Composition For Alleviating, Preventing Or Treating Premenstrual Syndrome, Containing, As Active Ingredient, Pinitol, D-Chiro-Inositol Or Analog Compound Thereof

Abstract

The present invention relates to a use of pinitol, D-chiro-inositol or an analog thereof in preventing, alleviating or treating premenstrual syndrome. According to the present disclosure, pinitol, D-chiro-inositol, or an analog thereof can be developed into a drug or a nutraceutical for prevention, alleviation, or treatment of premenstrual syndrome thanks to the alleviative effect thereof on the main symptoms of premenstrual syndrome inclusive of dysmenorrhea, a period of dysmenorrhea, and coldness of hands and feet, and may elicit few side effects when applied to the human body because they are derived from natural products.

Claims

1.-12. (canceled)

13. A method for preventing or treating premenstrual syndrome, the method comprising: administering to a subject a pharmaceutical composition comprising pinitol, D-chiro-inositol or an analog thereof as an effective ingredient.

14. The method of claim 13, wherein the analog of pinitol or D-chiro-inositol is a derivative or metabolite of pinitol or D-chiro-inositol, a pinitol- or D-chiro-inositol-containing compound, or a prodrug of pinitol or D-chiro-inositol.

15. The method of claim 13, wherein pinitol, D-chiro-inositol or an analog thereof is contained in a concentration of 50 to 5000 mg in the entire composition.

16. The method of claim 13, wherein the premenstrual syndrome includes a physical symptom or a mental symptom.

17. The method of claim 16, wherein the physical symptom of premenstrual syndrome includes at least one selected from tension-type headaches, tenderness in the breasts, bloating, swelling, abdominal cramps, generalized pain, weight gain, flushing, syncope, dizziness, nausea, fast heartbeat, and feeling tired.

18. The method of claim 16, wherein the mental symptom of premenstrual syndrome includes at least one selected from anxiety-related symptoms inclusive of tension, mood swings, anger, and dithering; anxious depression, loneliness, insomnia, animosity, wrath, amnesia, confusion, concentration impairment, and distractibility.

Description

BRIEF DESCRIPTION OF THE DRAWINGS

[0061] FIG. 1 shows results of alleviating effects on premenstrual syndrome after administration of a placebo and pinitol at a dose of 600 mg a day.

[0062] FIG. 2 shows results of alleviating effects on premenstrual syndrome after administration of a placebo and pinitol at a dose of 1,200 mg a day.

[0063] FIG. 3 shows results of alleviating effects on premenstrual syndrome after administration of a placebo and pinitol at a dose of 2,400 mg a day.

[0064] FIG. 4 shows results of alleviating effects on premenstrual syndrome after administration of a placebo and D-chiro-inositol (DCI) at a dose of 600 mg a day.

[0065] FIG. 5 shows results of alleviating effects on premenstrual syndrome after administration of a placebo and D-chiro-inositol (DCI) at a dose of 1,200 mg a day.

[0066] FIG. 6 shows results of alleviating effects on premenstrual syndrome after administration of a placebo and D-chiro-inositol (DCI) at a dose of 2,400 mg a day.

MODE FOR CARRYING OUT THE INVENTION

[0067] A better understanding of the present invention may be obtained through the following examples which are set forth to illustrate, but are not to be construed as limiting the present invention.

EXAMPLES

[0068] Experiment Methods

[0069] 1. Evaluation of Administration of Pinitol or D-Chiro-Inositol to Female Subject

[0070] Pinitol and D-chiro-inositol were purchased from Biosearch Life (Camino de Purchil, 66. 18004 Granada, Spain). Selected as experiment subjects were 80 normal women of reproductive age, that is, 80 women at the age of 25-40 who had neither skipped three or more cycles of menstruation, nor been administered with a contraceptive pill, and nor received a psychiatric treatment.

[0071] Of them, 40 persons were classified into four groups of 10 which were then administered respectively with a placebo free of pinitol and having no pharmaceutical effects and with pinitol at three different doses. Likewise, the remaining 40 persons were equally divided into one placebo group and three experimental groups to which D-chiro-inositol was administered at three different doses, respectively. A blind test was conducted in which the placebo and pinitol or D-chiro-inositol was administered once a day for eight weeks. Pinitol or D-chiro-inositol was administered at daily doses of 600 mg, 1,200 mg, and 2,400 mg for eight weeks. A survey was made of the experimental subjects before and after the clinical test of placebo and pinitol or D-chiro-inositol to evaluate the alleviating effect of pinitol or D-chiro-inositol on premenstrual syndrome.

[0072] 2. Survey

[0073] In the present disclosure, the questionnaire that experimental subjects had completed with respect to the severity of premenstrual syndrome were analyzed. The experimental subjects evaluated the placebo, pinitol, or D-chiro-inositol for a pharmacological effect on premenstrual syndrome on the basis of four grades: complete alleviation, significant alleviation, somewhat alleviation, and no change for dysmenorrhea, a period of dysmenorrhea, and coldness of hands and feet. The questionnaire used in the present disclosure is given in Table 1.

