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. 2024 May;309(5):2089-2098.
doi: 10.1007/s00404-023-07363-4. Epub 2024 Feb 23.

Use of Vitex agnus-castus in patients with menstrual cycle disorders: a single-center retrospective longitudinal cohort study

Martina Höller  1 , Hubert Steindl  1 , Dimitri Abramov-Sommariva  1 , Julia Kleemann  1 , Alexey Loleit  2 , Christoph Abels  1 , Petra Stute  3
Affiliations

Use of Vitex agnus-castus in patients with menstrual cycle disorders: a single-center retrospective longitudinal cohort study

Martina Höller et al. Arch Gynecol Obstet. 2024 May.

Abstract

Purpose: To evaluate clinical characteristics, quality of life (QoL) and effectiveness in patients with menstrual cycle disorders (MCDs) including abnormal uterine bleeding, dysmenorrhea and mastodynia/mastalgia related to premenstrual syndrome taking the Vitex agnus-castus (VAC) products Cyclodynon® or Mastodynon® in a real-world setting.

Methods: A single-center retrospective longitudinal cohort study (3 ± 1 months), using data obtained from healthcare data archive and telephone interviews. The main study variables were changes in bleeding, menstrual pain, breast tenderness and patients' QoL.

Results: Data from 1700 women with a mean age of 30.2 years (± 6.3) were analyzed. The most common MCDs were dysmenorrhea (43.8%) and mastodynia/mastalgia (21.1%). Three-month treatment with VAC extract substantially decreased the percentage of patients with irregular cycle (from 9.1% to 0.1%) and breast tenderness (from 39.9% to 0.8%). Improvement in bleeding intensity, frequency and menstrual pain was experienced by 83.4%, 79.2%, and 85.2% of the patients, respectively. When analyzed by disease category, these parameters improved in almost all dysmenorrhea patients, while they improved to a lesser extent in mastodynia/mastalgia patients. QoL improved in all aspects, but was reported by a higher proportion of dysmenorrhea patients compared to mastodynia/mastalgia patients. Treatment was overall well tolerated with a favorable safety profile.

Conclusion: These real-world data demonstrate the effectiveness of the VAC-containing products Cyclodynon® and Mastodynon® in the three-month treatment of MCDs, with a pronounced improvement in key disease symptoms and QoL. Intriguingly, while QoL was generally greatly improved, the response to VAC therapy varied depending on the type of underlying MCD.

Keywords: Agnucaston; Cyclodynon; Dysmenorrhea; Mastalgia; Mastodynia; Mastodynon.

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Conflict of interest statement

Martina Höller, Hubert Steindl, Dimitri Abramov-Sommariva, Julia Kleemann and Christoph Abels are employees of Bionorica SE; Alexey Loleit is an employee of Traverse Health Europe B.V. and was an employee of Data Matrix GmbH during the conduct of the study. Petra Stute has received honoraria as a speaker at conferences.

Figures

Fig. 1
Fig. 1
Patients with irregular cycle or breast tenderness before and after treatment by disease category
Fig. 2
Fig. 2
Proportion of patients with improvement in bleeding length, bleeding intensity, bleeding frequency and pain during menstruation after treatment by disease category
Fig. 3
Fig. 3
Proportion of patients with improvement in categories of QoL by disease category
See this image and copyright information in PMC

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