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Wednesday, 12 March 2014

Adding Flavanols to Dark Chocolate Doesn't Improve Health Benefits

Excuses for regularly indulging in dark chocolate keep accumulating, with the added possibility that its ingredients, thought to promote relaxed arteries, also have biochemical effects that may discourage atherosclerosis. But special flavanol-enriched formulations of dark chocolate may do little to enhance its vascular benefits, suggests a report published in the March 2014 issue of the FASEB Journal.

In a randomized, double-blind study, eating dark chocolate—acutely and over weeks—not only improved objective measures of endovascular function, it also improved biochemical markers that reflect leukocyte activation, inflammation, and other signs of atherogenesis.

The study further compared normal- vs high-flavanol dark-chocolate consumption by its participants, a few dozen overweight and mildly obese middle-aged male volunteers. It saw few important differences in vascular functional or biochemical effects following ingestion of either formulation of chocolate.

Changes in endothelial function were reflected in improved flow-mediated dilation (FMD), blood pressure, and augmentation index (AIX), while "changes in leukocyte-cell counts, plasma cytokines, and leukocyte adherence markers after chocolate consumption point toward a less-activated state of cellular adherence and, hence, a less atherogenic milieu," according to the authors, led by Dr Diederik Esser (Top Institute Food and Nutrition and Wageningen University, the Netherlands).

"Extra flavanols did not augment these effects," they write, "but did affect taste and had a negative effect on the motivation to eat chocolate."

Beneficial vascular changes and even improved clinical outcomes have long been attributed to consumption of flavanol- and polyphenol-rich foods like chocolate, red wine, cinnamon, and tea in both observational and interventional studies. Chocolate itself has been associated with improved blood pressure and cerebral perfusion and a reduction in stroke, heart failure, and other cardiovascular-event outcomes.

Acute Chocolate Effects
In a double-blind crossover randomization, 29 men consumed 70 g of chocolate on each of two days separated by at least one week. On one occasion, the chocolate contained normal levels of flavanols, and on the other it was supplemented with extra flavanols.

Ingestion of both types of chocolate decreased AIX (indicating decreased central aortic pressure) but didn't affect FMD (reflecting endothelial function). Similarly, hematocrit and counts of thrombocytes, lymphocytes, monocytes, and neutrophils went up within two hours. Plasma soluble intercellular adhesion molecule (sICAM) 3, interleukin (IL)-1β, and von Willebrand factor levels went up, and plasma IL-6 levels fell two hours after ingestion of both kinds of chocolate. Insulin also went up after both chocolates, but more so after the high-flavanol kind.

The Four-Week Crossover Trial
The same 29 subjects plus an additional 15 participated in a second double-blind experiment in which four weeks of 70 g per day of either high- or low-flavanol chocolate was followed by a four-week washout period and then crossover to four weeks of the other kind of chocolate. They followed certain dietary restrictions to minimize background flavanol intake.

Four weeks of consuming chocolate of either kind elevated fasting FMD by a percentage point and dropped AIX to a similar extent; both measures reverted to baseline after the washout period. The literature suggests a significant 13% reduction in cardiovascular-event risk for every 1% rise in FMD after chocolate consumption, according to the authors.

In a novel finding, four weeks of chocolate consumption significantly lowered counts of circulating leukocytes, suggesting decreased inflammation; also, "leukocytes can transmigrate through the endothelium and therefore play a crucial role in the formation of atherosclerosis."

Chocolate also lowered protein expression of lymphocytes CD62L and CD11b, monocyte CD62L, and neutrophils CD66b and CD11c. "These cell-surface molecules are involved in leukocyte recruitment and adherence to the endothelium during the initial steps of atherosclerosis," the group writes.

"A minor but significant" 0.1-mL rise in fasting plasma glucose and 0.3-mL increase in plasma free fatty acids was evident after four weeks of chocolate of either kind.

Taking the High-Fat Challenge
"High-fat-challenge" tests conducted after each four-week period of chocolate intake required drinking a 95 fat-gram shake of yogurt, canola oil, and other ingredients followed by endothelial-function and metabolic marker tests at 1.5 and 3.0 hours to assess postprandial responses.

