Few rheumatoid arthritis clinical trials compare drugs: study

NEW YORK (Reuters Health) - To test whether a new drug is an improvement over existing treatments, the ideal clinical trial would compare the medications head to head, but few trials of rheumatoid arthritis treatments happen that way, according to a new study.

Instead, researchers found that for certain new rheumatoid arthritis medications, subjects in the comparison groups were often assigned to continue taking a drug that didn't help them or to take a fake drug called a placebo -- in both cases effectively depriving those patients of treatment for their disease.

"Of course it's easier to compare to a placebo than an active treatment but in no way can it justify exposing patients to irreversible morbidity," said Dr. Candice Estellat at the French national medical research institute, INSERM, who led the study.

Her concern is that if studies don't compare a new drug to other effective ones, people's conditions will persist or even worsen throughout the study.

Additionally, without so-called head-to-head trials, doctors will have little evidence to go on to determine whether one treatment is better than another, Estellat said.

Rheumatoid arthritis is an autoimmune disease that causes inflammation and damage to joints.

About 1.5 million adults have the painful disorder, and they typically require lifelong treatment with physical therapy or medications, such as methotrexate.

The newest forms of rheumatoid arthritis medications to become available are called biologic disease-modifying antirheumatic drugs (DMARDs).

These include the brand-name medications Enbrel and Humira. They come in the form of an injection, and cost around $15,000 per year.

Estellat and a colleague gathered information on all clinical trials of biologic DMARDs registered with the U.S. government's clinicaltrials.gov website and that were ongoing between 2002 and 2009.

She said they decided to do the study after hearing from specialists about the lack studies comparing these new drugs against other biologic DMARDs.

Of the 91 trials they identified, just five studies compared one biologic medication to another.

"Unfortunately we were not surprised as it confirms rheumatologists' feeling(s)," Estellat said.

The remaining trials will not provide doctors and patients with information for making evidence-based decisions, she and her coauthor write in the Archives of Internal Medicine.

"There (are) plenty of studies to show that A is better than placebo, B is better than placebo, C is better than placebo but so few to know which one is the best between A, B or C," Estellat told Reuters Health by email.

Not only are placebo-compared experiments less useful in understanding how well a drug works compared to others, but, the report points out, they may violate international ethical research standards and specific guidelines from the American College of Rheumatology if people are not given treatment for a serious condition like rheumatoid arthritis.

The 91 trials included 102 comparisons of a biologic medication against something else -- in most cases that something else was a placebo or a treatment previously shown not to work for them.

"Despite recommendations to give biologic treatments to patients with an inadequate response to conventional treatment, 9,879 patients were or will be randomized to control arms to receive no treatment or their previous ineffective treatment," Estellat said.

Studies on humans have to go through ethical scrutiny by independent bodies called institutional review boards, and in the U.S. they must also be approved by the Food and Drug Administration.

A spokesperson for the pharmaceutical trade group, PhRMA, wrote in an email to Reuters Health that "much of that decision-making is done under the guidance of FDA, whose experts are able to work with companies to evaluate the pros and cons of different types of trials."

Dr. Steven Pearson, the president of the Institute for Clinical and Economic Review in Boston, explained the possible reasons for not using head-to-head trials for certain drugs in an editorial accompanying Estellat's study.

He agreed that using placebos is a less desirable trial design to ultimately help physicians determine which medication they should prescribe for their patients, but said it's a trade-off for making an experiment less difficult.

"For one, having an active agent against a comparator would require many more patients," he told Reuters Health.

"In order to be able to get clear signals of the safety and effectiveness of new agents it's going to be easiest to compare it to a placebo, in terms of costs and duration," Pearson added.

To be most useful to patients and physicians, clinical trials need to compare one drug to another, and Pearson said that companies, regulators and researchers should think of creative ways to do so without having the studies become prohibitively expensive or unwieldy.

"I think the study is helpful to (the Food and Drug Administration) and others to take stock and see if there are other innovative study designs and approaches that allow more head-to-head trials," Pearson said.

Estellat said that people involved in clinical studies "have to imagine original designs to conciliate ethics and scientific requirements."

SOURCE: http://bit.ly/yh1orf Archives of Internal Medicine, February 13, 2012.

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Study questions antidepressant-suicide link

NEW YORK (Reuters Health) - The Food and Drug Administration has a blanket warning on antidepressant medications stating they increase the risk of suicidal thoughts and behaviors among kids and young adults, but a new review of clinical data finds no link between suicide and at least two of the medications.

The new analysis, based in part on previously unpublished data, also concludes that treatment with antidepressants decreases the risk of suicide among adults of all ages.

"These results have to instill some additional confidence that prescribing these medications is not necessarily going to lead to suicidal thoughts or behavior," said Robert Gibbons, a professor at the University of Chicago and lead author of the study, published in Archives of General Psychiatry.

The findings -- based on data for kids and adults using fluoxetine (Prozac) and for adults on venlafaxine (Effexor) -- are not enough to change everyone's view of the risks of antidepressants, especially to kids.

"The authors in this study examined the risk of suicidal thinking or behavior associated with one drug, fluoxetine," said Jeff Bridge, a researcher at Nationwide Children's Hospital in Columbus, Ohio. "My view is that the weight of evidence shows a small but significant increased risk of suicidal ideation/suicidal behavior in pediatric patients treated with antidepressants."

