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, September 7, 2004)
JAMA NEWS RELEASES
FITNESS LEVEL MAY BE MORE ACCURATE THAN OBESITY IN PREDICTING CARDIOVASCULAR DISEASE RISK IN WOMEN
MEDICATION NOT EFFECTIVE IN TREATING CHRONIC FATIGUE SYNDROME
SMALLPOX VACCINE CAN BE DILUTED AND STILL BE EFFECTIVE, EXPANDING SUPPLY IF NEEDED
INFORMATION CONTAINED IN THESE NEWS RELEASES IS PROTECTED BY COPYRIGHT. JOURNAL ATTRIBUTION IS REQUIRED.
TV Note: This week's JAMA video news release is on fatness vs. fitness in predicting cardiovascular disease risk in women. The release will be fed Tuesday, September 7, from 9:00 - 9:30 a.m. ET on Intelsat America 6 (formerly Telstar 6), Transponder 11 (C-Band) and from 2:00 - 2:30 p.m. ET on Intelsat America 6, Transponder 11 (C-Band). For more information, call 312/464-JAMA (5262).
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Embargoed for Release: 3 p.m. CT, TUESDAY, September 7, 2004
Media Advisory: To contact Timothy R. Wessel, M.D., call Mike Garrison at 352-392-7579.
To contact Amy R. Weinstein, M.D., M.P.H., call Amy Smith at 617-534-1603.
To contact editorial author Steven N. Blair, P.E.D., call Sarah Grohmann at 972-716-7092.
FITNESS LEVEL MAY BE MORE ACCURATE THAN OBESITY IN PREDICTING CARDIOVASCULAR DISEASE RISK IN WOMEN
CHICAGO—Women reporting higher levels of physical fitness have fewer coronary artery disease risk factors, less coronary artery disease, and a lower risk for cardiovascular events, whereas measures of obesity are not as strongly associated with these outcomes, according to a study in the September 8 issue of JAMA.
Individual contributions of obesity and physical fitness (physical activity and functional capacity) to risk of coronary heart disease (CHD) in women remain unclear, according to background information in the article. Most obesity studies have not adequately measured physical activity and many studies of physical fitness have excluded women with known or suspected coronary heart disease.
Timothy R. Wessel, M.D., of the University of Florida College of Medicine, Gainesville, and colleagues investigated the relationships of physical fitness and obesity measures with CHD risk factors, coronary angiographic findings, and adverse cardiovascular events among a group of women undergoing coronary angiography to evaluate suspected ischemia.
The study (Women's Ischemia Syndrome Evaluation [WISE]) included measures of obesity (body mass index [BMI] waist circumference, waist-hip ration, and waist-height ratio) and physical fitness (self-reported Duke Activity Status Index [DASI] and Postmenopausal Estrogen-Progestin Intervention questionnaire [PEPI-Q] scores). Participants included 936 women enrolled at four U.S. academic medical centers, 1996-2000, at the time of coronary angiography, and then assessed for adverse outcomes (average follow-up time, 3.9 years).
The researchers found that of 906 women with complete data, 76 percent were overweight, 70 percent had low functional exercise capacity, and 39 percent had obstructive coronary artery disease (CAD). "During follow-up, 337 (38 percent) women had a first adverse event, 118 (13 percent) had a major adverse event, and 68 (8 percent) died. Overweight women were more likely than normal weight women to have CAD risk factors, but neither BMI nor abdominal obesity measures were significantly associated with obstructive CAD or adverse cardiovascular (CV) events after adjusting for other risk factors," the authors write. "Conversely, women with lower DASI scores [lower levels of physical fitness] were significantly more likely to have CAD risk factors and obstructive CAD (44 percent vs. 26 percent) at baseline, and each 1-MET [measure of energy expenditure] increase in DASI score was independently associated with an 8 percent decrease in risk of major adverse CV events during follow-up."
"These results suggest that fitness may be more important than overweight or obesity for CV risk in women. Evaluation of physical activity and functional capacity using simple questionnaires should be an integral part of CV risk stratification, and interventions aimed at increasing physical fitness levels should be included in the management of all women at risk for CHD," the authors conclude.
