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Latest Research


A summary of the "must-read" articles from the journals in that pile on your desk.

Deep-Brain Stimulation Studied in Dystonia

Treatment significantly improves scores on the Burke-Fahn-Marsden Dystonia Rating Scale

In patients with primary generalized or segmental dystonia, bilateral pallidal deep-brain stimulation is more effective than sham stimulation, according to a study published in the Nov. 9 issue of the New England Journal of Medicine.

Andreas Kupsch, M.D., of Charite Universitatsmedizin Berlin in Germany, and colleagues randomly assigned 40 patients with an implanted device for deep-brain stimulation to receive either three months of neurostimulation or sham stimulation.

The researchers found that the neurostimulation group had a significantly greater change from baseline in mean movement scores on the Burke-Fahn-Marsden Dystonia Rating Scale than the sham-stimulation group (−15.8 points versus −1.4 points). They also identified 22 adverse events in 19 patients. The most common adverse event was dysarthria, but complications also included four infections at the stimulator site and one lead dislodgment.

"The clinical significance of the benefits of neurostimulation that we observed were greater than was the effect of high-dosage trihexyphenidyl, the most potent drug for the treatment of dystonia," the authors write.

The study was supported by a grant from Medtronic.

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Kidney Transplant Induction Therapies Compared

Researchers find that antithymocyte globulin reduces acute rejection better than basiliximab

In patients who receive kidney transplants from deceased donors, induction therapy with antithymocyte globulin reduces the incidence and severity of acute rejection compared to basiliximab, but not the incidence of delayed graft function, according to a report in the Nov. 9 issue of the New England Journal of Medicine.

Daniel C. Brennan, M.D., of the Washington University School of Medicine in St. Louis, and colleagues compared one-year outcomes in 141 patients who received rabbit antithymocyte globulin and 137 patients who received basiliximab. All patients had received a renal transplant from a deceased donor and were at high risk for acute rejection or delayed graft function.

The antithymocyte globulin group had lower incidences of acute rejection than the basiliximab group (15.6 percent versus 25.5 percent) and of acute rejection that required treatment with antibody (1.4 percent versus 8 percent). But both groups had similar incidences of graft loss (9.2 percent versus 10.2 percent), delayed graft function (40.4 percent versus 44.5 percent) and death (4.3 percent versus 4.4 percent).

"Graft survival and function were not altered at 12 months, but for long-term survival and function, only time will tell," states the author of an accompanying editorial. "Some centers may switch to antithymocyte globulin, but both treatments…will continue to have their supporters."

The study was supported by SangStat Medical Corp. and by Genzyme.

AbstractFull Text (subscription or payment may be required)Editorial

Chloroquine Returns as Anti-Malarial Drug in Malawi

After a 13-year withdrawal, chloroquine is shown to be more effective than its replacement

The anti-malarial drug chloroquine, withdrawn by Malawi in 1993 because of declining efficacy, may once again be an effective treatment, according to study findings published in the Nov. 9 issue of the New England Journal of Medicine.

Miriam K. Laufer, M.D., of the University of Maryland School of Medicine in Baltimore, and colleagues randomly assigned 210 Malawi children with uncomplicated Plasmodium falciparum malaria to receive either chloroquine or the preferred treatment -- sulfadoxine-pyrimethamine -- and followed them for 28 days.

The researchers found that only one of the 80 children in the cholorquine group experienced treatment failure, compared with 71 of 87 children in the sulfadoxine-pyrimethamine group, resulting in a cumulative efficacy of 99 percent for chloroquine and 21 percent for sulfadoxine-pyrimethamine.

"How good is this news from a public health perspective?" asks the author of an accompanying editorial. "Can we now abandon these new, relatively expensive anti-malarial agents and return to our old and trusted friend chloroquine? Laufer and her colleagues wisely counsel against doing so. Malawi is surrounded by a sea of chloroquine resistance…Chloroquine could re-enter the increasingly promising queue of new candidate anti-malarial agents -- but it needs to leave before it can come back."

AbstractFull Text (subscription or payment may be required)Editorial

Low-Carb Diet Does Not Change Heart Disease Risk

Moderate reduction when fat and protein come from vegetable sources

A low-carbohydrate diet does not influence heart disease risk in women, though risk is moderately reduced when fat and protein come from vegetable rather than animal sources, researchers report in the Nov. 9 issue of the New England Journal of Medicine.

Frank B. Hu, M.D., Ph.D., from the Harvard School of Public Health in Boston, and colleagues calculated a low-carbohydrate-diet score from food frequency questionnaires completed by 82,802 women who were part of the Nurses' Health Study. The score considers the percentage of energy taken in as fat, carbohydrate and protein.

The researchers found 1,994 cases of coronary heart disease during the 20-year follow-up. There was no significant change in the risk of heart disease when comparing the highest and lowest tenths of the low-carbohydrate-diet score. While there was no significant change in risk based on the percentages of energy from carbohydrate, animal fat and animal protein, there was a significant decrease in risk when the fat and protein came from vegetables (relative risk 0.70, when comparing the highest and lowest tenths of the score).

"Diets lower in carbohydrate and higher in protein and fat are not associated with increased risk of coronary heart disease in women," the authors conclude. "When vegetable sources of fat and protein are chosen, these diets may moderately reduce the risk of coronary heart disease."

