Journal of Food and Nutrition Research
ISSN (Print): 2333-1119 ISSN (Online): 2333-1240 Website: https://www.sciepub.com/journal/jfnr Editor-in-chief: Prabhat Kumar Mandal
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Journal of Food and Nutrition Research. 2022, 10(7), 496-502
DOI: 10.12691/jfnr-10-7-8
Open AccessArticle

Treatment of Postmenopausal Syndrome with UBPN01: A Randomized, Double-blind, Placebo-controlled Study

Jeong Eun Kwon1, Yeong-Geun Lee1, Tae Hee Kim1, Gyoungok Gang2, Gokce Altun2, Farzana Mushtaq Ahmed3, Narayanaswamy Venkatappa4, Hyukjin Kwon5, Jihyeong Park5 and Se Chan Kang1,

1Department of Oriental Medicine and Biotechnology, Kyung Hee University, Giheung-gu, Yongin 17104, Republic of Korea

2ResearchMentor, 909 SK V1 tower #905, Yeonmujang 5 ga-gil 25, Seongdong-gu, Seoul 04782, Republic of Korea

3Santosh Hospital. 6/1, Promenade Road, near Coles park, Bengaluru 560005, India

4Vagus Super Specialty Hospital, #6-8 18th Cross, Malleshwaram, Bengaluru 560003, India

5UNDBIO Co., Ltd. #1101, 91, Changnyong-daero 256 beon-gil 77, Suwon 16229, Republic of Korea

Pub. Date: July 19, 2022

Cite this paper:
Jeong Eun Kwon, Yeong-Geun Lee, Tae Hee Kim, Gyoungok Gang, Gokce Altun, Farzana Mushtaq Ahmed, Narayanaswamy Venkatappa, Hyukjin Kwon, Jihyeong Park and Se Chan Kang. Treatment of Postmenopausal Syndrome with UBPN01: A Randomized, Double-blind, Placebo-controlled Study. Journal of Food and Nutrition Research. 2022; 10(7):496-502. doi: 10.12691/jfnr-10-7-8

Abstract

This study evaluated the efficacy of UBPN01 (Salvia miltiorrhiza extract) for alleviating menopausal syndrome. This study was a randomized, double-blind, placebo-controlled clinical trial involving female subjects (40 – 60 years) with menopausal syndrome. Subjects were administered 600 mg/day UBPN01 or placebo, and efficacy endpoints were menopausal symptoms according to the total Kupperman Index (KI) score and individual categories. After 12 weeks, the total KI scores decreased and depression and vaginal dryness symptoms improved, especially in UBPN01 compared to placebo. Moreover, we observed no significant difference between the two groups in estradiol, follicle stimulating hormone, or luteinizing hormone. These results demonstrated that UBPN01 alleviates menopausal symptoms without notable side effects and improves quality of life, suggesting its efficacy as an alternative supplement for women ineligible for hormone therapy.

Keywords:
postmenopausal syndrome clinical trial Salvia miltiorrhiza KI

Creative CommonsThis work is licensed under a Creative Commons Attribution 4.0 International License. To view a copy of this license, visit http://creativecommons.org/licenses/by/4.0/

References:

[1]  Nelson, H.D. Menopause. Lancet. Elsevier Publishers. 760-770.
 
[2]  Avis, N.E, Stellato, R, Crawford, S, Bromberger, J, Ganz, P, Cain, V. “Is there a menopausal syndrome? Menopausal status and symptoms across racial/ethnic groups,” Social Science & Medicine. 52 (3). 345-356. Feb. 2001.
 
[3]  Dennerstein, L, Dudley, E.C, Hopper, J.L, Guthrie, J.R, Burger, H.G. “A prospective population-based study of menopausal symptoms,” Obstet Gynecol., 96(3). 351-358. Aug. 2000.
 
[4]  Casper, R.F, Yen, S.S. “Neuroendocrinology of menopausal flushes: a hypothesis of flush mechanism,” Clinical Endocrinology, 22(3). 293-312. Mar. 1985.
 
[5]  Brown, W.J, Mishra, G.D, Dobson, A. “Changes in physical symptoms during the menopause transition,” International Journal of Behavioral Medicine, 9. 53-67. Mar. 2002.
 
[6]  Patel, S. “Disruption of aromatase homeostasis as the cause of a multiplicity of ailments: A comprehensive review,” Journal of Steroid Biochemistry & Molecular Biology, 168. 19-25. Apr. 2017.
 
[7]  Ruiz-Cabello, P, Coll-Risco, I, Acosta-Manzano, P, Borges-Cosic, M, Gallo-Vallejo, F.J, Aranda, P, Lopez-Jurado, M, Aparicio, V.A. “Influence of the degree of adherence to the Mediterranean diet on the cardiometabolic risk in peri and menopausal women,” Nutrition, Metabolism and Cardiovascular Diseases, 27(3). 217-224. Mar. 2017.
 
[8]  Zago, V, Sanguinetti, S, Brites, F, Berg, G, Verona, J, Basilio, F, Wikinski, R, Schreier, L. “Impaired high density lipoprotein antioxidant activity in healthy postmenopausal women,” Atherosclerosis, 177(1). 203-210. Nov. 2004.
 
[9]  Roa-Diaz, Z.M.; Raguindin, P.F.; Bano, A.; Laine, J.E.; Muka, T.; Glisic, M. “Menopause and cardiometabolic diseases: What we (don't) know and why it matters,” Maturitas, 152. 48-56. Oct. 2021
 
[10]  Kupperman, H.S, Blatt, M.H, Wiesbader, H, Filler, W. “Comparative clinical evaluation of estrogenic preparations by the menopausal and amenorrheal indices,” The Journal of Clinical Endocrinology and Metabolism, 13(6). 688-703. Jun. 1953.
 
