Effect of human placental extract on menopausal symptoms, fatigue, and risk factors for cardiovascular disease in middle-aged Korean women.
OBJECTIVE
In Korea, human placental extract (HPE) has recently been used to treat various diseases (chronic liver diseases, menopause syndrome, chronic fatigue, skin pigment diseases, etc.), but evidence-based studies are not yet sufficient. The aim of this study was to examine the effects of HPE on menopausal symptoms, fatigue, and risk factors for cardiovascular disease in middle-aged Korean women in a randomized controlled trial.


METHODS
Korean women, aged 40 to 64 years, with menopausal symptoms and fatigue were recruited as participants. The women were randomly assigned to a placebo group or an HPE group. The HPE group received subcutaneous injections of HPE in the abdomen for 8 weeks, whereas the placebo group received normal saline. Then, the Menopause Rating Scale, and Fatigue Severity Scale, and Visual Analog Scale were administered, and risk factors for cardiovascular disease were assessed.


RESULTS
The Menopause Rating Scale total baseline score was not different between the two groups; however, the score of the HPE group decreased significantly at 8 weeks compared with that of the placebo group (P = 0.033). Fatigue Severity Scale and Visual Analog Scale scores of the placebo group did not change, whereas the scores of the HPE group decreased significantly during the study period (Fatigue Severity Scale, P = 0.002; Visual Analog Scale, P = 0.001). The baseline 17beta-estradiol level was not significantly different between the two groups, but the 17beta-estradiol level of the HPE group was significantly increased at 8 weeks compared with that of the placebo group (P = 0.031). No changes in risk factors for cardiovascular disease were observed in either group.


CONCLUSIONS
Menopausal symptoms and fatigue in middle-aged Korean women improved after 8 weeks of HPE treatment, whereas risk factors for cardiovascular disease did not change during the study period.
Kong
Mi-Hee
MH
Department of Family Practice, Ajou University, Suwon, Korea. MHKong@paran.com
Lee
Eun-Ju
EJ
Lee
Soon-Yong
SY
Cho
Seong-Jin
SJ
Hong
Young-Sun
YS
Park
Sat-Byul
SB
D000328:Adult; D002318:Cardiovascular Diseases / Q000453:epidemiology / Q000517:prevention & control*; D004958:Estradiol / Q000378:metabolism; D005221:Fatigue / Q000188:drug therapy*; D005260:Female; D006801:Humans; D007279:Injections, Subcutaneous; D007723:Korea; D008593:Menopause / Q000187:drug effects*; D008875:Middle Aged; D010924:Placental Extracts / Q000032:analysis / Q000627:therapeutic use*; D012307:Risk Factors
D010924:Placental Extracts; D004958:Estradiol