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More Procedures after Pneumatic Dilatation for Achalasia

Much higher incidence of secondary procedures after primary pneumatic dilatation compared to myotomy

Patients with achalasia treated initially with pneumatic dilatation have a greater risk for a subsequent intervention at one, five and 10 years compared to those who had primary surgical myotomy, according to a report in the Nov. 8 issue of the Journal of the American Medical Association.

Steven R. Lopushinsky, M.D., of the University of Toronto in Ontario, Canada, and a colleague conducted a retrospective comparative outcomes study of 1,461 adults with achalasia, 1,181 of whom had pneumatic dilatation (80.8 percent) and 280 of whom had surgical myotomy (19.2 percent).

The risk for any secondary intervention for primary pneumatic dilatation was 36.8 percent at one year, 56.2 percent at five years and 63.5 percent at 10 years. The risk for intervention after primary surgical myotomy was 16.4 percent at one year, 30.3 percent at five years and 37.5 percent at 10 years.

"Subsequent intervention after the initial treatment of achalasia is common. Although the risk of subsequent interventions among persons treated with surgical myotomy in typical practice settings is higher than previously thought, the risk of subsequent intervention is greater among persons treated with pneumatic dilatation than with surgical myotomy. This difference is attributable to the use of subsequent pneumatic dilatation rather than surgical procedures," the authors conclude.

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Malaria Prevention Strategies Should Be Individualized

Specialists need to individualize malaria prevention strategies for long-term travelers

Until a consensus on guidelines is reached, individually tailored strategies are needed to help prevent malaria among long-term travelers, according to a literature review published in the Nov. 8 issue of the Journal of the American Medical Association.

Lin H. Chen, M.D., of Mount Auburn Hospital in Cambridge, Mass., and colleagues conducted a literature review of all studies concerning the risks of malaria transmission through July 2006. They found that long-term travelers (those traveling six months or longer) are at higher risk of developing malaria than short-term travelers, adhere poorly to continuous chemoprophylaxis regimens and underuse personal protection methods such as staying inside from dusk to dawn, wearing barrier clothing and spraying residences with insecticide.

The various strategies used for chemoprophylaxis have benefits and drawbacks, the authors state. Relapses of vivax malaria are not prevented with any of the current first-line chemoprophylaxis regimens because they don't eliminate liver-stage parasites. Presumptive antirelapse therapy should be considered if a traveler has been intensively exposed to P. vivax. Moreover, travelers should consider evacuation insurance and carry their own medication, as counterfeit drugs are rampant in developing countries.

"General guidelines are desirable, but recommendations for malaria prevention in long-term travelers must be individualized and should be provided by travel medicine specialists," the authors conclude.

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Half of HF Patients Have Preserved Ejection Fraction

Mortality risk similar in those with and without preserved ejection fraction

More than half of heart failure patients in the community have preserved ejection fraction and more than 40 percent have isolated diastolic dysfunction, according to a report in the Nov. 8 issue of the Journal of the American Medical Association. What's more, six-month mortality is similar in those with preserved and reduced ejection fraction.

Francesca Bursi, M.D., M.Sc., of the Mayo Clinic in Rochester, Minn., and colleagues studied 556 patients with heart failure who underwent echocardiography, of whom 308 (55 percent) had preserved ejection fraction of at least 50 percent. This was associated with older age, female sex and no prior history of myocardial infarction.

The investigators found that 242 of patients (44 percent) had isolated diastolic dysfunction. Among those with reduced ejection fraction, there was a 1.67 times greater chance of having moderate or severe diastolic dysfunction compared with those with preserved ejection fraction. Higher levels of brain natriuretic peptide were independently related to low ejection fraction and diastolic dysfunction.

"The prevalence of moderate and severe diastolic dysfunction among patients with heart failure and preserved ejection fraction was strikingly higher than that observed in elderly patients with cardiovascular disease but without heart failure…supporting the hypothesis that diastolic dysfunction is present in a large segment of patients presenting with heart failure and preserved ejection fraction," the authors conclude.

AbstractFull Text (subscription or payment may be required)Editorial

Systolic Blood Pressure Can Predict Heart Failure Prognosis

Low systolic blood pressure is an independent predictor of mortality and morbidity

Patients admitted to the hospital with heart failure often also have low systolic blood pressure (SBP), which is an independent predictor of mortality and morbidity, researchers report in the Nov. 8 issue of the Journal of the American Medical Association.

Mihai Gheorghiade, M.D., of Northwestern University in Chicago, and colleagues conducted a study of 48,612 heart failure patients aged 18 or older admitted to 259 hospitals across the United States. The patients were divided into quartiles according to SBP -- less than 120, 120-139, 140-161 and greater than 161 mm Hg. In all, 41,267 patients with left ventricular function were assessed, of whom 21,149 (51 percent) had preserved left ventricular function. A subgroup of 5,791 (10 percent of the cohort) were followed up post-discharge between 60 and 90 days.

Women and black patients were more likely to have higher SBP, and half of the patients had SBP above 140 mm Hg at admission. In-hospital and post-discharge mortality rates were higher among those with low SBP.

"Low SBP (less than 120 mm Hg) at hospital admission identifies patients who have a poor prognosis despite medical therapy. These findings may have important therapeutic implications because characteristics and outcomes differ greatly among patients with heart failure with varying SBP," the authors conclude.

GlaxoSmithKline funded the registry data used in the study and reviewed the manuscript before publication.

