MSM
Patent #
4,973,605
| United States Patent |
4,973,605 |
| Herschler |
Nov. 27, 1990 |
Use of methylsulfonylmethane to relieve pain and relieve pain and
nocturnal cramps and to reduce stress-induced deaths in animals
Abstract
Methylsulfonylmethane is effective to relieve pain and
nocturnal cramps and to reduce stress-induced deaths in animals.
| Inventors: |
Herschler; Robert J. (3080 NW. 8th Ave., Camas, WA
98607). |
| Appl. No.: |
385,117 |
| Filed: |
Jul. 26, 1989 |
Related U.S. Application Data
| Division of Ser No. 878,949, Jun. 26, 1986, Pat. No. 4,863,748continuation
of (including streamline cont.) Ser. No. 727,989, Apr. 29, 1985, Pat.
No. 4,616,039,
and a continuation-in-part of Ser No. 601,771, Apr. 17, 1984, Pat. No.
4,559,329,
and a continuation-in-part of Ser No. 584,354, Feb. 28, 1984, Pat. No.
4,568,547,
and a continuation-in-part of Ser No. 418,110, Sept. 14, 1982, Pat.
No. 4,514,421,
which is a continuation-in-part of Ser. No. 277,592, Jun. 26, 1981,
Pat. No. 4,477,469division
of Ser No. 71,068, Aug. 6, 1979, Pat. No. 4,296,130. |
| Intl. Cl. : |
A61K 31/10 |
| Current U.S. Cl.:
|
514/708 |
| Field of Search: |
514/708 |
References Cited | [Referenced By]
Primary Examiner: Friedman; Stanley J.
Attorney, Agent or Firm: Millen, White & Zelano
14 Claims, No Drawings
| United States Patent |
4,973,605 |
| Herschler |
November 27, 1990 |
Use of methylsulfonylmethane to relieve pain and relieve pain
and nocturnal cramps and to reduce stress-induced deaths in animals
Abstract
Methylsulfonylmethane is effective to relieve pain and nocturnal cramps and
to reduce stress-induced deaths in ainmals.
| Inventors: |
Herschler; Robert J. (3080 NW. 8th
Ave., Camas, WA 98607) |
| Appl. No.: |
385117 |
| Filed: |
July 26, 1989 |
| U.S. Class: |
514/708 |
| Intern'l Class: |
A61K 031/10 |
| Field of Search: |
514/708 |
References Cited [Referenced
By]
U.S. Patent Documents
Primary Examiner: Friedman; Stanley J.
Attorney, Agent or Firm: Millen, White & Zelano
Parent Case Text
This application is a division of application Ser. No. 878,948, now U.S. Pat.
No. 4,863,748, filed June 26, 1986, as a continuation-in-part of applications
Ser. No. 727,989, now U.S. Pat. No. 4,616,039, filed Apr. 29, 1985; Ser. No.
601,771, now U.S. Pat. No. 4,559,329, filed Apr. 17, 1984, Ser. No. 584,354, now
U.S. Pat. No. 4,568,547, filed Feb. 28, 1984 and Ser. No. 418,110, now U.S. Pat.
No. 4,514,421, filed Sept. 14, 1982, as continuations-in-part of application
Ser. No. 277,592, now U.S. Pat. No. 4,477,469, filed June 26, 1981, as a
division of Ser. No. 071,068, now U.S. Pat. No. 4,296,130, filed Aug. 6,1979,
all of whose disclosures are incorporated herein by reference.
Claims
1. A method for inhibiting nocturnal and arthritic activity-induced muscle
cramps in a person having a propensity for such muscle cramps, which comprises
orally ingesting an amount of methylsulfonylmethane effective to inhibit the
muscle cramps.
2. A method according to claim 1, wherein the person is a geriatric experiencing
reoccurring nocturnal muscle cramps.
3. A method according to claim 1, wherein at least about 10 mg of
methylsulfonylmethane is ingested daily for a succession of days.
4. A method according to claim 3 of ameliorating the pain and discomfort
associated with arthritis in an animal which comprises administering to an
animal manifesting overt symptoms of the disease an amount of
methylsulfonylmethane effective to ameliorate the pain.
5. A method according to claim 4, wherein the animal is a human being.
6. A method according to claim 5, wherein the arthritis is rheumatoid arthritis.
7. A method according to claim 6, wherein the methylsulfonylmethane is
administered orally on successive days.
8. A method according to claim 4, wherein the animal is a domestic or farm
animal.
9. A method according to claim 8, wherein the methylsulfonylmethane is admixed
with the animal's feed.
10. A method according to claim 3 of alleviating intractible pain, which
comprises administering intravenously to a patient suffering from a disease
producing such pain an amount of methylsulfonylmethane effective to alleviate
the pain.
11. A method according to claim 10, wherein the methylsulfonylmethane is
administered as an aqueous solution over a period of at least 1/2 hour.
12. A method according to claim 10, wherein at least about 1 mg/kg of body
weight of the methylsulfonylmethane is administered.
13. A method according to claim 10, wherein the disease is rheumatoid arthritis.
14. A method of ameliorating the pain and discomfort associated with arthritis,
or with nocturnal or arthritic activity-induced muscle cramps, with gastric
hyperactivity or with intractable pain, which comprises administering to the
animal or individual suffering from such pain an amount of methylsulfonylmethane
effective to ameliorate the pain.
Description
BACKGROUND OF THE INVENTION
This invention relates to uses of methylsulfonylmethane (MSM.RTM.).
In my prior U.S. Pat. No. 4,296,130, I disclose compositions containing
methylsulfonylmethane to soften, smooth, lubricate and preserve the pliancy of
human tissues and for reducing the brittleness of finger and toe nails. I
disclose therein that methylsulfonylmethane is substantially inert to the
chemistry of the body and, because of its extremely low toxicity and inertness
to the diverse chemical reactions involved in the life processes, it can be used
as a diluent for blood. The ingestion of oral compositions is disclosed therein
to preserve the pliancy of intestinal and other tissue U.S. 4,477,469 relates to
methylsulfonylmethane and carbamide compositions. U.S. Pat. No. 4,514,421
relates to methods of ameliorating symptoms of stress of allergy with
methylsulfonylmethane.
U.S. Pat. No. 4,296,104 discloses DMSO compositions which optionally can contain
a protein modifying agent, such as methylsulfonylmethane. U.S. Pat. No.
4,112,946 discloses the use of an aqueous solvent system comprising
methylsulfonylmethane in a process for the introduction of a health modifying
agent into water-living animals as an osmotic factor. S.N. 584,354 relates to
the use of methylsulfonylmethane as the diluent or carrier for storage unstable
pharmaceutically active agents. S.N. 601,771 relates to oral pharmaceutical
compositions comprising a gastointestinal upset-promoting pharmaceutical and and
ameliorating amount of methylsulfonylmethane.
J.J. Kocsis et al, Annals N.Y. Acad. Sci. 243, 104-109 (1975), cite literature
which report that methylsulfonylmethane, a known metabolite of dimethylsulfoxide,
persists for as long as three weeks after percutaneous application in man and
one week after i.v. administration. The authors report that
methylsulfonylmethane, like DMSO, enhances urinary taurine secretion produced by
aromatic hydrocarbons in man, antagonizes the lethal effects of
anticholinesterases such as paraoxon, tetraethyl pyrophosphate and octamethyl
pyrophosphoramide; lowers the body temperature of rats exposed to 5.degree. C.
temperature; and reduces motor activity (when administered i.p.). Kulshestha et
al, C.A. 83; 22910n (1975), report that methylsulfonylmethane occurs naturally
in a variety of fruits, vegetables and vegetable products, grains in at least
trace amounts ( 3.3 ppm). T.W. Pearson et al, C.A. 95:113654w (1981). It is
present in small amounts in normal urine. Williams et al, Archs. Biochem.
Biophys. 1966, 113, 251-2. The following Chemical Abstracts refer to the
biological aspects of methylsulfonylmethane as a DMSO metabolite, in cattle,
83:183a; Escherichia coli inhibition by, 83:72577e; nervous system depression
by, 84:173608a; Salmonella typhimurium inhibition by, 82:71; of urine,
75:86025v; heart response to, 74:2429y; lung constrictivity activity of,
62:9634f; in tissue culture protection against X-rays, 58:9391e; toxicity of,
ETOH and, 64:7229h; in urine after administration of, 65:17537g; in urine of
humans, 64:10170g; and in urine as methylsulfonylmethane metabolite, 64:7213a;
65:17535b.
Siegel, (1985, Private Communication) has evaluated methylsulfonylmethane in
mice with a genetic predisposition to a form of cancer and rheumatoid arthritis.
The sulfone was administered orally. There was a significant delay in the
development of lymphomas as well as decreased tumor incidence, compared with
control. In addition and only grossly examined, treated animals demonstrated a
marked reduction in joint involvement. An increased titer of primary IgM and
secondary IgG was measured.
In a separate pilot study, female rats given an abdominal application of DMBA
while receiving methylsulfonylmethane in their drinking water did not develop
tumors, while mammary tumors were seen in control animals. Waltering, G. and
James, A. (1985, Private Communication).
Metcalf, L., L. Equine Vet. Sci. 3(5):148-174 (1983) describes the benefits
observed when methylsulfonylmethane was added to the diet of animals. One
disorder, epiphysitis, involving calcium/phosphorous imbalance in the horse was
rapidly corrected with oral methylsulfonylmethane.
I have found that notwithstanding its extreme lack of toxicity and inertness of
the diverse chemical reactions involved in the life processes, surprisingly
methylsulfonylmethane nevertheless is metabolized sufficiently to supply the
nutritional sulfur requirements of animals, including humans and other
vertebrates, whose diet is deficient in assimilable sulfur. The incidence of
such assimilable sulfur-deficient diets is very high because of the high
percentage of processed foodstuffs therein in advanced cultures.
I have also found that in addition to the pharmacologically beneficial effects
methylsulfonylmethane has in humans and other animals which are specifically
disclosed in my parent applications, it is useful in the treatment of a
surprising variety of other diseases and adverse physiological conditions, as
disclosed in detail hereinafter.
Since the early part of 1983, methylsulfonylmethane has been sold in tablet form
(250 mg) as a dietary supplement.
OBJECTS OF THE INVENTION
It is an object of this invention to provide a method for treating diverse and
adverse physiological conditions in humans and other animals with
methylsulfonylmethane.
