Natural Medicine Update

STUDY: FDA hopes to cut down on unnecessary prescriptions

JOURNAL: Food and Drug Administration

AUTHORS: Mark McClellan

ABSTRACT: Antibiotics will soon need to carry warnings advising doctors to avoid unnecessary prescriptions, which have become a major contributor to the problem of drug-resistant infections.

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COMMENTARY: The new requirement, announced by the Food and Drug Administration on Wednesday, aims to reduce inappropriate prescribing of antibiotics for common ailments such as ear infections and chronic coughs, which often are caused by viruses that do not respond to antibiotics.

Antibiotics only kill bacteria, but patients often request them for treating a variety of infections.

Starting next year, antibiotic labels will be required to include instructions for doctors to prescribe them only when an infection is proven or strongly suspected to be caused by bacteria.

The labels also will encourage physicians to counsel patients about what types of infections require antibiotic treatment, as well as remind them to take all of their medication, even if they feel better in a few days.

Not completing a full course of treatment can give microbes the chance to mutate to resist antibiotics, causing infections that are harder to treat.

According to the Center for Disease Control and Prevention, half of the 100 million prescriptions a year written by office-based physicians in the United States are unnecessary because they are prescribed for the common cold and other viral infections.



“Antibiotic resistance is a serious and growing public health problem, not only in this country but worldwide,” FDA Commissioner Mark McClellan said, noting that the growth of resistant germs is outpacing development of new antibiotics.

“We may end up in a situation where we don’t have effective antibiotic drugs for common infections that were once easily treated.”

The agency plans to try and publicize the warnings through medical journals and professional medical societies.

STUDY: Progesterone could help stem growing problem

JOURNAL: Society for Maternal-Fetal Medicine

AUTHORS: Dr. Paul Meis

ABSTRACT: Obstetricians say they may have discovered a powerful new solution to the dramatic rise in premature births in the last two decades.

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The hormone progesterone prevented premature births in a surprisingly high number of high-risk pregnancies, according to a groundbreaking study.

COMMENTARY: “The evidence of this treatment’s effectiveness was so dramatic, the research was stopped early,” said the study’s lead researcher, Dr. Paul Meis of Wake Forest University Baptist Medical Center.

Progesterone is naturally produced by the ovaries. It softens the uterus lining into a spongy bed that holds a fertilized egg.

Weekly injections of the hormone reduced the chance of premature births by 34 percent in the 306 high-risk women who received the therapy, the study reported. Another 153 women were injected with a placebo. All the women had previously given birth prematurely, the single biggest indication of risk.

“The results are so good that it’s surprising,” said Dr. Fredric Frigoletto, chief of obstetrics at Massachusetts General Hospital in Boston. “No intervention that we have ever applied has had any measurable effect. This is very good news.”

Doctors have prescribed progesterone for years to help infertile and menopausal women.

STUDY: Cutting 100 calories a day could prevent annual weight gain

JOURNAL:

AUTHORS: Dr. James Hill

ABSTRACT: The average adult slips on about 2 extra pounds a year, a weight creep that some researchers argue could be prevented merely by eating one less cookie a day.

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That treat or even three fewer bites of a fast-food hamburger — the equivalent of 100 calories daily — can keep the pounds off in the first place so people do not face the harder battle of losing weight.

COMMENTARY: Scientists are searching for different approaches to what is fast becoming a national epidemic. Sixty percent of U.S. adults are overweight, and the government blames 300,000 deaths a year on weight-related diseases.

“The biggest problem we face in America is not terrorism. The biggest health problem we’re facing is obesity,” Dr. Julie Gerberding, head of the Centers for Disease Control and Prevention.

It is just a theory, and Hill acknowledges he has not proved yet that such a simple step works. But scientists are searching for different approaches to what is fast becoming a national epidemic.

Sixty percent of U.S. adults are overweight, and the government blames 300,000 deaths a year on weight-related diseases.