AbstractFull Text (subscription or payment may be required)Editorial

Inhaled Insulin Safe and Effective Alternative to Shots

Hemoglobin A1C levels similar after inhaled, subcutaneous insulin

Inhaled insulin is a safe and effective alternative to injections for pre-meal insulin administration, according to a meta-analysis of randomized, controlled trials published in the Nov. 7 issue of the Annals of Internal Medicine.

Anastassios G. Pittas, M.D., M.Sc., from Tufts-New England Medical Center in Boston, and colleagues reviewed the literature for randomized, controlled trials testing the safety, efficacy and patient acceptability of inhaled insulin for treatment of non-pregnant adults with diabetes mellitus.

Hemoglobin A1C levels were slightly higher in the inhaled insulin group, but the number of patients achieving a level of less than 7 percent was similar to the subcutaneous insulin group. Efficacy compared to oral insulin varied based on oral insulin delivery regimen (fixed dose versus titration) but severe hypoglycemia was more likely to occur in the inhaled group compared with the oral group.

"Inhaled insulin offers an alternative non-invasive option for pre-meal insulin administration, with glycemic efficacy comparable to subcutaneous regular insulin and increased patient acceptability," the authors conclude. "This new insulin technology will need continued evaluation in long-term efficacy and safety trials."

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Colorectal Screening in Older, Sick Patients Reconsidered

Study finds life expectancy after cancer diagnosis less than five years for 81 year olds with multiple illnesses

Colorectal screening in older patients with multiple chronic conditions should be carefully considered because their life expectancy is substantially reduced, according to a report in the Nov. 7 issue of the Annals of Internal Medicine.

Cary P. Gross, M.D., from Yale University School of Medicine in New Haven, Conn., and colleagues conducted a population-based retrospective cohort study of patients aged 67 or older diagnosed with colorectal cancer from 1993 to 1999, to determine the effects of age and coexisting chronic illness on life expectancy.

In the final cohort of 35,755 patients, the investigators found that life expectancy after diagnosis of stage I colorectal cancer for males who were 67 years old decreased from 19.1 years for patients without additional illness to 7.6 years for patients with three or more chronic illnesses. Similar trends were seen in women. Men and women between 76 and 81 with stage I colorectal cancer and three or more chronic diseases had life expectancies of five years or less.

"Coexisting chronic illness is associated with a substantial reduction in life expectancy after diagnosis of early-stage colorectal cancer," the authors write. "Physicians should consider this when deciding whether to screen older persons."

AbstractFull Text (subscription or payment may be required)

Lower Breast Cancer Survival Rates for Disabled Women

Fewer disabled women receive breast-conserving treatment, radiotherapy, lymph node dissection

Women with disabilities have a higher mortality rate from breast cancer and are less likely to undergo standard therapy after breast-conserving surgery, according to the results of a study published in the Nov. 7 issue of the Annals of Internal Medicine.

Ellen P. McCarthy, Ph.D., M.P.H., from Beth Israel Deaconess Medical Center in Brookline, Mass., and colleagues conducted a retrospective cohort study of 100,311 women diagnosed with stage I to IIIA breast cancer from 1988 to 1999. Treatment and survival data were compared between women with and without disabilities according to their qualification for Medicare and Social Security Disability Insurance.

Disabled women had lower overall survival and breast cancer-specific survival than other women (hazard ratio, 2.02 and 1.31, respectively). Disabled women also had lower rates of breast-conserving surgery than other women (43.2 versus 49.2 percent) and disabled women that had surgery were less likely to receive radiation therapy and axillary lymph node dissection.

"Whether the cause of these differences in care is physician bias or patient preference is unknown, but the search for the causes need not delay a solution," according to David Casarett, M.D., M.A., in an accompanying editorial. "Physicians must talk to their patients about their preferences for treatment and their knowledge of the options."

AbstractFull Text (subscription or payment may be required)Editorial

Study Questions Beta-Blockers for Some with Heart Failure

Diastolic versus systolic definition misleading and may lead therapy down wrong path

Patients with heart failure and a preserved ejection fraction have reduced vasodilator and cardiac output reserve during exercise, which may not be due entirely to impaired diastolic function, according to a report published online Nov. 6 in Circulation: Journal of the American Heart Association. The findings suggest that beta-blockers may not be the best treatment for patients with "diastolic" heart failure, the authors say.

David A. Kass, M.D., of the Johns Hopkins Medical Institutions in Baltimore, and colleagues studied 17 patients with heart failure with preserved ejection fraction (HFpEF) and 19 matched controls who did not have heart failure but did have left ventricular hypertrophy, hypertension and other characteristics similar to the heart failure patients, such as obesity and diabetes. The patients underwent maximal-effort upright cycle ergometry to determine cardiovascular function during rest and exercise.

While both groups had similar cardiovascular function at rest and limited exercise capacity, those in the HFpEF group had a mean exercise duration of 180 seconds versus 455 seconds for the control group, and peak oxygen consumption of 9.0 mL/kg/min versus 14.4 mL/kg/min for the control group. The authors conclude that greater understanding of all facets of heart disease is needed as there are increasing numbers of heart failure patients who have apparently normal heart pumping.

"Although diastolic dysfunction occurs in HFpEF, the present data suggest that other factors such as heart rate and vasodilator reserve also play a role in exertional symptoms. These abnormalities may deserve equal attention in efforts to develop more effective treatments for this disorder," the authors write.

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Statins Lower Mortality in Heart Failure Patients

Treatment linked to better clinical outcomes in patients with and without coronary disease

Statin therapy lowered mortality rates in eligible heart failure patients and was linked to fewer hospitalizations and better clinical outcomes in those with and without cardiac disease, researchers report in the Nov. 1 issue of the Journal of the American Medical Association.

