Colostrum and arthritis



by Nathan Wei, MD, FACP, FACR

Nathan Wei is a nationally known board-certified rheumatologist and author of the Second Opinion Arthritis Treatment Kit. It's available exclusively at this website... not available in stores.

Click here: Second Opinion Arthritis Treatment Kit




This is a controversial topic. You will see how controversial as the page goes on. At the time I wrote this, colostrum was becoming popular in the alternative health news. So I looked for information about it and gleaned much of it from the internet. Take what is written here with a grain of salt...

Colostrum ("mothers' milk" ) is a thick yellow fluid produced from the mammary glands during the first few hours after birth. This fluid is not only a source of nutrients but it also contains several biologically-active materials which are essential for proper immune function. At least, that is what many people claim. The following is a summation of some of the ingredients found in colostrum and what they can do. This is not an endorsement for the material.

Colostrum has been explored as an alternative therapy for many disease conditions. Bovine (cow) colostrum appears to have many similarities to human colostrum and is safe for human consumption. The immune and growth factors found in bovine colostrum resemble those in human colostrum.

Bovine colostrum contains glyco-proteins and protease inhibitors, which protect the colostrum's active components from being destroyed during digestion.

Since colostrum is only available during the first hours after calving, supplies are limited.

Colostrum provides two important ingredients. Immune factors provide immunity and protection against infections during early infancy, while growth factors stimulate the growth and development of a newborn.

It has also been said that the growth factors in colostrum provide fat burning potential which leads to an improved ability to build lean muscle and to rejuvenate skin.

Immunoglobulins have been shown to provide defense with viral infections, bacterial infections, allergies, fungus and yeast. There are five types of immunoglobulins present in colostrum, specifically IgA, IgD, IgE, IgG, & IgM. Bovine colostrum contains mostly IgG with very small amounts of IgA, IgD, IgE, and IgM. Human colostrum typically contains 2% IgG content, while bovine colostrum can have from 8% to above 25% IgG content. Immunoglobulins in colostrum may also have anti-inflammatory properties.



Colostrum has been shown to contain specific antibodies to more than 19 specific disease-causing pathogens including; rotavirus, h. pylori, cryptosporidium, salmonella, candida, streptococcus, staphylococcus and E. coli.

Lactoferrin is an iron-binding protein with antiviral, antibacterial, anti-inflammatory properties. It is also found in colostrum.

Glycoproteins in colostrum protect the immune and growth factors in colostrum from destruction by the digestive juices in the stomach and intestinal tract.

Research indicates that the lactalbumins in colostrum can be effective against numerous forms of cancer and viruses. Lactalbumin has also been shown in some studies to raise brain serotonin activity, reduce cortisol concentration, and improve mood under stress.

Colostrum contains cytokines which are protein messengers. One cytokine, interleukin-10, is a potent anti-inflammatory agent that has been shown to have a profound effect on pain relief. Other cytokines in colostrum, such as interleukins, have shown particular promise in treating arthritis.

Lysozymes help protect the body from bacterial infections. Lysozyme has actually been shown to destroy bacteria.

It has been shown that growth factors present in colostrum help accelerate the repair of aged or injured muscle, skin, bone, cartilage and nerve tissues. Growth factors also stimulate the building of lean muscle.

Epithelial growth factor is instrumental in protecting and maintaining the skin. Along with the other growth factors in colostrum, EGF can stimulate normal skin growth and repair cellular tissue.

Insulin-like Growth Factor I and II are the most abundant growth factors in colostrum. They affect how the body uses fat, protein and sugar. IGF-I has been clinically proven to help increase lean muscle mass and may help regulate blood sugar and cholesterol levels.

Transforming growth factor stimulates the multiplication of cells in connective tissue and assists in the formation of bone and cartilage. It is also showing promise as a therapeutic agent in bone and wound healing.

Platelet-Derived Growth Factor has been shown to help with cell division in connective tissue, smooth muscle, and fibroblasts.

Colostrum has anti-inflammatory activity.

--Dr. Zoltan Rona, The American Journal of Natural Medicine, March 1998.



Growth Factors help build and restore bone, muscle, nerve tissue, connective tissue, skin and cartilage. These factors have also been shown to help increase lean muscle, help the body burn fat for fuel, and assist in wound healing. Growth factors have also been shown to help slow the signs of aging.



