Vitex more effective than pyridoxine in PMS
Good clinical evidence bears out the strong traditional reputation
of Vitex agnus-castus L., Verbenaceae in the treatment of menstrual
abnormalities, premenstrual syndrome (PMS), menopausal complaints, and
even infertility. Recently, this team of German investigators designed
a controlled, double-blind study to evaluate the efficacy and safety
of a standardized Vitex capsule formulation (Agnolyt®, Madaus AG)
in comparison with pyrodoxine (vitamin B6) in 175 women with PMS. Pyridoxine
was chosen for purposes of comparison because earlier research indicates
that it can be effective in alleviating various symptoms of PMS, which
may include nervousness, irritability, depression, bloating, breast
tenderness, weight gain, and skin and digestive problems.
The 175 women were randomized to receive daily treatment with one standardized
Vitex extract capsule (reported to be equivalent to 3.5 to 4.2
mg Vitex) plus one placebo capsule (n=90) or two 100 mg capsules
of pyridoxine (n=85). Duration of treatment was three menstrual cycles.
Therapeutic response was assessed with the premenstrual tension syndrome
(PMTS) scale, recording of six typical PMS complaints, and the clinical
global impression (CGI) scale. Treatment efficacy was assessed by both
patients and physicians. At the end of the trial, 127 subjects were
eligible for inclusion in the efficacy analysis; all 175 were included
in the safety analysis.
In comparison with pyridoxine, Vitex was associated with "a
considerably more marked alleviation of typical PMTS complaints, such
as breast tenderness, edema, inner tension, headache, constipation,
and depression." Overall, 77.1% of subjects taking Vitex
reported improvements, compared to 60.6% of those in the pyridoxine
group. With regard to physician assessments, 80% felt that both treatments
provided "adequate" efficacy. However, 24.5% rated Vitex
treatment as "excellent," compared to only 12.1% with pyridoxine.
Side effects were reported by 5 women in the pyridoxine group and 12
in the Vitex group, including headache, gastrointestinal and
lower abdominal complaints, and skin problems. No serious adverse events
were seen. Although women wishing to conceive were excluded at the beginning
of the study, 5 women taking Vitex became pregnant during the
course of the trial. -- Evelyn Leigh, HRF
[Lauritzen, C., Reuter, H.D.,
Repges, R., Bohnert, K.-J., Schmidt, U. Treatment of premenstrual
tension syndrome with Vitex agnus castus. Controlled, double-blind
study versus pyridoxine. 1997. Phytomedicine, Vol. 4, No.