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Current Drug Delivery

Editor-in-Chief

ISSN (Print): 1567-2018
ISSN (Online): 1875-5704

Clinical Trial

Comparison of the Effects of Fenugreek Vaginal Cream and Ultra Low- Dose Estrogen on Atrophic Vaginitis

Author(s): Maryam Safary, Sevil Hakimi*, Noushin Mobaraki-Asl, Paria Amiri, Habib Tvassoli and Abbas Delazar

Volume 17, Issue 9, 2020

Page: [815 - 822] Pages: 8

DOI: 10.2174/1567201817666200708112655

Price: $65

Abstract

Introduction: Atrophic vaginitis is a common problem in postmenopausal women and results from decreased levels of blood estrogen. It is associated with symptoms of itching, burning, dyspareunia, and postmenopausal bleeding. The present study evaluated the effects of fenugreek extract on atrophic vaginitis.

Materials and Methods: This randomized controlled clinical trial was performed on 60 postmenopausal women in Ardabil, Iran, in 2018. The participants were selected using block randomization with the allocation ratio 1:1. Those in the intervention group received 0.5g (the applicator filled to the half-full mark) fenugreek vaginal cream 5% twice a week for 12 weeks. The control group received conjugated estrogens vaginal cream at the dose of 0.625 mg (the applicator filled to the half-full mark) containing 0.3 mg of conjugated estrogens. Atrophic vaginitis was evaluated before and after the treatment through clinical examination, clinical signs, and measurement of Vaginal Maturation Index (VMI).

Findings: After the 12-week intervention and modification of the baseline score, the mean (standard error) score for atrophic vaginitis signs was 3.100 (1.43-4.75). This difference was statistically significant in intragroup comparison and in favor of the control group in intergroup comparison (p=0.001). VMI was less than 49% in 86.7% and 46.7% of the participants in the intervention and control groups, respectively. This was a significant difference in favor of the control group (p=0.001).

Conclusion: The results of this study showed that total fenugreek extract could be effective in treating signs of atrophic vaginitis, but it was not as effective as ultra-low-dose estrogen.

Keywords: Atrophic vaginitis, estrogen vaginal cream, fenugreek vaginal cream, vaginal maturation index, steroid hormones, collagen fibers.