(JAMA. 2004;292:1179-1187. Available post-embargo at jama.com)
Editor's Note: This study was supported by the NHLBI and by grants from the Gustavus and Louis Pfieffer Research Foundation, Danville, N.J.; the Women's Guild of Cedars-Sinai Medical Center, Los Angeles; the Ladies Hospital Aid Society of Western Pennsylvania, Pittsburgh; and QMED Inc., Laurence Harbor, N.J.
BEING OVERWEIGHT IS STRONGER INDICATOR OF RISK FOR DIABETES THAN LEVEL OF PHYSICAL ACTIVITY IN WOMEN
Amy R. Weinstein, M.D., M.P.H., formerly of Brigham and Women's Hospital, Boston, and colleagues investigated the combined relationship of BMI and physical activity with diabetes to understand whether increasing physical activity levels reduces the elevated risk of diabetes from obesity. The study included 37,878 participants from the Women's Health Study, an ongoing clinical trial. The participants were free of cardiovascular disease, cancer, and diabetes at the beginning of the study, and follow-up averaged about 7 years. Weight, height, and recreational activities were reported at study entry. Normal weight was defined as a BMI of less than 25; overweight, 25 to less than 30; and obese, 30 or higher. A 5'4" woman would have a BMI of 25 if she weighed 145 lbs.; a BMI of 30 if she weighed 174 lbs. Active was defined as expending more than 1,000 kilocalories on recreational activities per week.
The researchers found that individually, BMI and physical activity were significant predictors of incident diabetes. Compared with normal-weight individuals, overweight individuals had a 3.2 times increased risk for diabetes; obese individuals, a 9.1 times increased risk. For overall activity (kilocalories expended per week), compared with the least active first quartile, a decreased risk of diabetes in the other quartiles ranged from 9 percent to 18 percent.
"We observed a modest reduction in the risk of diabetes with increasing physical activity level compared with a large increase in the risk with increasing BMI," the authors write. "These findings underscore the critical importance of adiposity [level of fat content] as a determinant of type 2 diabetes. Because physical activity is a significant individual predictor and has a beneficial effect on BMI, it remains an important intervention for diabetes prevention. Our study suggests that to further reduce the risk of diabetes with physical activity, it should be performed in conjunction with achieving weight loss. By furthering our understanding of the relative influence of BMI and activity on diabetes, we may improve our ability to risk stratify patients and in turn may reduce the incidence of diabetes," they write.
(JAMA. 2004;292:1188-1194. Available post-embargo at jama.com)
Editor's Note: This study was supported by research grants from the National Institutes of Health, Bethesda, Md.. Dr. Weinstein is now at Beth Israel Deaconess Medical Center, Boston.
EDITORIAL: THE FITNESS, OBESITY, AND HEALTH EQUATION - IS PHYSICAL ACTIVITY THE COMMON DENOMINATOR?
In an accompanying editorial, Steven N. Blair, P.E.D., and Tim S. Church, M.D., M.P.H., Ph.D., of the Cooper Institute, Dallas, write that the findings of Wessel et al and Weinstein et al provide a timely opportunity to examine an ongoing debate and offer a resolution.
"The results presented by Weinstein et al suggest that increased BMI is substantially more important for incident diabetes, and Wessel et al suggest that inactivity or low fitness is a greater threat to health in terms of CVD outcomes. In recent years, the 'fitness vs. fatness' issue has led to controversy and heated debate. Although the debate may never be fully resolved the relative contribution of fitness and obesity to overall health and risk actually may be a trivial matter because a common treatment is already available for both low fitness and excess body weight. Increasing regular physical activity results in predictable increases in fitness, and it is widely accepted that regular physical activity is a core component of successful weight loss programs and, more importantly, of long-term weight loss maintenance.
