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Appendix G

Treatments That Have Been Claimed to Be of Benefit in MS 1

Diet

Allergen-Free Diet. Regular use of a diet from which foods are eliminated that are known to produce hives, other skin eruptions, asthmatic attacks, and so on. There is no relationship of MS to external allergens demonstrated. The diet has not been shown to be effective and has dropped out of favor.

Kousmine Diet. A low-fat, low-concentrated sugar, high-fiber diet, supplemented by vitamins A, D, E, C, and B complex. There is no scientific evidence that this particular dietary method is effective in treating MS.

Gluten-Free Diet. A balanced diet excluding wheat and rye. This diet must be considered ineffective in MS.

Raw Food, Evers Diet. A diet containing only natural (unprocessed) foods, including a daily intake of germinated wheat. It appears that this diet should be considered ineffective in MS.

MacDougal Diet. This diet combines a low-fat diet with a gluten-free diet and adds supplements of vitamins and minerals. There is no scientific evidence that this diet is effective in MS.


1 This list is based on evaluations made by the Therapeutic Claims Committee of the International Federation of MS Societies. SOURCE: Murray TJ. In Press. Alternative therapies used by MS patients. Polman CH, Thompson AJ, Murray TJ, McDonald WI, eds. Multiple Sclerosis: The Guide to Treatment and Management. New York: Demos Publications.


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Page 405 Appendix G Treatments That Have Been Claimed to Be of Benefit in MS 1 Diet Allergen-Free Diet. Regular use of a diet from which foods are eliminated that are known to produce hives, other skin eruptions, asthmatic attacks, and so on. There is no relationship of MS to external allergens demonstrated. The diet has not been shown to be effective and has dropped out of favor. Kousmine Diet. A low-fat, low-concentrated sugar, high-fiber diet, supplemented by vitamins A, D, E, C, and B complex. There is no scientific evidence that this particular dietary method is effective in treating MS. Gluten-Free Diet. A balanced diet excluding wheat and rye. This diet must be considered ineffective in MS. Raw Food, Evers Diet. A diet containing only natural (unprocessed) foods, including a daily intake of germinated wheat. It appears that this diet should be considered ineffective in MS. MacDougal Diet. This diet combines a low-fat diet with a gluten-free diet and adds supplements of vitamins and minerals. There is no scientific evidence that this diet is effective in MS. 1 This list is based on evaluations made by the Therapeutic Claims Committee of the International Federation of MS Societies. SOURCE: Murray TJ. In Press. Alternative therapies used by MS patients. Polman CH, Thompson AJ, Murray TJ, McDonald WI, eds. Multiple Sclerosis: The Guide to Treatment and Management. New York: Demos Publications.

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Page 406 Pectin-and Fructose-Restricted Diet. A diet from which unripe fruits, fruit juices, and pectin-containing fruits and vegetables are eliminated, supplemented with menadione (vitamin K3). The methanol hypothesis and the dietary regimen based on it remain unproven. Cambridge and Other Liquid Diets. A balanced, very low-calorie liquid, used in the treatment of obesity. Calorie intake is 330/day with a suboptimal level of protein at 22 g/day. Extra potassium is supplied. This diet is not recommended for the treatment of MS. Sucrose-and Tobacco-Free Diet. Elimination of all food products containing sucrose in the form of cane, brown, or maple sugars, molasses, sorghum, or dates; also products containing propylene glycol or glycol stearate. Tobacco is not to be used in any form. This therapy remains unproven. Vitamins. Individual vitamins or combinations of vitamins are taken in capsule or liquid form as a supplement to a normal diet. Adequate intake of vitamins is advised in all patients with MS, but there appears to be no scientific proof that supplementary doses of vitamins, alone or in combination, favorably affect the course of this disease. Megavitamin Therapy. Massive doses of vitamins. There appears to be no reliable evidence that megavitamin therapy influences the course of MS. Megascorbic Therapy. Massive doses of vitamin C (ascorbic acid), referred to as an orthomolecular treatment. The value of megascorbic therapy in MS is unproven and this treatment is not recommended. Minerals. Addition of various mineral salts to diet. There appears to be no clear evidence that any of these regimens should be considered effective in MS. Cerebrosides. Dietary supplementation with fatty acids of cerebrosides from beef spinal cord. On the basis of published evidence, this treatment is considered ineffective in MS. Aloe Vera. Juice of the aloe vera plant, available over-the-counter, taken by mouth on a regular basis. Aloe vera is not recommended for use in MS. Enzymes. A diet similar to the Evers diet, supplemented with plant and bacterial enzymes, normal digestive enzymes, vitamins, and minerals, lipolytic enzymes, and others. Enzyme supplementation is not recommended. Oral Administration St. John's Wort. This plant has been used for hundreds of years and has recently been popularized as a treatment for many conditions. The active ingredi-