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[1]
Weber, M.A.; Limpens, J.; Roovers, J.P. Assessment of vaginal atrophy: a review. Int. Urogynecol. J. Pelvic Floor Dysfunct., 2015, 26(1), 15-28.
[http://dx.doi.org/10.1007/s00192-014-2464-0 ] [PMID: 25047897]
[2]
Hsieh, C.H.; Su, T.H.; Chang, S.T.; Lin, S.H.; Lee, M.C.; Lee, M.Y. Prevalence of and attitude toward urinary incontinence in postmenopausal women. Int. J. Gynaecol. Obstet., 2008, 100(2), 171-174.
[http://dx.doi.org/10.1016/j.ijgo.2007.08.013 ] [PMID: 17977542]
[3]
Shen, J.; Song, N.; Williams, C.J.; Brown, C.J.; Yan, Z.; Xu, C.; Forney, L.J. Effects of low dose estrogen therapy on the vaginal microbiomes of women with atrophic vaginitis. Sci. Rep., 2016, 6, 24380.
[http://dx.doi.org/10.1038/srep24380 ] [PMID: 27103314]
[4]
Sturdee, D.W.; Panay, N. International menopause society writing group. Recommendations for the management of postmenopausal vaginal atrophy. Climacteric, 2010, 13(6), 509-522.
[http://dx.doi.org/10.3109/13697137.2010.522875 ] [PMID: 20883118]
[5]
Moegele, M.; Buchholz, S.; Seitz, S.; Ortmann, O. Vaginal estrogen therapy in postmenopausal breast cancer patients treated with aromatase inhibitors. Arch. Gynecol. Obstet., 2012, 285(5), 1397-1402.
[http://dx.doi.org/10.1007/s00404-011-2181-6 ] [PMID: 22212649]
[6]
Kingsberg, S.A.; Wysocki, S.; Magnus, L.; Krychman, M.L. Vulvar and vaginal atrophy in postmenopausal women: findings from the REVIVE (REal Women’s VIews of Treatment Options for Menopausal Vaginal ChangEs) survey. J. Sex. Med., 2013, 10(7), 1790-1799.
[http://dx.doi.org/10.1111/jsm.12190 ] [PMID: 23679050]
[7]
Le Donne, M.; Caruso, C.; Mancuso, A.; Costa, G.; Iemmo, R.; Pizzimenti, G.; Cavallari, V. The effect of vaginally administered genistein in comparison with hyaluronic acid on atrophic epithelium in postmenopause. Arch. Gynecol. Obstet., 2011, 283(6), 1319-1323.
[http://dx.doi.org/10.1007/s00404-010-1545-7 ] [PMID: 20577750]
[8]
Kokot-Kierepa, M.; Bartuzi, A.; Kulik-Rechberger, B.; Rechberger, T. [Local estrogen therapy--clinical implications--2012 update Ginekol. Pol., 2012, 83(10), 772-777.
[PMID: 23383564]
[9]
Bachmann, G.A.; Nevadunsky, N.S. Diagnosis and treatment of atrophic vaginitis. Am. Fam. Physician, 2000, 61(10), 3090-3096.
[PMID: 10839558]
[10]
Nappi, R.E.; Kokot-Kierepa, M. Women’s voices in the menopause: results from an international survey on vaginal atrophy. Maturitas, 2010, 67(3), 233-238.
[http://dx.doi.org/10.1016/j.maturitas.2010.08.001 ] [PMID: 20828948]
[11]
Griffith, H.W.; Moore, S.W. Complete guide to prescription and nonprescription drugs 2018-2019; Penguin, 2017.
[12]
Jarjani, M. Physiology and pharmacology of estrogens. Razi., 1996, 7(1), 69-76.
[13]
Ekin, M.; Yaşar, L.; Savan, K.; Temur, M.; Uhri, M.; Gencer, I.; Kıvanç, E. The comparison of hyaluronic acid vaginal tablets with estradiol vaginal tablets in the treatment of atrophic vaginitis: a randomized controlled trial. Arch. Gynecol. Obstet., 2011, 283(3), 539-543.
[http://dx.doi.org/10.1007/s00404-010-1382-8 ] [PMID: 20135132]
[14]
Heinrich, M. Ethnobotany and its role in drug development. Phytotherapy research. An Int. J. Devoted Pharmacol. Toxicol. Evaluat. Natural Prod. Derivat., 2000, 14(7), 479-488.
[15]