Upon further study of the specification and appended claims, further objects and
advantages of this invention will become apparent to those skilled in the art.
SUMMARY OF THE INVENTION
In a method-of-use aspect, this invention relates to a method of ameliorating
the pain and discomfort associated with arthritis in an animal which comprises
administering to an animal manifesting overt symptoms of the disease an amount
of methylsulfonylmethane effective to ameliorate the pain.
In another method-of-use aspect, this invention relates to a method of
alleviating intractible pain, which comprises administering intravenously to a
patient suffering from a disease producing such pain an amount of
methylsulfonylmethane effective to alleviate the pain.
In another method-of-use aspect, this invention relates to a method of
inhibiting nocturnal and arthritic and activity-induced muscle cramps in a
person having a propensity for such muscle cramps, which comprises orally
administering thereto an amount of methylsulfonylmethane effective to inhibit
the muscle cramps.
In other method-of-use aspects this invention relates to the treatment of other
adverse physiological conditions with methylsulfonylmethane including the
pharmacological uses described hereinafter.
Other aspects of this invention will be apparent to those skilled in the art to
which this invention pertains.
DETAILED DISCUSSION
Notwithstanding the fact that methylsulfonylmethane is omnipotent in body fluids
and is so non-toxic that it can be used as a diluent for blood without upsetting
the blood chemistry, as disclosed and claimed in U.S. Pat. No. 4,514,421 and S.N.
601,777, at daily dosages of at least about 100 mg, methylsulfonylmethane is an
ameliorating agent for a variety of pathological conditions when administered
systemically and preferably orally to persons displaying symptoms of
physiological response to stress, e.g., gastrointestinal distress, inflammation
of the mucous membranes and allergic reactions.
Methylsulfonylmethane and many precursor compounds which are readily converted
to methylsulfonylmethane in the body, are normal ingredients found in most
natural, i.e., unprocessed foods consumed by man and other animals.
Methylsulfonylmethane and its precursors have been available as nutritional and
possibly essential factors in the vertebrate diet long before terrestrial life
occurred. Methylsulfonylmethane has multiple functions in the body. At low
levels of ingestion, it functions as a normal dietary ingredient, viz., as a
food or food ingredient; at higher levels it functions as a pharmaceutically
active agent.
Sulfur also plays important roles in the body, including the forming of
"tie-bars" or disulfide bonds holding molecular strands of connective
tissue together. It plays many other essential roles, such as determining the
contour of diverse biomolecules, and is essential to the activity of many
enzymes that protect and sustain life processes. To perform these roles,
constant intake of assimilable sulfur is needed by the body. Heretofore, it was
believed that ingested protein supplied sufficient metabolic sulfur for balanced
nutritional needs. However, it now appears that this is not the case and that
methylsulfonylmethane ingestion is required in order to maintain nutritionally
adequate levels of assimilable sulfur in the body. While it was known for
several decades that methylsulfonylmethane was a normal constituent of the body,
there was no recognition of the importance of its role in animal nutrition and
good health. With today's modern diet of cooked and otherwise processed and
diluted foods, most if not all diets of civilized man and domesticated lower
animals are deficient in this critically important ingredient.
Methylsulfonylmethane is a key nutritional ingredient, available and assimilated
by all plant and animal life from their beginnings on earth. It is essential to
a healthful diet and is a nutritional essence found in almost every fresh food
of any origin now consumed by animal life. However, it is volatile and therefore
readily becomes lost when fresh food is processed and/or stored.
It is known that many foodstuffs are altered by conventional processing. For
example, proteins are denatured or altered so that water soluble proteins become
insoluble and insoluble protein becomes soluble, for example, the
insolubilization of egg white by cooking and the conversion of collagen to
soluble gelatin. Fats are altered when processed or stored and starches can be
rendered either more or less digestible. The average diet thus is deficient in
methylsulfonylmethane because it is readily lost during conventional food
processing, such as heating, drying or dehydrating, dilution with synthetic
fillers and other poorly nutritional additives, cooking, radiation or
pasteurizing, and long-term storage. Thus, methylsulfonylmethane is similar to
vitamins and minerals which, as a general rule are also partially or totally
lost during normal processing.
Generally speaking, processing any food, as by heating or drying, essentially
eliminates the biologically important, sulfur-rich (about 1/3 by wt. of sulfur)
methylsulfonylmethane. Sulfur, a required macronutrient, must be constantly
replaced in the mature animal and supplied for growth and good health in the
young animal. An aspect of this invention is the discovery that
methylsulfonylmethane is a preferred dietary source of sulfur. Although
methionine, a sulfur-containing aminoacid, may serve as a partial back-up source
during biometabolism where the diet is methylsulfonylmethane deficient,
methionine demonstrates undesirable toxicity parameters.
Studies to date indicate that it is desirable that animals ingest about 0.5-1.0
milligram/kg body weight/day of methylsulfonylmethane to maintain optimum good
health. However, any lower level will serve some benefit. Higher levels are
either stored in the body as a sulfur reserve, provide a sufficient
concentration to optimize synthesis of the multitude of required sulfur
containing biomolecules, or simply are excreted as by the renal pathway or
through the skin. The intact molecule has been shown to beneficially effect
tissue, as for example improving the pliability and softness of the skin.
It is also important to recognize that alternate food sources of utilizable
sulfur in the diet are most costly and the most difficult foods to generally
obtain world-wide, for example fresh meat and fish. While fresh, unprocessed
foods of plant and animal origin are the richest natural sources of
methylsulfonylmethane, at best these are generally plentiful only seasonally.
For geographic, political, religious, cultural and economic reasons, man and
lower animals heretofore are believed to have suffered an unrecognized dietary
deficiency preventing optimum health. This invention resolves this problem.
An individual consuming only unpasteurized milk, raw fish and meats, and
uncooked, fresh vegetables and other plant-derived foods probably would derive
sufficient naturally occurring methylsulfonylmethane and therefore not require
sulfur supplements to the diet. Obviously this is impossible to achieve with
customary meal preparation, food handling and storage. For example, milk, a food
relatively rich in naturally occurring methylsulfonylmethane, loses a
substantial portion of this compound as well as precursors, when subject to
pasteurization to protect the product from microbial decomposition. Milk that
has been spray dried, ordinarily is totally devoid of methylsulfonylmethane.
Domestic animals are dependent on man for their nutritional requirements.
Because the majority of the food sources of domestic animals is now processed
food, their diets are similarly subject to loss of valuable nutrients, including
methylsulfonylmethane, during processing. Man cooks most foods and thus drives
off most, if not all naturally occurring methylsulfonylmethane together with the
precursors, and, accordingly, suffers a greater methylsulfonylmethane deficiency
than any other animal.
As a basic supplier of metabolizable sulfur, methylsulfonylmethane is a
foodstuff as well as being a natural ingredient of various foodstuffs. There are
few, if any, natural and synthetic agents ingested by man and other animals as
part of their diets that would not be improved nutritionally by
methylsulfonylmethane being added thereto. Man and lower animals require about 1
mg/kg body weight of methylsulfonylmethane per day to replace the naturally
occurring methylsulfonylmethane now lost in food processing.
Preferably, the methylsulfonylmethane is added to processed foods after
processing has been completed and to heated foods immediately before serving.
Although methylsulfonylmethane taken alone or as solid or liquid forms taken in
the manner of minerals and vitamins would provide maximum benefits in
maintaining good health, this procedure is not always possible. Therefore one
must consider a wide variety of compositions which when ingested will supply the
critical minimum of about 1 mg/kg body weight per day.
As well as processed foodstuffs, methylsulfonylmethane can be incorporated into
salt, beverages, spices, conventional vitamin and mineral products and other
orally ingested products, such as confectionary products and chewing gum.
In numerous testings, methylsulfonylmethane has been found to enhance the flavor
and improves the taste of many ingested products including foods, beverages,
condiments and pleasure items such as chewing gum, breath sweeteners, lozenges
and similar compositions.
Methylsulfonylmethane may also be included in certain non-food products, as for
example, tobacco products. This can be accomplished by adding
methylsulfonylmethane dissolved in a tobacco humectant, such as a polyhydric
alcohol. A burning cigarette would provide sublimed methylsulfonylmethane along
with the smoke. Adding methylsulfonylmethane to the smoke enhances its flavor
and taste.
This invention is based in part on the discovery that inorganic hydrogen sulfide
and sulfate salts are not the primary sources of sulfur required to balance the
natural sulfur cycle. It has been theorized that simple organic molecules such
as the methyl-S-methane series (S =sulfenyl, sulfinyl or sulfonyl), available
before or at the time the first simple life appeared on earth, are primary
sources of the sulfur atom for sulfur containing biomolecules. Consistent with
this proposal is the fact that methylsulfonylmethane is found naturally in most
foods of plant and animal origin as well as all the water (as marine derived
rain) falling on earth.
Sulfur is a required nutrient (food) for biological normalcy of plants as well
as animals and methylsulfonylmethane plays a major role as the sulfur-rich food
naturally available to man and lower vertebrates. The equation: ##STR1## is
essential to life forms and a minimum amount of methylsulfonylmethane in the
daily diet is important, if not essential, for good to optimum health of man and
lower vertebrates.
To understand the historic role of methylsulfonylmethane in life processes, one
should begin at the beginning. From the primoridial soup of life resident in the
ancient seas, long before even the simplest terrestrial life forms appeared,
algae and later phytoplankton produced organic molecules which released dimethyl
sulfide to the atmosphere, an on-going process to this day. These simple forms
of life, living in the upper or surface layer of the earth's oceans assimilated
and converted inorganic sulfur into diverse organic molecules, mainly terniary
dimethyl sulfonium salts. These terniary salts, by enzymatic and physical means,
are broken down to methyl sulfide. Exemplary of these salts is
dimethyl-beta-propiothetin, (CH.sub.3).sub.2 S.sup.+ CH.sub.2 CH.sub.2 COOH,
which appears to be the most common organic sulfur containing molecule in marine
plant life, (10% or more of the dry weight of some organisms). Dimethyl sulfide,
a virtually water insoluble molecule which is even less soluble when
"salted out" from marine waters, passes to the atmosphere in
quantities sufficient to supply the sulfur needs for all terrestrial life forms.
