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January 13, 2009

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 p.m. CT Tuesday, January 13, 2009)

JAMA NEWS RELEASES

>   Treadmill Exercise Improves Walking Endurance For Patients With Peripheral Arterial Disease

>   Use of Antidepressants Associated With Improvement in Symptoms of Fibromyalgia

>   Intake of Certain Fatty Acid Appears to Improve Neurodevelopment For Preterm Girls, But Not Boys

JAMA REPORT (VIDEO SCRIPT)

>   VIDEO: Windows Media | Quicktime

>   Study Finds Patients With Peripheral Arterial Disease Can Improve Walking Ability With Supervised Treadmill Exercise

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

TV Note: This week's JAMA Report video is on beneficial therapies for peripheral arterial disease. The report will be fed Tuesday, January 13, from 9:00 - 9:30 a.m. ET and 2:00 - 2:30 p.m. ET, on Galaxy 28 (C-Band), Transponder 19, downlink frequency: 4080 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 13, 2009
Media Advisory: To contact Mary M. McDermott, M.D., call Marla Paul at 312-503-8928 or email marla-paul{at}northwestern.edu.

Treadmill Exercise Improves Walking Endurance For Patients With Peripheral Arterial Disease

CHICAGO—Patients with peripheral arterial disease (PAD), which can include symptoms such as pain in the legs, who participated in supervised treadmill exercise improved their walking endurance and quality of life, according to a study in the January 14 issue of JAMA. The treadmill exercise also improved walking performance for PAD patients without the classic symptoms of pain in the leg muscles.

Lower extremity PAD (a condition that develops when the arteries that supply blood to the legs become completely or partially blocked as a result of plaque build-up) affects 1 in 16 U.S. adults 40 years or older. Men and women with PAD have greater functional impairment and more rapid rates of functional decline than those who do not have PAD, according to background information in the article. Most patients with PAD do not have symptoms of intermittent claudication (pain in the leg muscles that comes and goes), but PAD patients without these symptoms have greater functional impairment and functional decline than those without PAD. No prior exercise interventions have been tested on PAD participants with and without symptoms of intermittent claudication. Additionally, benefits of lower extremity resistance (strength) training for PAD patients are unclear.

Mary M. McDermott, M.D., of the Northwestern University Feinberg School of Medicine, Chicago, and colleagues conducted a study to determine whether supervised treadmill exercise and lower extremity-resistance training improves functional performance and other outcomes among participants with PAD with and without intermittent claudication symptoms. The randomized controlled clinical trial included 156 patients with PAD who were randomly assigned to supervised treadmill exercise, to lower extremity resistance training, or to a control group, for six months. Patients were tested for six-minute walk performance and a short physical performance battery, as well as brachial artery flow-mediated dilation (a measurement of change in the diameter of an artery in the arm), treadmill walking performance, the Walking Impairment Questionnaire, and the 36-Item Short Form Health Survey physical functioning (SF-36 PF) score.

For the 6-minute walk, those in the supervised treadmill exercise group increased their distance from baseline by an average of about 69 feet vs. those in the control group, whose distance decreased from baseline by an average of 49 feet, for an average increase of 118 feet between groups. Participants in the resistance training group increased their distance walked by 41 feet compared with the control group. Those in the lower extremity resistance training group did not experience change in their 6-minute walk performance compared with the control group.

There were no differences in change in short physical performance battery score between the treadmill exercise and control groups or between the resistance training and the control groups at the 6-month follow-up.

Participants in the treadmill exercise group had more favorable changes in brachial arterial flow-mediated dilation than the control group, whereas changes among participants in the resistance training group were not different from the control group. Those in the treadmill exercise and the resistance training groups each had significantly greater increases in average maximum treadmill walking time at the 6-month follow-up than the control group.

The treadmill exercise group had significantly greater average improvement in their SF-36 physical functioning score and in their walking impairment distance score than the control group. The resistance training group had greater average improvement in their SF-36 physical functioning score and in their walking impairment distance and stair climbing scores than the control group.

"Based on findings reported in this trial, physicians should recommend supervised treadmill exercise programs for PAD patients, regardless of whether they have classic symptoms of intermittent claudication," the authors conclude.
(JAMA. 2009;301[2]:165-174. 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.

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Embargoed for Release: 3:00 p.m. CT, Tuesday, January 13, 2009
Media Advisory: To contact Winfried Häuser, M.D., email whaeuser{at}klinikum-saarbruecken.de.

Use of Antidepressants Associated With Improvement in Symptoms of Fibromyalgia

CHICAGO—The use of antidepressant medications by patients with fibromyalgia syndrome is associated with a reduction in pain, sleep disturbances and depressed mood and improvement of health-related quality of life, according to an analysis of previous studies, which is published in the January 14 issue of JAMA.

Fibromyalgia syndrome (FMS), which consists of chronic widespread pain and tenderness, with other symptoms including fatigue and sleep difficulties, has an estimated prevalence of 0.5 percent to 5.8 percent in North America and Europe. "Patients with FMS experience disability and reduced health-related quality of life (HRQOL). Fibromyalgia syndrome is also associated with high direct and indirect disease-related costs. Effective treatment of FMS is therefore necessary for medical and economic reasons," the authors write.

