-Caveat Lector- Dave Hartley http://www.Asheville-Computer.com http://www.ioa.com/~davehart -----Original Message----- From: Prof. Garth Nicolson [mailto:[EMAIL PROTECTED]] Sent: Saturday, October 30, 1999 5:51 PM To: Dave Subject: Re: Anthrax vaccinations, Military resistors, Mycoplasma Fermentans-3 Here is some general information. Prof. Garth Nicolson The Institute for Molecular Medicine 15162 Triton Lane Huntington Beach, CA 92649 714-903-2900 http://www.immed.org Please note that our address is no longer in Irvine, CA. You can also call our telephone number and use the menu to request materials and publications be Faxed back immediately. _________________________________________________________ The Fibromyalgia Society of Canada (1998) DIAGNOSIS AND TREATMENT OF CHRONIC INFECTIONS IN CHRONIC FATIGUE SYNDROME, FIBROMYALGIA SYNDROME AND RHEUMATOID ARTHRITIS Prof. Garth L. Nicolson The Institute for Molecular Medicine 15162 Triton Lane, Huntington Beach, CA 92649-1401 Patients with chronic illnesses Chronic Fatigue Syndrome/ME (CFS/ME), Fibromyalgia Syndrome (FMS), Gulf War Syndrome or Gulf War Illnesses (GWI) and some Rheumatoid Arthritis (RA) usually have overlapping, complex, multi-organ chronic signs and symptoms . These include chronic fatigue, headaches, memory loss, muscle pain, nausea, gastrointestinal problems, joint pain, lymph node pain, memory loss, and other signs and symptoms. Often included in this complex clinical picture are increased sensitivities to various environmental agents and enhanced allergic responses. Although these syndromes have been known for several years, most patients with CFS/ME, FMS, GWI or RA have had few options when it comes to effective treatments. This may be due to the imprecise nature of their diagnoses, which are often based on clinical observations rather than laboratory tests that could identify an underlying cause for their illnesses. The signs and symptoms of CFS/ME and FMS overlap with those found in GWI, suggesting that these are not a separate syndromes, they are all CFS/ME-like disorders.(1) The main distinguishing characteristic of FMS is severe muscle pain and soreness, and this can also be seen in many FMS, RA and GWI patients. In some cases, these illnesses have apparently spread to immediate family members. In the case of GWI, over 100,000 veterans of the Persian Gulf War in 1991 have been found to have this disorder, not including immediate family members. According to one government study, GWI has spread to family members, (2) and it is likely that it has also spread in the workplace. Although this U.S. Senate committee study was incomplete, investigators found after surveying approximately 1,200 GWI families that 77% of spouses and a majority of children born after the war had the signs and symptoms of GWI. (2) Notwithstanding the official position of Department of Defense remains that family members have not contracted GWI, this U. S. Senate study indicates that at least a subset of GWI patients have a transmittable illness. (2) Similarly, some CFS/ME patients have complained that their immediate family members now show some of the signs and symptoms of CFS/ME. Does Stress affect CFS/ME, FMS, GWI or RA? Can stress affect chronic illnesses? Most researchers would agree that it can, especially by affecting the immune system, but the notion that stress is the cause of chronic illnesses like CFS/ME, FMS, GWI and RA is, in my opinion, far fetched. Patients with CFS/ME, FMS, GWI and sometimes RA often have cognitive problems, such as short term memory loss, problems concentrating and other psychological problems. In fact, psychologists or psychiatrists who examine CFS/ME, FMS or GWI patients often find psychological or psychiatric problems in these patients and decide in the absence of contrary laboratory findings that these conditions are somatoform disorders. That means that these practitioners decide that these illnesses are caused solely by psychological or psychiatric problems, not medical problems that can be treated with medicines or treatments that are not specific for the Central Nervous System. Stress is often mentioned as an important factor or the important factor in these disorders. In particular, GWI patients are often diagnosed with Post Traumatic Stress Disorder (PTSD) in veterans¹ and military hospitals. (4) The evidence that physicians have offered as proof that stress or PTSD is the source of most GWI sickness is the assumption that most veterans must have suffered from stress by virtue of the stressful environment in which they found themselves during the Gulf War. (4) In fact, veterans themselves do not feel that stress-related diagnoses are an accurate portrayal of their illnesses. Most testimony to the U. S. House of Representatives Committee on Government Reform and Oversight studying the origins of GWI refutes the notion that stress is the major cause of GWI. (4) The General Accounting Office (GAO), the investigation arm of the U.S. Congress, after studying government and civilian data on the subject concluded that while stress can induce some physical illness, the statement that stress is the causes of GWI has not been established. (5) Similarly, evidence is lacking that stress can cause CFS/ME, FMS or RA. The main effect of stress appears to be that it can exacerbate chronic illnesses and suppress immune systems. But most military personnel that we interviewed, including highly disciplined U. S. Special Forces and Navy SEALS, indicated that the Gulf War was not a particularly stressful war, and they strongly disagreed that stress was the origin of their illnesses. (6) However, in the absence of physical or laboratory tests that can identify possible origins of CFS/ME, FMS or GWI, many physicians accept that stress is the cause of these chronic illnesses. It was only recently that other causes have been seriously considered, including chemical and biological exposures. Chronic Illnesses and Toxic Exposures When trying to determine why chronic illness patients are sick, we feel it is imperative to have some idea of the types of toxic exposures. In the case of GWI, toxic exposures occurred in 1991 during the Gulf War, and this provides us with a baseline for study. All Canadian and U.S. military personnel had to pass a medical exam before deployment, and thus the chance that previously sick soldiers were deployed is very unlikely. We have assumed that chemical and biological exposures occurred during the Gulf War, and many civilian patients may have also been exposed to chemical and biological substances that could be the underlying cause of their illness. The complex signs and symptoms found in CFS/ME, FMS, GWI and some RA patients, or in at least many of these patients, maybe due to system-wide or systemic chronic infections and/or chemical insults that can penetrate various tissues and organs, including the Central and Peripheral Nervous Systems. (7) When such infections occur, they can cause the complex signs and symptoms seen in CSF/ME, FMS and GWI, including immune dysfunction. Changes in environmental responses as well as increased titers to various endogenous viruses that are commonly found to be expressed in these patients have been seen in CFS/ME, FMS and GWI. If infectious agents are involved, few can produce the complex chronic signs and symptoms found in CFS/ME, FMS and GWI and some RA patients. One type of airborne infection that has received renewed interest of late as an important element in these disorders is represented by the class Mollicutes. (7) These microorganisms, principally mycoplasmas and other rather primitive bacteria, although not well known agents in causing disease, are now considered important emerging pathogens