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| Date: 08-15-2018 | HC# 011864-598 |
Re: Systematic Review of Chaste Tree Berry for the Treatment of Premenstrual Syndrome
Cerqueira
RO, Frey BN, Leclerc E, Brietzke E. Vitex
agnus castus for premenstrual syndrome and premenstrual dysphoric disorder:
a systematic review. Arch Womens Ment
Health. December 2017;20(6):713-719. doi:
10.1007/s00737-017-0791-0.
Premenstrual
syndrome (PMS) is characterized by increased sensitivity to physical symptoms
and emotional and behavioral changes in the late luteal phase of the menstrual
cycle. PMS affects as many as 70-85% of women. Premenstrual dysphoric disorder
(PMDD) is a severe type of PMS that is characterized by intense emotional
distress and/or a significant negative impact on a woman's ability to function.
In many cases of PMS and PMDD, pharmacotherapy is prescribed, including
antidepressants and ovarian suppression. Women, particularly those who cannot
tolerate pharmaceutical treatments, often use alternative therapies. Chaste
tree (Vitex agnus-castus; Lamiaceae)
berry is commonly used for the treatment of PMS and PMDD. Chaste tree berry contains
several phytochemicals that have been found to effect hormones,
neurotransmitters, and inflammatory and pain pathways. The goal of this systematic
review of randomized controlled trials (RCT) was to evaluate the effectiveness
of chaste tree berry for the treatment of PMS and PMDD.
PubMed
and SciELO databases were searched for all RCTs published in English, French,
Italian, Spanish and Portuguese. Inclusion criteria were RCTs in individuals diagnosed
with PMS or PMDD that compared chaste tree berry with either placebo or active control and included a description of blinding
and dropouts/withdrawals. Studies that used chaste tree berry in adjunct with another
therapy or investigated chaste tree berry efficacy as a secondary outcome were
excluded.
Twenty-nine
studies were identified, eight of which met the inclusion criteria and were evaluated
in this review. Included studies were published between 1997 and 2012. Given the
changing diagnostic criteria over these years, most studies focused on PMS. The
following preparations were used in the studies: three different dry extract
tablets were used in five studies, including BNO
1095 (n=2; Bionorica
SE; Neumarkt, Germany), Ze 440 (n=2; Prefemin; Max Zeller Söhne AG; Romanshorn,
Switzerland), and Agnolyt (n=1;
Rottapharm Madaus; Monza, Italy); one study used a liquid ethanolic extract (no
information provided on the manufacturer); two studies specified dose (40 mg
daily and 20-40 mg daily not further specified) but not the preparation form.
BNO 1095 tablets contain 40 mg of dry ethanolic (70%) extract (drug
extract ratio [DER] 8.3-12.5: 1)
corresponding to 40 mg of herbal drug, and the dose used was one tablet daily. Ze
440 tablets contain 20 mg of native dry ethanolic (60%) extract (DER 6-12:1) standardized
for casticin and corresponding to 180 mg herbal drug, and the dose was one
tablet daily; one study with Ze 440 used 20 mg, and the second study used 8 mg,
20 mg, and 30 mg dry extract dosages daily, however. Each Agnolyt capsule
contains 3.5-4.2 mg of dry extract (DER 9.58-11.5:1) corresponding to 40 mg of
herbal drug; the dose used was one tablet daily. The liquid ethanolic extract
was administered as 40 drops (approximately 4.5 mg) in a glass of fruit juice
daily before breakfast.
Reviewed
studies included a total of 1036 women, and study duration ranged from two to
three months. Five studies compared chaste tree berry to placebo, and three used
active comparators, specifically pyridoxine (n=1) and fluoxetine (n=2). There
was a significant improvement in PMS and/or PMDD symptoms in all five of the
studies comparing chaste tree berry to placebo. In the study comparing
different dry extract dosages of Ze 440, both 20 mg and 30 mg were more efficacious
than placebo and 8 mg, with no significant differences between 20 mg and 30 mg,
showing that 20 mg of dry extract would be the preferred daily dosage. Chaste
tree berry extract was more effective than pyridoxine for PMS symptoms. One study
found chaste tree berry as effective as fluoxetine and one study found fluoxetine
was more efficacious in alleviating psychological symptoms of PMS. Chaste tree berry
was generally well-tolerated, with only mild side effects reported.
There
were many limitations that made it difficult to compare results among studies,
including the use of different diagnostic criteria, heterogeneous outcome
measures, and the variation in the chaste tree berry preparation forms and
dosages. Despite these limitations, the authors conclude that the available
RCTs indicate chaste tree berry is a safe and effective short-term treatment
for PMS and PMDD, especially for alleviation of somatic symptoms. However, they
point out that longer duration studies are needed to fully evaluate the safety
and efficacy of long-term use of chaste tree berry.
—Erin Smith, MSc.,
CCH