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Page 407ent is hypericum. St. John's Wort can be helpful in mild depression. If depression is severe or protracted, standard antidepressants should be used. In the opinion of the committee, St. John's Wort is not a treatment for MS, but might be beneficial in patients who have mild depression or mood change. Oral Calcium + Magnesium + Vitamin D. Inexpensive chemicals available commercially, taken by mouth. The efficacy of this treatment is yet to be determined. Hyperimmune Colostrum (Immune Milk). Pregnant cows are inoculated with measles vaccine or other viruses considered to be related to MS. Colostrum (early milk) is frozen for preservation and taken by mouth. This treatment remains unproven and is not recommended. A clinical trial of adequate size would be required to determine whether it has any value. Metabolic Therapy. A complex program of regimens and medications said to affect mineral balance, diet, and bowel function, e.g., alkalinity of the small intestine; also immune colostrum and high doses of vitamin C, SOD, vitamin A, ”thymotropic“ tablets to stimulate the immune system, octacosanol, B complex vitamins. This is an unproven, expensive, and possibly dangerous procedure with no known scientific basis. Promazine Hydrochloride (Sparine). A phenothiazine drug. The value of phenothiazine and related drugs in aborting MS exacerbations is unsubstantiated. Le Gac Therapy. Treatment with broad-spectrum antibiotics combined with hot baths. This treatment is not recommended. Nystatin. An antifungal agent usually employed with a yeast-free, low carbohydrate diet. Use of nystatin is not recommended. Injected Materials and Oral Administration Calcium Orotate, Calcium Aminoethyl Phosphate. Calcium orotate and calcium animoethyl phosphate (AEP) are calcium salts of synthetic organic compounds, given intravenously and by mouth. In the absence of a properly designed clinical study, the claim of favorable effect remains undocumented. Sodium Bicarbonate, Phosphates. Simple chemicals, given intravenously (sodium bicarbonate) or by mouth (phosphates). These substances are not recommended as treatments. The Committee believes there appears to be no generally accepted scientific basis for use of this therapy; it has never been tested in a properly controlled trial. Risks are undetermined.

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Page 408 Injected Materials Intravenous yeasts (proper-myl). A preparation of cells from three species of yeast. Administered intravenously, proper-myl appears to be ineffective in the treatment of MS. Pancreatic Extract (Deporpanex). A preparation derived from beef pancreas, given intramuscularly. The exact composition is not known, but it does not contain protein. Due to limited data, this treatment cannot be considered effective in MS. The Committee believes this therapy has been adequately tested and shown to be without value. Risks are undetermined. Heart and Pancreas Extract (Pancorphen). A weak protein solution prepared by digesting beef heart with hog pancreas. It was used as a culture medium for growing bacteria. Pancorphen appears unacceptable as a treatment for MS as there is no evidence of benefit and evidence of side effects and an adverse effect on MS symptoms. The Committee believes that this therapy should not be used. Snake Venom (PROven, Venogen, Horvi MS9). Proven is a processed mixture of cobra, krait, and water moccasin venoms for subcutaneous injection. It has had spectrographic analysis. Although its exact composition is not established, it appears to contain many proteins and some of the numerous enzymatic activities of the original venoms used in the mixture. This therapy is not recommended because of lack of evidence of benefit and because of the side effects and danger of allergic reaction. Honey Bee Venom. Extracts of the bee venom. There are no objective controlled studies. Based on the evidence, this treatment is not recommended. The Committee feels that there is no generally accepted scientific basis for use of this therapy because it never has been tested in a properly controlled trial, and its use carries significant risk. Octacosanol. A simple long-chain alcohol. The Committee believes that there is no generally accepted scientific basis for use of this therapy and that the risks are undetermined. Superoxide Dismutase (Orgotein, Orgosein, Palosein). Superoxide dismutase (SOD) is a metalloprotein enzyme that combines with and ”neutralizes“ free radicals of oxygen (superoxides) appearing as a normal toxic byproduct of cellular metabolism. It is available in health food stores as an extract of liver in tablet form and is used in veterinary practice as an anti-inflammatory agent (by injection). The Committee believes there appears to be no generally accepted scientific basis for the use of this therapy.

