Drug – bio-affecting and body treating compositions – Designated organic active ingredient containing – 9,10-seco- cyclopentanohydrophenanthrene ring system doai
Reexamination Certificate
1993-05-10
2001-05-08
Criares, Theodore J. (Department: 1617)
Drug, bio-affecting and body treating compositions
Designated organic active ingredient containing
9,10-seco- cyclopentanohydrophenanthrene ring system doai
C424S682000, C424S686000, C424S687000
Reexamination Certificate
active
06228849
ABSTRACT:
BACKGROUND OF THE INVENTION
This invention relates to a method for reducing or relieving symptoms associated with premenstrual syndrome (“PMS”) by administering to an individual exhibiting PMS symptomology a therapeutically effective amount of a combination of calcium and vitamin D.
BACKGROUND OF THE ART
Symptoms generally experienced by women with PMS, the occurrence and exaggeration of mood and behavioral disturbances in women during the latter half of their menstrual cycle, without limitation include (1) somatic symptoms such as abdominal cramps, headaches including vascular headaches such as migraine headaches, breast fullness and tenderness, back pain and bloating and (2) psychological symptoms such as, depression, irritability and anxiety. While these symptoms, which are among those generally related to PMS, do not occur solely in women with PMS, it has been estimated that as much as 90% of all premenopausal women exhibit some degree of symptoms such as those above related to PMS, ranging from mild to incapacitating, and that about 7 million women suffer severe and incapacitating symptoms related to PMS.
U.S. Pat. No. 4,946,679 of Thys-Jacobs and the article by Thys-Jacobs et al. entitled “Calcium Supplementation in Premenstrual Syndrome. A Randomized Crossover Trial”,
J. Gen. Int. Med.,
1989:4:183, showed that elemental calcium is effective in significantly reducing symptoms associated with PMS when administered, for example, in a daily dose of 1000 mg for 3 months. Thys-Jacobs et al. reported a 50% reduction in PMS symptomology for the daily administration of elemental calcium in the dose of 1000 mg for three months. Similarly, Chuong et al., in an abstract presented at the American Fertility Annual Meeting in 1991 entitled “Calcium Levels in Premenstrual Syndrome” showed that women with PMS had significantly lower calcium levels during the luteal phase of the menstrual cycle as compared with asymptomatic controls and also showed that women with PMS had significantly lower calcium levels during the luteal phase of the menstrual cycle as compared to the follicular phase of the menstrual cycle.
However, there still exists a need for therapy that provides further reduction or relief of symptoms associated with PMS, especially in particularly persistent cases.
SUMMARY OF THIS INVENTION
An object of this invention is to reduce or relieve symptoms associated with PMS in an individual exhibiting such symptoms, especially in those patients who do not demonstrate improvement when treated with calcium alone.
The present invention is directed to a method of at least reducing symptoms associated with PMS. A therapeutically effective amount of a combination of calcium and vitamin D is administered to an individual exhibiting symptomatology associated with PMS.
DETAILED DESCRIPTION OF THE INVENTION
The method of the present invention treats individuals exhibiting symptoms associated with PMS by the administration of a therapeutically effective amount of a combination of calcium and vitamin D. Preferably, the dosage of elemental calcium administered is in the range of from about 1000 mg to about 2000 mg per day. Preferably, the dosage of vitamin D administered is in the range of from about 400 to about 2000 IU per day. Preferably, the dosage of vitamin D elevates 25 hydroxyvitamin D levels to levels greater than 30-40 ng/ml. The calcium and vitamin D may be administered concurrently such as, for example, by administration of a tablet, a capsule, a powder, liquid, candy or mint, cookie or food additive containing the desired dosages of the calcium and the vitamin D. Preferably, the combination is administered orally in the form of a tablet. Calcium may be administered in the form of calcium carbonate, calcium gluconate, calcium citrate, calcium phosphate, calcium chloride, calcium stearate or calcium acetate, and preferably in the form of calcium carbonate. Vitamin D may be administered as at least one of vitamin D
2
(ergocalciferol), vitamin D
3
(cholecalciferol) or 25 hydroxyvitamin D (calcidiol or calcifediol). The dose can be taken as a single daily combination dose or in split doses of smaller concentrations in adequate levels for prevention of PMS symptoms. Examples of combinations for single doses are as follows:
Elemental calcium
Vitamin D
2
or D
3
1000
mg
400
IU
1000
mg
600
IU
1000
mg
800
IU
1200
mg
400
IU
1200
mg
600
IU
1200
mg
800
IU
1200
mg
1000
IU
1200
mg
1200
IU
1500
mg
400
IU
1500
mg
300
IU
1500
mg
800
IU
1500
mg
1000
IU
1500
mg
1200
IU
1500
mg
2000
IU
Examples of smaller concentration embodiments to be administered at least 2 to 3 times daily are as follows:
Elemental calcium
Vitamin D
2
or D
3
300
mg
200
IU
300
mg
250
IU
500
mg
200
IU
500
mg
300
IU
500
mg
400
IU
600
mg
300
IU
600
mg
400
IU
600
mg
500
IU
600
mg
600
IU
700
mg
700
IU
800
mg
400
IU
800
mg
800
IU
800
mg
800
IU
2000
mg
2000
IU
The combination is effective for reducing or relieving symptoms associated with PMS, which include somatic symptoms such as without limitation headaches, especially vascular headaches such as migraine headaches, tenderness and swelling of the breasts, abdominal bloating, abdominal cramping, generalized aches and pains, lower backache, fatigue, increased/decreased appetite, craving for sweet/salt, swelling or edema of extremities and insomnia and which include psychological symptoms such as mood swings, depression, tension, anxiety, anger and crying spells.
