多成分营养补充剂与PCOS女性六个月BMI、月经周期特征及Ferriman-Gallwey评分变化的前瞻性观察研究
Six-Month Changes in BMI, Menstrual-Cycle Characteristics, and Ferriman-Gallwey Scores Associated With a Multi-ingredient Nutritional Supplement Blend in Women With PCOS: A Prospective Observational Study
摘要
该前瞻性观察研究纳入35例18–40岁、未接受二甲双胍或激素治疗的黎巴嫩PCOS女性,评估含肌醇、α-硫辛酸、N-乙酰半胱氨酸、锯棕榈与叶酸的多成分营养补充剂使用6个月后BMI、月经周期规律性及Ferriman-Gallwey多毛评分的变化。32例完成随访:BMI由26.5±2.8降至25.7±2.5 kg/m²(平均变化-0.88,p=0.003);多毛评分由15.3降至6个月时14.4,混合效应模型校正后差异仍显著(-1.08,95%CI -1.38~-0.77),但2个月时的变化经多重比较校正后不显著;月经规律比例由8.6%升至18.8%,无统计学意义(p=0.250)。作者指出为初步观察性结果,需随机对照试验验证。
原文摘要
Introduction Multi-ingredient nutritional supplements combining insulin-sensitizing and anti-androgenic compounds are increasingly used in polycystic ovary syndrome (PCOS), yet evidence on their combined clinical effects remains limited. This study aimed to evaluate whether the use of a multi-ingredient nutritional supplement blend containing myo-inositol, α-lipoic acid, N-acetylcysteine, saw palmetto, and folic acid was associated with six-month changes in body mass index (BMI), menstrual-cycle characteristics, and Ferriman-Gallwey hirsutism scores in women with PCOS. Methods Thirty-five Lebanese women with PCOS aged 18 to 40 and not receiving metformin or hormonal therapy were enrolled. BMI, menstrual cycle frequency, and Ferriman-Gallwey hirsutism scores were assessed at baseline. Hirsutism was reassessed at two and six months, while BMI and cycle regularity were reassessed at six months. Paired analyses and a linear mixed-effects model for repeated Ferriman-Gallwey scores were applied as appropriate, with significance set at p < 0.05. Three participants were lost to follow-up. Results At six months (N=32), mean BMI decreased significantly from 26.5 ± 2.8 to 25.7 ± 2.5 kg/m² among participants with complete paired BMI data (mean change = -0.88 ± 1.56 kg/m²; p = 0.003). Ferriman-Gallwey scores declined from 15.3 ± 3.2 at baseline to 15.1 ± 3.0 at 2 months and 14.4 ± 2.6 at 6 months. In a linear mixed-effects model, the baseline-to-six-month reduction remained statistically significant (mean difference: -1.08; 95% CI: -1.38 to -0.77; Holm-adjusted p < 0.001), while the smaller baseline-to-two-month change did not remain statistically significant after adjustment for multiple comparisons. Menstrual cycle regularity showed a non-significant improving trend (regular cycles: 8.6% to 18.8%; p=0.250). Conclusions Six months of using the supplement blend was associated with a modest reduction in BMI and a statistically significant but small baseline-to-six-month reduction in Ferriman-Gallwey hirsutism scores, with no statistically significant improvement in menstrual-cycle regularity. These observational findings should be interpreted as preliminary and support further randomized controlled trials with standardized lifestyle monitoring, objective metabolic and hormonal outcomes, and systematic safety assessment.
推荐理由:单臂、无对照、样本小(n=32可分析)、终点为替代指标且效应量很小,证据等级有限;对PCOS营养补充的临床咨询仅有边缘参考价值,不足以改变实践。
文献解读
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