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January 1, 2008

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 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 CONTENT

JAMA NEWS RELEASES
(Embargoed for Release: 3:00 p.m. CT, Tuesday, January 1, 2008)


JAMA NEWS RELEASES

>   TESTOSTERONE SUPPLEMENTATION FOR OLDER MEN APPEARS TO HAVE LIMITED BENEFIT

>   STUDY EXAMINES GENETIC DEFECTS LINKED TO BODY ABNORMALITIES IN PATIENTS WITH CHILDHOOD CANCER

>   USE OF OPIOIDS TO TREAT PAIN IN EMERGENCY DEPARTMENTS ON THE RISE, BUT RACIAL DIFFERENCES IN OPIOID USE STILL EXIST

JAMA REPORT (VIDEO SCRIPT)

>   VIDEO: Windows Media | Quicktime

>   TESTOSTERONE SUPPLEMENTATION NOT BENEFICIAL IN COMBATING MOST EFFECTS OF AGING IN MEN

INFORMATION CONTAINED IN THESE NEWS RELEASES IS PROTECTED BY COPYRIGHT. JOURNAL ATTRIBUTION IS REQUIRED.

TV Note: This week's JAMA Report video is on the effects of testosterone supplementation for older men. The report will be fed Tuesday, January 1, from 9:00 - 9:30 a.m. ET and 2:00 - 2:30 p.m. ET, on Galaxy 26 (formerly Intelsat America 6) C-Band, Transponder 14, downlink frequency: 3880 vertical, audio 6.2/6.8. For more information, call 312/464-JAMA.

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Embargoed for Release: 3:00 p.m. CT, Tuesday, January 1, 2008
Media Advisory: To contact Marielle H. Emmelot-Vonk, M.D., email: m.h.emmelotvonk{at}umcutrecht.nl.

TESTOSTERONE SUPPLEMENTATION FOR OLDER MEN APPEARS TO HAVE LIMITED BENEFIT

CHICAGO—Older men with low testosterone levels who received testosterone supplementation increased lean body mass and decreased body fat, but were no stronger and had no improvement in mobility or cognition compared with men who did not use the supplement, according to a study in the January 2 issue of JAMA.

“Male aging is associated with a gradual but progressive decline in serum levels of testosterone, occurring to a greater extent in some men than in others. Decline in testosterone is associated with many symptoms and signs of aging such as a decrease in muscle mass and muscle strength, cognitive decline, a decrease in bone mass, and an increase in (abdominal) fat mass,” the authors write. Clinical trials examining whether testosterone supplementation provides benefits or adverse effects have yielded mixed findings.

Marielle H. Emmelot-Vonk, M.D., of University Medical Center Utrecht, the Netherlands, and colleagues conducted a randomized, placebo-controlled study to assess the effects of testosterone supplementation on functional mobility, cognition, bone mineral density, body composition, lipids, quality of life, and safety parameters in older men with testosterone levels less than 13.7 nmol/L (less than the average level in this age group) during a period of six months. The trial, conducted from January 2004 to April 2005, included 207 men between the ages of 60 and 80 years. Participants were randomly assigned to receive 80 mg of testosterone undecenoate or a matching placebo twice daily for six months.

The researchers found that during the study, lean body mass increased and fat mass decreased in the testosterone group compared with the placebo group but these factors were not accompanied by an increase of functional mobility or muscle strength. Cognitive function and bone mineral density did not change. Insulin sensitivity improved but high-density lipoprotein cholesterol (the “good” cholesterol) decreased. By the end of the study, 47.8 percent in the testosterone group vs. 35.5 percent in the placebo group had the metabolic syndrome (a strong risk factor for cardiovascular disease and type 2 diabetes, a group of several metabolic components in one individual including obesity and dyslipidemia). This difference was not statistically significant. Quality-of-life measures did not differ aside from hormone-related quality of life in the testosterone group. Adverse events were not significantly different in the two groups. Testosterone supplementation was associated with an increase in the concentrations of blood creatinine, a measure of kidney function, and hemoglobin and hematocrit, two red blood cell measures. No negative effects on prostate safety were detected (some reports have suggested that testosterone therapy could increase the risk of development or progression of prostate disease or cancer).

