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March 16, 2009JAMA news releases are made available to the public after 3 pm US Central time on the first 4 Tuesdays of each month. The Archives of Journals news releases are made available to the public after 3 pm Central time on Mondays. We also provide a list of previous news releases. THIS WEEK'S CONTENTS
ARCHIVES OF SURGERY NEWS RELEASES
(Embargoed Until: 3 P.M. (CT), Monday, March 16, 2009)
ARCHIVES OF FACIAL PLASTIC SURGERY
(Embargoed Until: 3 P.M. (CT), Monday, March 16, 2009)
ARCHIVES OF DERMATOLOGY NEWS RELEASES
(Embargoed Until: 3 P.M. (CT), Monday, March 16, 2009)
ARCHIVES OF OTOLARYNGOLOGY—HEAD & NECK SURGERY
(Embargoed Until: 3 P.M. (CT), Monday, March 16, 2009) INFORMATION CONTAINED IN THESE NEWS RELEASES IS PROTECTED BY COPYRIGHT. JOURNAL ATTRIBUTION IS REQUIRED. JOURNALISTS CAN NOW ACCESS EMBARGOED JAMA/ARCHIVES STUDIES ON-LINE. Go to www.jamamedia.org for more information and to apply for access. Please Note: The FOR THE MEDIA website now has a search feature to enable media to find previous JAMA/Archives news releases on specific medical topics. This search feature link is located on the home page at www.jamamedia.org EMBARGOED FOR RELEASE UNTIL 3 P.M. (CT), MONDAY, March 16, 2009
Obesity Associated With Worse Outcomes After Pancreatic Cancer Surgery
CHICAGO—Obese patients with a body mass index (BMI) of more than 35 appear more likely to have cancer that has spread to their lymph nodes, lower rates of survival and higher rates of recurrence following surgery for pancreatic cancer, according to a report in the March issue of Archives of Surgery, one of the JAMA/Archives journals. Obesity rates have dramatically increased in the United States over the past 20 years, according to background information in the article. "In many obesity-related diseases and malignant neoplasms [cancerous tumors], an increased prevalence of pancreatic cancer has been reported in numerous epidemiologic and cohort studies focusing on obese patients," the authors write. "Further, obesity has been associated with decreased survival in patients with pancreatic adenocarcinoma, although the mechanism remains unknown." Jason B. Fleming, M.D., of the University of Texas M.D. Anderson Cancer Center, Houston, and colleagues studied 285 consecutive patients who underwent pancreatic resection (removal of some or all of the pancreas) to treat pancreatic cancer between 1999 and 2006. Data about surgery, patient BMI and outcomes were obtained from the institutional database and electronic medical records. A total of 152 patients (53 percent) died during a median (midpoint) of 16 months of follow-up. Patients with a BMI higher than 35 survived a median of 13.2 months, compared with 27.4 months for those with a BMI of less than 23. At the last follow-up, 15 of 20 patients (75 percent) with a BMI of more than 35 had died, compared with 137 of 265 patients (52 percent) with a BMI of 35 or less. "We identified a subset of obese patients (BMI greater than 35) who were at 12-fold risk of lymph node metastasis compared with non-obese patients (BMI of 35 or less). The estimated disease-free and overall survival rates were decreased in the obese patients, and the risk of cancer recurrence and death after pancreatectomy [removal of the pancreas] was nearly twice that in non-obese patients," the authors write. "Cancer recurrence was observed in 95 percent (19 of 20) of patients in the group with a BMI of more than 35 vs. 61 percent (161 of 264) of all other patients."
Previous studies have shown an association between a BMI of more than 35 and an increased risk of death from pancreatic cancer, the authors note. "Our findings extend these observations to those patients who undergo surgery to treat pancreatic cancer and suggest that obesity is a host factor affecting tumor biology independent of the difficulties (patient- and treatment-related) involved in delivering oncologic care in obese patients. Future investigations should include a search for systemic or tumor biomarkers in this group of patients that could provide additional insight."
