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Clinical Indications:
Shown to be helpful in the treatment of symptoms of PMS.

Can help reduce physical symptoms such as headache, breast pressure and tenderness, bloating, and fatigue, which may be associated with PMS.

To assist with the treatment of psychological symptoms such as increased appetite, craving for sweets, nervousness, restlessness, anxiety, irritability, lack of concentration, depression, mood swings, and aggressiveness, which may be associated with PMS.

    Chastetree Berry - General Information and Traditional Uses
    Vitex is approved by the German Commission E for the treatment of PMS and other menstrual irregularities. [i]

    Vitex has been used traditionally for many things, mostly for menstrual conditions and problems associated with childbirth. It has been reported to be used to help expel the placenta after childbirth, to promote menstruation, and for inflammation of the uterus. [ii] [iii] It was also used to promote lactation in new mothers and to suppress libido. Vitex has also been reported to be an emmenagogue and galactagogue, and for impotence and “sexual melancholia”. [iv]

    Pharmacology & Mechanism of action
    It has been shown in both human and animal studies that Vitex binds dopamine receptors in the anterior pituitary, which decreases basal and thyrotropin releasing hormone stimulation of prolactin. [v] [vi] [vii]

    It is suggested that inhibition of prolactin leads to a reversal of LH suppression.  Increased LH levels leads to an increase of progesterone levels, which can decrease premenstrual symptoms. [viii] [ix] This mechanism of increasing or balancing progesterone levels is an indirect hormonal action. [x]

    Biochemistry
    Vitex increases LH production and mildly inhibits the release of FSH. This results in a shift in the ratio of estrogen to progesterone, in favor of progesterone. [xi]

    Physiologic changes
    Vitex fruit and extract decreases lactation. [xii] Dopamine is known as a prolactin inhibitory factor (pif), which also decreases lactation. Dopamine is one of the neurotransmitters, which has inhibitory effect on the Hypothalamic-Pituitary-Gonadal (HPG) axis. [xiii] [xiv] It seems that the inhibitory effect of Vitex fruit extract on the HPG axis is probably due to this activation of the dopaminergic pathway.

    Constituents
    Agnuside is an active iridoglycoside isolated and used as a reference for Vitex extracts. [xv] [xvi]

    Part(s) Used Traditionally
    The primary part used of Vitex agnus castus is the ripe berry.

    Clinical Trials
    Controlled German monitoring studies of Vitex used for menstrual disorders in 1542 women, showed 90% of symptoms relieved, with less than 2% of patients reporting mild side effects. [xvii]

    A study of 36 patients using Vitex liquid extract daily for 3 cycles showed a reduction in both physical symptom and psychological symptoms of PMS. Luteal phase was prolonged, and a diphasic cycle was established. [xviii]

    Several double-blind randomized trials of women with PMS have been conducted. One trial showed a 77.1% CGI (Clinical Global Impressions) score for Vitex. Another showed a 52% positive response rate and concluded that Vitex is an effective and well-tolerated intervention for PMS. [xix] [xx]

    Toxicology
    Long-term comprehensive tests on toxicity (long-term or serious side effects) have not been performed on Vitex as of this writing.

    Historically, Vitex has been used during both pregnancy and lactation, in preventing miscarriage and stimulating milk production, but uses during pregnancy and lactation should be under the supervision of a licensed health care provider.

    There are reports of women taking Vitex safely for up to sixteen years.

    There are no reports of serious side effects, but some report that a small proportion of women experience mild side effects during Vitex treatment, such as nausea, gastric disturbance or headaches. These seem to occur in low numbers of patients and resolve with cessation of treatment.

    Interactions with conventional medications
    There are no known drug interactions, yet since Vitex affects female hormones, it should only be taken with other endocrine therapies or hormonal medications under the care of a licensed health care provider.

    Vitex may be contraindicated for women who are taking dopamine-receptor antagonists, as the herb may interfere with its actions.

    Dong Quai Root - General Information and Traditional Uses
    Dong quai has been used in traditional Chinese medicine (TCM) and Native American medicine for centuries. It has most commonly been used to treat cramps and pain during menstruation, as well as to ease some of the symptoms of menopause (including hot flashes, night sweats).

    Dong quai has been traditionally used in balancing the reproductive hormone system, as an anti-inflammatory and anti-spasmodic agent. [xxi]

    Dong quai has been called the “female ginseng” and has been used for centuries in China for regulating hormones. [xxii] [xxiii]

    Pharmacology
    Dong quai contains two substances that have opposing effects on the uterus.  The volatile oil, which includes ligustilide, inhibits contractions, while the non-volatile oil, which includes ferulic acid, stimulates contractions.  Research has suggested that both these substances prevent spasms, relax vessels, and prevent blood clotting in peripheral vessels.

    Blood pressure is reduced by dilation of blood vessels. This has been attributed to the presence of coumarins.  Coumarins can also have antispasmodic and vasodilatory actions.

    Polysaccharides are said to have immune stimulating effects by stimulating the production of interferon and leukocytes.