in causing chronic diseases and may also be important cofactors in some illnesses, including AIDS and other Immunodeficiency Disorders, skin diseases and some autoimmune diseases. (8) As chronic illnesses such as GWI (and in some cases CFS/ME, FMS and RA) progresses, there are a number of accompanying clinical problems, particularly increases in autoimmune problems. These include in some patients acquiring some of the signs and symptoms of Multiple Sclerosis (MS), Amyotrophic Lateral Sclerosis (ALS or Lew Gehrig¹s Disease), Lupus, Graves¹ Disease, Arthritis and other complex autoimmune diseases. Such usually rare autoimmune responses are consistent with certain chronic infections, such as mycoplasmal infections that penetrate into nerve cells, synovial cells and other cell types. It is proposed that these autoimmune signs and symptoms are caused when intracellular pathogens, such as mycoplasmas and other bacteria, escape from cellular compartments. Some microorganisms like mycoplasmas can incorporate into their own structures pieces of host cell membranes that contain important host membrane antigens that can trigger autoimmune responses. Thus patients with such infections may be responding to microorganism antigens as well as their own membrane antigens, producing unusual autoimmune signs and symptoms. Microorganisms Cause Morbidity in Many CFS/ME, FMS, GWI and RA Patients Most microorganisms like mycoplasmas are not considered as important human pathogens when they are found at superficial sites, such as the oral cavity, but some species, such as M. fermentans, M. penetrans, M. pneumoniae, M. genitalium, M. pirum and M. hominis, among others, have the capacity to penetrate into blood and colonize various tissues and have been closely associated with various human diseases. (7) Do these agents cause CFS/ME, FMS, GWI or RA? Not necessarily on their own, but microorganisms like Mycoplasma, Chlamydia, Brucella and other bacteria and some viruses appear to be important in causing patient morbidity, or exacerbating the major signs and symptoms seen in patients with chronic illnesses. If such microorganisms are associated with chronic illnesses, is there any evidence for microorganism infections in CFS/ME, FMS, GWI or RA patients? The answer is YES. In about 60% of CFS/ME, 70% of FMS, 50% of GWI and 55% of RA patients examined we and others, principally Dr. Daryl See of the University of California College of Medicine, Irvine, and Eli Mortechai of Medical Diagnostics of New Jersey, are finding strong evidence for mycoplasmal blood infections that can explain much if not most of the chronic signs and symptoms found in these patients. In our studies on GWI, a CFS/ME/FMS-like illness, (1) we have found mycoplasmal infections in the blood of about one-half of over 200 patients, and these patients were found to have principally one infectious species of mycoplasma, M. fermentans.(8,9) However, in about 60% of the 150 civilians with CFS/ME, FMS or RA that we have examined we are finding a variety of pathogenic mycoplasma species, such as M. fermentans, M. penetrans, M. pneumoniae, M. genitalium, M. pirum and M. hominis, in the white blood cell fractions of blood samples. (10) The tests that we use to identify mycoplasmal infections, polymerase chain reaction(10) and nucleoprotein gene tracking, (11) are very sensitive and highly specific for mycoplasmas. These tests are a dramatic improvement over the relatively insensitive serum antibody tests that are currently used to assay for systemic mycoplasmal infections. We have recently received a Department of Defense contract to train scientists and physicians to perform these tests, including the training of staff from the Armed Forces Institute of Pathology and Walter Reed Army Medical Center. New Antibiotic/Vitamin/Nutritional Treatments for Chronic Illnesses When microorganism infections are identified in the white blood cell fractions of subsets of CFS, FMS, GWI and RA patients, these patients can be treated as medical not psychological or psychiatric patients. If such infections are important in these disorders, then appropriate treatment with antibiotics should result in improvement and even recovery. This is exactly what has been found. (8-10, 12) The recommended treatments for mycoplasmal blood infections require long-term antibiotic therapy, usually multiple 6-week cycles of doxycycline (200-300 mg/day), ciprofloxacin or Cipro (1,500 mg/day), azithromycin or Zithromax (500 mg/day) or clarithromycin or Biaxin (750-1,000 mg/day). Multiple cycles are required, because few patients recover after only a few cycles, (9, 10) possibly because of the intracellular locations of mycoplasmas and the slow-growing nature of these microorganisms. The clinical responses that are seen are not due to placebo effects, because administration of some antibiotics, such as penicillins, resulted in patients becoming more not less symptomatic, and they are not due to immunosuppressive effects of some of the antibiotics because others that do not cause immune suppression are just as effective but only if they can suppress mycoplasmal infections. Some of these patients recover to a certain pt and then fail to continue to respond to the suggested antibiotics, suggesting that other problems, such as viral infections, chemical exposures and other toxic events also play an important role in these illnesses, and may play a predominant role in some patients. It is thus unlikely that any one explanation for chronic illnesses, such as CFS/ME, FMS, GWI or RA, is correct. Rather, it is probably a combination of multiple toxic exposures, chemical and biological, in combination with genetic susceptibility (immune system and/or detoxification systems) that determines whether a person contracts a chronic illness. Treatment recommendations for CFS/ME, FMS, GWI and RA patients with mycoplasmal infections are similar to those used to treat Lyme Disease, caused by other slow-growing intracellular bacteria that are difficult to identify and treat. Interestingly, CFS/ME, FMS, GWI and RA patients that slowly recover after several cycles of antibiotics are generally less environmentally sensitive, suggesting that their immune systems may be returning to pre-illness states. If such patients had illnesses that were caused by psychological or psychiatric problems or by environmental or chemical exposures, they should not respond to the recommended antibiotics and recover their health. In addition, if such treatments were just reducing the autoimmune responses, then patients should not recover after the treatments are discontinued. A comprehensive approach to therapy must be undertaken. (13) In addition to antibiotics, patients with CFS/ME, FMS, GWI or RA have nutritional and vitamin deficiencies that must be corrected. For example, these patients are often depleted in vitamins B, C and E and certain minerals. Unfortunately, patients with these chronic illnesses often have poor absorption. Therefore, high doses of some vitamins must be used, and others, such as vitamin B complex, cannot be easily absorbed by the gut, so sublingual natural B-complex vitamins in small capsules or liquids should be used instead of oral capsules that are swallowed. General vitamins plus extra C, E, CoQ-10, beta-carotene, folic acid, bioflavoids and biotin are best. L- cysteine, L-tyrosine, L-carnitine and malic acid are reported by some to be useful. Certain minerals are also often depleted in GWI/CFS/FMS patients, such as zinc, magnesium, chromium and selenium. Some recommend doses as high as 300 mg/day sodium selenite for a few days, followed by lower maintenance doses. There are also other considerations. (13) Antibiotic use that depletes normal gut