Bridge's position is in line with the FDA's current stance on suicide risk for children taking antidepressants.

In 2004, the agency asked manufacturers of antidepressants to include what's called a "black box" warning on its packaging for the medications, alerting physicians, patients and parents to an increased risk of suicide among children taking the drugs. (See FDA announcement at http://1.usa.gov/yjXP1G).

Three years later, the FDA expanded that warning to include young people up to age 25.

Gibbons has long been opposed to the labeling. As an advisory board member to the FDA, he voted against adding the warning to antidepressant packaging.

"I didn't think the data were very convincing, and I was concerned physicians would stop prescribing antidepressants," he told Reuters Health.

The FDA had looked for any reports of suicidal thinking or action among 4,400 children who were in clinical trials comparing an antidepressant drug to a fake drug called a placebo.

They found that suicidal thoughts or attempts were twice as common among the kids taking an antidepressant, although none of the children had committed suicide.

To get a better handle on the risk of suicide over the course of treatment, Gibbons' team gathered data from experiments that compared the antidepressants to placebo and that had measured suicide risk from the get-go.

Some results came from a study of adolescents by the National Institute of Mental Health and the rest came from two drug makers, Eli Lilly, which markets Prozac, and Wyeth, whose parent company markets Effexor.

The authors have served as consultants or have received research money from drug makers in the past, but Gibbons said neither company had access to this study -- which was funded by the federal government -- before it was published.

The analysis found that among the 708 children in the reviewed studies, the risk of having suicidal thoughts or attempts after eight weeks was no different between the kids who took Prozac and the kids who took the placebo.

Although fluoxetine is the only antidepressant drug approved for use in children, doctors can prescribe other drugs "off-label" to treat depression in kids.

"I think it's premature to extrapolate these findings to other antidepressants," Bridge told Reuters Health in an email.

The studies in the FDA review that found an increased risk of suicide looked at fluoxetine and eight other drugs.

In Gibbons' review, treatment with fluoxetine or venlafaxine resulted in a 90 percent decreased risk of suicidal thoughts or behaviors after eight weeks among adults and the elderly, compared to a 79 percent decrease after eight weeks of taking a placebo.

Gibbons said the drop in suicide risk seen in adults was tightly linked to the improvement in depression symptoms.

"What that means -- and it's not a surprising result - is if you don't treat depressive severity, you continue to have a high rate of suicide," he said.

At the beginning of the studies, children had higher rates of suicidal thoughts and behaviors overall than adults; about 20 percent of kids and three to five percent of adults started out thinking about or attempting suicide.

Gibbons said it was interesting that the kids' suicide risk didn't fall like the adults' did, even though the results indicated the antidepressants did work to relieve the kids' depression symptoms too.

"Suicide and depression are very strongly linked in adults and the elderly, and apparently not so strongly linked in children," he said.

Bridge said he'd like to see future studies examine whether antidepressants are tied to behavioral problems, such as hostility and agitation, and if an increased risk of those behaviors is related to more suicidal thoughts and behaviors.

As for the black box warning, Gibbons said he would support the FDA in gathering more data to better evaluate whether the warning is warranted, but he would not say whether it should be removed.

The FDA did not respond to requests for comment.

Keri McGrath-Happe, a communications manager at Eli Lilly and Company, wrote in a statement to Reuters Health that "at this time, we do not plan to discuss this matter further with the FDA."

She added that "some depressed individuals, on treatment and off, have worsening suicidal ideas and acts. It is prudent for clinicians and patients to remain vigilant for this possibility."

SOURCE: http://bit.ly/xmhAJq Archives of General Psychiatry, online February 6, 2012.

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Contagious Cancer: Genome Study Reveals How Tasmanian Devil Cancer Has Spread

tasmanian_devil_cancer_genome Image courtesy of Save the Tasmanian Devil Program

A killer cancer that is threatening to wipe Tasmanian devils off the map for good has been spreading from an original infected female 15 years ago via live cancer cells, according to evidence from genome sequences of the cancer and the animal, published online Thursday in Cell. Finding out how this happened could help save this species from extinction and it could also prepare researchers for the unlikely event that a contagious cancer ever appeared in humans.

The facial cancer, which is spread through bites, has plagued this animal’s precarious population for more than a decade. Tasmanian devils (Sarcophilus harrisii) are the largest surviving carnivorous marsupials and live on Australia’s island state Tasmania. [Read more about this scourge in "The Devil's Cancer," from Scientific American's June 2011 issue.] All of the tumors afflicting the animals today contain cells from one original devil, genetic sequences show. “I call her the immortal devil,” Elizabeth Murchison, a researcher at the Wellcome Trust Sanger Institute and co-author of the new paper, said in a prepared statement. “Her cells are living on long after she died.”

An earlier version of the Tasmanian devil genome was published last year in Proceedings of the National Academy of Sciences and revealed some secrets about why the cancer hasn’t killed off the species already. One of the two devils sequenced, named Cedric, showed resistance to at least two strains of the cancer, although he later succumbed to a third.

