The effect of vaginal cream containing herbal extracts (Foeniculum vulgare, Salvia officinalis and Flaxseed) on the mental symptoms of vaginal atrophy in postmenopausal women: A randomized controlled clinical trial

Document Type : Original Article

Authors

1 M.Sc. in Midwifery, Student Research Committee, School of Nursing & Midwifery, Shahid Beheshti University of Medical Sciences, Tehran, Iran.

2 Instructor, Department of Midwifery and Reproductive Health, Midwifery and Reproductive Health Research Center, School of Nursing and Midwifery, Shahid Beheshti University of Medical Sciences, Tehran, Iran.

3 Assistant professor, Department of Pharmacongnosy, Research Center for Traditional Medicine and History of Medicine, School of Pharmacy, Shiraz University of Medical Sciences, Shiraz, Iran.

4 Assistant professor, Department of Biostatistics, School of Nursing and Midwifery, Shahid Beheshti University of Medical Sciences, Tehran, Iran.

5 Student of Electrical engineering, Student Research Committee, School of Electrical and Computer Engineering, Semnan University, Semnan, Iran.

Abstract

Introduction: Most menopausal women experience changes due to decreased estrogen secretion. Vaginal atrophy is one of the most common changes during menopause. This study was performed with aim to determine the effect of vaginal cream containing herbal extract (Foeniculum vulgare, Salvia officinalis and Flaxseed) on mental symptoms of vaginal atrophy in postmenopausal women.
Methods: The triple-blind clinical trial study was performed in 2019 on 60 postmenopausal women with symptoms of vaginal atrophy referred to the selected health centers in Ahvaz, Iran. The subjects were randomly divided into two groups of 30 women to receive vaginal cream containing herbal extract (Foeniculum vulgare, Salvia officinalis and Flaxseed) and placebo for eight weeks. Mental symptoms of vaginal atrophy including dryness, burning and itching, vaginal pain and pain during intercourse were assessed using the most bothersome symptom (MBS) checklist before the intervention and two, four and eight weeks after the treatment. Data were analyzed by SPSS software (version 22) and Mann-Whitney, Friedman and independent t-test. P<0.05 was considered statistically significant.
Results: After treatment with the vaginal cream containing herbal extracts (Foeniculum vulgare, Salvia officinalis and Flaxseed) in the intervention group, the mental symptoms of vaginal atrophy significantly reduced compared to the beginning of the study (P<0.001). The vaginal cream containing herbal extracts (Foeniculum vulgare, Salvia officinalis and Flaxseed) compared to placebo cream significantly reduced the mental symptoms of vaginal atrophy in postmenopausal women after two weeks (P=0.046), four weeks (P<0.000) and eight weeks (P<0.000).
Conclusion: The use of vaginal cream containing herbal extracts (Foeniculum vulgare, Salvia officinalis and Flaxseed) compared with placebo cream reduces the symptoms of vaginal atrophy in postmenopausal women. Therefore, this cream is recommended for women with vaginal atrophy.

