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March 30, 2010

Placebo Effect Helps Some Psoriasis Patients

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esearchers have long wondered why placebos — fake medications — sometimes help sick patients get better.

Now, a new study says placebos can help psoriasis patients get by on smaller doses of a steroid drug that dampens their immune systems.

The study authors, from the University of Rochester Medical Center in New York, think they may be able to develop other treatments that rely on the placebo effect to boost the power of lower doses of existing drugs.

“Our study provides evidence that the placebo effect can make possible the treatment of psoriasis with an amount of drug that should be too small to work,” lead investigator Dr. Robert Ader, a professor at the University of Rochester School of Medicine & Dentistry, said in a news release from the school. “While these results are preliminary, we believe the medical establishment needs to recognize the mind’s reaction to medication as a powerful part of many drug effects, and start taking advantage of it.”

There are limitations, however. Placebos can’t help people who are unconscious or stimulate the release of substances in the body, such as insulin, Ader said.

The researchers tested creams on 46 patients with mild and moderate cases of psoriasis. One group got fully medicated creams, while others got mixtures that were partially medicated or received full doses only part of the time.

In some cases, the patients seemed to do well despite not getting the full dose, suggesting a psychosomatic effect.

March 28, 2010

Proteins show promise for ovarian cancer screening

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Elevated levels of three proteins show ovarian cancer is starting to grow years before women are diagnosed, but they do not increase soon enough to be an early indicator of the disease, U.S. researchers said on Wednesday.

The researchers analyzed blood samples from a large clinical trial and identified 34 women with ovarian cancer along with a control group of 70 women who did not have cancer. Their blood samples were used to evaluate six proteins identified as potential indicators of ovarian cancers.

Levels of three of the proteins began to increase slightly in ovarian cancer patients three years before diagnosis but did not reach a level that could be detected in a screening program, the researchers wrote in the Journal of the National Cancer Institute.

“Even though an elevation appears to start in women with cancer maybe three years before her symptoms lead her to the doctor the levels aren’t really what we’d probably define as abnormal until within the last year before diagnosis,” wrote lead author Garnet Anderson of the Fred Hutchinson Cancer Research Center in Seattle.

There is no simple and reliable screening program to test for ovarian cancer in women who do not have symptoms.

Ovarian cancer, which mainly strikes older women, causes more deaths than any other cancer of the female reproductive system. Women diagnosed in the earliest stages have a five-year survival rate of nearly 93 percent, according to the American Cancer Society.

SEEKING EARLY DETECTION

Researchers seeking to a screening program to detect ovarian cancer are looking for something similar to the PSA for prostate cancer, Anderson said.

PSA, or Prostate-specific antigen, is a protein monitored for early detection of prostate cancer in men.

“We’d like that for ovarian cancer because it’s clear that women who are detected at the stage where the disease is still confined to the ovaries do very well. Their prognosis is excellent,” Anderson said.

“CA125, which is one of the markers we looked at, is the best biomarker that’s been identified to date and our study confirms that and this prediagnostic period as well. But it’s not sufficiently accurate.”

In an accompanying editorial, Patricia Hartge of the National Cancer Institute said the authors had taken research at step closer to a successful screening design.

“The careful evaluation technique applied in the current study fits into a staged approach necessary for testing performance of early markers of disease,” Hartge wrote.

The U.S. Centers for Disease Control and Prevention estimates that more than $2.2 billion is spent on the treatment of ovarian cancer per year in the United States.

March 27, 2010

Quitting smoking after heart attack extends lives

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Confirming that it really is never too late to quit smoking, a new study finds that heart attack survivors who kick the habit live longer than those who keep puffing away.

The study, which followed more than 1,500 heart attack survivors for 13 years, also found a survival advantage for smokers who did not quit but managed to cut down on cigarettes.

Israeli researchers found that compared with first-time heart attack sufferers who continued to smoke, those who quit were 37 percent less likely to die during the study period. That was close to the risk reduction seen among heart attack survivors who had never smoked — who had a 43 percent lower risk of dying during the study than persistent smokers.