Alan S. Go, M.D., of Kaiser Permanente of Northern California in Oakland, Calif., and colleagues retrospectively identified 24,598 patients with chronic heart failure between 1996 and 2004, who were eligible for lipid-lowering treatment and who had not been on statins.

Compared to those who did not start therapy, patients who began using statins were more likely to be male, younger and to have cardiovascular disease and risk factors, but few other comorbidities. After adjusting for potential confounders and concomitant cardiac medications, incident statin use remained linked to lower mortality (hazard ratio 0.76) and cardiac specific hospitalizations (hazard ratio 0.79) in patients eligible for statins. Incident statin treatment was also linked to fewer adverse outcomes in those with and without known heart disease.

"Among adults diagnosed with heart failure who had no prior statin use, incident statin use was independently associated with lower risks of death and hospitalization among patients with and without coronary heart disease," the authors conclude.

Some authors received research support funding from Amgen, Wyeth and Novartis.

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Constraint Therapy Helps Arm Function After Stroke

Immobilization of less-affected extremity forces patients to use impaired arm

Stroke patients who force themselves to use a paretic upper extremity by restraining their less-impaired arm can improve motor function in the impaired arm within a year, according to a report in the Nov. 1 issue of the Journal of the American Medical Association.

Steven Wolf, Ph.D., P.T., of Emory University School of Medicine in Atlanta, and members of the Extremity Constraint-Induced Therapy Evaluation (EXCITE) study conducted a prospective, single-blind, randomized trial of constraint-induced movement therapy (CIMT) in 222 individuals with predominately ischemic stroke in the previous three to nine months.

Twelve months after treatment, the CIMT group had improved motor function scores and used their impaired extremity more than the control group. The CIMT group also reported a greater decrease in self-perceived hand function difficulty than the control group.

"The EXCITE trial clearly suggests that more recovery after stroke is possible than neuroscientists currently teach in professional schools or training programs and than clinicians have been telling patients to expect," write Andreas R. Luft, M.D., of the University of Tubingen, Germany, and a colleague in an accompanying editorial.

AbstractFull Text (subscription or payment may be required)Editorial

Brain Stem Changes Linked to Sudden Infant Death

Serotonin responsive neurons, receptors altered in medulla of SIDS victims

Abnormalities in a region of the brain stem containing serotonergic neurons and critical for respiratory drive may play an important role in sudden infant death syndrome (SIDS), according to a report in the Nov. 1 issue of the Journal of the American Medical Association.

David Paterson, Ph.D., from Harvard Medical School in Boston, and colleagues used autopsy tissue to measure the number and density of serotonergic neurons and serotonin receptors in the brain stem of infants who died from SIDS. Depending on the assay, 16 to 31 SIDS cases were used and compared to six to 10 controls.

SIDS cases had significantly higher serotonergic neuron counts and density, but lower numbers of serotonin receptor binding sites in the medulla compared with control cases. Male SIDS cases had significantly lower serotonin receptor binding sites in the raphe obscurus compared with females, perhaps identifying a reason for the higher prevalence of SIDS in boys.

"Recognizing that 5-HT influences a broad range of physiological systems including the regulation of breathing, the cardiovascular system, temperature and the sleep-wake cycle, the study by Paterson et al extends the available literature in support of the underlying hypothesis that SIDS is the result of 5-HT-mediated dysregulation of the autonomic nervous system," writes Debra Ellyn Weese-Mayer, M.D., of Rush University Medical Center in Chicago, in an accompanying editorial.

AbstractFull Text (subscription or payment may be required)Editorial

About One in Eight U.S. Blacks Consider Suicide

Study suggests suicide in black communities is similar to general U.S. population

Nearly 12 percent of U.S. blacks have thought about committing suicide, according to the results of a survey conducted between 2001 and 2003 and reported in the Nov. 1 issue of the Journal of the American Medical Association. The results suggest that the black community is just as affected by suicide as the general population.

Sean Joe, M.S.W., Ph.D., of the University of Michigan in Ann Arbor, and colleagues used data from the National Survey of American Life to examine the prevalence and correlates of suicide ideation, planning and attempts among black Americans of African and Caribbean descent.

Survey respondents reported an 11.7 percent prevalence of suicide ideation and 4.1 percent prevalence for attempts. Among black Americans, Caribbean men had the highest rate of attempts compared with African American men and women of both ethnicities. The greatest risk for progressing from ideation to planning or attempts was found within the first year of ideation.

"Advancing research on the transition from suicide planning to attempt is vital to the efficacy of health care professionals' ability to screen blacks at risk for suicide," the authors write. "Physicians have an important role to play in the prevention of suicide among black patients, given our results that a majority of attempters sought care from a health professional."

AbstractFull Text (subscription or payment may be required)

Left Ventricular Assist Device Can Reverse Heart Failure

Most patients have device removed within one year

Many patients with severe heart failure secondary to non-ischemic cardiomyopathy could be treated effectively and see regression of their disease with the use of a left ventricular assist device, according to a report in the Nov. 2 New England Journal of Medicine.

Emma J. Birks, M.R.C.P., Ph.D., of the Royal Brompton and Harefield National Health Service Trust in Middlesex, U.K., and colleagues implanted a left ventricular assist device in 15 patients with severe heart failure due to non-ischemic cardiomyopathy. Patients were treated with lisinopril, carvedilol, spironolactone and losartan to enhance reverse remodeling, followed by a beta-agonist after regression occurred.

