Changes in menopausal symptoms comparing oral estradiol versus transdermal estradiol

Abstract

Objective

This study aimed to compare the efficacy and safety of oral and transdermal estradiol in alleviating menopausal symptoms.

Method

A total of 257 recently menopausal women were randomized into two groups. The t-E₂ group received transdermal estradiol (2.5 g per day) (n = 128) and the o-E₂V group received oral estradiol valerate (2 mg per day) (n = 129) for 24 weeks; both groups received micronized progesterone (200 mg per day). The primary outcome measure is the change in the modified Kupperman Menopausal Index (KMI) after 24 weeks of treatment. Menopausal symptoms were recorded at screening and at 4, 12 and 24 weeks using both the KMI and the Menopause Rating Scale (MRS).

Results

Significant amelioration was observed by KMI and MRS scores for both groups after treatment (p < 0.001). The mean KMI scores showed no difference between the two groups. The mean MRS scores were similar between the two groups at baseline and after 4 weeks of treatment. The results showed statistical differences after 12 weeks and 24 weeks of treatment (p = 0.005 and p = 0.011). Both the after-treatment scores minus the baseline scores of KMI and MRS and the incidence of adverse effects showed no difference between the two groups.

Conclusions

This study shows that both transdermal and oral estradiol are effective in relieving menopausal symptoms, with little difference in treatment efficacy and safety.

Clinical trial number

ChiCTR2300073146

摘要

目的: 本研究旨在比较口服和经皮雌二醇缓解绝经症状的有效性和安全性。

方法: 将257例新近绝经的妇女随机分为两组。t-E₂组接受经皮雌二醇2.5g/d(n = 128), o-E₂V组口服戊酸雌二醇2 mg/d(n = 129), 疗程24周；两组均给予微粉化黄体酮(200mg / d)。主要结局指标为治疗24周后改良Kupperman绝经指数(KMI)的变化。使用KMI和绝经等级评定量表(Menopause Rating Scale, MRS)分别在初筛时、4周、12周和24周记录绝经症状。

结果: 两组患者治疗后KMI、MRS评分均有明显改善(p < 0.001)。KMI平均得分在两组间无差异。在基线和治疗4周后, 两组的平均MRS评分相似。治疗12周和24周后比较, 差异有统计学意义(p = 0.005和p = 0.011)。两组治疗后KMI和MRS减去基线评分及不良反应发生率均无明显差异。

结论: 本研究表明, 雌二醇经皮贴剂和口服雌二醇均能有效缓解更年期症状, 其疗效和安全性差异不大。

临床试验编号: ChiCTR2300073146

Keywords:

• Menopausal hormone therapy
• estradiol
• oral estrogen
• transdermal estrogen
• menopause
• Kupperman Menopausal Index

Acknowledgements

The authors are deeply grateful to all participants involved in this study and all of the doctors and researchers who participated in the study. Written informed consent was obtained for all participants and the institutional review boards of Peking Union Medical College Hospital (PUMCH) approved all protocols (JS-1135). Data will be made available on request.

Potential conflict of interest

No potential conflict of interest was reported by the authors.

Additional information

Funding

This work was supported by National Key Research and Development Program [2022YFC2703802]; National High Level Hospital Clinical Research Funding [2022-PUMCH-B-123, 2022-PUMCH-C-065]; National Natural Science Foundation of China Project [grant number 82201781].