Consumption of the high-fat shake was followed by average declines in FMD by 1.8 percentage points, in AIX by four percentage points, and in diastolic blood pressure by 2 mm Hg, regardless of whether the background chocolate contained normal or high flavanol levels. Also seen at postprandial testing were rises in hematocrit; counts of thrombocytes, lymphocytes, monocytes, and neutrophils; plasma concentrations of sICAM1, soluble vascular cell adhesion molecule (sVCAM) 1, sICAM3, P-selectin, IL-8, and tumor necrosis factor-alpha (TNF-α); and expression of lymphocytes CD11c and CD11b, monocyte CD11c and CD11b, and neutrophils CD62l and CD11b adhesion molecules. At the same time, monocyte CD62l expression and IL-6 plasma levels fell.

"Our results indicate that flavanol-enriched chocolate was not healthier than regular dark chocolate with respect to vascular health markers," according to Esser et al.

Limits on flavanol absorption didn't account for the similar effects, they determined, based on plasma and urine measures of flavanol intake; normal-flavanol–level chocolate may simply attain maximal flavanol effects on vascular health, the group writes.

Wednesday, 12 February 2014

Low-Dose Aspirin Ups Survival in Heart Failure

Daily low-dose aspirin, defined as 75 mg/day, was followed by a 42% mortality reduction over several years in a cohort of patients participating in a heart-failure disease-management program [1] . Aspirin prolonged survival regardless of whether patients had a standard aspirin indication, such as ischemic heart disease, peripheral vascular disease, or stroke, reported investigators in their study, published online February 3, 2014 in Circulation: Heart Failure. There was no such survival benefit, however, at dosages higher than 75 mg/day, although both low- and higher-dose aspirin improved heart-failure hospitalizations.

The findings contrast with and go beyond prior studies of narrower heart-failure populations treated with aspirin, observe its authors, led by Dr Margaret Bermingham (St Vincent's University Hospital, Dublin, Ireland). Of those randomized trials, they note,WARCEF saw more bleeding and otherwise no clinical advantage for warfarin over aspirin; and in WASH and WATCH , neither aspirin nor warfarin seemed to protect against events.

But the group notes that aspirin in those trials was given at two to four times the low dose of the current analysis, which suggests "that low-dose aspirin may have a continuing role in secondary prevention once patients are diagnosed with HF" and points to a need for "more, preferably prospective, trials of low-dose aspirin use in HF."

Of the 1476 patients in the retrospective analysis, who were followed for a median of 2.15 years (range one day to 12 years), 892 (about 60%) were prescribed aspirin at baseline. Of those, 91% received aspirin at 75 mg/day and the remainder received aspirin at higher dosages.

Another antiplatelet, such as clopidogrel, was also given to 18.4% of the aspirin group, while 27.8% of them took added warfarin, and 2.1% received dual antiplatelets and warfarin.

The findings "add to the controversy on aspirin use in HF by presenting reassuring results on low-dose aspirin use in a clinical-practice population," the group writes. "They challenge the belief that aspirin should be avoided in secondary-prevention patients who go on to develop HF and suggest that patients on higher antiplatelet doses may benefit from dose reduction."

Low fat yoghurt cuts risk of type 2 diabetes

Swapping snacks — such as potato chips — for low-fat yogurt can cut the risk of developing type 2 diabetes by almost half, according to the results of a new observational study.

The findings, involving a randomly selected subgroup from the larger EPIC-Norfolk study, were published online February 5 inDiabetologia by Nita G. Forouhi, MBB, PhD, from the Medical Research Council (MRC) Epidemiology Unit, University of Cambridge School of Clinical Medicine, United Kingdom, and colleagues.

"A good place to include yogurt in your diet to reap the benefits against onset of diabetes would be instead of a packet of crisps [potato chips].We found that swapping crisps for yogurt offered protection against onset of diabetes. This may form a practical dietary change suggestion for patients at risk of diabetes as well as among the general population," Dr. Forouhi revealed in an email.

In the study — the first to examine the relationship of dairy consumption with incident type 2 diabetes using prospective 7-day food diaries — subjects with the highest low-fat yogurt consumption had a 28% lower risk of developing type 2 diabetes over 11 years of follow-up compared with those who ate very little or no yogurt, after adjustment for a variety of possible confounders.