“The Tasmanian devil cancer is the only cancer that is threatening an entire species with extinction,” Murchison said. After the first tumor appears on the doomed animals face, it will likely die within three months.

But by turning to genetics, researchers and conservationists hope to be able to find clues to at least slow the cancer’s spread. The researchers studied tumors from 104 tumors collected from Tasmanian devils from various locations on the island and found that there were separate geographic groups of cancer types but that all of them contained cells from the original female. “Sequencing the genome of this cancer has allowed us to catalogue the mutations that caused this cancer to arise and to persist,” Murchison said. More detailed genetic details could point the way to targeted cancer drugs. It might also suggest how the cancer is able to sneak past the immune system and start its explosive growth so quickly.

“Tracing the evolutionary history and spread of this cancer helps us to understand not only what caused this disease but also to predict how it might behave in the future,” David Bentley, chief scientist at Illumina Cambridge, Ltd. and study co-author, said in a prepared statement.

The Tasmanian devil’s cancer has more than 17,000 mutations. “This is fewer mutations that are found in some human cancers and indicates that cancers do not need to be extremely unstable in order to become contagious,” Bentley said. Only one other type of contagious cancer is known a venereal tumor that infects dogs and wolves. The next step is “to use the genome sequence to understand more about how this cancer became transmissible,” Michael Stratton, director of the Wellcome Trust Sanger Institute and study co-author, said in a prepared statement. “Cancers that transmit through populations are obviously incredibly rare, he said, but we should use the Tasmanian devil example to be prepared in the extremely unlikely event that such an epidemic ever occurs in humans.”

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Microchip successfully delivers bone-loss drug: study

A microchip inserted under the skin has been shown for the first time to successfully deliver a bone-loss drug to a small sample of women, according to US-led research published Thursday.

The device may someday allow patients to avoid daily injections of medication and permit doctors to adjust their doses from afar, said the study which appears in the journal Science Translational Medicine.

"We hope this really is the dawn of a whole new way of thinking about delivering medications," said co-author Robert Langer, a professor of cancer research at the Massachusetts Institute of Technology.

Langer and colleagues presented their findings at the annual meeting of the American Association for the Advancement of Science in Vancouver, Canada. Langer addressed the conference by phone.

The device is about the size of a pacemaker, or a computer flash stick, and contains daily doses of medication inside small wells that open up either on a predetermined schedule, or when the chip is given a wireless signal to release the drugs.

Each well is covered by a nano-thin layer of gold which protects the drug and prevents it from being released.

The wireless signal causes the gold to dissolve and allows the drug to enter the bloodstream.

In this case, researchers tested the device on seven women aged 65-70 in Denmark who were prescribed the drug teriparatide for osteoporosis. The microchip was implanted just below their waistlines.

After tracking the women for 12 months, researchers found that the treatment improved bone formation and reduced the risk of bone fracture, and delivered the drug just as effectively as daily injections.

However, the same issues that raised concerns in animal studies were also observed in the women: the formation of fibrous collagen-based tissue around the microchip.

The presence of the tissue had raised concerns among researchers over its potential to interrupt drug delivery, though no such problems were observed in the one-year study, after which the women had the chips removed.

Lead author Robert Farra, president and chief operating officer at MicroCHIPS, which was founded by some of the researchers and licensed the microchip technology from MIT, said the device is best suited for potent drugs needed in small but regular doses.

"For the 200 million people worldwide with osteoporosis, and for patients with many other diseases, taking a daily injection is not an appealing way to take every day for a chronic disease that you may face for the rest of your life."

No adverse events were observed in the patients in the study, though one had a device implanted that malfunctioned and did not release the drugs. Farra told reporters that diagnostic changes have been made to prevent such problems in the future.

He added that the cost was likely to be $10,000-$12,000 per year, comparable to the current costs of administering the osteoporosis drug that the team tested.

Scientists plan to continue studies on the microchip delivery system in heart disease, multiple sclerosis, cancer and chronic pain. The device is likely about five years away from potential market approval, the authors said.

The technology was first envisioned about 15 years ago, and according to an accompanying editorial in the journal by John Watson, a professor of bioengineering at the University of California, many questions still remain.

Among them, how reliable and durable the chip may be over time, and how it may be adapted to other diseases -- a process he likened to a meandering path with many sharp turns.

"For Farra, Langer, and colleagues, the 'hairpin' road to the clinic might be long and winding, but a versatile implantable device that exploits the microchip approach for controlled drug delivery will be well worth the wait for patients with chronic diseases," Watson wrote.

ksh/ag

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'Autoinjector' Offers Safe, Speedy Care for Life-Threatening Seizures: Study

WEDNESDAY, Feb. 15 (HealthDay News) -- Using an autoinjector device to deliver anti-seizure drugs into muscle is a fast, safe and effective way to treat status epilepticus, a prolonged type of seizure that lasts longer than five minutes, researchers report.

"This is a very important study for persons with epilepsy," said one outside expert, Dr. Jacqueline French, first vice president of the American Epilepsy Society. "Prolonged seizures and status epilepticus can lead to brain damage, prolonged hospitalization, and other serious harm. The earlier treatment is initiated, the greater the likelihood that the seizure activity can be aborted quickly, and harm can be avoided," she said.