Eleven of the patients had sufficient myocardial recovery to allow explantation of the device at an average of 320 days after surgery. While two patients died -- one immediately after surgery from an intractable heart rhythm and one later from a lung carcinoma -- 100 percent of the surviving patients were free of heart failure at one year. Four years later, 89 percent were still free of disease.

"The treatment of stage D heart failure now includes more than end-of-life strategies, transplantation and permanent implantation of left ventricular assist devices," according to Dale G. Renlund, M.D., and Abdallah G. Kfoury, M.D., of the Utah Transplantation Affiliated Hospitals, in an accompanying editorial. "Indeed, left ventricular assist devices may sustain therapies that enable reverse remodeling, improve myocardial energetics and prepare the heart for removal of the device."

Some of the authors received grants from Thoratec, the manufacturer of the HeartMate left ventricular assist device used in the study.

AbstractFull Text (subscription or payment may be required)Editorial

Epirubicin Enhances Therapy for Early Breast Cancer

Two studies show better relapse-free and overall survival when epirubicin added to regimen

Epirubicin in addition to cyclophosphamide, methotrexate and fluorouracil (CMF) is a better adjuvant therapy for early breast cancer than just CMF alone, according to a report in the Nov. 2 issue of the New England Journal of Medicine.

Christopher J. Poole, F.R.C.P., at the University of Birmingham in the U.K., along with the National Epirubicin Adjuvant Trial (NEAT) group members and the Scottish Cancer Trials Breast Group (SCTBG) compared four cycles of epirubicin followed by four cycles of CMF with six cycles of CMF-alone for treatment of 2,391 women with early breast cancer.

Relapse-free and overall survival rates after two and five years were higher in the epirubicin plus CMF group than the CMF-alone group. For example, relapse-free and overall survival at five years were 76 and 82 percent for the epirubicin plus CMF group but only 69 and 75 percent for the CMF-alone group, respectively. Adverse effects were higher for the epirubicin plus CMF group but did not affect treatment or quality of life.

Each trial used a different CMF regimen and did not include data regarding radiation and tamoxifen treatment, both of which can influence outcome, according to an editorial by Mark N. Levine, M.D., and Timothy Whelan, B.M., B.Ch. "It is reassuring," they add, "that…the benefit of the sequential regimen was seen in both trials."

A number of the authors of the original study have received grant support or compensation from Pharmacia (now Pfizer) or other pharmaceutical companies.

AbstractFull TextEditorial

Men Have More Advanced Colorectal Cancer at Diagnosis

Large colonoscopy screening study suggests age should be included in screening recommendations

Male patients undergoing colonoscopy tend to have more advanced colorectal cancer at diagnosis than female patients, according to a report in the Nov. 2 issue of the New England Journal of Medicine. The findings suggest that gender should be taken into account along with age and family history when making screening recommendations.

Jaroslaw Regula, M.D., and colleagues from the Maria Sklodowska-Curie Memorial Cancer Center in Warsaw, Poland, performed a cross-sectional analysis of 50,148 participants undergoing colonoscopy screening to determine associations between patient characteristics and advanced neoplasia.

The investigators found that advanced neoplasia was detected in 5.9 percent of participants aged 50 to 66 years and in 3.4 percent of participants aged 40 to 49 years. In addition, advanced neoplasia was more likely to be detected in male subjects (adjusted odds ratio, 1.73) and fewer additional colonoscopies would be required to detect one advanced cancer in men than in women in all age groups.

"We found that sex is an independent predictor of the detection of advanced neoplasia during colonoscopic screening," the authors write. "Different rates of detection of advanced neoplasia during colonoscopic screening of men and women may warrant a refinement of the screening recommendations to include sex along with age and family history of colorectal cancer."

AbstractFull Text (subscription or payment may be required)

NEJM Retracts Two Oral Cancer Studies

Investigation calls data into question; most authors ask to pull the paper

The New England Journal of Medicine (NEJM) has retracted two studies on oral cancer because the supporting data is believed to be fabricated, according to an editorial in the Nov. 2 issue of the journal.

Jeffrey M. Drazen, M.D., editor-in-chief of the NEJM, and colleagues report that the retraction follows an 'Expression of Concern' published on Feb. 9 regarding two papers by Jon Sudbo et al. One was published in 2001 on DNA content as a prognostic marker for cancer in oral leukoplakia patients, and another in 2004 that suggested that aneuploidy was associated with greater mortality risk in oral leukoplakia patients, despite resection.

Sudbo is affiliated with two institutions, Rikshospitalet-Radium-Hospitalet Medical Center and the University of Oslo, which subsequently set up a commission to investigate the allegations of data fabrication, including the doctoring of photographs that accompanied the study findings. The English translation of the report was available on Sept. 1 and was then forwarded to all the authors of the two reports.

With the exception of Asle Sudbo (who did not respond to the report) and Jon Sudbo, all authors requested a retraction of the articles. "Jon Sudbo alone does not agree with the commission's report. Given the weight of evidence offered in the commission's report and the requests of most of the authors or the articles, we retract both articles," the NEJM editorial states.

The investigation was prompted by allegations of fraud regarding another study by Sudbo, which was published in October 2005 in The Lancet, which suggested that smokers who took nonsteroidal anti-inflammatory drugs could reduce their risk of oral cancer.