"Current US dietary guidelines recommend increasing intake of fat-free or low-fat milk and milk products such as milk, yogurt, and cheese… Recommending yogurt intake is therefore in keeping with dietary guidelines for all patients," Dr. Forouhi said.

And, she noted, "At a time when other research has shown that certain foods raise health risks, such as consuming high amounts of added sugar, it is reassuring to have messages about other foods, like yogurt and low-fat fermented dairy products, that could be good for our health."

Dietary Dairy Examined
The study compared a detailed daily record of all the food and drink consumed over a week at the time of study entry among 753 people who developed new-onset type 2 diabetes over 11 years of follow-up, with 3502 randomly selected study participants from EPIC-Norfolk, which comprised more than 25,000 men and women.

At baseline, subjects had a mean age of 59 years and body mass index (BMI) of 26 kg/m 2; they filled in detailed diary questionnaires that asked about all foods containing dairy as the main ingredient and the type of dairy product (yogurt, cheese, or milk). These were divided into high-fat and low-fat based on a 3.9% cutoff for total fat content. Fermented dairy products (all yogurt, all cheese, sour cream, and crème fraiche) were also categorized separately into high- and low-fat.

Milk was the most-consumed dairy product, accounting for 82%, followed by cheese (9%) and yogurt (8%). Total average dairy consumption was 269 g/day, of which 65% was low-fat.

Total overall dairy consumption was not associated with the development of diabetes, but low-fat dairy intake was, after adjustment for age and sex. Yet even this became nonsignificant after further adjustment for other confounders including BMI, smoking, alcohol consumption, social class, physical activity, and other dietary components.

Similarly, total fermented dairy-product consumption was associated with a 19% lower risk, but this also became nonsignificant after adjustment for possible confounders.

Low-Fat Fermented Dairy Products Linked to Lower Risk
But after full adjustment, a significant relationship remained between intake of low-fat fermented dairy products and the development of type 2 diabetes, with a hazard ratio of 0.76 for the highest vs lowest tertiles (P for trend = .049).

"In public-health terms this equates to 4.5 standard-size portions (125 g) per week of low-fat fermented dairy products, largely composed of yogurt (all types) and including low-fat unripened cheese such as low-fat cottage cheese and fromage frais," the researchers say.

Low-fat yogurt in particular was associated with a 35% reduced risk after adjustment for age and sex ( P for trend < .001), and this relationship remained significant even after adjustment for other potential confounders (HR 0.72, P for trend = .017).

In a separate analysis, the effect of substituting dairy products for snacks — such as cake, pudding, biscuits, or chips — was examined. Eating yogurt instead of such snacks resulted in a 47% lower risk for diabetes, but none of the other substitutions resulted in a significant reduction in diabetes risk.

Several possible mechanisms could explain the relationship between fermented dairy and diabetes, including promotion of the synthesis of menaquinone (vitamin K 2), which has been linked to reduced rates of type 2 diabetes, or the actions of probiotic bacteria, which have been found to improve lipid profiles and antioxidant status in patients with type 2 diabetes, the researchers suggest.

Moreover, low-fat fermented dairy products are "naturally low in fat and high in water content and are, therefore, low energy-dense foods. Studies have shown an independent association of low energy-dense foods with lower fasting insulin levels and the metabolic syndrome and a lower risk of type 2 diabetes," they say.

Dr. Forouhi said that the use of 7-day food diaries allows for a much more careful analysis of dairy intake than has been done in prior studies.

"This work gives us important…and more detailed information than our own past research and that of others. We were able to estimate people's diets in much more detail and in real time with all food and drink that was consumed being recorded with a 7-day food diary.

"This gets around an important limitation of the past research, which has relied on participants' recall of foods they have eaten in the past. This gives us greater confidence that low-fat fermented dairy and yogurt specifically within that group can be important for the prevention of diabetes as part of an overall healthy lifestyle," she concluded.

Thursday, 6 February 2014

Coffee Linked to Lower Type 2 Diabetes Risk

Coffee consumption is strongly associated with a reduced risk for type 2 diabetes, regardless of whether the coffee is caffeinated or not, according to a new meta-analysis of 28 prospective studies, published in the February issue of Diabetes Care.

