Dr. Hansel DeBartolo 1-630-859-1818

DeBartoloPMS™

Nutritional Support For Menstrual Discomforts

DESCRIPTION

DeBartoloPMS™ capsules provide a select vitamin, mineral, and standardized botanical extract combination that helps support and moderate some of the physical changes experienced by many women prior to menstruation, including alterations in hormone metabolism and fluid balance.

OVERVIEW

Premenstrual syndrome (PMS) is characterized by physical and emotional symptoms that develop following ovulation and decrease with the beginning of menstruation. These recurrent symptoms typically include anxiety, depression, irritability, fatigue, abdominal bloating, fluid retention in fingers and ankles, breast tenderness, altered sex drive, headache, and food cravings. The combination and severity of symptoms vary among women. The Office of Women’s Health within the Department of Health and Human Services reports that as many as 75 percent of women experience some symptoms of premenstrual syndrome.

Although there are a variety of symptoms associated with premenstrual syndrome, research suggests that there are common hormonal patterns in women with premenstrual syndrome that are distinct from those seen in women who do not experience premenstrual discomfort. One of the most common findings is an imbalance in the estrogen-to-progesterone ratio. Following ovulation and prior to the onset of menstruation, estrogen levels increase and progesterone levels decrease. It is at this time that women with PMS typically show mild estrogen excess and progesterone deficiency compared to non-PMS women. This may be due in part to dysfunction of the corpus luteum which plays an important role in progesterone and estrogen production.

In many cases of PMS, there is a slight increase in aldosterone, a hormone involved in fluid balance. Aldosterone may rise in response to elevated estrogen levels, an increase in sodium intake, or a lack of magnesium.

There is also increasing evidence to suggest a role of neurotransmitters, particularly serotonin, in certain forms of premenstrual syndrome. Finally, poor diet quality is also a suspected factor in the etiology of premenstrual syndrome. Many studies have found women who experience premenstrual syndrome symptoms, have inadequate levels of several key nutrients, including magnesium, calcium, and certain B vitamins.

Central to the effective relief of PMS symptoms is the body’s ability to restore a more optimal estrogen-to-progesterone ratio during the luteal phase. Specific nutrients which may be altered by excess estrogen can be supplemented in higher amounts that the body can use to help increase progesterone production and decrease estrogen production.

Vitamin B6: Vitamin B6 is involved in numerous chemical processes within the body, including, but not limited to, the production of brain neurotransmitters, hormone balancing, energy production, and immune system function. Through these roles in neurotransmitter production, particularly serotonin synthesis, and hormone balancing, vitamin B6 appears to help moderate symptoms associated with premenstrual syndrome. Women with PMS, particularly those with depression, exhibit low vitamin B6 levels due at least in part to an inhibiting effect of excess estrogen on vitamin B6.  Vitamin B6 appears to help raise progesterone levels, while also facilitating the excretion of excess estrogen, thereby promoting a more balanced ratio of progesterone to estrogen. Vitamin B6 is necessary for the synthesis of serotonin, a brain neurotransmitter involved in mood regulation. Certain mood disorders, including depression and anxiety, have been associated with suboptimal levels of vitamin B6.

Magnesium: Magnesium plays a critical role in a wide range of essential activities throughout the body, including many functions relevant to premenstrual changes experienced by some women. Magnesium is necessary for serotonin synthesis, which in turn is critical in mood regulation. Magnesium also appears to promote proper fluid balance, helping to ease the uncomfortable build up of excess fluid experienced by some women prior to menstruation. Inadequate magnesium levels have been found in women who experience premenstrual cravings and appetite changes. In addition to these roles, magnesium is also essential to maintaining proper muscle and nerve functioning, promoting optimal bone formation, regulation of heart rhythm, and energy production. Despite the importance of this mineral, two national, government nutrition surveys found that the diets of the majority of US adults provide insufficient amounts of magnesium. Many clinical studies have demonstrated that a large portion of women who experience unpleasant premenstrual changes have low levels of magnesium.

