Human Reproduction Department, Hospital Juárez de México, México City, Mexico; Facultad de Medicina, Universidad Nacional Autónoma De México (UNAM), México City, México.
Eur Rev Med Pharmacol Sci. 2021 Apr;25(8):3316-3324. doi: 10.26355/eurrev_202104_25743.
This open-label non-randomized clinical study aimed at evaluating the effects of myo-inositol plus alpha-lactalbumin in two groups of PCOS women, treated in Mexico and Italy. Alpha-lactalbumin was used being effective in increasing myo-inositol intestinal absorption. This effect is very useful in greatly reducing the therapeutic failure of myo-inositol in some patients (inositol resistant subjects).
The study involved 34 normal weight or overweight patients (14 in Mexico and 20 in Italy), aged 18 to 40 years, with anovulation and infertility > 1 year and insulin resistance diagnosed by HOMA-Index. Patients were administered orally with 2 g myo-inositol, 50 mg alpha-lactalbumin, and 200 µg of folic acid twice a day for 6 months. Controls were the same patients at t0 (baseline). The primary outcome was HOMA-index decrease after 3 and 6 months of treatment. Other parameters monitored were BMI, progesterone, LH, FSH, total testosterone, free testosterone, androstenedione, total cholesterol, HDL, LDL, triglycerides.
Recovery was general, and its relevance was higher when the starting point was further away from the normal range. The most important results were obtained with insulin, HOMA-index, LH, and androstenedione. No significant adverse effects were detected in both groups of patients.
This clinical trial demonstrated for the first time that myo-inositol and alpha-lactalbumin improve important parameters in PCOS patients characterized by different metabolic profiles.
本开放性、非随机临床研究旨在评估肌醇加α-乳白蛋白对两组多囊卵巢综合征（PCOS）女性的影响，这些患者分别在墨西哥和意大利接受治疗。使用α-乳白蛋白是因为它能有效增加肌醇的肠道吸收。这种作用在很大程度上降低了某些患者（肌醇抵抗者）治疗失败的风险，非常有用。
该研究纳入了 34 名体重正常或超重的患者（14 名在墨西哥，20 名在意大利），年龄 18 至 40 岁，患有排卵障碍和不孕不育>1 年，且通过 HOMA-Index 诊断存在胰岛素抵抗。患者每天口服 2 克肌醇、50 毫克α-乳白蛋白和 200 微克叶酸，持续 6 个月。对照组为 t0（基线）时的相同患者。主要结局是治疗 3 个月和 6 个月后 HOMA-Index 的降低。监测的其他参数包括 BMI、孕酮、LH、FSH、总睾酮、游离睾酮、雄烯二酮、总胆固醇、HDL、LDL、甘油三酯。
恢复情况普遍，且起始值离正常范围越远，相关性越高。胰岛素、HOMA-Index、LH 和雄烯二酮的结果最重要。两组患者均未发现明显的不良反应。
本临床试验首次证明，肌醇和α-乳白蛋白可改善具有不同代谢特征的 PCOS 患者的重要参数。
