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Supporting Evidence

Top 10 clinical research studies of 2004


Science is working constantly to help us understand the role vitamins, minerals, herbal products, and other natural compounds play in promoting health and healing. Many noteworthy clinical studies with natural products were published in 2004.

1. Echinacea does work if you use an effective product

In 2004, four double-blind studies evaluated echinacea preparations in the treatment of the common cold. In three of these studies, the echinacea products used were shown to be no more effective than placebos. However, one study published in the Journal of Clinical Pharmaceutical Therapy demonstrated quite clearly that echinacea could be of significant value in reducing the severity and duration of a cold. The difference in results from these clinical studies with echinacea is most likely due to a lack of or insufficient quantity of active compounds in the negative studies.

The single most important aspect in getting results from an echinacea product is to make sure that it is guaranteed to provide sufficient levels of all three classes of all three key categories of active compounds in their proper ratio. For example, in the study demonstrating positive results, the commercially available echinacea product contained standardized levels of alkamides, cichoric acid, and polysaccharides at concentrations of 0.25, 2.5, and 25 milligrams per millilitres respectively.

Prepared from freshly harvested Echinacea purpurea plants, the standardized product showed just how impressive results can be when a high quality product is used. In the double-blind study, the echinacea preparation or placebo was given to 282 subjects aged 18 to 65 years with a history of two or more colds in the previous year. Subjects were instructed to start the echinacea or placebo at the onset of the first symptom related to a cold, consuming 10 doses the first day and four doses per day on subsequent days for seven days. The total daily symptom scores were found to be 23.1 percent lower in the echinacea group than in placebo. The researcher concluded that early intervention with this standardized echinacea product results in reduced symptom severity in subjects with upper respiratory tract infection. Cold symptoms in some people cleared up to three times faster than the placebo group.

2. US Government study acknowledges health benefits of omega-3 fatty acids

According to a detailed evaluation of the scientific evidence conducted by scientists at the Tufts-New England Medical Center Evidence-based Practice Center in Boston, the United States Agency for Healthcare Research and Quality concluded that the long-chain omega-3 fatty acids, either from fish consumption or supplementation, significantly reduce the risk of heart attacks and strokes. The review also found other evidence indicating that fish oil supplementation can help lower high blood pressure slightly, reduce risk of coronary artery re-blockage after angioplasty, increase exercise capability among patients with clogged arteries, and reduce the risk of irregular heartbeats–particularly in individuals who’d recently had a heart attack.

3. Omega-3 index emerges as the most significant marker for heart disease

When researchers measured the level of the long-chain omega-3 fatty acids EPA and DHA within red blood cells they found that they had discovered one of the most significant predictors of heart disease. This laboratory value was termed the Omega-3 Index and published in Preventive Medicine in July 2004. An Omega-3 Index of equal to or greater than eight percent was associated with the greatest protection, whereas an index of four percent or lower was associated with the least. The Omega-3 Index was shown to be the most significant predictor of coronary artery disease compared to C-reactive protein; total, LDL, or HDL cholesterol; and homocysteine. Researchers subsequently determined that a total of a combined 1,000 mg of EPA and DHA daily is required to achieve or surpass the Omega-3 Index target of eight percent or more.

4. Black cohosh extract exerts anticancer effects against breast cancer cell

Black cohosh (Cimicifuga racemosa) is without question the most popular natural approach to menopausal symptoms. Its popularity has been increasing in part because of all of the negative press on hormone replacement therapy, or HRT. Specifically, last year the National Institutes of Health halted a major clinical trial designed to help settle the debate over whether HRT benefits postmenopausal women. The results clearly concluded that the risks of taking combined estrogen and progestin outweighed the benefits and considerably increased the risk of stroke, coronary heart disease, and breast cancer.

The mechanism of action for black cohosh is thought to be via control centres in the brain and vascular system rather than through any estrogenic effect. According to detailed review of clinical and pre-clinical data, black cohosh appears to be safe even in women at risk for breast cancer as well as breast cancer survivors. This position was bolstered even further in 2004 as a study in human breast cancer cell lines published in Breast Cancer Research and Treatment showed black cohosh extract exerts no proliferative activity on these cell, but actually promotes both estrogen receptor positive and estrogen receptor negative breast cancer cells to commit cellular suicide (apoptosis).

5. Combination of glucosamine and MSM superior to either alone in treating osteoarthritis

In a double-blind clinical trial published in Clinical Drug Investigation, 118 patients with mild to moderate osteoarthritis were treated three times daily with either 500 mg of glucosamine, 500 mg of MSM, a combination of both, or an inactive placebo. After 12 weeks of treatment, the average pain score had fallen from 1.74 to 0.65 in the glucosamine-only group; 1.53 to 0.74 in the MSM-only group, and 1.7 to 0.36 in the combination group. The researchers also found that the combination treatment had a faster effect on pain and inflammation compared to glucosamine alone.

6. Antioxidant supplementation reduces risk of Alzheimer’s disease

Combined use of both vitamin C and vitamin E was associated with a dramatic 78 percent reduced prevalence of Alzheimer’s disease in a population-based study published in Archives of Neurology. This finding is not unexpected, as the damage to the brain in Alzheimer’s disease is believed to be the result of significant oxidative damage. The finding that there was no protection associated with the use of either vitamin E or C alone is not surprising and once again highlights the importance of using a combination of antioxidant nutrients versus any single antioxidant.

7. Long-term study shows CLA effective as weight-loss aid

Supplementation with conjugated linoleic acid, or CLA, at a dosage of 4.5 grams per day was shown in a 12-month double-blind study, published in the American Journal of Clinical Nutrition, to help overweight adults decrease body fat mass and increase lean body mass by as much as nine percent. This 2004 study is the first to clearly establish the efficacy of CLA supplementation over an extended time period without changes in exercise or diet.

8. Even brief exposure to statin drugs lowers CoQ10 levels

The fact that cholesterol-lowering drugs in the statin family, such as Lipitor and Pravachol, reduce coenzyme Q10 levels is well established. In 2004 a study published in Archives of Neurology better quantified this effect. Dosages of the drug atorvastatin (Lipitor) could cut CoQ10 levels in the blood to well below normal levels. Researchers also concluded that inhibition of CoQ10 synthesis by these drugs could explain the most commonly reported adverse effects, especially fatigue and muscle pain.

9. Lutein improves vision in patients with age-related macular degeneration

Lutein is the yellow-orange carotene that has been shown to offer significant protection against macular degeneration, the leading cause of vision loss in the elderly in the United States and Canada. In 2004 a double-blind study published in the journal Optometry indicated that 10 mg per day of lutein could significantly improve visual function in people with existing macular degeneration.

10. Ginkgo biloba extract benefits elderly subjects

Ginkgo biloba extract (GBE) continues to show impressive clinical usefulness in elderly subjects. In the most significant study with GBE, published in Phytotherapy Research, a dosage of only 120 mg per day was shown to produce a clear demonstrable effect in improving mood and tasks of everyday living in elderly subjects.

These 10 scientific studies published in 2004 help us understand the way nature functions and highlight the year’s achievements in the development of natural health.



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Matthew Kadey, MSc, RDMatthew Kadey, MSc, RD