Keywords


  1. Taylor HS, Pal L, Sell E. Speroff's clinical gynecologic endocrinology and infertility. Lippincott Williams & Wilkins; 2019.
  2. Nackers LM, Appelhans BM, Segawa E, Janssen I, Dugan SA, Kravitz HM. Associations between body mass index and sexual functioning in midlife women: The Study of Women’s Health Across the Nation (SWAN). Menopause (New York, NY) 2015; 22(11):1175.
  3. Noroozi E, Miri MR, Gol Mohammadi S. Application of behavioral analysis phase of PRECEDE model for quality of life survey in postmenopausal women in Birjand. Journal of Birjand University of Medical Sciences 2012; 19(3):312-23.
  4. Nobahar M, Vafaaee A. Elderly sleep disturbances and management. Geriatric 2007; 2(4):263-8.
  5. Labrie F, Martel C, Pelletier G. Is vulvovaginal atrophy due to a lack of both estrogens and androgens?. Menopause 2017; 24(4):452-61.
  6. Naumova I, Castelo-Branco C. Current treatment options for postmenopausal vaginal atrophy. International journal of women's health 2018; 10:387.
  7. Minkin MJ, Reiter S, Maamari R. Prevalence of postmenopausal symptoms in North America and Europe. Menopause 2015; 22(11):1231-8.
  8. Palma F, Xholli A, Cagnacci A. The most bothersome symptom of vaginal atrophy: Evidence from the observational AGATA study. Maturitas 2018; 108:18-23.
  9. Lindahl SH. Reviewing the options for local estrogen treatment of vaginal atrophy. International journal of women's health 2014; 6:307.
  10. Nappi RE, Martini E, Cucinella L, Martella S, Tiranini L, Inzoli A, et al. Addressing vulvovaginal atrophy (VVA)/genitourinary syndrome of menopause (GSM) for healthy aging in women. Frontiers in endocrinology 2019; 10:561.
  11. Briggs P. Genitourinary syndrome of menopause. Post reproductive health 2020; 26(2):111-4.
  12. Sánchez-Borrego R, Manubens M, Navarro MC, Cancelo MJ, Beltrán E, Duran M, et al. Position of the Spanish Menopause Society regarding vaginal health care in postmenopausal women. Maturitas 2014; 78(2):146-50.
  13. Gandhi J, Chen A, Dagur G, Suh Y, Smith N, Cali B, et al. Genitourinary syndrome of menopause: an overview of clinical manifestations, pathophysiology, etiology, evaluation, and management. American journal of obstetrics and gynecology. 2016; 215(6):704-11.
  14. Ee C, Xue C, Chondros P, Myers SP, French SD, Teede H, et al. Acupuncture for menopausal hot flashes: a randomized trial. Annals of internal medicine 2016; 164(3):146-54.
  15. Caruso S, Cianci S, Fava V, Rapisarda A, Cutello S, Cianci A. Vaginal health of postmenopausal women on nutraceutical containing equol. Menopause 2018; 25(4):430-5.
  16. Fait T. Menopause hormone therapy: latest developments and clinical practice. Drugs in context 2019; 8.
  17. Hamza TM, Camplese LR. Phytoestrogens in Breast Cancer. Worcester Polytechnic Institute; 2020. p.4-16.
  18. Kargozar R, Azizi H, Salari R. A review of effective herbal medicines in controlling menopausal symptoms. Electronic physician 2017; 9(11):5826.
  19. Moskalets TZ, Moskalets VV, Vovkohon АH, Shevchuk ОА, Matviichuk ОА. Modern breeding and cultivation of unpopular fruits and berries in Ukraine. Ukrainian Journal of Ecology 2019; 9(3).
  20. Viljoen A, Combrinck S, Vermaak I, Sandasi M. The application of classic and modern pharmacognosy in monographing African traditional medicines–a botanical travelogue. Planta Medica 2019; 85(18):PL-09.
  21. Heydarpour S, Sharifipour F, Salari N. Effect of aromatherapy using Salvia officinalis on sleep quality of postmenopausal women. Iran J Obstet Gynecol Infertil 2020; 23(3):50-7.
  22. Mirghafourvand M, Charandabi SM, Javadzadeh Y, Ahmadpour P. Comparing the effects of vitexagnus and flaxseed on premenstrual symptoms: A randomized controlled trial. Hayat 2015; 21(1):68-78.
  23. Yaralizadeh M, Abedi P, 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 2016; 84:75-80.
  24. Dadfar F, Bamdad K. The effect of Saliva officinalis extract on the menopausal symptoms in postmenopausal women: An RCT. International Journal of Reproductive BioMedicine 2019; 17(4):287.
  25. Cetisli NE, Saruhan A, Kivcak B. The effects of flaxseed on menopausal symptoms and quality of life. Holistic nursing practice 2015; 29(3):151-7.