“This study is, as far as we know, the largest study of testosterone supplementation with the most end points and a randomized, double-blind design. Adherence was high and the dropout rate was low,” the authors write. “The findings in this study do not support a net benefit on several indicators of health and functional and cognitive performance with 6 months of modest testosterone supplementation in healthy men with circulating testosterone levels in the lower range.”
(JAMA. 2008;299(1):39-52. Available pre-embargo to the media 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 the JAMA/Archives Media Relations Department at 312/464-JAMA (5262) or email: mediarelations{at}jama-archives.org.

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Embargoed for Release: 3:00 p.m. CT, Tuesday, January 1, 2008
Media Advisory: To contact Johannes H. M. Merks, M.D., Ph.D., email: j.h.merks{at}amc.uva.nl.

STUDY EXAMINES GENETIC DEFECTS LINKED TO BODY ABNORMALITIES IN PATIENTS WITH CHILDHOOD CANCER

CHICAGO—Children with cancer have a higher prevalence of body abnormalities, such as asymmetric lower limbs and curvature of the spine, suggesting that the genetic defect responsible for the abnormality may play a role in the development of cancer, according to a study in the January 2 issue of JAMA.

Certain genetic syndromes can be associated with an increased risk for tumor and cancer development in children. Several studies have shown that developmental genes, which play a role in body plan formation during embryogenesis, are also involved in the development of cancer, according to background information in the article.

Johannes H. M. Merks, M.D., Ph.D., of Emma Children’s Hospital, Academic Medical Center, Amsterdam, the Netherlands, and colleagues conducted a study to assess the prevalence of morphological (body structure) abnormalities in a large group of childhood cancer patients. The study, conducted between January 2000 and March 2003, included 1,073 patients who underwent a physical examination for morphological abnormalities (such as differing length in limbs; broad hands or feet; prominent ears; curvature of the spine). The patient group consisted of 898 long-term survivors of childhood cancer and 175 newly diagnosed pediatric patients with cancer. The control group consisted of 1,007 schoolchildren examined in an identical way. The average ages of patients and controls were 21.2 and 10.4 years, respectively.

The researchers found that both major abnormalities and minor anomalies were significantly more prevalent in the pediatric cancer group (per 1,000 cases, patients had 268 major abnormalities and controls had 155 abnormalities). One or more major abnormalities were present in 26.8 percent of individual patients (15.5 percent in controls), two or more abnormalities in 5.1 percent of patients (1.6 percent in controls), and three or more abnormalities were found in 0.9 percent compared with none in controls.

One or more minor anomalies were found in 65.1 percent of individual patients (56.2 percent in controls), two or more minor anomalies in 32.8 percent of patients (22.1 percent in controls), and three or more minor anomalies were found in 15.2 percent of patients compared with 8.3 percent in controls.

In 42 patients (3.9 percent), an established clinical genetic syndrome was diagnosed. Analysis showed 14 age-independent morphological abnormalities that were independently and significantly associated with childhood cancer. For two of these (blepharophimosis [eyelid abnormalities] and asymmetric lower limbs), the researchers identified statistically significant patterns of co-occurring morphological abnormalities suggestive of new tumor predisposition syndromes. Thirty-four patients fit one of the two tumor predisposition patterns.

“We conclude that the high incidence of single and combined morphological abnormalities in pediatric patients with cancer indicates that constitutional genetic defects play a more important role in pediatric oncogenesis than is currently estimated. Furthermore, the detection of patterns of morphological abnormalities allows identification of new tumor predisposition syndromes,” the authors write.
(JAMA. 2008;299(1):61-69. Available pre-embargo to the media 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 the JAMA/Archives Media Relations Department at 312/464-JAMA (5262) or email: mediarelations{at}jama-archives.org.

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Embargoed for Release: 3:00 p.m. CT, Tuesday, January 1, 2008
Media Advisory: To contact Mark J. Pletcher, M.D., M.P.H., call Wallace Ravven at 415-476-2557.

USE OF OPIOIDS TO TREAT PAIN IN EMERGENCY DEPARTMENTS ON THE RISE, BUT RACIAL DIFFERENCES IN OPIOID USE STILL EXIST

CHICAGO—In the last 15 years, use of opioid medications to treat patients with pain-related emergency department visits has improved although white patients were more likely to receive opioids than patients of a different race/ethnicity, according to a study in the January 2 issue of JAMA.

