Transdermal estradiol for postpartum depression: results from a pilot randomized, double-blind, placebo-controlled study.
Transdermal estradiol for postpartum depression: results from a pilot randomized, double-blind, placebo-controlled study.
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DOI：
10.1007/s00737-019-00991-3
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发表时间：
2020-06
影响因子：
4.5
通讯作者：
Schmidt, Peter J.
中科院分区：
文献类型：
--
作者：
Li, Howard J.;Martinez, Pedro E.;Li, Xiaobai;Schenkel, Linda A.;Nieman, Lynnette;Rubinow, David;Schmidt, Peter J.
产后抑郁症（PPD）是分娩后常见的并发症，但循证治疗方案有限。本研究探讨了雌二醇透皮贴剂（TE）治疗PPD的可行性和有效性。在一项先导性、双盲、安慰剂对照试验中，患有PPD的女性被随机分配接受经皮17β-雌二醇（100 mcg/天）或安慰剂贴剂。在6周内，妇女每周完成贝克抑郁量表（BDI）、爱丁堡产后抑郁量表（EPDS）和汉密尔顿抑郁量表（HAM-D）的评分。主要结果指标为治疗反应（BDI较基线降低> 50%）和6周时的缓解（BDI < 10），次要结果指标包括第3周和第6周时所有量表的严重程度。在招募的12名女性中，6名接受TE，6名接受安慰剂。到第6周，5名接受TE治疗的妇女对治疗有反应，4名症状缓解，而安慰剂组有2名反应者和1名缓解者。该差异不显著（p = 0.24）。在BDI评分的混合模型中，与安慰剂相比，TE在3周时降低9.2分（95%CI − 19.5至+1.0，p = 0.074），在6周时降低10.5分（95%CI − 21.0-0.0，p = 0.049），尽管这些差异没有经过多重比较校正。HAM-D评分有类似的影响，但EPDS评分无类似影响。有趣的是，两组之间血浆雌二醇水平无显著差异。我们无法证明与安慰剂相比，TE在PPD中具有显著的治疗获益。尽管受招募不足和失访的限制，我们的结果表明TE是门诊PPD管理的可行选择，初步证据（基于次要结局）表明疗效。治疗效果可能早在3周内就可以看到，并且可能不直接依赖于雌二醇的外周测量。
Postpartum depression (PPD) is a common complication following delivery, though evidence-based treatment options are limited. This study explores the feasibility and efficacy of outpatient PPD treatment with transdermal estradiol (TE). In a pilot, double-blind, placebo-controlled trial, women with PPD were randomized to receive transdermal 17β-estradiol (100 mcg/day) or placebo patch. Over 6 weeks, women completed weekly ratings on the Beck Depression Inventory (BDI), Edinburgh Postnatal Depression Scale (EPDS), and Hamilton Depression Scale (HAM-D). Primary outcome measures were treatment response (> 50% decrease from baseline BDI) and remission (BDI < 10) at 6 weeks, and secondary outcome measures included severity on all scales at weeks 3 and 6. Of 12 recruited women, 6 received TE and 6 received placebo. By week 6, 5 women receiving TE responded to treatment and 4 showed symptom remission, compared to 2 responders and 1 remitter in the placebo group. This difference was not significant (p = 0.24). In a mixed-model of BDI ratings, TE was associated with a 9.2 point decrease at 3 weeks (95%CI − 19.5 to + 1.0, p = 0.074) and a 10.5 point decrease at 6 weeks (95%CI − 21.0–0.0, p = 0.049) compared to placebo, though these differences did not survive multiple comparisons correction. Analogous effects were found for HAM-D but not EPDS scores. Interestingly, no significant difference in plasma estradiol levels existed between groups. We were unable to demonstrate a significant therapeutic benefit of TE compared with placebo in PPD. Although limited by under-recruitment and loss to follow-up, our results suggest TE is a feasible option for outpatient PPD management, with preliminary evidence (based on secondary outcomes) for efficacy. Therapeutic effects may be seen as early as 3 weeks and may not directly depend on peripheral measures of estradiol.
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影响因子：
5.3
作者：
Berle, JO;Steen, VM;Spigset, O
通讯作者：
Spigset, O
DOI：
10.1097/gme.0000000000000528
发表时间：
2016-03
期刊：
Menopause (New York, N.Y.)
影响因子：
--
作者：
Gordon JL;Rubinow DR;Eisenlohr-Moul TA;Leserman J;Girdler SS
通讯作者：
Girdler SS
影响因子：
64.3
作者：
Furukawa, Toshi A.;Cipriani, Andrea;Salanti, Georgia
通讯作者：
Salanti, Georgia
影响因子：
5.3
作者：
Ahokas, A;Kaukoranta, J;Aito, M
通讯作者：
Aito, M
影响因子：
4.8
作者：
CLARK, JH;PASZKO, Z;PECK, EJ
通讯作者：
PECK, EJ