Santoro Nanette, Teal Stephanie, Gavito Christina, Cano Sandra, Chosich Justin, Sheeder Jeanelle
Department of Obstetrics and Gynecology, University of Colorado School of Medicine, Aurora, CO.
Menopause. 2015 Dec;22(12):1301-7. doi: 10.1097/GME.0000000000000557.
The aim of this study was to compare perimenopausal symptomatology using a levonorgestrel-containing intrauterine system (LNG-IUS) + low-dose transdermal estradiol (TDE) with LNG-IUS alone.
The trial was a double-blind, randomized, controlled pilot trial. Regularly cycling women aged 38 to 52 years, with at least one self-reported symptom (hot flashes, bloating, headache, adverse mood, or poor sleep), were randomized to either LNG-IUS + low-dose TDE gel (intervention) or LNG-IUS alone (control). TDE was administered once daily as a 0.06% gel containing 0.75 mg of TDE for 50 days. LNG-IUS was placed at least 90 days before TDE or placebo gel treatment to assure stable circulating LNG. Participants completed the Center for Epidemiologic Studies Depression scale (CESD), Hot Flash Related Daily Interference scale (HFRDIS), Pittsburgh Sleep Quality Index (PSQI), and Fatigue Severity Scale (FSS) at the time of LNG-IUS placement, at 90 days (the time of randomization to TDE/placebo), and 140 days (end of study). TDE and placebo groups were compared using repeated-measures analysis of variance.
Thirty-eight women aged 42.9 ± 2.7 years, with a mean BMI of 24.7 ± 3.3 kg/m², were enrolled; 20 were randomized to TDE. Women receiving TDE had significantly improved FSS scores between days 90 and 140 (mean difference TDE: -0.8 ± 1.2 vs placebo: 0.1 ± 0.7; P = 0.026) and borderline significant improvement in HFRDIS scores (mean difference TDE: -5.5 ± 15.3 vs placebo: 4.2 ± 13.1; P = 0.076). Women who reported hot flashes at baseline and who received TDE had a significant decrease in HFRDIS scores between days 90 and 140 (n = 9, P = 0.035). CESD and PSQI scores were not associated with TDE use.
A brief, low-dose estrogen intervention, combined with a LNG-IUS, led to significant improvement of some common perimenopausal symptoms. Such a "minimalist" approach to management of the perimenopause holds promise for reducing common, bothersome perimenopausal symptoms while maintaining effective contraception.
本研究旨在比较含左炔诺孕酮宫内节育系统（LNG-IUS）+低剂量经皮雌二醇（TDE）与单纯使用LNG-IUS的围绝经期症状。
该试验为双盲、随机、对照的试点试验。年龄在38至52岁、月经周期规律、至少有一项自我报告症状（潮热、腹胀、头痛、不良情绪或睡眠不佳）的女性被随机分为LNG-IUS+低剂量TDE凝胶组（干预组）或单纯LNG-IUS组（对照组）。TDE作为含0.75毫克TDE的0.06%凝胶每日给药一次，共50天。在TDE或安慰剂凝胶治疗前至少90天放置LNG-IUS，以确保LNG循环稳定。参与者在放置LNG-IUS时、90天（随机分组至TDE/安慰剂的时间）和140天（研究结束）完成流行病学研究中心抑郁量表（CESD）、潮热相关日常干扰量表（HFRDIS）、匹兹堡睡眠质量指数（PSQI）和疲劳严重程度量表（FSS）。使用重复测量方差分析比较TDE组和安慰剂组。
纳入了38名年龄为42.9±2.7岁、平均BMI为24.7±3.3kg/m²的女性；20名被随机分配至TDE组。接受TDE的女性在90天至140天之间FSS评分显著改善（TDE组平均差异：-0.8±1.2 vs安慰剂组：0.1±0.7；P=0.026），HFRDIS评分有临界显著改善（TDE组平均差异：-5.5±15.3 vs安慰剂组：4.2±13.1；P=0.076）。基线时报告有潮热且接受TDE的女性在90天至140天之间HFRDIS评分显著降低（n=9，P=0.035）。CESD和PSQI评分与使用TDE无关。
短期、低剂量雌激素干预联合LNG-IUS可显著改善一些常见的围绝经期症状。这种“极简主义”的围绝经期管理方法有望在维持有效避孕的同时减轻常见、烦人的围绝经期症状。
