Many patients already take herbal supplement available over counter

When it comes to her health, Janice Winfield of Portland, Ore., does her research. That's why the stay-at-home mom, who was diagnosed with multiple sclerosis in July 2000, was willing to turn to popular, over-the-counter herbal supplements like ginkgo biloba to deal with memory problems, fatigue and occasional muscle pain. "I'm definitely interested in alternative medicine," said Winfield, 49, whose form of the neurological disease – relapsing-remitting MS – is characterised by frequent symptom flare-ups. Ginkgo "is not only given to someone like me with MS. There's benefit to anyone taking it."

Findings by scientists in the Oregon Health & Science University School of Medicine's Department of Neurology and the OHSU MS Center of Oregon appear to back up that claim. A study presented this month at the American Academy of Neurology's 57th Annual Meeting in Miami Beach, Fla., suggests that ginkgo may be effective in improving attention in MS patients with cognitive impairment. Side effects also were minimal.

The study's lead author, Jesus Lovera, M.D., a research fellow and instructor in neurology, OHSU School of Medicine, said those receiving ginkgo "performed better on a test that measures a person's ability to pay attention and to sort conflicting information." Of 39 patients completing the study, 20 received ginkgo biloba and 19 received placebo.

Researchers found there were no differences in results between the two groups in the areas of gender, education, type of MS, years since onset, or baseline performance on a battery of neuropsychological tests. But the ginkgo group was four seconds – about 13 percent – faster than the placebo group on a timed colour and word test that measures attention and such "executive functions" as planning, decision making, and controlling goal-directed behaviour and execution of deliberate actions. During the test, called a "Stroop," patients are shown coloured boxes and asked to name the colours. They are then shown the names of colours printed with different-coloured inks, such as the word "green" printed in red, and asked to read the word. Finally, patients are asked to describe the ink used for each word. Lovera said the differences in the Stroop result would be comparable to differences in scores between healthy people ages 30 to 39 and those ages 50 to 59.

Ginkgo appeared to be more beneficial for MS patients having specific problems in the Stroop, so "we would like to do another study in which we choose patients that are impaired in this particular test," Lovera said. "We would also like to test it at higher doses."

Ginko biloba is among several complementary and alternative medicine therapies being investigated by OHSU's Department of Neurology for their effects on symptoms of neurological disease. Studies have ranged from clinical trials of lactoferrin for treating Alzheimer's disease to the use of yoga as a therapy for MS fatigue.

Ginkgo is derived from the leaves of the ginkgo tree, one of the oldest species of trees, and has been used for thousands of years by the Chinese as an herbal remedy for a variety of ailments. It contains potent antioxidants called flavoglycosides that have been shown to have neuroprotective effects in animal models of spinal cord injury. It also has terpene-lactones that block a substance known as platelet activitating factor, which is important in regulating blood vessel function as well as the mediating inflammation and the sticking of inflammatory cells to blood vessels.

Many MS patients have long suspected that ginkgo improves disease symptoms. In a recent survey of 1,913 patients in Oregon, 20 percent reported using the supplement and 39 percent found it to be beneficial. However, until now, there was no evidence the supplement had any effect on memory. "It has been shown to be of benefit in Alzheimer's, but we did not know if it would work for MS," Lovera said. "We wanted to see if there was any suggestion that it could help patients with MS that are having cognitive problems."

Lovera said the study results demonstrate that ginkgo shouldn't be discounted for treating MS, but its safety and efficacy must be tested in much larger clinical trials before doctors should recommend it to their patients.

 "The study suggests that for cognitive problems, it may only help a certain group of patients," he said. "We need to study this further." And for MS sufferers like Winfield, who participated in the ginkgo study, the herbal supplement will remain one of the many weapons in her arsenal for fighting the disease. "I would do it again," she said of taking ginkgo. "It could have a benefit for me that I didn't have before." But she emphasises that "every MS is different, so what might work for me may not work for anybody else. But when it comes to alternative medicine, I'm all for that."

MS patients who take supplements of long chain polyunsaturated fatty acids have fewer attacks and slower progression, American neurologists have found.

Dr Weinstock-Guttman and colleagues ⁽¹⁾ set out to study the effects of adding a low-fat diet supplemented with long chain polyunsaturated fatty acids (PUFA) to either beta interferon or glatiramer acetate.

They chose this fatty-acid supplement because of prior laboratory evidence showing that PUFA can modulate the function of immune cells in ways that may be beneficial in autoimmune conditions such as MS ⁽²⁾ .

The PUFA they used was Omega 3, found in fish oils. Patients with RRMS taking either interferon-beta or glatiramer acetate were randomly assigned to either a diet including PUFA or a standard low-fat diet, as a control.

Of 32 patients enrolled, 29 were assessed with an average follow up of about 10 months. Compared to the patients only on the low-fat diet, those patients receiving PUFA supplementation were reported to have fewer attacks and possibly less worsening of disability.