Colostrum's growth factors may:

• Affect the brain’s mood regulating chemicals to brighten our moods. (serotonin & dopamine)
• Assist in regeneration and improve normal growth of aged or injured muscle, bone, cartilage, skin collagen and nerve tissue.
• Help burn fat for fuel instead of muscle tissue in times of fasting (diet), and build and retain lean muscle (non-diet).
• Assist the internal regulation of blood glucose levels and "brain chemicals", supporting alertness and better concentration.
• Support healing skin when applied topically
• Repair our body’s precious RNA and DNA.


Some websites that promote and sell colostrums claim the following:

Vitamins and minerals are nutrients that are essential for normal metabolism, growth and development. They act as coenzymes, enabling chemical process to take place throughout the body. Vitamins and minerals are indispensable for the maintenance of health.

Amino acids are the building blocks of proteins. They are required for growth and development. Amino acids are divided into essential (not produced by the body) and nonessential (can be produced by the body).

Every person differs on the amount of Colostrum that is needed. It has been suggested that for best results, Colostrum should be front loaded (taken in larger doses initially and then lowered after desired results are obtained). If benefits decrease, go back to your initial intake.

For best results, begin with 4-6 capsules (2,000 to 3,000 mg.) taken twice a day. You could take Colostrum when you wake in the morning and your stomach is empty and then again maybe a couple of hours after lunch. If you have trouble sleeping, try to take your dosages early in the day.

Some people may experience a healing incident as the body releases toxins (digestive problems, skin eruptions, rashes or flu-like symptoms). These symptoms usually disappear in a couple of days. It's interesting that if you listen to your body, you become aware of where Colostrum has gone in your body to do its work Colostrum's growth factors may create initial pain in areas of old wounds or injuries as it heals. If this becomes uncomfortable, you may want to cut back on the Colostrum for a few days and then resume at a lower quantity, increasing your intake slowly as you reach optimum levels.

Many people engaging in athletic activity find colostrum benefits helpful to improve performance. Body-builders like colostrum because colostrum has been shown to increase muscle mass. It's best to take the colostrum 30-45 minutes before workout. Athletes often use 3000-6000 milligrams per day. This is the recommended usage, although many body-builders use more.

Colostrum is a food. It can be consumed in any quantity without side effects or drug interactions. Although colostrum has no drug interactions, you may experience side effects from other supplements, herbs or medications you take that you never experienced before. Colostrum heals the bowel. This means you are better utilizing the nutrients from the food you eat as well as anything else you put in your body. You may want to cut back or even rethink other herbal and nutritional supplements. Medications may need to re-evaluated for dose and need by your medical professional.

If you are pregnant, ask your physician about taking any prescription drugs, over the counter medicines, herbal and nutritional supplements.

Colostrum works best if it is taken in capsule form, on an empty stomach with 8-12 ounces of water. If you cannot swallow capsules, you may open the capsule and mix it with a few tablespoons of yogurt, applesauce or other food. Don't forget the water. Do not take any other supplements with Colostrum and wait at least twenty minutes before you eat.

Bovine Colostrum - In studying 12 patients with either rheumatoid arthritis or osteoarthritis, average age of 52.5 years, who were taking between 1 and 5 medications, individuals were started on Infopeptides as an adjuvant supplement. The treatment lasted at least 3 months, and was given in a dose of 5 ml per day orally. Thepatients were instructed to keep the product in contact with the oralmucosa for 2-3 minutes, and then swallow it. If there was noimprovement in 4 weeks, the dose was then doubled to 5 ml, 2 times aday.

Clinical and subjective improvement (subjective and objectivereduction or disappearance of pain, edema and inflammation, improvement in joint mobility and better tolerance to physical activity) wasdocumented after 2 to 6 weeks of treatment in 10 out of 12 rheumatoidarthritis patients.

Ten additional osteoarthritis patients, average age of 58.4 years, with disease duration of 6 months to 11 years (average 5.6 years), and who were all on non-steroidal anti-inflammatory medicines, entered the trial. Nine out of the 10 patients reported a significant reduction of pain, and showed clinical reduction of inflammation between 15 and 21 days after starting the therapy.