TABLE-US-00001 TABLES 1 condition grades somewhat significant complete Symptom no change alleviation alleviation alleviation 1. dysmenorrhea 2. period of dysmenorrhea 3. coldness of hands and feet

[0074] Experimental Results

[0075] 1. Alleviative Effect of Pinitol or D-Chiro-Inositol on Premenstrual Syndrome

[0076] A survey was made of women to evaluate the alleviative effect of pinitol or D-chiro-inositol on premenstrual syndrome. For the control administered with the placebo, main symptoms of premenstrual syndrome, such as dysmenorrhea, a period of dysmenorrhea, and coldness of hands and feet, were alleviated by 10-20%. Significant reductions in the main symptoms of premenstrual syndrome, such as dysmenorrhea, a period of dysmenorrhea, and coldness of hands and feet were detected in the experimental groups administered with pinitol or D-chiro-inositol at a daily dose of 600 mg, 1,200 mg, and 2,400 mg (Tables 2 and 3). Questionnaire results are shown in Table 2 after the administration of placebo or pinitol and in Table 3 after the administration of placebo or D-chiro-inositol (DCI).

TABLE-US-00002 TABLES 2 complete alleviation significant alleviation alleviation no change the number the number the number the number of people percentage of people percentage of people percentage of people percentage classification (person) (%) (person) (%) (person) (%) (person) (%) placebo dysmenorrhea 0 0.0 0 0.0 1 10.0 9 90.0 period of 0 0.0 0 0.0 2 20.0 8 80.0 dysmenorrhea coldness of 0 0.0 0 0.0 1 10.0 9 90.0 hands and feet Pinitol dysmenorrhea 0 0.0 3 30.0 3 30.0 4 40.0 (600 mg) period of 0 0.0 3 30.0 2 20.0 5 50.0 dysmenorrhea coldness of 0 0.0 1 10.0 4 40.0 5 50.0 hands and feet Pinitol dysmenorrhea 6 60.0 2 20.0 1 10.0 1 10.0 (1,200 mg) period of 5 50.0 2 20.0 2 20.0 1 10.0 dysmenorrhea coldness of 4 40.0 3 30.0 1 10.0 2 20.0 hands and feet Pinitol dysmenorrhea 8 80.0 2 20.0 0 0.0 0 0.0 (2,400 mg) period of 8 80.0 2 20.0 0 0.0 0 0.0 dysmenorrhea coldness of 7 70.0 1 10.0 1 10.0 1 10.0 hands and feet

TABLE-US-00003 TABLES 3 complete alleviation significant alleviation alleviation no change the number the number the number the number of people percentage of people percentage of people percentage of people percentage classification (person) (%) (person) (%) (person) (%) (person) (%) placebo dysmenorrhea 0 0.0 0 0.0 2 20.0 8 80.0 period of 0 0.0 0 0.0 2 20.0 8 80.0 dysmenorrhea coldness of 0 0.0 0 0.0 1 10.0 9 90.0 hands and feet DCI dysmenorrhea 0 0.0 4 40.0 2 20.0 4 40.0 (600 mg) period of 0 0.0 3 30.0 2 20.0 5 50.0 dysmenorrhea coldness of 0 0.0 2 20.0 3 30.0 5 50.0 hands and feet DCI dysmenorrhea 5 50.0 3 30.0 2 20.0 0 0.0 (1,200 mg) period of 6 60.0 2 20.0 1 10.0 1 10.0 dysmenorrhea coldness of 5 50.0 2 20.0 2 20.0 1 10.0 hands and feet DCI dysmenorrhea 9 90.0 1 10.0 0 0.0 0 0.0 (2,400 mg) period of 8 80.0 2 20.0 0 0.0 0 0.0 dysmenorrhea coldness of 8 80.0 1 10.0 0 0.0 1 10.0 hands and feet

[0077] As many as 50-60% of the administration group of 600 mg pinitol experienced somewhat or significant alleviation of the main symptoms of premenstrual syndrome before administration. Only 10% of the administration group of pinitol 1,200 mg or 2,400 mg did not feel changes in the main symptoms of premenstrual syndrome whereas alleviation was answered by as many as 80-90% of the group, with the complete alleviation found in 50% or more of the administration group of 1,200 mg and in 70-80% in the administration group of 2,400 mg (see FIGS. 1-3).

[0078] The main symptoms of premenstrual syndrome were somewhat or significantly alleviated in 50-60% of the administration group of D-chiro-inositol 600 mg, compared to pre-administration results, like the result of the administration group of pinitol 600 mg. Similar results to those of the administration groups of pinitol 1,200 mg or 2,400 mg were obtained in the administration groups of D-chiro-pinitol. That is, only 10% of the administration group of D-chiro-pinitol 1,200 mg or 2,400 mg did not experience changes in the main symptoms of premenstrual syndrome whereas 80-90% of the group answered alleviation in the main symptoms, with the complete alleviation found in 50% or more of the administration group of 1,200 mg and in 70-80% in the administration group of 2,400 mg (see FIGS. 4-6).

[0079] The analysis result of the survey indicates that pinitol and D-chiro-inositol has the effect of significantly alleviating the main symptoms of premenstrual syndrome such as dysmenorrhea, a period of dysmenorrhea, and coldness of hands and feet.

[0080] Although the preferred embodiments of the present invention have been disclosed for illustrative purposes, those skilled in the art will appreciate that various modifications, additions and substitutions are possible, without departing from the scope and spirit of the invention as disclosed in the accompanying claims.