Be Wary of Multiple Sclerosis "Cures"

Stephen Barrett, M.D.

Multiple sclerosis (MS) is a degenerative disease in which patches of inflammation and scarring interfere with the function of the brain, spinal cord, and/or the nerves to the eyes. The cause of MS is unknown, but the most attractive theory is that it is an immune reaction to the nervous system. Its symptoms include muscular weakness, loss of coordination, and difficulty with speech and vision. It occurs chiefly in young adults and, like arthritis, can have a very variable course. Some people have only a single attack. Others have only a few attacks in a lifetime, recover from these, and experience no disability except during attacks. Others have frequent attacks from which they don't recover completely, but which cause only partial disability. Still others have a slow progression of disability over a period of 10 to 25 years, which eventually leaves them helpless. When attacks occur, symptoms may come and go suddenly and may even vary from hour to hour.

MS's extreme variability makes it a perfect disease for quacks. The only way to know whether a treatment is effective is to follow many patients for years to see whether those who receive the treatment do better than those who do not. Quacks don't bother with this kind of testing, however. They simply claim credit whenever anyone who consults them improves. And since the majority of attacks are followed by complete or partial recovery, persuasive quacks can acquire patients who swear by whatever they recommend.

The Therapeutic Claims Committee of the International Federation of Multiple Sclerosis Societies has analyzed more than a hundred alleged treatments and published the results in a book called Therapeutic Claims in Multiple Sclerosis, which is revised every few years [1]. Each analysis includes a description of the method, the proponents' rationale, a scientific evaluation, estimate of risks and/or costs, and the authors' conclusion. The methods are then classified according to plausibility, extent of study, risk, and cost.

No cure is known, but a few methods are useful in shortening the duration of attacks, reducing their severity, or helping to deal with the symptoms. Methods that have a plausible rational but have not been sufficiently tested are considered "investigational." I am not listing the useful or investigational methods because I believe that advice about them should be obtained from a qualified neurologist who can thoroughly discuss them. Reliable information is also available from the National Multiple Sclerosis Society.

The committee noted that no nutritional deficiency is known to be a factor in MS, and that no special diet or the addition of vitamins or minerals has been proven to alter its course. Polyunsaturated fatty acids (PUFA) have slight immunosuppressive properties, but studies involving sunflower seed oil, evening primrose oil, safflower seed oil, and fish oils, have produced conflicting results. The committee concluded that other than a possible benefit of PUFA-containing oils, there is no evidence that any dietary change affects MS.

Methods to Avoid

The methods considered implausible or ineffective are listed below. I believe these methods should be avoided:

Adequately tested but ineffective in influencing the course of MS
Aspirin and sodium salicylate; colchicine (for immune modulation); thymectomy (removal of the thymus gland); transfer factor; myelin basic protein; hyperbaric oxygen (HBO).

Implausible and untested or inadequately tested
Various nonsteroidal antiinflammatory drugs (NSAIDs); thyrotropin-releasing hormone; cannabis (marijuana); Diltiazam; Nifedipine; Verapamil; intravenous yeasts (Proper-myl); pancreatic extract (epropanex); honey bee venom (safety is uncertain); octacosanol; superoxide dismutase (SOD); procaine hydrochloride; dimethyl sulfoxide (DMSO); Alphasal (formerly Chlororazone or Vitamin X); allergens; Rodilemid; alpha-fetoprotein; Proneut; immunobiological revitalization; proteolytic enzymes; injections of calcium orotate or calcium aminoethyl phosphate; oral calcium + magnesium +vitamin D; sodium bicarbonate or phosphate; hyperimmune colostrum ("immune milk"); Nystatin; transcutaneous nerve stimulation (TNS); ultrasound treatment applied near the spinal column; magnet therapy; dental approaches such as correction of bad bite, TMJ treatments, or removal of mercury-amalgam fillings; hysterectomy; low-fat diet; allergen-free diet; Kousmine diet; gluten-free diet; raw food diet (Evers diet); MacDougal diet; pectin- and fructose-restricted diet; sucrose- and tobacco-free diet; vitamin regimens; mineral supplements; cerebrosides; aloe vera juice; and various enzymes (Wobenzym, digestive enzymes, Vitafestal, Bilicomb, Panpur, Panzynorm).

Implausible and known to have significant risk or side effects
ACTH or other corticosteroids administered into the spinal canal; chloroquine; x-ray treatment; immunosuppression with chlorambusil (Leukoran), Lumustine, or 5-Fluorouracil; immune modulation with thymus hormones (Thymosin, Thymuline/Facteur Thymique Scrique, Thymopoetin 5, TFX-Polfa, THX, T-Activin); myelin basic protein; Interferon gamma; interferon inducers (Tilorone, Poly-ICLC, Staphage Lysate); Progabide (for spasticity); heart and pancreas extract (Pancorphen); snake venom (PROven, Venagen, Horvi MS9); cellular therapy; autogenous vaccines; chelation therapy; "metabolic therapy"; promazine hydrochloride (Sparine); Le Gac Therapy (antibiotics plus hot tubs); acupuncture; electrical stimulation of the dorsal column of the spinal cord; hyperbaric oxygen (HBO); sympathectomy; ganglionectomy; surgical spinal cord relaxation (cervicolordodesis); vertebral artery surgery; surgical implantation of pig brain tissue; Cambridge or other very-low-calorie liquid diets; high-dosage or vitamin C, and various other high-dosage vitamin or mineral regimens.