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Preterm Birth Unaffected by Periodontitis Treatment

Researchers also see no change in rates of low birth weight or fetalgrowth restriction

Rates of preterm birth are not significantly lower in pregnant women with gum disease who are treated for periodontitis compared to women with gum disease who are not treated, according to a study published in the Nov. 2 issue of the New England Journal of Medicine.

Bryan S. Michalowicz, D.D.S., of the University of Minnesota in Minneapolis, and colleagues randomly assigned 823 pregnant women with periodontal disease to undergo scaling and root planing early in the second trimester or after delivery.

The researchers found that the rate of preterm birth (before 37 weeks of gestation) was 12 percent in the group treated during pregnancy compared to 12.8 percent in the group treated after delivery. They also found that periodontal treatment during pregnancy did not result in an upward shift in the gestational age distribution or affect other outcomes such as low birth weight and the proportion of infants who were small for gestational age.

"Although the occurrence of adverse events before 32 weeks of gestation was not a prespecified outcome, it was less common in the treatment group than in the control group. An effect of treatment on early adverse outcomes is plausible," state the authors of an accompanying editorial. "In future studies, major adverse outcomes might include late miscarriage, early stillbirth and spontaneous preterm birth before 32 weeks, rather than all preterm births before 37 weeks."

AbstractFull Text (subscription or payment may be required)Editorial

Commercial HMOs Embrace Pay-for-Performance Programs

Study finds that more than half of HMOs use pay-for-performance in their provider contracts

Pay-for-performance programs are now used by a majority of commercial health maintenance organizations, according to a special report published in the Nov. 2 issue of the New England Journal of Medicine.

Meredith B. Rosenthal, Ph.D., of Harvard Medical School in Boston, and colleagues surveyed 252 HMOs in 41 metropolitan areas.

The researchers found that 126 HMOs used pay-for-performance in their provider contracts and that nearly 90 percent of them had programs for physicians and 38 percent had programs for hospitals. These HMOs accounted for more than 80 percent of the patients enrolled by the surveyed HMOs. The researchers also found that use of pay-for-performance was statistically associated with geographic region, use of capitation to pay primary care providers, use of primary care providers as gatekeepers, and whether the plans received bonuses or were penalized for performance.

"Patterns of diffusion of pay-for-performance are largely consistent with the notion that health plans that are better situated to benefit from these programs are more likely to incorporate them into their payment systems than HMOs that are less well-situated to do so," the authors conclude. "As the Centers for Medicare and Medicaid Services begins to design a pay-for-performance program for Medicare, information on commercial models may prove critical."

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Teenagers' Attitudes About Sex Similar Worldwide

Social factors must be taken into account in safe-sex programs aimed at teens

Safe-sex programs aimed at young people must take into account social factors and teenagers' attitudes if they are to succeed, according to a study published in the Nov. 4 issue of The Lancet. The study found strong similarities between the factors that affect the sexual behavior of teens in different countries.

Cicely Marston, Ph.D., and Eleanor King, M.Sc., of the London School of Hygiene and Tropical Medicine in the U.K., conducted a meta-analysis of 268 qualitative studies on sexual behavior and young people to tease out the key themes from this field of study.

The same themes were present in all countries assessed, the authors note. "Social expectations, especially ideas about how men and women should behave, are a powerful influence on behavior; the influence of sexual partners is also considerable, as are young people's ideas about stigma and risk; and social pressures make it difficult to communicate clearly with partners, which makes safer sex less likely," they write.

Given that many of the studies covered the same ground, the authors recommend future studies need to have a broader scope, for example to further investigate deviance from expected behavior and forces of change in sexual behavior, as well as ask more detailed questions and focus on areas so far only covered in passing such as the relation between pleasure and sexual behavior.

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Study Highlights Diversity in Sexual Behavior Across Globe

Evidence shows no general approach to sexual-health promotion will work everywhere

Contrary to popular belief, there is not a trend toward earlier sexual intercourse across the globe, according to the results of a new study of sexual behavior in 59 countries that appears in a special online issue of The Lancet.

Kaye Wellings, F.R.C.O.G., of the London School of Hygiene and Tropical Medicine in London, U.K., and colleagues report that men and women tend to have their first sexual experience between the ages of 15 to 19, with men having intercourse earlier than women. The trend toward later marriage led to an increase in rates of premarital sex across the globe. Rates were highest in developed countries and men were more likely than women to have premarital sex.

Married people have the most sex and monogamy reigns across the world. Having two or more partners in the past year was more common among men than women and higher among residents of industrialized countries. Condom use has increased all over, but rates are still low in many developing countries.

"The comparative data are important in countering misinformation and quelling fears relating to sexual behavior. The selection of public-health messages needs to be guided by epidemiological evidence rather than by myths and moral stances," the researchers conclude.

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Women's Access to Caesareans Insufficient Around World

But Caesareans are overused in Latin America

Sub-Saharan African women have dangerously poor access to Caesarean sections, while many Latin American women undergo the procedure unnecessarily, researchers report in the Oct. 28 issue of The Lancet.

Carine Ronsmans, Ph.D., of the London School of Hygiene and Tropical Medicine in the U.K., and colleagues analyzed data from 42 surveys in south and southeast Asia, Latin America and the Caribbean, and sub-Saharan Africa.

The researchers found Caesarean section rates under 1 percent for the least-advantaged fifth of the population in 20 countries, and under 1 percent for four-fifths of the population in six countries. In seven primarily Latin American countries, Caesareans exceeded the recommended 15 percent maximum for at least 40 percent of the population.

