Updates

April 2001

 CORTISOL, IMMUNOSTIMULATION, AND MPB

     It has been established that cortisol, the “stress” hormone and estrogen are  significantly elevated in individuals with androgenetic alopecia, which is immunosuppressive.

     It is also known that balding is essentially an interplay between hormones (notably DHT, Androstendione, Estrogen) and immunologically mediated inflammation, essentially causing the body to treat hair follicles like organs being rejected.  Dr. Proctor and Dr. Rushton of Bioscientic Ltd., among others, contend that this immunological rejection and the inflammation associated with it is much more significant and primary to balding than the androgens, which simply play a role in initiating the process.  That is why antiandrogens are fairly effective at preventing further loss, but initiate little to no regrowth, except for very recently lost hair.  Several prominent researchers have been issued multiple patents for immunostimulation based, hair loss treatments aimed at neutralizing existing follicular inflammation.  Their research and recommendations will be integrated into our treatment protocol to provide an even more comprehensive treatment approach, in addition to enhancing the overall health of the individual.  The recommended compounds for hair growth via immunostimulation are:

1.     Growth Hormone (GH) Releasers – Growth Hormone has been reliably shown to increase muscle mass, thicken skin, reduce body fat index and grow scalp hair.  Injections are quite expensive, but coming down in price.

2.     Arginine/Lysine at 4 grams each stimulate thymic functioning, and GH release, Dr. Rushton, of Bio Scientific Ltd. Has a patent on L-Lysine as a hair growth treatment.

3.     Anti-aromatases (in males) or estrogen antiagonists.  Soy extract, acts as a “phytoestrogen” which competes with estrogen at the receptor site, neutralizing estrogenic stimulation of androgen mediated processes.  Daidzen, a soy isoflavone, also appears to regenerate thymus in males.  Dr. Sheffield has been issued patents on anti-aromatases as hair-loss agents.  One mention here: anti-aromatases in females cause hairloss, whereas in men they appear to have the opposite effect.  They also have a negative effect on thymic functioning in females, and a positive effect in males.

4.     Androgen antagonists/DHT inhibitors.

5.     Zinc

6.     Vit A/Beta Carotene

7.     Magnesium Aspartate

8.     Gaba – sublingually (may also interrupt stress axis which is detrimental to thymic functioning.  Gaba transminase levels decrease with age.

     At the root of this phenomena of age related immune system decline is a process known as “thymic involution” (deterioration of the thymus gland functioning), which is genetically predetermined, and responsible for an age related cascade of events and inflammatory autoimmune process including arthritis and balding.

EXCESS ESTROGEN

     It is well known that aging results in the shrinkage of the thymus gland, along with a reduction in the secretion of thymic hormones and T-cells, all of which are essential for maintaining youthful immune synchronization. 

     A study published in the journal Immnological Reviews (1997, Vol. 160) showed that excess estrogen may be the primary sex hormone responsible for age-induced thymic involution (shrinkage) and associated immune dysfunction.  The name of this extensive study was “Thymic Aging and T-Cell Regeneration,” and it suggested that hormone modulation was one way of accomplishing thymic regeneration.

     A chapter from the 1998 textbook Principles and Practices of Geriatric Medicine entitled “Immunity and Aging” also discussed the role sex steroid hormones play in thymic involution.

     These studies suggest that restoring youthful sex hormone profiles could assist in protecting against immune impairment caused by the shrinking thymus gland.

     There are also two studies that conclusively show that men with MPB have elevated levels of cortisol, estrogen, and androstendione.  

PROTOCOL MODIFICATIONS

     Based on the most recent research, compounds addressing both thymic involution and elevated estrogen will be integrated into our recommended treatment protocol.

GHO HAIR MULTIPLICATION UPDATE

     Dr. Coen Gho is a dermatological researcher in Holland who developed a process called hair multiplication. He has a patented technique, whereby he takes 1-2 healthy donor hairs, extracts some of the growing hair cell matter, cultivates it in a lab, and injects it back into the scalp  where it will develop into an unlimited number of hair producing follicles.

     There has lately been a lot of speculation that he is ready to start performing procedures. On the contrary though, we have information that indicates the opposite – that his procedure is not quite ready yet.

     Will Gerritson, the journalist who originally featured Dr. Gho in 98’ in the European Press, contacted various organizations with the latest information.  Following is his

Comminque:

     “Dr. Gho and I agreed upon him contacting me within a year and a half, as soon as there’s a breakthrough.  He has made progression, but is still having some difficulties with the protocol.  I suggest you follow our site, www.limburger.nl on Wednesdays.  This is the day when we publish our weekly extra edition, Scala-Health.

