Heger Peter W, Hotz Dirk, Kalder Matthias, Kostev Karel
Health Research Services GmbH, Hofaeckerstr. 14, 76698, Ubstadt-Weiher, Germany.
Department of Gynecology and Obstetrics, Philipps-University, Marburg, Germany.
Breast Cancer Res Treat. 2025 Jul;212(1):139-148. doi: 10.1007/s10549-025-07711-9. Epub 2025 May 13.
The special extract ERr 731 from the roots of rhapontic rhubarb has been prescribed for women with menopausal symptoms for more than 30 years. The aim of the present study is to evaluate the association between ERr 731 therapy and subsequent breast cancer in women in a real-world setting. ERr 731 users were compared to women without this therapy as well as women receiving hormone therapy.
This retrospective cohort study included data of women treated by 260 office-based gynecologists in Germany who received a prescription for ERr 731 between 1993 and 2022 (IQVIA Disease Analyzer database). These women were matched to women without ERr 731 prescriptions as well as women with hormone replacement therapy (HRT) prescriptions (1:3) using nearest neighbor propensity scores. A univariate Cox regression analysis was conducted to evaluate the associations between ERr 731 prescription and breast cancer risk compared to women without ERr 731 prescription and women with HRT prescriptions.
A total of 5,686 women with versus 17,058 women without ERr 731 prescription were available for the first analysis, and 2,616 women with ERr 731 prescription (a proportion of the 5,686 women used in the first analysis) and 7,848 women with HRT prescriptions for the second (average age 52-53 years). ERr 731 was not associated with an increased risk of breast cancer diagnosis when the group of women with ERr 731 prescription was compared to women without (OR: 1.01, 95% CI: 0.81-1.26) or to that of women with HRT prescription ((OR: 0.96, 95% CI: 0.69-1.33). No associations were observed in age-stratified analyses or in women with and without menopausal or other perimenopausal disorders.
The present study provides strong evidence that ERr 731 is not associated with an increased risk of breast cancer diagnosis compared to both non-users and HRT users. Given its favorable safety profile, ERr 731 may represent a viable alternative to HRT, particularly for women concerned about breast cancer risk.
源于新疆大黄根部的特殊提取物ERR 731已被用于治疗有更年期症状的女性30多年。本研究的目的是在现实环境中评估ERR 731治疗与女性后续患乳腺癌之间的关联。将使用ERR 731的女性与未接受该治疗的女性以及接受激素治疗的女性进行比较。
这项回顾性队列研究纳入了德国260名基层妇科医生治疗的女性的数据，这些女性在1993年至2022年期间接受了ERR 731处方（IQVIA疾病分析器数据库）。使用最近邻倾向评分将这些女性与未开具ERR 731处方的女性以及接受激素替代疗法（HRT）处方的女性进行匹配（1:3）。进行单变量Cox回归分析，以评估与未开具ERR 731处方的女性和开具HRT处方的女性相比，ERR 731处方与乳腺癌风险之间的关联。
第一次分析共有5686名使用ERR 731的女性和17058名未使用ERR 731的女性，第二次分析有2616名使用ERR 731的女性（占第一次分析中5686名女性的一部分）和7848名开具HRT处方的女性（平均年龄52 - 53岁）。将使用ERR 731处方的女性组与未使用ERR 731的女性组相比（OR：1.01，95%CI：0.81 - 1.26），或与开具HRT处方的女性组相比（OR：0.96，95%CI：0.69 - 1.33）时，ERR 731与乳腺癌诊断风险增加无关。在年龄分层分析中，以及在有和没有更年期或其他围绝经期疾病的女性中均未观察到关联。
本研究提供了有力证据，表明与未使用者和HRT使用者相比，ERR 731与乳腺癌诊断风险增加无关。鉴于其良好的安全性，ERR 731可能是HRT的一个可行替代方案，特别是对于担心乳腺癌风险的女性。
