Aspirin guidelines need overhaul, researchers say

NEW YORK (Reuters Health) - Healthy people shouldn't be taking aspirin to prevent heart disease, researchers say in a new report that casts doubt on recommendations from U.S. health officials.

Medical guidelines currently urge people to take low doses of the drug if they are at high risk of heart disease but have never had any symptoms, or if they have already suffered a heart attack.

But the first piece of advice, known as primary prevention, has come under attack from more and more doctors because aspirin therapy can also be harmful.

"What we need to focus on is lifestyle, smoking cessation, and statin and blood pressure medications," said Dr. Kausik Ray, who studies heart disease prevention at St. George's University of London and led the new work. "I don't recommend aspirin."

Ray and his colleagues took a fresh look at nine previous trials of aspirin use in people who had never had chest pain or other symptoms of an ailing heart. They also looked for signs that the medication might stave off cancer, which some research has suggested.

Based on more than 100,000 men and women followed for an average of six years, there was no sign aspirin prevented fatal heart attacks. But it did cause a tiny drop in non-fatal heart attacks.

Among people taking placebo pills without active ingredients, 1.7 percent had a heart attack and survived, compared to 1.3 percent of people on aspirin.

That means 162 people would have to be treated for six years to avert just one non-fatal heart attack, the researchers write in the Archives of Internal Medicine.

There was no difference in fatal heart attacks or cancer deaths, and overall death rates were 3.8 percent in both groups. However, there was a clear harm from taking the drug, which can be bought for pennies at any pharmacy.

"The flipside is, there is a 30-percent increased risk of bleeding and these are not trivial bleeds," Ray told Reuters Health.

The rate of serious bleeding -- say, from a stomach ulcer -- was 10.1 percent among people on aspirin and 9.6 percent in the placebo group.

'A NET HARM'

Even among people at high baseline risk, Ray said, "there is never a net benefit."

For every two cases of heart disease and stroke prevented by aspirin, there were more than three cases of serious bleeding.

"It is actually not net benefit, it is a net harm," Ray said, adding that the findings were the same for men and women.

Other teams of scientists have recently analyzed the same data Ray looked at, and one interpreted the results in favor of aspirin.

Currently, U.S. guidelines all recommend aspirin for primary prevention as long as the benefits outweigh the harms, an equation that depends on baseline risk. This advice is backed by an editorial accompanying the new report.

However, even for people at high risk, not all researchers think aspirin is worth it.

In November, for instance, Dutch researchers reported that 50 women at high risk for heart disease would need to take aspirin for 10 years to see a net benefit for one.

Based on the latest findings, Ray's team concludes, "it is perhaps timely to reappraise existing guidelines for aspirin use in primary prevention."

SOURCE: http://bit.ly/7qXyI Archives of Internal Medicine.

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Statin use tied to more diabetes in women

NEW YORK (Reuters Health) - Cholesterol-lowering drugs may be linked to an increased risk of diabetes, according to a new study of middle-aged and older women.

But researchers said that shouldn't dissuade people with heart disease -- or at risk of it -- from taking so-called statins.

Instead, statin users should try to reduce their risk of diabetes in other ways, such as by losing weight, and should have their blood sugar regularly monitored, they said.

"The conclusion still stands that overall, those people who've got existing heart disease or have had previous strokes, they still would get vast benefits from statins," as would those at high risk for heart disease, said Naveed Sattar, a metabolism and diabetes researcher at the University of Glasgow, UK.

Instead, the finding "may make us a bit more cautious about putting statins in the water, for example," Sattar, who wasn't involved in the new study, told Reuters Health.

In other words, not all people with few heart risks should be taking the drugs, as some researchers have suggested, because they aren't side effect-free.

For their report, Dr. Yunsheng Ma of the University of Massachusetts Medical School in Worchester and his colleagues used data from the Women's Health Initiative, including more than 150,000 diabetes-free women in their 50s, 60s and 70s.

As part of that larger trial, some of the women were prescribed diet changes or took daily hormone therapy or vitamins, while others weren't told to change their diet or lifestyle.

At the start of the study in the mid-1990s, women filled out health questionnaires that included whether or not they were taking statins, as well as information on other diabetes risks, such as weight and activity levels. The researchers then followed participants for six to seven years, on average, and tracked how many of them were diagnosed with diabetes.

In total, just over 10,200 women developed diabetes. Ma's team found that the women who reported using any kind of statin at the start of the study -- about one in 14 of the participants -- were 48 percent more likely to be diagnosed with diabetes than those not taking statins.

That was after considering other known diabetes risks, the researchers reported Monday in the Archives of Internal Medicine.About one-quarter of adults age 45 and older in the United States now take statins -- which run anywhere from $11 to over $200 per month -- to lower their cholesterol and heart disease risks.

Previous studies, mostly in men, have suggested a smaller, 10-to-12-percent increase in diabetes among statin users, according to Sattar.

Those numbers may be more accurate because they come from trials in which participants were randomly assigned to take a statin or not, which can better account for possible differences in groups of patients, he added.

What's more, this type of "observational" study can't prove cause-and-effect.

Still, "broadly speaking, this kind of confirms that stains may well increase diabetes risk," Sattar said. Why that's the case isn't totally clear, he said, but statins' effects on the muscles and liver may lead the body to make slightly more sugar than it normally would, or cause users to exercise a bit less.

'A VERY FAIR TRADE-OFF'

Dr. David Jenkins, a nutrition and chronic disease researcher from the University of Toronto, said the medical community has accepted an increased risk of diabetes with statins as "a very fair trade-off," since statins lower the risk of heart disease, the primary concern related to diabetes.