bacteria can result in over-growth of less desirable bacteria. To supplement bacteria in the gastrointestinal system yogurt and especially Lactobacillus acidophillus tablets are recommended. One product is a mixture of Lactobacillus acidophillus, Lactobacillus bifidus and FOS (fructoologosaccharides) to promote growth of these "friendly" bacteria in the gut. In addition, number of natural remedies that boost the immune system, such as whole lemon/olive extract drink or an extract of olive leaves with antioxidants are available and are potentially useful, especially during or after antibiotic therapy has been completed. Although these products appear to help some patients, their clinical effectiveness in CFS/ME/GWI/FMS patients has not been evaluated. They appear to be useful during therapy to boost the immune system or after antibiotic therapy in a maintenance program to prevent relapse of illness. (13) Chronic Infections: Only Part of the Answer Although chronic infections fulfill many of the criteria necessary to explain their roles in chronic illnesses, is there one underlying cause of all the above chronic illnesses? Certainly not! Are chronic, systemic mycoplasmal infections the answer to CFS/ME, FMS, GWI, RA and other chronic disorders? Of course not! However, chronic infections, such as mycoplasmal and other bacterial and some viral infections, are likely to be an appropriate explanation for the morbidity or illness signs and symptoms found in a rather large subset of CFS/ME, FMS, GWI and some RA patients, but certainly not every patient will have the same types of chronic infections or the same degree of morbidity caused by chronic infections. Some patients may have chemical exposures or other environmental problems as the underlying reason for their chronic signs and symptoms. In these patients, chronic infections may be opportunistic. In others somatoform disorders or illnesses caused by psychological or psychiatric problems may indeed be important. However, in these patients antibiotics should have no effect whatsoever, and they should not recover on antibiotic therapies. The identification of specific infectious agents in the blood of chronically ill patients may allow many patients with CFS/ME, FMS, GWI or RA to obtain more specific diagnoses and more effective treatments for their illnesses. The Institute for Molecular Medicine can test patients for evidence of mycoplasmal infections of the types that cause human diseases like CFS/ME, FMS, GWI and RA. Blood samples can be sent to the Institute for Molecular Medicine for mycoplasma and other testing. Since the IMM is a nonprofit institution, all testing is done at cost for a tax-deductible donation. The website for further information is: www.immed.org. For Further Information Contact: Prof. Garth L. Nicolson The Institute for Molecular Medicine 15162 Triton Lane Huntington Beach, CA 92649-1401 Tel: 714-903-2900 Fax: 714-379-2082 email: [EMAIL PROTECTED] References 1. Nicolson, G.L. and Nicolson, N.L. Chronic fatigue illness and Operation Desert Storm. J. Occup. Environ. Med. 1996; 38: 14-16. 2. U. S. Congress, Senate Committee on Banking, Housing and Urban Affairs, U. S. chemical and biological warfare-related dual use exports to Iraq and their possible impact on the health consequences of the Persian Gulf War , 103rd Congress, 2nd Session, Report May 25, 1994. 3. Nicolson, G.L. and Nicolson, N.L. The eight myths of Operation Desert Storm and Gulf War Syndrome. Medicine Conflict & Survival 1997; 13(2): 140-146. 4. U. S. Congress, House Committee on Government Reform and Oversight, Gulf War veterans¹: DOD continue to resist strong evidence linking toxic causes to chronic health effects, 105th Congress, 1st Session, Report 105-388, 1997. 5. U. S. General Accounting Office, Gulf War Illnesses: improved monitoring of clinical progress and reexamination of research emphasis are needed. Report GAO/SNIAD-97-163, 1997. 6. Nicolson, G.L. and Nicolson, N.L. Chronic Fatigue Illnesses Associated with Service in Operation Desert Storm. Were Biological Weapons Used Against our Forces in the Gulf War? Townsend Lett. Doctors 1996; 156: 42-48. 7. Baseman, J.B. and Tully, J.G. Mycoplasmas: Sophisticated, reemerging, and burdened by their notoriety. Emerg. Infect. Diseases 1997; 3: 21-32. 8. Nicolson, G.L. and Nicolson, N.L. Diagnosis and treatment of mycoplasmal infections in PersianGulf War Illness-CFIDS patients. Intern. J. Occup. Med. Immunol. Tox. 1996; 5: 69-78. 9. Nicolson, G.L., Nicolson, N.L. and Nasralla, M. Mycoplasmal infections and Chronic FatigueIllness (Gulf War Illness) associated with deployment to Operation Desert Storm. Intern. J. Med. 1998; 1: 80-92. 10. Nicolson, G.L., Nasralla, M, Hier, J. and Nicolson, N.L. Diagnosis and treatment of chronic mycoplasmal infections in Fibromyalgia Syndrome and Chronic Fatigue Syndrome: relationship to Gulf War Illness. Biomed. Therapy 1998; 16: 266-271. 11. Nicolson, N.L. and Nicolson, G.L. The isolation, purification and analysis of specific gene-containing nucleoproteins and nucleoprotein complexes. Methods Molecular Genet. 1994; 5: 281-298. 12. Nicolson, G.L. and Nicolson, N.L. Doxycycline treatment and Desert Storm. JAMA 1995; 273: 618-619. 13. Nicolson, G.L. Considerations when undergoing treatment for chronic infections found in Chronic Fatigue Syndrome, Fibromyalgia Syndrome and Gulf War Illnesses. (Part 1). Antibiotics Recommended when indicated for treatment of Gulf War Illness/CFIDS/FMS (Part 2). Intern. J. Med. 1998; 1: 115-117, 123-128. ___________________________________________________________________ >From the Intern. J. Medicine 1998; 1: 115-117, 123-128. CONSIDERATIONS WHEN UNDERGOING TREATMENT FOR GULF WAR ILLNESS, CHRONIC FATIGUE SYNDROME, FIBROMYALGIA SYNDROME OR RHEUMATOID ARTHRITIS by Prof. Garth L. Nicolson The Institute for Molecular Medicine, 15162 Triton Lane, Huntington Beach, California 92649-1041 Tel: (714) 903-2900 Fax: (714) 379-2082 E-mail: [EMAIL PROTECTED] Website: www.immed.org There are a number of considerations when undergoing therapy. The IMM is a nonprofit institution and does not endorse commercial products. The products and procedures below are only examples of the types of substances that could be beneficial to patients. Consult your personal physician for advice. Antibiotic Therapy for Chronic Infections and Inhibiting Drugs Please consult p. 3-6. Subsets of GWI (~40%), FMS (~70%), CFS (~60%) or RA (~45%) patients have chronic mycoplasmal infections, and probably other infections as well. Several months of doxycycline, ciprofloxacin, azithromycin, minocycline, clarithromycin or other antibiotics with cycles of Augmentin in between or concurrently, if needed, work best. Oral antibiotics must be taken with a full glass of water, crackers or bread to avoid esophageal irritation. During the first 6 months the cycles are usually run together without a break. To overcome Herxheimer reactions or die-off (chills, fever, night sweats, muscle aches, joint pain, short term memory loss and fatigue) or adverse responses i.v. antibiotics have been used for a few weeks, and oral Benadryl (diphenhydramine HCl) 50 mg and lemon/olive drink are useful (1 blended whole lemon, 1 cup fruit juice, 1 tbs olive oil--strain and drink liquid). This period usually passes within 1-2+ weeks. Some add the antiviral Famvir (500 mg 3X/day) or other antivirals for the first 2 weeks in a 6-week antibiotic cycle. Mycoplasmas have some characteristics of viruses, so this can be useful, and viral infections are also important in these illnesses. Antibiotic uptake and immune responses may be inhibited by some drugs, and anti-depressants (sertaline or Zoloft, fluoxetine or Prozac, amitriptyline or Elavil, maprotiline