Kong Mi-Hee, Lee Eun-Ju, Lee Soon-Yong, Cho Seong-Jin, Hong Young-Sun, Park Sat-Byul
Department of Family Practice, Ajou University, Suwon, Korea.
Menopause. 2008 Mar-Apr;15(2):296-303. doi: 10.1097/gme.0b013e3181405b74.
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 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.
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.
在韩国，人胎盘提取物（HPE）最近被用于治疗各种疾病（慢性肝病、更年期综合征、慢性疲劳、皮肤色素沉着疾病等），但基于证据的研究尚不充分。本研究的目的是在一项随机对照试验中，检验HPE对韩国中年女性更年期症状、疲劳及心血管疾病风险因素的影响。
招募年龄在40至64岁、有更年期症状和疲劳的韩国女性作为参与者。这些女性被随机分为安慰剂组或HPE组。HPE组在腹部皮下注射HPE，为期8周，而安慰剂组接受生理盐水注射。然后，使用更年期评定量表、疲劳严重程度量表和视觉模拟量表进行评估，并对心血管疾病风险因素进行评估。
两组的更年期评定量表总基线得分无差异；然而，与安慰剂组相比，HPE组在8周时的得分显著降低（P = 0.033）。安慰剂组的疲劳严重程度量表和视觉模拟量表得分未发生变化，而HPE组的得分在研究期间显著降低（疲劳严重程度量表，P = 0.002；视觉模拟量表，P = 0.001）。两组的基线17β-雌二醇水平无显著差异，但与安慰剂组相比，HPE组在8周时的17β-雌二醇水平显著升高（P = 0.031）。两组均未观察到心血管疾病风险因素的变化。
韩国中年女性在接受8周的HPE治疗后，更年期症状和疲劳有所改善，而在研究期间心血管疾病风险因素未发生变化。