Vitex: Vitex agnus-castus, commonly referred to as chasteberry, is derived from the fruit of the chasteberry shrub. Vitex is widely used throughout Europe for moderating many of the discomforts experienced by women prior to menstruation. Research continues at this time to fully understand the activity and actions of vitex, but it is thought that much of its activity can be attributed to combined presence of several constituents, including flavonoids, iridoid glycosides, and terpenoids. Vitex does not contain any hormones, however, it appears to act largely by influencing hormone activity. Vitex is thought to promote the production of luteinizing hormone by the pituitary gland, which then results in an increase in progesterone production. Vitex also appears to moderate prolactin secretion. DBartoloPMS™ provides Vitex agnus-castus standardized to 0.5% agnuside content.

INDICATIONS

DeBartoloPMSä is intended as a nutritional adjunct for women wishing to supplement their dietary intake with a combination of nutrients and botanical extracts known to support the body through physical changes that occur prior to menstruation.

FORMULA

Amount Per Capsule

SUGGESTED USE

One capsule twice daily with food.

ADVERSE REACTIONS

None reported.

CONTRAINDICATIONS

Individuals with renal disease disease should consult with their physician before taking a magnesium supplement. Mild stomach upset and/or skin rash may occur in rare instances with use of Vitex. Vitex is not recommended for use during pregnancy, lactation, or hormone therapy, or by women trying to conceive.

DRUG INTERACTIONS

As many potential drug-nutrient interactions exist with both vitamin B6 and magnesium, careful review of medication use is advised when supplementing with these nutrients. Based on animal and in vitro pharmacological studies, Vitex should not be taken concurrently with hormone therapies or dopamine agonists.

DRUG-INDUCED NUTRIENT DEPLETION

Magnesium deficiencies may result from use of diuretics, estrogens, and corticosteroids. Vitamin B6 deficiencies may result from use of estrogens and  antibiotics.

HOW SUPPLIED

120 capsules (Vcaps™) per bottle with full-bottle shrink-wrap. Packaged 12 bottles per case.

STORAGE

Store in a cool, dry place (59ºF-85ºF) away from direct light or keep refrigerated. Keep out of reach of children.

REFERENCES

Barnhart KT, Freeman EW, Sondheimer SJ. A clinician's guide to the premenstrual syndrome. Med Clin North Am  1995 Nov;79(6):1457-72.

Chuong CJ, Hsi BP, Gibbons WE. Periovulatory beta-endorphin levels in premenstrual syndrome. Obstet Gynecol  1994 May;83(5 Pt 1):755-60.

Facchinetti F, Nappi G, Petraglia F, Volpe A, Genazzani AR. Oestradiol/progesterone imbalance and the premenstrual syndrome. Lancet  1983 Dec 3;2(8362):1302.

Munday MR, Brush MG, Taylor RW. Correlations between progesterone, oestradiol and aldosterone levels in the premenstrual syndrome. Clin Endocrinol  1981 Jan;14(1):1-9.

National Women’s Health Information Center, Office of Women’s Health, Department of Health and Human Services.

    Premenstrual Syndrome. www.4woman.gov/faq/pms.htm. 2002.

Shils, Maurice E., James A. Olsen, Moshe Shike, A. Catherine Ross, eds. 1999. Modern Nutrition in Health and Disease, 9^th Edition.

    Philadelphia: Lippincott Williams & Wilkens.

Sundstrom I, Backstrom T, Wang M, Olsson T, Seippel L, Bixo M. Premenstrual syndrome, neuroactive steroids and the brain. Gynecol Endocrinol  1999 Jun;13(3):206-20.

Wang M, Seippel L, Purdy RH, Backstrom T. Relationship between symptom severity and steroid variation in women with premenstrual syndrome: study on serum pregnenolone, pregnenolone sulfate, 5 alpha-pregnane-3,20-dione and 3 alpha-hydroxy-5 alpha-pregnan-20-one. J Clin Endocrinol Metab  1996 Mar;81(3):1076-82.

For ordering information, please contact:

The DeBartolo Clinic

11 DeBartolo Drive

Sugar Grove, IL  60554

 (630) 859-1818

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