or Ludiomil, desipramine or Norpramin, clomipramine or Anafranil, nortriptyline or Pamelor, bupropion or Wellbutrin), muscle relaxants (cyclobenzaprine or Flexeril), opiate agonists, anticonvulsives or analgesics (oxycodone or Percodan, carbamazepine or Tegretol, acetaminophen/hydrocodone or Vicodin), narcotics (codeine w/ Penergan, propoxyphene or Darvon, morphine), antacids, antidiarrheas, metal salts, others should not be taken, if possible, during therapy. Some (certain antibiotics, antidepressants, analgesics, narcotics, etc.) may inhibit immune responses. Oxidative Therapy for Chronic Infections Oxidative therapy appears to be useful in suppressing anaerobic infections: Hyperbaric Oxygen, American Biologics Dioxychlor are useful, or peroxide baths using 2 cups of Epsom salt in 20 inches of hot bath or Jacuzzi. After 5 min add 2-4 bottles 16 oz. of 3% hydrogen peroxide. Repeat 2-3X week; no vitamins 8 hr before bath. The hydrogen peroxide is added after your pores open. Hydrogen peroxide can also be directly applied to skin after a work-out or hot shower/tub. One approach is to apply Swedish Beauty type A tanning accelerator for 5 min before peroxide. Leave hydrogen peroxide on for 5 min and then wash off. For oral irrigation, mix 1 part 30% hydrogen peroxide with 2 parts water and use like a mouth wash 3X per day. Most chronic illness patients have dental problems, and infections are common. General Nutritional Considerations GWI/CFS/FMS/RA patients are often immunosuppressed and susceptible to opportunistic infections, so proper nutrition is imperative. You should not smoke or drink alcohol or caffeinated products. Drink as much fresh fluids as you can, lots of fruit juices or pure water are best. Try to avoid high sugar and fat foods, such as military (MRE) or other fast foods and acid-forming, allergen-prone and system stressing foods or high sugar/fat junk foods. Increase intake of fresh vegetables, fruits and grains, and decrease intake of fats and simple or refined sugars that can suppress your immune system. To build your immune system cruciferous vegetables, soluble fiber foods, such as prunes and bran, wheat germ, yogurt, fish and whole grains are useful. In some patients exclusive use of 'organic' foods has been beneficial. Vitamins and Minerals Chronic illness patients are often depleted in vitamins (especially B complex, C, E) and certain minerals. These illnesses often result in poor absorption. Therefore, high doses of some vitamins are useful; others, such as vitamin B complex, cannot be easily absorbed by the gut (oral). Sublingual (under the tongue) natural B-complex vitamins in capsules or liquids (Total B, Real Life Research, Norwalk, CA, 562-926-5522 or GNC) should be used instead of swallowed capsules. General vitamins plus extra C, E, CoQ-10, beta-carotene, folic acid, bioflavoids and biotin are best. L-cysteine, L-tyrosine, L-carnitine, malic acid and especially flaxseed or fish oils are reported to be useful. Certain minerals are depleted in chronic illness patients, such as zinc, magnesium, chromium and selenium. Some recommend up to 300 mcg/day sodium selenite, followed by lower doses. Minerals should not be taken at the same time of day as antibiotics because the minerals can affect the absorption of antibiotics. Replacement of Natural Gut Flora with Lactobacillus Patients undergoing treatment with antibiotics and other substances risk destruction of normal gut flora. Antibiotic use that depletes normal gut bacteria and can result in over-growth of less desirable bacteria. To supplement bacteria in the gastrointestinal system yogurt and especially Lactobacillus acidophillus tablets are recommended. Mixtures of Lactobacillus acidophillus, L. bifidus, B. bifidum, L. bulgaricus and FOS (fructoologosaccharides) to promote growth of these "friendly" bacteria in the gut (example, DDS-1, NeutraCeuticals, DDS-Plusor Multi-Flora ABF, UAS Labs (800-422-3371); Intestinal Care-DF. L. acidophillus mixtures above (2.5-3 billion live organisms) should be taken 3X daily. Natural Immunoenhancers or Immunomodulators A number of natural remedies, such as ginseng root, herbal teas, lemon/olive drink, olive leaf extract with antioxidants and are useful, especially during or after antibiotic therapy. Examples are Immunocal (800-337-2411), Echinacea-C (NF Formulas, 800-547-4891), Super-Immunotone (Phyto Pharmica, 800-553-2370), olive leaf extract (Immunoscreen, 818-966-1610), NSC-100 (Nutritional Supply, 888-246-7224), Nu-Life Formula (Sophista-Care, 760-837-1908), Tahitian Noni (Morinda, 800-445-8596) or Super Defense Plus (BioDefense Nutritionals, 800-669-9205). These have been used to boost immune systems. Although these products appear to help many patients, their clinical effectiveness in chronic illness patients has not been evaluated. They appear to be useful during therapy or after to boost the immune system or after antibiotic therapy in a maintenance program to prevent relapse of illness. Yeast/Fungal or Bacterial Overgrowth Yeast overgrowth can occur, especially in females (vaginal infections). Gynecologists recommend Nizoral, Diflucan, Mycelex, or anti-yeast creams. Metronidazole (Flagyl, Prostat) has been used to prevent fungal or parasite overgrowth or other antifungals (Nystatin, Amphotericin B, Fluconazole, Diflucan) have been administered for fungal infections occuring while on antibiotics. As above, L. acidophillus mixtures are used to restore gut flora. Bacterial overgrowth can also occur, for example, in between cycles of antibiotics or after antibiotics have been stopped. This can be controlled with 2 week courses of Augmentin (3 X 500 mg/day) in between cycles or concurrent with other antibiotics. Flying, Exercise and Saunas Flying, excessive exercise and lack of sleep can make signs/symptoms worse. Flying exposes you to lower oxygen tension, and can stimulate borderline anaerobes that grow better at low oxygen (see above). Some exercise is essential, but avoid relapses due to overexertion. Dry saunas help rid the system of chemicals, and saunas should be taken at least 3X per week--moderate exercise, followed by 15-20 min of dry sauna and tepid shower. Repeat saunas no more than 2X per day. Work up a good sweat, eliminating chemicals without placing too much stress on your system, and replace body fluids after each session. During exercise patients should always avoid pollutant and allergen exposures. For recovery after exercise and to decrease muscle soreness, some use a Jacuzzi or hot tub, but only after a sufficient cool-down period. Don¹t get overheated in the process. Don¹t over do it!!! Antibiotics Recommended When Indicated for Treatment of Gulf War Illness/CFS/FMS/Arthritis by Prof. Garth L. Nicolson The Institute for Molecular Medicine, 15162 Triton Lane, Huntington Beach, California 92649-1041 Tel: (714) 903-2900 Fax: (714) 379-2082 e-mail: [EMAIL PROTECTED] Website: www.immed.org Doxycycline (aka Vibramycin, Monodox, Doxychel, Doxy-D, Doryx) Doxycycline is a broad spectrum tetracycline with good lipid solubility and ability to penetrate the blood-brain-barrier. This antibiotic acts by inhibiting microorganism protein synthesis; it is readily absorbed by the (normal) gut, and peak blood concentrations are maintained between 2-18 hours (half-life, 18-22 hrs) after an oral dose of drug. Food, calcium, magnesium, antacids and some drugs reduce absorption, and alcohol, phenytoin [Dilantin] or barbiturates reduce blood half-life or suppress the immune system. Minocycline (Minocin) can be substituted, and for some illnesses (RA) it is preferred (same dose/day). For GWI/CFS/FMS/RA use, the recommended oral dose is 200-300 mg/day (2-3X 100 mg capsules, 2 in morning) for 6 months. After 6 