Meanwhile, patients who had quit smoking sometime before their heart attack were half as likely to die during the study period as smokers who kept up the habit.

The findings, reported in the Journal of the American College of Cardiology, bolster the case for routinely offering heart attack patients smoking-cessation counseling — which other studies have suggested can lower the risk of further complications.

“Smokers who have had a heart attack should be provided with appropriate interventions to help them quit,” write Dr. Yariv Gerber and colleagues from Tel Aviv University.

The study included 1,521 adults age 65 and older who were treated at one of eight Israeli hospitals for a first-time heart attack in 1992 or 1993. At the time, 27 percent had never smoked, 20 percent were former smokers, and more than half were current smokers. After hospital discharge, a majority of smokers tried to quit; 35 percent managed to remain continuously abstinent over the next 10 to 13 years.

A total of 427 patients died during the 13-year study period. The risk was greatest among those who had continued to smoke, even with factors like obesity, exercise habits, education and income, and overall health taken into account.

And while quitting altogether was best, smokers who cut back after their heart attack also improved their outlook, Gerber’s team found.

Among the 381 patients who continued to smoke, the risk of dying during the study period declined by 11 percent for every five daily cigarettes they cut out.

The researchers point out that the quit rates in this study — with more than one-third continuously abstinent for at least a decade — were high as compared with the norm for smokers, but consistent with what’s been seen for heart attack survivors.

They also note that the benefits of quitting, either before or after a heart attack, are at least as great as those of other common therapies to prevent further heart problems — including cholesterol lowering, and use of aspirin and beta-blocker medications, which lower the risk of death by anywhere from 15 percent to 29 percent.

February 28, 2010

Angioplasty Outcomes May Vary Little Between Hospitals

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Do hospitals that conduct the most angioplasties necessarily produce the best results for patients? Maybe not.

Prior research had suggested that “practice makes perfect” when it comes to artery-opening procedures, but a new study involving over 30,000 patients finds low- and high-volume hospitals performing more or less equally.

The study included patients with what are called primary angioplasties, cared for at 166 hospitals across the United States between 2001 and 2007.

The researchers found no significant difference in outcome between medical centers that did high volumes of such procedures and those that didn’t do all that many.

“The message here is that volume alone is not a sufficient target marker for outcome,” said study senior author Dr. Deepak Bhatt, chief of cardiology at the VA Boston Healthcare System and associate professor of medicine at Harvard Medical School. His team reported the findings in the Nov. 25 issue of the Journal of the American Medical Association.

Studies done several years ago did find better results at high-volume hospitals, “but I think things have changed,” Bhatt said. “Devices and techniques, and overall results have improved.”

Hospitals were classified in three groups: low-volume, with fewer than 36 primary angioplasties a year; middle-volume, between 36 and 70 procedures; and high-volume, with 70 or more procedures a year.

The in-hospital death rate was 3 percent for high-volume hospitals, 3.2 percent for medium-volume hospitals and 3.9 percent for low-volume hospitals, a difference that is not statistically significant, the report said.

The length of hospital stays was virtually the same for all hospitals: 4.6 days for low-volume, 4.5 days for medium-volume, 4.7 days for high-volume. But there was a difference in the interval between arrival at the hospital and beginning of angioplasty: 98 minutes for low-volume hospitals, 90 minutes for medium-volume and 88 minutes for high-volume. And high-volume hospitals were more likely to fulfill the guideline recommending start of an angioplasty within 90 minutes of arrival at a hospital.

Overall, the new findings are “really good news for patients in general, because it means that whatever hospital you go to, the result is likely to be good,” said Dr. Issam D. Moussa, associate professor of medicine and director of the endovascular service at Weill Medical College of Cornell University, New York City, and a spokesman for the Society for Cardiovascular Angiography and Interventions.

The study results also confirm current guidelines about emergency treatment for heart attacks, Moussa said. “When they pick you up, they should take you to the nearest hospital,” he said. “This study doesn’t change that.”

