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July 16, 2008

Breast Self-Exams Do Not Appear to Reduce Breast Cancer Deaths

Filed under: Uncategorized — @ 1:00 am

It is a staple of women’s health advice and visits to the OB/GYN: the monthly breast self-exam to check for lumps or other changes that might signal breast cancer. However, a review of recent studies says there is no evidence that self-exams actually reduce breast cancer deaths.

Instead, the practice may be doing more harm than good, since it led to almost twice as many biopsies that turned up no cancer in women who performed the self-exams, compared to women who did not do the exams.

“At present, screening by breast self-examination or physical examination [by a trained health worker] cannot be recommended,” Jan Peter Kosters, Ph.D., and Peter Gotzsche, Ph.D., of the Nordic Cochrane Centre, conclude in the review.

The review is an updated version of a 2003 review of studies, which came to a similar conclusion.

Debbie Saslow, Ph.D., director of breast and gynecologic cancers for the American Cancer Society, said the assoication revised its guidelines and stopped recommending monthly breast self-exams five years ago in light of the evidence that had emerged. The guidelines now call the monthly exam “an option” for women beginning in their 20s.

“We are advising that women should be aware of what is normal for how their breasts looked and felt, and to promptly report any changes to their health care provider,” Saslow said. “Women who want to should keep doing breast self-exam, and women who don’t want to, don’t need to.”

The authors recognize that some women will want to continue with breast self-exams and women should always “seek medical advice if they detect any change in their breasts that might be breast cancer,” Kosters said.

“We suggest that the lack of supporting evidence…should be discussed with these women to enable them to make an informed decision,” he said.

Carolyn Runowicz, director of The Carole and Ray Neag Comprehensive Cancer Center at the University of Connecticut Health Center, encourages women to do the self-exams if they are comfortable with them, noting that 50 percent to 60 percent of women detect their own breast masses.

“I think what we are seeing is that women are familiar with their breast through breast self-exam and when there is a lump, they notice the difference,” she said.

The new review appears in the latest issue of The Cochrane Library, a publication of The Cochrane Collaboration, an international organization that evaluates medical research. Systematic reviews like this one draw evidence-based conclusions about medical practice after considering both the content and quality of existing medical trials on a topic.

In the two large studies of 388,535 women in Russia and China included in the review, women who used self-breast exams had 3,406 biopsies, compared with 1,856 biopsies in the group that did not do the exams. At the same time, there was no significant difference in breast cancer deaths between the two groups.

The China study published data on how breast cancers detected in the women were treated. Rates of both mastectomy and breast-conserving surgery such as lumpectomy were very similar between the exam and no-exam groups.

Kosters JP, Gotzsche PC. Regular self-examination or clinical examination for early detection of breast cancer. The Cochrane Database of Systematic Reviews 2008, Issue 3.

The Cochrane Collaboration is an international nonprofit, independent organization that produces and disseminates systematic reviews of health care interventions and promotes the search for evidence in the form of clinical trials and other studies of interventions. Visit http://www.cochrane.org for more information.

Long-Acting Insulin: Safer, Slightly Tighter Glucose Control in Type 1 Diabetes

Filed under: Uncategorized — @ 1:00 am

Introduced this decade, the long-acting insulin medications glargine and detemir have largely replaced the older intermediate-acting insulin NPH in the treatment of type 1 diabetes. However, a review of studies reveals that the newer drugs offer only a slight benefit over NPH in terms of blood glucose control.

The researchers did see a clear benefit of long-acting insulin in the risk for hypoglycemia — dangerously low blood glucose that can result from insulin injections — particularly at night.

The review comprised 23 studies of more than 6,500 people.

“Long-acting insulin preparations have gained much popularity in recent years for the treatment of type 1 diabetes mellitus,” said review author Moshe Vardi, M.D. “Our objective was to assess whether there is a significant clinical advantage for these drugs.”

Vardi, a physician in the internal medicine department at Carmel Medical Center in Haifa, Israel, said pharmaceutical companies have waged a tremendous marketing campaign to promote these newer insulin medications.