Winfried Häuser, M.D., of Klinikum Saarbrücken, Saarbrücken, Germany, and colleagues conducted a meta-analysis to evaluate the effects of treatment with antidepressants on FMS-related symptoms. The researchers identified 18 randomized controlled trials, involving 1,427 participants, for inclusion in the study.

Overall, there was strong evidence for a reduction of pain, fatigue and depressed mood and improved sleep and HRQOL with the use of antidepressants by patients with FMS.

The researchers found large effect sizes of tricyclic and tetracyclic antidepressants (TCAs) for reducing pain, fatigue, and sleep disturbances; small effect sizes of selective serotonin reuptake inhibitors (SSRIs) for reducing pain; small effect sizes of serotonin and noradrenaline reuptake inhibitors (SNRIs) for reducing pain, sleep disturbances, and depressed mood; and small effect sizes of monoamine oxidase inhibitors (MAOIs) for reducing pain.

"Before treatment is initiated, [accompanying] diseases related to potential adverse effects of the drugs and patients' preferences should be considered. Goals of pharmacological therapy should be defined (no cure, but possible symptom reduction). Since evidence for a long-term effect of antidepressants in FMS is still lacking, their effects should be re-evaluated at regular intervals to determine whether benefits outweigh adverse effects," the authors write. "The identification of patient characteristics associated with positive and negative therapeutic outcomes are needed to better target antidepressant therapy for FMS."
(JAMA. 2009;301[2]:198-209. 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.

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Embargoed for Release: 3:00 p.m. CT, Tuesday, January 13, 2009
Media Advisory: To contact Maria Makrides, B.Sc., B.N.D., Ph.D., email maria.makrides{at}cywhs.sa.gov.au.

Intake of Certain Fatty Acid Appears to Improve Neurodevelopment For Preterm Girls, But Not Boys

CHICAGO—Preterm infant girls who received a high amount of dietary docosahexaenoic acid (DHA; an omega-3 fatty acid) had higher measures of neurodevelopment than preterm girls who received a standard amount of DHA, but this effect was not seen among preterm boys, according to a study in the January 14 issue of JAMA.

Infants born before 33 weeks' gestation are at high risk of developmental disorders and learning disabilities. An inadequate nutrient supply during the newborn period is believed to contribute to this poor developmental outcome, according to background information in the article. DHA deficiency is hypothesized to result in poor neurodevelopmental outcomes in preterm infants, but uncertainty exists about the benefit of dietary DHA.

Maria Makrides, B.Sc., B.N.D., Ph.D., of Women's and Children's Hospital and Flinders Medical Centre, Adelaide, Australia and colleagues conducted a randomized controlled trial to determine the effect of high-dose dietary DHA on neurological outcomes in preterm infants. The study included infants born at less than 33 weeks' gestation from five Australian hospitals. Of the 657 infants enrolled, 93.5 percent completed the 18-month follow-up.

The infants were randomized to high-DHA (approximately 1 percent total fatty acids) compared with standard DHA (approximately 0.3 percent total fatty acids) from day 2 to 4 of life until the infants reached their expected date of delivery. The infants received DHA from either breast milk or infant formula. Lactating mothers allocated to the high-DHA group were asked to consume six 500-mg DHA-rich tuna oil capsules per day to achieve a high breast milk DHA concentration. If supplementary formula was required, infants were given a high-DHA preterm formula. Mothers with infants allocated to the standard-DHA group were asked to consume six 500-mg placebo soy oil capsules that did not change the fat content or fatty acid composition of their milk.

To measure neurological development, the researchers used the Bayley Mental Development Index (MDI), which evaluates memory, problem solving, early number concepts and language. They found that the average MDI score did not differ between the high-DHA and standard-DHA groups, but that the MDI score among girls fed the high-DHA diet was significantly higher than among girls fed the standard-DHA diet, while the MDI score among boys did not differ between groups.

"The lack of responsiveness of boys to the intervention is puzzling, and the reasons are unclear...," the authors write.

The MDI score among infants born weighing less than 2.8 lbs. and fed a high-DHA diet until the expected date of delivery was higher than that of infants fed standard-DHA diets in the unadjusted comparison, but did not reach statistical significance following adjustment for gestational age, sex, maternal education, and birth order. The MDI score of infants born weighing at least 2.8 lbs. did not differ between groups.

An evaluation of movement abilities found no significant difference between groups.

Additional analyses indicated that, overall, fewer infants had significantly delayed mental development with high-DHA diets compared with standard DHA and that there were fewer girls with mild and significant mental delay in the high-DHA group relative to the standard-DHA group, but there were no differences among the boys.

"Infants ranged in gestational age from 23 to 33 weeks and, thus, had a range of nutritional stressors, organ immaturity, and [illnesses]. Despite this, the intervention was sufficiently robust to consistently elicit an improvement in the MDI scores of girls and may point the way for higher-dose interventions in future studies. Given the lack of an alternative therapy for cognitive delay in this group of infants and the apparent safety of the current dose of DHA, further studies are warranted," the authors conclude.
(JAMA. 2009;301[2]:175-182. 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.

