferns GA, et al. 2018. High dose vitamin D supplementation can improve menstrual problems, dysmenorrhea, and premenstrual syndrome in adolescents. Gynecol Endocrinol. 34(8):659–663. doi: 10.1080/09513590.2017.1423466.
  • Bahrami A, Bahrami-Taghanaki H, Khorasanchi Z, Timar A, Jaberi N, Azaryan E, Tayefi M, Ferns GA, Sadeghnia HR, Ghayour-Mobarhan M. 2020. Menstrual problems in adolescence: relationship to serum vitamins A and E, and systemic inflammation. Arch Gynecol Obstet. 301(1):189–197. doi: 10.1007/s00404-019-05343-1.
  • Beck AT, Ward CH, Mendelson M, Mock J, Erbaugh J. 1961. An inventory for measuring depression. Arch Gen Psychiatry. 4(6):561–571. doi: 10.1001/archpsyc.1961.01710120031004.
  • Bertone-Johnson ER, Powers SI, Spangler L, Larson J, Michael YL, Millen AE, Bueche MN, Salmoirago-Blotcher E, Wassertheil-Smoller S, Brunner RL, et al. 2012. Vitamin D supplementation and depression in the women’s health initiative calcium and vitamin D trial. Am J Epidemiol. 176(1):1–13. doi: 10.1093/AJE/KWR482.
  • Buysse DJ, Reynolds CF, Monk TH, Berman SR, Kupfer DJ. 1989. The pittsburgh sleep quality index: a new instrument for psychiatric practice and research. Psychiatry Res. 28(2):193–213. doi: 10.1016/0165-1781(89)90047-4.
  • Campagne DM, Campagne G. 2007. The premenstrual syndrome revisited. Eur J Obstet Gynecol Reprod Biol. 130(1):4–17. doi: 10.1016/j.ejogrb.2006.06.020.
  • Chou PB, Morse CA, Xu H. 2008. A controlled trial of Chinese herbal medicine for premenstrual syndrome. J Psychosom Obstet Gynaecol. 29(3):185–192. doi: 10.1080/01674820801893011.
  • Ciotta L, Pagano I, Stracquadanio M, Di Leo S, Andò A, Formuso C. 2011. Psychic aspects of the premenstrual dysphoric disorders. New therapeutic strategies: our experience with Vitex agnus castus. Minerva Ginecol. 63(3):237–245. https://pubmed.ncbi.nlm.nih.gov/21654609.
  • Darbinyan V, Aslanyan G, Amroyan E, Gabrielyan E, Malmström C, Panossian A. 2007. Clinical trial of Rhodiola rosea L. extract SHR-5 in the treatment of mild to moderate depression. Nord J Psychiatry. 61(5):343–348. doi: 10.1080/08039480701643290.
  • Dericks-Tan JSE, Schwinn P, Hildt C. 2003. Dose-dependent stimulation of melatonin secretion after administration of Agnus castus. Exp Clin Endocrinol Diabetes. 111(1):44–46. doi: 10.1055/S-2003-37500.
  • Dilbaz B, Aksan A. 2021. Premenstrual syndrome, a common but underrated entity: Review of the clinical literature. J Turk Ger Gynecol Assoc. 22(2):139–148. doi: 10.4274/jtgga.galenos.2021.2020.0133.
  • Duvan CI, Cumaoglu A, Turhan ON, Karasu C, Kafali H. 2011. Oxidant/antioxidant status in premenstrual syndrome. Arch Gynecol Obstet. 283(2):299–304. doi: 10.1007/s00404-009-1347-y.
  • Ebrahimi E, Khayati Motlagh S, Nemati S, Tavakoli Z. 2012. Effects of magnesium and vitamin b6 on the severity of premenstrual syndrome symptoms. J Caring Sci. 1(4):183–189. doi: 10.5681/jcs.2012.026.
  • Fathizadeh PS, Amani R, Nutr R, Hossein Haghighizadeh M, HormoziP R. 2016. Comparison of serum zinc concentrations and body antioxidant status between young women with premenstrual syndrome and normal controls: A case-control study. In Int J Reprod BioMed. 14(11):699–704. Erratum in: Int J Reprod Biomed. 2023 Aug 23;21(7):591.
  • Foster R, Vaisberg M, Bachi ALL, Dos Santos JDMB, De Paula Vieira R, Luna-Junior LA, Araújo MP, Parmigiano TR, Borges F, DI-Bella ZIKJ. 2019. Premenstrual Syndrome, Inflammatory Status, and Mood States in Soccer Players. Neuroimmunomodulation. 26(1):1–6. doi: 10.1159/000494559.