The review appears in the latest issue of The Cochrane Library, a publication of The Cochrane Collaboration, an international organization that evaluates medical research. Systematic reviews draw evidence-based conclusions about medical practice after considering both the content and quality of existing medical trials on a topic.

Type 1 diabetes — formerly called juvenile diabetes because of its early onset in children, teenagers and young adults — accounts for only about 5 percent of all cases of diabetes. Patients with type 1 diabetes have a defect in the pancreas that prevents them from making enough insulin. All patients with type 1 diabetes require insulin treatment to control blood glucose.

The newer therapies allow for insulin replacement that more closely mimics how the body releases insulin. To do this, injected insulin needs to replace basal or “background” insulin secretion that occurs at a continuous level in the body, as well as to replace the spike in insulin that occurs after eating a meal.

Most people with type 1 diabetes inject basal (long- or intermediate-acting) insulin once or twice a day under the skin, with additional boluses of short- or rapid-acting insulin at meals. Insulin pumps are an alternative option.

The intermediate-acting insulin NPH has served to help replace basal insulin secretion since the 1950s; however, some physicians consider the newer long-acting insulin analogues glargine and detemir to be clinically superior to NPH. Most of the review studies compared glargine or detemir with NPH.

To determine effectiveness, the researchers looked at the results for hemoglobin A1c, a widely used measure of long-term blood glucose control. They also looked at fasting glucose levels in the blood.

To assess safety, they evaluated rates of hypoglycemia and adverse events. In severe cases, hypoglycemia can lead to seizures or coma if left untreated. Because type 1 patients often need large amounts of insulin, the risk of hypoglycemia is much greater in type 1 patients than in insulin-treated type 2 patients.

The researchers found that long-acting insulin medications offered only a slight improvement in A1c and blood glucose levels over intermediate-acting options.

“We were surprised to find such a minor advantage in the overall glucose-lowering abilities of the long-acting drugs compared to the older, intermediate-acting drugs,” Vardi said.

However, when compared with intermediate-acting insulin, long-acting insulin medicines decreased the risk for severe nighttime hypoglycemia by 30 percent. The review noted no additional differences between the two types of insulin for other adverse events.

Irl Hirsch, M.D., an expert in type 1 diabetes from the University of Washington School of Medicine’s Diabetes Center in Seattle, said that currently there is very little use of NPH in the treatment of type 1 diabetes in the United States, primarily because the newer insulin medications are much less likely to cause severe hypoglycemia.

“The reduction in the frequency of hypoglycemia has been profound,” Hirsch said. “Insulin analogues have totally revolutionized our ability to reduce hypoglycemia in adults with diabetes in the U.S.”

Despite the review findings, Hirsch said, “NPH is not a good basal insulin,” because it has an unnatural peak in its action that the long-acting medications glargine and detemir do not have. This difference becomes more important in patients aggressively trying to reduce their A1c levels to a target normal level, which many diabetic patients do not try to achieve. This could explain why many studies do not find differences in blood glucose control between intermediate- and long-acting insulin choices, he said.

However, the review authors concluded, “When compared to intermediate-acting insulin, their effect on glucose control appears to be subtle, if at all.” Vardi cautioned that none of the studies examined risks for development of long-term diabetes-related complications, such as heart disease, blindness or kidney disease.

Vardi M, et al. Intermediate acting versus long acting insulin for type 1 diabetes (Review). Cochrane Database of Systematic Reviews 2008, Issue 3.

The Cochrane Collaboration is an international nonprofit, independent organization that produces and disseminates systematic reviews of health care interventions and promotes the search for evidence in the form of clinical trials and other studies of interventions. Visit http://www.cochrane.org for more information.

Contests to Quit Smoking Don’t Work in Long Run

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Face it: we all have our price. Still, despite prizes ranging from lottery tickets to cash payments, quit-smoking contests do not help people kick the habit in the end, according to a new systematic review of studies.