Colostrum-derived products contain one or more immunomodulating agents that promote anti-inflammatory cytokine-type activity.

This medication is given orally, and is low cost compared to other biological response modifiers. It's most profound effect is on pain relief. "The Clinical Use of Bovine Colostrum," Nitsch A and Nitsch FP, Journal of Orthomolecular Medicine, 1998;13(2):110-118. (Address: Alejandro Nitsch, MD, 15-45 zone 10. Centro Empresarial Tower 1 Office No. 405, Guatemala City, Guatemala 01010) 30275

The consumer needs to be aware that the benefits of colostrum –particularly in specific disease states like arthritis- have not been proven to be effective in large controlled studies. Almost all the studies have been small and uncontrolled. In addition, many of the supporting pieces of evidence on websites touting the benefits of colostrum are testimonials.

Although colostrums is theoretically promising, it needs more good quality research behind it before it becomes accepted. This isn’t to say that it isn’t effective. It may well be as good as all the claims say it is. Unfortunately, when statements are made about a product that are too good and that the substance can cure everything, I think it pays to be skeptical.

The following letter is offered as a cautionary note…

August 1, 2002

CERTIFIED MAIL
RETURN RECEIPT REQUESTED
Mrs. Elizabeth Miller
New Horizons
5380 W 34th Street, #228
Houston, Texas 77092
Ref. No. CL-02-HFS-810-30
Dear Mrs. Miller:
This is to advise you that the Food and Drug Administration (FDA) has reviewed your web site at the Internet address: http://www.behealthy.com and has determined that the products "Bioumune OSF Plus," "Km by Matol Botanical International," "Bovine Colostrum," and "Olive Leaf Extract" being offered are promoted for conditions that cause the products to be drugs under section 201(g)(1) of the Federal Food, Drug, and Cosmetic Act (the Act) [21 USC 321(g)(1)]. The therapeutic claims on your web site establish that the products are drugs because they are intended for use in the cure, mitigation, treatment, or prevention of disease. The continued marketing of these products with these claims violates the Act and may subject you or the products to regulatory action without further notice.

Examples of some of the claims observed on your web site include:

Bioumune OSF Plus claim located at "products" link: "If You or anyone you know has the following health issues...check this out NOW! AIDS, Allergy Conditions, CFIDS – Severe, Appendix Adenocarcinoma, Arthritis, Auto Immune Disorders, Basal Cell Carcinoma, Bursitis, Cancer – Breast – Bladder – Cervical, etc., Carcinoma, Chronic Infection, Colds and Flu, Colitis, Colon Cancer, Diabetes, Ductal Carcinoma … Fibromyalgia, Gout, Hepatitis C, Herpes Stomatitis – Severe, High Cholesterol, Hypoglycemia, … Leukemia – Lymphocytic – B-cell, Lung Cancer, Lupus, Lyme Disease, Lymphoma, Mononeucleosis [sic]– Acute, Multiple Sclerosis, Myelodysplasia,… Osteoporosis, Ovarian Cancer, Pneumonia, Prostate Cancer, Psoriasis, Schleroderma [sic], Sinus and Coughing, Sinusitis, Sore Throat, Staph, Thyroiditis, Tumors, Biomune OSF Express (used for Sinus, Sore Throat, Ears…GREAT FOR CHILDREN, etc.)"

Km by Matol Botanical International claim located at "product" link: "If You or anyone you know has the following health issues…. Check this out NOW! Allergy Conditions – Severe, Arthritis, Bursitis, Candida, Chronic Fatigue, Colitis, Diabetes … Gout, High Blood Pressure, High Cholesterol, Hypoglycemia, Lupus, Lyme Disease, Psoriasis, Sinus and Coughing, Sinusitis, Thyroiditis."

Bovine Colostrum claim located at "products" link: "Success Stories of Colostrum have been seen in the following conditions: allergy conditions, sinus and coughing, bursitis, high cholesterol, after surgery, after accidents, colds and flu, auto-immune disorders, multiple sclerosis, asthma, cuts, hypoglycemia, tumors, diabetes, hemorrhaging, arthritis, rheumatoid arthritis, osteoporosis, burns, gingivitis … balance and regulate blood sugar, irregular bowel, chronic fatigue, scleroderma, … epstein barr virus, depression."

