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 6, 2009)
JAMA NEWS RELEASES
TREATMENT INVOLVING DEEP BRAIN STIMULATION FOR PATIENTS WITH ADVANCED PARKINSON DISEASE PROVIDES BENEFITS
PREVIOUSLY RELEASED EARLY ONLINE
SUPPLEMENTATION WITH VITAMIN E OR SELENIUM DOES NOT REDUCE RISK OF PROSTATE CANCER
NEITHER VITAMIN C OR E ASSOCIATED WITH REDUCED RISK OF PROSTATE CANCER, OR OTHER CANCERS
JAMA REPORT (VIDEO SCRIPT)
VIDEO: Windows Media | Quicktime
STUDY FINDS THAT DEEP BRAIN STIMULATION OFFERS PATIENTS WITH ADVANCED PARKINSON DISEASE MORE BENEFIT THAN BEST MEDICAL THERAPY
INFORMATION CONTAINED IN THESE NEWS RELEASES IS PROTECTED BY COPYRIGHT. JOURNAL ATTRIBUTION IS REQUIRED.
Please Note: This week's JAMA Report video is on the results of a comparison of therapies for patients with advanced Parkinson disease. The report will be fed Tuesday, January 6, 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 6, 2009
Media Advisory: To contact Frances Weaver, Ph.D., call Maureen Dyman at 708-202-5627 or email maureen.dyman{at}va.gov. To contact editorial author Günther Deuschl, M.D., Ph.D., email g.deuschl{at}neurologie.uni-kiel.de.
TREATMENT INVOLVING DEEP BRAIN STIMULATION FOR PATIENTS WITH ADVANCED PARKINSON DISEASE PROVIDES BENEFITS
But Treatment Also Associated With Increased Risk of Serious Adverse Events
CHICAGO—Patients with advanced Parkinson disease (PD) who received deep brain stimulation treatment had more improvement in movement skills and quality of life after six months than patients who received other medical therapy, but also had a higher risk of a serious adverse events, according to a study in the January 7 issue of JAMA.
Deep brain stimulation is a surgical treatment involving the implantation of electrodes that send electrical stimulation to specific parts of the brain to reduce involuntary movements and tremors. It is the surgical intervention of choice when PD motor (movement) complications are inadequately managed with medications, according to background information in the article. "However, recent reports highlighting unexpected behavioral effects of stimulation suggest that deep brain stimulation, while improving motor function, may have other less desirable consequences," the authors write. They add that there are few randomized trials comparing treatments, and most studies exclude older patients.
Frances M. Weaver, Ph.D., of Hines VA Hospital, Hines, Ill., and colleagues conducted a randomized trial to compare the benefits and risks of deep brain stimulation with those of best medical therapy for patients, of a wide age range, with PD. A total of 255 patients with PD were enrolled; 25 percent were age 70 years or older. The participants were randomized to receive bilateral deep brain stimulation with leads of the stimulation device implanted in the following locations of the brain: subthalamic nucleus (n = 60) or globus pallidus (n = 61); or received best medical therapy (n = 134), which included management by movement disorder neurologists, who monitored medication use and nonpharmacological therapy (e.g., physical, occupational, and speech therapy).
The researchers found that at 6 months, deep brain stimulation patients gained an average of 4.6 hours per day of on time (the time of good symptom control or unimpeded motor function) without troubling dyskinesia (involuntary movements), while the average change for the best medical therapy group was 0 hours. Motor function improved significantly with deep brain stimulation compared with best medical therapy, with 71 percent of deep brain stimulation patients vs. 32 percent of best medical therapy patients experiencing clinically meaningful motor function improvements at 6 months, while 3 percent of deep brain stimulation patients and 21 percent of best medical therapy patients had clinically worsening scores.