NIZORAL 1% STUDY SHOWS BENEFITS FOR PATTERN BALDING

     In a study presented to the Am Academy of Dermatology, the researchers associated with McNeil, makers of the 1% OTC version of Nizoral Shampoo found that it had, as it has been shown for the 2% precription version, beneficial effects on Androgenetic Alopecia (MPB).

     In short they found that 1% Nizoral Shampoo reduced sebum emission, and increased hair shaft diameter (which decreases in MPB) after being used 2-3 times a week for a period of 6 months.  They also found a percentage increase in the overall number of anagen hairs, which typically decreased overtime in MPB.  By comparison they found Zinc Pyrithione Shampoo (Head and Shoulders) did not decrease sebum emission or increase hair shaft diameter, but did increase the overall number of anagen hairs as well.

     The decrease in sebum emission caused by 1% Nizoral Shampoo, seems to confirm its antiandrogenic action, which is though by most to be only one of the reasons it helps hair loss.

 EMU OIL UPDATE

     The use of topical Emu Oil has grown in popularity, Dr. Holick of Boston University will soon start phase 1 trials on Emu Oil based, topical hair regrowth compounds.

     Dr. Pickart, founder of Skin Biology, and developer of Tricomin and Folligen, has formulated and Emu Oil based topical treatment with copper peptides for hair growth, and has reported that many subjects are obtaining rapid and dense regrowth.   

     Research has shown that emu oil contains a high level of linolenic acid which further researchhas shown to be an efficient antiandrogen. Linolenic acid is a potent 5 alpha reductase inhibitor and may be usefull in the treatment of disorders related to the hormone Dihydrotestosterone. Linolenic Acid has been suggested to be of use in the disorders such as benign prostratic hyperplasma, acne androgenetic alopecia and hirsuitism.

And hair restoration products which contain Emu Oil have been recently patented.

     Studies in which Emu oil was applied to mice demonstrated that the topical application of emu oil increased the synthesis of DNA in the epidermis which is a measure of increase in the proliferative activity of the epidermis. The increase in pigmentation and hair of animals receiving emu oil demonstrates that the topical application of emu oil can stimulate melanogenesis and hair follicle development and growth. The histological analysis demonstrating an increase in the thickness of the epidermis and size and length of the hair follicle provides strong evidence that the topical application of emu oil stimulates skin growth, hair growth and induces the proliferation of the cells around the hair follicle.

** For our latest recommended treatments see the Protocol Section on the Home page.  

                                        January 2001

                A GENE THERAPY IN THE MAKING
     Scientists from the Max Planck Institute in Germany have discovered the genetic basis of hair formation and are in the process of creating new preparations for treating hair loss.
     They have succeeded in finding the mechanism of action of a crucial component of hair formation. It is a "protein switch" which regulates the actions of numerous genes, which "encode" the protein structure of the hair (Keratin). Keratin is a durable protein material that gives structure and tensile strength to the hair. After previously locating the "protein switches", the researchers started solving the exact mechanisms by which they work. This research is now resulting in new methods of stimulating hair growth.
     The scientist originally working with Dr. Boehm were initially working on the molecular basis of immune system function. This resulted in the accidental discovery of a protein switch for hair formation. It originated out of studies investigating a genetic anomaly in mice which are afflicted by a hereditary immune weakness that results in hair loss. "We asked ourselves at the time, which gene is actually defective in these naked mice, because this particular gene must be responsible for growing hair as well", says Boehm.
     Hair growth occurs in anagen (growth) and telogen (resting) cycles. At the end of each cycle, hair sheds and is usually replaced by a new hair in the next cycle. The regulation of this cycle is influenced by many variables. Few treatments have been developed by the pharmaceutical industry over the years, and those that have been are either inefficacious or have problematic side effects.
     Research done by the German scientists show that certain existing treatments may not be necessary when the protein switch is "turned on". As opposed to an oral drug, only a local topical treatment treatment with a lotion or special shampoo is required, doing away with concerns about side effects.
     This team of researchers are pondering the possibility of creating their own biotech company, and possibly making this type of treatment commercially available in the next 5-8 years. What remains yet to be seen are the costs and actual effectiveness. Many using combination therapies are possibly getting results that would be equivocal to gene therapy anyway. Eventually, hopefully in our lifetimes, they will get to a cure, a one time, genetic intervention that will permanently, "turn on" the gene, no longer necessitating the need for daily application.


