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.
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.
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 17β-estradiol level was not significantly different between the two groups, but the 17β-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.
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.
This randomized, controlled trial showed improvement of fatigue and menopausal symptoms in middle-aged Korean women after 8 weeks of human placental extract injection, whereas risk factors for cardiovascular disease did not change during the study period.
From the Departments of 1Family Practice, 2Radiology, and 3Preventive Medicine and Public Health, College of Medicine, Ajou University, Suwon, Korea; 4Department of Pathology, College of Medicine, Hallym University, Seoul, Korea; and 5Department of Internal Medicine, College of Medicine, Ewha Woman's University, Seoul, Korea.
Received March 28, 2007; revised and accepted June 13, 2007.
Funding/support: This work was supported by a 2006 grant from the Department of Medical Sciences, Graduate School, Ajou University, Suwon, Korea.
Financial disclosure: None reported.
Address correspondence to: Sat-Byul Park, MD, Departments of Family Medicine and Community Health, Ajou University, College of Medicine, Suwon 443-721, Korea. E-mail: MHKong@paran.com