“The biggest problem we face in America is not terrorism. The biggest health problem we’re facing is obesity,” Dr. Julie Gerberding, head of the Centers for Disease Control and Prevention, said last week.

Fixing the problem will require changing societal norms starting with children, she added, such as doing more and eating less in a society that encourages more driving than walking and provides unfettered access to calorie-laden foods.

To focus attention on the problem, the journal Science, turned to some well-known obesity researchers for opinions on what it will take to lower the scales.

Hill’s response was to examine government figures showing about 40 million adults are obese and how steadily Americans have put on weight in recent years.



“The future is not hopeful unless we act now,” he concluded. Hill estimated that if current trends continue, 39 percent of adults will be obese by 2008, compared with 31 percent in 2000.



Losing weight and keeping it off can be hard. The possibly easier short-term goal would be to get no fatter. So Hill and colleagues calculated what he calls the energy gap — how many calories are eaten but not burned off.

Using that same government data, he estimates that on average people gain 2 pounds a year, which equals 50 extra calories stored each day. Because the body can store half of calories consumed, he said preventing that 2-pound weight gain might simply require eating 100 fewer calories a day.

There are problems with that simple approach, says Dr. Jeffrey Friedman of Rockefeller University, who discovered the obesity hormone leptin in 1995. Some people gain 10 pounds in a year while others gain none. Few people actually know how many calories they consume, a key difficulty in cutting them.

Scientists have discovered a number of hormones and genes that generate a basic biological drive to eat that can be difficult to fight, he explains.

Genetics aside, scientists also know that the more volume and variety of food people are offered — think super-sized restaurant portions and buffets — the more they’ll overeat, adds CDC nutrition chief Dr. Willian Dietz.

“Portion size is an issue. How one goes about controlling it is not so simple,” he cautions.

For people reluctant to eat less, Colorado’s Hill points to a current experiment in which Colorado is encouraging people to buy $20 battery-operated step-counters and take an extra 2,000 steps a day, enough to walk a mile and burn 100 calories.

Hill is studying 500 participants to see if that extra little bit helps their weight; results are not due for another year or two. He plans to add his theory on eating 100 fewer calories to the study, too.

STUDY: Testosterone Replacement: Good or Bad

JOURNAL: National Institutes of Health

AUTHORS: Marc Blackman

ABSTRACT: Federal advisers began the first of several meetings that will result in recommendations later this year on how to best determine if testosterone replacement therapy is good or bad for aging men.

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COMMENTARY: An unknown, but significant number of older men have begun using patches, gels or other forms of testosterone in the hopes of reversing the aging process and a flagging sex drive, but there is no scientific evidence that hormone supplements can help.

And, there may even be some dangerous side effects, including an increased risk of prostate cancer.

"The chasms of our ignorance here are vast," Marc Blackman, an endocrinologist with the National Institutes of Health, told a 17-member Institute of Medicine (IOM) advisory committee.

The panel has been asked to make recommendations on how to answer questions on the pros and cons of testosterone replacement, and its mechanism of action.

They are also weighing how to properly inform potential study participants when the benefits and the risks of therapy are very unclear.

Over the last few decades, studies on relatively young men with testosterone deficiencies have shown that replacement can counter increased body fat and cholesterol levels, decreased skeletal strength and decline in immune function associated with lower testosterone levels, said Blackman.

Four to five million relatively young American men have below-normal testosterone levels, and 5% are receiving replacement therapy, he said.

The few studies in older men with naturally declining testosterone levels has shown that replacement therapy decreases fat and increases lean muscle mass. But only one, a small 15-person study in very frail elderly men, has shown any improvement in muscle strength or function. So it is unclear if increased muscle mass leads to better physical functioning, Blackman said.

It's also not known if testosterone replacement reduces the risk of disability, falls, or fractures, or otherwise improves health outcomes. And it's unclear if supplementation would have similar effects in healthy older men and physically impaired older men.

A big concern is whether testosterone supplementation will increase the risk of prostate cancer. Increased levels of male hormones can enlarge the gland, and most researchers believe that increased prostate volume eventually leads to cancer.