  • Frankel RA, Michels KA, Kim K, Kuhr DL, Omosigho UR, Wactawski-Wende J, Levine L, Perkins NJ, Mumford SL. 2021. Serum antioxidant vitamin concentrations and oxidative stress markers associated with symptoms and severity of premenstrual syndrome: a prospective cohort study. BMC Women’s Health. 21(1):1–11. doi: 10.1186/s12905-021-01187-7.
  • Ghoreishi PS, Shams M, Nimrouzi M, Zarshenas MM, Lankarani KB, Fallahzadeh Abarghooei E, Talebzadeh M, Hashempur MH. 2023. The Effects of Ginger (Zingiber Officinale Roscoe) on Non-Alcoholic Fatty Liver Disease in Patients with Type 2 Diabetes Mellitus: A Randomized Double-Blinded Placebo-Controlled Clinical Trial. J Diet Suppl. 1–19. Advance online publication. doi: 10.1080/19390211.2023.2263788.
  • Granda D, Szmidt MK, Kaluza J. 2021. Is premenstrual syndrome associated with inflammation, oxidative stress and antioxidant status? A systematic review of case-control and cross-sectional studies. Antioxidants (Basel). 10(4):604. doi: 10.3390/antiox10040604.
  • Hajimonfarednejad M, Ostovar M, Hasheminasab FS, Shariati MA, Thiruvengadam M, Raee MJ, Hashempur MH. 2023. Medicinal plants for viral respiratory diseases: a systematic review on persian medicine. Evid Based Complement Alternat Med. 2023:1928310–1928310. doi: 10.1155/2023/1928310.
  • Hara T, Takeda T a, Takagishi T, Fukue K, Kambe T, Fukada T. 2017. Physiological roles of zinc transporters: molecular and genetic importance in zinc homeostasis. J Physiol Sci. 67(2):283–301. doi: 10.1007/S12576-017-0521-4.
  • Hashim MS, Obaideen AA, Jahrami HA, Radwan H, Hamad HJ, Owais AA, Alardah LG, Qiblawi S, Al-Yateem N, Faris MAE. 2019. Premenstrual syndrome is associated with dietary and lifestyle behaviors among university students: a cross-sectional study from Sharjah, UAE. Nutrients. 11(8):1939. doi: 10.3390/nu11081939.
  • Heidari H, Amani R, Feizi A, Askari G, Kohan S, Tavasoli P. 2019. Vitamin D supplementation for premenstrual syndrome-related inflammation and antioxidant markers in students with vitamin D deficient: a randomized clinical trial. Sci Rep. 9(1):14939. doi: 10.1038/s41598-019-51498-x.
  • Hofmeister S, Bodden S. 2016. Premenstrual syndrome and premenstrual dysphoric disorder. American Family Physician. 94(3):236–240. doi: 10.1016/b978-1-4160-5461-0.00032-9.
  • Hussein RA, Hafiz M, Bin-Afif S, Al-Omari E, Al-Helou M. 2012. Premenstrual syndrome prevalence, and correlation with carbohydrate intake in young women. HealthMED. 6(3):774–780.
  • Jafari F, Amani R, Tarrahi MJ. 2019. Effect of zinc supplementation on physical and psychological symptoms, biomarkers of inflammation, oxidative stress, and brain-derived neurotrophic factor in young women with premenstrual syndrome: a randomized, double-blind, placebo-controlled trial. Biol Trace Elem Res. 194(1):89–95. doi: 10.1007/S12011-019-01757-9.
  • Jehan S, Auguste E, Hussain M, Pandi-Perumal SR, Brzezinski A, Gupta R, Attarian H, Jean-Louis G, Mcfarlane SI. 2016. Sleep and premenstrual syndrome HHS public access. J Sleep Med Disord. 3(5):1–17.
  • Liu X, Machado GC, Eyles JP, Ravi V, Hunter DJ. 2018. Dietary supplements for treating osteoarthritis: a systematic review and meta-analysis. Br J Sports Med. 52(3):167–175. doi: 10.1136/bjsports-2016-097333.
  • Ma L, Lin S, Chen R, Wang X. 2010. Treatment of moderate to severe premenstrual syndrome with Vitex agnus castus (BNO 1095) in Chinese women. Gynecol Endocrinol. 26(8):612–616. doi: 10.3109/09513591003632126.
  • Panay N. 2009. Management of premenstrual syndrome. J Fam Plann Reprod Health Care. 35(3):187–194. doi: 10.1783/147118909788708147.
  • Parazzini F, Di Martino M, Pellegrino P. 2017. Magnesium in the gynaecological practice: A literature review. Magnes Res. 30(1):1–7. doi: 10.1684/mrh.2017.0419.