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Page 409 Procaine Hydrochloride. Procaine is a simple chemical with anesthetic properties. KH3 is the proprietary name for a procaine compound in capsule form available by prescription in limited areas of the U.S. and in Europe. It is said to improve physical and mental efficiency and to improve the depression of old age. The Committee believes that there is no generally accepted scientific basis for use of this therapy since it has never been tested in a properly controlled trial and its use carries significant risk. Dimethyl Sulfoxide. Dimethyl sulfoxide (DMSO) is a potent solvent for chemicals and has been widely used in industry as a degreaser. The Committee believes that there appears to be no generally accepted scientific basis for use of this therapy. It has never been tested in a properly controlled trial and there are risks of serious side effects. Alphasal (formerly Cholorazone or Vitamin X). A product of electrolysis of a saline solution. If used immediately, contains ozone. Taken orally or by injection. According to the Committee, no scientifically acceptable evidence exists for the usefulness of alphasal in MS. Cellular Therapy. Injection of ground-up brain or other tissues freshly prepared from unborn calves, lambs, or pigs. The little published information suggests that this treatment should be considered ineffective in MS and potentially dangerous. Allergens. Repeated injections of food or other allergens, used in desensitization for asthma and hay fever. The Committee feels that this treatment should be considered ineffective in MS. Rodilemid. A mixture of chelating (metal-binding) agents, developed in Rumania. It includes L-cysteine, the calcium sodium salt of ethylenediamine tetraacetic acid (EDTA), and calcium gluconate. It is taken as a series of six daily intramuscular injections at intervals of one to four months. Rodilemid is unproven as a therapy for MS. Autogenous Vaccine. Vaccine prepared from bacteria growing in or on the patient's own body. Bacterial products may be IFN inducers, including IFN-gamma. Because of this and lack of controlled studies, this treatment should not be used. Proneut. A combination of measles vaccine, influenza vaccine, and histamine phosphate, the dose being individually determined for each patient. There appears to be no convincing evidence at present that this treatment is effective in MS. Alpha-Fetoprotein (a-Fetoprotein). Alpha-fetoprotein (AFP) is a protein produced by the liver of the fetus in the womb to protect it against the