Scientists at Baylor College of Medicine have drawn up plans to carry out a large, long-term study of testosterone replacement therapy in older men. The trial has been put on hold while the IOM panel considers its merits.

Lead investigator Glenn Cunningham said the study aims to enroll 6,000 men over age 65. They would be in the study for four years, and then followed for five years more. The main goal is to see if testosterone replacement reduces fractures, since men, just like women, are at risk for osteoporosis as they age, primarily due to declining hormone levels.

Researchers will also measure testosterone replacement's ability to reduce heart attacks and strokes, and to improve mood, energy levels, cognition and sexual function.

Finally, they will assess whether replacement therapy increases the incidence of prostate cancer or leads to more procedures to reduce prostate size.

STUDY:

JOURNAL: Journal of Nutrition

AUTHORS: Donald K. Layman

ABSTRACT: A relatively high-protein diet improves body composition, enhances weight loss, and improves glucose and insulin homeostasis.

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COMMENTARY: "Amino acids interact with glucose metabolism both as carbon substrates and by recycling glucose carbon via alanine and glutamine; however, the effect of protein intake on glucose homeostasis during weight loss remains unknown," write Donald K. Layman and colleagues from the University of Illinois at Urbana-Champaign.

In this study, 24 adult women who were more than 15% above ideal body weight were assigned to either a predominantly protein diet or a predominantly carbohydrate diet. The protein diet included 1.6 g/kg/day protein, with less than 40% of energy coming from carbohydrate, while the carbohydrate diet included 0.8 g/kg/day protein, with more than 55% of energy coming from carbohydrate. Both diets were equal in calories (7100 kJ/day) and in fat (50 g/day).



After 10 weeks, weight loss was 7.53 ± 1.44 kg in the protein group and 6.96 ± 1.36 kg in the carbohydrate group. Subjects in the carbohydrate group had lower fasting (4.34 ± 0.10 vs. 4.89 ± 0.11 mmol/L) and postprandial blood glucose (3.77 ± 0.14 vs. 4.33 ± 0.15 mmol/L) and an elevated insulin response to meals (207 ± 21 vs. 75 ± 18 pmol/L).

"This study demonstrates that consumption of a diet with increased protein and a reduced carbohydrate/protein ratio stabilizes blood glucose during nonabsorptive periods and reduces the postprandial insulin response," the authors write.

According to a second report from the same study group, "claims about the merits or risks of carbohydrate vs. protein for weight loss diets are extensive, yet the ideal ratio of dietary carbohydrate to protein for adult health and weight management remains unknown."

In this study, 24 women were assigned to either a predominantly carbohydrate diet containing 68 g/day protein with a carbohydrate/protein ratio of 3.5, or to a predominantly protein diet containing 125 g/day protein with a ratio of 1.4. Each diet provided 7100 kJ/day and approximately 50 g/day of fat. Age range was 45 to 56 years and body mass indices were greater than 26 kg/m2.

After 10 weeks, weight loss was 6.96 ± 1.36 kg in the carbohydrate group and 7.53 ± 1.44 kg in the protein group.

Compared with the carbohydrate group, weight loss in the protein group had an increased ratio of fat to muscle loss (6.3 ± 1.2 g/g vs. 3.8 ± 0.9 g/g). Serum cholesterol reduction was approximately 10% in both groups, but only the protein group had significant reductions in triacylglycerols (TAG; 21%) and in the ratio of TAG to high-density lipoprotein cholesterol (23%).



"This study demonstrates that increasing the proportion of protein to carbohydrate in the diet of adult women has positive effects on body composition, blood lipids, glucose homeostasis and satiety during weight loss.

Although it is unlikely that any one diet will be ideal for all individuals, these results indicate that changes in the ratio of protein to carbohydrate toward a higher protein diet can be effective in the control of body weight with parallel improvements in blood lipids.

The National Cattlemen's Beef Association and Kraft Foods helped support this study.