"Compared with no coffee consumption…6 cups/day of coffee was associated with a 33% lower risk of type 2 diabetes," the authors write, adding, "Caffeinated coffee and decaffeinated coffee consumption were both associated with a lower risk of type 2 diabetes."

Drinking coffee has been well-established in previous meta-analyses as being associated with a reduced risk for type 2 diabetes; however, the new review was needed to account for more recent trials evaluating the benefits of caffeinated vs decaffeinated coffee, the authors explain.

"We found that a 1-cup/day increment of regular coffee was associated with a 9% reduction in diabetes, and 1 cup/day of decaf was associated with 6% reduction in diabetes, but the difference in risk reduction between the 2 types of coffee was not statistically different," said senior author Frank B. Hu, MD, PhD, a professor of nutrition and epidemiology with the Harvard School of Public Health in Boston, Massachusetts.

"This study provides strong evidence that regular consumption of coffee is beneficial for prevention of diabetes," Dr. Hu said. "For individuals who already drink coffee, they may enjoy this and other potential health benefits, and for those who are sensitive to the effects of caffeine, decaf may confer similar benefits."

Robust Findings
The 28 studies in the analysis included 1,109,272 participants, and all had the outcome of risk for type 2 diabetes; there were 45,335 cases of diabetes, with follow-up ranging from 10 months to 20 years.

The relative risk for type 2 diabetes with coffee consumption, compared with no or rare consumption, ranged from 0.92 for 1 cup per day, 0.85 for 2 cups, 0.79 for 3 cups, 0.75 for 4 cups, 0.71 for 5 cups, and 0.67 for 6 cups.

Meanwhile, the relative risk for diabetes associated with 1 cup of caffeinated coffee per day (compared to no or rare coffee consumption) was 0.91 compared with 0.94 for 1 cup of decaffeinated coffee per day ( P = .17).

The findings were consistent for men as well as women, and while coffee-brewing methods were not assessed in the studies, the inclusion of diverse populations likely covered a wide array of methods, the authors note.

"Most coffee is likely to be filtered coffee, and the results from studies conducted in various populations, including US, European, and Asian, were similar, indicating consistency of the results despite potentially different preparation and processing methods," they observe.

And while none of the studies assessed levels of sugar and dairy added to coffee, the amounts are "likely to be small compared with other food sources," they add.

While this meta-analysis does provide "strong evidence" that higher consumption of coffee is associated with a significantly lower risk for diabetes," longer-term randomised controlled trials are needed to establish causality and to elucidate the underlying mechanisms," they conclude.

Coffee Just a Small Part of the Diabetes Equation
One possible explanation for the reduced risk for diabetes with coffee consumption could be the role of chlorogenic acid, a phenolic compound and a major component of coffee, Dr. Hu said.

"Chlorogenic acid has been shown to improve insulin sensitivity and reduce blood sugar absorption," he said.

"Compounds in coffee also include antioxidant polyphenols, minerals such as magnesium and chromium, [and] vitamins; however, it is impossible to tease out the effects of individual compounds, because they don't exist in isolation in coffee and they may have synergistic effects."

He stressed also that coffee consumption remains a small piece of the picture.

"Coffee is only one of many dietary and lifestyle factors that can contribute to diabetes prevention. Clearly, maintaining a healthy weight through diet and exercise is the most important way to reduce risk of diabetes. For those who drink coffee regularly, they should enjoy it, but they still need to watch their weight and be physically active."

Resistance training boosts testosterone in older men

Resistance training can increase the production of sex steroids in the muscles of older men, a new study shows.

If borne out by further research, the findings could have important implications for a wide range of conditions experienced by many aging individuals and linked to a decline in sex steroid hormones, say Koji Sato, PhD, and colleagues from Ritsumeikan University in Kyoto, Japan in their report in the Journal of the Federation of American Societies for Experimental Biology published online January 17.

"Resistance-training–induced increased muscular sex steroid hormone may positively affect age-related concerns such as accidental falls, diabetes, sarcopenia, and osteoporosis and may improve the quality of life for older individuals," they note.

