Russo Roberto, Corosu Roberto
I Clinica Ostetrica e Ginecologica, Policlinico Umberto I, Università, La Sapienza, Roma.
Acta Biomed. 2003 Dec;74(3):137-43.
In order to evaluate the efficacy of soya isoflavones (genistein and daidzein) in the treatment of the principal menopausal disorders, a double blind randomized study was performed on a sample of 50 women (with an average age of 53.3 +/- 3.1 years) with Climacteric syndrome referred to the I Clinica Ostetrica e Ginecologica, Policlinico Umberto I, Roma. The research protocol involved the random subdivision of the enrolled sample into two groups of 25 women, group 1 (with an average age of 53.3 +/- 3.5 years, and an average menopausal age of 51.6 +/- 1.8 years) and group 2 (with an average age of 53.1 +/- 2.9 years, and an average menopausal age of 51.3 +/- 1.2 years), who were to receive treatment for three months with the product being studied and with a placebo. After the three-month period, as an additional check, the group initially treated with the placebo would move to the phyto-oestrogens and viceversa. All of the patients were subjected to a series of clinical and instrumental examinations and were asked to fill in a questionnaire concerning their complaints, at the start, at halfway (third month) and at the end (sixth month) of the trial. The results of the evaluation of the questionnaires performed on the 47 patients who had completed the trial showed, in the first three months, an improvement in the symptoms (hot flushes) in 11 patients treated with phyto-oestrogens against 6 patients from the group that received only the placebo. In the second three-month period the hot flushes reappeared in 4 of the 11 patients who had previously seen improvements and had then passed to the placebo. In contrast, the group that passed to the phyto-oestrogens, after treatment with the placebo, experienced the disappearance of hot flushes in 11 women, including the 6 who had already improved in the first three months. There was no significant reduction in anxiety, insomnia or vaginal dryness. None of the enrolled patients indicated complaints linked to the treatment. It can be concluded that the use of a product based on phyto-oestrogens, such as the one experimented, can lead to a significant reduction in some of the disorders linked with the menopause, especially hot flushes.
为评估大豆异黄酮（染料木黄酮和大豆苷元）治疗主要更年期疾病的疗效，对罗马翁贝托一世综合医院第一妇产科收治的50名患有更年期综合征的女性（平均年龄53.3±3.1岁）进行了一项双盲随机研究。研究方案包括将入组样本随机分为两组，每组25名女性，第1组（平均年龄53.3±3.5岁，平均绝经年龄51.6±1.8岁）和第2组（平均年龄53.1±2.9岁，平均绝经年龄51.3±1.2岁），两组分别接受为期三个月的受试产品和安慰剂治疗。三个月后，作为额外检查，最初接受安慰剂治疗的组将改用植物雌激素，反之亦然。所有患者在试验开始、中期（第三个月）和结束（第六个月）时均接受了一系列临床和仪器检查，并被要求填写一份关于其不适症状的问卷。对完成试验的47名患者进行问卷评估的结果显示，在前三个月中，接受植物雌激素治疗的11名患者的症状（潮热）有所改善，而仅接受安慰剂治疗的组中有6名患者症状改善。在第二个三个月期间，之前症状有所改善并转而接受安慰剂治疗的11名患者中有4名再次出现潮热。相比之下，在接受安慰剂治疗后改用植物雌激素的组中，11名女性的潮热症状消失，其中包括在前三个月中已经有所改善的6名女性。焦虑、失眠或阴道干涩症状没有显著减轻。所有入组患者均未表示有与治疗相关的不适。可以得出结论，使用基于植物雌激素的产品，如本试验所用产品，可显著减轻一些与更年期相关的疾病，尤其是潮热。
