Drug – bio-affecting and body treating compositions – Plant material or plant extract of undetermined constitution... – Containing or obtained from labiatae
Reexamination Certificate
2001-08-31
2003-07-01
Lilling, Herbert J. (Department: 1651)
Drug, bio-affecting and body treating compositions
Plant material or plant extract of undetermined constitution...
Containing or obtained from labiatae
C424S732000, C424S734000, C424S757000, C424S760000, C424S765000
Reexamination Certificate
active
06586018
ABSTRACT:
FIELD OF THE INVENTION
The invention is an herbal composition for women for the treatment of premenstrual syndrome, perimenopausal symptoms, menopausal symptoms and postmenopausal symptoms.
BACKGROUND OF THE INVENTION
Menopause is defined as the cessation of menstruation in women. Six to twelve months without a period is the commonly accepted rule for diagnosing menopause. The follicle stimulating hormone (“FSH”) laboratory test is used by physicians in diagnosing menopause. Most women experience menopause between the ages of 40 and 55. Menopause is characterized by hot flashes, headaches, night sweats, atrophic vaginitis, frequent urinary tract infections, cold hands and feet, forgetfulness and an inability to concentrate. Emotional indicators of menopause include distress, irritability, mood swings, depression and decreased sex drive. There are many undesirable symptoms too numerous to articulate which are attributed to pre-menstrual, perimenstrual and premenopause changes in the female body.
Hot flashes are common in menopausal women. Dilation of peripheral blood vessels leads to a rise in skin temperature and flushing of the skin. The skin of a menopausal women during a hot flash becomes red and warm for a period of a few seconds up to two minutes. During a hot flash, the skin on the head and neck of a menopausal woman is particularly affected and becomes red and warm. Other symptoms such as increased heart rate, headaches, dizziness, weight gain, fatigue and insomnia may be associated with a hot flash. Sixty-five (65) to eighty (80) percent of the menopausal women in the United States experience hot flashes. Hot flashes may appear prior to the cessation of the menses and may be the first sign that menopause is approaching.
The term “perimenopausal” is the time period prior to menopause and the term “postmenopausal” is the time period after menopause.
Menopause is now viewed as a disease rather than a normal physiological process. Current medical treatment of menopause involves the use of hormone replacement therapy (“HRT”) for an indefinite period of time utilizing a combination of estrogen and progesterone. Estrogen is one of a group of steroid hormones including estriol, estrone and estradiol that controls the amount of sexual development promoting the growth and function of the female sex organs and female secondary sexual characteristics. Synthetic hormones are made in an attempt to mimic the action of naturally occurring hormones.
Progesterone is a steroid hormone responsible for the changes in the endometrium in the second half of the menstrual cycle preparatory for implantation, development of maternal placenta and development of mammary glands. HRT is not recommended for women with hypertension, diabetes, significant liver or gallbladder disease, coronary artery disease or during pregnancy.
Beginning in the 1940's estrogen was widely prescribed for ameliorating the symptoms of menopause and over time estrogen became the medical treatment of choice for women in menopause. It is now well established that estrogen replacement therapy is associated with a an increased risk of developing uterine cancer, breast and ovarian cancer. Estrogen has also been discovered to cause heart attack and strokes. Estrogen was prescribed for women in an attempt to compensate for the normal decline in estrogen that comes with age.
In an effort to reduce the increased risk of cancer which was being observed through the use of estrogen, physicians and drug companies began recommending that estrogen be combined with progesterone. The combination of estrogen and progesterone has reduced the risks of certain types of cancer such as endometrial cancer but other cancers occur through the use of this combination. Hypertension and coronary artery disease are additional undesirable side effects which occur in women treated with estrogen and progesterone. Women and their physicians are naturally concerned about these remaining risks.
Certain herbs are recognized in the treatment of hot flashes. They include but are not limited to licorice root (
Glycyrrhiza glabra
), chaste berry (
Vitex agnus
-
castus
), black cohosh (
Cimicifuga racemosa
) and angelica (
Cong quai
(
angelica sinensis
). The literature states that these herbs may be effective individually and that combining them is thought to produce an even greater benefit. Black cohosh relieves hot flashes, depression and vaginal atrophy.
Phytoestrogens and phytoprogesterone are plant compounds which closely resemble estrogen and progesterone. Phytohormones are capable of binding to estrogen and progesterone receptors. Phytoestrogens represent a family of plant compounds that have been shown to have both estrogenic and antiestrogenic properties. If estrogen levels are low, phytoestrogens will cause an increase in estrogen effect since they have some estrogenic activity. If estrogen levels are high, phytoestrogens will cause a decrease in estrogen since they bind to estrogen-receptor sites. Some foods such as soy, nuts, whole grains, clover and apples contain phytoestrogens. Women in some cultures remote to the United States have a largely plant based diet and do not experience the symptoms previously mentioned herein and/or do not experience them to the extent that women in the United States experience them. Diets high in phytoestrogens are believed to explain why the women in these remote cultures do not experience the menopausal symptoms that women here in the United States experience. Japanese women intake considerably more phytoestrogens than do American women.
Isoflavones are structurally similar to the body's natural form of estrogen and are found in soy. Isoflavones are a form of phytoestrogens. Isoflavones when consumed by a menopausal woman have many cardiovascular benefits. The estrogen like activity of isoflavones can reduce hot flashes and night sweats.
U.S. Pat. No. 5,707,630 to Morrow issued Jan. 13, 1998 is directed to an herbal compound for women suffering from premenstrual syndrome but it does not disclose or claim the subject matter of the instant application and invention. U.S. Pat. No. 6,238,707 to Chun issued May 29, 2001 is directed to a hormone balance composition but it does not disclose or claim the subject matter of the instant application and invention. U.S. Pat. No. 5,569,459 to Shlyankevich issued Oct. 29, 1996 is directed to a pharmaceutical compositions for the management of premenstrual syndrome and alleviation of menopausal disorders but it does not disclose or claim the subject matter or the instant invention. In fact, the '459 patent states that most of the plant products identified therein and some vitamins and minerals are used in different special menopausal formulas which are manufactured by several producers and are available in health food stores. Further, the '459 patent states that none of these products has proved satisfactory in the treatment of post-menopausal disorders and that all of the known products merely treat symptoms and do not alleviate a hormonal deficiency.
The invention will be better understood when reference is made to the following Summary Of The Invention, Description Of The Invention and Claims which follow hereinbelow.
SUMMARY OF THE INVENTION
It is an object of the present invention to provide an herbal composition which treats premenstrual, perimenopausal, menopausal, and postmenopausal symptoms.
It is a further object of the present invention to provide an herbal composition which provides relief from the distress and discomfort of the premenstrual symptom through the stages of menopause.
It is a further object of the present invention to provide an herbal composition which stimulates naturally occurring hormones so as to minimize or eliminate the symptoms or effects of premenstrual syndrome, perimenopause, menopause and postmenopause.
The invention disclosed and claimed includes sage leaf, red clover extract and kudzu root extract used by themselves. Sage leaf and red clover extract may be used by themselves without the kudzu root extract. Sage leaf and ku
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