More and more men are using testosterone supplements in the hope of improving their strength, energy, and sexual performance. But this use has become increasingly controversial, because many experts believe such supplementation is not necessary and there is also mounting evidence of concerning side effects associated with the use of testosterone, particularly in older individuals.

Just last week, the US Food and Drug Administration (FDA) announced it is investigating the potential that FDA-approved testosterone products increase the risk for serious adverse cardiovascular outcomes. The agency cited two studies, the most recent of which shows that men treated with testosterone were significantly more likely to have a myocardial infarction (MI) in the first 90 days after starting the medication.

The second study, of Veterans Affairs (VA) patients, published last year, also found that testosterone therapy in men was linked with an increased risk of death, MI, or ischemic stroke.

Sex Hormones in Skeletal Muscles Boosted by Training
In their new paper, Dr. Sato and colleagues explain that while the testes, ovaries, and adrenal cortex produce most steroid sex hormones in humans, recent animal work has shown that skeletal muscle can also synthesize testosterone, estradiol, dehyroepiandrosterone (DHEA), and dihydrotestosterone (DHT). However, a previous study in men and women in their 20s showed no immediate sign of an increase in these hormones in the quadriceps muscle following training ( J Appl Phys. 2008;105: 1754-1760).

To see what effect resistance training might have on older men over a longer period of training, the Japanese researchers recruited 13 men with a mean age of 67.2 years and 6 men with a mean age of 24.3.

The subjects were moderately active, but none regularly performed resistance exercises.

The older men performed knee extensions and flexions 3 times a week on alternate days, using starting weights that were 70% of each subject's single-repetition maximum strength. Trainers retested this measurement and adjusted weights for each of these men every 4 weeks. The study lasted 12 weeks.

Levels of sex steroid hormones and precursors in each man's vastus lateralis (the largest muscle in the quadriceps) were measured by biopsy before the weight training. The same measurement was taken again in the older men after the weight training.

The researchers also sampled the hormones in the men's blood and measured the size of their quadriceps before and after the training.

The older men had much lower levels of steroidogenic enzymes as well as sex steroid hormones and insulinlike growth factor (IGF-1) than the younger men in both their blood and their muscles. The older men were also weaker and had smaller quadriceps.

Nevertheless, the levels of sex steroid hormones increased significantly in the older men's muscles after the weight training. The older men's isokinetic extension strength and quadriceps sizes also increased significantly.

Serum Testosterone Not Significantly Increased
In the blood, however, although the older men had significantly increased serum DHEA and DHT levels after training ( P < .01), their serum free testosterone did not rise significantly ( P = .052), nor did serum IGF-1 ( P= .055).

Levels of steroidogenic enzymes, as well as their androgen-receptor protein expression, did significantly increase, however.

The muscular steroid hormone levels significantly correlated with muscle strength and size, leading the investigators to conclude that "progressive resistance training seems to restore muscle sex steroid hormone levels via enhancement of steroidogenesis-related enzyme expressions in the skeletal muscle and may partly contribute to the increase in muscle strength and [size]."

Asked to comment on the findings, Jakob Vingren, PhD, an associate professor of kinesiology at the University of North Texas Denton, said that the results reinforce the importance of resistance training. "There are definitely benefits to aerobic exercises and there are definitely benefits to resistance training, and they combine, but there are unique benefits to both," he said.

Dr. Vingren added that men who are on androgen-deprivation therapy, for example, for prostate and other cancers, might particularly benefit from resistance training, since these findings indicate it could help strengthen them without increasing their serum testosterone.

Wednesday, 22 January 2014

Berries, tea, grapes and wine lower diabetes risk

A new study in healthy women suggests that consuming high levels of flavonoids, including compounds found in berries, tea, grapes, and wine, could potentially lower the risk of type 2 diabetes.

The study, published in the February issue of the Journal of Nutrition, indicates that greater intake of these dietary compounds is associated with lower insulin resistance and better blood glucose regulation. The researchers, led by Amy Jennings, PhD, from the department of nutrition, University of East Anglia, Norwich, United Kingdom, say their study is one of the first to examine consumption of different flavonoid subclasses and insulin resistance.