[11]  Tao, M.F, Shao, H.F, Li, C.B, Teng, Y.C. “Correlation between the modified Kupperman Index and the Menopause Rating Scale in Chinese women,” Patient Prefer Adherence, 7. 223-229. Mar. 2013.
 
[12]  Heinemann, L.A, Potthoff, P, Schneider, H.P. “International versions of the Menopause Rating Scale (MRS),” Health and Quality of Life Outcomes, 28(1). Jul. 2003. [Online]. Available: https://hqlo.biomedcentral.com/articles/10.1186/1477-7525-1-28 [Accessed Jul. 30. 2003].
 
[13]  Wu, Y.L, Lin, H, Li, H.F, Don, M.J, King, P.C, Chen, H.H. “Salvia miltiorrhiza Extract and Individual Synthesized Component Derivatives Induce Activating-Transcription-Factor-3-Mediated Anti-Obesity Effects and Attenuate Obesity-Induced Metabolic Disorder by Suppressing C/EBP alpha in High-Fat-Induced Obese Mice,” Cells, 11(6). Mar. 2022. [Online] Available: https://www.mdpi.com/2073-4409/11/6/1022
 
[14]  Ji, X.Y, Tan, B.K, Zhu, Y.Z. “Salvia miltiorrhiza and ischemic diseases,” Acta Pharmacologica Sinica, 21(12). 1089-1094. Dec. 2000.
 
[15]  Tian, D.D.; Jia, W.W.; Liu, X.W.; Wang, D.D.; Liu, J.H.; Dong, J.J.; Li, L.; Du, F.F.; Xu, F.; Wang, F.Q.; et al. “Methylation and its role in the disposition of tanshinol, a cardiovascular carboxylic catechol from Salvia miltiorrhiza roots (Danshen),” Acta Pharmacologica Sinica, 36. 627-643. Apr. 2015.
 
[16]  Guo, Y, Sun, J, Zhang, R, Yang, P, Zhang, S, Wu, Z. “Salvia miltiorrhiza improves type 2 diabetes: A protocol for systematic review and meta-analysis,” Medicine (Baltimore), 100(6). Feb. 2021 [Online]. Available: https://www.ncbi.nlm.nih.gov/pmc/articles/PMC7886461/.
 
[17]  Nagappan, A, Kim, J.H, Jung, D.Y, Jung, M.H. “Cryptotanshinone from the Salvia miltiorrhiza Bunge Attenuates Ethanol-Induced Liver Injury by Activation of AMPK/SIRT1 and Nrf2 Signaling Pathways,” International Journal of Molecular Sciences, 21(1). Dec. 2019. [Online] Available: https://www.mdpi.com/1422-0067/21/1/265.
 
[18]  Kim, J.M, Noh, E.M, Song, H.K, Lee, M, Lee, S.H, Park, S.H, Ahn, C.K, Lee, G.S, Byun, E.B, Jang, B.S. et al. “Salvia miltiorrhiza extract inhibits TPA-induced MMP-9 expression and invasion through the MAPK/AP-1 signaling pathway in human breast cancer MCF-7 cells,” Oncology Letters 14. 3594-3600. Jul. 2017.
 
[19]  Lee, S.R, Jeon, H, Kwon, J.E, Suh, H, Kim, B.H, Yun, M.K, Lim, Y.J, Kang, S.C. “Anti-osteoporotic effects of Salvia miltiorrhiza Bunge EtOH extract both in ovariectomized and naturally menopausal mouse models,” Journal of Ethnopharmacology, 258. 112874. Aug. 2020.
 
[20]  Park, B, Song, H.S, Kwon, J.E, Cho, S.M, Jang, S.A, Kim, M.Y, Kang, S.C. “Effects of Salvia miltiorrhiza extract with supplemental liquefied calcium on osteoporosis in calcium-deficient ovariectomized mice,” BMC Complementary and Alternative Medicine, 545(17). Dec. 2017. [Online] Available: https://link.springer.com/article/10.1186/s12906-017-2047-y.
 
[21]  Zhang, X, Zheng, W, Wang, T, Ren, P, Wang, F, Ma, X, Wang, J, Huang, X. “Danshen-Chuanxiong-Honghua Ameliorates Cerebral Impairment and Improves Spatial Cognitive Deficits after Transient Focal Ischemia and Identification of Active Compounds,” Frontiers in Pharmacology, 8(452). Jul. 2017 [Online] Available: https://www.frontiersin.org/articles/10.3389/fphar.2017.00452/full.
 
[22]  Gu, S, Ma, Y, Ge, K, Nie, R, Wu, E, Li, Y. “Danshen-Honghua Ameliorates Stress-Induced Menopausal Depression in Rats,” Neural Plasticity, 2018(6589608). May. 2018. [Online] Available: https://www.hindawi.com/journals/np/2018/6589608/.
 
[23]  Alder, E. “The Blatt-Kupperman menopausal index: a critique,” Maturitas, 29(1). 19-24. May. 1998.
 
[24]  Schneider, H.P, Heinemann, L.A, Rosemeier, H.P, Potthoff, P, Behre, H.M. “The Menopause Rating Scale (MRS): comparison with Kupperman index and quality-of-life scale SF-36,” Climacteric, 3:1. 50-58. Jan. 2000.
 
[25]  Ahn, K, Kim, S, Yi, K, Park, H, Shin, J, Kim, Y, Hur, J, Kim, S, Lee, K, Kim, T. “The Effect of Pomegranate on Postmenopausal Syndrome A Randomized, Double-blind, Placebo-controlled Trial,” The Journal of Korean Society of Menopause, 16(2). 99-106. Aug. 2010.