months, 6 week cycles are suggested. Initially, doxycycline exacerbates signs/ symptoms (Herxheimer reactions or adverse responses, such as transient fever, skin, gut discomfort, etc.) but these are usually reduced within 2 weeks or so (see p. 1). Patients usually start feeling better with alleviation of most major signs and symptoms within 12 weeks, but in some patients major symptoms are not alleviated until after 12 weeks. Severe reactions or prior damage to the gastrointestinal track may require i.v. administration of 100-150 mg/day (rapid i.v. administration must be avoided) for 2-3 weeks, then the remainder of the course should be oral (to avoid thrombophlebitis complications which can occur with prolonged i.v. therapy). Some react to the starch filler in the capsules and must use Doryx, a granular form of pure doxycycline. Virtually all patients relapse (show the same major signs and symptoms) if they stop therapy before 6 months. In a pilot study, ~85% relapsed after 12 weeks of therapy, so the first 6 months without a break is recommended. Doxycycline has been used successfully in addition to other antibiotics in situations where either antibiotic alone had minimal effects (ie., doxycycline with ciprofloxacin or azithromycin). Doxycycline and minocycline are primarily bacteriostatic and effective against the following organisms: gram-negative bacteria (N. gonorrhoeae, Haemophilus influenzae, Shigella species, Yersinia pestis, Brucella species, Vibrio cholera); gram-positive bacteria (Streptococcus pneumoniae, Streptococcus pyogenes); mycoplasmas (Mycoplasma pneumoniae, Mycoplasma fermentans [incognitis], Mycoplasma penetrans); others (Bacillus anthracis [anthrax], Clostridium species, Chlamydia species, Actinomyces species, Entamoeba species, Treponema pallidum [syphilis], Plasmodium falciparum [malaria] and Borelia species). Precautions: Avoid direct sunlight and drink fluids liberally, especially with oral capsules. Doxycycline or minocycline therapy may result in overgrowth of fungi or yeast and nonsensitive microorganisms (see Considerations, p.1). Patients on anticoagulants may require lower anticoagulant doses. Use during pregnancy or in children under 8 years are not recommended, in the latter case due to tooth discoloration, but lower doses of doxycycline have proven to be very effective in children with GWI/CFS (weight 100 lbs or less, 1-2 mg/lb divided into two doses; weight over 100 lbs use adult dose). Patients with impaired kidney function should not take doxycycline, and the following drugs should not be taken with doxycycline: methoxyflurane [Penthrane], carbamazepine [Tegretol], digoxin or diuretics. Other drugs can effect uptake or immune systems (see above). For complicating bacterial infections, 2 weeks Augmentin (3X 500 mg/day) can be taken inbetween courses of antibiotics. For fungal and yeast complications, please see the instructions under Other Considerations. Adverse Reactions: In a few patients doxycycline causes gastrointestinal irration, anorexia, vomiting, nausea, diarrhea, rashes, mouth dryness, hoarseness and in rare cases hypersensitivity reactions, hemolytic anemia, skin hypersensitivity and reduced white blood cell counts. In general, doxycycline is considered a safe drug, in that there are few adverse reactions reported in the literature. Ciprofloxacin (aka Cipro, Cifox, Cifran, Ciloxan, Ciplox) Ciprofloxacin is a broad spectrum synthetic fluoroquinolone antibiotic with good absorption characteristics. This drug acts on bacterial DNA gyrase to inhibit bacterial DNA synthesis. Ciprofloxacin is secreted rapidly in the urine and has a half-life in the blood of ~4 hrs. Food delays the absorption (by ~2 hrs) but doesn¹t effect total absorption; antacids containing magnesium, aluminum or other salts as well as various drugs reduce absorption and should not be taken at the same time of day. For GWI/CFS/FMS use, the recommended dose is 1,500 mg/day (oral, 3X 500 mg capsules, 2 in morning) for 6 months, then 6 week cycles of therapy. Ciprofloxacin may or may not be taken with meals. Initially, ciprofloxacin may exacerbate some signs/symptoms (Herxheimer reactions or adverse antibiotic responses) but these are usually gone within 2+ weeks or so. Patients report that doses of 1000 mg/day or lower are not effective in alleviating symptoms. Patients usually start feeling better with alleviation of major signs/symptoms within 4-6 weeks, but in some patients signs/symptoms are not reduced until after 6 weeks. Ciprofloxacin has been used in patients in which doxycycline cannot be tolerated or in some patients that no longer respond to doxycycline. In a few cases ciprofloxacin has been used simultaneously with doxycycline. Herxheimer reactions, if present, usually pass within days to 2+ weeks; prior damage to the gastrointestinal system may require i.v. 400-500 mg X2/day (over one hour per each infusion, rapid i.v. administration is to be avoided) for 2-4 weeks, then the remainder on oral antibiotic (oral doses). Virtually all patients relapse (with major signs/symptoms) if drug is stopped at a 6-12 week course of therapy. Additional antibiotic courses result in milder relapses after drug is discontinued. Subsequent cycles of antibiotics may require the use of doxycycline or other antibiotics. Sparfloxacin, a floxacin with better tissue penetration, can be substituted (oral dose, 400 mg/day). Ciprofloxacin is effective against the following organisms: gram-negative bacteria (Shigella species, Citrobacter diversus, Citrobacter freundii, Escherichia coli, Klebisella pneumoniae, Haemophilus influenzae, Enterobacter species, Proteus vulgaris, Psuedomonas aeruginosa, Yersinia pestis, Vibrio cholera), Moraxella catarrhalis; gram-positive bacteria (Streptococcus pneumoniae, Streptococcus pyogenes, Staphylococcus hominis, Staphylococcus aureus, Staphylococcus saprophytieus); mycoplasmas, moderately active (Mycoplasma species); others (Clostridium species, Chlamydia species, Mycobacterium tuberculosis). Precautions: Direct sunlight is to be avoided, especially with sparfloxacin, and patients should not take floxacin and theophylline concurrently. Ciprofloxacin therapy may result in drug crystals in the urine in rare cases, and patients should be well hydrated to prevent concentration of urine. Pregnant women and children should not use this drug due to reduction in bone and cartilage development. Adverse Reactions: Adverse antibiotic responses resulted in discontinuing drug in ~3.5% of patients, and such reactions included nausea (5%), diarrhea (2%), vomiting (2%) abdominal pain (1.7%), headache (1.2%) and rash (1.1%). In rare cases cirprofloxacin may cause cardiovascular problems (<1%) and central nervous system (dizziness, insomnia, tremor, confusion, convulsions and other reactions (<1%). Small numbers of patients have experienced hypersensitivity (anaphylactic) reactions which have required immediate emergency treatment. Other drugs may effect absorption and immune systems. Azithromycin (aka Zithromax) Azithromycin is a azalide (macrolide) antibiotic with good absorption and a serum half-life of ~68 hrs. This class of drug acts by binding to the 50S ribosomal subunit of susceptible organisms where it interferes with protein synthesis. Food decreases absorption rate, but absorption is unaffected by antacids containing magnesium, aluminum or other salts; other drugs may affect absorption (see above). For GWI/CFS/FMS use, the recommended dose is 500 mg/day (oral, 2X 250 mg capsules taken at once) for each 6-week cycle of therapy. Azithromycin should not be taken with meals (1 hour before or 1hour after). Initially, azithromycin may exacerbate some symptoms but these are usually gone within 2+ weeks. Patients