"We found that those who consumed plenty of anthocyanins and flavones had lower insulin resistance. So what we are seeing is that people who eat foods rich in these 2 compounds — such as berries, herbs, red grapes, wine — are less likely to develop the disease," said senior author Aedin Cassidy, PhD, also from the department of nutrition, University of East Anglia, in a statement.

Researchers also found that those who ate the most anthocyanins were least likely to suffer chronic inflammation, which is associated with diabetes, obesity, cardiovascular disease, and cancer. And those who consumed the most flavone compounds had improved levels of adiponectin, which helps regulate a number of metabolic processes, including glucose levels, Dr. Cassidy noted.

Importantly, the difference between the highest and lowest intakes of foods containing these compounds was small, consisting of just one portion of grapes or berries or a couple of oranges, say the authors. Also, the effects on insulin that were associated with high consumption of such foods was equivalent to those observed for other lifestyle factors, such as an hour's walk a day or low-fat diet for a year, they noted.

Nevertheless, Dr. Cassidy said it is not yet know exactly how much of one of these compounds is necessary to potentially reduce the risk of type 2 diabetes. "Dose–response trials are needed to ascertain optimal intakes for the potential reduction of type 2 diabetes risk," she and her colleagues stress.

One of the First Large Human Studies of Flavonoid Subclasses
Researchers note that a previous prospective study, published last year in the American Journal of Clinical Nutrition suggested a 15% reduction type 2 diabetes risk by comparing the highest and lowest quintiles of anthocyanin intake. However, the researchers emphasize that their current study is one of the first large-scale human trials to examine all subclasses of these powerful bioactive compounds to see how they might affect insulin resistance, blood glucose regulation, and inflammation.

The cross-sectional study was conducted in almost 2000 women aged 18 to 76 years from the Twins UK registry. Women who had high glucose levels were excluded. Participants completed a 131-item food-frequency questionnaire, from which flavonoid intakes were estimated using a United States Department of Agriculture database.

The researchers looked at the self-reported intake of 6 subclasses of flavonoids: flavanones, anthocyanins, flavan-3-ols, polymeric flavonoids, flavanols, and flavones.

In multivariable analyses, higher anthocyanin and flavone intakes were associated with significantly lower peripheral insulin resistance (homeostasis model assessment of insulin resistance; quintile 5 [Q5] to Q1 = 20.1, P-trend = .04 for anthocyanins and flavones), as a result of a decrease in insulin concentrations (Q5–Q1 = 20.7 mU/mL, P-trend = .02 anthocyanins; Q5–Q1 = 20.5 mU/mL, P-trend = .02 flavones).

Tea was the main source of overall flavonoid intake, with 4 foods contributing more than 10% of anthocyanin intake (grapes, pears, berries, and wine) and 3 foods making up more than 10% of flavone consumption (oranges, wine, and peppers).

Higher anthocyanin intake was also associated with lower C-reactive protein (hs-CRP) levels (Q5–Q1 = 20.3 mg/L, P-trend = .04), whereas those in the highest quintile of flavone intake had improved adiponectin levels (Q5–Q1 = 0.7 mg/L, P-trend = .01).

Higher intakes of both anthocyanins and flavones were associated with improvements in insulin resistance and hs-CRP, the researchers note.

No significant associations were observed for total or other flavonoid subclasses.

Findings Are Clinically Relevant, Easy to Achieve
Although these findings are from cross-sectional data and require confirmation, they are clinically relevant because of the 0.7-mU/mL difference in insulin observed between the top and bottom quintiles of anthocyanin intake, the researchers note.

The difference in anthocyanin intake between the top and bottom quintiles was 35 mg, which can be readily incorporated into the diet by consuming approximately one portion of grapes (78 g) or berries, such as strawberries (105 g), raspberries (90 g), blueberries (21 g), or blackberries (39 g).

Similarly, the difference in flavones between the top and bottom quintiles was 3.6 mg, equivalent to that found in approximately 2.5 oranges.

These results "are of public-health importance because the intakes associated with these findings are easily achievable through the habitual diet" and make a significant contribution to the knowledge base needed to refine the current fruit and vegetable dietary recommendations, the authors conclude.