"‘I have been in a research program for Osteoporsis [sic] and put on medication. The side effect from the pain medication caused sever [sic] stomack [sic] problems and swelling of the hands. After taking 3 Colostrum per day for two days, the next morning my hands were not swollen and the pain was gone.’"

Olive Leaf Extract (claim located at "products" link): "A Natural Approach to: Viruses – Epstein-Barr, HIV, etc., Yeast – Candidiosis [sic], Fungi, Cholesterol Problems, Chronic Fatigue Syndrome, Colds & Flu, Cold Sores, Diabetes, E. Coli, Ear Infections, Eczema, Epstein-Barr, Fibromyalgia, Parasites and Worms, Common Cold and Flu, Vital Infections, Bacterial Infections, Arthritis, Skin Disease, Heart Problems, High Blood Pressure, Hardening of Arteries, Herpes, Hiatal Hernias, High Cholesterol, Hypertension, Gulf War Syndrome, Parasites, Pneumonia, Psoriasis, Rabies, Rheumatoid Arthritis, Roundworm, Rubella, Hepatitis, Salmonella, Skin Conditions and Diseases, Staphylococcus, Streptococcus, Ulcers, Yeast Infections."

Furthermore, FDA has no information that your products are generally recognized as safe and effective for the above referenced conditions and therefore, the products may also be "new drugs" under section 201 (p) of the Act [21 USC 321(p)]. New drugs may not be legally marketed in the U.S. without prior approval from FDA as described in section 505(a) of the Act [21 USC 355(a)]. FDA approves a new drug on the basis of scientific data submitted by a drug sponsor to demonstrate that the drug is safe and effective.

FDA is aware that Internet distributors may not know that the products they offer are regulated as drugs or that these drugs are not in compliance with the law. Many of these products may be legally marketed as dietary supplements or as cosmetics if therapeutic claims are removed from the promotional materials and the products otherwise comply with all applicable provisions of the Act and FDA regulations.

Under the Act, as amended by the Dietary Supplement Health and Education Act (DSHEA), dietary supplements may be legally marketed with truthful and non-misleading claims to affect the structure or function of the body (structure/function claims), if certain conditions are met. However, claims that dietary supplements are intended to prevent, diagnose, mitigate, treat, or cure disease (disease claims), excepting health claims authorized for use by FDA, cause the products to be drugs. The intended use of a product may be established through product labels and labeling, catalogs, brochures, audio and videotapes, Internet sites, or other circumstances surrounding the distribution of the product. FDA has published a final rule intended to clarify the distinction between structure/function claims and disease claims. This document is available on the Internet at http://vm.cfsan.fda.gov/~lrd/fr000106.html (codified at 21 C.F.R. 101.93(g)).

In addition, only products that are intended for ingestion may be lawfully marketed as dietary supplements. Topical products and products intended to enter into the body directly through the skin or mucosal tissues, such as transdermal or sublingual products, are not dietary supplements. For these products, both disease and structure/function claims may cause them to be new drugs.

Certain over-the-counter drugs are not new drugs and may be legally marketed without prior approval from FDA. Additional information is available in Title 21 of the Code of Federal Regulations (21 CFR) Parts 310 and 330-358, which contain FDA's regulations on over-the-counter drugs.

This letter is not intended to be an all-inclusive review of your web site and products your firm may market. It is your responsibility to ensure that all products marketed by your firm are in compliance with the Act and its implementing regulations.

If you need additional information or have questions concerning any products distributed through your web site, please contact FDA. You may reach FDA electronically (e-mail) at APope@CFSAN.FDA.GOV, or you may respond in writing to Angela F. Pope,Compliance Officer, Food and Drug Administration, Division of Compliance and Enforcement, 5100 Paint Branch Parkway, College Park, Maryland 20740-3835. If you have any questions concerning any issue in this letter, please contact Ms. Pope at (301) 436-2375.

Sincerely yours,

/s/
John B. Foret Director
Division of Compliance and Enforcement
Office of Nutritional Products, Labeling and Dietary Supplements
Center for Food Safety and Applied Nutrition

Moral of the story: if you're making outrageous claims, the feds will take notice.



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