usually start feeling better with alleviation of most major signs/symptoms within weeks, but in some patients major symptoms are not alleviated within months. Azithromycin has been used in patients in which doxycycline cannot be tolerated or in patients that no longer respond to doxycycline. Herxheimer reactions usually pass within a few days to weeks. Virtually all patients relapse (show the same major signs/symptoms) after 12 weeks then terminating therapy. Additional cycles of antibiotic result in milder relapses after drug is discontinued. Azithromycin has been shown to be safe for pediatric use (10 mg/kg/day is recommended for children under 14, but see below). Azithromycin is effective against the following organisms: gram-negative bacteria (Bordetella pertussis, Shigella species, Haemophilus influenzae, Chlamydia species, Yersinia pestis, Brucella species, Vibrio cholera); gram-positive bacteria (Streptococci group C, F, G); mycoplasmas (Mycoplasma species); others (Clostridium species, Treponema pallidum [syphilis], and Borelia sp). Precautions: Azithromycin is principally absorbed by the liver, and caution should be exercised with patients with impaired liver function. Antacids containing magnesium, aluminum or other salts should not be taken at the same time of day with azithromycin. Other drugs can also interfere. Macrolides and terfenadine (Seldane) or astemizole (Hismaral) may dangeriously evelate plasma antihistamine and cause arrhythmias and increase serum theophyline levels in some patients, particularly those receiving methylated xanthine causing nausea, vomiting, seizures. Plasma levels of carbamazepine (Tegretol) can also be elevated, leading to carbamazepine toxicity and nausea, vomiting, drowsiness and ataxia. Adverse Reactions: Adverse antibiotic responses were mild to moderate in clinical trials and included diarrhea (5%), nausea (3%), abdominal pain (3%). In rare cases (<1%) azithromycin may cause cardiovascular problems (palpitations, tachycardia, chest pain) and central nervous system (dizziness, headache, vertigo), allergic (rash, photosensitivity, angioderma), fatigue and other reactions (<1%). In pediatric patients >80% of the adverse reponses were gastrointestinal. In children, doses above the suggested 10 mg/kg/day have been shown to produce hearing loss in some patients. Clarithromycin (aka Biaxin) Clarithromycin is a broad spectrum macrolide antibiotic with good absorption and serum half-life. This drug acts by binding to the 50S ribosomal subunit of susceptible organisms and interfering with protein synthesis. The drug is mostly bacterostatic but high concentrations can be bactericidal. Food decreases absorption rate, but absorption is unaffected by antacids containing magnesium, aluminum or other salts. Some drugs may interfere with absorption or depress immune systems (see above). The recommended dose is 500-750 mg/day (oral, 2-3X 250 mg capsules, 2 taken in morning) for 6 months of therapy, then 6-week cycles. Clarithromycin should not be taken with meals (1 hr before or 1 hr after). Initially, clarithromycin may exacerbate some symptoms due to Herxheimer reactions and bacterial death but these are usually gone within weeks. Patients usually start feeling better with alleviation of most major signs and symptoms within 1-2 weeks, but in some patients major symptoms are not alleviated until after 12 weeks or so. Clarithromycin has been used in patients that do not respond or cannot tolerate doxycycline. Herxheimer reactions usually pass within days to weeks. Virtually all patients relapse (show the same major signs/symptoms) when therapy stopped within 12 weeks. Additional cycles of antibiotic result in milder relapses after drug is discontinued. For children, the recommended dose is 15 mg/kg/day X2; at this dose some children have gastrointestinal problems. Clarithromycin is effective against the following organisms: gram-negative bacteria (Neisseria gonorrhoeae, N. menigitidis, Moraxella catarrhalis, Campylobacter jejuni, Eikenella corrodens, Haemophilus ducreyi, Bordetella pertussis, Shigella species, Salmonella species, Haemophilus influenzae, Chlamydia species, Yersinia pestis, Brucella species, Vibrio cholera, Aeromonos species, E. coli, gram-positive bacteria (Streptococcus pyogenes, S. pneumeniae, anerobic Streptococci, Enterococcus faccalis, Staphlococcus aureus, S. epidermidis, Bacillus anthracis, Corynebacterium diptheriae, C. minutissimum, Listeria monocytogenes, Actinomyces israelii); mycoplasmas (Mycoplasma species, M. pneumoniae, Ureaplasma urealyticum); others (Clostridium species, Treponema pallidum [syphilis], Legionella pneumophilia, L. micdadei, Mycobacterium avium, M. chelonae, M. chelonae absessus, M. fortuitim, Rickettsia species and Borrelia species). Yeasts, fungi and viruses are resistant. Precautions: Clarithromycin is principally absorbed by the liver, and caution should be exercised with patients with impaired liver function. Antacids containing magnesium, aluminum or other salts should not be taken at the same of day as azithromycin. Other drugs may also interfere (see above). Macrolides and terfenadine (Seldane) or astemizole (Hismaral) may dangerously elevate plasma antihistamine and cause arrhythmias and increase serum theophyline levels in some patients, particularly those receiving methylated xanthine causing nausea, vomiting, seizures. Plasma levels of carbamazepine (Tegretol) can also be elevated, leading to carbamazepine toxicity and nausea, vomiting, drowsiness and ataxia. Macrolides like clarithromycin should not be used with cyclosporin (Sandimmune). Adverse Reactions: Adverse antibiotic responses were mild to moderate in clinical trials and included diarrhea , nausea, and abdominal pain. In rare cases (<1%) azithromycin may cause cardiovascular problems (palpitations, tachycardia, chest pain) and central nervous system (dizziness, headache, vertigo), allergic (rash, photosensitivity, angioderma) and fatigue. Clindamycin (aka Cleocin, Dalacin, Lacin) Clindamycin is a semisynthetic antibiotic made from lincomycin and is effective against severe anaerobic infections. It is primarily bacteriostatic against a wide range of Gram-positive and anaerobic pathogens, including some protozoa. It has good absorption and tissue penetration; its half-life is ~3 hrs in adults and ~2 in children. Since clindamycin use can result in severe colitis even weeks after cessation of therapy, it should not be used as primary therapy. Food does not adversely affect absorption rate, but absorption is affected by antacids containing magnesium, aluminum or other salts. Some drugs may interfere with absorption or depress immune systems (see above). The recommended dose is 600-1200 mg/day (oral, 4-8 X 150 mg capsules, in three divided doses) for 6-week cycles of therapy. Herxheimer reactions may exacerbate signs/symptoms but these are usually gone within days-weeks. Patients usually start feeling better with alleviation of most major signs and symptoms within days to weeks, but in some patients major symptoms are not alleviated until after several weeks or so. For children, the recommended dose is 8-16 mg/kg/day divided into 3-4 doses. Precautions: Clindamycin should not be used in patients with nonbacterial (viral, fungal) infections. Its use is associated in some patients with colitis and severe, persistent diarrhea and abdominal cramps, and when this occurs the drug should be discontinued. It must not be used with opiates or diphenoxylate with atropine (Lomotil). Patients with hepatic or renal problems require dosage adjustment. Antidiarrheal drugs that reduce peristalsis, such as dipenoxylate, loperamide or opioids, should be avoided. If prolonged therapy is used, periodic