Still, the findings highlight the importance of monitoring risks for diabetes, including blood sugar levels, and encouraging patients who are on the drugs to try to eat better and be physically active, researchers said.

"Statins will always be with us, they will always be valuable, and we will always prescribe them," Jenkins, who wasn't tied to the new research, told Reuters Health. But, "Statins, brilliant as they are, haven't actually completely precluded the use of changing one's diet and one's lifestyle."

Ma told Reuters Health that there's a need for future studies to evaluate both the risks and benefits of statins for people of different ages and genders, with and without heart disease. For some with high cholesterol, he said, a smart choice may be starting out with changes in diet and lifestyle, before going straight to a statin.

"Each person deserves a careful risk versus benefit assessment," agreed his co-author, Annie Culver, from the Mayo Clinic in Rochester, Minnesota.

Then, she told Reuters Health, "Once (you) receive the statins, don't abandon the idea of making lifestyle changes."

SOURCE: http://bit.ly/fO01ME Archives of Internal Medicine, online.

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Acupuncture little better than 'sham' for migraine

NEW YORK (Reuters Health) - Traditional Chinese acupuncture seems little better than a "sham" version of the procedure when it comes to preventing migraines, a study published Monday suggests.

The findings, reported in the Canadian Medical Association Journal, add to a pattern commonly seen in studies on acupuncture and migraines.

Many have found that people with migraines can get relief from acupuncture. But often, "true" acupuncture has worked no better than "sham" acupuncture -- where the needles are inserted only to a superficial depth in the skin, or into sites that are not considered acupuncture points in traditional medicine.

That raises the question of whether acupuncture works by "non-specific" effects, according to the researchers on the new study, led by Dr. Ying Li of Chengdu University of Traditional Chinese Medicine in China.

That is, some people might feel better because they expect to, or because of the personal attention from the acupuncturist.

But other experts said that the findings do not mean that acupuncture offers nothing more than a "placebo effect" for migraine sufferers.

For the study, Li's team recruited 480 adults who had migraines at least twice a month.

They randomly assigned people to one of four groups: In three, patients were given one of three different types of acupuncture that focused on traditional points, with electrical stimulation added to the needling; the fourth group received a sham version.

In the sham group, needles were inserted in the skin at non-traditional sites, with electrical stimulation. But the needles were not manipulated to create a so-called "de qi" sensation.

Patients in all four groups were offered 20 acupuncture sessions over four weeks.

In the month after treatment ended, migraine sufferers in all four groups were reporting fewer headache days, Li's team found.

On average, they had migraine pain on about three days out of the month -- down from around six days at the study's start.

In the third month after treatment, the "real" acupuncture groups were doing slightly better, while the sham group held steady at around three headache days. But the advantage was "clinically minor," according to Li's team, who did not respond to requests for comment.

'SHAM' MAY HAVE REAL EFFECTS

So does that mean acupuncture's benefits are all in your head?

No, according to Dr. Albrecht Molsberger, of Ruhr University Bochum in Germany, who wrote an editorial published with the study.

The problem, he told Reuters Health by email, is that sham acupuncture is not a true placebo -- and may have real physiological effects.

According to traditional Chinese medicine, acupuncture eases pain by stimulating certain points on the skin believed to affect the flow of energy, or "qi" (pronounced "chee"), through the body.

But some modern research suggests that the needle stimulation triggers the release of pain- and inflammation-fighting chemicals in the body, even if it doesn't strictly follow traditional principles.

"The sham acupuncture effect is so strong and long lasting, that this suggests that other factors, like the stimulation of cytokines or endorphins, are important too," Molsberger said.

And even though real acupuncture has not clearly beaten the sham version, it has outperformed standard migraine treatments in some studies.

A recent research review looked at four clinical trials that tested acupuncture against medications proven to prevent migraine attacks. Overall, acupuncture patients reported somewhat fewer migraines in the couple months after treatment, with fewer side effects.

Dr. Jongbae J. Park, who directs Asian Medicine & Acupuncture Research at the University of North Carolina at Chapel Hill School of Medicine, agreed that the sham in this study was not a true placebo.

"In my mind, it's far from being a true 'control,'" Park said in an interview.

In fact, Park said, the issue with acupuncture research in general is that sham procedures vary from study to study.

Researchers need to settle on a form of true placebo that is used consistently, according to Park -- who acknowledged that questions about acupuncture's effectiveness remain, and further studies are needed.

But based on research overall, acupuncture "should be an option" for treating migraines, said Molsberger, who is also president of Forschungsgruppe Akupunktur, which profits by offering acupuncture training.

Acupuncture is considered a generally low-risk procedure, with side effects like bruising at the needle site. The cost can vary widely -- and may or may not be covered by insurance -- but a session would typically start around $100.

At his center, Park said a typical migraine patient might start with six weekly sessions, and then come monthly, tapering down to once every six months. But the acupuncture sessions would also involve "whole-person" care, with advice on diet, sleep and other lifestyle habits.

There are, of course, other ways to tackle migraines. Several types of medications can prevent attacks, including a group of drugs known as triptans, certain antidepressants, high blood pressure drugs and anti-seizure medications.

Another non-drug option is biofeedback, in which people learn to control the physical responses to stress, like muscle tension -- which may help head off or ease migraine pain.

SOURCE: http://bit.ly/wdot9I Canadian Medical Association Journal, online.

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