Mehrafarin, A.; Rezazadeh, S.; Naghdi Badi, H.; Noormohammadi, G.; Zand, E.; Qaderi, A. A review on biology, cultivation and biotechnology of fenugreek (Trigonella foenum-graecum L.) as a valuable medicinal plant and multipurpose. Faslnamah-i Giyahan-i Daruyi, 2011, 1(37), 6-24.
[16]
Chaudhary, S. Review on Fenugreek (Trigonella foenum-graecum L.) and its important secondary metabolite diosgenin. Not. Bot. Horti Agrobot. Cluj-Napoca, 2018, 46(1), 22-31.
[http://dx.doi.org/10.15835/nbha46110996]
[17]
Petit, P.; Sauvaire, Y.; Ponsin, G.; Manteghetti, M.; Fave, A.; Ribes, G. Effects of a fenugreek seed extract on feeding behaviour in the rat: metabolic-endocrine correlates. Pharmacol. Biochem. Behav., 1993, 45(2), 369-374.
[http://dx.doi.org/10.1016/0091-3057(93)90253-P ] [PMID: 8327543]
[18]
Patil, S.P.; Niphadkar, P.V.; Bapat, M.M. Allergy to fenugreek (Trigonella foenum graecum). Ann. Allergy Asthma Immunol., 1997, 78(3), 297-300.
[http://dx.doi.org/10.1016/S1081-1206(10)63185-7 ] [PMID: 9087156]
[19]
Hasanzadeh, E.; Rezazadeh, S.; Shamsa, S.; Dolatabadi, R.; Zarringhalam, J. Review on phytochemistry and therapeutic properties of fenugreek (Trigonella foenum-graceum). Faslnamah-i Giyahan-i Daruyi, 2010, 9(34), 1-18.
[20]
Nikander, E.; Kilkkinen, A.; Metsä-Heikkilä, M.; Adlercreutz, H.; Pietinen, P.; Tiitinen, A.; Ylikorkala, O. A randomized placebo controlled crossover trial with phytoestrogens in treatment of menopause in breast cancer patients. Obstet. Gynecol., 2003, 101(6), 1213-1220.
[PMID: 12798527]
[21]
Ciura, J.; Szeliga, M.; Tyrka, M. Optimization of in vitro culture conditions for accumulation of diosgenin by fenugreek. J. Medicinal Plants Studies, 2015, 3(3), 22-25.
[22]
Yoshikawa, M.; Murakami, T.; Komatsu, H.; Murakami, N.; Yamahara, J.; Matsuda, H. Medicinal foodstuffs. IV. Fenugreek seed. (1): structures of trigoneosides Ia, Ib, IIa, IIb, IIIa, and IIIb, new furostanol saponins from the seeds of Indian Trigonella foenum-graecum L. Chem. Pharm. Bull. (Tokyo), 1997, 45(1), 81-87.
[http://dx.doi.org/10.1248/cpb.45.81 ] [PMID: 9023970]
[23]
Keshavarzi, Z.; Janghorban, R.; Alipour, S.; Tahmasebi, S.; Jokar, A. The effect of vitamin D and E vaginal suppositories on tamoxifeninduced vaginal atrophy in women with breast cancer. Support. Care Cancer, 2019, 27(4), 1325-1334.
[http://dx.doi.org/10.1007/s00520-019-04684-6 ] [PMID: 30729333]
[24]
Mazalzadeh f, hekmat k, namjoyan f, saki ma. Effect of fenugreek vaginal cream on dyspareunia and sexual satisfaction in menopausal women: a randomized clinical trial. Majallah-i Zanan, Mamai va Nazai-i Iran, 2018, 21(3), 22-30.
[25]
Mozaffarian, V. Identification of medicinal and aromatic plants of Iran, 2nd ed; Tehran Farhang Moser, 2015.
[26]
Abedi, P.; Yaralizadeh, M.; Najar, S.; Namjoyan, F.; Saki, A. Effect of Foeniculum vulgare (fennel) vaginal cream on vaginal atrophy in postmenopausal women: a double-blind randomized placebo controlled trial. Maturitas, 2017, 100, 145.
[http://dx.doi.org/10.1016/j.maturitas.2017.03.108]
[27]
Chedraui, P.; Hidalgo, L.; San Miguel, G.; Morocho, N.; Ross, S. Red clover extract (MF11RCE) supplementation and postmenopausal vaginal and sexual health. Int. J. Gynaecol. Obstet., 2006, 95(3), 296-297.
[http://dx.doi.org/10.1016/j.ijgo.2006.08.013 ] [PMID: 17007858]
[28]