French, who is also professor of neurology at the Comprehensive Epilepsy Center at New York University Langone Medical Center, New York City, believes the study "will set a new standard for treatment by emergency teams, that will lead to substantial benefit for persons with epilepsy."

The study, funded by the U.S. National Institute of Neurological Disorders and Stroke (NINDS), appears in the Feb. 16 issue of the New England Journal of Medicine.

Status epilepticus is a serious, potentially life-threatening medical emergency that causes 55,000 deaths each year in the United States. First-line treatment typically involves intravenous (IV) delivery of anti-seizure drugs. However, starting an IV in a patient having a seizure can be challenging for paramedics and takes up precious time.

This study, carried out by paramedics, examined whether using an autoinjector to deliver an anti-seizure drug directly into a patient's thigh muscle is as safe and effective as using an IV. The researchers compared how well each method stopped patients' seizures by the time the ambulance arrived at the emergency department.

Two different seizure-fighting medicines -- midazolam and lorazepam -- were used in the study. Both are benzodiazepines and are known to be effective in controlling seizures. Midazolam was used in the autoinjectors because it is rapidly absorbed from muscle.

The researchers say that 73 percent of patients who received midazolam through an autoinjector were seizure-free when they arrived at the emergency department, compared with 63 percent of those who received IV treatment with lorazepam.

Patients in the autoinjector/midazolam group were also less likely to require hospitalization than those in the IV/lorazepam group. Both groups had similarly low rates of recurrent seizures.

"Patients with status epilepticus can suffer severe consequences if seizures are not stopped quickly. This study establishes that rapid intramuscular injection of an anticonvulsant drug is safe and effective," Dr. Walter Koroshetz, NINDS deputy director, said in an institute news release.

Another expert agreed.

"This study represents a major step toward keeping epilepsy patients safer from the serious neurologic and medical risks of prolonged status epilepticus," said Dr. Cynthia Harden, chief of the Division of Epilepsy and Electroencephalography at the Cushing Neuroscience Institute, part of the North Shore-LIJ Health System in Manhasset, N.Y.

Could the autoinjector be safely used by non-medical personnel, such as family or friends? Harden said only more research can tell. "The device has great value in the clinical setting, when used by paramedics," she said, "and the safety of its use by non-medical persons such as family members remains to be clarified."

The study authors agreed. Currently, they said, the use of midazolam requires on-site medical supervision, and further research is needed before autoinjectors with the drug might be available for use by epilepsy patients and their family members.

More information

The Epilepsy Foundation has more about status epilepticus.

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Microchip successfully delivers bone-loss drug: study

A microchip inserted under the skin has been shown for the first time to successfully deliver a bone-loss drug to a small sample of women, according to US-led research published Thursday.

The device may someday allow patients to avoid daily injections of medication and permit doctors to adjust their doses from afar, said the study which appears in the journal Science Translational Medicine.

"We hope this really is the dawn of a whole new way of thinking about delivering medications," said co-author Robert Langer, a professor of cancer research at the Massachusetts Institute of Technology.

Langer and colleagues presented their findings at the annual meeting of the American Association for the Advancement of Science in Vancouver, Canada. Langer addressed the conference by phone.

The device is about the size of a pacemaker, or a computer flash stick, and contains daily doses of medication inside small wells that open up either on a predetermined schedule, or when the chip is given a wireless signal to release the drugs.

Each well is covered by a nano-thin layer of gold which protects the drug and prevents it from being released.

The wireless signal causes the gold to dissolve and allows the drug to enter the bloodstream.

In this case, researchers tested the device on seven women aged 65-70 in Denmark who were prescribed the drug teriparatide for osteoporosis. The microchip was implanted just below their waistlines.

After tracking the women for 12 months, researchers found that the treatment improved bone formation and reduced the risk of bone fracture, and delivered the drug just as effectively as daily injections.

However, the same issues that raised concerns in animal studies were also observed in the women: the formation of fibrous collagen-based tissue around the microchip.

The presence of the tissue had raised concerns among researchers over its potential to interrupt drug delivery, though no such problems were observed in the one-year study, after which the women had the chips removed.

Lead author Robert Farra, president and chief operating officer at MicroCHIPS, which was founded by some of the researchers and licensed the microchip technology from MIT, said the device is best suited for potent drugs needed in small but regular doses.

"For the 200 million people worldwide with osteoporosis, and for patients with many other diseases, taking a daily injection is not an appealing way to take every day for a chronic disease that you may face for the rest of your life."

No adverse events were observed in the patients in the study, though one had a device implanted that malfunctioned and did not release the drugs. Farra told reporters that diagnostic changes have been made to prevent such problems in the future.

He added that the cost was likely to be $10,000-$12,000 per year, comparable to the current costs of administering the osteoporosis drug that the team tested.

Scientists plan to continue studies on the microchip delivery system in heart disease, multiple sclerosis, cancer and chronic pain. The device is likely about five years away from potential market approval, the authors said.

The technology was first envisioned about 15 years ago, and according to an accompanying editorial in the journal by John Watson, a professor of bioengineering at the University of California, many questions still remain.

Among them, how reliable and durable the chip may be over time, and how it may be adapted to other diseases -- a process he likened to a meandering path with many sharp turns.