    There are reports in the literature to suggest that Dong quai acts as a phytoestrogen in the body (similar to isoflavones). More recent research suggests that there does not appear to be any estrogenic compounds present in the plant.

    Constituents include coumarins, ferulic acid and ligustilide, and essential oils, which are compounds that may be useful for blood flow and for relaxing the uterus in premenstrual uterine cramping. [xxiv] 21 Coumarins are known vasodilators and antispasmodics. [xxv]

    Part(s) used traditionally
    The primary part used of Dong quai is the dried root.

    Clinical Trials
    Based on available evidence, Dong quai may have efficacy for the treatment of PMS when used in multiple herb formulas. [xxvi]

    Toxicology
    Reported adverse events include bloating, loss of appetite, diarrhea, photosensitivity, and gynecomastia. [xxvii] [xxviii] [xxix] People taking Dong quai should minimize their exposure to sunlight or use sunscreen while taking the herb.

    Long-term comprehensive tests on toxicity (long-term or serious side effects) have not been performed as of this writing, therefore Dong quai is not recommended for use by pregnant or lactating women. Because of Dong quai’s ability to increase bleeding time, use should be discontinued as soon as menstruation begins (if using to control PMS symptoms).

    Interactions with conventional medications
    Due to the coumarin content, the activity of anticoagulants may be potentiated. [xxx]

    Dong quai should not be combined with other anticoagulant or antiplatelet drugs unless drug levels are monitored regularly under the supervision of a licensed health care provider.

    Wild Yam Root - General Information and Traditional Uses
    Wild yam is known for its’ hormone balancing/modulating effects, which can be beneficial in treating the symptoms of PMS. [xxxi]

    Wild yam has long been used as a liver tonic, digestive aid, and muscle relaxant.

    Ayurvedic practitioners have used wild yam as a remedy for impotence and infertility.

    Wild yam is known as colic root because of its antispasmodic action.

    It has also been used for diverticulitis, nausea during pregnancy, and flatulence.

    Pharmacology
    Dioscorea has anti-inflammatory and antispasmodic effects. [xxxii]

    Wild yam contains alkaloids as well as diosgenin and other saponins. While diosgenin can be converted in the laboratory to make sex hormones, it cannot be converted in the body into Progesterone, DHEA, or other sex hormones. The herb may, however, have mild hormonal effects through other mechanisms.

    Part(s) used traditionally
    The primary part used of wild yam is the dried root tuber.

    Toxicology
    Long term comprehensive tests on toxicity (long-term or serious side effects) have not been performed as of this writing, therefore wild yam is not recommended for use by pregnant or lactating women. There is no known toxicity with wild yam, and it appears to be a very safe herbal remedy. Nausea and diarrhea have been reported when excessive levels have been consumed.

    Interactions with conventional medications
    There are no known drug or nutrient interactions associated with wild yam.

    Passionflower - General Information and Traditional Uses
    Passiflora is known for its potential ability to safely decrease anxiety and for its calming effects.  It may also decrease pain and muscle spasms. 

    Passionflower has been shown to be directly anxiolytic and may increase the effectiveness of other anxiolytic herbs.

    Passiflora has been traditionally used for symptoms of nervousness and sleeplessness, as an antispasmodic, as well as for treating cardiac rhythm abnormalities. [xxxiii] [xxxiv] [xxxv] [xxxvi]  It has also been employed as an aphrodisiac, for colic, diarrhea, dysentery, menstrual difficulties, neuralgia, eye disorders, epilepsy and convulsions, and as an analgesic.

    Pharmacology
    Reported actions are as a nonaddictive sedative, anxiolytic, and antispasmodic. [xxxvii] The available pharmacodynamic studies generally support the empirically accepted central nervous system sedative and anxiolytic effects. [xxxviii] 50

    A tri-substituted benzoflavone moiety (BZF) has been proposed to be responsible for many of the biological activities of this plant. Passiflora also contains glycosides, flavonoids (vitexin, chrysin), coumarin derivatives, sterols, cholorogenic acid, volatile oil, and traces of alkaloids (including harmine, harman), which may contribute synergistically to biological mechanisms as well. [xxxix] [xl]  [xli]

    Part(s) used traditionally
    The primary parts used of Passionflower are the dried aerial parts.

    Clinical Trials
    One study including 36 men and women with generalized anxiety disorder found that passionflower was as effective as a leading anti-anxiety medication when taken for one month. A second study including 91 people with anxiety symptoms revealed that an herbal European product containing passionflower and other herbal sedatives significantly reduced symptoms compared to placebo. [xlii] [xliii] [xliv] [xlv] [xlvi] [xlvii] [xlviii]

    Toxicology
    Long term comprehensive tests on toxicity (long-term or serious side effects) have not been performed as of this writing, therefore Passiflora is not recommended for use by pregnant or lactating women. There is currently no known toxicity with consumption of Passiflora.

