Efficacy of Wash Gel Containing Pueraria Mirifica Root Extract on External Genital Care of Vulvovaginal Atrophy Bearing Postmenopausal Women
Article Sidebar
Main Article Content
Abstract
Objective: To investigate the efficacy of a wash gel containing Pueraria mirifica root extract for external genital care in postmenopausal women bearing vulvovaginal atrophy. Methods: The study was a double-blind, randomized controlled trial with 72 participants, evenly divided into an experimental group and a control group. The experimental group used a wash gel containing Pueraria mirifica root extract and aloe vera at a daily dose of 20 milligrams of Pueraria mirifica, while the control group used a wash gel containing aloe vera. Both groups used the wash gel for external genital care twice a day for a 12-week period. The researchers conducted face-to-face interviews to assess the condition of external genital skin, vulva symptoms and vaginal symptoms before and after the use of the wash gel for at 4 and 12 weeks. Results: At the end of the study, both groups experienced a statistically significant reduction in symptoms associated with vulvovaginal atrophy, including dryness and erythema of the external genital skin, itching/irritation, and dyspareunia, compared to those at the pre-study period (P < 0.05). Moreover, the experiment group demonstrated significantly greater improvements in external genital skin and symptoms associated with vulvovaginal atrophy compared to the control group (P < 0.05). However, there was no statistically significant difference between the two groups regarding vaginal soreness (P =0.10). Both the experimental and control groups expressed satisfaction with the product and reported only minor side effects, such as slight irritation during applying. Conclusion: Use of the wash gel containing Pueraria mirifica root extract and aloe vera, at a daily dose of 20 milligrams of Pueraria mirifica, is a safe and effective approach to enhancing the health of external genital skin and relieving symptoms linked to vulvovaginal atrophy in postmenopausal women. This approach proves more effective than utilizing the wash gel containing only aloe vera without the extract.
Article Details
This work is licensed under a Creative Commons Attribution-NonCommercial-NoDerivatives 4.0 International License.
ผลการวิจัยและความคิดเห็นที่ปรากฏในบทความถือเป็นความคิดเห็นและอยู่ในความรับผิดชอบของผู้นิพนธ์ มิใช่ความเห็นหรือความรับผิดชอบของกองบรรณาธิการ หรือคณะเภสัชศาสตร์ มหาวิทยาลัยสงขลานครินทร์ ทั้งนี้ไม่รวมความผิดพลาดอันเกิดจากการพิมพ์ บทความที่ได้รับการเผยแพร่โดยวารสารเภสัชกรรมไทยถือเป็นสิทธิ์ของวารสารฯ
References
Alvisi S, Gava G, Orsili I, Giacomelli G, Baldassarre M, Seracchioli R, et al. Vaginal health in menopausal women. Medicina 2019; 55: 615.
Suwanrattanadech S, Lertbunnaphong T, Boriboonhi runsarn D. Use of feminine hygiene products in Thai women. Siriraj Med J 2011; 63: 111–4.
Nappi RE, Palacios S, Panay N, Particco M, Krychman ML. Vulvar and vaginal atrophy in four European countries: evidence from the European REVIVE Survey. Climacteric 2016; 19: 188–97.
Choombuathong A. Pueraria mirifica: Queen of Thai herb. Journal of Science and Technology Mahasara kham University 2014; 34: 202–9.
Chattuwatthana T, Okello E. Anti-collagenase, anti-elastase and antioxidant activities of Pueraria candollei var. mirifica root extract and Coccinia grandis fruit juice extract: An in vitro study. Eur J Med Plants 2014; 318–27.
Chandeying V, Lamlertkittikul S. Challenges in the conduct of Thai herbal scientific study: efficacy and safety of phytoestrogen, Pueraria mirifica (Kwao Keur Kao), phase I, in the alleviation of climacteric symptoms in perimenopausal women. J Med Assoc Thai 2007; 90: 1274–80.