"In essence, physical activity is the common denominator for the clinical treatment of low fitness and excess weight, making the 'fitness vs. fatness' debate largely academic. Thus, physicians, researchers, and policymakers should spend less energy debating the relative health importance of fitness and obesity and more time focusing on how to get sedentary individuals to become active," they write.
(JAMA. 2004;292:1232-1233. Available post-embargo at jama.com)
Editor's Note: This work was supported by grants from the National Institutes of Health.
For More Information: Contact the JAMA/Archives Media Relations Department at 312/464-JAMA (5262) or email: mediarelations{at}jama-archives.org (please note new email address).
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Embargoed for Release: 3 p.m. CT, TUESDAY, September 7, 2004
Media Advisory: To contact C.V. Russell Blacker, F.R.C.Psych., M.D., email: c.v.r.blacker{at}btinternet.com. To contact editorial author Stephen E. Straus, M.D., call the NCCAM Press Office at 301-496-7790.
MEDICATION NOT EFFECTIVE IN TREATING CHRONIC FATIGUE SYNDROME
CHICAGO—The drug galantamine (used for treatment of mild to moderate dementia) did not demonstrate a clinical benefit in treating chronic fatigue syndrome when compared with placebo, according to a study in the September 8 issue of JAMA.
Chronic fatigue syndrome (CFS) is a complex disorder characterized by long-term disability, according to background information in the article. There is no established pharmacological treatment for the core symptoms of CFS. Galantamine hydrobromide has pharmacological properties, including improving sleep quality, that researchers have speculated may benefit CFS patients. A pilot trial with CFS patients suggested that the drug might be helpful in CFS.
C.V. Russell Blacker, F.R.C.Psych., M.D., of the University of Exeter, England, and colleagues conducted a study to determine the efficacy and tolerability of galantamine hydrobromide in patients with CFS. The randomized, double-blind trial was conducted from June 1997 through July 1999 at 35 outpatient centers in Western Europe and the U.S. The study included 434 patients with a clinical diagnosis of CFS. A total of 89 patients were randomly assigned to receive 2.5 mg of galantamine hydrobromide; 86 patients, 5.0 mg; 91 patients, 7.5 mg; and 86 patients, 10 mg (these patients received medicine in the tablet form three times per day); a total of 82 patients received matching placebo tablets three times per day.
The researchers found that after 16 weeks there was no statistically significant differences between any of the galantamine or placebo groups in clinical condition, as measured by various tests and surveys.
"The lack of effect of galantamine on cognitive performance was surprising given the extent of the patients' cognitive impairment at baseline," the authors write. "In conclusion, in this study, galantamine did not provide a significant clinical benefit in the treatment of patients with CFS."
(JAMA. 2004;292:1195-1204. Available post-embargo at jama.com)
Editor's Note: This research was sponsored and funded by Shire Pharmaceutical Development Ltd., Andover, England. Dr. Blacker received research support from Shire Pharmaceutical Development Ltd.
EDITORIAL: PHARMACOTHERAPY OF CHRONIC FATIGUE SYNDROME - ANOTHER GALLANT ATTEMPT
In an accompanying editorial, Stephen E. Straus, M.D., of the National Center for Complementary and Alternative Medicine, National Institutes of Health, Bethesda, Md., examines the results of the trial conducted by Blacker et al.
"On its face, the study appears to be another in a virtually unbroken series of failed drug trials for CFS. Yet, by many criteria, the study is a resounding success. It pursued encouraging pilot data with a cholinesterase [an enzyme] inhibitor approved for the management of Alzheimer disease and its plausible underlying hypothesis that defects in [certain types of neurologic] pathways could also underlie some CFS symptoms. The present data further clarify, at least by exclusion, the pathogenesis of CFS."
"Fortunately for the science, but not for the patients, the results were unequivocal in that galantamine was well tolerated but yielded no meaningful benefits to any subset of patients. Yet the study reaffirmed the importance and feasibility of studying CFS rigorously, even if it remains a poorly understood and controversial illness," Dr. Straus concludes.
