Effect of porcine placental extract on the mild menopausal symptoms of climacteric women

<b>Objectives:</b> This study assessed the effects of oral porcine placental extract (PPE) on the mild menopausal symptoms of climacteric women. <b>Methods:</b> In this 12-week, multicenter, randomized, double-blind, placebo-controlled, parallel-group study, 50 climacteric Japanese women were randomized 1 : 1 to oral PPE (300 mg/day) or placebo. Menopausal symptoms were evaluated by using the Simplified Menopausal Index (SMI), as were serum estradiol (E2) and follicle stimulating hormone (FSH) levels. Blood biochemical and cellular and urinary tests were done to evaluate safety aspects of repeated oral administration of PPE. <b>Results:</b> The total SMI score of the PPE group was significantly more improved after 12 weeks than that of the placebo group (<i>p</i> = 0.031). This score and three subscores (vasomotor, psychological, and somatic symptoms) were significantly improved at 8 and/or 12 weeks compared with the initial values in the PPE group (<i>p</i> <b>Conclusions:</b> Oral PPE at 300 mg/day improved the mild menopausal symptoms of climacteric women. Since oral PPE did not improve serum E2 and FSH levels, PPE is thought not to ameliorate hormonal balance itself but to improve subjective feelings of climacteric women.

研究目的：本研究评估了口服猪胎盘提取物（porcine placental extract, PPE）对更年期女性轻度更年期症状的改善作用。
研究方法：本项为期12周的多中心、随机、双盲、安慰剂对照平行组临床试验中，50名日本更年期女性按1:1比例被随机分配至口服PPE组（每日300mg）或安慰剂组。采用简化更年期指数（Simplified Menopausal Index, SMI）评估更年期症状，同时检测血清雌二醇（estradiol, E2）与卵泡刺激素（follicle stimulating hormone, FSH）水平。通过血液生化、细胞及尿液检测，评估重复口服PPE的安全性。
研究结果：给药12周后，PPE组的SMI总评分较安慰剂组获得了更为显著的改善（p=0.031）。与基线值相比，PPE组在8周及/或12周时，该总评分及三项子评分（血管舒缩症状、心理症状与躯体症状）均得到显著改善（p<）。
研究结论：每日300mg的口服PPE可改善更年期女性的轻度更年期症状。由于口服PPE未对血清E2与FSH水平产生显著影响，因此推测PPE并非通过调节激素平衡本身发挥作用，而是通过改善更年期女性的主观不适感受实现症状缓解。