The foregoing and other objects, features, aspects and advantages of the present invention will become more apparent from the following detailed non-limiting examples of the present invention.
REFERENCES:
patent: 3077437 (1963-02-01), Heckel
patent: 3608075 (1971-09-01), Glen et al.
patent: 3639599 (1972-02-01), Mehrhof et al.
patent: 4035504 (1977-07-01), Hidy et al.
patent: 4076811 (1978-02-01), Lachnit-Fixson et al.
patent: 4145416 (1979-03-01), Lachnit-Fixson et al.
patent: 4225596 (1980-09-01), DeLuca
patent: 4241087 (1980-12-01), Mir et al.
patent: 4252797 (1981-02-01), Rosenthal
patent: 4291028 (1981-09-01), Vorys
patent: 4315033 (1982-02-01), Lawrason
patent: 4372951 (1983-02-01), Vorys
patent: 4415554 (1983-11-01), Horrobin
patent: 4439432 (1984-03-01), Peat
patent: 4495181 (1985-01-01), Norman et al.
patent: 4497800 (1985-02-01), Larson et al.
patent: 4501738 (1985-02-01), Yamoto et al.
patent: 4521410 (1985-06-01), Holick et al.
patent: 4542026 (1985-09-01), Rios
patent: 4588716 (1986-05-01), DeLuca et al.
patent: 4590184 (1986-05-01), Macdo et al.
patent: 4650668 (1987-03-01), Barron et al.
patent: 4738856 (1988-04-01), Clark
patent: 4946679 (1990-08-01), Thys-Jacobs
patent: 5037823 (1991-08-01), Jones et al.
patent: 5063221 (1991-11-01), Nishii et al.
patent: 5075499 (1991-12-01), Walsdorf et al.
patent: 5104864 (1992-04-01), DeLuca et al.
patent: 5141927 (1992-08-01), Kroltkowski
patent: 2 169 202 (1986-07-01), None
patent: 2 254 556 (1992-10-01), None
Thys-Jacobs S. et al. Calcium supplementation in Premenstrual syndrome. A randomized crossover trial. J. Gen Int Med 1989; 4:183.
Chuong J. et al. Calcium levels in Premenstrual syndrome. Abstract presentation at The American Fertility Annual Meeting in 1991.
Nordin BEC, Peacock M, Aaron J et al. Osteoporosis and osteomalacia. Clin Endocrinol Metab 1980;9:177-205.
Frank RT. The hormonal causes of premenstrual tension. Arch Neurol Psycinatry. 1931;26:1503-7.
Reid RL. Premenstrual Syndrome. Am J Obstet Gynecol. 1981; 139:85-104.
Penland J. et al. Dietary calcium and manganese effects on menstrual cycle symptomatology. (1993—in press).
Barrett-Connor E. The RDA for calcium in the elderly: too little, too late. Calcif Tisue int 1989; 44:303.
Rubinow Dr. The Premenstrual Syndrome. JAMA, Oct. 14, 1992—vol. 268, No. 14, pp. 108-12.
Manoglas SC, et al. Metabolic Bone and Mineral Disorders. Churchill Livingstone (publisher), 1988, pp. 13-32.
Harrison M. “Self-Help for Premenstrual Syndrome,” Random House, 3-5, 10-29, 75-77, 104-106 (1985).
Cummings, S. and Ullman, D., “Menstrual Cramps and Premenstrual Syndrome (PMS)”, Everybody's Guide to Homeopathic Medicines, 149
Criares Theodore J.
Gottlieb Rackman & Reisman P.C.
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