Volatile, non-polar dimethyl sulfide moves to the upper atmosphere, sometimes
called the ozone layer, where, catalyzed by sunlight, it is oxidized to the
hygroscopic dimethyl sulfoxide (DMSO) and to methylsulfonylmethane. Both polar
compounds dissolved in atmospheric moisture are delivered by rain to all land
masses. Plant roots rapidly absorb and accumulate surprisingly high levels of
these compounds, as determined by spectrophotometric and radiotracer techniques.
The stable end products in plants, are methylsulfonylmethane and methionine, an
essential amino acid, as well as other sulfur containing compounds naturally
occurring in plants. A number of recent publications report that there is not
enough hydrogen sulfide in the atmosphere to satisfy minimum cycle requirements
and support this sulfur transport mechanism.
Challenger and Hayward reported in 1954 on the presence of dimethyl sulfonium
salts, all precursors of methyl-S-methanes, in many marine and terrestrial plant
forms serving as animal food. Since then, many scientific articles report on the
natural occurrence of the methyl-S-methane series and the most stable member of
the series (methylsulfonylmethane) in virtually every vegetable, nut, fruit,
meat, fish and beverages as well as coffee, beer, tea and milk.
Metabolic sulfur was as important to life forms hundreds of millions of years
ago as it is today. Before life "invented" the complex sulfur donor
methionine (or cysteine), primitive life utilized the simpler
methylsulfonylmethane and its precursors. Blue-green algae, which is found
together with primitive bacteria in the earliest precambrian fossil remains,
still grows widely today in the earth's surface waters and continues to produce
DMS, helping to balance the sulfure equation of life. Considering that early
life was programed to use methyl-S-methanes, one can understand why higher forms
of life are genetically programmed to employ methylsulfonyl-methane as a sulfur
donor. Therefore, methylsulfonylmethane is as acceptable and as assimilable to
modern life forms as NaC1 or water and thus presents an extremely low toxicity
profile to at least the higher forms of life.
Methylsulfonylmethane and its precursors are as necessary for a good diet as is
adequate potassium. The methyl-S-methane series, at food levels of up to about a
hundred milligrams/day, supplies already normal, healthy tissue with maintenance
levels of sulfur; with methionine and cystene degradation products also
contributing though apparently not as directly nor as easily in. It is
interesting that some forms of life can convert methionine to
methylsulfonylmethane as well as the reverse synthesis sequence.
A number of biological effects of methylsulfonylmethane are described in my
copending patent applications and issues patents cited above, as is the
intentional ingestion of methylsulfonylmethane combinations as foods or
flavorant ingredients thereof. The effect of high levels of
methylsulfonylmethane ingestion in favorably altering the course of abnormal or
disease states is believed to depend primarily on actions of the intact
molecule. The major differences between the use of methylsulfonylmethane as a
food and as a normalizer of biological function is the concentration and amount
employed, dosage forms, and routes of systemic entry. As a food,
methylsulfonylmethane plays an important role in the multitude of sulfhydryl (--SH)
and disulfide (--S--S--) disruptions, destructions and repair associated with
normal life processes. Systemic availability of methylsulfonylmethane for sulfur
donation to repair and restore tissue damaged covalent disulfide bonds and
synthesize having sulfhydryl groups critical to reactivity, is thus a basic
nutritional requirement.
As with so many constituents of natural foods, excess amounts of
methylsulfonylmethane are excreted unchanged from the body, the excretion routes
being the feces, the renal pathway and through the skin. Orally ingested
methylsulfonylmethane is stored to some degree in various organs, presumably
banked for future sulfur needs of the body. The skin excretion route is unusual,
particularly since about one-third of a given oral dose can be found in the
perspiration. Like NaC1, excretion depends somewhat on perspiration rate. The
accumulation in and excretion of methylsulfonylmethane from the skin is believed
to account for its cosmetic effect, viz., more youthful appearing, pliable,
blemish-reduced skin. Chemical and radiolabeled sulfur (35-S) assays can be used
to determine the extent to which important biomolecules as heparin, insulin,
co-enzyme A and other --SH bearing enzymes, biotin, methionine enkaphalin, human
growth factor, hemoglobin, calcitonin, fibrinogen, muscle protein and other
compounds derive their thiol (--S--) and disulfide (--S--S--) groups from
methylsulfonylmethane and the possible preference of methylsulfonylmethane over
S-content amino acids as the donor with such synthesis.
The word "food" broadly means a nutritive material taken into an
organism for growth, work, protection, repair, restoration and maintenance of
vital processes. Therefore, all animal life needs a continuing supply of food
and cannot survive for long without it. However, food can also cause poor health
and disease. Thus, balanced food intake or balanced nutrition are better
definitions than "food" for the nutritional factor essential to good
health. "Balanced food" implies that not only are all of the elements
of good nutrition present, they are available in ample amounts for supplying the
body's needs. Based on my findings with methylsulfonylmethane to date, a
balanced food intake requires significant amounts of methylsulfonylmethane as a
metabolic sulfur source, since all evidence suggests that no other ingredient or
combination thereof, including methionine, cysteine, cystine and degradation
products thereof, fulfills the role of methylsulfonylmethane.
The present invention relates to compositions and methods for replacing or
supplementing methylsulfonylmethane, a natural but fugitive ingredient of food.
Methylsulfonylmethane is lost from natural foods by virtually every known method
of processing because although stable, it is quite volatile. It is, of course,
absent in synthetic food additives, dietary mineral compositions, food
substitutes and most fillers used to dilute or modify foods. It is also absent
in "comfort" products, such as tobacco products, various alcoholic
beverages, and cosmetic products such as toothpaste, mouth washes, breath
sweeteners, and other similar agents that directly contact the mucous membranes
of the buccal cavity and in some cases the entire respiratory tract, as in the
case of cigarette smoke.
Using conventional analytical procedures, one can readily determine the
naturally occurring methylsulfonylmethane (and/or its precursor) content of the
cooked, processed and/or stored food and how it compares with the corresponding
unaltered or natural food. For example, unprocessed milk from cows fed a
nutritionally balanced feedstuff and permitted to field graze typically contains
about 2-5 ppm of methylsulfonylmethane. In contradistinction, the
methylsulfonylmethane content of unprocessed milk from cows fed dried animal
feedstuffs and of milk and milk products which have been processed and
pasteurized is negligible. One can readily calculate the amount of
methylsulfonylmethane needed to restore milk, buttermilk, cream, yogurt, etc.,
to their "natural" levels. This is most conveniently accomplished at
the bulk level, just before the milk or dairy product is to be bottled or
packaged. Since other nutritional factors, such as Vitamin D, are customarily
added to milk, the technology and equipment for such additions is conventional
and readily available.
Many of the fruits and vegetables customarily consumed by humans contain
approximately 1-4 ppm by weight of methylsulfonylmethane when freshly harvested.
However, during processing, e.g., canning, most of the methylsulfonylmethane is
lost. As in the case of dairy products, it is convenient to add the amount of
methylsulfonylmethane required to restore it to its natural value to the
processed product just prior to packaging or use.
It is apparent from the discussion above that superior nutritional benefits are
obtained when methylsulfonylmethane is added to foodstuffs that do not require
further processing, particularly processing requiring extended periods of
heating or drying. Thus, it is preferable that methylsulfonylmethane be added to
dairy products, canned fruits, desserts and other confections, vegetables, etc.,
which are not heated or which require only a minimum of warming prior to
consumption.
Foodstuffs
Methylsulfonylmethane has, since 1983, been sold both as a food and food
supplement for human consumption and its utility for such purposes has
extensively been established. Its utility as a restorative additive in
foodstuffs adapted for consumption by human beings or other animals has
similarly been confirmed in a variety of species.
Examples of processed foodstuffs adapted for human consumption which typically
have naturally occurring methylsulfonylmethane levels below about 0.25 ppm, are
pasteurized milk and milk products, breakfast cereals, bread and other bakery
products, canned fruits, vegetables, meats and fish and dried meats and fish.
Examples of processed foodstuffs adapted for domestic animal consumption which
typically have naturally occurring methylsulfonylmethane levels below
about..0.25ppm are dry, semi-dry and canned cat and dog foods; multi-ingredient
feeds adapted for consumption by herbivores, poultry, swine, etc.
All of the foregoing products are processed in a manner which includes a heating
and/or drying step which reduces their naturally occurring methylsulfonylmethane
content to below about 0.25 pm. Methylsulfonylmethane can be admixed therewith
after the aforesaid heating and/or drying step. e.g., after cooking in an open
vessel at or above 100.degree. C., to bring the methylsulfonylmethane content
thereof to about 0.01 to 20 ppm, preferably about 1 to 15ppm, in the case of
foodstuffs intended for human, dog or cat consumption, and about 0.01 to 20 ppm,
preferably 1 to 10 ppm in the case of feed intended for consumption by a species
of farm animal.
The methylsulfonylmethane can in some instances be admixed in crystalline form
with one or more ingredients of the foodstuff as part of a final dry mixing step
or as an aqueous, alcoholic or other ingestible solvent solution thereof, e.g.,
by spray mixing. Because of its volatility the foodstuff should not be subjected
to an open-container cooking or drying step after the methylsulfonylmethane is
admixed therewith. In the case of dry foodstuffs, the volatility of
methylsulfonylmethane can, if desired, be counteracted by encapsulating or
coating the individual particles of methylsulfonylmethane prior to its addition
to the foodstuff with a continuous coating, e.g., a natural waxy or synthetic
polymeric film, which is dissolvable or removable in the digestive system.
Techniques for coating moisture-unstable products intended for ingestion, to
protect them from the adverse effects of atmospheric moisture and/or oxygen, are
well-known in the pharmaceutical arts and can be employed to inhibit the loss of
the methylsulfonylmethane from the foodstuff prior to its ingestion by
evaporation. Loss of the methylsulfonylmethane from wet processed foodstuff
products can be reduced by conducting all heating steps and storing the
processed foodstuff in a sealed container.
In addition to or alternative to being administered in admixture with one or
more of the foodstuffs ingested by the animal, as described more fully elsewhere
herein, methylsulfonylmethane can also be incorporated into the diet of humans
and lower animals by ingesting the crystalline methylsulfonylmethane or a
solution, e.g. aqueous, thereof separately from other foodstuffs, preferably, in
unit dosage form, e.g., as a tablet, capsule, dragee or pill, as such or in
admixture with the usual pharmaceutically acceptable excipients, diluents,
tableting aids, etc., with tablets and capsules being preferred, especially
those containing from 100 mg to 500 mg methylsulfonylmethane each.
