JAMA 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, June 18, 2007)
CLOT-DISSOLVING AGENT MAY BE BENEFICIAL IN TREATMENT OF SEVERE FROSTBITE
BARIATRIC SURGERY APPEARS TO BE SAFE FOR CAREFULLY SELECTED OLDER, MEDICARE PATIENTS
ARCHIVES OF OTOLARYNGOLOGY—HEAD & NECK SURGERY NEWS RELEASES
(Embargoed Until: 3 P.M. (CT), Monday, June 18, 2007)
EVIDENCE LACKING TO GUIDE TREATMENT FOR SUDDEN HEARING LOSS
ARCHIVES OF DERMATOLOGY NEWS RELEASES
(Embargoed Until: 3 P.M. (CT), Monday, June 18, 2007)
LONG-TERM ETANERCEPT TREATMENT REDUCES PSORIASIS SEVERITY WITHOUT INCREASED ADVERSE EVENTS
INFORMATION CONTAINED IN THESE NEWS RELEASES IS PROTECTED BY COPYRIGHT. JOURNAL ATTRIBUTION IS REQUIRED.
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EMBARGOED FOR RELEASE UNTIL 3 P.M. (CT), MONDAY, June 18, 2007
Media Advisory: To contact corresponding author Jeffrey R. Saffle, M.D., call Phil Sahm at 801-581-7387.
CLOT-DISSOLVING AGENT MAY BE BENEFICIAL IN TREATMENT OF SEVERE FROSTBITE
CHICAGO—A preliminary study suggests that a blood clot-dissolving medication that is administered to some patients following a stroke or heart attack may help to reduce the risk of amputation following severe frostbite, according to a report in the June issue of Archives of Surgery, one of the JAMA/Archives journals.
Frostbite treatment has remained essentially the same for the past 25 years, according to background information in the article. “Today, traditional therapy consists of tissue rewarming, prolonged watchful waiting and often delayed amputation,” the authors write. “While many other areas of burns, trauma and critical care have advanced significantly in their treatment modalities, the saying ‘Frostbite in January, amputate in July’ is still relevant today.”
Kevin J. Bruen, M.D., and colleagues at the University of Utah, Salt Lake City, studied the anti-clotting agent tissue plasminogen activator (tPA) for the treatment of frostbite beginning in 2001. Patients who were admitted with severe frostbite underwent imaging studies to assess blood flow to the affected limb. From 2001 to 2006, six patients with abnormal blood flow on angiography received tPA within 24 hours of severe frostbite injury. These individuals were compared with 25 frostbite patients treated from 1995 to 2006 who did not receive tPA, plus one who received tPA more than 24 hours after injury.
Among the six patients who received tPA within 24 hours of injury, six of 59 (10 percent) affected fingers or toes were amputated, compared with 97 of 234 (41 percent) among those who did not receive tPA. “Moreover, no proximal [closer to the body than the fingers or toes] amputations were required in the patients who received tPA within 24 hours in our series,” the authors write. “The control group underwent 14 proximal amputations, including five below the knee. The preservation of limbs, which maximizes patient functional outcome, is perhaps the greatest benefit conferred by use of tPA in frostbite injury.”
The researchers suspect tPA helps reduce the injury caused when frozen skin is warmed again. Inflammation during thawing typically stimulates clotting that blocks small blood vessels, leading to cell death. Because tPA reverses this clotting, blood flow is restored before permanent damage is done.
“Based on the dramatic improvements in perfusion [blood flow] and reduction in rates of amputations when tPA was administered within 24 hours of frostbite injury, we anticipate the continued use of tPA in patients who are admitted to our institution with acute frostbite,” the authors write. “Candidates for this therapy are patients who present with severe frostbite as suggested by full-thickness tissue involvement, hemorrhagic blisters and abnormal perfusion on either angiogram or pyrophosphate scanning. Initiation of therapy within 24 hours of rewarming also appears to be necessary. Exclusion criteria would include superficial frostbite, involvement of the tips of the distal phalanges and contraindications to tPA, including concurrent trauma, neurological impairment or recent surgery or hemorrhage.”
“Additional studies are warranted to confirm our findings and to determine the best methods of assessing tissue damage and administering thrombolytics [anti-clotting drugs] in terms of timing, duration and route,” they conclude.
(Arch Surg. 2007;142:546-553. Available to the media pre-embargo at www.jamamedia.org).
Editor's Note: Support for this project was provided by departmental and division funds from the Department of Surgery and the Burn Center at the University of Utah. 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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EMBARGOED FOR RELEASE UNTIL 3 P.M. (CT), MONDAY, June 18, 2007
Media Advisory: To contact Peter T. Hallowell, M.D., call Susan Licate at 216-368-3635.