THE USE OF SOY ISOFLAVONS TO PREVENT HAIR LOSS AND PRESERVE THE INTEGRITY OF EXISTING HAIR
Applicant: Natures, Sunshine Products, Orem, UT

     An American Herb company was recently issued a patent for the use of soy extract for the treatment and prevention of hair loss. Following are excerpts from the patent itself.
     "The present invention is based on the principle that plants and plant extracts containing isoflavones can inhibit hair loss. Plants or plant extracts containing isoflavones can be administered either orally or topically to prevent hair loss. The present invention provides the additional benefit that the administration of isoflavone-containing plants or plant extracts can provide other health benefits in addition to preventing hair loss. Another advantage of the invention is that the isoflavone-containing plants and plant extracts can be combined with other pharmaceutical treatments for preventing hair loss without adversely affecting the beneficial and positive effects of such treatments."
     "It is a further object of the invention to provide a method of preventing hair loss which may be used orally."
     "The present invention is based on the principle that plants or plant extracts containing isoflavones may be administered orally or topically to prevent hair loss."
     "The isoflavones of the present invention include those which exhibit estrogenic activity and which bind to testosterone receptors. Such isoflavones prevent the "hair loss" effect of testosterone by inhibiting the binding of testosterone to the hair and scalp receptor, thereby resulting in maintenance of scalp hair integrity."
     "The present invention includes compositions containing isoflavones in general, and particularly soybean isoflavonoids, may be used to prevent hair loss in mammals, including both in men and women, by the aforementioned mechanism of action. Such isoflavones may include, but are not limited to, genistein (II) and variants thereof. Genistein is also termed 5,7-dihydroxy-3-(4-hydroxyphenyl)-4H-1-benzopyran-4-one or 4',5,7-trihydroxy-isoflavone Sources of the preferred isoflavones include soy and other members of the Leguminosae family and the Rosaceae, Podocarpaceae, Iridaceae, Moraceae, Amarantaceae and Compositae families, as will be appreciated by those in the art."
     "Orally-administrable dosage forms of the invention may include, but are not limited to, capsules, tablets, powders and liquids (hereinafter referred to as "oral dosage forms"). Other equivalent oral dosage forms are within the scope of the invention, as will be readily appreciated by those of skill in the art. As an oral dosage form, the composition may be administered alone or in combination with food."
     "In a still more preferred embodiment of the invention, an oral dosage form contains from about 400 to about 500 mg total weight plant or plant extract. In the most preferred embodiment, the oral dosage will contain about 450 mg of isoflavone-containing plant or plant extract. The total amount of plant, plant extract, carriers, excipients, diluents, lubricants and other so-called "pharmaceutical aids" included in an oral dosage form may be varied according to the preferred size of the oral dosage form. For capsules, the total weight may range from about 275 mg to about 500 mg, although greater or lesser capsule weights are within the scope of the invention."
     "In its oral form, the composition may be taken alone or in combination with food or liquids. In the preferred embodiment of the invention, the composition is preferably taken with a meal or with liquid. Generally from 1 to 2 oral doses may be taken in from 1 to 4 or more times a day."

Editor's Note
     The rural Japanese, who traditionally have low rates of breast and prostate cancer, and almost no incidence of male pattern balding typically consume 20-80 mg. of genistein a day, a phytochemical almost entirely derived from soy beans. In the US, where pattern loss in epidemic, the daily dietary intake is only 1 to 3 mg. Previously, doctor's thought that the disproportionate amount of androgen mediated disorders, i.e. prostate cancer, acne, and pattern loss was because of the high fat content of the western diet. New studies, however, fail to show a significant link between dietary fat and these types of disorders. Many researchers have now concluded that the heightened incidence of these disorders results from a diet that is deficient in soy. For the treatment or prevention of pattern hair loss it would be reasonable to consume 300-500 mg. of soy extract (not just protein) a day, preferably in divided doses.