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JAMA REPORTS

VIDEO: Windows Media | Quicktime

Study Finds Patients With Peripheral Arterial Disease Can Improve Walking Ability With Supervised Treadmill Exercise

INTRO:
Peripheral Arterial Disease affects an estimated 8 million people in the United States and typically makes walking, even short distances, difficult for sufferers. A recent study looks at the effectiveness of two different types of exercise in treating the condition. Haley Weldon explains in this week's JAMA Report.

VIDEO:
B-ROLL
Charles walking through the RIC hallway

AUDIO:
CHARLES MEADOWS KNEW HIS PAINFUL LEG CRAMPS MEANT SOMETHING WAS WRONG.

VIDEO:
SOT/FULL
Super @ :05
Charles Meadows
Has Peripheral Arterial Disease
Runs : 06

AUDIO:
"I could walk maybe a block then I had to stop and rest and I knew this is not normal."

VIDEO:
GFX/Peripheral Arterial Disease illustration
B-ROLL
Dr. McDermott in her office
Charles w/trainer exercising

AUDIO:
AFTER HIS DOCTOR DIAGNOSED HIM WITH PERIPHERAL ARTERIAL DISEASE – BLOCKAGES IN THE ARTERIES THAT REDUCES BLOOD FLOW TO THE LEGS - HE ENROLLED IN A STUDY BEING LED BY DR. MARY MCDERMOTT, OF NORTHWESTERN UNIVERSITY'S FEINBERG SCHOOL OF MEDICINE, EXAMINING WHETHER SUPERVISED EXERCISE COULD IMPROVE THE WALKING PERFORMANCE OF PATIENTS WITH THE CONDITION.

VIDEO:
SOT/FULL
Super @ : 28
Mary McDermott, M.D.
Professor of Medicine, Northwestern University Feinberg School of Medicine
Runs : 16

AUDIO:
"...the patients in the study were assigned by chance to one of 3 groups, one being the supervised treadmill exercise, the second being leg strengthening with a trainer and the third being a control group that did not get any exercise."

VIDEO: GXF/JAMA COVER
B-ROLL
Charles Meadows working out

AUDIO:
THE STUDY APPEARS THIS WEEK IN JAMA, JOURNAL OF THE AMERICAN MEDICAL ASSOCIATION AND WAS THE FIRST OF ITS KIND TO INCLUDE PATIENTS BOTH WITH AND WITHOUT INTERMITTENT CLAUDICATION - THE CLASSIC SYMPTOM OF PERIPHERAL ARTERIAL DISEASE, DEFINED AS LEG PAIN THAT OCCURS WHILE WALKING THAT GOES AWAY WITH REST.

VIDEO:
SOT/FULL
Mary McDermott, MD
Runs : 12

AUDIO:
"...patients with Peripheral Arterial Disease, even when they don't have classic symptoms still have significant impairment in their functional performance and an increased rate of functional decline over time."

VIDEO:
B-ROLL
RIC SIGNAGE

GFX/2 pages
STUDY FINDINGS AT 6 MONTHS:
TREADMILL EXERCISE GROUP:
Improved walking ability
OFF the treadmill
ON the treadmill
Improved quality of life
Improved overall cardiovascular health
LEG STRENGTHENING GROUP:
Improved walking ability ON the treadmill
Improved stair climbing ability
Improved quality of life

AUDIO:
THE RESEARCH WAS CONDUCTED AT THE REHABILITATION INSTITUTE OF CHICAGO AND REVEALED THAT AFTER 6 MONTHS, PATIENTS IN THE TREADMILL EXERCISE GROUP IMPROVED THEIR WALKING ABILITY SIGNIFICANTLY – BOTH OFF AND ON THE TREADMILL - AND ALSO SAW IMPROVEMENT IN THEIR QUALITY OF LIFE AND OVERALL CARDIOVASCULAR HEALTH.

PATIENTS IN THE LEG STRENGTHENING GROUP IMPROVED THEIR TREADMILL WALKING ENDURANCE, THEIR REPORTED ABILITY TO CLIMB STAIRS AND ALSO THEIR QUALITY OF LIFE.

VIDEO:
SOT/FULL
Mary McDermott, M.D.
Runs: 16

AUDIO:
"The study clearly demonstrates that patients with Peripheral Arterial Disease whether or not they have the classic symptom of intermittent claudication benefit from supervised treadmill exercise - and also have some benefit from resistance training of the legs."

VIDEO:
SOT/FULL
B-ROLL
Charles on treadmill
Runs: 06

AUDIO:
"I was able to walk with less pain and I felt better! All around I felt better."

VIDEO:
B-ROLL
Charles on treadmill

AUDIO:
THIS IS HALEY WELDON WITH THE JAMA REPORT.

TAG:
The research team will follow the study patients for another 6 months to see if results can be maintained through unsupervised exercise at home. For more information about phase one, you can log on to www.jama.com.

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