Researchers Argue the Benefits of Homeopathic Remedies
The benefits of homeopathy have come under attack by Swiss researchers in a recent issue of The Lancet. The claim that the benefits can be explained by the placebo effect angered some American researchers, who say the methodological approach used in the research is incomplete in evaluating homeopathic medicine.
At the beginning of their reportpublished in the journal's Aug. 27 issuethe researchers say that specific effects of homoeopathic remedies seem implausible. "Bias in the conduct and reporting of trials is a possible explanation for positive findings of trials of both homoeopathy and conventional medicine." They then chose to analyze trials of homoeopathy and conventional medicine and estimated treatment effects in trials "least likely to be affected by bias."
The researchers conducted a meta-analysis that looked at 110 homoeopathy trials and 110 matched conventional medicine trials. In both groups, smaller trials and those of lower quality showed more beneficial treatment effects than larger and higher-quality trials, they say. When the analysis was restricted to large trials of higher quality, the odds ratio was 0.88 (an odds ratios below 1 indicates benefit) for homoeopathy (eight trials) and 0.58 for conventional medicine (six trials).
The researchers concluded that biases are present in placebo-controlled trials of both homoeopathy and conventional medicine. "When account was taken for these biases in the analysis, there was weak evidence for a specific effect of homoeopathic remedies, but strong evidence for specific effects of conventional interventions," they say. "This finding is compatible with the notion that the clinical effects of homoeopathy are placebo effects."
However, American researchers associated with the American Center for Homeopathy in Alexandria, VA, strongly disagree. "[The researchers' approach] did not include criteria that would apply to high-quality homeopathic research reflecting the nature of homeopathic practice. Such criteria include consideration of the quality of the homeopathy provided," said Iris Bell, MD, PhD, director of research for the Program in Integrative Medicine at the University of Arizona College of Medicine in Tucson.
"Furthermore," she continues, "a single remedy selection for a given conventionally diagnosed condition is not homeopathy; yet there are numerous conventionally judged high-quality studies that were so designed."
The Swiss researchers seemed to have a bias even before the study began, another American researcher says. "Out of the millions of trials in conventional medicine, their primary outcome relied on the comparison of ridiculously small numberseight trials of homeopathy and six trials of conventional medicine," says Joyce Frye, DO, MBA, president of the American Institute of Homeopathy and researcher at the University of Pennsylvania in Philadelphia. "They began their work with the assumption that the effects observed in placebo-controlled trials of homoeopathy could be explained by a combination of methodological deficiencies and biased reporting.' Sound research is not conducted from this starting position."
Benefits of Soy Protein Inconclusive
Eating daily amounts of soy protein found in tofu and other soybean products may slightly lower low-density lipoprotein (LDL) and triglyceride levels, says an evidence review published by the Agency for Healthcare Research and Quality in Rockville, MD. Isoflavones found in soy also may reduce the frequency of hot flashes in postmenopausal women. However, the available studies on the health impacts of soy were found to be limited in number, of poor quality, or too short of duration to lead to definite conclusions.
The evidence review was completed by AHRQ's Tufts-New England Medical Center Evidence-based Practice Center in Boston. The researchers found that across the 68 studies that examined the impact of soy on cholesterol levels, consumption of soy products resulted in a 5 mg/dL (about 3%) reduction in LDL and an 8 mg/dL (about 6%) decrease in triglyceride levels in the populations studied. Among these studies, a large variety of soy products, doses of soy protein, and doses of soy isoflavones were tested. The average dose of soy protein in the studies was equivalent to about one pound of tofu or three soy shakes daily.
There was some indication that soy consumption may be more effective at lowering LDL among people with higher LDL levels. Also, larger amounts of soy protein, but not soy isoflavones, are more effective in people with abnormally elevated LDL levels. Similarly, soy consumption may be more effective at lowering triglycerides among people with higher triglyceride levels; however, there was no evidence of how much soy protein or isoflavones would be needed to affect triglycerides.
Reviews on the relationship between soy consumption and high-density lipoprotein (HDL) levels and between soy consumption and blood pressure did not find significant effects. Among 21 studies evaluating the consumption of soy isoflavones for menopause-related symptoms, there was a net reduction in hot flash frequency ranging from 7% to 40%. However, these trials were mostly rated as poor quality. Among studies with statistically significant improvements in symptoms, the dose of soy isoflavones ranged from 17.5 mg/day to 100 mg/day.
The evidence review also found insufficient data among the 200 human studies examined as part of this analysis to suggest that soy had an effect on bone health, cancer, kidney disease, endocrine function, reproductive health, neurocognitive function, or glucose metabolism. A wide variety of soy products were studied, including foods such as soybeans, soy flour, soy milk, tofu, miso, tempeh, natto, and okara; isolated and textured soy protein that is added to foods; and soy-derived isoflavone supplements. Except for minor gastrointestinal problems reported in some short-term studies, consumption of soy products by study participants was not associated with adverse events. However, long-term safety data are lacking.
The Effects of Soy on Health Outcomes can be found on-line at www.ahrq.gov/clinic/tp/soytp.htm. The research was supported by the National Institute of Health's National Center for Complementary and Alternative Medicine and Office of Dietary Supplements.
FDA Allows a Qualified Health Claim for Chromium Picolinate
The FDA has issued a favorable response to a qualified health claim petition filed by Nutrition 21, a nutritional bioscience company based in Purchase, NY, regarding chromium picolinate as a nutritional supplement that may reduce the risk of insulin resistance and possibly Type 2 diabetes, the company reports.
In a letter to the company, the FDA's Center for Food Safety and Applied Nutrition made the following statement: "One small study suggests that chromium picolinate may reduce the risk of insulin resistance, and therefore possibly may reduce the risk of Type 2 diabetes. FDA concludes, however, that the existence of such a relationship between chromium picolinate and either insulin resistance or Type 2 diabetes is highly uncertain."
The FDA also makes a statement about the safety of chromium picolinate, saying: "FDA concludes at this time, under the preliminary requirements of 21 CFR 101.14(b)(3)(ii), that the use of chromium picolinate in dietary supplements as described in the [approved] qualified health claims discussed in section IV is safe and lawful under the applicable provisions Act."
The FDA, however, declined to permit other qualified health claims that were proposed by Nutrition 21.Researchers argue the benefits of homeopathic remedies. Altern Ther Women's Health 2005;9(10):78-79. Benefits of soy protein inconclusive. Altern Ther Women's Health 2005;9(10):79. FDA allows a qualified health claim for chromium picolinate. Altern Ther Women's Health 2005;9(10):79-80.
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