This work extends prior studies that also suggested a role for PUFA in decreasing inflammation in MS. Marracci and colleagues studied which parts of fatty acid molecules may be most important in mediating their anti-inflammatory effects ^(3).

They used an animal model of MS, EAE, and found that manipulating the structure of the fatty acids resulted in compounds that had different abilities to suppress EAE. These results further support the potential role of using fatty acid derivatives as a therapeutic approach in MS and provide useful structural information that may enable the design of more effective derivatives.

References

1. Weinstock-Guttman B, Baier M, Feichter J, Gallagher E, Vekatraman J, Meksawan K, Youngmin P, Rudick R. A Randomized Study of Low Fat Diet with omega-3 Fatty Acid Supplementation in Patients with RelapsingRemitting Multiple Sclerosis, Abstract [P02.139], AAN Annual meeting, 2003.
2. Simopoulos AP Omega-3 fatty acids in inflammation and autoimmune diseases. Journal of the American College of Nutrition, 21(6):495-505,-2002.
3. Marracci G, McKeon GP, Marquardt WE, Jones RE, Bourdette DN. Structural Requirements for Therapeutic and Immunologic Effects of A-Lipoic Acid in an Animal Model of Multiple Sclerosis. Abstract [P03.100], AAN Annual meeting, 2003.

Tolpa (named after the Polish professor who developed and pioneered the use of peat as a medicine) has been shown to enhance and balance the immune system, making it ideal for autoimmune diseases.

A one-year double blind trial started in September 2002 in Wroclaw, Poland, to evaluate the benefits of Tolpa Peat Preparation for MS. The trial, lead by Professor Ryszard Szechiski, neurologist, and Professor Podemski, is for relapsing/remitting MS, with 90-120 patients aged 16-60 years. One third of the patients will be given 5mg Tolpa per day (one tablet), one third 10mg (two tablets), and one third a placebo. Results should be made public after September 2003.

Studies have also been carried out on Tolpa for adult periodontal disease. Although the researchers carried out sub-gingival scaling, curettage and bite adjustment where necessary on all patients, recovery was markedly improved with Tolpa tablets (oral administration) and 'tampons' soaked in a solution of Tolpa and water, applied locally. Since the solution w2 only 2% Tolpa, the researchers concluded that application of Tolpa Chamosaldont Gel would be even more effective.

Some herbal supplements are likely to be banned, and some vitamins and minerals will only be available in smaller doses.

The Food Supplements Directive has already been finalised in Europe and is due to be introduced into UK law in the next few months. Pressure group Consumers for Health Choice , who have more than 250,000 supporters, are concerned about the effects these directives will have on consumer choice.

Although the Directive is couched as a consumer safety and free trade measure, it is designed to standardise regulation on food supplements across the 15 EU Member states. However, it will have a disproportionate effect on the UK and Netherlands, as millions of consumers in these countries, who have been using higher – yet perfectly safe - dose vitamins and minerals for several decades, will find they can no longer obtain their products.

Key points:

• Maximum permitted levels for nutrient content will be set. Levels are likely to be well below the scientifically assessed 'upper safe level'.

• The Directive contains a list of permitted nutrients and nutrient sources. Unless a nutrient is on the list it cannot be used. There are currently over 300 safe and popular nutrients that have been on sale for up to 50 years in the UK that are not on the list. Nutrients will only be added to the list if extensive and expensive safety dossiers are submitted. Many supplements will be lost due to these restrictions.

Traditional Herbal Medicinal Products Directive

The draft Directive recommends that herbal remedies be licensed as medicines without having to prove their efficacy.

 However, to be licensed they must show that they are safe, produced to high standards and that the product (not the ingredients) has been on the market for 30 years (15 of which must be in Europe). The likely impact of this is:

• Any product introduced since 1972 would not be included.
• Future product innovation would be prevented.
• Herbal products will be classed and licensed in the same way as pharmaceutical drugs. So eg a garlic-based product would have to go through the same regulatory procedure as a vaccine or prescription drug.
• The Directive has not provided for combination products containing currently legal ingredients that are a mixture of herbs with vitamins - so they will be banned.

Examples of Affected Supplements:

• Herb and nutrient mixtures such as Echinacea with Vitamin C or Vitamin B6 with Evening Primrose Oil would be illegal under EU law.
• Doses of B Vitamins. Likely to be dosage restrictions.
• Multi-vitamin/mineral tablets: Dosage restrictions.
• Antioxidants: Dosage restrictions.
• Vitamin D – Dosage restrictions.

Effects on Consumers:

• Will have to pay more to get dosage needed.
• Will have to take more pills to get dosage needed.
• If they cannot get supplements in UK, will have to buy in US or via Internet, or not take those supplements at all.
• Choice of products will be limited to those coming from big companies as only they can afford the additional testing - small companies may not survive.