But he also said the findings of the study were not unshakable because of the relatively small number of people treated in low-volume hospitals.

“Low-volume hospitals [in the study] included only 3,000 patients,” Moussa said. “Because of that low number, the results cannot be conclusive.”

The difference between in-hospital death rates found in the study might have been statistically significant had the numbers been higher, he said. And the study also excluded about 120 hospitals because they reported too few primary angioplasties, Moussa said.

The study also looked only at in-hospital deaths, Bhatt noted. “If we looked at longer-term outcomes, differences might emerge,” he said.

Still, the study casts some doubt on the notion that in cardiology, practice makes perfect, Bhatt noted. “Within the range we studied and the kinds of hospitals we studied, the difference was not there,” he said.

In a related study published in the same issue of the journal, Norwegian researchers say that giving out-of-hospital cardiac arrest patients intravenous epinephrine therapy does not boost long-term survival.

A team from Oslo University compared outcomes for over 850 patients experiencing out-of-hospital cardiac arrest. Half received standard IV epinephrine as part of advanced cardiac life support, while the other half did not. The team found that about 10 percent of patients survived to hospital discharge, whether or not they had received the IV treatment.

February 22, 2010

Antioxidants could help preserve muscle strength

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In a study in older adults, dietary intake of vitamins C and E was linked with muscle strength, leading the researchers to suggest at a meeting in Atlanta this past weekend that a diet high in antioxidants could play an important role in preserving muscle function in older adults

“Muscle strength is really a marker of aging,” one of the investigators, Dr. Anne Newman of the University of Pittsburgh, told Reuters Health. “Muscle strength starts declining when people are in their 40s, but it decreases dramatically after age 60.”

This decline is “a major risk factor” for becoming frail and disabled, she said, but certain strategies may slow down the loss.

In previous work, Newman and her associates identified physical activity and, separately, dietary protein as important for maintaining muscle strength.

For their current study, to evaluate the potential benefits of micronutrients, the researchers asked more than 2,000 men and women in their 70s about their long term eating habits. They also measured participants’ grip strength at the outset and two years later.

On Saturday at the Gerontological Society of America’s annual meeting, the researchers reported a significant positive link between dietary intake of vitamins C and E and subsequent change in muscle strength, regardless of participants’ initial strength levels.

At this point, it’s not clear whether vitamins C and E specifically help preserve muscle strength, or if intake of these micronutrients is a marker of a healthy diet, Newman said. “Since they’re in the food, they could be directly related, or they could be marking diets high in fruits and vegetables and low in sodium — all of which would have beneficial effects.”

The average daily dietary intakes of vitamins C and E in the study were 144 milligrams and 11 milligrams, respectively. “For vitamin E at least, our cohort’s intake was on average a little lower than the recommended daily allowance,” Newman pointed out. “So while it’s possible to get enough of this micronutrient in the diet, you have to pay attention and be sure to include foods rich in that vitamin.”

The team is trying now to determine “the optimal level of physical activity and optimal nutrients in the diet that will preserve muscle strength,” Newman said.

Meanwhile, she added, the current findings provide “another reason for doctors to encourage patients to eat a balanced diet, rich in fruits and vegetables.”

Newman cautioned consumers not to start taking high-dose supplement of vitamins C and E. “In clinical trials with very high doses of antioxidants, you don’t see any benefits and in some cases, they’re potentially harmful,” the researcher said.

February 16, 2010

Childbirth May Slow Progression of Multiple Sclerosis

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Having children may slow the progression of multiple sclerosis, new research suggests.

Belgian researchers followed 330 women who had experienced their first MS symptoms between the ages of 22 and 38.

Women who had given birth to at least one child were 34 percent less likely to have the disease progress to a stage in which they needed walking assistance, such as a cane or brace, than women without children.

