Drug – bio-affecting and body treating compositions – Preparations characterized by special physical form – Capsules
Reexamination Certificate
2000-07-07
2002-02-12
Spear, James M. (Department: 1615)
Drug, bio-affecting and body treating compositions
Preparations characterized by special physical form
Capsules
C424S455000, C424S456000, C424S464000, C424S489000
Reexamination Certificate
active
06346267
ABSTRACT:
BACKGROUND OF THE INVENTION
1. Field of Invention
The present invention relates to a method and composition for prevention, mitigation and treatment of symptoms caused by insufficient estrogenic hormonal levels, such as occurs during menopause, wherein the method uses a composition containing (1) herbs having substantial recognized activity as phytoestrogens such as soy isoflavones, black cohosh, and wild yam and (2) other herbs which have been traditionally used for alleviating menopausal and related symptoms, such as sage, chastetree berry, vervain, astragalus and motherwort.
2. Background Art
Menopause is a cessation of menses, the end of menstrual cycles. The years just prior to menopause are known as perimenopause. As one ages, follicles become fewer in number and don't develop fully. For example, a follicle from a woman who is 40 is not as strong and healthy as a follicle from a woman who is in her twenties. Reduced follicle development leads to less estrogen being produced. The pituitary detects that low estrogen level and tries to stimulate the ovary to make more estrogen by releasing more follicle stimulating hormone (FSH). However, reduced follicle numbers or size will not allow for the production of any more estrogen. Thus, estrogen does not reach a peak strong enough to stimulate the luteinizing hormone (LH) surge. Without the LH surge, there is no ovulation. Without ovulation, there is no progesterone. Without progesterone, women begin to skip cycles. During this period, most women experience unpleasant symptoms, such as hot flashes, anxiety and/or depression, tiredness/fatigue, and vaginal dryness, all at least in part due to the hormonal imbalance. Such symptoms last for more than one year in 80% of women and for up to five years in one in three women. Perimenopause, the transition time into menopause, is officially diagnosed when a woman is over 40 and experiencing such symptoms.
Many trials have been conducted to ameliorate these menopause symptoms by administrating phytoestrogens derived from herbs. Especially, soybean isoflavones have been studied extensively and have demonstrated a number of health benefits, including relief of menopausal symptoms (JP-10-114653,JP7-506822). Soybean isoflavones have been marketed and acquired a feasible reputation as dietary supplements to alleviate menopause and related symptoms and reduce the risk of osteoporosis and breast cancer.
Other herbs, such as black cohosh, wild yam, chastetree berry, sage, vervain and astragalus have also been used historically to ameliorate menopause and related symptoms. Many supplements containing these herbs have been marketed for quite a long time. Most of these products contain either single herbs or two or more herbs combined, or herbs combined with minerals and vitamin D, which enhance the osteogenesis activity.
Although these products have been used as menopause remedies for a long time, their effectiveness has not really been satisfactory to the majority of women.
Previously, the present inventors have also used a formula consisting of soy, red clover, black cohosh and wild yam (Table 1, formula #1) in their clinical practices. Unfortunately, the efficacy of this formula against menopause symptoms, such as hot flash, insomnia and vaginal dryness, was not satisfactory. Furthermore, many patients who received this formula complained of several complications such as tiredness, absent-mindedness, and lack of energy, after taking this remedy.
SUMMARY OF THE INVENTION
Accordingly, one object of the present invention is to provide a composition useful for treatment of symptoms caused by insufficient estrogen production, particularly those associated with menopause and perimenopause, without the side-effects produced by previous treatments.
A further object of the present invention is to provide a method for the treatment of symptoms associated with insufficient estrogen production using a herbal formula without the side-effects of previous remedies.
These and other objects of the present invention have been satisfied by the discovery of a composition containing (1) at least one herb containing phytoestrogens and (2) at least four members selected from the group consisting of sage, vervain, astragalus, motherwort and chastetree berry, that provides relief from the symptoms associated with insufficient estrogen production, particularly during perimenopause and menopause, without the difficult side-effects of tiredness, absentmindedness and lack of energy seen in previous formulations and providing alleviation of common menopause symptoms such as hot flash, insomnia and vaginal dryness.
DETAILED DESCRIPTION OF THE INVENTION
The present invention relates to a composition comprising two types of herbs: (1) herbs containing phytoestrogens and (2) traditional herbs which ameliorate women's discomfort, for prevention, alleviation and treatment of various unpleasant symptoms due to the decreased estrogenic hormones around menopause. The term “phytoestrogens” refers to natural plant chemicals that mimic estrogen and have estrogenic activities. Representative examples of herbs containing phytoestrogens are soy, black cohosh, and wild yam. Preferably, the composition comprises two or more herbs selected from those containing phytoestrogens, more preferably three or more herbs containing phytoestrogens, most preferably all three of the following phytoestrogen containing herbs: soy isoflavone, wild yam and black cohosh. The phytoestrogen levels can be further improved by consumption of various foods high in isoflavones or phytoestrogens, including but not limited to, broccoli, carrots, cauliflower, Brussels sprouts, snow peas, flaxseed oil, lentils, beans, chick peas, soybean products, cherries, apples, peas, stone fruits, linseed, sunflower seeds, fennel, vegetable oils including olive oil, and alfalfa.
The composition also contains a plurality of herbs used for the treatment of symptoms arising from decreased estrogenic hormone levels. Representative examples of traditional herbs which have been used for this type of women's discomfort are sage, motherwort, astragalus, vervain, chastetree berry, St Johns wort, panax ginseng, dong quai, licorice, damiana, raspberry leaves, fennel, ginseng and gotucola, with sage, motherwort, astragalus, vervain and chastetree berry being preferred. The present composition preferably contains at least four of the above named herbs, more preferably five of the above named herbs, most preferably, the herbs sage, motherwort, astragalus, vervain and chastetree berry.
Another notable phytoestrogen containing herb is red clover. However, the present inventors have found that use of red clover has an adverse effect on menopausal symptoms when used in conjunction with other phytoestrogens. This type of formulation is summarized in Table 1, formula #1. As noted above, women administered that formula complained of tiredness, absentmindedness and a lack of energy, as well as hot flashes, insomnia and vaginal dryness.
This invention is based on the new findings that by adding wild yam, sage, vervain, astragalus and motherwort instead of red clover to the previous formula (Table 1, formula #2), tiredness, absentmindedness and lack of energy, which have been observed in formula #1, were drastically diminished. Furthermore, other common menopause symptoms, such as hot flush, insomnia, and vaginal dryness, were also alleviated in the majority of the patients.
The ingredients comprising the present invention are either extracts which contain higher dosages of active ingredients or powders of a corresponding part of the herb. In the former case, admixture of herbal extracts can be processed into tablet, capsules, soft gelatin capsules, powders, granules and liquid products in combination with appropriate pharmaceutical excipients or food ingredients. In the latter case, herbs can be provided as tea-packs for decoction after being dried, cut and packaged. Further, a fine powder of herbs can be processed into suitable form as a drug or as a dietary supplement as
Fry Kathleen K.
Wingo Claudia J.
Spear James M.
Wakunaga of America Co., Ltd.
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