Although human beings are the preferred recipients, other vertebrates, including
mammals, e.g., domestic animals, such as horses, cows, sheep and pigs, pets,
e.g., cats, dogs and fish, and wild animals kept in zoos, and fowls, e.g.,
chickens and other poultry, can be treated according to this invention. Both
small children and adults, including geriatrics, gain a more beneficial balanced
diet when methylsulfonylmethane levels match natural, unprocessed foods.
Although this invention is directed primarily to
methylsulfonylmethane-containing foodstuff, methylsulfonylmethane is useful in
other oral forms, e.g., mouth washes and toothpaste preparations, because of its
chemical and light stability, low toxicity, good solvency, water solubility and
dispersibility.
Methylsulfonylmethane, alone or in combination with an appropriate
pharmaceutically active agent, has demonstrated usefulness when introduced into
other body cavities, e.g., vaginally and rectally. Methylsulfonylmethane can be
introduced into the lungs and bronchial tree as an aerosol of a solution thereof
or as a sublimate produced by heating, which can be inhaled.
Since methylsulfonylmethane has an additive flavor or flavor enhancing property,
e.g., for chocolate, soy sauce, salt, sweet vermouth and other alcoholic
beverages, carbonated cola beverages, rye bread and other baked goods, it can be
included in condiments and admixed or co-crystallized with NaC1 or other
particulate flavorings and condiments. Methylsulfonylmethane can also be safely
administered by intravenous or parenteral injection. Additional benefits are
seen when methylsulfonylmethane is provided in combination with the
water-soluble vitamins.
Animal Feed
The animal feed aspect of this invention can be practiced in a number of ways.
For example, the methylsulfonylmethane can be added to low moisture corn
(approximately 14% moisture) at levels in the range of 15.times.10.sup.-4 % to
3.0%, usually 0.01% to 1.0%. Inasmuch as methylsulfonylmethane is a solid, the
addition can be carried out in a batch feed mixer.
After the corn has been treated, it can be used as such as an animal feed or it
can be stored and used at a later date or it can be mixed with other
ingredients, e.g., alfalfa meal, soybean meal, minerals and vitamins. The
resultant mixture can be used as such as an animal feed or it can be pelleted
and the pellets employed as an animal feed.
One method of preparing pellets is to grind corn, alfalfa meal, soybean meal,
minerals and vitamins, add steam to bring the moisture content up to 16% water
and then allow the mixture to stand and cool so that the final moisture content
is around 14%. Methylsulfonylmethane is added to this mixture, preferably before
pelleting in proportions sufficient to give a mixed feed containing the desired
concentration of methylsulfonylmethane. The corn admixed with the
methylsulfonylmethane can be used as whole kernels or it can be cracked or
ground and used as such or in mixed feeds. In case the product is to be used
without lengthy storage, the methylsulfonylmethane content can be as low as
15.times.10.sup.-4 % to 3.0%. Because of the volatility of the
methylsulfonylmethane, if the corn or feed is stored prior to use, the
methylsulfonylmethane content is preferably about 0.01% to 5%.
The methylsulfonylmethane can also be administered to the animals in the form of
a solution in their drinking water, e.g., 0.01% to 3%, preferably 0.1% to 2% by
weight.
The methylsulfonylmethane can also be added to the animal feed immediately prior
to feeding time, e.g., by spraying a solution thereof into the feed or stirring
crystalline methylsulfonylmethane into the feed in amounts which will provide
the desired ingested amount.
The animal feed aspect of this invention is particularly important where it is
desired to improve the overall appearance of or maintain the health of
herbivorous animals, especially beef cattle, dairy cattle, hogs, horses, sheep,
goats and fowl. It is particularly useful in reducing the incidence of
stress-related deaths, e.g., due to close confinement.
The methylsulfonylmethane is usually provided in the animal's normal feed
rations, periodically throughout the day or on successive days, or both, e.g.,
for 2 to 21 days or even longer. The daily food ration appropriate for the
animal being fed is supplemented with an amount of methylsulfonylmethane
calculated to correspond to a predetermined amount per total body weight of the
animals being fed. The exact amount of methylsulfonylmethane ingested each day
is not always critical, particularly when methylsulfonylmethane administration
is over an extended period of days, because the ingested methylsulfonylmethane
accumulates in the body tissues and fluids, i.e., reaches an effective titer.
Methylsulfonylmethane-supplemented rations providing levels of as low as 0.5-1
mg/kg animal body weight are sometimes effective and levels as high as 300 mg/kg
body weight or more are well tolerated. The usual target level per individual
animal is about 0.2-2.0 mg/kg body weight preferably 0.5-1.0 mg per kg body
weight. Total daily supplements corresponding to up to about 1 gm/kg body weight
or more, are preferably employed, depending on the degree of deficiency. Healthy
animals often have methylsulfonylmethane blood levels of at least 1 ppm, and
desirably, enough methylsulfonylmethane is provided to raise blood levels to
above 1 ppm. The oral ingestion of amounts of methylsulfonylmethane in excess of
that required to elevate blood levels is not harmful because of the extremely
non-toxic nature of methylsulfonylmethane.
Because methylsulfonylmethane is naturally present in the body fluids and
tissues of animals, its mode of action resembles that of a vitamin-like dietary
supplement. Although methylsulfonylmethane has not yet been established to be a
vitamin, at least a vitamin deficiency-type disease has not yet been proved to
occur in animals with abnormally low methylsulfonylmethane blood levels, it does
have a vitamin-like moderating or normalizing activity correlation between
abnormal physiological symptoms and low methylsulfonylmethane blood levels.
Whether this is due to the inability of such animals to adequately store
methylsulfonylmethane from natural sources thereof, to inadequate amounts of
methylsulfonylmethane in the diet of those animals or the depletion of the
methylsulfonylmethane usually present in the body as a result of the abnormal
condition, is not known. Whatever the reason, the oral ingestion of
methylsulfonylmethane in sufficient amounts will ultimately bring
methylsulfonylmethane levels to or above those usually present in healthy
animals and will ameliorate a variety of symptoms associated with stress.
Like vitamin C, glucose and other substances normally present in animal diets,
methylsulfonylmethane exhibits remarkably low acute and chronic toxicity in the
hosts diet. Primates with high (greater than 1 gm/kg body wt.)
methylsulfonylmethane blood levels for at least two years lack evidence of
methylsulfonylmethane toxicity.
Although methylsulfonylmethane is found as a natural constituent of foodstuffs,
like vitamin D, the principal supply in animals is believed to be synthesized by
the body using dimethyl sulfide or one of its naturally occurring precursor
salts as commonly found in meat, fish, vegetables and fruit. Too low a body
concentration of methylsulfonylmethane results in adverse physical and
psychological stress, tissue and organ malfunction, fatigue and increased
susceptibility to diseases.
Based on the excretion rate from young compared with older animals,
methylsulfonylmethane appears to be present in lowering concentrations with
increasing age. Generally, with maturity, there is less than 0.5 ppm
methylsulfonylmethane in the humoral fluid. This may explain why
methylsulfonylmethane has proved generally more useful as a dietary supplement
with mature animals, in whom naturally occurring levels of
methylsulfonylmethane, generally are lower than optimum for providing optimum
protection of the organism from stress challenge. A conventional diet does not
supply the minimum requirement for optimum health. For example, unprocessed
milk, one natural source of methylsulfonylmethane, contains only about 2-5 ppm
depending on the source. To obtain and retain a minimum blood level of
methylsulfonylmethane of about 1 ppm, animals would be required to ingest an
impractically large amount of this or any other single unprocessed food product.
According to this invention, the diet of a methylsulfonylmethane-deficient
animal is supplemented with sufficient methylsulfonylmethane to provide blood
levels of more than 1 ppm and, where health is threatened, a level of 10-20 ppm
or higher.
Additional benefits are seen when methylsulfonylmethane is provided in
combination with the water-soluble vitamins.
Conventional feedstuffs for meat producing animals comprise supplemented
complete or basal animal feeds or, alternatively, premixes for preparing such
feeds. The carrier or basal feed is usually hay or corn derived but may include
dried fermentation residue, alfalfa, cotton-seed, barley meal, soybean meal,
corn meal, rice hulls, molasses, mineral salts, vitamins, silages, beet pulp,
citrus pulp, fish meal, oats, rice bran, milo, sesame meal, milk or other
standard animal feed ingredients. In premix compositions the other ingredients
are mixed in high concentration with a carrier ingredient which is usually
desirable in the complete feed such as soybean meal, corn oil, ground corn,
barley, mineral mixtures such as vermiculite or diatomaceous earth, corn gluten
meal, corn distillers solubles or soyflour. As examples of the livestock feed
normally ingested per meat producing animal per day are: sheep 3-4 lbs., feed
lot steer 20-25 lbs., swine 1-8 lbs., poultry 0.03-1 lb. The
methylsulfonylmethane contents of these animals feed is adjusted to provide the
desired mg/kg body weight methylsulfonylmethane daily ingestion rate.
Dairy cattle typically are fed two different types of vegetable feed, the first
roughage including hay and corn silage and the second, a supplemental ration
usually containing ingredients of the type listed above. In the case of an
average dairy cow, this supplemented ration might be within the range of 10 to
20 pounds per day.
Feed intended for chickens would not contain added roughage. The ratio of starch
to protein would depend on whether the bird is being raised for meat or is a hen
producing eggs.
Also well known and readily available commercially are pet foods for dogs, cats,
hamsters, etc., and fish food, etc.
As previously stated, methylsulfonylmethane when included in animal feed rations
is useful as a flavor enhancer, as a health maintainer and in preventing stress
death in the animals.
Stress deaths are a well known phenomena for some species of animals, especially
chickens, because of the crowded manner in which they are raised and transported
and the generally rough treatment given to them in transferring them from one
area to another; turkeys, because of their temperament; and fish, especially
species of tropical fish which are normally sold for aquariums, because of their
extreme sensitivity to changes in the composition of or temperature of their
water. Methylsulfonylmethane is particularly useful in reducing the incidence of
stress-related deaths when administered daily for from 7 to 90 days, preferably
14 to 28 days prior to the animals being exposed to the death-inducing stress,
and during the period of such stress, e.g., at dosages from about 0.01 to 10
mg/kg, preferably from about 0.01 to 5 mg/kg body weight per day.
