Generic placeholder image

Current Pharmaceutical Design

Author(s): Pasquale De Franciscis*, Anna Conte, Antonio Schiattarella, Gaetano Riemma, Luigi Cobellis and Nicola Colacurci

DOI: 10.2174/1381612826666200721002022

DownloadDownload PDF Flyer Cite As
Non-hormonal Treatments For Menopausal Symptoms and Sleep Disturbances: A Comparison Between Purified Pollen Extracts and Soy Isoflavones

Page: [4509 - 4514] Pages: 6

  • * (Excluding Mailing and Handling)

Abstract

Background: Besides hot-flushes, sleep disturbances increase around menopause, impacting on the quality of life. When hormone replacement therapy is contraindicated, it is necessary to provide alternative treatments.

Objectives: This study aimed to observe the effects of an herbal remedy from pollen extracts and soy isoflavones for menopausal complaints, particularly on sleep disorders.

Methods: A six-month prospective observational study was performed in women in natural menopause suffering from menopausal symptoms and sleep disturbances. Three groups were compared: 57 women receiving two tablets/ day containing herbal remedy from pollen extracts (group A), 60 women receiving one tablet/day containing isoflavones 60 mg (group B), 47 women not receiving any treatment (group C). At 3 (T3) and 6 months (T6), the daily number of hot-flushes, Kupperman index for menopausal symptoms, the Pittsburgh Sleep Quality Index (PSQI) test were assessed.

Results: Both groups A and B showed a significant improvement of hot flushes (p<0.001) and Kuppermann Index (p<0.001) from T0 to T3 and from T0 to T6. No significant differences between treatment groups were found at T3, while at T6 group A showed greater decrease of daily hot flashes and better improvement of Kupperman Index as compared to group B (respectively, -48.8% versus -18.4% and -24.4% versus -15.4%; p<0.001). Improvement of global sleep quality was more evident in the pollen treated group compared to isoflavones group at both three (-24.7% versus -9.3%, p<0.001) and six (-52.9% vs -4.0%; p<0.001) months, mainly for the scores related to subjective sleep quality, sleep latency and habitual sleep efficiency.

Conclusion: Non-hormonal treatments can effectively be used in symptomatic menopausal women: among these, after six months of treatment, pollen extracts might achieve a better improvement of hot flushes, sleep disturbances and menopause-related symptoms than soy isoflavones. Herbal remedy from pollen extracts is mainly effective when the quality of sleep is the most disturbing complaint.

Keywords: Menopausal symptoms, hot flushes, sleep disturbances, PSQI, isoflavones, pollen extracts.

