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一项关于促进围绝经期、绝经和绝经后妇女头发生长的营养补充剂的长期安全性和有效性的研究。

A Long-Term Study of the Safety and Efficacy of a Nutraceutical Supplement for Promoting Hair Growth in Perimenopausal, Menopausal, and Postmenopausal Women.

出版信息

J Drugs Dermatol. 2022 Jul 1;21(7):783. doi: 10.36849/JDD.776.

Abstract

The prevalence of female hair loss and hair thinning increases with advancing age and is most common among post-menopausal women. Recent statistics show that by age 60, an estimated 80% of women experience hair loss. A previous publication detailing the results of the 6-month randomized, double-blind, placebo-controlled phase of this study demonstrated the ability of a nutraceutical supplement to significantly improve hair growth and shedding compared to placebo. Here, we present results from a subsequent 6-month, open-label extension phase assessing the continued safety and efficacy of this nutraceutical for promoting and improving hair growth and evaluate potential long-term benefits on quality of life and menopausal symptoms. After a total of 12 months with the active nutraceutical, subjects had progressive improvements in hair growth, quality, and shedding. Quality of life measures and menopausal symptoms also improved over the duration of the study. When transitioned to daily intake of the supplement, subjects previously treated with placebo achieved significant increases in all hair counts, a significant decrease in shedding, and significant improvement in blinded investigator global hair growth and quality assessments. The results of this long-term study demonstrate that continued use of a novel nutraceutical provides significant incremental improvement over the beneficial effects achieved during the initial 6-month randomized, placebo-controlled phase. Continued use may provide ongoing improvements in hair growth and exert a positive effect on secondary symptoms of menopause, and quality of life in perimenopausal, menopausal, and postmenopausal women with selfperceived thinning hair (ClinicalTrials.gov Identifier: NCT04048031). J Drugs Dermatol. 2022;21(7):776-783. doi:10.36849/JDD.6912.

摘要

随着年龄的增长,女性脱发和头发稀疏的患病率增加,绝经后妇女最为常见。最近的统计数据显示,到 60 岁时,估计有 80%的女性脱发。之前的一项出版物详细说明了这项研究的 6 个月随机、双盲、安慰剂对照阶段的结果,表明一种营养补充剂能够显著改善头发生长和脱落,与安慰剂相比。在这里,我们展示了随后 6 个月、开放标签扩展阶段的结果,该阶段评估了这种营养补充剂促进和改善头发生长的持续安全性和有效性,并评估了其对生活质量和更年期症状的潜在长期益处。在使用活性营养补充剂 12 个月后,受试者的头发生长、质量和脱落情况逐渐改善。研究过程中,生活质量指标和更年期症状也有所改善。当过渡到每天服用补充剂时,之前接受安慰剂治疗的受试者的所有头发计数都显著增加,脱落显著减少,盲法研究者评估的头发生长和质量也显著改善。这项长期研究的结果表明,继续使用一种新型营养补充剂可在初始 6 个月随机、安慰剂对照阶段的有益效果基础上提供显著的增量改善。持续使用可能会持续改善头发生长,并对围绝经期、绝经和绝经后有自我感知头发稀疏的女性的次要更年期症状和生活质量产生积极影响(临床试验标识符:NCT04048031)。J 皮肤病学杂志。2022;21(7):776-783. doi:10.36849/JDD.6912.

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