The following are pharmacological uses for methylsulfonylmethane in addition to
its use in foodstuffs as described hereinabove:
1. Reducing the adverse response to inhalant allergens. This action may be due
entirely or in part to a physical blocking action. Labeled 35-S dimethyl sulfone
binds tightly to the surface of mucous membranes and by autoradiography, the
membranes appears to be coated, as with a paint.
2. Controlling problems associated with gastric hyperacidity, e.g., relieving
epigastric pain.
3. Providing relief from chronic constipation.
4. Reducing or eliminating hypersensitivity problems associated with oral
medications, such as non-steroidal antiarthritic agents. This effect may be the
result of the interaction of the methylsulfonylmethane with plasma prostaglandin
F2.
5. Providing relief from the symptoms of lung dysfunction, e.g., by plasticizing
effect on the membrane surface of the lung involved in gas exchange.
6. Controlling parasitic infections associated with the intestinal or
urinogenital tract, e.g., those caused by giardia or trichomonads.
Methylsulfonylmethane also has a beneficial effect in the treatment of disease
conditions caused by a spectrum of other micro-organisms.
7. Mood elevators, e.g., for the terminally ill.
8. Improving the chemical profile of arthritic patients, e.g., providing relief
from pain and stiffness, reduced swelling and inflammation, coupled with a
return of blood chemistry towards normalcy, for example, a RH titer drop from
600+to 300 or lower.
9. Relieving leg and back cramps, muscle spasms and general soreness,
particularly in the geriatric patient, and in the premier athlete after
competition stress.
10. Reduction in hypertension.
11. Promoting remission in myositis ossificous generalis (a rare,
genetic/autoimmune dysfunction).
12. Improving the overall health of domestic and farm animals, e.g., dairy and
beef cattle, horses, pigs, sheep, goats, chickens and turkeys whose caloric
intake is predominantly or exclusively processed food rather than growing
grasses and plants.
13. Reducing the incidence of stress deaths in animals raised and/or shipped in
crowded or otherwise stressful conditions.
Leg Cramps
Methylsulfonylmethane has the surprising ability to reduce the incidence of or
eliminate entirely muscle cramps, leg and back cramps, particularly in geriatric
patients who experience such cramps at night and after long periods of
inactivity, e.g., while sitting, and leg cramps in athletes, e.g., runners,
football, basketball and soccer players, who experience severe leg cramps during
participation in their sport. Ingesting methylsulfonylmethane, either in
pharmaceutical composition form or in admixture with one or more foodstuffs for
from 1 to 90 days will reduce the incidence of such cramps or eliminate them
entirely.
Parasitic Infections
Methylsulfonylmethane has an ameliorating or curing effect on a variety of
parasitic systemic microbial infections. Efficacy can be determined by in vitro
testing to determine growth inhibition or killing of the specific organism by
exposure to methylsulfonylmethane at various concentrations in an otherwise
acceptable growth-maintaining in vitro media for the organism. If inhibition or
death of the organism occurs when exposed to methylsulfonylmethane at
concentrations below about 100 ppm, the methylsulfonylmethane will exhibit in
vivo activity against that organism. Examples of parasitic infections
susceptible to treatment with methylsulfonylmethane are those commonly
associated with infection of the intestinal or urinogenital tract, e.g.,
Nematodes, Trichomonas vaginalis, Giardia, Enterobius and other intestinal
worms, systemic infections by Histoplasma capsulation, Cocoidioides, Toxoplasm
and other in vitro susceptible organisms.
Intravenous Administration
In U.S. Pat. No. 4,296,130, I teach that methylsulfonylmethane is so inert and
non-toxic that aqueous solutions thereof can be used as a blood diluent. In
healthy humans or other animals having adequately high methylsulfonylmethane
blood levels, methylsulfonylmethane is in fact "inert" in the sense
the term is used in that patent. However, in acutely ill patients, dramatic
beneficial benefits are often obtained by the intravenous administration of
large doses of methylsulfonylmethane. For example, rheumatoid arthritic patients
suffering from a flair-up of the disease which produces intense pain or
crippling swelling of the joints or both achieve prompt relief, even those
patients who obtain only minimal or delayed benefits from oral ingestion of
methylsulfonylmethane.
Apparently, when a patient is in an acute stage of intense pain-producing
disease, such as rheumatoid arthritis, osteoporosis, degenerative disc syndrome,
an autoimmune disease or metathesized carcinoma, which produces intense pain,
the relief from pain from oral ingestion of methylsulfonylmethane is sometimes
too subtle or takes too long for the patient to obtain reasonably prompt
subjective benefits therefrom. In contradistinction, intravenous administration
of methylsulfonylmethane gives prompt, i.e., within hours and often within
minutes, relief from pain and often dramatic benefits, e.g., a significant
reduction in the crippling effects of rheumatoid arthritis.
Therefore, in one aspect this invention relates to a method for rapidly
ameliorating at least the pain associated with an intense pain-producing disease
by the intravenous administration of methylsulfonylmethane in an amount
effective to ameliorate the pain.
The amount of methylsulfonylmethane intravenously administered can vary
substantially because of its lack of toxicity and adverse side effects.
Individual doses can vary from about 0.01 to 2 gm/kg, preferably from about 0.1
to 1 gm/kg, on a body weight basis, the usual dosage range is about 0.25 to 0.75
gm/kg, preferably about 0.5 gm/kg.
When large amounts are administered, e.g., in the order of 1 g/kg of body weight
or more, i.e., infusion of 5% to 10% solution of methylsulfonylmethane in water,
physiological saline or 5% dextrose is preferred. The rate of administration is
preferably no greater than about 1 gm/kg/hr, although infusion rates as high as
2 gm/kg/hr are tolerated by patients, except for light-headedness of the type
experienced by some blood donors is experienced by some patients at this rate.
Because methylsulfonylmethane is very rapidly excreted, the intravenous
administration can be repeated frequently, e.g., every 12-24 hours. However, one
i.v. administration often suffices to achieve amelioration of pain and other
symptoms, which remission can be maintained for weeks or months with orally
ingested methylsulfonylmethane.
Without further elaboration, it is believed that one skilled in the art can,
using the preceding description, utilize the present invention to its fullest
extent. The following preferred specific embodiments are, therefore, to be
construed as merely illustrative, and not limitative of the remainder of the
disclosure in any way whatsoever. In the following examples, all temperatures
are set forth uncorrected in degrees Celsius; unless otherwise indicated, all
parts and percentages are by weight.
Example 1 - Human Food
During the cooling step of a conventional continuous milk pasteurization
process, inject a sterile 25% aqueous solution of methylsulfonylmethane into the
pasteurized milk at a rate which imparts a final concentration thereof in the
milk of about 15 ppm.
Example 2 - Human Food
Incorporate prior to cooking, along with the NaC1, sugar or any condiment which
is added to a vegetable or fruit cooked under pressure in a sealed can, e.g.,
corn, peas, tomatoes, green beans, peaches, pears, pineapples, apple sauce,
etc., an amount of methylsulfonylmethane which provides a concentration thereof
in the cooked product of about 5 ppm.
Example 3 - Equine Feed
Calcium/phosphorous balance is critical in the horse, where these elements
comprise roughly 70% of the mineral content of the horse's body. Calcium
deficiency, or the reverse, viz., phosphorous excess, is undesirable.
Phosphorous excess in feed will decrease intestinal absorption, resulting in
lowered blood plasma calcium. One result is a stimulation in the dietary
deficiency condition called nutritional secondary hyperparathyroidism. Calcium
denied for bone development results in an enlargement of structurally defective
fibrous tissue. In horse leg bones, it is called epiphysitis when stress
inflammation is presented.
Two colts and four fillies were studied, all diagnosed as having nutritional
secondary hyperparathyroidism with obvious epiphysitis. Each was provided with
12 grams of methylsulfonylmethane twice daily in a bran/molasses blend
intermixed with their standard dry feed prior to feeding. The supplemented feed
was well accepted. All signs and symptoms of this nutritional deficiency disease
was corrected in from seven to ten days. Conventional treatment for correcting
dietary calcium deficiency requires a minimum of 60-90 days before relief from
inflammation is obtained. Except for the added methylsulfonylmethane, there was
no change in the diet of these seven horses. The added dietary factor corrected
this easily recognizable dietary deficiency in all of the horses.
Example 4 - Equine Feed
A valuable breeding mare, treated for a respiratory infection developed
bilateral fibrinous pleuritis, easily heard with auscultation of the chest.
After six weeks therapy with a combination of conventional antibiotics and
anti-inflammatory drugs, there was little if any improvement. Conventional
therapy was terminated. Methylsulfonylmethane was added to the diet of this
refractory case (24 g, twice daily, over a period of 5 days). This was the only
special treatment given. By the fifth day the animal no longer demonstrated pain
and the shallow, rapid breathing returned to normal. Auscultation of the chest
was negative. This horse was followed over the next two years and was judged
normal and healthy.
Example 5 - Methylsulfonylmethane in Tobacco
Distribute methylsulfonylmethane in the tobacco used to provide cigarettes at
the rate of 100 ppm by weight by spraying the tobacco just prior to being formed
into cigarettes with a 10 % ethanolic solution of methylsulfonylmethane at the
rate of one ml/kg.
The inhaled smoke from such cigarettes includes sublimed methylsulfonylmethane,
which counteracts the adverse effect of the smoke on the lung mucosa. Also, a
significant number of smokers find the flavor and taste of the cigarette more
desirable than otherwise identical cigarettes lacking the methylsulfonylmethane.
Example 6 - Nail Growth In Animals
Rate of nail growth is an indication of the overall health of an animal. To
determine the effect of methylsulfonylmethane on nail growth, two litter mate
female labradors, age 8.5 months, were maintained in side by side straw bedded
cages. Before any testing, the front paws of each dog were embedded in partially
set plaster of paris, allowing the animals to exert full body weight, thereby
obtaining good clear impressions of paw pads and nail length.
Each dog was fed Purina dog chow and water ad lib for 45 days. One of the dogs,
(Animal A) had no ration change and the other (Animal B) was supplied only with
water containing 5% of methylsulfonylmethane dissolved therein. After 45 days,
plaster impressions of the front paws of each dog were again taken. Once the
plaster had fully hardened the pre- and post-testing castings of each animal
were compared. The straw bedding protected both animals from normal nail wear.