"For Farra, Langer, and colleagues, the 'hairpin' road to the clinic might be long and winding, but a versatile implantable device that exploits the microchip approach for controlled drug delivery will be well worth the wait for patients with chronic diseases," Watson wrote.

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Aspirin could beat cancer spread: Australian study

Aspirin and other household drugs may inhibit the spread of cancer because they help shut down the chemical "highways" which feed tumours, Australian researchers said Tuesday.

Scientists at Melbourne's Peter MacCallum Cancer Centre said they have made a biological breakthrough helping explain how lymphatic vessels -- key to the transmission of tumours throughout the body -- respond to cancer.

"We've shown that molecules like the aspirin... could effectively work by reducing the dilation of these major vessels and thereby reducing the capacity of tumours to spread to distant sites," researcher Steven Stacker said.

Doctors have long suspected that non-steroidal anti-inflammatory drugs such as aspirin may help inhibit the spread of cancer but they have been unable to pinpoint exactly how this is done.

By studying cells in lymphatic vessels, the researchers found that a particular gene changed its expression in cancers which spread, but not when the cancer did not spread.

The results published in Cancer Cell journal reveal that the gene is a link between a tumour's growth and the cellular pathway which can cause inflammation and dilation of vessels throughout the body.

Once these lymphatic vessels widen, the capacity for them to act as "supply lines" to tumours and become more effective conduits for the cancer to spread is increased.

But aspirin acts to shut down the dilation of the vessels.

"So it seems like we have found a pivotal junction point in a biochemical sense between all these different contributors," Stacker said.

The discovery could lead to new and improved drugs which could help contain many solid tumours, including breast and prostate cancer, as well as potentially provide an "early warning system" before a tumour begins to spread.

Last year, a study published in medical journal The Lancet found that rates of cancer of the colon, prostate, lung, brain and throat were all reduced by daily aspirin use.

Many doctors recommend regular use of aspirin to lower the risk of heart attack, clot-related strokes and other blood flow problems. A downside of extended daily use is the risk of stomach problems.

mfc/mp/jms

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Lab study raises questions over nano-particle impact

Tests involving chickens have raised questions about the impact on health from engineered nano-particles, the ultra-fine grains commonly used in drugs and processed foods, scientists said on Sunday.

Chickens exposed to high oral doses of polystyrene particles 50 nanometres (50 billionths of a metre) across absorbed less iron in their diet, according to their study.

At the same time, birds that were chronically exposed to these doses had a "remodelling" of their intestinal villi, the microscopic finger-like projections that play an important role in absorbing nutrients.

The changes meant that the villi increased the surface area available for taking in iron.

Intestinal uptake of calcium, copper, zinc and vitamins A, D, E and K may also be affected by high exposure to nanoparticles, although further research is needed to investigate this, say the authors.

The team, led by Michael Shuler of Cornell University in New York, tested the particles on chickens as a substitute for the human intestine and also used lab-dish cells from the lining of the human gut.

The chickens were given roughly the same dose, weight for weight, as an adult human in a developed country.

"The intestinal epithelial layer represents the initial gate that ingested nanoparticles must pass to reach the body," says the paper, which appears in the specialist journal Nature Nanotechnology.

"The polystyrene particles used in these experiments are generally considered non-toxic, but their interaction with a normal physiological process suggests a potential mechanism for a chronic, harmful, but subtle response."

Engineered nano-particles are used increasingly in the form of titanium oxide or as aluminium silicates in pills to help deliver pills and in food, where they are used as stabilisers or anti-caking agents in fluids and creams.

In developed countries, individuals may be consuming each day a thousand billion engineered particles ranging from fine to ultrafine in scale, according to figures from 2002 research quoted in the study.

Previous research has suggested micron- and nano-sized particles could play a role in the painful inflammatory gut disorder called Crohn's disease, says the paper.

Most of these particles have a negatively-charged surface, which means they adhere to biomolecules in the gut, accumulating at lymphoid nodules called Peyer's patches, according to the earlier research.

ah/ri/hmn

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Antibiotics no help against most sinus infections: study

(Reuters) - Antibiotics don't help fight most sinus infections, although doctors routinely prescribe them for that purpose, according to a U.S. study.

Researchers whose work was published in the Journal of the American Medical Association found that antibiotics didn't ease patients' symptoms or get them back to work any sooner than an inactive placebo pill.

Antibiotics are known to fuel the evolution of drug-resistant bacteria and experts have grown increasingly worried about overuse.

This is a particular concern with sinus infections, because doctors can't tell if the disease is caused by bacteria or by a virus, in which case antibiotics are useless.

"There is not much to be gained from antibiotics," said Jane Garbutt of Washington University School of Medicine in St. Louis, who led the study.

"Rather than give everybody an antibiotic hoping to find the (patients) with bacteria, our findings would suggest refraining from antibiotics and doing what we call watchful waiting," she told Reuters Health.

That involves keeping an eye on patients to see if they get better, but not using drugs other than over-the-counter painkillers.

People with sinus infections, also called acute sinusitis, have lasting and severe cold-like symptoms such as a runny nose and pain around the eyes, nose or forehead.

"It's the fifth most common reason antibiotics are prescribed for adults. It's hard for doctors not to give an antibiotic because patients are so miserable, and we don't have anything else to give them," said Garbutt.