(JAMA. 2004;292:1234-1235. Available post-embargo at jama.com)
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 p.m. CT, TUESDAY, September 7, 2004
Media Advisory:To contact corresponding author Kathryn M. Edwards, M.D., call Clinton Colmenares at 615-322-4747.
SMALLPOX VACCINE CAN BE DILUTED AND STILL BE EFFECTIVE, EXPANDING SUPPLY IF NEEDED
CHICAGO—Diluted doses of a smallpox vaccine, originally manufactured in the 1950s and stored as a frozen preparation, are nearly 100 percent effective, allowing for expansion of the current stockpile if needed, according to an article in the September 8 issue of JAMA.
According to background information in the article, smallpox vaccination is an effective way to prevent the smallpox disease both before and after exposure to the virus. In 2002, the U.S. resumed limited vaccination, and in 2003 the military successfully inoculated more than 500,000 people. However, the current supply of the vaccine falls short of the Department of Health and Human Services goal of having one dose for every U.S. citizen, and the effectiveness of diluted doses in unclear.
Thomas R. Talbot, M.D., M.P.H., of Vanderbilt University School of Medicine, Nashville, Tenn., and colleagues injected 340 healthy volunteers with the smallpox vaccine in a double-blind, randomized controlled trial conducted between October 2002 and February 2003. Test subjects, aged 18 to 32 years, were given one of three strengths of the Aventis Pasteur smallpox vaccine (APSV): undiluted, a one to five dilution, or a one to ten dilution. The researchers followed up with the volunteers every three to five days until the injection site healed. Subjects also participated in one- and two-month evaluations and a six-month phone interview.
Of all the vaccinated individuals, 99.4 percent had successful vaccinations, defined by a vesicle or pustule at the inoculation site six to 11 days after injection. For subjects receiving an undiluted vaccine (n = 113), there was a 100 percent success rate. Those injected with the one to five dilution (n = 114) had a 98.2 percent success rate, while those receiving the one to ten dilution (n = 113) also had a 100 percent success rate of vaccination. Nearly all of the study volunteers (99.7 percent) reported at least one post vaccination symptom in the two weeks following vaccination, including vaccination site itching (96.8 percent) or pain (92.1 percent), fatigue (79.1 percent), muscle pain (78.2 percent), headache (75 percent), and fever (21.5 percent). One-fourth of the volunteers missed planned duties due to vaccine-related symptoms.
Reactogenicity (the capacity to produce adverse reactions) of the vaccine was not reduced with dilution and decreasing strengths of the vaccine. This study was conducted before reports of adverse events, including heart disease, were reported in February 2003 among civilian and military smallpox vaccine recipients. The authors report "although symptoms of cardiac disease were not actively sought from volunteers at follow-up, five volunteers reported cardiac symptoms 5 to 14 days post vaccination that resolved without [complications]."
The authors conclude: "The results of our study show that a frozen preparation of APSV has a high vaccination success rate and is an available option for smallpox vaccination of vaccinia-naïve persons, even at ten-fold diluted doses. This allows for amplification of the current smallpox vaccine stockpile [approximately 85 million doses of APSV], if needed."
(JAMA. 2004;292:1205-1212. Available post-embargo at jama.com)
Editor's Note: This study was supported by the National Institute of Allergy and Infectious Diseases Division of Microbiology and Infectious Diseases Vaccine Trial and Evaluation Unit, and grants from the General Clinical Research Center of Vanderbilt University School of Medicine and University of Iowa. Co-author Dr. Crowe receives research funding from Aventis Pasteur, is a member of the Scientific Advisory Board of and received research funding from MedImmune, and is a consultant to Mapp and Syngenta Pharmaceuticals. Co-author Dr. Edwards receives research funding from Aventis Pasteur, MedImmune, and VaxGen.
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 VIDEO NEWS REPORT
FATNESS VS. FITNESS - LACK OF PHYSICAL FITNESS MORE IMPORTANT THAN OBESITY AS PREDICTOR OF HEART PROBLEMS
VIDEO:
NAT SOT UP FULL FOR :05
Nurse questioning patient/Pattie Grant
AUDIO:
"How about walking a block without stopping?"
