Lee Yoo-Kyung, Chung Hyun Hoon, Kang Soon-Beom
Department of Obstetrics and Gynecology, Seoul National University College of Medicine, Seoul, Korea.
J Obstet Gynaecol Res. 2009 Dec;35(6):1096-101. doi: 10.1111/j.1447-0756.2009.01066.x.
To assess the efficacy and safety of human placenta extract in the relief of climacteric symptoms.
A prospective, randomized, double-blind, placebo-controlled trial was performed on 108 women with menopausal symptoms. Human placenta extract or placebo was administered to the women for 4 weeks. Climacteric symptoms were assessed with the Kupperman Index (KMI).
Both groups showed a significant reduction in the KMI score at the end of treatment. However, the decrease in the KMI score was significantly greater in the product group than in the placebo group (-12.30 +/- 10.44 vs -7.15 +/- 9.11, P = 0.012) after 4 weeks of treatment. The level of lipid profiles and liver function tests demonstrated no significant changes before and after treatment in both groups.
Human placenta extract reduced climacteric symptoms more than the placebo. The safety evaluation showed a good safety and tolerability profile in the placenta extract group. The results of the present study suggest that human placenta extract can be an alternative therapy in women with menopausal symptoms.
评估人胎盘提取物缓解更年期症状的疗效和安全性。
对108名有更年期症状的女性进行了一项前瞻性、随机、双盲、安慰剂对照试验。给这些女性服用人胎盘提取物或安慰剂，为期4周。采用库珀曼指数（KMI）评估更年期症状。
治疗结束时，两组的KMI评分均显著降低。然而，治疗4周后，产品组的KMI评分下降幅度显著大于安慰剂组（-12.30±10.44对-7.15±9.11，P = 0.012）。两组治疗前后血脂水平和肝功能检查均无显著变化。
人胎盘提取物比安慰剂更能减轻更年期症状。安全性评估显示胎盘提取物组具有良好的安全性和耐受性。本研究结果表明，人胎盘提取物可作为有更年期症状女性的替代疗法。
