BIO ACTIVES JAPAN CORPORATION

INTRODUCTION:

　Premenstrual syndrome is a complex combination of psychological symptoms including irritability, aggression, tension, anxiety and depression and other changes including fluid retention, breast tenderness, headache, feeling of bloating and also weight increase. The causes of the premenstrual syndrome have not been clearly elucidated but have been attributed to hormonal changes, neurotransmitters, diet, drugs and lifestyle, hence casual treatment is difficult.

　Bio Actives introduces Vitex agnus-castus extract or chastetree standardized for 0.5% agnuside. Vitex is a deciduous shrub reaching height of up to 5 m, belonging to the genus Vitex of the Verbenaceae family. It is widespread on river banks and on shores in the Mediterranean Europe, Central Asia and parts of India.

　Vitex has a long tradition of application dating back as far as the Greeks and Romans. Used as a herbal remedy in ancient times Vitex was found application as an anaphrodisiac and for preserving chastity and also against diverse disturbances of the female genital system. It has been used medicinally for at least two thousand years. Christian monks used to eat the berries which smell and taste like pepper as a spice and as an anaphrodisiac. Today in Europe especially in Germany, Vitex has been approved for gynecological conditions. Medical doctors in Germany frequently prescribe chastetree to patients and it is commonly used throughout Europe and North America.

CONSTITUENTS:

　The fruits of chastetree contain a mixture of iridoids and flavonoids and some compounds similar in structure to the sex hormones have been isolated from the leaves and flowers. The fruit extract consists of a multitude of constituents, of which none reaches a share of > 1%. The iridoid glycoside agnuside is a good marker for Vitex, since the substance is less frequent in other species.

USAGE & INDICATIONS:

　Scientific evidence suggests that chastetree is beneficial for the treatment of premenstrual syndrome, cyclical mastalgia (breast pain) and hyperprolactinemia (high levels of prolactin). The principal activity of chastetree appears to be derived from dopaminergic compounds present in the herb that improve premenstrual mastodynia (breast pain) and possibly other symptoms of premenstrual syndrome. Evidence indicate that an extract of chastetree binds to dopamine receptors (D2) in the hypothalamus and anterior pituitary thereby inhibiting the release of prolactin and thus reducing corresponding mastodynia. Other endocrine effects include increased progesterone secretion. Other studies also show the effect of chastetree for the treatment of infertility.

CLINICAL EVALUATION:

　Several clinical studies conducted have proven the medical benefit of chastetree in the treatment of premenstrual syndromes. In one randomized, placebo controlled study conducted in Germany, 170 women (86 active; 74 placebo) with mean age of 36 years were evaluated for premenstrual syndromes with a fruit extract of chastetree. The women were evaluated for their self assessment of irritability, mood alteration, anger, headache, breast fullness and other menstrual symptoms including bloating. Patients treated with the active had a significant improvement in combined symptoms compared with those on placebo. Over half the women had a 50% or greater improvement in their symptoms. These effects were confirmed by both patients as well as after doctors’ evaluation.

　Another open study conducted without control in Germany amongst 1634 patients suffering from premenstrual syndrome indicated that Chasteberry after a treatment period of three menstrual cycles 93% of patients reported a decrease in the number of symptoms or even cessation of PMS complaints. 94% of patients assessed the tolerance of Vitex treatment as good or very good. Adverse drug reactions were suspected by physicians in 1% of patients, but there were no serious adverse drug reactions. Hence, the risk/benefit ratio of the new Vitex preparation can be rated as very good.