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Weight-loss pills "shouldn't be used alone," said Dr. Susan Yanovski, director of the Obesity and Eating Disorders Program at the U.S. National Institute of Diabetes and Digestive and Kidney Diseases. She's also the author of a commentary on the Meridia (sibutramine) study, published in the Nov. 17 issue of the New England Journal of Medicine.
"The real take-home message from this article is that when you combined lifestyle modification with the weight-loss drug, you lost twice as much weight," she said. "You lost more than 26 pounds with combined treatment vs. 11 pounds with sibutramine alone."
Meridia is just one of two weight-loss drugs currently approved for use by the U.S. Food and Drug Administration, the second being Xenical (orlistat). A second article in the same issue of the journal found promising results for a third medication, rimonabant, which is currently undergoing FDA review.
Most obesity experts say lifestyle changes, especially improved diet and exercise, are the real keys to shedding excess pounds. But Dr. Thomas Wadden, director of the Weight and Eating Disorders Program at the University of Pennsylvania Medical School, said many overweight Americans still find it tough to lose weight.
"There's nothing worse than to be watching your calories and exercising, but the scale just doesn't budge," said Wadden, who was also lead researcher on the Meridia-plus-lifestyle study. "You just feel like, 'My efforts are for naught.' That's when people tend to give up."
And that's when diet pills may come in handy, according to Yanovski. "All the weight-loss drugs have shown generally what I'd consider a modest weight loss compared with placebo, usually in the range of five to 15 pounds additional weight loss," she said.
Few studies have focused on whether this modest weight loss might be improved upon if diet-pill users also switched to low-calorie diets and exercised more.
In its one-year trial, Wadden's team randomly assigned 224 obese adults to either 15 milligrams of Meridia per day or the same dose given in conjunction with counseling on how to drop weight through environmental changes, improved diet and exercise.
Among other things, the counseling "teaches you how to stay away from all-you-can-eat buffets and fast-food restaurants, gets you to keep food records and to shop from a [healthy foods] list," Wadden explained.
These changes, along with a healthy diet and physical activity, "helps you modify the external environment," Wadden said, while drugs such as Meridia "help modify the internal environment" as they work on brain chemicals to lower appetite and help patients feel fuller, sooner.
The combination seems to work: According to the researchers, people taking Meridia who also changed their lifestyles lost double the amount of weight compared to those who took the drug but made no lifestyle changes.
The bottom line? When it comes to obesity, "Don't look for a quick fix from the drug store," Yanovski said. "Combining therapy seems to be much more effective than drug treatment alone."
A second study in the journal looked at the potential of an experimental drug, rimonabant, in helping obese individuals shed weight over the course of one year.
"Rimonabant is a little bit different in that it acts not only on the brain but also on other tissues in the body, such as fat cells and those in the gastrointestinal tract," Yanovski said.
The international study was led by Jean-Pierre Despres of Laval University in Ste.-Foy, Quebec, Canada and involved more than 1,000 overweight or obese patients with untreated high cholesterol. Participants were given either daily rimonabant (at doses of 5 milligrams or 20 milligrams) or a placebo, and were also placed on a low-calorie diet.
The researchers reported that rimonabant did help users lose an average of just under seven kilograms (15 pounds) over one year. And the drug may have an added health benefit, since it also seemed to lower levels of dangerous blood fats known as triglycerides while boosting blood levels of HDL "good" cholesterol.
"We know that it improves [cardiovascular] risk factors, but we don't know yet if that translates into a reduction in heart disease or death," Yanovski said.
While drugs such as Meridia, Xenical and rimonabant can help shrink waistlines, keeping that weight off may be the toughest part, Wadden said. Study after study has shown that obesity can easily return once individuals quit exercising and eating right, or stop using a weight-loss medication.
"We now realize that people may have to take weight-loss medications on a long-term basis," Wadden said, "just like they have to take other medications such as those that control cholesterol or high blood pressure."
In the case of Meridia, that means long-term physician monitoring, too, since the drug can trigger a rise in pulse rate and blood pressure in about 10 percent of users, the researchers said.
The Meridia study was supported by a grant from the National Institute of Diabetes and Digestive and Kidney Diseases, while the rimonabant study was funded by the drug's maker, Sanofi-Aventis.
A third study, appearing in the December Annals of Behavioral Medicine, found that people who get in the habit of weighing themselves each day are more successful at keeping obesity at bay.
The study involved more than 3,000 obese or overweight individuals enrolled in weight-loss programs for two years. Researchers at the University of Minnesota found that those who checked their weight daily lost more than those who didn't.
"If people see that their [weight] has gone up, they may realize it's time to do something. It's probably easier to make that small correction," lead researcher Jennifer Linde said in a prepared statement.
All that monitoring and hard work could pay off, though, since even minor weight loss can trigger major health benefits.
According to Wadden, "the Diabetes Prevention Program showed that if people lost just 7 percent of their initial body weight -- about 15 pounds through 150 minutes of exercise per week -- they reduced their risk of developing type 2 diabetes by 58 percent. A little bit of weight loss goes a long way."
More information
Find out more about obesity at the U.S. National Institute of Diabetes and Digestive and Kidney Diseases.
The condition affects about 10 million American women each year. It can cause fatigue and anemia and restrict a woman's personal and professional activities.
The survey of 653 women ages 35 to 49 who experience menorrhagia found that 58 percent have not discussed their condition with a health-care provider, even though menorrhagia greatly affects their lives and is easily treated.