BARIATRIC SURGERY APPEARS TO BE SAFE FOR CAREFULLY SELECTED OLDER, MEDICARE PATIENTS
CHICAGO—Complications after bariatric surgery appear similar between patients younger and older than age 60 and also between Medicare recipients and non-recipients, according to a study in the June issue of Archives of Surgery, one of the JAMA/Archives journals.
“Obesity has become the leading cause of preventable death in the United States,” according to background information in the article. “Rates of obesity have continued to climb in the last decade across all age groups. Surgery for morbid obesity is currently the most effective treatment.” The success of bariatric surgery has expanded the treatment of morbid (severe) obesity and its conditions for patient populations that had not previously been served. Medicare has recently begun covering bariatric surgery although significant death rates have been reported in Medicare patients undergoing surgery.
Peter T. Hallowell, M.D., and colleagues of University Hospitals Case Medical Center and Case Western Reserve University School of Medicine, Cleveland, reviewed the cases of 892 patients who had gastric bypass surgery from 1998 to 2006. The patients were divided into four groups. Group one, 46 patients age 60 to 66 years was compared with group two, 846 patients age 18 to 59 years. Group three, 31 Medicare recipients (age 31 to 66), was compared with group four, 861 non-Medicare recipients (age 18 to 64). The age, sex and body mass index of each patient were documented as well as time spent in the operating room, length of stay, other illnesses and complications (including death).
When comparing older and younger patients, male-female ratios and BMIs were similar and length of stay was a half-day longer for group one. The older group spent an average of 17 minutes less in the operating room than the younger group. There was no statistically significant difference found between the two groups for any postoperative complication or death. “No mortality was seen in the older group (group one) at 30 days, 90 days or one year. Three deaths occurred within 30 days in the younger group (group two) with one additional death within one year,” the authors note.
When comparing Medicare and non-Medicare patients, group three (Medicare patients) had a greater average BMI of 56 and spent an average of 14 minutes longer in the operating room. Medicare patients also spent an average of a day-and-a-half longer in the hospital. There was no significant difference between the two groups for any complication or death after surgery. No Medicare patients died at 30 days, 90 days or one year. Three non-Medicare patients died within 30 days and one additional patient died within one year.
“Bariatric surgery can be performed in carefully selected Medicare recipients and patients 60 years or older with acceptable morbidity and mortality,” the authors conclude. “We believe that these results reflect careful patient selection, intensive preoperative education and expert operative and perioperative management. Our results indicate that bariatric surgery should not be denied solely based on age or Medicare status.”
(Arch Surg. 2007;142:506-512. Available to the media pre-embargo at www.jamamedia.org).
Editor's Note: 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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EMBARGOED FOR RELEASE UNTIL 3 P.M. (CT), MONDAY, June 18, 2007
Media Advisory: To contact corresponding author Lorne S. Parnes, M.D., F.R.C.S.C., call Kathy Wallis at 519-661-2111, ext. 81136.
EVIDENCE LACKING TO GUIDE TREATMENT FOR SUDDEN HEARING LOSS
CHICAGO—Although steroids are the most widely used treatment for sudden hearing loss, little scientific evidence supports their use or that of any other therapies for this condition, according to a systematic review and meta-analysis both published in the June issue of Archives of Otolaryngology—Head & Neck Surgery, one of the JAMA/Archives journals.
Sudden sensorineural hearing loss is acute hearing impairment involving loss of at least 30 decibels of hearing over at least three test frequencies occurring within three days, according to background information in the article. The condition affects about five to 20 of every 100,000 individuals yearly. Treatment varies widely and includes antiviral medications, vitamins, minerals, herbs, hyperbaric oxygen and agents that dilute the blood. “In addition, some otolaryngologists choose not to treat sudden sensorineural hearing loss at all, citing spontaneous recovery rates of 32 percent to 70 percent,” the authors write. “However, the most common approach to treatment of sudden sensorineural hearing loss in North America is with systemic steroids, which has been deemed by some authors to be the gold standard of treatment.”
Anne Elizabeth Conlin, B.A. & Sc., M.D., of the University of Ottawa, Ontario, and Lorne S. Parnes, M.D., F.R.C.S.C., of the University of Western Ontario, London, Canada, searched for all randomized clinical trials evaluating treatments for sudden hearing loss published between 1966 and 2006.
For the systematic review, 21 trials were identified and evaluated, all of which used measures from hearing tests to define treatment outcomes. “Only two studies used identical criteria to define sudden sensorineural hearing loss,” the authors write. “The method of randomization was described in two studies. Validity scores ranged from two to eight (of nine). Positive results were reported favoring systemic steroids, intratympanic [inside the inner ear] steroids, batroxobin, magnesium, vitamin E and hyperbaric oxygen, although there were serious limitations in each study with a positive finding.”