[1]
Bruyneel M. Sleep disturbances in menopausal women: Aetiology and practical aspects. Maturitas 2015; 81(3): 406-9.
[http://dx.doi.org/10.1016/j.maturitas.2015.04.017] [PMID: 26002789]
[2]
Xu Q, Lang CP. Examining the relationship between subjective sleep disturbance and menopause: a systematic review and meta-analysis. Menopause 2014; 21(12): 1301-18.
[http://dx.doi.org/10.1097/GME.0000000000000240] [PMID: 24800878]
[3]
The NAMS 2017 Hormone Therapy Position Statement Advisory Panel. The 2017 hormone therapy position statement of The North American Menopause Society. Menopause 2017; 24(7): 728-53.
[http://dx.doi.org/10.1097/GME.0000000000000921] [PMID: 28650869]
[4]
Nonhormonal management of menopause-associated vasomotor symptoms: 2015 position statement of The North American Menopause Society. Menopause 2015; 22(11): 1155-72.
[http://dx.doi.org/10.1097/GME.0000000000000546] [PMID: 26382310]
[5]
Rabin DS, Cipparrone N, Linn ES, Moen M. Why menopausal women do not want to take hormone replacement therapy. Menopause 1999; 6(1): 61-7.
[http://dx.doi.org/10.1097/00042192-199906010-00012] [PMID: 10100182]
[6]
Panay N. Integrating phytoestrogens with prescription medicines-a conservative clinical approach to vasomotor symptom management. Maturitas 2007; 57(1): 90-4.
[http://dx.doi.org/10.1016/j.maturitas.2007.02.017] [PMID: 17383125]
[7]
Albertazzi P, Steel SA, Clifford E, Bottazzi M. Attitudes towards and use of dietary supplementation in a sample of postmenopausal women. Climacteric 2002; 5(4): 374-82.
[http://dx.doi.org/10.1080/cmt.5.4.374.382] [PMID: 12626217]
[8]
Mahady GB, Parrot J, Lee C, Yun GS, Dan A. Botanical dietary supplement use in peri- and postmenopausal women. Menopause 2003; 10(1): 65-72.
[PMID: 12544679]
[9]
Lethaby A, Marjoribanks J, Kronenberg F, Roberts H, Eden J, Brown J. Phytoestrogens for menopausal vasomotor symptoms. Cochrane Database Syst Rev 2013; (12): CD001395
[PMID: 24323914]
[10]
Colacurci N, De Franciscis P, Atlante M, et al. Endometrial, breast and liver safety of soy isoflavones plus Lactobacillus sporogenes in post-menopausal women. Gynecol Endocrinol 2013; 29(3): 209-12.
[http://dx.doi.org/10.3109/09513590.2012.738724] [PMID: 23194023]
[11]
Vitale SG, Caruso S, Rapisarda AMC, Cianci S, Cianci A. Isoflavones, calcium, vitamin D and inulin improve quality of life, sexual function, body composition and metabolic parameters in menopausal women: result from a prospective, randomized, placebocontrolled, parallel-group study Prz menopauzalny = Menopause Rev 2018; 17(1): 32-8.
[http://dx.doi.org/10.5114/pm.2018.73791]
[12]
Gerhardsen G, Hansen AV, Killi M, Fornitz GG, Pedersen F, Roos SB. The efficacy of Femal in women with premenstrual syndrome: a randomised, double-blind, parallel-group, placebo-controlled, multicentre study. Adv Ther 2008; 25(6): 595-607.
[http://dx.doi.org/10.1007/s12325-008-0072-4] [PMID: 18568441]
[13]
Eriksson E, Hedberg MA, Andersch B, Sundblad C. The serotonin reuptake inhibitor paroxetin is superior to the noradrenaline reuptake inhibitor maprotiline in the treatment of premenstrual syndrome. Neuropsychopharmacology 1995; 12(2): 167-76.
[http://dx.doi.org/10.1016/0893-133X(94)00076-C] [PMID: 7779245]
[14]
Freeman EW, Rickels K, Sondheimer SJ, Polansky M, Xiao S. Continuous or intermittent dosing with sertraline for patients with severe premenstrual syndrome or premenstrual dysphoric disorder. Am J Psychiatry 2004; 161(2): 343-51.
[http://dx.doi.org/10.1176/appi.ajp.161.2.343] [PMID: 14754784]
[15]
Riemma G, Schiattarella A, La Verde M, et al. Efficacy of Low-Dose Paroxetine for the Treatment of Hot Flushes in Surgical and Physiological Postmenopausal Women: Systematic Review and Meta-Analysis of Randomized Trials. Medicina (Kaunas) 2019; 55(9)E554
[http://dx.doi.org/10.3390/medicina55090554] [PMID: 31480427]
[16]
Hellström A-C, Muntzing J. The pollen extract Femal-a nonestrogenic alternative to hormone therapy in women with menopausal symptoms. Menopause 2012; 19(7): 825-9.
[http://dx.doi.org/10.1097/gme.0b013e31824017bc] [PMID: 22334059]
[17]
Winther K, Rein E, Hedman C. Femal, a herbal remedy made from pollen extracts, reduces hot flushes and improves quality of life in menopausal women: a randomized, placebo-controlled, parallel study. Climacteric 2005; 8(2): 162-70.
[http://dx.doi.org/10.1080/13697130500117987] [PMID: 16096172]
[18]
Fait T, Sailer M, Regidor P-A. Prospective observational study to evaluate the efficacy and safety of the pollen extract Sérélys® in the management of women with menopausal symptoms. Gynecol Endocrinol 2019; 35(4): 360-3.
[http://dx.doi.org/10.1080/09513590.2018.1538347] [PMID: 30741042]
[19]
Paszkowski T, Skrzypulec-Plinta V. Assessment of quality of life in women using Femelis Meno Prz menopauzalny = Menopause Rev 2018; 17(2): 77-85..
[http://dx.doi.org/10.5114/pm.2018.77306]
[20]
De Franciscis P, Grauso F, Luisi A, Schettino MT, Torella M, Colacurci N. Adding Agnus Castus and Magnolia to Soy Isoflavones Relieves Sleep Disturbances Besides Postmenopausal Vasomotor Symptoms-Long Term Safety and Effectiveness. Nutrients 2017; 9(2)E129
[http://dx.doi.org/10.3390/nu9020129] [PMID: 28208808]
[21]
von Elm E, Altman DG, Egger M, Pocock SJ, Gøtzsche PC, Vandenbroucke JP. STROBE Initiative. The Strengthening the Reporting of Observational Studies in Epidemiology (STROBE) statement: guidelines for reporting observational studies. Lancet 2007; 370(9596): 1453-7.
[http://dx.doi.org/10.1016/S0140-6736(07)61602-X] [PMID: 18064739]
[22]
Ameratunga D, Goldin J, Hickey M. Sleep disturbance in menopause. Intern Med J 2012; 42(7): 742-7.
[http://dx.doi.org/10.1111/j.1445-5994.2012.02723.x] [PMID: 22288870]
[23]
De Franciscis P, Colacurci N, Riemma G, et al. A Nutraceutical Approach to Menopausal Complaints. Medicina (Kaunas) 2019; 55(9): 544.
[http://dx.doi.org/10.3390/medicina55090544] [PMID: 31466381]
[24]
Ohayon MM. Severe hot flashes are associated with chronic insomnia. Arch Intern Med 2006; 166(12): 1262-8.
[http://dx.doi.org/10.1001/archinte.166.12.1262] [PMID: 16801508]
[25]
Lampio L, Saaresranta T, Polo O, Polo-Kantola P. Subjective sleep in premenopausal and postmenopausal women during workdays and leisure days: a sleep diary study. Menopause 2013; 20(6): 655-60.
[http://dx.doi.org/10.1097/gme.0b013e31827ae954] [PMID: 23321945]
[26]
Archer DF, Sturdee DW, Baber R, et al. Menopausal hot flushes and night sweats: where are we now? Climacteric 2011; 14(5): 515-28.
[http://dx.doi.org/10.3109/13697137.2011.608596] [PMID: 21848495]
[27]
Freedman RR. Menopausal hot flashes: mechanisms, endocrinology, treatment. J Steroid Biochem Mol Biol 2014; 142: 115-20.
[http://dx.doi.org/10.1016/j.jsbmb.2013.08.010] [PMID: 24012626]
[28]
De Franciscis P, Cobellis L, Fornaro F, Sepe E, Torella M, Colacurci N. Low-dose hormone therapy in the perimenopause. Int J Gynaecol Obstet 2007; 98(2): 138-42.
[http://dx.doi.org/10.1016/j.ijgo.2007.04.008] [PMID: 17572422]