While having a baby either before or after the onset of MS symptoms seemed to help, women who had a child after they began experiencing MS symptoms were even better off. During the study, women with MS symptoms who’d had a baby were 39 percent less likely to have their disease progress to the point of needing walking assistance. In the study, women had the disease for an average of 18 years.

“Women with MS who have children seem to have a more benign MS course than those who don’t,” said study author Marie D’hooghe, of the department of neurology at Nationaal MS Centrum in Melsbroek, Belgium.

The research appears in the Nov. 24 online issue of the Journal of Neurology, Neurosurgery & Psychiatry.

Multiple sclerosis is an autoimmune disease in which the body’s own defense system attacks myelin, or the protective fatty substance that surrounds nerve fibers in the central nervous system, according to the National Multiple Sclerosis Society. The damage causes a disruption to nerve signals traveling to and from the brain, which causes the numbness, walking problems, blurry vision and fatigue.

About 85 percent of those with MS start with a relapsing-remitting course, in which attacks are followed by partial or total recovery, according to the study. More than half go on to develop a more progressive form of the disease, in which symptoms worsen over time and there are fewer, shorter periods without symptoms. Eventually, the disease can lead to loss of vision and paralysis.

Women are twice as likely to develop MS as men, though women tend to have less severe cases than men, according to the study.

About three-quarters of the women in the study had children. The researchers measured the time it took for women to reach level 6 on the Expanded Disability Status Scale (EDSS), a rating system used by doctors to describe symptoms, with level 1 being the least severe and 10 being death due to MS. Level 6 is defined as needing a cane, crutch or brace to walk.

Women who did not have children took an average of 13 to 15 years to progress to EDSS 6, while women who had children took an average of 22 to 23 years to reach that stage, the researchers found.

“Having one or more children does seem to be beneficial,” said Patricia O’Looney, director of biomedical research for the National Multiple Sclerosis Society. “But we don’t know enough about the patient demographics to really draw some major conclusions.”

Among the unknowns are the treatments the women in the study were getting for MS or if perhaps the women who decided to have children were feeling better and having fewer symptoms.

Though much remains to be learned about the role of pregnancy in MS, a possible reason why it may help slow the progression of the disease is that during pregnancy, the immune system is “downregulated,” in part to prevent the mother’s body from rejecting the fetus, O’Looney explained. Suppressing the immune system may also help to control MS, O’Looney noted.

Treatments for MS, such as interferon beta-1a and -1b, work by suppressing the immune system.

A second possibility for why childbirth might help delay the progression of MS is that during pregnancy, estrogen levels rise. Previous research has suggested estrogen may help protect from MS by stimulating the cells that make myelin. The MS Society is currently funding a clinical trial in which women with MS are given estriol, a form of estrogen, along with standard MS treatments.

“The sex hormones do seem to have some neuroprotective role, though we are not quite sure how,” O’Looney said.

Still, O’Looney stressed that women should not interpret the results as reason to have a baby to delay the progression of the disease, or blame themselves if they decided not to have children.

“We still don’t know a lot about the great variability of MS — why does one person become more progressive while another follows a more benign course,” O’Looney said. “What’s certain is that one should not conclude it’s based on whether or not you have a child. There are so many other factors, including possibly genetic factors, that determine that.”

February 8, 2010

Cholesterol Plays Role in Heart Failure Risk

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Abnormal cholesterol levels can significantly increase the risk of heart failure, a new study has found.

U.S. researchers analyzed data on 6,860 participants in the National Heart, Lung, and Blood Institute’s Framingham Heart Study. None of the participants, average age 44, had coronary heart disease at the start of the study. After about 26 years of follow-up, 680 people had developed heart failure.

The incidence of heart failure was:
12.8 percent in participants with low levels of high-density lipoprotein (HDL, or “good”) cholesterol. Low HDL is less than 40 milligrams per deciliter (mg/dL) in men and less than 50 mg/dL in women.
6.1 percent among participants with desirable HDL levels (at least 55 mg/dL in men and 65 mg/dL in women).
13.8 percent in participants with high levels (at least 190 mg/dL) of non-HDL cholesterol, which includes triglycerides and low-density lipoprotein (LDL, or “bad”) cholesterol.
7.9 percent in those with desirable levels (less than 160 mg/dL) of non-HDL cholesterol.