Among the women who have sought treatment, 82 percent had to bring up the topic with their health-care provider, and 62 percent waited more than a year to do so, the survey found.
The survey was funded by an unrestricted educational grant from the Cytyc Corporation, which markets NovaSure, a medical device used to treat menorrhagia.
"Given the dramatic impact this condition has on a woman's daily life, it is unfortunate that the majority of women we surveyed accepted this monthly burden as something they just have to live with, when, in fact, that is not the case at all," Amy Niles, NWHRC president and CEO, said in a prepared statement.
"This condition restricts women in the most personal ways, from their sexual activity to spending quality time with their families and friends," Niles said.
"Treatment for this condition is broadly available. What's critical is that women and their health-care provider discuss menstruation as part of a routine physical exam. Beginning a dialogue about this vastly under-diagnosed condition and available treatment options -- both between a woman and her doctor and among national health-care leaders -- is the first step toward helping women live healthier more enjoyable lives," Niles said.
More information
The American Academy of Family Physicians has more about menstrual problems.
The new diet shifts about 10 percent of calories from carbohydrates to either protein-rich foods or to monounsaturated fats such as olive or canola oil.
"This diet should be a frontrunner," said Dr. Frank Sacks, one of the authors of the study and a professor of medicine and nutrition at Brigham and Women's Hospital and Harvard in Boston. "It improved the whole cardiovascular risk spectrum. A lot of patients are tough to control with the medications we have. Patients might not even need drugs if they go on the diet."
"This is a modified version of the old diet," Sacks explained. "The DASH diet was a real breakthrough for lowering blood pressure and we changed it. We reduced the carbohydrate content and replaced it with unsaturated fat or protein, and it lowered blood pressure more and improved lipids, and overall cardiovascular risk goes down."
He called the new regimens "an improvement over something that's already good."
Another expert agreed that the two new versions of the DASH diet, as well as the original DASH, which was developed by the National Heart, Lung and Blood Institute, should work.
"These are just alternative versions," said Dr. Jay Skyler, a professor of medicine and associate director of the diabetes research institute at the University of Miami School of Medicine. "To me, whether you get a little bit more lowering with one or another diet than the other matters less than the fact that you ought to stick to any one of these three. They're all better than the conventional diet that these people were on."
The findings were presented Tuesday at the American Heart Association's annual meeting in Dallas, and also appear in the Nov. 16 issue of the Journal of the American Medical Association.
The DASH diet has been considered the gold standard of heart-healthy nutrition since it was pioneered in the mid-1990s. The original diet was carbohydrate-rich, emphasizing fruits, vegetables and low-fat dairy products. Unfortunately, in addition to lowering "bad" or LDL cholesterol, the regimen also reduced "good" or HDL cholesterol, and had no effect on blood fats called triglycerides.
To help make the regimen even healthier, the same researchers updated the diet and compared the two new versions with the old one.
For this study, 164 adults aged 30 and older with elevated blood pressure were assigned to one of three diets: one in which carbohydrates represented 55 percent of calories (close to the original DASH diet); one that shifted 10 percent of carbohydrate calories to protein (about two-thirds from plant sources and the rest from chicken and egg whites); and one that shifted 10 percent of calories to unsaturated fat, mostly olive or canola oils. About half of the participants were black, a group at especially high risk of developing hypertension.
All of the diets lowered participants' blood pressure, LDL cholesterol and estimated coronary heart disease risk, the researchers report, and the protein and unsaturated fat diets showed even better improvements.
Compared to the old diet, the enhanced-protein version decreased blood pressure by an extra 1.4 mm Hg overall and by an extra 3.5 mm Hg among those with hypertension; it decreased LDL cholesterol by an additional 3.3 mg/dL and triglycerides by 15.7 mg/dL.
Compared to the original DASH diet, the unsaturated fat-rich version decreased systolic blood pressure by an additional 1.3 mm Hg overall and by 2.9 mm Hg among those with hypertension; it increased HDL cholesterol by an extra 1.1 mg/dL and lowered triglycerides by 9.6 mg/dL.
Both the protein and unsaturated fat diets reduced heart disease risk more than the DASH diet.
Breakfast was similar in all three diets and included fresh fruit, fruit juice, whole grain cereal and skim milk. Lunches and dinners were varied. A typical protein-diet dinner might include one ounce of raisins and cherries, where the carbohydrate dinner included a peppermint patty.
How practical are the improvements? All the study participants were given their meals. In the real world, people will have to prepare these meals themselves.
"Would people be able to stick to any of these as effectively when they're doing it at home? That's the unknown thing here," Skyler said. "I think whatever people will stick to and are happy with will work. I would be happy with the results of any of these three."
Sacks said his team was working on making the diet easy to use. "Our next project is to work on foods and menus and things that people can use, to give people more specific guidance," he said. "Hopefully that'll be out in a couple or three months. We feel a sense of urgency to get some real practical stuff out like we did with the DASH diet."
An accompanying editorial also emphasized the need for lifestyle changes such as more exercise, in addition to diet, to keep blood pressure low.
A second study, also presented Tuesday at the American Heart Association meeting, found that men and women who reduced their sodium intake lowered their risk of cardiovascular disease or death by 26 percent.
More information
For more on the original DASH diet, head to the National Heart, Lung, and Blood Institute.
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