Tuesday, 21 January 2014

Chinese herbal formula reduces progression to diabetes by 32%

A combination of 10 Chinese medicinal herbs in a capsule, known as Tianqi, reduced progression to type 2 diabetes in people with impaired glucose tolerance (IGT) in a randomized controlled trial in China.

This is the first study to show that a Chinese herbal medicine can "reduce the progression of prediabetes to diabetes," says study author Chun-Su Yuan, MD, PhD, from the Tang Center for Herbal Medicine Research at the University of Chicago, Illinois. Tianqi "could provide a new option for diabetes management, using herbal medicine alone or as an adjuvant to currently used therapies," he noted.

The results are published online January 16 in the Journal of Clinical Endocrinology & Metabolism, and Dr. Yuan said robust data such as these are needed to help promote the use of Chinese herbal medicine by physicians in different countries.

Most significantly, the researchers found that taking Tianqi reduced the risk for diabetes by almost a third (32.1%) compared with placebo, after adjustment for age and gender.

A Role for Chinese Medicine in Diabetes Prevention?
The findings show that the Chinese herbal medicine was comparable to some pharmaceuticals in reducing progression to type 2 diabetes, say the researchers. For example, the results seen with Tianqi were similar to those found with acarbose, at 25%, and metformin, at 31%.

"Although no direct comparison has been made between Tianqi and antidiabetic prescription drugs, our data indicate that this Chinese herbal medicine had similar effects to metformin," reported Dr. Yuan.

Asked to comment on whether diabetes prevention was regularly practiced in the United States, he remarked that unacceptable adverse effects limited regular use of conventional therapies in the prevention of type 2 diabetes, with reports showing that long-term administration of acarbose or metformin had often been associated with unfavorable gastrointestinal events.

Around 79 million individuals in the United States aged over 20 years have prediabetes, a state in which blood glucose levels are higher than normal but do not meet the diagnostic criteria for type 2 diabetes.

Dr. Yuan added that their data also show that after a period of cessation of the Tianqi treatment, the preventive effects on type 2 diabetes development remained significant. "Moreover, the safety profile of this herbal medicine is very good without obvious adverse effects," he commented.

Chinese Herb Combination and Study Design
The Chinese medicine comprises several herbs that have been shown to lower blood glucose levels after meals. The Tianqi capsule is manufactured by Heilongjiang Baoquan Pharmaceutical and consists of 10 Chinese herbal medicines: Astragali Radix, Coptidis Rhizoma, Trichosanthis Radix, Ligustri Lucidi Fructus, Dendrobii Caulis, Ginseng Radix, Lycii Cortex, Ecliptae Herba, Galla Chinensis, and Corni Fructus. The quality of these herbs and decoction preparation was in accordance with the Chinese Pharmacopoeia, the researchers note.

Dr. Yuan said the key herb in the combination was Huanglian (Coptidis Rhizoma). "The critical component of this herb is berberine, which has been reported to have good antidiabetic effects," he said in an interview. "Huanglian has been used traditionally in Chinese medicine in treating diabetic symptoms."

A total of 420 participants with IGT recruited from 11 research sites in China underwent double-blind randomization to receive either Tianqi (n=210) or a placebo (n=210) for 12 months. Participants had IGT with a 2-hour plasma glucose concentration of 7.8–11.1 mmol/L after a 75-g oral glucose tolerance test and fasting plasma glucose greater than 7.0 mmol/L.

Oral glucose tolerance tests were conducted every 3 months to assess the development of diabetes or restoration to normal glucose tolerance. In addition, all participants received similar lifestyle education.

The primary end point was the conversion of IGT to type 2 diabetes; body weight, body mass index, and adverse effects were monitored.

Need For More Controlled Trials of Chinese Medicinal Herbs
"Although the results of the present study need to be confirmed in future larger clinical trials, Tianqi holds promising potential as an effective and practical means to prevent type 2 diabetes, particularly in places in which herbal medicines are culturally accepted and widely used," say the authors.

They note that treating diabetes with Chinese herbal medicines is popular in China, particularly in rural areas.

"Our encouraging data should initiate further studies, both in China and in the West, to evaluate the role of Chinese herbal medicine in preventing and treating diabetes," said Dr. Yuan. "We are currently conducting several studies in this field."