"In the poorest countries -- mostly in sub-Saharan Africa -- large segments of the population have almost no access to potentially life-saving Caesareans, whereas in some mid-income countries more than half the population has rates in excess of medical need," the authors write.

In an editorial, Fernando Althabe, M.D., of the Perinatal Research Unit in Montevideo, Uruguay, and a colleague warn: "Although urgent action is needed in sub-Saharan Africa, measures to prevent what is already occurring in Latin America should also be a priority."

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Rimonabant Can Reduce Weight in Type 2 Diabetics

With diet and exercise, drug produces meaningful weight loss, improves hemoglobin A1c

A daily dose of 20 milligrams of rimonabant combined with an exercise and diet regimen can help diabetes patients lose weight and improve their hemoglobin A1c (HbA1c), according to study findings published online Oct. 27 in The Lancet.

Andre J. Scheen, M.D., of the University of Liege in Belgium, and colleagues studied 1,047 type 2 diabetics who were overweight or obese, had an HbA1c concentration of 6.5 to 10 percent at baseline and were taking metformin or sulphonylurea monotherapy. The subjects were given a low-calorie diet, exercise suggestions and either 5 mg/day or 20 mg/day of rimonabant, or a placebo, for one year.

By the one-year mark, 692 patients remained in the study, with a similar number of subjects in each group. There was significantly greater weight loss among the rimonabant groups -- 2.3 kg for the 5 mg/day group and 5.3 kg for the 20 mg/day group -- compared with 1.4 kg for the placebo group.

"These data indicate that 20 mg/day rimonabant, in combination with diet and exercise, can produce a clinically meaningful reduction in bodyweight and improve HbA1c and a number of cardiovascular and metabolic risk factors in overweight or obese patients with type 2 diabetes inadequately controlled by metformin or sulphonylureas," the authors conclude.

The study was sponsored by Sanofi Synthelabo Research, a division of Sanofi Synthelabo Inc.

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Pneumococcal Vaccine Still Effective with Fewer Doses

Two or three doses just as effective as the four doses currently recommended

Vaccination of pediatric patients with two or three doses of the seven-valent pneumococcal conjugate vaccine is just as effective at preventing pneumococcal disease as the currently recommended schedule of four doses, according to the results of a study published in the Oct. 28 issue of The Lancet.

Cynthia G. Whitney, M.D., of the U.S. Centers for Disease Control and Prevention in Atlanta, and colleagues conducted a study of 782 children aged 3 months to 59 months with invasive pneumococcal disease and 2,512 healthy controls.

Disease caused by all seven serotypes was prevented by vaccination, as well as vaccine-related serotype 6A. One or more doses of the vaccine gave 96 percent protection against vaccine serotypes in healthy children and 81 percent among children with coexisting disorders. The vaccine had 76 percent efficacy against infections that were not susceptible to penicillin. Three infant doses with a booster was the most effective schedule.

"This information adds to evidence indicating that pneumococcal conjugate vaccines have the potential to greatly reduce the 800,000 to 1 million deaths of children from pneumococcal disease every year. The next challenge is to ensure that conjugate vaccines become part of routine immunization in more places, especially in developing countries where most pneumococcal deaths in young children occur," the authors conclude.

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Data On Flu Vaccine's Effectiveness Questioned

Amid gap between policy and evidence, a call for re-evaluation

Although public policy worldwide advises using inactivated influenza vaccine against seasonal flu outbreaks, systematic reviews show that the flu vaccine's performance is questionable, according to a report published in the Oct. 28 issue of BMJ.

Tom Jefferson, M.D., of the Cochrane Vaccines Field in Rome, Italy, writes that each year, vast resources go into identifying circulating flu viruses, developing matching vaccine and delivering it to the most susceptible sections of the population.

But after analyzing decades of systematic reviews of studies involving the flu vaccine, Jefferson found that many original studies are poor-quality and may exaggerate the benefits of inactivated flu vaccines.

Overall, Jefferson found a lack of reliable case-control studies of the flu vaccine's effectiveness or safety. The researcher found only five randomized studies reporting adverse effects among the elderly; insufficient data considering the widespread annual administration of vaccine in the elderly. With the current surveillance system unable to distinguish between influenza and influenza-like illness, better surveillance procedures are also needed.

"Reasons for the current gap between policy and evidence are unclear, but given the huge resources involved, a re-evaluation should be urgently undertaken," the researcher writes.

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Exercise Improves Heart Risk Factors in Obese Teens

Three hours a week for six months reduces carotid intima-media thickness

Six months of exercise can boost vascular function in obese adolescents and improve their cardiovascular disease risk factors, including a reduction in carotid intima-media thickness, researchers report in the Nov. 7 issue of the Journal of the American College of Cardiology.

Andreas A. Meyer, M.D., of the University of Rostock Children's Hospital in Rostock, Germany, and colleagues analyzed the effects of a six-month exercise program on 67 obese children (mean age 14.7), who were randomly assigned to three hours of exercise a week or no exercise, and compared them to lean controls. At baseline, the obese children had a flow-mediated vasodilation of 4.09 and a carotid intima-media thickness of 0.48, versus 10.65 and 0.37, respectively, for the lean children.

After six months, the researchers found that the obese children who exercised had flow-mediated vasodilation of 7.71 and a carotid intima-media thickness of 0.44. Exercise improved the children's body mass index and other key cardiovascular risk factors.