On visual examination, the nails of Animal B, the animal receiving
methylsulfonylmethane in its water, were obviously longer. Upon comparing the
castings it was seen that Animal B had nails that averaged about 1/8th inch
greater length than those of Animal A.
The hair, horn, and nails of animals can contain 5% or more sulfur based on
elemental analysis. This test indicates that the sulfur of
methylsulfonylmethane, roughly 1/3 the molecule's weight, is utilized
beneficially in stimulating at least nail growth.
Example 7 - Animal Coats
The coats of animals A and B of Example 6 were examined by three individuals.
Each judged the coat of Animal B to be superior, based on thickness and the
shiny appearance generally associated with good health.
Example 8 - Animal Coats
Ten 4-week old guinea pigs were housed in individual metal cages in a standard
temperature room with a 12-hour light/dark cycle and acclimated over a 5-day
period of feeding Purina guinea pig chow with water ad lib.
On day six, five animals were marked on the belly with red and the other five
with blue water-insoluble ink. The marks were not visible when the animals were
observed from above. Each animal after marking was returned to its cage and a
corresponding red or blue tape affixed to the animal's watering bottle. The red
marked bottles were maintained with tap water and the blue marked bottles were
filled with tap water containing 2 wt.% methylsulfonylmethane. During a 28 day
period, the animals were fed and allowed access to their water or water +2%
methylsulfonylmethane, respectively, ad lib. On day 28, the animals were placed
in common confinement on a well lighted table. Four individuals, totally
unfamiliar with the test and its purpose were asked to evaluate the coat of each
animal. Animals at each evaluation were removed by the evaluator and placed into
one of two groups based on better or poorer quality of the animal's coat without
seeing the color on the animal's belly. Three of the four evaluators quickly
selected five animals with superior coats, all of which were later determined to
bear a blue belly mark, i.e., the methylsulfonylmethane treated group. The
fourth evaluator selected three animals with a blue belly mark as having
superior coats but concluded he could not distinguish better from the poorer
with the remaining seven animals. Despite the failure of one evaluator to
clearly distinguish all animals given methylsulfonylmethane from the controls,
the testing demonstrated that a generally visible improvement is seen in the
coat of a guinea pig having methylsulfonylmethane as an added food in its
ration.
Example 9 - Stress Death in Chickens
Feed broiler chickens, no more than a few days old, were fed one of two diets,
viz., standard feed or standard feed plus 0.2wt.% methylsulfonylmethane for a
period of 30 days. There will be a significant difference between the stress
death rates in the two lots during that period. With those fed unmodified feed,
the death rate will be normal, viz., about 10%, whereas with
methylsulfonylmethane modified feed the death rate will be less than 1%.
Example 10 - Stress Death in Fish
Fish of any species demonstrate stress death in crowded conditions. Commercially
valuable species, such as salmonids, are very prone to stress-death during
confinement in hatcheries or aquaculture farms.
62 Goldfish, about 2 inches long, were divided into two 31 population lots and
placed in acclimated aquariums (2) maintained at 50.degree. F. On receipt of the
fish, two small one gallon aquariums were filled with tap water and stablized
for 5 days by aeration with an aerator/filter combination connected to a common
aquarium air pump. Air delivery during the test period was standardized at 100
ml of air per minute. From a 1 oz. package of "Wardleys" goldfish food
two 10 gram samples were removed. One sample was untreated and the other was
moistened with about one ml of pure ethanol containing 0.2 gram
methylsulfonylmethane in solution. The feed absorbed all the
methylsulfonylmethane (the lot after air drying for 48 hours weighed 10.2
grams). Both feeds were pulverized to a coarse powder suitable for feeding small
fish.
The 31 fish in each of the two holding aquariums were identified as batch A and
batch B. During the acclimatization and test periods the batch A fish were fed
0.5 gram of untreated "Wardleys" food once daily. Batch B fish were
fed 0.5 gram of the feed containing the methylsulfonylmethane during the
acclimatization and test periods. Neither batch A nor B consumed all of the feed
as some eventually collected in the fiberglass filter. However, most of each
feeding was consumed in the first 5-10 minutes after delivery. During the 5th
day, 25 fish of batch A were transferred to one small aquarium (designated A)
and 25 fish of batch B were moved to the other small aquarium (designated B).
Before transfer, each aquarium was temperature adjusted with ice to 41.degree.
F. The water was allowed to return to ambient, e.g., to 50.degree. F., after the
fish were added to the tank. The fish of both batches were thus subject to a
total of 9.degree. F. temperature change, which stressed the fish. Feeding was
resumed after starving them for one day in the small tanks. By day ten, (five of
them in the small aquariums), there had been a total of 11 deaths in aquarium A
(control) and one death in aquarium B.
The combination of impressed negative temperature, tank transfers, marginal
oxygenation of the tanks, and confinement of a beginning population of 25
fish/gallon aquarium imposed sufficient stress to kill nearly 1/2 the control
fish. The addition of only 2% by weight of methylsulfonylmethane to the feed
reduced stress significantly.
Example 11 - Oral Hygiene
Subjects not having professional dental cleaning for at least four-six months
and demonstrating minor yet discernable gum inflammation, probably due to plaque
irritation, were given either a paste (Colgate tooth paste) prepared by
combining a commercial dental product with methylsulfonylmethane on a 50/50 w/w
basis. Subjects cleansed their teeth on a twice daily regimen. Following one
week use, the oral mucosa of all subjects was free of signs of inflammation. One
subject (T.K., M 22) troubled with recurring canker sores reported freedom from
this problem during and after the one month testing was terminated.
Methylsulfonylmethane, a solvent and dispersant in aqueous media, was shown to
be an excellent agent alone for cleansing of teeth and the buccal cavity.
Subjects of this test with a viscid mucoid nasopharyngeal discharge experience a
reduction in the viscosity of the mucous and generally a productive cough.
Interestingly, two subjects with a restricted sense of smell found a sharpening
of this sense while methylsulfonylmethane was being evaluated by them in a
gargle. Critical observers noted their sense of taste was improved.
Bad breath associated with smoking or food, such as onion and garlic, is reduced
or eliminated by cleansing the teeth and mouth with methylsulfonylmethane in
water, saline solution or a conventional oral hygiene product.
Example 12 - Maintenance of Good Health
14 subjects of both sexes, all in apparent good health, ages 33.times.59, were
given oral methylsulfonylmethane in amounts ranging from 250 to 500 mg daily
which maintained their blood levels above 1 ppm. These individuals were
continued on methylsulfonylmethane, taken as a solution in orange juice for
periods of from about seven months to over one year. None of the 14 became ill
during this testing and each reported feeling better and stronger with increased
endurance while methylsulfonylmethane was a part of their diet.
Example 13 - Connective Tissue and Dermatological Disorders
Primary and secondary pruritis, acne (including Grade 4), acne rosacea and
diverse other dermatological problems which are often allergy related respond
favorably to a diet supplemented with methylsulfonylmethane. Pruritis due to
various causes and acne respond promptly to diet supplemented levels of about
100-1000 mg per day. Teenagers found methylsulfonylmethane in cola drinks a
particularly acceptable satisfactory combination when treating acne. With
rosacea, visual improvement was much slower. In one subject (J.H., F 51) daily
ingestion of 500 mg methylsulfonylmethane for at least several weeks was
required before telangiectasis diminished.
Example 14 - Inflammation of the Eye
A 15% solution of methylsulfonylmethane in isotonic saline was a soothing
treatment for the eye following accidental injury due to particulate matter in
the eye as dust or pollen. A rabbit eye, irritated with aqueous sodium lauryl
sulfate, quickly cleared when treated every hour with 10% aqueous solution of
methylsulfonylmethane.
Example 15 - Pain Associated With Systemic Inflammatory Disorders
Individuals presenting signs and symptoms of pain and inflammation associated
with various musculoskeletal system disorders reported substantial and long
lasting relief while including from about 100 up to about 5,000 mg of
methylsulfonylmethane per day in their daily diet. Most, trying
methylsulfonylmethane first alone and then in combination with ascorbic acid,
reported greater benefit with the combination. The combination of
methylsulfonylmethane with ascorbic acid was seen to be particularly useful in
correcting night leg cramps. Migrane sufferers have obtained substantial relief
at oral dose levels of 50-500 mg per day.
One subject (M.P., F 81), presented chronic arthritis with painful involvement
of the lower trunk. Over the years she had evaluated most new antiarthritic,
analgesic drugs with disappointing results. She included methylsulfonylmethane
(1/2 tsp. daily) in her diet and found almost total pain relief by the end of
the second week. After ingesting methylsulfonylmethane daily at 1/4-1/2 tsp. for
about 16 months, the subject is enjoying a substantially pain-free life.
Example 16 - Mental Normalcy
In man, mental normalcy is demonstrated by alertness with inner calmness which
is not subject to sharp swings in mood change. Individuals on
methylsulfonylmethane generally reported increased alertness, a plateau of mood
changes, and particularly very infrequent depression. A few subjects on
medication intermittently for depression observed that methylsulfonylmethane
relieved depression within hours rather than days, as had been their prior
experience with antidepression medication. Students reported that while taking
methylsulfonylmethane, their ability to concentrate is enhanced.
Methylsulfonylmethane therefore is useful in conjunction with CNS therapeutants.
The most useful application for methylsulfonylmethane seen to date in the field
of mental normalizing is as an aid to the terminally ill, to relieve anxiety and
depression.
To a chronically or terminally ill patient suffering from mental depression,
administer 1000 mg/kg body weight of methylsulfonylmethane daily, in tablet or
capsule form, dissolved in water or a cold beverage, or admixed in a cold food.
Within 12.-hours to 2 days, a significant improvement in the mental attitude of
the patient will be noted.
Example 17 - Wound Healing
Four sets of 5 hamsters were subject to scarification of the right cheek pouch,
using standard methodology. One week prior to pouch injury, one set was started
on a daily regimen of 0.1 gm/kg of methylsulfonylmethane in the diet of standard
hamster feed, a second group was given 0.1 gm/kg of methylsulfonylmethane plus
100 mg of ascorbic acid in the same feed, a third group was given only 100 mg of
ascorbic acid in the same feed, and the last group, fed only the feed, was held
as control. Daily post-scarification examination was made to determine the rate
of injury repair. After 36 hours, the animals receiving methylsulfonylmethane
plus vitamin C orally had sharply reduced inflammation about the wounds and
prominent healing granulation. This baseline result was matched by day three
with both methylsulfonylmethane alone and vitamin C alone treated subjects. By
day.4 and 5, controls (no medication) matched the healing status seen at 36
hours with those animals receiving the methylsulfonylmethane/ vitamin C
combination.
