Generic placeholder image

Current Drug Discovery Technologies

Editor-in-Chief

ISSN (Print): 1570-1638
ISSN (Online): 1875-6220

Research Article

Efficacy of a Herbal Formulation Based on Foeniculum Vulgare in Oligo/Amenorrhea: A Randomized Clinical Trial

Author(s): Farnoush Falahat, Sedigheh Ayatiafin, Lida Jarahi, Roshanak Mokaberinejad, Hasan Rakhshandeh, Zohre Feyzabadi* and Mandana Tavakkoli

Volume 17, Issue 1, 2020

Page: [68 - 78] Pages: 11

DOI: 10.2174/1570163815666181029120512

Price: $65

Abstract

Background: The aim of this study was to evaluate the efficacy of the herbal tea based on Foeniculum vulgare, on inducing regular bleeding in women with oligomenorrhea and secondary amenorrhea( oligo/amenorrhea).

Methods: Forty women aged 18- 40 with oligo/amenorrhea were enrolled in this randomized controlled clinical trial and were allocated to two groups equally. The women in the first group were treated by Fomentex (Foeniculum vulgare / Mentha longifolia / Vitex agnus-castus) herbal tea 11.2 g/day in 2 divided doses for 2 weeks and the second group were treated by medroxy progesterone acetate (MP)10 mg/day for the last 10 days of their menstrual cycles. The intervention was repeated in three cycles of menstruation in both groups. Bleeding pattern was documented by the patient on diary cards. The occurrence (yes/no) of bleeding, the regularity of bleeding pattern, the interval of cycles, the duration of bleeding, the volume of blood flow, the hormonal parameters (total testosterone, free testosterone luteinizing hormone and follicle-stimulating hormone), and the endometrial thickness in sonography before and after the intervention were evaluated and compared as outcomes.

Results: The number of women with bleeding during the first cycle was in the Fomentex group and the MP group 83.3% and 94.1% respectively (p = 0.61). The regularity of bleeding did not significantly differ in patients treated with Fomentex from those given MP (66.7% vs. 94.1%; p = 0.088). Mean interval of cycles decreased in both groups after intervention (P<0.001). Mean duration decreased significantly in MP group after the intervention but it was not different in patients treated with Fomentex. The difference between 2 groups was not significant (P=0.705).

Volume of blood flow, with regard to Pictorial Blood Assessment Chart (PBAC), increased significantly in MP group after the intervention (P=0.001) and it was not different in patients treated with Fomentex (P=0.757); however, difference between 2 groups was not significant (P=0.063). The percentage of patients with on time menstruation in the next (drug-free) episode, was higher in the Fomentex group compared with the MP group (50% vs. 23.5%; p = 0.105). Secondary outcomes such as dysmenorrhea, acne and hirsutism reduced in the Fomentex group (P≤0.05), while they increased in the MP group (P=0.007). At the end of the treatment, there was a significant decrease in luteinizing hormone, total testosterone and free testosterone in patients taking Fomentex. The decrease of endometrial thickness, was significant in both groups after the intervention (P=0.001), but the difference between 2 groups was not significant (P=0.58). No notable complication or side effect was reported in relation to Fomentex.

Conclusion: Fomentex herbal tea is a safe, well-tolerated, and effective choice in inducing bleeding and maintaining regular bleeding in women with oligo/amenorrhea.

Keywords: Fomentex, amenorrhea, oligomenorrhea, bleeding, Foeniculum vulgare, Mentha longifolia, Vitex agnus-castus.