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Page 410mother's immune system. It has been purified and used experimentally. No recommended use at present Immunoglobulins (Gamma Globulin, Immunoglobulin G, IgG). Immunoglobulins are the antibody-containing fraction of human plasma. They are usually injected intramuscularly, but certain special preparations can be given intravenously. The evidence is conflicting as to whether intravenous IgG reduces the frequency of exacerbations in MS. Studies confirming that intravenous IgG might promote remyelination in humans have not been completed. Immunobiological Revitalization. Purified rabbit antibodies against human bone marrow, spleen, and thymus, supplemented by an unidentified ”human placental product.“ This treatment is not recommended. Proteolytic Enzymes. A mixture of digestive enzymes (pancreatin, chymotrypsin, and several others), given intravenously in repeated dosage. Inadequate published information exists to permit informed judgement about this therapy. Chelation Therapy with Ethylenediamine Tetraacetic Acid (EDTA). A simple chemical that chelates metals very efficiently and is used in cases of lead poisoning to remove lead from the body. Must be injected intravenously over several hours. Chelation therapy for MS is not based on acceptable published evidence and is dangerous. Physical and Surgical Manipulations Acupuncture, Acupressure, Qigong. These procedures are part of traditional Chinese medicine (TCM). Acupuncture, a 4,000 year old Chinese procedure, is performed by inserting fine needles into specific skin sites with the expectation of influencing the function of underlying organs. The belief is that body energy flows in channels that connect to organs, and an imbalance can be restored by the acupuncture needles inserted into 365 points. Qigong is an approach to restore balance by deep breathing, concentration and relaxation exercises. This treatment is considered to have no effect on the disease process in MS and has not been shown to have any value in the symptomatic management of patients with disease. Dorsal Column Stimulation. The dorsal columns of the spinal cord are large bundles of nerve fibers that carry the sense of touch and the sense of position from the legs, trunk, and arms up to the brain. The spinal cord is protected by a connective tissue wrapping known as dura. Electrical stimulation of the dorsal columns requires implantation of two electrodes on the overlying dura, which is done by passing the electrodes

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Page 411through a special needle. The electrodes are connected with an implanted stimulator or radio receiver. This procedure is ineffective and dangerous. The costs and risks are high. It is not recommended for use in patients with MS. Hyperbaric Oxygen. Breathing oxygen under increased pressure in a specially constructed chamber. Large-scale, double-blind controlled studies have proven that HBO is ineffective as a treatment for MS. Transcutaneous Nerve Stimulation. Transcutaneous nerve stimulation (TNS) is a procedure in which electrodes are placed on the surface of the skin over certain nerves and electrical stimulation is carried out. The dose, varied by changing frequency, pulse width, and intensity, determines which nerve fibers are activated. TNS is a moderately effective treatment for pain, but there is no evidence that it alters the underlying disease in MS. Thalamotomy, Thalamic Stimulation. Destruction of part of the thalamus by surgical means. More recently, electrical stimulation of the thalamus by surgically implanted electrodes has been reported to have a similar effect. Thalamotomy and thalamic stimulation are not recommended for MS except in a small number of carefully selected MS patients. Sympathectomy and Ganglionectomy. Sympathetic nerves and ganglions supplying blood vessels to the head are surgically removed in an effort to increase blood supply to the CNS. There is no convincing evidence that this surgical procedure is effective in treating MS. Surgical Spinal Cord Relaxation. Surgical procedure to fix the cervical spine to restrict forward bending. This therapy is without value in MS. Vertebral Artery Surgery. An operation devised to eliminate kinking or narrowing of the vertebral arteries in the neck. The existing evidence does not support the conclusion that these procedures may be effective in the treatment of MS. Ultrasound. Repeated application of ultrasound, i.e., high-frequency sound, to the area of the back next to the spinal column (backbone). The evidence suggests that this treatment if unlikely to be effective in MS. The high price clearly reflects commercial exploitation. Magnetotherapy. Repeated application of a low-frequency pulsing magnetic field. This treatment is not yet proven. Further controlled studies are underway. Dental Occlusal Therapy. Correction of dental malocclusion with occlusal splints and other procedures, attention to other dental needs, and physi-

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Page 412cal therapy to muscles and structures of the temporomandibular joints. There is neither a scientific basis nor acceptable medical evidence that dental occulusion therapy could favorably influence the MS disease process. Replacement of Mercury Amalgam Fillings. Removal and replacement of all fillings made of silver and mercury amalgam. There is no evidence to suggest that this procedure is of value to MS. Implantation of Brain Substances. Surgical implantation of pig brain in the abdominal wall. The evidence examined demonstrates that this treatment should be regarded as ineffective and dangerous. Hysterectomy. Surgical removal of the uterus. This procedure is not recommended for MS.