Example 18 - Diet Supplement in Animals
Immature laboratory animals, including dogs, consistently gained weight at a
greater rate over controls where methylsulfonylmethane was included in their
water and/or food. This was observed at both low and high dosage levels, viz.,
about 60 and about 500 mg/day/kg body wt. A possible explanation for this is
that any minor allergic response to the diet was neutralized by the
methylsulfonylmethane. Additionally, the fur quality improved and somewhat
faster nail growth was noted. Weight increases were not seen with adult animals
during comparable feeding experiments.
Example 19 - Parasite Infection (Enterobius)
Laboratory mice determined by fecal cast examination to have pin worms were
given commercial feed and drinking water, ad lib, both of which contained 2% by
wt. methylsulfonylmethane. Examination 17 days after test initiation indicated
the fecal cast were free of worms and eggs. The blood level of
methylsulfonylmethane in one animal examined exceeded 30 ppm.
Methylsulfonylmethane's ability in returning parasite susceptible tissue to
normalcy where host injury is minimal or nil, suggests that
methylsulfonylmethane in the diet aids in overcoming varied microbial
infections, by strengthening body resistance thereto rather than by direct
attack on the organism.
Methylsulfonylmethane antagonizes anticholinesterases in vivo and possesses weak
in vitro antibacterial action, for example, against Escherichia coli,
Leuconostoc citrovorum, Salmonello typhimurium, Staphlococcus aureus and
Streptococcus thermophilus. It is a potent antifungal agent, demonstrating good
antiparasitic activity at 500 ppm against Aspergillus niger, Phytophthora
cinnamomi and Sclerotium rolfsii. While not as potent or toxic to microbial
populations as specific drug agents, by reason of its extremely low host
systemic toxicity, methylsulfonylmethane contrasts sharply with present
antiinfective therapeutants and methodology. It is doubtful if chemical
resistance will develop with infective agents controlled by high, but safe,
systemic levels of methylsulfonylmethane.
One can safely administer 1-2 grams/kg body wt. of methylsulfonylmethane on a
daily basis (equal to 1000-2000 ppm w/w basis). One therefore builds a safely
tolerated blood level of about 4000 ppm, which level is highly toxic to many
infective organism yet is harmless to the host. Methylsulfonylmethane provides a
unique new therapeutic approach, used alone or with concurrent, conventional
therapy.
An evaluation of methylsulfonylmethane as concurrent therapy with conventional
anti-malaria drugs is indicated. Around one million humans die annually from
this parasitic infection. Testing to date indicates that methylsulfonylmethane
is a useful adjunct with the therapeutic modalities used to combat adverse
health problems by increasing a subject's baseline resistance to adversity and
moderating untoward effects associated with drugs, vaccines and physical
assaults against illnesses as by radiation or hyperthermia.
Example 20 - Vascular Complications Associated With Diabetes
A subject (F.B., M 58), diagnosed to have diabetes mellitus 22 years earlier was
seen with a serious vascular complication. Arteriosclerosis has decreased the
arterial blood supply to the lower limbs, resulting in chronically cold feet and
intermittent claudication. In addition, the subject had suffered a bruise to the
foot which was not healing. This subject received 500 mg of
methylsulfonylmethane with 250 mg of ascorbic acid twice daily over a period of
21 days. The first observed improvement was the healing rate of the bruise. By
the end of the third week, the cold foot problem was partially relieved and the
subject was able to double his walking distance without undo tiring. Post
treatment laboratory workup suggested a possibility that his insulin requirement
could be reduced.
Example 21 - Acute Pain
Methylsulfonylmethane administered orally has proven useful in relieving acute
pain in the mid-back region of an adult male caused by calculi obstructed ureter
(single 1.5 gm dose dissolved in warm water) and pain spasms in the lower
abdomen region of an adult female resulting from an accidental blow to the
abdomen (two 1 gm doses in warm water at 4-hour intervals).
Example 22 - Low Platelet Count
Methylsulfonylmethane administered orally raised the platelet count of an adult
female with lupus erythematosus from 84,000 (after prednisone therapy) to
200,000 over a 2-year period (1.5 gm/day in 3 doses).
Example 23 - Sun and Wind Burn
Persons ingesting from 0.5-2 gm/day of methylsulfonylmethane suffered only
mildly from about 4 hours of exposure to summer sun and wind, whereas their
companions who had not ingested methylsulfonylmethane were severely sun- and
wind-burned.
Example 24 - Pleuritis
Bilateral fibrinous pleuritis developed in a breeding mare with a respiratory
infection, which did not respond to six weeks of conventional antibiotic and
anti-inflammatory therapy, responded favorably (normal breathing, negative
ausculation of the chest) after five days of methylsulfonylmethane (2.times.12
gm/day in diet).
Example 25 - Post-Athletic Activity Fatigue
The physical fatigue syndrome following intense athletic activity in competitive
sports which usually persists for 8-10 days in athletes was gone in 2-3 days in
individuals who had ingested methylsulfonylmethane (from 1-2 gm/day in split
dosages) for the preceding six months.
Example 26 - Leg Cramps
Administer methylsulfonylmethane to a geriatric patient (over 65 years)
suffering from chronic night leg cramps at the rate of 10 mg/kg/day, either in
tablet or capsule form, as described in parent application S.N. 418,110, S.N.
584,354 or S.N. 601,771, or in admixture with one or more foodstuffs ingested
daily by the patient, e.g., milk, coffee, tea, cold desserts, etc. Within about
2 days, the leg cramps will diminish in frequency or disappear.
Example 27 - Leg Cramps
Before a marathon race, administer methylsulfonylmethane to the runner for at
least 7 days at the rate of 15 mg/kg/day. The likelihood of the runner
experiencing severe leg cramp during or after the race will be significantly
reduced.
Example 28 - Parasite Infection Control
Methylsulfonylmethane has highly variable toxicities for various nematodes.
Based on this discovery, tests were conducted on several parasites adverse to
the health of vertebrates.
(a) Trichomonas vaginalis
Strain ATCC No. 30001 was cultured in vitro employing diamonds tym medium.
Methylsulfonylmethane was added thereto at levels varying from 5.5 to 109.3
mg/ml. At concentrations of 5.5 to 10.9 mg/ml, the methylsulfonylmethane had no
effect on this protozoan. However, at 21.9 mg/ml it was inhibitory and all
higher concentrations were lethal to this parasite Based on this assay,
methylsulfonylmethane is about half as active as metronidazole HCL.
Methylsulfonylmethane was evaluated in vivo in conjunction with metronidazole
HCL, given to two female subjects at a treatment level of 250 mg, taken every
eight hours for ten days. Both had prior courses of therapy for this disorder
without adequate response. Methylsulfonylmethane was administered as 500 mg
capsules with each Flagyl dose during the treatment period. During this course
of treatment, neither patient experienced stomach upset and nausea, although
this was a side effect expericnced by one subject during the first course of
metronidazole HCL treatment alone.
The concurrent treatment of methylsulfonylmethane and Flagyl was successful in
both cases, as confirmed by wet film examination. One subject was later
reinfected by her sexual partner but the reinfection was cleared employing a
daily douch of 5% aqueous methylsulfonylmethane for one week. The subject's
partner was successfully treated with 500 mg of methylsulfonylmethane given
twice daily for two weeks.
(b) Giardia lamblia
This microorganism is associated with "travelers diarrhea",
particularly where persistent and refractory to antimicrobial therapy. Like many
intestinal parasites, there is variable resistance to the organism by man,
perhaps associated with receptor site availability and hence an immunological
problem.
With this parasite, in vitro concentrations of methylsulfonylmethane of 1 mg/ml
and lower demonstrated no significant inhibition of Giardia. However, at 20
mg/ml concentration, it was strongly inhibitory and concentrations above 40
mg/ml promptly killed the organism.
One subject with confirmed Giardia, apparently contacted from contaminated water
in a primitive area, was given 500 mg of methylsulfonylmethane orally three
times/24 hours X 14 days. By the eighth day he was asymptomatic. Two stool
specimens collected one week apart were free of the organism.
(c) Enterobius
Laboratory mice determined by fecal cast examination to have pin worms were
given 2 % by wt. of methylsulfonylmethane in both their commercial feed and
drinking water, ad lib. Fecal examination seventeen days after test initiation
indicated the feces were free of worms and eggs.
Example 29 - Treatment of Lung Dysfunction
Seven human subjects with respiratory deficiency were given
methylsulfonylmethane by the oral route in amounts ranging from 250-1,500
mg/day, in single or divided units. Five presented emphysema believed associated
with cigarette smoking. Two presented tumor involvement of the lung with
additional function impairment due to pleural fluid accumulation.
Two of five subjects with emphysema had prior cardiorespiratory function tests
and follow-up evaluations at six and eight weeks after starting a course of 500
mg/day orally of methylsulfonylmethane. Though both demonstrated several
abnormal values prior to the test period, in particular lowered arterial oxygen
tension, both had values in the normal range while ingesting
methylsulfonylmethane.
A more striking improvement was seen in physical achievement values determined
with all subjects. Prior to and during the test period, at approximately
two-week intervals, all presenting emphysema were required to walk a measured
distance compatible with their physical resources. Within 2-4 weeks of beginning
the ingestion of methylsulfonylmethane, alone or with 1000 mg of ascorbic
acid/day, all emphysema sufferers had at least doubled their
"comfortable" walking distance. Both subjects seen with lung tumors
were evaluated by attending physicians and nurses as well as family as being
more alert, comfortable, and with a better outlook and attitude than before the
test period. The lung cavity fluid problem of each subject disappeared during
the first months of the test period. Both were on radiation/chemotherapy prior
to including methylsulfonylmethane in their diet, but without apparent benefit.
Example 30 - Canine Arthritis and Other Sources of Pain
Methylsulfonylmethane was evaluated as an additive to the diet of older dogs of
various breeds, all suffering from some form of arthritis and in some cases
demonstrating other disorders. In each case the methylsulfonylmethane was
admixed with the animal's food just prior to feeding.