Garbutt and her colleagues used official U.S. guidelines to identify patients with sinus infections. They randomly assigned 166 adults to either placebo pills or a 10-day treatment with the antibiotic amoxicillin.

Based on patient ratings on a symptom scale known as the modified Sinonasal Outcome Test-16, or SNOT-16, the researchers found little difference between the two patient groups.

Using the scale, where 0 equals "no problem" and 3 a "severe problem," the antibiotic group rated their symptoms at 1.12 after three days, while the placebo group averaged 1.14.

After seven days, there were signs of benefit from the antibiotic, but the effect was small and had vanished another three days later.

After 10 days, 78 percent of the people on antibiotics and 80 percent of the placebo-treated people said they felt a lot better or no longer had symptoms.

Fewer than two percent of sinus infections are bacterial, said Anthony Chow, an expert in infectious diseases at the University of British Columbia in Vancouver, Canada.

"Most cases are viral, and the vast majority don't require antibiotics," he said.

"Antibiotics have been abused, so there is a need to be more cautious in prescribing them and to hold back."

But he said that antibiotics still do have a place and recently chaired a committee at the Infectious Diseases Society, which has developed guidelines to help spot infections that are more likely to be bacterial.

Those guidelines, still in press, recommend treating only patients whose symptoms last for at least 10 days and keep worsening, who are severely sick with high fever and other symptoms, or who improve and then get worse again. SOURCE: http://bit.ly/A4EKuo

(Reporting from New York by Frederik Joelving at Reuters Health; editing by Elaine Lies and Bob Tourtellotte)

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Baby unharmed if pregnant mum has chemotherapy - study

Women who are given chemotherapy during pregnancy do not run a risk of harming their baby, doctors reported in The Lancet Oncology on Friday.

European cancer specialists looked at 68 pregnancies, producing 70 children, during which 236 cycles of cancer drugs were administered.

On average, the women were 18 weeks pregnant when their cancer was diagnosed. The children were born at 36 weeks on average.

The investigators assessed the children at birth, at the age of 18 months, and at either five, eight, nine, 11, 14 or 18 years.

They examined the children for general health, damage to the central nervous system, heart and hearing problems, and tested their cognitive skills.

They found no evidence that the children were harmed by the cancer treatment, said the study.

Babies born prematurely tended to do less well in cognitive tests, but this is common among pre-term infants across the general population, it noted.

"We show that children who were prenatally exposed to chemotherapy do as well as other children," the paper concluded.

Doctors should not be fearful about administering cancer drugs to pregnant women, nor should they be tempted into inducing early birth in the belief that this will protect the baby, it said.

"In practice, it is possible to administer chemotherapy from 14 weeks gestational age onwards," said the paper.

"To allow the bone marrow to recover and to minimise the risk of maternal and foetal sepsis and haemorrage, delivery should be planned at least three weeks after the last cycle of chemotherapy, and chemotherapy should not be given after 35 weeks since spontaneous labour becomes more probable."

The study added a small note of caution, saying further work is needed to assess whether chemo causes any long-term problems.

The research was led by Frederic Amant of Leuven Catholic University's Cancer Institute.

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Stopping Bone Drug Cuts Risk of Second Thigh Fracture: Study

THURSDAY, Feb. 9 (HealthDay News) -- People who suffer a rare type of fracture of the thigh bone while taking bone-building drugs known as bisphosphonates can cut the risk of a second fracture by discontinuing the medication, a new study says.

Bisphosphonates such as Fosamax, Boniva and Actonel are often prescribed for postmenopausal women or people taking steroid medications to prevent or slow the bone-weakening disease osteoporosis. But the drugs have been linked to a small risk of unusual fractures of the femur. One out of 1,000 taking the drugs for six years will suffer such a fracture, the researchers said.

For the study, the researchers examined femur fracture records for patients older than 45 from a large California insurer. Over two years, they found 126 patients reportedly taking bisphosphonates suffered an atypical femur fracture.

Of those patients, 41.2 percent who continued taking the drugs suffered a second femur fracture in the other thigh three or more years later. In contrast, 19.3 percent of those who stopped taking the medication had a similar break. Overall, the study revealed, subsequent atypical femur fractures dropped by 53 percent -- more than half -- when patients stopped taking bisphosphonates after the first break.

"The risk of a contralateral atypical femur fracture [on the opposite side] increases over time if the bisphosphonates are continued," said lead investigator Dr. Richard Dell, a researcher in the department of orthopedics at Kaiser Permanente.

"Based on these observations, we recommend discontinuing bisphosphonate use as soon as possible after the initial atypical femur fracture has occurred," Dell said in a news release from the American Academy of Orthopaedic Surgeons.

The study authors speculated that bisphosphonates may disrupt the bone remodeling process, whereby bones replace old tissue with healthy new bone tissue. The result might be brittle bones that break more easily. In these cases, the femur is at particular risk.

Patients on bisphosphonates who suffer this rare femur fracture also need ongoing evaluation since they remain at greater risk for another break, Dell added. They probably should use another osteoporosis medication, he said.

The findings were slated for presentation Wednesday at the annual meeting of the American Academy of Orthopaedic Surgeons in San Francisco.