In the 1990s, national attention focused on increasing awareness of the problem of inadequately treated pain. Also, racial and ethnic minority groups appeared to be at higher risk of receiving inadequate treatment for pain in the emergency department, according to background information in the article. National quality improvement initiatives were implemented in the late 1990s, followed by substantial increases in opioid (narcotic agents used for pain relief) prescribing in the United States, but it is unknown whether opioid prescribing for treatment of pain in the emergency department has increased and whether differences in opioid prescribing by race/ethnicity have decreased.

Mark J. Pletcher, M.D., M.P.H., of the University of California, San Francisco, and colleagues examined whether opioid prescribing is increasing in U.S. emergency departments for patients presenting with pain and whether non-Hispanic white patients are more likely to receive an opioid than other racial/ethnic groups. Pain-related visits to U.S. emergency departments were identified using reason-for-visit and physician diagnosis codes from thirteen years (1993-2005) of The National Hospital Ambulatory Medical Care Survey.

During the survey years, pain-related visits accounted for 156,729 of 374,891 (42 percent) emergency department visits. An opioid analgesic was prescribed at 29 percent of pain-related visits. This proportion increased during the study period, from 23 percent in 1993 to 37 percent in 2005. Despite this time trend, the researchers found no evidence that the difference in opioid prescribing by race/ethnicity diminished over time. Averaged over the 13 survey years, opioid prescribing was more likely for pain-related visits made by whites (31 percent) than by blacks (23 percent), Hispanics (24 percent), or Asians/others (28 percent), and there was no evidence of an interaction between the time trend and race/ethnicity during the study period. In 2005, opioid prescribing rates were 40 percent in whites and 32 percent in all others.

Differential opioid prescribing was consistently present across different types of pain, across different levels of pain severity, for visits in which pain was the first or second/third reason for visit, and for two specific painful diagnoses, long-bone fracture and kidney stones. Differences in prescribing between whites and nonwhites were larger as pain severity increased and were particularly pronounced for patients with back pain (48 percent vs. 36 percent, respectively), headache (35 percent vs. 24 percent), abdominal pain (32 percent vs. 22 percent), and other pain (40 percent vs. 28 percent). Blacks were prescribed opioids at lower rates than any other race/ethnicity group for almost every type of pain visit.

Statistical adjustment for pain severity and other factors did not substantially change these differences. Compared with white patients, black patients were 34 percent less likely to receive an opioid prescription; Hispanic patients, 33 percent less likely; and Asian/other patients, 21 percent less likely.

“Our results suggest that new strategies are needed to understand and improve the quality and equity of management of acute pain in the United States. Future initiatives should continue to monitor pain management quality indicators and processes of care that may contribute to inadequate care, to educate physicians about the importance of adequate pain control, and to promote cultural competence within individual physicians. It is likely, however, that eliminating disparities in pain control will also require nonphysician interventions such as patient-targeted self-efficacy education, nurse-initiated pain-treatment protocols, and other system-level changes to facilitate equitable, systematic, and consistent alleviation of pain in emergency department patients,” the authors write.
(JAMA. 2008;299(1):70-78. Available pre-embargo to the media 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 the JAMA/Archives Media Relations Department at 312/464-JAMA (5262) or email: mediarelations{at}jama-archives.org.

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JAMA REPORTS

VIDEO: Windows Media | Quicktime

TESTOSTERONE SUPPLEMENTATION NOT BENEFICIAL IN COMBATING MOST EFFECTS OF AGING IN MEN

INTRO:
As men age, the level of the hormone testosterone in their blood decreases, sometimes dramatically. Researchers had hoped replacing that testosterone could help some men combat the signs and symptoms of aging. But a new study from the Netherlands got some mixed results. Jennifer Mitchell explains in this week’s JAMA Report.

VIDEO:
B-ROLL
Henk sitting on exam table as Dr. Vonk puts blood pressure cuff on him

AUDIO:
SIXTY-FIVE YEAR OLD HENK VONK SAYS HE CAN TELL HIS TESTOSTERONE LEVELS HAVE GONE DOWN WITH AGE.