Graphical Abstract

[1]
Gibbs RS, Karlyn BY, Haney AF, Nygaard I. Danforth’s obstetrics and gynecology. Lippincott williams & wilkins 2008.
[2]
Berek J. Novak”s Gynecology. 15th ed. Baltimore: Lippincot Williams & Wilkins 2012.
[3]
Norman RJ, Dewailly D, Legro RS, Hickey TE. Polycystic ovary syndrome. Lancet 2007; 370(9588): 685-97.
[http://dx.doi.org/10.1016/S0140-6736(07)61345-2] [PMID: 17720020]
[4]
Amato MC, Verghi M, Galluzzo A, Giordano C. The oligomenorrhoic phenotypes of polycystic ovary syndrome are characterized by a high visceral adiposity index: a likely condition of cardiometabolic risk. Hum Reprod 2011; 26(6): 1486-94.
[http://dx.doi.org/10.1093/humrep/der088] [PMID: 21447694]
[5]
Genazzani AD, Ricchieri F, Lanzoni C, Strucchi C, Jasonni VM. Diagnostic and therapeutic approach to hypothalamic amenorrhea. Ann N Y Acad Sci 2006; 1092: 103-13.
[http://dx.doi.org/10.1196/annals.1365.009] [PMID: 17308137]
[6]
Genazzani AD, Chierchia E, Santagni S, Rattighieri E, Farinetti A, Lanzoni C. Hypothalamic amenorrhea: from diagnosis to therapeutical approach. Ann Endocrinol (Paris) 2010; 71(3): 163-9.
[http://dx.doi.org/10.1016/j.ando.2010.02.006] [PMID: 20362965]
[7]
Speroff L, Glass RH, Kase NG. Clinical gynecologyic endocrinology and infertility. 8th. Baltimore: lippincot willims wikins Wolters Kluwer 2011; pp. 435-620.
[8]
Cesta CE, Kuja-Halkola R, Lehto K, Iliadou AN, Landén M. Polycystic ovary syndrome, personality, and depression: A twin study. Psychoneuroendocrinology 2017; 85: 63-8.
[http://dx.doi.org/10.1016/j.psyneuen.2017.08.007] [PMID: 28825976]
[9]
Weiss J, Kuepker W. Obesity, polycystic ovary syndrome, cancer. Gynakologische Endokrinologie 2017; 15(2): 116-20.
[10]
Ollila MM, West S, Keinänen-Kiukaanniemi S, et al. Overweight and obese but not normal weight women with PCOS are at increased risk of Type 2 diabetes mellitus-a prospective, population-based cohort study. Hum Reprod 2017; 32(2): 423-31.
[http://dx.doi.org/10.1093/humrep/dew329] [PMID: 28031324]
[11]
Sills ES, Perloe M, Tucker MJ, Kaplan CR, Genton MG, Schattman GL. Diagnostic and treatment characteristics of polycystic ovary syndrome: descriptive measurements of patient perception and awareness from 657 confidential self-reports. BMC Womens Health 2001; 1(1): 3.
[http://dx.doi.org/10.1186/1472-6874-1-3] [PMID: 11545683]
[12]
Fleming R, Hopkinson ZE, Wallace AM, Greer IA, Sattar N. Ovarian function and metabolic factors in women with oligomenorrhea treated with metformin in a randomized double blind placebo-controlled trial. J Clin Endocrinol Metab 2002; 87(2): 569-74.
[http://dx.doi.org/10.1210/jcem.87.2.8261] [PMID: 11836287]
[13]
Donnan PT, MacDonald TM, Morris AD. Adherence to prescribed oral hypoglycaemic medication in a population of patients with Type 2 diabetes: a retrospective cohort study. Diabet Med 2002; 19(4): 279-84.
[http://dx.doi.org/10.1046/j.1464-5491.2002.00689.x] [PMID: 11942998]
[14]
Grant RW, Devita NG, Singer DE, Meigs JB. Polypharmacy and medication adherence in patients with type 2 diabetes. Diabetes Care 2003; 26(5): 1408-12.
[http://dx.doi.org/10.2337/diacare.26.5.1408] [PMID: 12716797]
[15]
Legro RS, Barnhart HX, Schlaff WD, et al. Cooperative Multicenter Reproductive Medicine Network Clomiphene, metformin, or both for infertility in the polycystic ovary syndrome. N Engl J Med 2007; 356(6): 551-66.
[http://dx.doi.org/10.1056/NEJMoa063971] [PMID: 17287476]
[16]
Arentz S, Smith CA, Abbott JA, Bensoussan A. A survey of the use of complementary medicine by a self-selected community group of Australian women with polycystic ovary syndrome. BMC Complement Altern Med 2014; 14(1): 472.
[http://dx.doi.org/10.1186/1472-6882-14-472] [PMID: 25481654]
[17]
Rooney S, Pendry B. Phytotherapy for polycystic ovarian syndrome: A review of the literature and evaluation of practitioners’ experiences. J Herb Med 2014; 4: 159-71.
[http://dx.doi.org/10.1016/j.hermed.2014.05.001]
[18]
Ushiroyama T, Hosotani T, Mori K, Yamashita Y, Ikeda A, Ueki M. Effects of switching to wen-jing-tang (unkei-to) from preceding herbal preparations selected by eight-principle pattern identification on endocrinological status and ovulatory induction in women with polycystic ovary syndrome. Am J Chin Med 2006; 34(2): 177-87.
[http://dx.doi.org/10.1142/S0192415X06003746] [PMID: 16552830]
[19]
Takeuchi T, Nishii O, Okamura T, Yaginuma T. Effect of traditional herbal medicine, shakuyaku-kanzo-to on total and free serum testosterone levels. Am J Chin Med 1989; 17(1-2): 35-44.