liver and kidney function tests and blood counts should be performed. It should not be used by pregnant women. Prolonged use can result in overgrowth of yeasts and other nonsusceptible microorganisms. Cholestyramine or colestipol resins bind clindamycin and should not be administered simultaneously. Adverse Reactions: Adverse antibiotic responses were mainly diarrhea in 2-20% of cases, some severe and dangerous (colitis). Psuedomembranous colitis may develop during or several weeks after therapy. This can be serious if ignored. Other gastrointestinal effects of the drug have been reported (nausea, vomiting, esophagitis, abdominal pain or cramps), and hypersensitivity reactions, including skin rashes occur in up to 10% of patients. Mild cases of colitis should be managed promptly with fluid, electrolyte and protein supplementation as indicated. Other effects include transient leucopenia, polyarthritis and abnormal liver function (jaundice and hepatic damage rarely occur). Clindamycin should not be used with erythromycin. Clindamycin has been shown to have neuromuscular blocking properties that may enhance the action of other neuromuscular drugs. It should only be used with caution in patients receiving such drugs. Final Comments Recovery will be gradual not rapid. Be patient. Do not take antibiotics at the same time of day as vitamins, minerals, supplements, etc. Stop antibiotics if adverse reactions continue. Eventually you will be off antibiotics but you will need to continue various supplements to maintain your immune system. ******************************************************************* Recent Publications of Prof. Garth L. Nicolson on Gulf War Illness, CFS [Myalpic Encepthalomyelitis or CFIDS], FMS, Rheumatoid Arthritis (From a Total of 495 Medical/Scientific Publications and 14 Books) …Nicolson, G.L. and Nicolson, N.L. Doxycycline treatment and Desert Storm JAMA 1996; 273: 618-619. …Nicolson, G.L., Hyman, E., Korényi-Both, A., Lopez, D.A., Nicolson, N.L., Rea, W. and Urnovitz, H. Progress on Persian Gulf War Illnesses--reality and hypotheses. Int. J. Occup. Med. Tox. 1995; 4: 365-370. …Nicolson, G.L. and Nicolson, N.L. Chronic fatigue illness and Operation Desert Storm. J. Occup. Environ. Med. 1996; 38: 14-16. …Nicolson, G.L. Further information on Persian Gulf War Illnesses. Int. J. Occup. Med. Immunol. Tox. 1996; 5: 83-86. …Nicolson, G.L. and Nicolson, N.L. Diagnosis and treatment of mycoplasmal infections in Persian Gulf War Illness-CFIDS patients. Int. J. Occup. Med. Immunol. Tox. 1996; 5: 69-78. …Nicolson, G.L. and Nicolson, N.L. Chronic Fatigue Illnesses Associated with Service in Operation Desert Storm. Were Biological Weapons Used Against our Forces in the Gulf War? Townsend Lett. Doctors 1996; 156: 42-48. …Nicolson, G.L. and Nicolson, N.L. British Society for Allergy and Environmental Medicine: Comments on the Gulf-War or human laboratory. Medicine Conflict & Survival 1996; 12: 260-262. …Nicolson, G.L. and Nicolson, N.L. Mycoplasmal infections--Diagnosis and treatment of Gulf War Syndrome/CFIDS. CFIDS Chronicle 1966; 9(3): 66-69. …Nicolson, G.L. and Nicolson, N.L. The eight myths of Operation Desert Storm and Gulf War Syndrome. Medicine Conflict & Survival 1997; 13: 140-146. …Nicolson, G.L. Chronic infections as a common etiology for many patients with Chronic Fatigue Syndrome, Fibromyalgia Syndrome and Gulf War Illnesses. Intern. J. Med. 1998; 1: 42-46. …Nicolson, G.L., Nicolson, N.L. and Nasralla, M. Mycoplasmal infections and Chronic Fatigue Illness (Gulf War Illness) associated with deployment to Operation Desert Storm. Intern. J. Med. 1998; 1: 80-92. …Nicolson, G.L. and Nicolson, N.L. Gulf War Illnesses: complex medical, scientific and political paradox. Medicine Conflict & Survival 1998; 14: 156-165. …Nicolson, G.L. New treatments for chronic infections found in Fibromyalgia Syndrome, Chronic Fatigue Syndrome, and Gulf War Illnesses. Intern. J. Med. 1998; 1: 118-122. …Nicolson, G.L. Considerations when undergoing treatment for chronic infections found in Chronic Fatigue Syndrome, Fibromyalgia Syndrome and Gulf War Illnesses. (Part 1). Antibiotics Recommended when indicated for treatment of Gulf War Illness/ CFIDS/FMS (Part 2). Intern. J. Med. 1998; 1: 115-117, 123-128. …Nicolson, G.L., Nasralla, M, Haier, J. and Nicolson, N.L. Diagnosis and treatment of chronic mycoplasmal infections in Fibromyalgia Syndrome and Chronic Fatigue Syndrome: Relationship to Gulf War Illness. Biomed. Therapy 1998; 16: 266-271. …Leisure, K.M., Nicolson, N.L. and Nicolson, G.L. Hospitalizations for unexplained illnesses among U.S. veterans of the Persian Gulf War. Emerg. Infect. Diseases 1998; 4: 707-709. …Nasralla, M., Haier, J. and Nicolson, G.L. Mycoplasmal infections in blood from patients with Chronic Fatigue Syndrome, Fibromyalgia Syndrome or Gulf War Illness. In: The Clinical and Scientific Basis of Chronic Fatigue Syndrome, T. K. Roberts, ed., Proc. Intern. CFS Congress, Sydney, Lloyd Scott Enterp. Ltd, 1998; 16-20. …Haier, J., Nasralla, M., Franco, A.R. and Nicolson, G.L. Detection of mycoplasmal infections in blood of patients with Rheumatoid Arthritis. Rheumatol. 1999; 38: 504-509. …Nicolson, G.L., Nasralla, M, Haier, J., Erwin, R., Nicolson, N.L. and Ngwenya, R. Mycoplasmal infections in chronic illnesses: Fibromyalgia and Chronic Fatigue Syndromes, Gulf War Illness, HIV-AIDS and Rheumatoid Arthritis. Med. Sentinel 1999; 4: 172-176. …Nicolson, G.L., Nasralla, M, Haier, J. and Nicolson, N.L. Gulf War Illnesses: Role of chemical, radiological and biological exposures. In: War and Health, H. Tapanainen, ed., Helinsiki, 1999; in press. …Nicolson, G.L. The role of microorganism infections in chronic illnesses: support for antibiotic regimens. CFIDS Chronicle 1999; 12(3): 19-21. …Haier, J., Nasralla, M. and Nicolson, G.L. Multiple mycoplasmal infections detected in blood of Chronic Fatigue and Fibromyalgia Syndrome patients. Eur. J. Clin. Microbiol. Infect. Dis. 1999; in press. …Nasralla, M., Haier, J., Nicolson, G.L. Determination of Mycoplasmal infections in blood of 565 Chronic Fatigue Syndrome and Fibromyalgia Syndrome patients detected by polymerase chain reaction. 1999. …Nicolson, G.L., Nasralla, M, Franco, A.R., De Meirlier, K., Nicolson, N.L., Ngwenya, R. and Haier, J. Mycoplasmal infections in chronic diseases. J. Chronic Fatigue Syndrome 1999. _________________________________________________________________ PATIENT REGISTRATION FORM -- INSTITUTE FOR MOLECULAR MEDICINE (non-profit) INTERNATIONAL MOLECULAR DIAGNOSTICS, Inc. (for insurance reimbursement) Name: _____________________________________________________ Address: __________________________________________________ __________________________________________________ State ___________ Postal Code ____________ Country ______________ Age: ________ Date of Birth: _____________ Tel: ___________________ Sex:MALE ________ FEMALE _________ Gulf War Veteran? Yes ______ Do you have Persian Gulf War Illness (Gulf War Syndrome)? Yes ______ Are you a relative of a Gulf War Veteran? Yes ______ If YES, what is your relationship ____________________________ Do you have CFIDS? _________ Fibromyalgia? ________ Arthritis? ________ 1. General Mycoplasma Screen Test (MANDATORY) (US$150) The Above Test is Required; in Addition, the Following Tests Can Be Ordered: 2. Individual Species Tests (OPTIONAL) (US$150 Each One) (Each One Ordered Separately) M. fermentans___, M. penetrans ___, M. pneumoniae ___, M. hominis ___, M. genitalium ___ 3. PCR Panel (OPTIONAL) (4 Mycoplasma Species Tested for US$250) _____ By Filling out this form and providing a tax-deductible donation to the Institute for Molecular Medicine you will be joining the ŒFriends of the Institute¹ program and