(a) Dog A, a spayed, 15-year old German Shepherd, weighing 36 kg, demonstrated
ataxia, virtual immobility with pain and joint stiffness. The animal was not
responsive to cortisone or phenylbutazone. It was given 0.5 g/day of
methylsulfonylmethane b.i.d. for 7 days without apparent benefit. Dosage was
raised to 1.5 g/day b.i.d. and within 10 days the dog became freely mobile
without evident discomfort nor demonstrated ataxia.
(b) Dog B, a male, black Labrador, weighing 27 kg, demonstrated severe
musculoskeletal comprise of the hind quarters with urinary incontinence. This
animal, although owned by a veterinarian, had not responded to a variety of
therapeutic regimens over the previous 12 months. Methylsulfonylmethane was
given to this dog in it's food at a level of 1.5 grams b.i.d. X 1 month. This
dog derived no apparent benefit from methylsulfonylmethane, apparently due to
the terminal nature of its illness.
(c) Dog C, a spayed, 14-year old German Shepherd, demonstrated severe arthritis
of the back and legs. It was mobile but walked with obvious difficulty and
discomfort. The animals was refractory to both cortisone and phenylbutazone.
Methylsulfonylmethane was provided in the diet at a level of 0.5 grams b.i.d.
There was gradual improvement in mobility over the first month. During the third
month following methylsulfonylmethane supplementation of the diet, the dog
demonstrated neither musculoskelatal restriction nor discomfort.
(d) Dog D, a female, mixed-breed Terrier, weighing 20 kg, demonstrated severe
restriction in mobility and obvious discomfort with movement. The animal had not
responded to either cortisone nor phenylbutazone and it's condition was
deteriorating rapidly. Methysulfonylmethane was included in its diet at 1 gm/day
b.i.d. After one week, the dog appeared to be pain-free. This dog has received
methylsulfonylmethane in its diet for over six months and remains apparently
healthy and frisky, requiring no medication.
Example 31 - Pain in Humans
The following patients suffering from intractible pain were given
methylsulfonylmethane orally in the amounts and for the period of time set forth
in the table below:
______________________________________
Methylsulfonyl-
methane
Patient
Age Sex Diagnosis
Administration
Results
______________________________________
P.A. 61 F Deg. Arth.
1 g 4.times./day .times.
pain relief
19 months
B.A. 63 F Deg. Arth.
0.25 g qid
pain relief
C.A. 62 M Bursitis
0.25 g bid .times.
50% pain
Chronic 3 months relief
M.A. 55 F Rh. Arth.
0.25 g bid .times.
pain relief
9 months
A.B. 69 F Deg. Arth.
0.5 bid .times.
pain relief
18 months
N.B. 62 M Tendonitis
0.25 g qid
reduced pain
D.B. 35 M Low back
0.5 g qid .times.
pain relief
pain 9 months
I.B. 62 F Multiple
0.5 bid .times.
muscle pain
Sclerosis
18 months reduction
______________________________________
Deg. = Degenerative
Rh. = Rheumatoid
Arth. = Arthritis
Example 32 - Acute Pain in Humans
Methylsulfonylmethane was compared with codeine for the control of pain in
subject J.H., a male, age 47, who awakened in the early morning with
excruciating pain in the mid-back region, so intense it was difficult to
pin-point a specific region. Subject had a past history of urinary calculi.
Aspirin was ineffective but codeine provided acceptable relief during and after
X-ray. Analgesic requirements were 1/2 grain codeine with aspirin every two
hours. During day two, subject complained of mental confusion and codeine was
withdrawn. The intense pain returned. The subject was given 1.5 g of
methylsulfonylmethane dissolved in 1/2 glass of warm water. At 0.5 hours after
taking the methylsulfonylmethane, the pain had essentially disappeared.
Methylsulfonylmethane (1.5 g/day) was continued until the afternoon of the third
day, when X-ray confirmed that the calculi yet obstructed the ureter. Subject
was switched again to codeine with aspirin (1/2 grain X 2 hours). He reported
less pain relief than was provided by methylsulfonylmethane.
Methylsulfonylmethane was again administered (1.5 g.times.4 hours). On day 5 the
calculi passed. Recovery was uneventful, requiring neither codeine,
methylsulfonylmethane, nor a urinary tract antimicrobial.
Example 33 - Acute Pain in Humans
Codeine and methylsulfonylmethane were compared for the relief of pain in
subject M.R., a female, age 26, who had sharp pain spasms in the lower abdominal
region. Subject's appendix had been removed. Pain began after suffering an
accidental traumatic blow to the abdomen during a volley ball game. Pyelogram
examination indicated no obstruction. The pain pattern suggested ureter spasm.
Codeine (2) plus 1/4 grain with aspirin every 4 hours, provided some relief. The
codeine/aspirin was discontinued and 1 g methylsulfonylmethane in warm water was
given. A half-hour later all discomfort ceased. A second gram of
methylsulfonylmethane in water was given 4 hours later, after which the subject
continued pain free.
Example 34 - Intravenous Administration
For patients suffering from a serious chronic disease, e.g., an acute stage of
rheumatoid arthritis or other acute inflammatory conditions or a patient in
extreme pain, administer 1 gm/kg of methylsulfonylmethane i.v. as a 14% by wt.
solution in sterile 5% dextrose solution, at the rate of 1 gm/kg/hr. Within 2-4
hours, significant subjective relief from the symptoms of the disease or
condition is experienced by the patient, with the relief lasting for from 7 to
21 days.
Such massive i.v. administrations can be repeated as frequently as every 24
hours. Rates of dimethylsulfone administration as high as 2 gm/kg/hr are
possible but may produce transient light-headedness in the patient.
Example 35 - Myositis Ossificans Generalis
An eight year old girl, A.Z., has demonstrated serious, irreversible myositis
ossificans generalis. Her family belongs to a group of families each with a
family member suffering from the disease. She has been on one teaspoon of
methylsulfonylmethane orally, in split daily doses for nearly two years. The
disease process has stopped, she is out of her wheelchair and is improving. No
other child in the group is on methylsulfonylmethane and all are deteriorating
physically. The disease cause is unknown but probably is a genetic/autoimmune
type of disorder.
Example 36 - Resistance to DMBA-Induced Mammary Carcinoma
Forty-five female rats were stabilized to the laboratory and then divided into 3
groups of 15 each. Group 1 was designated control, Groups 2 and 3 were treated
by topical application to the hair-free abdomen with a solution of the
carcinogen dimethyl-benzanthracene (DMBA). All three groups were each fed a
standard laboratory diet with water, ad lib. .Group 3 also received in their
standard diet 2% by wt. of methylsulfonylmethane. At 5 months post treatment
with DMBA, both the control normal and Group 3 animals were free of mammary
carcinoma. The Group 2 animals demonstrated chemically induced mammary cancers
and were sacrificed.
Example 37 - Arresting the Development of Spontaneous Mouse Lymphomas
Laboratory mice genetically predisposed to lymphoma development were selected
for this test. Humoral immunity participation was measured as was the effect of
methylsulfonylmethane on an animal's life span. One set of 12 mice were
maintained as controls. The treated (T) group received identical treatment
except for their water given ad lib, which contained 3% by wt. of
methylsulfonylmethane in solution.
By month 4 of this test, all controls were dead, due to lymphoma development. No
T group mice had died by month 5. These normal balb/c strain mice of group T
were tested for t-lymphocyte dependent (t-d) and t-lymphocyte independent (t-i)
immune responses. Mice given methylsulfonylmethane demonstrated significantly
enhancement of primary IgM and secondary IgG responses to sheep erythrocytes (SRBC),
with significant suppression of the tnp-ficoll response. Based on these
preliminary results, at high enough daily rates of ingestion,
methylsulfonylmethane stimulates humoral immunity thereby providing protection
to otherwise lethal spontaneous mouse lymphomas.
It can be seen from the foregoing and from the disclosure of S.N. 584,354
dealing with the ameliorating of the symptoms of stress and of allergies, which
disclosure is incorporated herein by reference, that methylsulfonylmethane is
useful in maintaining or improving the health of a variety of animals in a
variety of ways.
The preceding examples can be repeated with similar success by substituting the
generically or specifically described reactants and/or operating conditions of
this invention for those used in the preceding examples.
From the foregoing description, one skilled in the art can easily ascertain the
essential characteristics of this invention, and without departing from the
spirit and scope thereof, can make various changes and modifications of the
invention to adapt it to various usages and conditions.
* * * * *
SUBSCRIBE:
The Wednesday Letter is a free electronic monthly newsletter written and published by Karl Loren.
You can view more than 50 back issues of this publication by clicking here.
The Wednesday Letter subscription list is maintained on a secure server, no name is ever given or sold to anyone, and it is never used except for this Newsletter.
It is automatically published on the Tuesday night just before the first Wednesday of every month.
You can subscribe to this free monthly electronic letter by entering your eMail address and name below.
You will then automatically receive a request for confirmation, sent to whatever address you have entered.
If you do NOT receive this confirmation request, then you will not be subscribed.
There may have been an error with your address and you should resubmit.
The letter is never sent twice to the same address -- so you do not have to worry about a duplicate subscription.
When you receive this confirmation request you must reply to it, or your subscription will not become active.
No one can subscribe your name, and address, without you being notified, and if you get an unwanted notice of subscription you only need to DO NOTHING and the subscription will NOT be active.
REMOVAL:
You can remove yourself from the subscription list in several different ways.
Click here to read about this entire newsletter system.
Every edition of The Wednesday Letter is delivered to your address with YOUR name and address in view on the letter, with a link that allows you to remove THAT name from the subscription list.
If you try to send this removal message from an address different from the one you used to send in your original confirmation, then you will get a warning notice first, sent to the subscription address, asking you to confirm that you want to be removed from the list -- by replying to THAT request for confirmation, you will then be automatically removed.
Thus, no one else can unsubscribe you, from some other computer, without your knowledge.
But, if you send in the unsubscribe notice from the same machine used to receive the Letter, then the removal from the subscription list is automatic.
Personal Message:
When you send a personal message to Karl Loren, you will receive a personal reply as per his instructions.
Karl pledges that every personal message will get a personal answer. When you provide your mail address, we will send you free information including our free catalog and a cassette tape lecture by Karl Loren about heart disease, no charge, by mail, even if outside the US.
You can select particular information you would like to receive, along with the free cassette tape and catalog.
