Possibilities of Phytomedicine in Monotherapy of Benign Breast Diseases
Condition: Fibrocystic Breast Disease
MeSH terms: Breast Diseases; Fibrocystic Breast Disease
Study type: Interventional
Phase: Phase 4

Summary: 
      The aim of this study is to evaluate the effectiveness of the use of the drug, containing
      Vitex agnus castus extract (VAC), in patients with fibrocystic breast disease . One hundred
      fifty women over 40 years old were randomized into patient (n=78) and control (n=72) groups.
      The groups were similar regarding age, nulliparity, menopause and abortion status, family
      history of breast cancer, alcohol consumption, and smoking. The patient group received two
      pills containing 200mg of VAC daily for six months, and all participants were evaluated by
      using a Visual Analogue Scale and ultrasound examination at baseline, 12th and 24th weeks.
    

Detailed description: 
      One hundred fifty patients presented at the Kazakh Institute of Oncology and Radiology
      diagnosed with FBD between January 2020, and May 2022 were prospectively enrolled in this
      study. The diagnosis was established based on complaints, palpation, and ultrasound findings.
      The patients over 40 years were also routinely screened by mammography to avoid breast cancer
      before including the study. Then, all patients were randomized one-to-one into either the
      control group (n=72) or the treatment (primary) group (n=78) according to the order of
      admission to the hospital. The envelope method was used so that the doctor and radiologist
      who performed the examination and ultrasound of the patients did not know which arm the
      patients were in.

      Persistent pain was identified as a pain that lasts more than 3 months despite medication or
      treatment . The treatment group received two pills containing 200mg of VAC daily for six
      months, while the investigators followed the control group during the same period. Treatment
      responses were assessed using some subjective like the intensity of breast pain (from no
      pain=10 to unbearable pain=10), breast tenderness, and objective measures like palpable lumps
      and ultrasonographic examination performed at baseline, 12th and 24th weeks after the
      treatment by the same equipment and investigator. For the evaluation of breast pain at
      baseline and follow-up, a visual analogue scale marked from "no pain" to "unbearable pain"
      was used. Patients were asked to choose pictures of faces ranging from smiling to
      pain-contorted, conveying their perception of pain severity . Pain intensity was assessed
      using a visual analogue scale (VAS) in scores. The state of breast tissue was evaluated
      according to ultrasound findings; progression (increase in size and/or the number of cysts or
      fibrosis), stabilization (no clinically significant changes), and regression (partial or
      complete clinical response).

      All participants read and signed written informed consent. The study was conducted at the
      Kazakh Institute of Oncology and Radiology based on a protocol proposed by the research team
      and approved by the Local Ethics committee according to principles of the World Medical
      Association (WMA) the Declaration of Helsinki 08/19 from 30th of October 2019.

      Statistical analysis To compare the subgroups in terms of numerical variables, the normality
      was assessed by the Kolmogorov-Smirnov normality test, and the homogeneity of group variances
      was assessed by the Levene test. Mann-Whitney U test was used to determine the difference in
      the groups with median (minimum-maximum values) as descriptive statistics due to the skewed
      nature of those variables. Frequencies and percentages were presented to describe the
      categorical variables. The association between the groups and categorical variables was
      assessed with univariate analysis by the Pearson Chi-square test or fisher exact test, and
      the Bonferroni method was used to compare subgroups; if there was no difference between the
      groups, it was shown with the same letter, and if there was a difference, it was shown with a
      different letter. The IBM SPSS Statistics (version 25.0 for Windows, Chicago, IL, USA) was
      used, and p<0.05 was considered signiﬁcant for all statistical analyses.
    

Intervention name(s): Vitex Agnus Castus Extract
Intervention type(s): Drug
Intervention description(s): The patient group received two pills containing 200mg of VAC daily for six months
Other intervention name(s): Mastodynone
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: all patients were randomized one-to-one into either the control group (n=72) or the treatment (primary) group (n=78) according to the order of admission to the hospital
Masking: None (Open Label)
Primary purpose: Supportive Care