Chaste Tree Improves Cyclic Mastalgia
Reviewer: Tori Hudson, N.D.
Author: Mirghafourvand M, Mohammad-Alizadeh-Charandabi S, Ahmadpour P, Javadzadeh Y.
Reference: Effects of Vitex agnus and Flaxseed on cyclic mastalgia: A randomized controlled trial.Complementary Therapies in Medicine 2016;24:90-95.
Design: This randomized, triple-blind, placebo-controlled trial investigated the effectiveness of chaste tree and flaxseed in alleviating cyclic mastalgia (breast pain). Patients were instructed on filling out a daily pain chart during their menstrual cycle and those with more pain, i.e. a score of above 7, were then included in the trial. In total, 960 women were evaluated and 159 were randomized to each group.
One group received 25 grams of flaxseed powder daily for two months. This group also received a placebo of chaste tree tablets. The second group received one chaste tree tablet and a placebo of flaxseed. Each chaste tree tablet contained 3.2-4.8 mg dried fruit of chaste tree and it was used daily after a meal. The flaxseed placebo was from wheat flour. The flaxseed was delivered in water, milk or juice. Treatments were taken throughout the menstrual cycle for 2 months. Patients were also given gelofen (400 mg, a non-steroidal anti-inflammatory drug) to treat any breast pain as necessary and reported its usage while also reporting any side effects from the treatments.
Participants: The subjects were women living in Iran between 18-45 years of age, and had cyclic breast pain and tenderness. The average age was 32.6 years old with average body mass index of 26.4 kg/m2 and nearly half were overweight. The majority of the women were housewives. Condoms as contraception were used by 40% while ejaculation withdrawal was used by 34%.
A physical exam was required and those with normal breasts were then included. Women were excluded if they had a chronic illness or were taking medications. The average breast pain intensity score at baseline was 12.44 and was the same in each group for both intensity and duration.
Primary outcome: The main outcome was the Cardiff Chart, marking the daily intensity of their pain. Patients saw a clinician at the end of the first and second interventional menstrual cycle. The Cardiff Chart is a standard table consisting of 31 columns representing the days in a month and each cell in the table represents date. The women then filled out the cells in terms of intensity of pain (severe, mild or none). A score above 14 represents severe pain while a score between 7 and 14 represents moderate pain and below 7 indicates mild pain.
Key findings: Breast pain intensity scores significantly decreased in all groups from baseline to the end of the study: flaxseed: 12.8 ± 5.6 vs. 3.5 ± 2.5, chaste tree: 12.0 ± 3.7 vs. 3.9 ± 2.8, and placebo: 12.5 ± 4.5 vs. 10.4 ± 4.2. At both 1 and 2 months, breast pain intensity scores in the flaxseed and chaste tree groups were significantly lower than the placebo group. Breast pain duration scores were also significantly lower at the end of the study for all. In addition, at 1 and 2 months, pain duration scores were significantly lower in the flaxseed and chaste tree groups as compared with the placebo group.
There were some adverse side effects that included dysentery symptoms and nausea that occurred in women taking flaxseed. At the 1 month mark, 4 women consuming flaxseed, 3 consuming chaste tree, and 9 of the placebo patients had taken the gelofen. At the end of the study, 3 flaxseed patients and 14 placebo patients took gelofen. No one took gelofen in the chaste tree group.
Cyclic breast pain in menstruating women can be as minimal as annoying to severe pain which can affect quality of life. One of the strongest areas of research for chaste tree (Vitex agnus-castus) is in the area of cyclic mastalgia with at least 5 published studies prior to this one. Flaxseed (Linum usitatissimum, Linaceae) contains phytoestrogens and fiber, both of which likely influence its effect in reducing breast pain.
Even though both flaxseed and chaste tree has a significant effect on reducing cyclic breast pain intensity and duration compared to placebo, those in the placebo group demonstrated significant improvement at the end of the study as well. One would question the placebo material used.