Selenium-containing compositions and uses thereof

Abstract

The use of selenite- or selenate-containing preparations supplemented with pharmaceutically acceptable or food-compatible acids for the preparation of an agent intended for topical or buccal application or mucosal administration is described.

Claims

1. A method for treating a papillomatosis or a papillomavirus-induced tumor comprising topically administering an effective amount of a composition comprising a selenite-containing compound and at least one of citric acid, acetic acid, malic acid, carbonic acid, sulfuric acid, hydrochloric acid, or a fruit acid to an individual in need thereof, wherein the composition is topically administered to a mucosa of the individual.

2. The method of claim 1, wherein the mucosa is buccal mucosa.

3. The method of claim 1, wherein the composition is topically administered to the anal or genital region.

4. The method of claim 1, wherein the composition is topically administered to a papilloma.

5. The method of claim 4, comprising topically administering the composition to the papilloma until the papilloma is gone.

6. The method of claim 1, wherein the composition comprises at least one citric acid, acetic acid, malic acid, carbonic acid, or fruit acid.

7. The method of claim 1, wherein the composition is an aqueous solution and has a pH of below 7.0.

8. The method of claim 7, wherein the composition has a pH of below 5.0.

9. The method of claim 8, wherein the composition has a pH of from 3.0 to 2.5.

10. The method of claim 1, wherein the composition is an ointment, gel, or emulsion.

11. The method of claim 1, wherein the composition comprises a silicon dioxide.

12. The method of claim 1, wherein the composition is on a carrier material.

13. The method of claim 12, wherein the carrier material is a medical sponge or a wound cone.

14. The method of claim 1, wherein the composition comprises sodium selenite pentahydrate, citric acid, silicon dioxide, methylparaben, polyparaben, and sodium sorbate.

15. The method of claim 1, wherein the treating comprises a superficial treatment of the tumor.

Description

EXAMPLES

Example 1

Preparation of an Acidified Sodium Selenite Solution

(1) An acidified sodium selenite solution was prepared to have the following composition (per 100 ml):

(2) TABLE-US-00002 Sodium selenite pentahydrate 0.111 g Maltodextrin 0.5 g Citrus flavor 0.1 g Citric acid 0.5 g Food dye 0.01 g Potassium sorbate 0.1 g Sodium benzoate 0.05 g Aqua destillata 99.29 g

Example 2

Treatment of Herpes Simplex Infections

(3) Twelve adult patients (seven females, five males) as well as eight children (four females, four males) suffering from diagnosed stomatitis herpetica/aphtosa were buccally administered five droplets five times a day (children having received a tenfold-diluted solution) and simultaneously treated externally (five time swabbing per day of the affected sites with the droplets), usually over a period of seven days. Seven out of eight children, in addition to the antioxidative selenium therapy, were prescribed local anaesthetics and/or antibiotics and/or antimycotics and/or analgetics and anti-inflammatory agents, but no additional antiviral therapy.

(4) Nine out of twelve adults were exclusively treated with the strongly antioxidative selenium droplets, one out of twelve patients received an antiviral drug (Aciclovir) besides the droplets. The results are indicated in the following Table 2.

(5) TABLE-US-00003 TABLE 2 Patient Previous Side Success of No. Sex Incidence treatment effects therapy Herpes Labialis Therapy 1 m 1 y local oint- none 1 ment ther- 2 m monthly apy none 1 3 m 3-5 y  Aciclovir none 1 4 f 3 y Aciclovir none 1 5 m — Aciclovir — 1 6 f 3 y — none 2 7 f monthly Famvir none 1 8 f 3-5 y  Aciclovir none 1 9 f 3 y Aciclovir none 1 10 f 3 y Aciclovir none 1 Aciclovir Stomatis Herpetica/Aphtosa Therapy 11 m — Xylocain none 1 12 f — — none 2 13 f — — none 1 14 m — — none 1 15 m — — none 1 16 f — — none 2 17 m — — none 1 18 f — — none 2 19 f — — none 2 20 m monthly — none 2 m = male f = female 1 y = once a year 2 y = twice a year 3 y = thrice a year 3-5 y = three to five times a year 1 = very good 2 = good 3 = insufficient

(6) The examination reports of the examining physician revealed excellent therapeutical successes (disappearance of itching, healing of vesicles) in nineteen out of twenty cases already after three to seven days. Those patients who suffered from herpes recurrences showed marked improvements in the recurrence rates (extension of recurrence-free intervals), or even the complete disappearance of recurrences, after the buccal and external application of the droplets as against an Aciclovir therapy.