Compared with patients in the best medical therapy group, patients in the deep brain stimulation group experienced significant improvements in the summary measure of quality of life and on 7 of 8 PD quality-of-life scores. Neurocognitive testing revealed small decrements in some areas of information processing for patients receiving deep brain stimulation vs. best medical therapy.
The overall risk of experiencing a serious adverse event was 3.8 times higher in deep brain stimulation patients than in best medical therapy patients. Forty-nine deep brain stimulation patients (40 percent) experienced 82 serious adverse events. Fifteen best medical therapy patients (11 percent) experienced 19 serious adverse events. The most common serious adverse event was surgical site infection, with other serious adverse events including nervous system disorders, psychiatric disorders, device-related complications and cardiac disorders.
"The clinical significance of the adverse events and minor neurocognitive changes observed in patients in the deep brain stimulation group and, more importantly, whether patients who undergo deep brain stimulation view improvement in motor function and quality of life as outweighing adverse events, remain to be explored. More detailed analyses of adverse events and neurocognitive functioning following the conclusion of phase 2 of this study will shed light on these issues. Caution should be exercised, however, against overstating or understating the risks of deep brain stimulation for patients with PD. Physicians must continue to weigh the potential short-term and long-term risks with the benefits of deep brain stimulation in each patient," the authors conclude.
(JAMA. 2009;301[1]:63-73. 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.
EDITORIAL: NEUROSTIMULATION FOR PARKINSON DISEASE
In an accompanying editorial, Günther Deuschl, M.D., Ph.D., of the Universitätsklinikum Schleswig-Holstein, Kiel, Germany, comments on the findings of Weaver and colleagues.
"Although deep brain stimulation is the most important innovation for treatment of advanced PD since the discovery of levodopa [drug used to treat PD], many questions are still unanswered. For instance, the optimal timing for the implantation is unknown. The majority of patients undergo deep brain stimulation surgery more than 10 years after disease onset when the patients are already incapable of working and when the disease-related psychosocial decline has already begun. As quality of life is improved with this treatment it may improve psychosocial functioning in general for these advanced stages. With the aging of the general population, PD will become even more common and patients with PD will get older. Therefore, the present results showing similar efficacy and tolerability of deep brain stimulation in younger and older patients must be replicated because it is at variance with some other reports demonstrating lower rates of operative and postoperative complications in younger patients."
"Overall the results of this important study by Weaver et al have convincingly confirmed the 6-month efficacy of deep brain stimulation for advanced PD in the largest patient group studied thus far. However, this study, along with previous research on this therapy, shows that such progress cannot be made without costs in terms of adverse effects."
(JAMA. 2009;301[1]:104-106. Available pre-embargo to the media at www.jamamedia.org)
Editor's Note: Please see the article for additional information, including financial disclosures, funding and support, etc.
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Previously Released Early Online, December 9, 2008
Media Advisory: To contact Scott M. Lippman, M.D., call Robin Davidson at 713-794-1731 or email RDavidson{at}mdanderson.org. To contact editorial author Peter H. Gann, M.D., Sc.D., call Sherri McGinnis Gonzalez at 312-996-8277 or email smcginn{at}uic.edu.
SUPPLEMENTATION WITH VITAMIN E OR SELENIUM DOES NOT REDUCE RISK OF PROSTATE CANCER
CHICAGO—In perhaps the largest cancer chemoprevention trial ever conducted, researchers have found that supplementation with vitamin E or selenium, alone or in combination, was not associated with a lower risk of prostate cancer or other cancers. This study, along with another cancer prevention study, will be published in the January 7 issue of JAMA, and both reports were released early online because of public health implications.
The number of prostate cancer deaths in the United States has declined in recent years, but this cancer remains one of the most common malignancies in U.S. men, with approximately 186,000 new cases and 29,000 deaths (the second leading cause of cancer death) estimated for 2008. An effective prevention strategy for prostate cancer would have substantial public health benefits, according to background information. Previous studies have indicated the potential of selenium and vitamin E for preventing prostate cancer.