Urasopon, N.; Hamada, Y.; Asaoka, K.; Cherdshewasart, W.; Malaivijitnond, S. Pueraria mirifica, a phytoestrogen-rich herb, prevents bone loss in orchidectomized rats. Maturitas, 2007, 56(3), 322-331.
[http://dx.doi.org/10.1016/j.maturitas.2006.09.007 ] [PMID: 17101247]
[29]
Leiblum, S.R.; Hayes, R.D.; Wanser, R.A.; Nelson, J.S. Vaginal dryness: a comparison of prevalence and interventions in 11 countries. J. Sex. Med., 2009, 6(9), 2425-2433.
[http://dx.doi.org/10.1111/j.1743-6109.2009.01369.x ] [PMID: 19627461]
[30]
Simon, J.; Nachtigall, L.; Gut, R.; Lang, E.; Archer, D.F.; Utian, W. Effective treatment of vaginal atrophy with an ultra-low-dose estradiol vaginal tablet. Obstet. Gynecol., 2008, 112(5), 1053-1060.
[http://dx.doi.org/10.1097/AOG.0b013e31818aa7c3 ] [PMID: 18978105]
[31]
Sreeja, S.; Anju, V.S.; Sreeja, S. In vitro estrogenic activities of fenugreek Trigonella foenum graecum seeds. Indian J. Med. Res., 2010, 131(6), 814-819.
[PMID: 20571172]
[32]
Abedinzade, M.; Nasri, S.; Jamal Omodi, M.; Ghasemi, E.; Ghorbani, A. Efficacy of Trigonella foenum-graecum seed extract in reducing metabolic and inflammatory alterations associated with menopause. Iran. Red Crescent Med. J., 2015, 17(11), e26685.
[http://dx.doi.org/10.5812/ircmj.26685 ] [PMID: 26732240]
[33]
Hakimi s mohammad acs siahi sm bamdad mr abbasalizadeh f mustafa gp. Effect of Fenugreek seed on early menopausal symptoms. Pharmaceut. Sci., 2005, (2), 83-90.
[34]
Hakimi, S.; Mohammad Alizadeh, S.; Delazar, A.; Abbasalizadeh, F.; Bamdad Mogaddam, R.; Siiahi, M. Probable effects of fenugreek seed on hot flash in menopausal women. Faslnamah-i Giyahan-i Daruyi, 2006, 3(19), 9-14.
[35]
Krum, H.; Schlaich, M.; Whitbourn, R.; Sobotka, P.A.; Sadowski, J.; Bartus, K.; Kapelak, B.; Walton, A.; Sievert, H.; Thambar, S.; Abraham, W.T.; Esler, M. Catheter-based renal sympathetic denervation for resistant hypertension: a multicentre safety and proof-of-principle cohort study. Lancet, 2009, 373(9671), 1275-1281.
[http://dx.doi.org/10.1016/S0140-6736(09)60566-3 ] [PMID: 19332353]
[36]
Pant, N.C. Fenugreek (Trigonella foenum-graecum L.) A potential source of dietary fibres and steroidal sapogenin (Diosgenin). IJCS, 2018, 6(2), 612-618.
[37]
Yeung, S.; Soliternik, J.; Mazzola, N. Nutritional supplements for the prevention of diabetes mellitus and its complications. J. Nutr. Intermed. Metab., 2018.
[http://dx.doi.org/10.1016/j.jnim.2018.07.003]
[38]
Steels, E.; Steele, M.L.; Harold, M.; Coulson, S. Efficacy of a proprietary Trigonella foenum‐graecum L de‐husked seed extract in reducing menopausal symptoms in otherwise healthy women: a double‐blind, randomized, placebo‐controlled study. Phytother. Res., 2017, 31(9), 1316-1322.
[http://dx.doi.org/10.1002/ptr.5856 ] [PMID: 28707431]
[39]
Mills, S.; Bone, K. Principles and practice of phytotherapy; Churchill Livingstone: Oxford, 2000.
[40]
Rijkens, F.; Boelens, H. Future of aroma research. Proc. Int. Sympos. Aroma Res., 1975.
[41]
Freitas, A.I.; Pereira, V.; Leça, J.M.; Pereira, A.C.; Albuquerque, F.; Marques, J.C. A simple emulsification-assisted extraction method for the GC-MS/SIM analysis of wine markers of aging and oxidation: application for studying micro-oxygenation in madeira wine. Food Anal. Methods, 2018, 11(8), 2056-2065.
[http://dx.doi.org/10.1007/s12161-018-1176-3]

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