                      STEM CELL RESEARCH UPDATE

     Here are some excerpts from an e-mail from Dr. Cotsarelis of the University of Pennsylvania, regarding stem cell research, the same area that Dr. Gho of Holland is actively pursuing.
     "Gene therapy simply involves introducing genes into cells, which would then produce the protein encoded by that gene. The question of which genes to introduce is a big one, but it is not dependent on finding the "baldness" gene. We are rapidly finding genes involved in hair growth and these should lead to new treatments."
     "We're trying to find out more about stem cells for multiple reasons, but two major reasons are: 1. We believe stem ells are important targets for gene therapy. By targeting stem cells, we should be able to cause long-lasting changes in the hair. 2. By isolating stem cells we may be able to "clone" follicles and reintroduce them to patients. This latter approach could come to fruition in shorter time frame, maybe 3-7 years."
     He puts hair multiplication in 3-7 year range, and states that more efficacious combination therapies will no doubt became available in the interim.

    L-LYSINE AND THE TREATMENT OF HAIR LOSS
US Patent 6136860
Applicant: Bio-Scientific Ltd., London, UK

     An English biotech company was recently issued a US patent for the use of L-Lysine in the treatment of various types of hair loss, including androgenic alopecia. Following are excerpts from the patent itself.
     "Studies involving the administration according to the present invention of L-lysine to those suffering from increased hair shedding show a remarkable increase in scalp hair growth."
     "Typically, the L-lysine is administered in a daily dose of from 200 to 2000 mg, and more usually in a daily dose of 500 to 1500 mg, e.g. in the form of a 500 mg dose administered orally once, twice or three times a day. L-lysine may conveniently be administered orally, for example as tablets, capsules."
     "We have also discovered that administration of lysine to patients results in a dramatic increase in the efficacy of known treatments for genetic hair loss (which term covers a number of conditions variously referred to as androgen-dependent alopecia, androgenic alopecia, androgenetic alopecia, common baldness, female baldness, diffuse hair loss and male pattern baldness)."
     "Thus, in a further aspect of the present invention there is provided a kit including a plurality of separate containers, each containing at least one active agent useful in a combination therapy for the treatment of genetic hair loss, wherein said kit includes L-lysine and at least one further active agent selected from minoxidil, anti-androgens, 5.alpha.-reductase inhibitors, aromatase inhibitors."
     "The co-administration of L-lysine with known treatments for genetic hair loss such as minoxidil and anti-androgens results in a significant improvement in the efficacy of the treatment."


  Treatment of Women Suffering from Genetic Hair Loss.

     "The effect of the administration of lysine on the efficacy of known treatments for genetic hair loss was investigated as follows."
     "Women suffering from genetic hair loss, all of whom had adequate iron stores within the normal range at the start of the test (i.e. serum ferritin levels of greater than 40 mg/ml) were divided into four groups"
     "The first group (17 women) was treated with minoxidil only (in the form of a topical formulation comprising 3% minoxidil by weight)."
     "The second group (15 women) had a combined treatment of minoxidil (again as a topical formulation comprising 3% minoxidil by weight) and an oral anti-androgen chosen from cyproterone acetate, medroxyprogesterone and spironolactone. The first two anti-androgens were administered in combination with ethinylestradiol or an oral contraceptive. The particular anti-androgen administered was chosen on the basis of clinical need."
     "The third group (8 women) received a combined treatment of minoxidil (again as a topical formulation comprising 3% minoxidil by weight) and 500 to 1500 mg per day of L-lysine (administered orally)."
     "The fourth group (13 women) received a combined treatment comprising minoxidil (again as a topical formulation comprising 3% minoxidil by weight), an oral anti-androgen (administeredas to the second group above) and 500 to 1500 mg per day of L-lysine (administered orally)."
     "The results in Table 5 suggest that the co-administration of L-lysine to patients being treated for genetic hair loss with known treatments such as the topical administration of minoxidil and/or the oral administration of anti-androgens results in a considerable improvement in the efficacy of these known treatments."

Editor's Note
     L-Lysine is an essential amino acid which is often deficient in vegetarian diets. It may help prevent glycosylation, the combining of sugar and protein molecule accelerated by elevated levels of sugar in the blood, which causes some signs of aging. Linus Pauling has provided evidence that it may also help prevent coronary heart disease and atherosclerosis by inhibiting the accumulation of apolipoprotein on arterial walls. L-Lysine in nontoxic and may be taken in any dose. For hair loss treatment purposes, 500 mg., 3 times daily is recommended. It is most effectively utilized when taken on an empty stomach with juice or water.


                            PROTOCOL ADDITIONS

          1. Mega Soy Extract - 3, capsules daily, in divided doses.
          2. L-Lysine - 2-3 500 mg. capsules daily, on an empty stomach, preferably in divided doses.