When the researchers factored in age, sex, body mass index, blood pressure, diabetes and smoking, the risk of heart failure was 29 percent higher in participants with high non-HDL cholesterol than in those with lower levels, and 40 percent lower in those with high HDL-cholesterol than in those with lower levels.

Further analysis showed that the risk of heart attack was 13 percent higher in participants with high non-HDL cholesterol and 25 percent lower in those with high HDL cholesterol.

“This study goes a step further in implicating cholesterol levels (both HDL and non-HDL) in heart failure and suggests that cholesterol-altering therapy may have long-term benefits in preventing heart failure above and beyond its effects on preventing [heart attack],” study senior author Dr. Daniel Levy, director of the Framingham Heart Study, said in a news release from the American Heart Association.

January 31, 2010

Stem Cells Repair Acute Lung Injury in Mice

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Adult stem cells from bone marrow can prevent acute lung injury in mice, U.S. researchers report.

Acute lung injury, which is caused by major inflammation or injury to the lungs, causes about 74,500 deaths each year in the United States. There is no effective drug treatment for the condition, which is a major cause of death among patients in intensive care units.

A team at the University of Illinois at Chicago College of Medicine identified progenitor stem cells in the bone marrow of mice that could prevent and treat acute lung injury. The researchers also found a way to culture the cells — called Flk-1 and CD34 — to increase their numbers and ability to attach to targets and make repairs.

When the purified and cultured Flk-1 and CD34 stem cells were injected into mice with acute lung injury, the cells repaired the lung injury, prevented fluid build-up and improved survival of the mice, the researchers found.

The study not only showed that stem cell treatment may be a promising therapy for acute lung injury, “but also provided us with the means to understand how these progenitor cells did their repair work. These therapeutic cells employed integrins to stick to the site of injury and turn on cellular and molecular repair machinery,” lead author Kishore Wary, an assistant professor of pharmacology, said in a university news release.

The researchers hope to test this stem cell therapy in human acute lung injury.

January 25, 2010

U.S. spends most, but health quality lags

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Americans are more likely than people in 10 other countries to have trouble getting medical treatment because of insurance restrictions or cost, an international survey of primary care doctors released on Wednesday found.

While the United States spends more than twice as much as other developed countries on healthcare, it lags well behind in key measures of quality, the annual survey found.

“Our weak primary care system puts patients at risk and results in poor health outcomes and higher costs,” said Karen Davis, president of the Commonwealth Fund, a private health policy group that sponsored the survey.

“The survey provides yet another reminder of the urgent need for reform that makes acceptable, high-quality care a national priority,” Davis told a news briefing.

Other countries have solved problems the United States is still struggling to conquer, she said.

The survey of more than 10,000 primary care doctors in 11 developed countries — Australia, Canada, France, Germany, Italy, the Netherlands, New Zealand, Norway, Sweden and the United Kingdom — found problems in all of them.

In the United States, cost and access to care stood out as a major challenge for primary care doctors.

“The majority of U.S. doctors — some 58 percent — say their patients often have difficulty paying for medications and other medical care, by far the highest rate in the survey,” Cathy Schoen of the Commonwealth Fund, whose study appears in the journal Health Affairs, told the briefing.

Paying for healthcare was a problem in 5 to 37 percent of other countries surveyed.

Insurance restrictions, such as provisions to limit or control medication or treatment, are a major impediment for U.S. doctors, with half of 1,400 physicians surveyed saying the time they and their staff spend dealing with insurance companies is a major problem.

The survey from February to July 2009 was conducted by mail, online and by phone.

AFTER HOURS

“It appears that U.S. doctors are adding staff to their offices that would not be typical of other countries just to cope with our complex, fragmented insurance system and advocate for their patients,” Schoen said.