This includes the article cited as the landmark study for the use of steroids, which was not described as a randomized trial and therefore may have produced exaggerated treatment effects, the authors note. The authors suggest that this study also used inconsistent doses of steroids and did not measure outcomes at the same time for all participants. “The study therefore does not inform the otolaryngologist of what dose of steroids to use, nor at what time after treatment to expect improvement,” the authors write.
“To our knowledge, no valid randomized controlled trial exists to determine effective treatment of sudden sensorineural hearing loss,” they conclude. “Systemic steroids cannot be considered the gold standard of treatment of sudden sensorineural hearing loss, given the severe limitations of the landmark study supporting their use.”
For the meta-analysis, data from the same trials were combined when they covered the same therapies. Five trials were eligible for the analysis. “Pooling of data from two randomized clinical trials that compared steroids with placebo showed no difference between treatment groups,” the authors write. “No difference existed between patients treated with antiviral plus steroid therapy vs. placebo plus steroid therapy. Finally, there was no difference between subjects treated with steroids vs. subjects treated with any other active treatment.”
Treating sudden hearing loss is difficult because its cause is often unknown, the authors note. However, it is still important to identify the therapy that most benefits the patient. “At present, sudden sensorineural hearing loss remains a medical emergency without a scientific understanding of its cause or a rational approach to its treatment,” they conclude.
(Arch Otolaryngol Head Neck Surg. 2007;133:573-581 and 582-586. Available to the media pre-embargo at www.jamamedia.org)
Editor's Note: Please see the articles 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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EMBARGOED FOR RELEASE UNTIL 3 P.M. (CT), MONDAY, June 18, 2007
Media Advisory: To contact Stephen Tyring, M.D., Ph.D., call Melissa McDonald at 713-500-3308.
LONG-TERM ETANERCEPT TREATMENT REDUCES PSORIASIS SEVERITY WITHOUT INCREASED ADVERSE EVENTS
CHICAGO—Extended exposure to the psoriasis medication etanercept does not appear to cause more infections or adverse events than placebo, and improvements in several measures of disease severity were observed for up to 96 weeks of therapy, according to a study in the June issue of Archives of Dermatology, one of the JAMA/Archives journals.
Psoriasis, a chronic inflammatory skin disorder, usually requires long-term therapy, according to background information in the article. “Serum and affected tissue levels of tumor necrosis factor (TNF) are elevated in patients with psoriasis compared with levels in uninvolved skin of patients with psoriasis and in healthy individuals, suggesting that TNF plays an important role in the pathogenesis of the disease,” the authors write. Etanercept, which binds with TNF, has been approved to treat several inflammatory diseases, including psoriasis.
Stephen Tyring, M.D., Ph.D., The University of Texas Health Science Center at Houston, and colleagues conducted a phase 3 randomized, double-blind trial with an open-label extension (during which all patients were aware that they were taking the active drug) from May 23, 2003, through June 22, 2005. After a 12-week period during which 618 patients with moderate to severe psoriasis were randomly assigned to receive either placebo or 50 milligrams of etanercept twice weekly (the current recommended dosage for psoriasis) for 12 weeks, all 591 continuing patients (average age 45.7) received etanercept for up to 84 weeks. During this open-label period, safety and efficacy evaluations were completed every 12 weeks. Psoriasis severity was measured using the Psoriasis Area and Severity Index (PASI) score, where zero means no disease and 72 is the most severe disease.
“Exposure-adjusted rates of adverse events, serious adverse events, infections and serious infections were similar for placebo and etanercept treatments,” the authors write. “Patients responded within two weeks to etanercept, with statistically significant differences in the Psoriasis Area and Severity Index and Dermatology Life Quality Index between the etanercept and placebo groups at week 12. At week 24, after 12 weeks of open-label etanercept treatment, patients in the original placebo group had clinical benefits comparable to those of patients in the original etanercept group.”
Improvements in PASI scores peaked at week 48, and at the end of the study, 51.6 percent of the original placebo group and 51.1 percent of the original etanercept group improved by at least 75 percent. A total of 18.3 percent of patients developed antibodies to etanercept during the study, but these antibodies did not appear to cause adverse events or reduce the drug’s effectiveness.
“In conclusion, this study represents, to our knowledge, the longest continuous exposure of patients with psoriasis to 50 milligrams of etanercept biweekly and provides further insights into the safety and efficacy of high-dose etanercept therapy for the management of moderate to severe psoriasis,” the authors conclude.
(Arch Dermatol. 2007;143:719-726. Available to the media pre-embargo at www.jamamedia.org).
Editor's Note: This study was supported by Immunex Corporation, a wholly owned subsidiary of Amgen Inc, and by Wyeth Pharmaceuticals. Please see the article for additional information, including other authors, author contributions and affiliations, financial disclosures, funding and support, etc.
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