Editor's Note: This study was supported by the Various Donor Fund for Pancreatic Cancer Research and by a grant to the University of Texas M.D. Anderson Cancer Center from the National Institutes of Health. Please see the article for additional information, including other authors, author contributions and affiliations, financial disclosures, funding and support, etc. For more information, contact JAMA/Archives media relations at 312/464-JAMA (5262) or e-mail mediarelations{at}jama-archives.org.
EMBARGOED FOR RELEASE UNTIL 3 P.M. (CT), MONDAY, March 16, 2009
Risk Score Helps Identify Candidates for Combined Heart and Kidney Transplants
CHICAGO—Researchers have identified a set of criteria that, when combined with a measure of kidney function, could help identify patients who are likely to receive a survival benefit from a combined heart and kidney transplant, according to a report in the March issue of Archives of Surgery, one of the JAMA/Archives journals. "In the past, patients with end-stage heart failure having concurrent renal [kidney] disease were not considered candidates for heart transplantation," the authors write as background information in the article. "With advances in operative techniques and perioperative [around the time of surgery] management, combined heart and kidney transplantation is offered to select patients in this population." A 1997 article demonstrated that heart and kidney transplant recipients have similar survival rates as recipients of heart transplants alone. However, there are still no standardized guidelines for heart and kidney transplants, despite an increasing number of these procedures being performed. In a new study, Mark J. Russo, M.D., M.S., of Columbia University Medical Center/New York-Presbyterian Hospital, New York, and colleagues analyzed data from the United Network for Organ Sharing (UNOS) for 19,373 patients who underwent heart transplantation between 1995 and 2005. This included 274 patients who received combined heart and kidney transplants and 19,109 who received heart transplants alone. The researchers assessed illness status as assigned by UNOS, pretransplantation demographics and medical history to determine which factors affected survival. Patients appeared less likely to survive following a combined heart and kidney transplant if, before surgery, they had peripheral vascular disease (disease of the blood vessels outside the heart and brain), were older than 65, had heart failure that was nonischemic (not caused by blocked or narrowed arteries), were dependent on dialysis or were placed on a ventricular assist device (pumping device that assists the heart) as a bridge to transplantation. When patients were stratified into three groups based on these risk factors, the one-year survival rate was 93.2 percent for those in the lowest-risk group and 61.9 percent for those in the highest-risk group. Previous studies have shown that patients with an estimated glomerular filtration rate (eGFR, a measure of kidney function) of less than 33 milliliters per minute have decreased survival following heart transplantation, the authors note. When the authors further stratified patients in the study based on eGFR, patients with an eGFR of less than 33 milliliters per minute who were in the low-risk group appeared to survive longer following heart and kidney transplants than following heart transplants alone. About one-fourth of patients in the highest-risk group died from infection. Patients who were bridged to transplantation with a ventricular assist device, had peripheral vascular disease or were older than 65 appeared more vulnerable to infection, explaining their increased risk of death. The underlying reasons for the increased risk of death due to nonischemic heart failure remains unclear, the authors note.
"Among patients with combined kidney failure (eGFR, less than 33 milliliters per minute) and heart failure, those classified by this risk stratification scheme as low-risk should undergo combined heart and kidney transplantation, while there is no demonstrable benefit for combined heart and kidney transplantation over heart transplantation alone in patients classified as high risk," they conclude.
Editor's Note: This study was supported in part by a contract from the Health Resources and Services Administration, U.S. Department of Health and Human Services, and by a training grant from the National Institutes of Health. Please see the article for additional information, including other authors, author contributions and affiliations, financial disclosures, funding and support, etc. For more information, contact JAMA/Archives media relations at 312/464-JAMA (5262) or e-mail mediarelations{at}jama-archives.org.