The survey also asked doctors if patients in their country could see a doctor after regular business hours without being forced to go to the emergency room.

Nearly all doctors surveyed from the Netherlands, New Zealand and the United Kingdom said this was offered, compared with just 29 percent of doctors in the United States — which ranked lowest in the survey.

“The vast majority say they have no arrangement at all,” Schoen said, adding that the 29 percent figure is a drop from 40 percent reported in 2006.

By contrast, doctors in the United States and Britain were least likely to say their patients faced long waits to see a specialist, compared with Canadian and Italian doctors, who were most likely to say this was a problem.

The study also shows the United States and Canada trail other developed countries in the use of basic electronic medical records. Less than half of U.S. doctors (46 percent) say they have electronic medical records, and just 37 percent of doctors in Canada have them.

Electronic medical records are nearly universal in the Netherlands, New Zealand, the United Kingdom, Australia, Italy, Norway and Sweden.

“The findings underscore the extent to which national policies matter,” Schoen said.

January 18, 2010

FDA Unveils Safe Use Initiative that Targets Preventable Harm from Medication Use

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Agency also releases drug dosage guidance for measuring devices included with OTC medications

The U.S. Food and Drug Administration today announced the Safe Use Initiative, a program aimed at reducing the likelihood of preventable harm from medication use.

“Too many people suffer unnecessary injuries from avoidable medication misuse, errors and other problems. The FDA is launching the Safe Use Initiative to develop targeted solutions for reducing these injuries,” said FDA Commissioner Margaret A. Hamburg, M.D.

Millions of people are harmed every year from inappropriate medication use. Many injuries occur as a result of incomplete access to information about a drug, a patient, or the patient’s condition.

Other preventable sources of harm include unintentional misuse of medications, medication abuse, and attempts at self harm. Unintended exposure to prescription medications such as opioid drugs can cause harm, even death, in a single dose, if taken by someone other than the patient who was prescribed the medication.

“Only through coordinated interventions across all sectors of the health care system can we substantially reduce preventable injuries from using medications,” said Janet Woodcock, M.D., director of the FDA’s Center for Drug Evaluation and Research. “All participants in the health care community have a role to play in reducing the risks and preventing injuries from medication use.”

More detailed information on the new program was contained in a report, titled, “FDA’s Safe Use Initiative – Collaborating to Reduce Preventable Harm from Medicines.” The report was released by Drs. Hamburg and Woodcock at FDA’s annual Science Writers Symposium at the agency’s White Oak Campus in Silver Spring, Md.

As outlined in the report, the FDA intends to collaborate with health care professionals and other stakeholders to identify drugs and drug classes that are linked to preventable harm. A list of specific problems, cross-sector interventions for reducing harm from these problems, and the metrics for success will be developed.

The report highlights several risk-reduction projects that may benefit from Safe Use collaborations, including evaluating consumer medication information, communicating about the risk of inadvertent overexposure to acetaminophen, implementing safeguards against surgery fires caused by alcohol-based surgical preps, and avoiding contamination of multiple use medication vials.

To further advance the Safe Use Initiative, the FDA intends to hold a series of public meetings to gather feedback as the candidate list is being developed and will open a public docket to receive comments on the report and proposed candidate cases.

The agency also today made public new FDA guidance for companies that manufacture, market, or distribute over-the-counter liquid medications packaged with dosage delivery devices such as calibrated cups, droppers, syringes and spoons.

The guidance document, titled “Dosage Delivery Devices for OTC Liquid Drug Products,” was posted for advanced viewing in the Federal Register today.

Accidental overdoses can be caused by dosage delivery devices that are unclear or are inconsistent with the labeled dosing instructions.

“This new drug dosage guidance document is an example of steps that can be taken to ensure safer medication use,” said Woodcock. “Many accidental overdoses result from confusion about exactly how much of a drug to take. Better measuring devices will help patients, parents, and other caregivers use the right amount of these medications – the safest and most effective dose – especially for children.”

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