Research presented at medical meetings should be considered preliminary until published in a peer-reviewed medical journal.

More information

The U.S. National Institutes of Health provides more information on osteoporosis.

View the original article here

'Hunger hormone' could help chemo patients: study

NEW YORK (Reuters Health) - A synthetic version of the "hunger hormone" ghrelin might help limit the loss of appetite that can come with cancer chemotherapy, a small study from Japan suggests.

Ghrelin is a hormone secreted by the gut to boost appetite. Because of that, scientists have been studying it as a target in the obesity war, which has included work on an anti-obesity "vaccine" that inhibits ghrelin. But the research has met with little success so far.

Since the hormone spurs hunger, in theory, infusions of synthetic ghrelin could help prevent the sometimes severe appetite loss caused by cancer drugs.

In particular, a commonly used cancer drug called cisplatin often causes nausea, vomiting and appetite loss -- and cuts the body's natural ghrelin levels.

For the new study, Japanese researchers tested the effects of ghrelin infusions in 41 patients undergoing cisplatin treatment for advanced cancer of the esophagus.

Half of the patients were randomly assigned to have ghrelin infusions twice a day, before their meals, over one week of chemotherapy. The rest were given infusions of saline.

In the end, the ghrelin patients maintained better appetites and were able to take in almost 50 percent more calories per day than patients given saline.

Overall, more than half of the saline group had nausea, versus one in five ghrelin patients. And while half of the saline group had anorexia -- significant appetite loss -- during chemo, only one in six ghrelin patients did.

Dr. Yuichiro Hiura and colleagues at Osaka University report their findings in the journal Cancer. The study was funded by a grant from the Japanese government.

It appears to be the first to show that ghrelin may help cancer patients being treated with cisplatin, so further studies are needed, the researchers say.

There is already a medication -- one that decreases the activity of the hormone serotonin -- that eases nausea and vomiting in the first 24 hours of cisplatin treatment, Hiura's team notes.

But, they add, lingering nausea and appetite loss in the following days are still a challenge to control. So ghrelin could offer a way to help with those longer-term effects.

Intensive chemotherapy with multiple drugs, including cisplatin, is commonly used for advanced-stage cancer, Hiura's team writes. But side effects may keep many patients from completing their treatment.

Ultimately, the researchers say, the goal is to make chemotherapy easier for patients to get through -- and, it's hoped, improve the treatment's effectiveness.

SOURCE: http://bit.ly/wB771x Cancer, online January 26, 2012.

View the original article here

'Hunger hormone' could help chemo patients: study

NEW YORK (Reuters Health) - A synthetic version of the "hunger hormone" ghrelin might help limit the loss of appetite that can come with cancer chemotherapy, a small study from Japan suggests.

Ghrelin is a hormone secreted by the gut to boost appetite. Because of that, scientists have been studying it as a target in the obesity war, which has included work on an anti-obesity "vaccine" that inhibits ghrelin. But the research has met with little success so far.

Since the hormone spurs hunger, in theory, infusions of synthetic ghrelin could help prevent the sometimes severe appetite loss caused by cancer drugs.

In particular, a commonly used cancer drug called cisplatin often causes nausea, vomiting and appetite loss -- and cuts the body's natural ghrelin levels.

For the new study, Japanese researchers tested the effects of ghrelin infusions in 41 patients undergoing cisplatin treatment for advanced cancer of the esophagus.

Half of the patients were randomly assigned to have ghrelin infusions twice a day, before their meals, over one week of chemotherapy. The rest were given infusions of saline.

In the end, the ghrelin patients maintained better appetites and were able to take in almost 50 percent more calories per day than patients given saline.

Overall, more than half of the saline group had nausea, versus one in five ghrelin patients. And while half of the saline group had anorexia -- significant appetite loss -- during chemo, only one in six ghrelin patients did.

Dr. Yuichiro Hiura and colleagues at Osaka University report their findings in the journal Cancer. The study was funded by a grant from the Japanese government.

It appears to be the first to show that ghrelin may help cancer patients being treated with cisplatin, so further studies are needed, the researchers say.

There is already a medication -- one that decreases the activity of the hormone serotonin -- that eases nausea and vomiting in the first 24 hours of cisplatin treatment, Hiura's team notes.

But, they add, lingering nausea and appetite loss in the following days are still a challenge to control. So ghrelin could offer a way to help with those longer-term effects.

Intensive chemotherapy with multiple drugs, including cisplatin, is commonly used for advanced-stage cancer, Hiura's team writes. But side effects may keep many patients from completing their treatment.

Ultimately, the researchers say, the goal is to make chemotherapy easier for patients to get through -- and, it's hoped, improve the treatment's effectiveness.

SOURCE: http://bit.ly/wB771x Cancer, online January 26, 2012.

View the original article here

Antidepressants May Not Raise Suicide Risk in Youth: Study

MONDAY, Feb. 6 (HealthDay News) -- Antidepressant drugs such as Prozac do not raise suicide risk in young people, a new study says.

The finding should help reassure doctors about prescribing antidepressants to youngsters, said first author Robert Gibbons, a professor of medicine, health studies and psychiatry at the University of Chicago.