EMBARGOED FOR RELEASE UNTIL 3 P.M. (CT), MONDAY, March 16, 2009
New Type of Botulinum Toxin Appears to Be Well Tolerated and May Help Reduce Forehead Wrinkles
CHICAGO—Injections with a new type of botulinum toxin appears to be well tolerated and may help to improve the appearance of moderate to severe forehead lines with no evidence of diminishing treatment response over 13 months, according to a report in the March/April issue of Archives of Facial Plastic Surgery, one of the JAMA/Archives journals. Injecting low doses of Clostridium botulinum toxin type A is a generally accepted method for treating lines on the face, according to background information in the article. A new botulinum toxin type A (Reloxin) has been used to treat neurological disorders outside the United States for more than 15 years and is approved to treat wrinkles in 23 countries. In the United States, this product has been under investigation for the treatment of glabellar or forehead lines since 2002, according to the authors. Ronald Moy, M.D., of the Moy-Fincher Medical Group, Los Angeles, and colleagues report data from a phase 3, open-label study of 1,200 patients. Investigators injected 0.05 milliliters of solution, each containing 10 units of the new botulinum toxin, into each of five injection sites in the forehead at the beginning of each treatment cycle. Patients maintained diaries of treatment effects, were telephoned seven days later to check for adverse events and were re-examined clinically after two weeks, 30 days and again every month until their next treatment, withdrawal from the study or the end of the study. Based on patient response, as many as five consecutive treatments were given with a minimum of 85 days in between. A total of 1,052 patients completed the 13-month study. During the study period, 2,838 adverse events were experienced by 880 patients. Of those, 804 (28 percent) were considered probably or possibly related to the treatment, including events at the injection site (18 percent), nervous system disorders (14 percent) such as headache (12 percent) and eye events (9 percent, including 4 percent with ptosis, drooping of the eyelid or brow). Only one patient discontinued the study because of adverse events. The authors suggest that based on investigators' and patients' assessments, the onset of effect and the duration of effect, the new botulinum toxin type A demonstrated benefits that did not diminish with repeat treatments. "The onset of effect was seen as soon as 24 hours and at a median [midpoint] of three days during all cycles," they write. By day seven of each treatment cycle, 93 percent to 95 percent of patients reported a response to treatment, and between 80 percent and 91 percent had a response by day 30 based on the investigators' assessments.
The authors conclude that multiple cycles of treatment with 50 units of the new botulinum type A toxin were well tolerated and maintained a clinical effect over 13 months and that the incidence of treatment-emergent adverse events decreased over time, showing no evidence of cumulative safety issues after more than 4,000 treatments with this product.
Editor's Note: Medicis Pharmaceutical Corp. provided Reloxin and funding for this study. Co-author Dr. Maas owns stock in, has acted as a consultant for and has received research support from Medicis Pharmaceutical Corp. Please see the article for additional information, including other authors, author contributions and affiliations, financial disclosures, funding and support, etc. For more information, contact JAMA/Archives media relations at 312/464-JAMA (5262) or e-mail mediarelations{at}jama-archives.org.