supporting the research that has made treatment of some of the most serious chronic diseases possible. Results will be available by mail in approx. four weeks after receipt of blood. ********************************************************** INFORMED CONSENT FORM FOR SENDING BLOOD FOR TESTING, IF YOU AGREE TO HAVE YOUR BLOOD USED IN CLINICAL STUDIES PROTOCOL TITLE: Chronic infections and Chronic Fatigue Syndrome/Fibromyalgia/Arthritis/ Gulf War Illness _________________________________________________________ Participant's Name Address You have the right to know about the procedures that are to be used in your participation in clinical research so as to afford you an opportunity to make the decision whether or not to undergo the procedure after knowing the risks and hazards involved. This disclosure is not meant to frighten or alarm you; it is simply an effort to make you better informed so that you may give or withhold your consent to participate in clinical research. DESCRIPTION OF RESEARCH 1. Purpose of the Study: The blood sample may be used as part of a research study to determine the presence of mycoplasmal infections in patients with Gulf War Syndrome, Chronic Fatigue Syndrome, Fibromyalgia Syndrome, Rheumatoid Arthritis or other autoimmune disorders. 2. Description of Research: In addition to the standard blood samples drawn for routine blood analysis, an additional 10 cc of blood will be collected and analyzed for the presence of mycoplasmal infections. There will be costs related to the tests or procedures that will be carried out at this institution. Completion of an Illness Survey Form is required for this study. 3. Risks, Side Effects and Discomforts to Participants: No ill-effects are expected from the drawing of 20 cc of blood. Although infrequent, the drawing of blood can be associated with some side effects, such as local bleeding, phlebitis or other adverse reactions. 4. Potential Benefits: The potential ability to detect mycoplasmal infections could eventually improve the ability to treat the disease. 5. Alternate Procedures or Treatments: There are no good alternative laboratory tests available for certain mycoplasmas. UNDERSTANDING OF PARTICIPANTS 6. I have been given an opportunity to ask any questions concerning the procedure involved and the investigator has been willing to reply to my inquiries. This procedure will be executed under the above titled and described clinical research protocol at this institution. 7. I understand that my participation in this study is voluntary and that I may discontinue my participation at any time. Such actions will be without prejudice, and there shall be no loss of benefits to which I might be otherwise entitled, and I will continue to receive treatment by my physician. the investigator may discontinue the clinical research study if, in the sole 8. In addition, I understand that the investigator may discontinue the study if in his sole opinion and discretion, the study or treatments offers me little or no future benefit or the supply of reagents ceases to be available or other causes prevent continuation of the study. The investigator will notify me should such circumstances arise, and my physician will advise me about available treatments that may be of benefit at that time. 9. I will be informed of any new findings developed during the course of this clinical research study that may relate to my willingness to continue participation. Should I decide not to participate or withdraw my consent from participation, I have been advised that I should discuss the consequences or effects of my decision with my physician. 10. I have been assured that confidentiality will be preserved. I understand that representatives from The Institute for Molecular Medicine may inspect the records of this research where appropriate and necessary. My name will not be revealed in any reports or publications resulting from this study, without my expressed consent. 11. I will not receive any compensation for my participation in this research study; however, I understand that this is not a waiver or release of my legal rights. 12. It is possible that this research project will result in the development of beneficial treatments, new drugs, or possible patentable procedures, in which event I understand that I cannot expect to receive any compensation or benefits from the subsequent use of information acquired and developed through participation in this research project. 13. I understand that there is a possibility that the blood samples which are being provided under this study may also be used in other research studies. I voluntarily and freely donate blood samples to The Institute for Molecular Medicine or International Molecular Diagnostics, Inc.for research purposes. 14. I may discuss questions or problems during or after this study with Dr. Garth L. Nicolson or other designated investigator or associate at (714) 903-2900. In addition. PATIENT CONSENT Based upon the above, I consent to undergo the described procedure and have received a copy of the consent form. FULL NAME _____________________________________________ DATE SIGNATURE _______________________________________ SIGNATURE OF INVESTIGATOR/ASSOCIATE _________________ ++++++++++++++++++++++++++++++++++++++++++++++++++++++ INFORMATION FOR SHIPMENT OF BLOOD SAMPLES: 1. Blood (10 cc total) should be collected in blue-top tubes (for overnight shipment with wet ice) or PLASTIC purple-top containers (EDTA tubes) (for shipment frozen in dry ice) and immediately cooled on ice and then sent cold on wet ice (blue-top tubes) OR directly quick frozen (DRY ICE) and sent on DRY ICE (plastic purple-top tubes only). Each tube should be labeled with the PATIENT¹S FULL NAME, DATE, DATE OF BIRTH. NOTE: Patients should be off all antibiotics for 4 weeks prior to testing. 2. The blood tubes should be sealed in a plastic bag and placed in an insulated container or ice box containing wet or dry ice (THE SAMPLE MUST BE MAINTAINED AS A COLD OR FROZEN SAMPLE DURING SHIPMENT) 3. The blood tubes should be shipped by air courier (NEXT DAY DELIVERY--DO NOT SEND LATER IN THE WEEK THAN WEDNESDAY) (PLEASE MAKE SURE IT WILL ARRIVE BETWEEN MONDAY AND THURSDAY) to the following address: Prof. Garth L. Nicolson The Institute for Molecular Medicine OR International Molecular Diagnostics, Inc. 15162 Triton Lane, Hungtington Beach, CA 92649 Tel: (714) 903-2900 Fax: (714) 379-2082 4. The courier box should contain the patient¹s return address and telephone number on both the outside of the box and on a card placed within a plastic bag (to protect it from water damage). 5. PATIENT DISCLOSURE FORM and ILLNESS SURVEY FORM should be sent separately by mail to the same address. 6. FOREIGN OR OVERSEAS SHIPMENTS: These must be shipped frozen (plastic purple-top tubes) on DRY ICE. These should also contain on the shipping box the following information: "MEDICAL EMERGENCY" "PERISHABLE BLOOD SAMPLES" "PLEASE EXPEDITE" "Have (or have not) been tested for HIV and Hepatitis B Antigens" "CONTAINS DRY ICE" +++++++++++++++++++++++++++++++++++++++++++++++++++ DECLARATION & DISCLAIMER ========== CTRL is a discussion and informational exchange list. Proselyzting propagandic screeds are not allowed. Substance—not soapboxing! These are sordid matters and 'conspiracy theory', with its many half-truths, misdirections and outright frauds is used politically by different groups with major and minor effects spread throughout the spectrum of time and thought. That being said, CTRL gives no endorsement to the validity of posts, and always suggests to readers; be wary of what you read. CTRL gives no credeence to Holocaust denial and nazi's need not apply. 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