VIDEO:
SOT/FULL
@ :10
Super: Henk Vonk
65 years old
Runs :03

AUDIO:
“I’m not so strong and fast anymore.”

VIDEO:
B-ROLL
Henk using instrument that tests hand strength

AUDIO:
LOSS OF STRENGTH CAN BE ASSOCIATED WITH LOW TESTOSTERONE, AS CAN LOSS IN MENTAL FUNCTION AND BONE MASS, AND AN INCREASE IN FAT MASS.

VIDEO:
SOT/FULL
@ :21
Super: Marielle Emmelot-Vonk, M.D.
University Medical Center Utrecht
Runs :09

AUDIO:
“With this study we want to investigate if it was possible with the testosterone to prevent the signs and symptoms of aging.”

VIDEO:
B-ROLL
Dr. Vonk doing ultrasound of Henk’s heart
Dr. Vonk and Dr. van der Schouw at computer
Different older man having physical exam
GFX/JAMA COVER

AUDIO:
SO DR. MARIELLE (mary-elle) EMMELOT- (EM-el-ott)VONK, WHO IS HENK’S DAUGHTER, AND HER COLLEAGUES AT UNIVERSITY MEDICAL CENTER UTRECHT (OO-trekt) IN THE NETHERLANDS, WERE AMONG THE RESEARCHERS WHO STUDIED SIX MONTHS OF TESTOSTERONE SUPPLEMENTATION IN OLDER MEN. THE FINDINGS APPEAR IN JAMA, JOURNAL OF THE AMERICAN MEDICAL ASSOCIATION.

VIDEO:
SOT/FULL
@ :47
Super: Yvonne van der Schouw, Ph.D.
University Medical Center Utrecht
Runs :10

AUDIO:
“The fat mass in the body decreased and the lean mass increased, and also the insulin sensitivity improved a bit.”

VIDEO:
B-ROLL
Let bite run through her name
Different man having ultrasounds
Henk and Dr. Vonk in exam room

AUDIO:
DR. YVONNE VAN DER SCHOUW SAYS THAT’S THE GOOD NEWS, BUT THE BAD NEWS IS, H-D-L, OR GOOD CHOLESTEROL, WENT DOWN IN THE MEN TAKING TESTOSTERONE. AND…

VIDEO:
SOT/FULL
Yvonne van der Schouw, Ph.D.
University Medical Center Utrecht
Runs :07

AUDIO:
“We would have hoped maybe to see a decrease of intra-abdominal fat, because that is the really harmful fat in the body.”

VIDEO:
B-ROLL
Dr. Vonk and Dr. van der Schouw at computer
Dr. Vonk with Henk who is lying on exam table

AUDIO:
BUT THEY DIDN’T SEE THAT DECREASE, NOR DID THEY SEE ANY OTHER IMPROVEMENTS. SO THE RESEARCHERS DO NOT RECOMMEND TESTOSTERONE. SO WHAT CAN MEN DO TO COMBAT THE EFFECTS OF AGING?

VIDEO:
SOT/FULL
Marielle Emmelot-Vonk, M.D.
University Medical Center Utrecht
Runs :14

AUDIO:
“It is important that you eat healthy food, and it’s important that you do a lot of activity. When you do these kinds of things, I think chance is big that you are becoming a healthy old person.”

VIDEO:
B-ROLL
Henk swallowing capsule

AUDIO:
HENK SAYS HE WISHES TAKING TESTOSTERONE HAD BEEN THE ANSWER TO AGING, BUT INSTEAD…

VIDEO:
SOT/FULL
Henk Vonk
65 years old
Runs :06

AUDIO:
“To be healthy, I make a walk every day and I go to the gym.”

VIDEO:
B-ROLL
Henk on exercise bike

AUDIO:
THIS IS JENNIFER MITCHELL WITH THE JAMA REPORT.

TAG:
To conduct this study, the researchers studied about 230 men between the ages of 60 and 80. Half got daily testosterone capsules containing a relatively small dose of testosterone, and the other half did not. After six months, the researchers compared the groups to see what impact the testosterone had. For more information, visit www.jama.com.

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