Superesonant Wavenergy (SRWE) Program

In the 1980s, Irving Dardik, M.D., a vascular surgeon, devised an exercise program which he claimed would to optimize the body's health patterns and lead to reversal of such disorders as multiple sclerosis. In 1995, New York State medical licensing authorities found him guilty of fraud, exercising undue influence, guaranteeing satisfaction or a cure, and failing to maintain adequate records. Case records indicate that he had charged four MS patients from $30,000 to $100,000 for their treatment. His New York medical license was revoked, he was fined $40,000, and his New Jersey license was subsequently revoked. One of the victimized patients, former TV investigative reporter Ellen Burstein MacFarlane, coauthored a book about her experience [2].

"Amalgam Toxicity" Scam

A few hundred physicians and dentists have been falsely claiming that "mercury toxicity" from amalgam fillings cause multiple sclerosis and that removing them may cure it. This claim is false and fraudulent. The mercury is amalgam is tightly bound so that the amount that gets into the body over time is insignificant. Moreover, no scientific study has demonstrated that removing amalgam fillings helps patients with multiple sclerosis or any other ailment. I believe that practitioners who recommend amalgam replacement as a treatment for multiple sclerosis have extremely poor judgment and should be delicensed [3].

Calcium EAP

Calcium ethylamino-phosphate (calcium EAP) has been promoted as a therapy or cure for MS and many other diseases. These claims are based on anecdotal reports rather than controlled clinical trials. The National Multiple Sclerosis Society has concluded that there is no objective evidence calcium EAP is effective against MS and "because the treatment protocol includes many different agents and may include a powerful drug that suppresses the immune system, the proposed therapy is not without serious risk." [4] The major proponent, a German physician named Hans Nieper, died in 1998, but the substance is still marketed here and abroad.

Coral Calcium

"Coral calcium" is a dietary supplement said to be derived from "remnants of living coral that have fallen from coral reefs, as a result of wave action or other natural processes." Since coral reefs are protected by law, "coral calcium" is made by grinding up limestone that no longer contains live organisms. Their principal promoter, Robert Barefoot, has claimed in widely aired infomercials that he has witnessed people with multiple sclerosis "get out of wheelchairs just by getting on the coral." He doesn't say how he determined that patients with multiple sclerosis were actually helped by coral calcium. There is neither scientific evidence nor any logical reason to believe that they were [5]. The Federal Trade Commission charged Barefoot with false advertising and obtained an injunction against further advertising claims of this type.

Hydrogen Peroxide

Practitioners who advocate this type of therapy argue that diseases develop in people whose bodies lack sufficient oxygen. They claim that hydrogen peroxide is an effective treatment because it increases the cellular oxygen levels, thereby correcting the alleged deficiency. "Oxidative therapy" has also been promoted for the treatment of cancer, asthma, emphysema, AIDS, arthritis, heart disease, and Alzheimer's disease. There is no scientific evidence that lack of cellular oxygen occurs as described by "oxidative therapy" proponents, that swallowing or injecting oxygen-rich substances actually effects cellular oxygen levels, or has any effect on the diseases it is used to treat. The National Multiple Sclerosis Society [6] and the American Cancer Society [7] have both warned that hydrogen peroxide therapy has not been proven safe or effective. The National Multiple Sclerosis Society was made in response to the death of a woman who had received hydrogen peroxide therapy [8].

Hyperbaric Oxygen

Hyperbaric oxygen therapy (HBOT) involves breathing pure oxygen in a specially designed chamber. It is appropriate for deep sea divers who suffer pressure problems (the "bends") after resurfacing). Some clinicians, particularly in the United Kingdom, speculate that some of the nerve damage in MS is caused by lack of oxygen. The most positive reports have not been based on controlled studies, so their data cannot be interpreted. In 2004, after an extensive literature search and analysis, the Cochrane Collaboration published a comprehensive review of the controlled studies—two positive and seven negative. The reviewers concluded:

We found no consistent evidence to confirm a beneficial effect of hyperbaric oxygen therapy for the treatment of multiple sclerosis and do not believe routine use is justified. The small number of analyses suggestive of benefit are isolated, difficult to ascribe with biological plausibility and would need to be confirmed in future well-designed trials. Such trials are not, in our view, justified by this review [9].

Prokarin

Prokarin (also called Procarin) is a skin cream that is administered using a patch that enables its ingredients to be absorbed. The treatment is based on a hypothesis that involves histamine and dates back to the 1940s. The primary promoter is Elaine DeLack, a nurse who "discovered" and patented a mixture of histamine and caffeine. Compounding pharmacists prepare the product, which is inexpensive to manufacture but is sold for about $250 for a month's supply.