"That's not a problem either."
VIDEO:
B-ROLL
Nurse questioning patient/Pattie Grant
AUDIO:
SIMPLE QUESTIONS ABOUT FITNESS CAN PROVIDE INFORMATION THAT TELLS US
WHETHER WOMEN ARE AT RISK FOR HEART PROBLEMS.
VIDEO:
SOT/FULL @ :13
Super: Timothy Wessel, M.D., Univ. of Florida College of Medicine
Runs :06
AUDIO:
"Are they able to climb a flight of stairs? Are they able to carry a
bag of groceries up a flight of stairs? Are they able to run a short
distance?"
VIDEO:
B-ROLL
Bite runs long over his name, then on "women who answer" goes back to
patient answering questions.
Obese women from file tapes
Dr. Wessel with colleague
Dr. Wessel with patient/Pattie Grant
GFX/JAMA COVER
AUDIO:
DR. TIMOTHY WESSEL SAYS THAT WOMEN WHO ANSWER THOSE QUESTIONS "YES" ARE
AT LOWER RISK OF HEART PROBLEMS, EVEN IF THOSE WOMEN ARE OBESE. DR.
WESSEL AND HIS COLLEAGUES AT UNIVERSITY OF FLORIDA SCHOOL OF MEDICINE,
ALONG WITH RESEARCHERS FROM FIVE OTHER INSTITUTIONS INCLUDING THE
NATIONAL INSTITUTES OF HEALTH, CONDUCTED THIS HEART HEALTH STUDY. IT'S
PUBLISHED IN JAMA, THE JOURNAL OF THE AMERICAN MEDICAL ASSOCIATION.
VIDEO:
SOT/FULL
Timothy Wessel, M.D., Univ. of Florida College of Medicine
Runs :17
AUDIO:
"There are many currently popular ways to lose weight, including
specific diets or surgeries. However, our study shows that the lack of
physical fitness is a stronger risk factor for developing heart disease
than being overweight or obese."
VIDEO:
B-ROLL
Obese women
Nurse taking Pattie Grant's blood pressure
AUDIO:
THE RESEARCHERS REVIEWED QUESTIONNAIRE ANSWERS FROM MORE THAN
NINE-HUNDRED WOMEN WHO WERE HAVING SYMPTOMS OF HEART PROBLEMS. THOSE
WOMEN WERE ALSO GIVEN COMPLETE PHYSICALS AND MEDICAL TESTS TO DETERMINE
THEIR HEART HEALTH, AND WERE STUDIED FOR FOUR YEARS.
VIDEO:
SOT/FULL
Timothy Wessel, M.D., Univ. of Florida College of Medicine
Runs :14
AUDIO:
"We found that many women who would be classified as obese based upon
their body mass index and these other measures were actually able to
perform a lot of these day to day activities which our questionnaires
judged to be physically fit."
VIDEO:
B-ROLL
File of overweight/obese women
Obese woman in jogging suit hurrying across street
AUDIO:
EVEN WOMEN WHO HAD OTHER RISK FACTORS LIKE DIABETES OR BLOCKED ARTERIES
WERE STILL MORE PROTECTED AGAINST SERIOUS HEART PROBLEMS IF THEY WERE
MODERATELY PHYSICALLY FIT.
VIDEO:
SOT/FULL
Timothy Wessel, M.D., Univ. of Florida College of Medicine
Runs :10
SOT/FULL
@ 1:45
Super: Pattie Grant, Has heart problems
Runs :04
B-ROLL
Pattie climbing stairs 3:11:56
AUDIO:
"So if you want to lose weight to reduce your risk of heart disease, you
need to be sure to increase your physical fitness levels and increase
your activity, rather than just losing weight alone."
"Actually I need to lose some weight, and I am working on that."
SHE'S DOING IT THROUGH EXERCISE, BECAUSE DIETING ALONE MAY NOT HELP HER
HEART STAY HEALTHY.
THIS IS MAVIS PRALL REPORTING.