EMBARGOED FOR RELEASE UNTIL 3 P.M. (CT), MONDAY, March 16, 2009
Wet Combing More Accurate Than Visual Inspection for Identifying Active Head Lice Infestation
CHICAGO—Combing through a child's wet hair may lead to more accurate identification of active head lice infestation than visual inspection, according to a report in the March issue of Archives of Dermatology, one of the JAMA/Archives journals. However, visual inspection may yield a more precise assessment of the number of children who have eggs or nits (larvae) in their hair. Head lice infestation (pediculosis capitis) is one of the most common childhood infections, affecting between 1 percent and 3 percent of 6- to 12-year-olds in industrialized nations, according to background information in the article. "In view of the high frequency of the infestation and the importance attributed to this parasitic skin disease by caregivers, governesses, teachers and health care providers, it comes as a surprise that the diagnostic accuracy of the techniques currently in use—visual inspection and wet combing—has never been determined appropriately," the authors write. Health care professionals and lay personnel frequently overdiagnose head lice infestation and fail to distinguish between active and extinct cases. Claudia Jahnke, M.D., of the City Health Department, Braunschweig, Germany, and colleagues compared the two diagnostic methods in 304 students age 6 to 12 attending five German primary schools with head lice epidemics in 2007. Every child attending the schools was examined first by visual inspection, where an applicator stick was used to part the hair at the temples, behind the ears and on the neck. A second investigator, who did not know the results of the inspection, then applied a conditioner to wet the hair and combed from roots to ends with a fine-toothed comb. The conditioner was wiped on white sanitary paper and any object trapped within was examined with a magnifying glass. Data from visual inspection were available for 304 children and from wet combing for 300 children. The presence of eggs or nits was detected in 79 children (26.3 percent) and lice in trophic stages (adults or nymphs) were seen in 21 children (7 percent). "Visual inspection underestimated the true prevalence of active infestation by a factor of 3.5," the authors write. Wet combing had a significantly higher sensitivity for detecting active infestations, correctly identifying them in 90.5 percent of the children (vs. 28.6 percent for visual inspections). However, visual inspection had a higher sensitivity for the identification of historic infestations (86.1 percent vs. 68.4 percent). "In contrast to settings in the developing world in which a high intensity of infestation is the rule, in industrialized countries most children carry only a few lice," the authors write. "In consequence, the optimal detection method should identify even a single louse and should have a high negative predictive value to exclude the possibility that individuals classified as negative for lice are actually false negative with the potential to spread the parasite. In this regard, wet combing is the only useful method if active infestation has to be ruled out."
"Because visual inspection is rapidly performed, requires no additional resources other than a reusable applicator stick and is more sensitive, this technique is the method of choice if the frequency of historic pediculosis capitis is to be determined," they conclude.
Editor's Note: This study was partially supported by Ärztekommittee für die Dritte Welt, Frankfurt, Germany, and the Kongregation der Franziskanerinnen, Salzkotten, Germany. Pohl-Boskamp GmbH & Co. KG, Hohenlockstedt, Germany, provided NYDA head lice combs free of charge. Please see the article for additional information, including other authors, author contributions and affiliations, financial disclosures, funding and support, etc. For more information, contact JAMA/Archives media relations at 312/464-JAMA (5262) or e-mail mediarelations{at}jama-archives.org.
EMBARGOED FOR RELEASE UNTIL 3 P.M. (CT), MONDAY, March 16, 2009
Acitretin Therapy May Help Reduce Nail Psoriasis
CHICAGO—Low-dose acitretin (a drug used to treat skin psoriasis) therapy appears to reduce nail psoriasis symptoms, according to a report in the March issue of Archives of Dermatology, one of the JAMA/Archives journals. Up to 78 percent of psoriasis patients experience nail psoriasis, which consists of irregular pitting, salmon-colored patches on the nail bed and onycholysis (separation of the nail from the nail bed) with erythematous (reddened and often inflamed) borders on several fingernails or toenails, according to background information in the article. "The quality of life of patients with severe nail psoriasis is affected as a result of pain and poor cosmetic appearance, subsequently leading to restricted activities of daily living," the authors write. Antonella Tosti, M.D., of University of Bologna, Italy, and colleagues evaluated the effectiveness of low-dose acitretin therapy (0.2 to 0.3 milligrams per kilogram per day for six months) on the nails of 36 patients (27 men and nine women, average age 41 years) who had psoriasis involving only the nails. Researchers used the Nail Psoriasis Severity Index (NAPSI) to grade the severity of the condition. Higher NAPSI scores indicated more severely affected nails. Patients were followed up for at least six months after treatment. "The mean percentages of reduction of the NAPSI score and modified NAPSI score were 41 percent and 50 percent, respectively," the authors write. "Clinical evaluation at six months showed complete or almost complete clearing of the nail lesions in nine patients (25 percent), moderate improvement in nine (25 percent), mild improvement in 12 (33 percent) and no improvement in six (11 percent)." "Only one of the 36 patients experienced adverse effects on the nail during treatment," the authors note. All participants whose condition improved did not return to pre-treatment conditions.