In 2004, the U.S. Food and Drug Administration ordered a "black box warning" for Prozac (generic name fluoxetine) after data from 25 clinical trials suggested the medications increased the risk of suicidal thoughts and behaviors in children and young adults up to age 25.

But this analysis of data from 41 clinical trials involving a total of more than 9,000 patients identified no such link in either adults or children.

"I hope that the [black box] warnings will not prevent depressed children and adults from getting treatment for depression," Gibbons said in a university news release.

One expert agreed. Dr. Mark Russ, director of psychiatric services at Zucker Hillside Hospital in Glen Oaks, N.Y., said the study "argues that treatment with the antidepressant medications examined ... is not associated with a higher risk of suicidal ideation and behavior, and should not be withheld for this reason."

The study also found that Prozac and another antidepressant called Effexor (venlafaxine) reduced suicidal behavior and depression in adults and seniors.

For their study, Gibbons and colleagues used clinical trial data -- some of it unpublished -- from drug makers and a large U.S. National Institute of Mental Health collaborative study of Prozac and Effexor. The study -- funded by the U.S. National Institute of Mental Health and the U.S. Agency for Healthcare Research and Quality -- appears online Feb. 6 in the journal Archives of General Psychiatry.

To assess the effects of antidepressants in children, the researchers examined four trials of Prozac. Until recently, it was the only antidepressant approved for use in children, according to a University of Chicago Medical Center news release.

The studies showed that the drug reduced depression symptoms in children and did not have any effect on their suicide risk.

The results from the trials of Prozac and Effexor in adults and seniors found that the drugs reduced both depression symptoms and suicide risk. This suggests that antidepressants cut the suicide risk in adults and seniors by easing patients' depression, the news release said.

"I think that this paper supports the general idea that the effects of antidepressants in kids and adults are not really the same, since we don't see anything but beneficial effects of antidepressants in adults and geriatrics," Gibbons said in the release. "In kids, we don't see a harmful effect, but we do see a disassociation between the beneficial effects on depression and the potential beneficial effect on suicide."

He added: "This raises continued questions about what's going on in children. Maybe children think about suicide in part because of depression, but also maybe due to other reasons not related to depression that are not affected by antidepressants."

One expert welcomed the study findings.

"This very important study goes a long way to undoing what I consider an ill-conceived FDA issued black box warning for antidepressants and risk of suicide in children and adolescents," said Dr. Norman Sussman, a psychiatrist at NYU Medical Center in New York City. "It was a finding of an increased rate of ideation [suicidal thoughts] and attempts during some clinical trials that formed the entire basis for the FDA black box warning. Yet, as the authors of the current paper point out, no actual suicides occurred in these [trials]."

According to Sussman, who is also professor of psychiatry at NYU School of Medicine, the warning led to a drop in antidepressant prescriptions for depressed children. "In what I hope will lead to a corrective series advisories that encourage antidepressant use, the results of this study confirm what clinicians have observed all along, namely, treatment with antidepressants decreases suicide risk," he said.

Gibbons agreed. "The greatest cause of suicide is untreated or undiagnosed depression," he said. "It's very important that this condition be recognized and appropriately treated and not discarded because doctors are afraid to be sued."

More information

The Nemours Foundation has more about children and depression.

View the original article here

Hard Drug Use in Middle Age Could Prove Fatal, Study Finds

FRIDAY, Feb. 3 (HealthDay News) -- People who start using hard drugs -- such as cocaine, opiates and amphetamines -- as young adults and continue to use them into their 50s have a fivefold increased risk of early death, researchers report.

The finding is from an analysis of hard drug use among 4,300 U.S. adults who took part in a long-term study of cardiovascular disease and risk factors. The participants, including blacks, whites, men and women, were recruited when they were 18 to 30 years of age and followed from 1985 to 2006.

The University of Alabama at Birmingham researchers compared those who stopped drug use early in life to those who continued, and calculated their risk of premature death.

"Fourteen percent of the people in the study reported recent hard-drug use at least once, and of these, half continued using well into middle age," lead author Dr. Stefan Kertesz, an associate professor in the preventive medicine division, said in a university news release.

Kertesz characterized most drug users as "dabblers" who used a few days a month, but not daily.

The researchers found that older drug users were more likely to have been raised in economically challenging circumstances in a family that was unsupportive, abusive or neglectful.

Those who were heavy drug users when they were young adults and continued into middle age were about five times more likely to die prematurely than people who didn't use drugs, according to the report published online Jan. 27 in the Journal of General Internal Medicine.

But, while the study uncovered an association between continued heavy drug use and premature death, it did not prove a cause-and-effect relationship, the study authors noted.

"We can't assume that drugs caused death, as in an overdose," Kertesz said. "Rather what we found is that middle-age adults who continue to dabble in hard drugs represent a group that is at risk of bad outcomes -- which could include death from trauma, heart disease or other causes that are not a direct result of their drug use -- at a higher rate than people who stopped using drugs."

About 9.4 percent of Americans aged 50 to 59 and 7 percent of those aged 35 to 49 reported use of a drug other than marijuana sometime in the past year, according to the U.S. National Survey on Drug Use and Health.

More information

The U.S. Substance Abuse and Mental Health Services Administration has more about illicit drug use among older adults.

View the original article here