  • Pu W, Zhang M, Bai R, Sun L, Li W, Yu Y, Zhang Y, Song L, Wang Z, Peng Y, et al. 2020. Anti-inflammatory effects of Rhodiola rosea L.: A review. Biomed Pharmacother. 121:109552. doi: 10.1016/j.biopha.2019.109552.
  • Puder JJ, Blum CA, Mueller B, De Geyter C, Dye L, Keller U. 2006. Menstrual cycle symptoms are associated with changes in low-grade inflammation. Eur J Clin Invest. 36(1):58–64. doi: 10.1111/j.1365-2362.2006.01591.x.
  • Quaranta S, Buscaglia MA, Meroni MG, Colombo E, Cella S. 2007. Pilot study of the efficacy and safety of a modified-release magnesium 250mg tablet (Sincromag®) for the treatment of premenstrual syndrome. Clin Drug Investig. 27(1):51–58. doi: 10.2165/00044011-200727010-00004.
  • Rapkin AJ, Akopians AL. 2012. PMS & PMDD: Pathophysiology. Menopause Int. 18(2):52–59. doi: 10.1258/mi.2012.012014.
  • Reiter RJ, Mayo JC, Tan DX, Sainz RM, Alatorre-Jimenez M, Qin L. 2016. Melatonin as an antioxidant: under promises but over delivers. J Pineal Res. 61(3):253–278. doi: 10.1111/jpi.12360.
  • Retallick-Brown H, Blampied N, Rucklidge JJ. 2020. A pilot randomized treatment-controlled trial comparing vitamin B6 with broad-spectrum micronutrients for premenstrual syndrome. J Altern Complement Med. 26(2):88–97. doi: 10.1089/acm.2019.0305.
  • Sabet-Birjandi S, Tadayon-Najafabadi M, Siyahpooshan A, Hossein Haghighizadeh M. 2010. Comparision the effect of Hypericum perforatum and vitamin B6 in the treatment of premenstrual syndrome. Zahedan Journal of Research in Medical Sciences. 13(4):e93929. https://sites.kowsarpub.com/zjrms/articles/93929.html.
  • Sarris J. 2007. Herbal medicines in the treatment of psychiatric disorders: a systematic review. Phytother Res. 21(8):703–716. doi: 10.1002/PTR.2187.
  • Schulz KF, Altman DG, Moher D. 2010. CONSORT 2010 Statement: updated guidelines for reporting parallel group randomised trials. BMC Med. 8(1):18. doi: 10.1186/1741-7015-8-18.
  • Shaw S, Wyatt K, Campbell J, Ernst E, Thompson-Coon J. 2018. Vitex agnus castus for premenstrual syndrome. Cochrane Database Syst Rev. 2018(3):CD004632. doi: 10.1002/14651858.CD004632.PUB2.
  • Spielberger CD, Gorsuch RL, Lushene RE. 2008. STAI. Cuestionario de ansiedad estado-rasgo, 7th ed. rev. Madrid: TEA.
  • THE WHOQOL GROUP,. Development of the World Health Organization WHOQOL-BREF Quality of Life Assessment. Psychol. Med. 1998;28:551–558. doi: 10.1017/S0033291798006667.
  • Van Die MD, Burger H, Teede H, Bone K. 2013. Vitex agnus-castus extracts for female reproductive disorders: A systematic review of clinical trials. Planta Med. 79(7):562–575. doi: 10.1055/s-0032-1327831.
  • World Medical Association (WMA). 2013. World medical association declaration of Helsinki: ethical principles for medical research involving human subjects. JAMA. 310:2191–2194. doi: 10.1001/jama.2013.281053.
  • Zamani M, Neghab N, Torabian S. 2012. Therapeutic effect of Vitex agnus castus in patients with premenstrual syndrome. Acta Med Iran. 50(2):101–106.

Reprints and Corporate Permissions

Please note: Selecting permissions does not provide access to the full text of the article, please see our help page How do I view content?

To request a reprint or corporate permissions for this article, please click on the relevant link below:

Academic Permissions

Please note: Selecting permissions does not provide access to the full text of the article, please see our help page How do I view content?

Obtain permissions instantly via Rightslink by clicking on the button below:

If you are unable to obtain permissions via Rightslink, please complete and submit this Permissions form. For more information, please visit our Permissions help page.