Lamlertkittikul S, Chandeying V. Efficacy and safety of Pueraria mirifica (Kwao Kruea Khao) for the treatment of vasomotor symptoms in perimeno pausal women: Phase II Study. J Med Assoc Thai 2004; 87: 33–40.
Virojchaiwong P, Suvithayasiri V, Itharat A. Compa- rison of Pueraria mirifica 25 and 50 mg for menopausal symptoms. Arch Gynecol Obstet 2011; 284: 411–9.
Chandeying V, Sangthawan M. Efficacy comparison of Pueraria mirifica (PM) against conjugated equine estrogen (CEE) with/without medroxyprogesterone acetate (MPA) in the treatment of climacteric symptoms in perimenopausal women: phase III study. J Med Assoc Thai 2007; 90: 1720–6.
Manonai J, Chittacharoen A, Theppisai U, Theppisai H. Effect of Pueraria mirifica on vaginal health. Menopause 2007; 14: 919–24.
Suwanvesh N, Manonai J, Sophonsritsuk A, Cherd shewasart W. Comparison of Pueraria mirifica gel and conjugated equine estrogen cream effects on vaginal health in postmenopausal women. Menopause 2017; 24: 210–5.
Poordast T, Ghaedian L, Ghaedian L, Najib FS, Alipour S, Hosseinzadeh M, et al. Aloe Vera; A new treatment for atrophic vaginitis, A randomized double-blinded controlled trial. J Ethnopharmacol 2021; 270: 113760.
Jenkins A, Money D, O’Doherty KC. Is the vaginal cleansing product industry causing harm to women? [editorial] Expert Rev Anti Infect Ther 2021; 19: 267–9.
Bruning E, Chen Y, McCue KA, Rubino JR, Wilkin son JE, Brown ADG. A 28 day clinical assessment of a lactic acid-containing antimicrobial intimate gel wash formulation on skin tolerance and impact on the vulvar microbiome. Antibiotics (Basel) 2020; 9: 55.
Fleiss JL, Levin B, Paik MC. Statistical methods for rates and proportions. 3rd ed. Hoboken, NJ: John Wiley; 2003.
Rosner B. Fundamentals of biostatistics. 5th ed. Pacific Grove, CA: Duxbury; 2000.
Sinnithithaworn N, Salung L, Pratipannawat S. Efficacy of low-dose (0.3 mg) conjugated estrogen cream for managing atrophic vaginitis. Thai J. Obstet. Gynaecol 2013; 21: 182–9.
Ungphaiboon S, Duangkhae M, Sungkharak S. Development of feminine hygiene wash gel containing Pueraria mirifica root extract [independent study]. Songkhla: Faculty of Pharmaceutical Sciences, Prince of Songkla University; 2019.
Ettinger B, Hait H, Reape KZ, Shu H. Measuring symptom relief in studies of vaginal and vulvar atrophy: the most bothersome symptom approach. Menopause 2008; 15: 885–9.
Eaton AA, Baser RE, Seidel B, Stabile C, Canty JP, Goldfrank DJ, et al. Validation of clinical tools for vaginal and vulvar symptom assessment in cancer patients and survivors. J Sex Med 2017; 14: 144–51.
Kingston A. The postmenopausal vulva. Obstet Gynaecol 2009; 11: 253–9.
Thai Food and Drug Administration. Manual for using the National List of Essential Medicines for Herbs B.E. 2564. Phra Nakhon Si Ayutthaya, Thailand: Greatest Company; 2022.
Chen Y, Bruning E, Rubino J, Eder SE. Role of female intimate hygiene in vulvovaginal health: Global hygiene practices and product usage. Women’s Health 2017; 13: 58–67.
Thai Food and Drug Administration. Criteria for considering notification of cosmetics (revised version B.E. 2564) [online]. 2021 [cited Aug 29, 2023]. Available from: cosmetic.fda.moph.go.th/permission-for-cosmetics/category/criteria-for-considering.