  26. US Department of Health and Human Services. Estrogen and estrogen/progestin drug products to treat vasomotor symptoms and vulvar and vaginal atrophy symptoms–recommendations for clinical evaluation: Draft guidance. Rockville: Food and Drug Administration Center for Drug Evaluation and Research (CDER) 2003.
  27. US Department of Health and Human Services FDA Center for Drug Evaluation and Research laurie. burke@ fda. hhs. gov, US Department of Health and Human Services FDA Center for Biologics Evaluation and Research toni. stifano@ fda. hhs. gov, US Department of Health and Human Services FDA Center for Devices and Radiological Health SXD@ cdrh. fda. gov. Guidance for industry: patient-reported outcome measures: use in medical product development to support labeling claims: draft guidance. Health and Quality of Life Outcomes 2006; 4:1-20.
  28. Erekson EA, Yip SO, Wedderburn TS, Martin DK, Li FY, Choi JN, et al. The VSQ: a questionnaire to measure vulvovaginal symptoms in postmenopausal women. Menopause (New York, NY) 2013; 20(9):973.
  29. Weber MA, Limpens J, Roovers JP. Assessment of vaginal atrophy: a review. International urogynecology journal 2015; 26(1):15-28.
  30. Greendale GA, Zibecchi L, Petersen L, Ouslander JG, Kahn B, Ganz PA. Development and validation of a physical examination scale to assess vaginal atrophy and inflammation. Climacteric 1999; 2(3):197-204.
  31. Mazalzadeh F, Hekmat K, Namjoyan F, SakiMalehi A. Effect of fenugreek vaginal cream on dyspareunia and sexual satisfaction in menopausal women: a randomized clinical trial. Iran J Obstet Gynecol Infertil 2018; 21(3):22-30.
  32. Mac Bride MB, Rhodes DJ, Shuster LT. Vulvovaginal atrophy. InMayo Clinic Proceedings 2010; 85(1):87-94.
  33. Hejazi ZA, Namjooyan F, Abbaspour MR, Azemi ME. Preparation and evaluation of Flax Seed, Foeniculum Vulgare and Salvia officinalis extracts topical cream [doctorate Thesis]: Ahvaz Jundishapur University of Medical Sciences School of Pharmacy http://centlib.ajums.ac.ir/faces/search/bibliographic/biblioFullView.jspx?_afPfm=w18m470l6; 1396.
  34. Yildirim B, Kaleli B, Düzcan E, Topuz O. The effects of postmenopausal Vitamin D treatment on vaginal atrophy. Maturitas 2004; 49(4):334-7.
  35. Krychman ML. Vaginal estrogens for the treatment of dyspareunia. The journal of sexual medicine 2011; 8(3):666-74.
  36. de Biazi Andreotti JD, Lima SM, Endo CM, Bernardo BF, Scorzelli AC, Fortunato FG, et al. Estudo da microbiota vaginal em mulheres após a menopausa com o uso de isoflavonas via vaginal/Vaginal microbiota in postmenopausal women with vaginal isoflavones. Arquivos Médicos dos Hospitais e da Faculdade de Ciências Médicas da Santa Casa de São Paulo 2014; 59(3):110-6.
  37. Abbaspoor Z, Ziagham S, Abbaspour MR. The comparison between the effects of hyaluronic acid vaginal suppository and vitamin E on the treatment of atrophic vaginitis in menopausal women. Maturitas 2015; 81(1):160-1.
  38. Sadeghi M, Abbaspoor Z, Namjouyan F, Cheraghian B. Effect of Glycyrrhiza glabra vaginal cream on the mental symptoms of vaginal atrophy in postmenopausal women. Iran J Obstet Gynecol Infertil 2018; 21(4):53-61.
  39. Brito J, LCSW, CST, Holland K. What Causes a Sore Vaginal Area After Sex? Available at: https://www.healthline.com/health/sore-vagina-after-sex; 2019.
  40. Tanmahasamut P, Jirasawas T, Laiwejpithaya S, Areeswate C, Dangrat C, Silprasit K. Effect of estradiol vaginal gel on vaginal atrophy in postmenopausal women: A randomized double‐blind controlled trial. Journal of Obstetrics and Gynaecology Research 2020; 46(8):1425-35.
  41. Kao A, Binik YM, Kapuscinski A, Khalifé S. Dyspareunia in postmenopausal women: a critical review. Pain Research and Management 2008; 13(3):243-54.
  42. Bosak Z, Iravani M, Moghimipour E, Haghighizadeh MH, Jelodarian P. Evaluation of the effect of chamomile vaginal gel on subjective symptoms of vaginal atrophy in postmenopausal women: a randomized clinical controlled trial. Iran J Obstet Gynecol Infertil 2019; 22(7):23-31.
  43. Suwanvesh N, Manonai J, Sophonsritsuk A, Cherdshewasart W. Comparison of Pueraria mirifica gel and conjugated equine estrogen cream effects on vaginal health in postmenopausal women. Menopause 2017; 24(2):210-5