"The present study documented increased intima-media thickness, impaired endothelial function, and various elevated cardiovascular risk factors in young obese subjects," the authors write. "Regular exercise over six months restores endothelial function and improves carotid intima-media thickness associated with an improved cardiovascular risk profile in obese children."

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Hospital Delay Reduces Survival in Primary Angioplasty

Researchers find that speed of angioplasty determines survival versus clot-busting drugs

The survival benefit of angioplasty over clot-busting drugs for ST-elevation myocardial infarction declines with increasing door-to-balloon times and also varies with patient characteristics, according to a study published online Oct. 30 in Circulation: Journal of the American Heart Association.

C. Michael Gibson, M.S., M.D., of Harvard Medical School in Boston, and colleagues subtracted median door-to-needle (DN) time from median door-to-balloon (DB) time at a hospital, using data from 192,509 patients at 645 hospitals. In the study, 126,909 patients were treated with clot-busting drugs and 65,600 had angioplasty.

The researchers found that the longer the DB-DN time, the greater the likelihood of mortality. The DB-DN time at which survival with angioplasty was no better than that of clot-busting drugs also depended on the patient's age, duration of symptoms, and location of the infarct.

"As indicated in the American College of Cardiology/American Heart Association guidelines, both the hospital-based primary percutaneous coronary intervention-related delay (DB-DN time) and patient characteristics should be considered when a reperfusion strategy is selected," the authors conclude.

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Multidetector CT Scan Can Rule Out Acute Coronary Syndrome

Study shows that coronary multidetector computed tomography may improve early triage

In patients presenting with acute chest pain, coronary multidetector computed tomography (MDCT) may help rule out acute coronary syndrome and improve the accuracy of triage, according to a study published online Oct. 30 in Circulation: Journal of the American Heart Association.

Udo Hoffmann, M.D., M.P.H., of Harvard Medical School in Boston, and colleagues performed contrast-enhanced 64-slice MDCT coronary angiography on 103 patients to evaluate the presence of coronary atherosclerotic plaques and areas of significant coronary artery stenosis.

The researchers found that 14 patients had acute coronary syndrome. They determined that the absence of significant coronary artery stenosis (73 of 103 patients) and non-significant coronary atherosclerotic plaques (41 of 103 patients) accurately ruled out acute coronary syndrome.

"Because acute coronary syndrome is rare in the absence of plaque, MDCT may identify a group of patients who can be sent home safely on the basis of the CT findings," the authors state. "However, in the presence of plaque, the CT result must be interpreted in the context of the patient's clinical presentation."

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Drug-Eluting Stents More Effective Than Bare Metal

Sirolimus-eluting and paclitaxel-eluting stents both safe and effective

Drug-eluting stents result in lower rates of revascularization, and both sirolimus-eluting stents and paclitaxel-eluting stents are safe and effective, according to a report published online Oct. 23 in Circulation: Journal of the American Heart Association.

David O. Williams, M.D., of Rhode Island Hospital in Providence, R.I., and colleagues analyzed data on 6,906 patients from 140 medical centers who underwent percutaneous coronary intervention, of which 397 received bare-metal stents, 3,873 received sirolimus-eluting stents and 2,636 received paclitaxel-eluting stents.

There were significant differences between patients receiving bare-metal stents and drug-eluting stents in terms of clinical characteristics and type of lesion, but no significant difference between those receiving sirolimus-eluting and paclitaxel-eluting stents. Among the bare-metal stent group, the rate of death/myocardial infarction was 9.0 percent versus 5.2 percent for the drug-eluting stent group.

While 9.5 percent of bare-metal stent patients underwent target vessel revascularization, only 6.0 percent of the drug-eluting stent patients did so, while the rates for sirolimus-eluting and paclitaxel-eluting patients were similar at 6.3 percent and 5.5 percent, respectively. However, rates of stent thrombosis were similar for all three groups -- 0.8 percent for bare-metal, 0.5 percent for sirolimus-eluting and 0.8 percent for paclitaxel-eluting stents.

"These observations confirm the effectiveness and safety of both sirolimus-eluting stents and paclitaxel-eluting stents in unselected patients," the authors conclude.

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Simple Stenting Best for Coronary Artery Bifurcation

Procedure produces excellent clinical and angiographic results

Treating de novo coronary artery bifurcation lesions with sirolimus-eluting stents (SES) produces excellent results, with a simple stenting strategy associated with reduced times for both the procedure and fluoroscopy, according to a report published online Oct. 23 in Circulation: Journal of the American Heart Association.

Leif Thuesen, M.D., of Aarhus University Hospital in Aarhus, Denmark, and colleagues conducted a study of 413 patients with bifurcation lesions who were randomized to receive either main vessel (MV) or main vessel and side branch (MV + SB) stenting with SES.

At the six-month mark, both groups produced similar rates of major adverse cardiac events: 3.4 percent for the MV + SB group versus 2.9 percent for the MV group. However, patients in the MV + SB group had significantly longer procedure and fluoroscopy times. Contrast volumes and procedure-related increases in biomarkers of myocardial injury were also higher in this group than in the MV group.

In total, 307 patients had a quantitative coronary assessment at the index procedure and at eight months. After eight months, the combined angiographic endpoint was similar in the two groups: 5.3 percent of the MV group and 5.1 percent of the MV + SB group had diameter stenosis of more than 50 percent of the main vessel and occlusion of the side branch.

"Independent of stenting strategy, the procedural success rates were high, the major adverse cardiac events rate low, and the angiographic restenosis rate low in both treatment groups," the authors conclude.

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