Rutgers-Robert Wood Johnson Medical School, Department of Obstetrics and Gynecology, New Brunswick, NJ.
Johns Hopkins University School of Medicine, Department of Gynecology and Obstetrics, Division of Reproductive Sciences and Women's Health Research, Baltimore, MD.
Menopause. 2020 Nov 12;28(2):217-224. doi: 10.1097/GME.0000000000001676.
Menopause is associated with bothersome symptoms for many women, including mood changes, hot flushes, sleep problems, and fatigue. Progesterone is commonly prescribed in combination with estrogen therapy. Although monotherapy with progestins has been used as treatment of menopausal symptoms in women with contraindications to estrogens, the optimal route, and dosage of progestin monotherapy has not been established.
To assess whether progestin as a standalone treatment is effective for treating vasomotor and mood symptoms associated with menopause.
We conducted a systematic review using PubMed and Embase databases from January 1980 to January 2020. We included randomized controlled trials (RCTs) that investigated different forms of progestin for the treatment of vasomotor or mood symptoms associated with menopause.
A systematic search of 892 studies identified seven RCTs involving a total of 601 patients. The available literature was heterogeneous in terms of formulation and dose of progesterone; administration ranged from 5 to 60 mg of transdermal progesterone, 10 to 20 mg oral medroxyprogesterone acetate, and 300 mg of oral micronized progesterone. Duration of treatment also differed between studies, ranging from 21 days to 12 months (median: 12 wks). Three of seven RCTs reported that progestin therapy led to an improvement of vasomotor symptoms (VMS) in postmenopausal women. The largest study administering oral progestin using 300 mg micronized progesterone reported a 58.9% improvement in VMS (vs 23.5% in placebo group, n = 133), whereas the largest study using transdermal progesterone reported no improvement (n = 230). No study reported an improvement of mood symptoms. Side effects, such as headaches and vaginal bleeding, were significant in five of seven RCTs and led to discontinuation of treatment in 6% to 21% of patients.
A beneficial effect was reported in some trials with the transdermal route at longer duration and with oral treatment at higher doses for VMS for progesterone-only therapy. This report may help to inform future studies of progestin-only therapy for the treatment of menopausal symptoms.
绝经后，许多女性会出现一些不适症状，如情绪变化、热潮、睡眠问题和疲劳。孕激素通常与雌激素联合用于治疗。虽然孕激素的单药治疗已被用于治疗对雌激素有禁忌的绝经症状，但孕激素单药治疗的最佳途径和剂量尚未确定。
评估孕激素作为单一治疗药物是否对治疗与绝经相关的血管舒缩和情绪症状有效。
我们使用 PubMed 和 Embase 数据库从 1980 年 1 月至 2020 年 1 月进行了系统评价。我们纳入了研究不同形式孕激素治疗与绝经相关血管舒缩或情绪症状的随机对照试验（RCT）。
系统搜索了 892 项研究，确定了 7 项 RCT，共涉及 601 名患者。由于孕激素制剂和剂量不同，现有文献存在异质性；给药途径包括 5 至 60mg 的经皮孕激素、10 至 20mg 的口服醋酸甲羟孕酮和 300mg 的口服微粒化孕激素。研究之间的治疗持续时间也不同，范围从 21 天到 12 个月（中位数：12 周）。7 项 RCT 中有 3 项报告孕激素治疗可改善绝经后妇女的血管舒缩症状（VMS）。使用 300mg 微粒化孕激素进行口服孕激素治疗的最大研究报告 VMS 改善了 58.9%（与安慰剂组的 23.5%相比，n=133），而使用经皮孕激素的最大研究报告无改善（n=230）。没有研究报告情绪症状得到改善。5 项 RCT 中有 7 项报告了副作用，如头痛和阴道出血，在 6%至 21%的患者中导致治疗中断。
一些试验报告了经皮途径较长时间和口服治疗较高剂量的孕激素治疗 VMS 的有益效果。这一报告可能有助于为未来孕激素单药治疗绝经症状的研究提供信息。