[http://dx.doi.org/10.1142/S0192415X89000073] [PMID: 2511749]
[20]
Heibashy MIA, Mazen GMA. SHahin MI. Metabolic changes and hormonal disturbances in polycystic ovarian syndrome rats and the amelioration effects of metformin and/or cinnamon extraction. J Am Sci 2013; 9: 54-62.
[21]
Moini Jazani A, Hamdi K, Tansaz M, et al. Herbal medicine for oligomenorrhea and amenorrhea: A systematic review of ancient and conventional medicine. BioMed Research International 2018.
[http://dx.doi.org/10.1155/2018/3052768]
[22]
Mohebbi-Kian E, Mohammad-Alizadeh-Charandabi S, Bekhradi R. Efficacy of fennel and combined oral contraceptive on depot medroxyprogesterone acetate-induced amenorrhea: a randomized placebo-controlled trial. Contraception 2014; 90(4): 440-6.
[http://dx.doi.org/10.1016/j.contraception.2014.05.001] [PMID: 24981150]
[23]
Mokaberinejad R, Zafarghandi N, Bioos S, et al. Mentha longifolia syrup in secondary amenorrhea: a double-blind, placebo-controlled, randomized trials. Daru 2012; 20(1): 97.
[http://dx.doi.org/10.1186/2008-2231-20-97] [PMID: 23351184]
[24]
Bergmann J, Luft B, Boehmann S, Runnebaum B, Gerhard I. [The efficacy of the complex medication Phyto-Hypophyson L in female, hormone-related sterility. A randomized, placebo-controlled clinical double-blind study]. Forsch Komplementarmed Klass Naturheilkd 2000; 7(4): 190-9.
[PMID: 11025394]
[25]
Shahnazi M, Khalili AF, Hamdi K, Ghahremaninasab P. The effects of combined low-dose oral contraceptives and Vitex agnus on the improvement of clinical and paraclinical parameters of polycystic ovarian syndrome: A triple-blind, randomized, Controlled Clinical Trial. Iran Red Crescent Med J 2016; 18(12)
[http://dx.doi.org/10.5812/ircmj.37510]
[26]
Rahimi R, Ardekani MR. Medicinal properties of Foeniculum vulgare Mill. in traditional Iranian medicine and modern phytotherapy. Chin J Integr Med 2013; 19(1): 73-9.
[http://dx.doi.org/10.1007/s11655-013-1327-0] [PMID: 23275017]
[27]
Aqili M. Makhzan-al-Adwiah Shams Ardakani MR. Editor Sabz Arang and Tehran University of Medical Sciences Tehran 2008.
[28]
Amoura M, Lotfy ZH, Neveen E, Khloud A. Potential effects of Mentha piperita (peppermint) on Letrozole-induced polycystic ovarian syndrome in female albino rat. Int J 2015; 3(10): 211-26.
[29]
Mokaberinejad R, Akhtari E, Tansaz M, et al. Effect of mentha longifolia on FSH serum level in premature ovarian failure. Open J Obstet Gynecol 2014; 4(07): 356.
[http://dx.doi.org/10.4236/ojog.2014.47053]
[30]
Kort DH, Lobo RA. Preliminary evidence that cinnamon improves menstrual cyclicity in women with polycystic ovary syndrome: a randomized controlled trial. Am J Obstet Gynecol 2014; 211(5): 487.e1-6.
[http://dx.doi.org/10.1016/j.ajog.2014.05.009] [PMID: 24813595]
[31]
Zare S, Nabiuni M, Tayanloo A, Hoseini S, Karimzadeh-Bardei L. The effects of Urtica dioica extract on lipid profile, insulin resistance index and liver histology in polycystic ovary syndrome-induced Wistar rats. Advanced Herbal Medicine 2015; 1(2): 23-33.
[32]
Pourahmadi M, Golami L, Farzam M, Kargarjahromi H. The effect of hydro alcoholic cinnamon extract on changes of gonadotropins (LH and FSH) in mice treated with Cocodamol. Biomed Pharmacol J 2014; 7(1): 369-73.
[http://dx.doi.org/10.13005/bpj/500]
[33]
Karampoor P, Azarnia M, Mirabolghasemi G, Alizadeh F. The effect of hydroalcoholic extract of fennel (foeniculum vulgare) seed on serum levels of sexual hormones in female wistar rats with polycystic ovarian syndrome. PCOS 2014; pp. 70-8.
[34]
Jelodar G, Askari K. Effect of Vitex agnus-castus fruits hydroalcoholic extract on sex hormones in rat with induced polycystic ovary syndrome (PCOS). Physiology and Pharmacology 2012; 16(1): 62-9.
[35]
Oliaee D, Boroushaki MT, Oliaee N, Ghorbani A. Evaluation of cytotoxicity and antifertility effect of Artemisia kopetdaghensis. Adv Pharmacol Sci 2014; 2014745760
[http://dx.doi.org/10.1155/2014/745760] [PMID: 24711816]
[36]
Hosseini A, Mollazadeh H, Amiri MS, Sadeghnia HR, Ghorbani A. Effects of a standardized extract of Rheum turkestanicum Janischew root on diabetic changes in the kidney, liver and heart of streptozotocin-induced diabetic rats. Biomed Pharmacother 2017; 86: 605-11.
[http://dx.doi.org/10.1016/j.biopha.2016.12.059] [PMID: 28027536]
[37]
Baqai Z, Khanam M, Parveen S. Prevalence of PCOS in infertile patients. Med Channel 2010; 16(3): 437-40.

Rights & Permissions Print Cite
© 2024 Bentham Science Publishers | Privacy Policy