None of the 17 studies, which involved roughly 6,300 participants, demonstrated significantly higher long-term quit rates for smokers offered incentives, despite some creative approaches.

In one study, participants were encouraged to toss their cigarettes down the toilet and rewarded with one lottery ticket per day. Another offered payments of $10 per month and participation in a monthly worksite lottery. Yet another offered cash prizes ranging from $100 to $250, along with certificates of recognition.

The review appears in the latest issue of The Cochrane Library, a publication of The Cochrane Collaboration, an international organization that evaluates medical research. Systematic reviews draw evidence-based conclusions about medical practice after considering both the content and quality of existing medical trials on a topic.

Studies occurred in the United States, Canada, the United Kingdom and Australia. Workplaces and clinics were common settings for the competitions.

“In my view, none of them was effective,” said review co-author Kate Cahill at the University of Oxford. “One of our main conclusions was that if incentives work at all, they only work while they’re in place; if you revisit those quitters 12 or 24 months down the line, they [smokers offered incentives] were generally no more successful” than counterparts not offered incentives.

One-year cessation rates for participants in one study were 22 percent — more than double that of those not offered incentives. However, by the one-year evaluation, the quit rate for participants was much closer to that of non-participants. In addition, the difference between participants and the group not offered incentives “had become non-significant at the two-year follow up,” the reviewers found.

Offering incentives is a tricky business. “An effective incentive should be large enough to attract smokers motivated to try and quit, but not so attractive that the desire to win outweighs the seriousness of the quit attempt,” the reviewers say.

In a 1994 paper, which was not part of the Cochrane review, an Australian researcher described how one smoking-cessation competition offered a $30,000 car as a grand prize.

By polling entrants after the contest, researchers “found that 34 percent were either ex-smokers or never-smokers who had entered the contest solely in order to win the prize, confident that they could confirm their smoke-free status with a breath sample.” Cahill recalled. “I think it’s a perfectly valid approach to reward people for entering a smoking cessation program … but the risk of deception rises with the scale of the cessation rewards.”

In a landmark announcement in 1964, the U.S. Surgeon General linked smoking and cancer. Census records show that as of the next year, 42 percent of all adults were “current” smokers. By 2006, after years of public awareness and education campaigns, roughly 21 percent identified themselves as current smokers. That dramatic decrease will be counted as one of the public health successes of the 20th century, said Michael Fiore, director of the University of Wisconsin Center for Tobacco Research and Interventions.

However, the pool of smokers — including younger people — is dynamic and health officials still struggle to eliminate tobacco use with limited resources. Fiore said that the cessation contests in the review clearly did not offer a big bang for the buck. However, he added, “Maybe some of these programs have collateral benefit, in that they encourage people – who may not have thought about quitting – to quit.”

There is no one unequivocal way to eliminate all tobacco use. Efforts hinge on prescription drug treatments, counseling and 1-800-QuitNow telephone lines. “Smokers are extraordinarily diverse as individuals,” Fiore said. “There is never going to be a one size fits all.”

If it were easy, it would have happened by now, researchers say. “We have an enormous number quitting every year. There are not a lot of smokers who say ‘I smoke and I love it,’” Fiore said. It is more common, he said, to encounter smokers who feel ‘hooked,’ who feel trapped by a disease, who feel discouraged in dealing with a powerful drug of dependence.”

Public health officials continue a barrage of efforts — including contests. Earlier this summer, a Scottish Health Board announced a three-month incentive plan in Dundee, Cahill said. Smokers who pass a weekly breath test will get the equivalent of about $24 each time in the form of grocery credit. Winners cannot use the money for alcohol or tobacco.

Cahill K, Perera R. Competitions and incentives for smoking cessation (Review). Cochrane Database of Systematic Reviews 2008, Issue 3.

The Cochrane Collaboration is an international nonprofit, independent organization that produces and disseminates systematic reviews of health care interventions and promotes the search for evidence in the form of clinical trials and other studies of interventions. Visit http://www.cochrane.org for more information.

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