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KMID : 1007320090150030178
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Journal of the Korean Society of Menopause
2009 Volume.15 No. 3 p.178 ~ p.185
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Effect and Safety of Human Placental Extract on Menopausal Symptoms
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Park Yu-Ran
Kim Chung-Hoon
Park Hyoung-Moo
Kim Sung-Hoon
Chae Hee-Dong
Kang Byung-Moon
Kim So-Ra
Choi Hoon
Jeon Gyun-Ho
Suh Chang-Suk
Lee Byung-Seok
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Abstract
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Objectives: In Korea, human placental extract (HPE) has been approved as a therapeutic agents for chronic liver diseases and menopause syndrome. However evidence-based studies about the effectiveness, mechanism of action, and side effects of HPE are incomplete. The aim of this study was to examine the effects of HPE on menopausal symptoms, and safety in middle-aged Korean women in a double-blind randomized controlled trial.
Methods: Korean women ＞40 years of age, with menopausal symptoms and hot flushes were recruited as participants in 5 university hospitals in Seoul, Korea. The 130 women were randomly assigned as followed to a double blind test: the HPE group (n=66) received 6 subcutaneous injections of HPE for 2 weeks; the placebo group (n=64) received normal saline. The KI (Kupperman index) score, severity of hot flushes were and concentrations of E2 and FSH in serum were measured. The side effects of HPE were assessed.
Results: The KI score was decreased significantly after 2 weeks of HPE treatment compared with the placebo group (P=0.0013); however, the severity of the hot flushes were not different between the two groups (P=0.8044). The E2 and FSH levels of the HPE group were not significantly increased at 2 weeks after HPE treatment compared with of the placebo group (E2 level, P=0.7665, FSH level, P=0.3577). No evidence of side effects were observed in either group (?2-test, P=0.7037).
Conclusion: The KI score in middle-aged Korean women improved after 2 weeks of HPE treatment, whereas the difference in hot flushes, and E2 and FSH levels did not change during the study period. No evidence of significant side effects were observed in patients treated with HPE.
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KEYWORD
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Human placental extract (HPE), Menopause syndrome
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