"Although more studies are required to thoroughly assess the effectiveness in larger controlled subject populations, our observations suggest that low-dose systemic acitretin should be considered in the therapeutic armamentarium in the treatment of nail psoriasis," the authors conclude.
Editor's Note: Contributing author, Dr. Romanelli, has received payments for speaking engagements from Amgen Inc., Abbott Laboratories and Genentech Inc. Please see the article for additional information, including other authors, author contributions and affiliations, financial disclosures, funding and support, etc. For more information, contact JAMA/Archives media relations at 312/464-JAMA (5262) or e-mail mediarelations{at}jama-archives.org.
EMBARGOED FOR RELEASE UNTIL 3 P.M. (CT), MONDAY, March 16, 2009
Steroid Nasal Wash Appears to Improve Health Status of Patients With Chronic Rhinosinusitis Without Affecting Adrenal Gland Function
CHICAGO—A nasal wash containing the corticosteroid budesonide appears to reduce symptoms of chronic rhinosinusitis without suppressing the function of the adrenal glands, a known complication of this type of drug that would indicate absorption throughout the whole body, according to a report in the March issue of Archives of Otolaryngology—Head & Neck Surgery, one of the JAMA/Archives journals. Chronic rhinosinusitis—a persistent inflammation of the nose and sinuses behind the nose—affects up to 14 percent of the U.S. population, according to background information in the article. An aqueous nasal spray containing budesonide has been shown to be safe and have a benefit for those with chronic rhinosinusitis and recurring allergies. The medication is also available in respules—small, plastic liquid-containing devices that can be opened and mixed with saline to produce a nasal wash. According to the authors, no previous studies have been conducted to demonstrate the safety of such a preparation. Neil S. Sachanandani, B.S., and colleagues at the Washington University School of Medicine, St. Louis, assessed the effects of budesonide on adrenal function in nine patients between 2005 and 2006. Participants were instructed to use a nasal wash composed of 0.25 milligrams of budesonide and 5 milliliters of saline in each nostril once daily for 30 days. At clinic visits before and after the treatment period, participants completed a questionnaire assessing their rhinosinusitis symptoms and related quality of life. Their cortisol levels were measured after injection with cosyntropin, a compound that stimulates the release of cortisol by the adrenal glands—a standard method of testing adrenal function. All patients showed an adequate adrenal response to cosyntropin before and after budesonide therapy, the authors report. Total scores on the questionnaire assessing symptoms improved clinically and statistically following therapy. All patients "reported some form of overall improvement with the use of budesonide, and six of the nine patients (67 percent) would recommend this drug to a friend," the authors write. "The clinical significance of this study is that budesonide nasal respules appear safe for short-term use for the relief of symptoms associated with chronic sinusitis," they continue. "Budesonide respules seem to provide an effective treatment option for the patient with chronic rhinosinusitis with minimal fear of systemic adverse effects."
The Food and Drug Administration has not approved the use of budesonide as a nasal wash, so therefore this preparation would be an off-label use, they note. Clinicians should discuss the risks associated with the use of the product. Decreased bone mineral density is one potential complication of long-term use and deserves further study, the authors conclude.
Editor's Note: This research was supported, in part, by a grant from the National Institutes of Health Roadmap Predoctoral Clinical Research Training Program and the Washington University General Clinical Research Center. Please see the article for additional information, including other authors, author contributions and affiliations, financial disclosures, funding and support, etc. For more information, contact JAMA/Archives media relations at 312/464-JAMA (5262) or e-mail mediarelations{at}jama-archives.org. |
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