In February 2002, the journal Multiple Sclerosis published the results of a 12-week study of MS patients in which 21 people took Prokarin, 5 took a placebo, and all participants were asked to limit their intake of caffeinated beverages to one cup of regular coffee per day. The authors concluded that Prokarin produced a "modest" lessening of fatigue. [10]. The National Multiple Sclerosis Society advised that the study was difficult to interpret because the number of participants was small; the numbers in the Prokarin and placebo groups were very different; the fact that Prokarin contains caffeine might mix up the results; and other reasons [11]. The Society also warned that Prokarin lacks a scientifically plausible rationale and has not been proven to modify the course of the disease [11] and that while Prokarin does not apppear to be harmful, the level of benefit does ot justiy its very high cost [12].

Prokarin proponents are promoting this study as showing that Prokarin "works." But even if it can lessen fatigue, there is no reason to believe it can influence the course of the disease, which is why most people take it. In my opinion, it is a poor investment and any marketing that arouses hope that it will influence the course of MS is both unethical and may be illegal. If you encounter a pharmacist selling Prokarin, ask the state pharmacy board to investigate what claims are being made.

Liberation Therapy

The FDA has warned that "liberation therapy" (also called liberation procdure) is unproven and unsafe. The procedure, in which balloon angioplasty devices or stents are used to widen narrowed veins in the chest and neck, is based on the unproven idea that a narrowing of veins in the neck and chest (chronic cerebrospinal venous insufficiency) may cause MS or contribute its progression by impairing blood drainage from the brain and upper spinal cord. However, studies exploring a link between MS and CCSVI are inconclusive, and the criteria used to diagnose CCSVI have not been adequately established. The FDA warning was generated by reports of death, stroke, detachment and migration of the stents, damage to the treated vein, blood clots, cranial nerve damage and abdominal bleeding associated with the "liberation" procedure [13].

Aetna's List

Aetna has issued a coverage policy bulletin that lists covered and not-covered MS treatments. The non-covered methods include linoleate supplementation to diet, low-fat diets, antilymphocyte globulin, Prokarin, oral myelin (Myloral), cladribine (Leustatin, 2-CDA), PUVA (psoralen ultraviolet light), gamma-interferon, total lymphoid irradiation, gluten-free diets, transforming growth factor-beta (TGF), hyperbaric oxygen, tumor necrosis factor antagonists, and IL-2-toxin [14]. Aetna's list also includes other methods that are undergoing clinical trials and may have some therapeutic potential. The National Multiple Sclerosis Society maintains a list of clinical trials that are planned, in progress, or recently completed [15].

Additional Information

References

  1. Sibley W and others. Therapeutic Claims in Multiple Sclerosis, 4th edition. New York: Demos Vernande, 1996.
  2. MacFarlane EB, Burstein P. Legwork: An Inspiring Journey Through a Chronic Illness. New York: MacMillin, 2000.
  3. Barrett S. The mercury toxicity scam: How anti-amalgamists swindle people. Quackwatch, revised Oct 16, 2002.
  4. Calcium EAP. In Multiple Sclerosis Information Sourcebook. New York: National Multiple Sclerosis Society, 2003.
  5. Barrett S. Be wary of coral calcium and Robert Barefoot. Quackwatch, revised Jan 25, 2004.
  6. Important medical alert: Hydrogen peroxide. National Multiple Sclerosis Society Web site, Sept 2004.
  7. American Cancer Society. Questionable methods of cancer management: Hydrogen peroxide and other "hyperoxygenation" therapies. CA—A Cancer Journal for Clinicians 43:47-55, 1993.
  8. Suit alleges death from IV hydrogen peroxide. Quackwatch, revised Oct 7, 2004.
  9. Bennett M, Heard R. Hyperbaric oxygen therapy for multiple sclerosis. Cochrane Database of Systematic Reviews DOI: 10.1002/14651858.CD003057.pub2, 2012.
  10. Gillson G and others. A double-blind pilot study of the effect of Prokarin on fatigue in multiple sclerosis. Multiple Sclerosis 8:30-35, 2002.
  11. NMSS Research Programs Department. Results of Prokarin to treat MS fatigue. National Multiple Sclerosis Society Research/Clinical Update, Jan 30, 2002.
  12. NMSS National Clinical Adviisory Board. Management of MS-related fatigue. National Multiple Sclerosis Society Expert Opinion Paper, 2006.
  13. FDA issues alert on potential dangers of unproven treatment for multiple sclerosis. FDA news release, May 10, 2012.
  14. Aetna Clinical Policy Bulletin 0264: Multiple sclerosis treatments, Feb 9, 2012.
  15. Clinical Trials In Multiple Sclerosis, Winter 2003 (Planned, In Progress, Recently Completed). New York: National Multiple Sclerosis Society, 2003.

This article was revised on May 15, 2012..