    Interactions with conventional medications
    When used as directed, passionflower is considered quite safe.  High doses may induce drowsiness and central nervous system depression. Therefore, Passiflora should not be combined with barbiturates, anti-anxiety medications, or antidepressants. Otherwise, no side effects or contraindications are reported for the herb.

    Bupleurum - General Information and Traditional Uses
    Bupleurum, also called Chinese thoroughwax, is considered a liver tonic in traditional Chinese medicine. Its traditional uses include treatment of infection with fever, liver disease, digestive problems, and uterine prolapse.

    It has also been used to treat muscle spasm and tension, as well as to regulate the menstrual cycle, reduce hot flashes, and relieve symptoms associated with premenstrual syndrome.

    Because of its ability to move energy and detoxify, it is generally thought of for conditions in which stagnation is prominent.

    Pharmacology
    Bupleurum has active constituents called saikosaponins which have been found to inhibit liver cancer cell growth in vitro [xlix] and to have anti-inflammatory properties. [l] [li]

    Essential oils found in bupleurum are anti-inflammatory, [lii] and have demonstrated antispasmodic effects on the uterus in animal research. [liii]

    Part(s) used traditionally
    The root is used in tincture and tea.

    Clinical Trials
    Bupleurum is usually used in combination with other medicinal herbs. Research has focused on a bupleurum-containing traditional formula, known as sho-saiko-to in Japanese, xiao-chai-hu-tang in Chinese, and minor bupleurum in English. Bupleurum makes up 16% of this widely used formula.

    In children and adults with hepatitis B, preliminary trials have found that minor bupleurum formula was helpful in relieving symptoms and decreasing liver enzymes. [liv] [lv] [lvi]

    Similar results were found in a trial using minor bupleurum formula in people with hepatitis C. [lvii]

    Preliminary studies suggest that minor bupleurum formula might reduce the risk of liver cancer in people with chronic viral hepatitis [lviii] and liver cirrhosis. [lix]

    Toxicology
    There is no information regarding the safety and efficacy of bupleurum in pregnancy and lactation. Women who are pregnant or nursing should consult a health care professional with expertise in the use of medicinal herbs before using bupleurum.

    Some minor side effects have been reported by people using bupleurum, including tiredness, flatulence, and increased bowel movements.

    A number of cases of pneumonitis have been reported in people using minor bupleurum formula alone and in combination with interfereon to treat hepatitis. [lx] [lxi] [lxii] [lxiii] [lxiv] However, no toxicity of bupleurum independent of the other herbs in this formula has been demonstrated.

    Interactions with conventional medications
    No herb-drug interactions have been documented for bupleurum, however, people using interferon should consult a health care professional with expertise in the use of medicinal herbs before using bupleurum.

    Pyridoxine (Vitamin B6) - General Information
    Vitamin B6 is a coenzyme for many biochemical pathways, involved in the metabolism of certain amino acids, in carbohydrate and lipid metabolism, and in the synthesis of some hormones and neurotransmitters.

    Pharmacology
    Vitamin B6 is a water-soluble component of the B complex, occurring in many foods as pyridoxine, pyridoxal, and pyridoxamine, and converted to pyridoxal phosphate and pyridoxamine phosphate in the body.

    Clinical Trials
    Some studies have found pyridoxine supplementation to be helpful in relieving the symptoms of PMS, [lxv] [lxvi] [lxvii] however, some studies have not. [lxviii] [lxix]

    In one study, pyridoxine was found to be more effective than bromocritine, a medication used to treat PMS, and caused fewer side effects. [lxx]

    One study found that a small amount of pyridoxine (50 mg per day) plus magnesium (200 mg per day) taken over the course of one menstrual cycle relieved PMS symptoms including anxiety, depression, cravings, and water retention. [lxxi]

    Toxicology
    Pyridoxine is considered nontoxic at usual doses, however, doses in excess of 2 grams per day for 2 months or longer has led to sensory neuropathy.

    Nausea, headache, numbness, sleepiness, and low serum folic acid levels have been reported in some people taking pyridoxine.

    Pyridoxine requirements increase during pregnancy and lactation, but very high doses during pregnancy have been implicated in some cases of vitamin B6 dependency syndrome in infants and should be avoided.

    Interactions with conventional medications
    A number of medications, including oral contraceptives, increase vitamin B6 requirement. Some other drugs on this list are anticonvulsants, antituberculous medicines, erythromycin, estrogens, penacillamine, tetracycline, theophylline, and tricyclic antidepressants. People using these medications should consult with a health care professional knowledgeable about nutritional supplements before taking pyridoxine.

    Recommended Daily Amounts

    Chastetree Berry Extract (Vitex agnus castus) 150-450mg twice daily
    Dong Quai Extract (Angelica sinensis Root)   125-375mg twice daily
    Wild Yam Extract (Dioscorea villosa Root)  125-375mg twice daily
    Bupleurum Root Extract 125-375mg twice daily
    Passionflower Extract (Passiflora incarnata)  75-225mg twice daily
    Pyridoxine (HCL)  25-75mg twice daily

                           

    References

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