Example 3

Treatment of Pigmented Spots

(7) Pigmented spots (socalled age spots) go back to an increased deposition of radically and peroxidically destroyed protein, fatty acid and membrane-fat structures in the subcutaneous tissue, appearing as locally delimited light- to dark-brown discolorations having approximately the sizes of pinheads. Three adult persons (two females, one male) applied the selenium droplets described (by rubbing in five to ten droplets five times a day on the affected sites on the back of the hand) over a period of two months. The application resulted in a noticeable reduction of the number of pigmented spots or a brightening of dark pigmented spots, respectively.

Example 4

Treatment of Periodontal Diseases

(8) Periodontal diseases rank among the most widespread health problems. The composition according to Example 1 was, therefore, applied as a spraying solution in the following nine patients: 6 patients suffering from stomatitis 3 patients afflicted by aphthae

(9) The patients received one to two spraying strokes three times a day for about one to two weeks. In all of the nine cases, at least a marked improvement of the clinical picture could be observed after the treatment.

(10) TABLE-US-00004 TABLE 3 Duration Patient Age of Success of No. Sex group Diagnosis therapy therapy 1 male 1974 gingivosto- 9 days complete regres- matitis sion; visible im- provement 2 male 1988 gingivosto- 13 days  visible im- matitis provement 3 female 1959 massive 7 days complete regres- gingivo- sion; visible im- stomatitis provement 4 male 1978 gingivosto- substantial im- matitis provement 5 female 1942 gingivosto- 4 days substantial im- matitis provement 6 female 1932 stomatitis, 6 days substantial im- Candida infec- provement tion 7 male 1968 aphthae 6 days substantial im- provement 8 female 1945 aphthae 3 days substantial im- provement 9 male 1972 aphthae 4 days substantial im- provement

Example 5

(11) In the course of the study, 53 patients were treated for “dolor post extractionem” and observed. The goal of the observation series was the reduction of pain and the improvement of wound healing.

(12) Those 53 patients, 30 females and 23 males, suffering from “dolor post extractionem” were treated with a preparation having the following composition:

(13) TABLE-US-00005 Sodium selenite pentahydrate  0.11 g Maltodextrin  0.5 g Citrus flavor  0.1 g Citric acid  0.5 g Food dye  0.01 g Potassium sorbate  0.1 g Sodium benzoate  0.05 g Aqua destillata 99.29 g n = 53 sex: F 30 56.6% M 23 43.4% n = 53 age: under 30 13 24.5% 31 to 50 31 58.5% 51 and up  9 17.0%
Mode of Procedure:

(14) After cleansing of the wound with a 0.9% sodium chloride solution, the inlay impregnated with the above-described solution was placed.

(15) Most of the patients were between 20 and 35 years old (Table 4).

(16) Also localization was distributed as follows: upper jaw 34.5% (19 patients) lower jaw 65.5% (38 patients)

(17) At the general medical examination, 30% of all patients (i.e., 16 cases) were diagnosed to have diseases like diabetes mellitus and/or arterial hypertension.

(18) 53% of all patients (28 cases) had taken analgetics and antibiotics before they began the selenite treatment.

(19) The evaluation of its action was based on the number of treatments until the attainment of freedom from pain:

(20) TABLE-US-00006 TABLE 5 Number of Patients treatments n = 53 in % 1 26  49 2 16  30 3 9 17 4 1 2 7 1 2

(21) Results: 49% of the patients (26 cases) were free from pain after one treatment, 30% of the patients (16 cases) were free from pain after two treatments. Thus, it can be said that freedom from pain was achieved by one to two treatments in 79% of all patients (42 cases).

(22) The extremely surprising results of the present application observations with the preparations to be used according to the invention have, thus, demonstrated that the application of antioxidants with strong (i.e., low) standard reduction potentials is very effective in the case of wounds and, in particular, inflammatory and/or non-inflammatory painful processes in the dental region.

Example 6

Treatment of Papillomatoses

(23) Papillomatoses are cauliflower-like growths which are caused by the socalled papillomavirus. From a histological point of view, papillomas are in most cases benign surface-epithelium tumors which are localized on the oral mucosa, the draining urinary tract, the thigh and lower leg as well as the anal and genital mucosae. A progression by papillomavirus-induced benign tumors to carcinomas may occur after long papilloma persistences.

(24) Three female patients (aged 6, 39, 53) exhibited perianal papilloma warts (verrucae) and were treated with a preparation having the following composition:

(25) TABLE-US-00007 Methylparaben PH Eur 0.61 g Polyparaben PH Eur 0.33 g Sodium sorbate PH Eur 1.27 g Purified water PH Eur 993.48 g Citrus flavor 1.00 g Peppermint oil 0.20 g Citric acid 2.00 g Sodium selenite pentahydrate 1.11 g Aerosil 200 30.00 g 1,030.00 g

(26) The silicate-containing selenite solution was applied on the afflicted skin sites at a dosage of 3-5 droplets five times a day. In all three patients, the papilloma warts disappeared within a period of 3 weeks. The treatment was stopped after the disappearance of the warts.