Scott M. Lippman, M.D., of the University of Texas M. D. Anderson Cancer Center, Houston, and Eric A. Klein, M.D., of the Cleveland Clinic Lerner College of Medicine, Cleveland, and colleagues conducted the Selenium and Vitamin E Cancer Prevention Trial (SELECT) to examine the effects of selenium and vitamin E, alone or in combination, on the risk of prostate cancer and other health outcomes in relatively healthy men. The trial included 35,533 men, age 50 years or older for African-American men and age 55 years or older for other men at the start of the study, from the U.S., Canada, and Puerto Rico. The participants were randomly assigned to receive one of four interventions between August 2001 and June 2004 for a planned minimum follow-up of 7 years: selenium (200 µg/day); vitamin E (400 IU/day), selenium + vitamin E, or placebo.
On September 15, 2008, the independent data and safety monitoring committee recommended the discontinuation of study supplements because the alternative hypothesis of no evidence of benefit from either study agent was convincingly demonstrated and there was no possibility of a benefit to the planned degree with additional follow-up. The notice to discontinue study supplements went out to all active study sites on October 23, 2008, when median (midpoint) overall follow-up was 5.46 years.
The researchers found that there were no statistically significant differences in the absolute numbers (or 5-year incidence rates) of prostate cancer diagnoses between the four groups: placebo, 416 cases (5-year rate of 4.43 percent); selenium, 432 cases (4.56 percent); vitamin E, 473 cases (4.93 percent); selenium + vitamin E, 437 cases (4.56 percent). There were nonsignificant increased risks of prostate cancer in the vitamin E group and type 2 diabetes mellitus in the selenium group, but not in the selenium + vitamin E group.
"In conclusion, SELECT has definitively demonstrated that selenium, vitamin E, or selenium + vitamin E (at the tested doses and formulations) did not prevent prostate cancer in the generally healthy, heterogeneous population of men in SELECT. These data underscore the prudence that is needed in considering recommendations to use agents for the prevention or control of disease in the absence of convincing clinical trial results. These findings also compel the medical research community to continue the search for new, effective agents for prostate cancer prevention," the authors write.
(JAMA. 2009;301[1]:39-51. 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.
EDITORIAL: RANDOMIZED TRIALS OF ANTIOXIDANT SUPPLEMENTATION FOR CANCER PREVENTION-FIRST BIAS, NOW CHANCE—NEXT, CAUSE
In a JAMA editorial, Peter H. Gann, M.D., Sc.D., of the University of Illinois at Chicago, comments on the "disappointing news" that two major trials (SELECT and Physicians' Health Study II, which were "conceived during the wave of hope" of earlier studies suggesting that cancer might be prevented by selenium or vitamin E) showed that neither selenium nor vitamin E produced any reduction in prostate cancer or other cancers.
"...single-agent interventions, even in combinations, may be an ineffective approach to primary prevention in average-risk populations. It may be time to give up the idea that the protective influence of diet on prostate cancer risk ...can be emulated by isolated dietary molecules given alone or in combination to middle-aged and older men. ...On the other hand, nonpharmacological dietary prevention of prostate cancer is probably more complex and may involve certain inconvenient truths. Fortunately, no dietary change this profound is likely to be beneficial for prostate cancer alone. If it requires whole foods, extracts, or dietary patterns, it may be necessary to give up the reductionist need to know which molecule is most responsible and perhaps give up the notion of placebo controls as well."
"Epidemiology teaches that every statistical association has only 3 possible explanations: bias, chance, and cause. Regarding nutritional prevention of prostate cancer, first-generation phase 3 trials were too reliant on biased interpretation of prior research, second-generation trials may have been too reliant on chance, yet there is every reason to believe that the next generation will have a firmer basis for causal hypotheses. Until then, physicians should not recommend selenium or vitamin E—or any other antioxidant supplements—to their patients for preventing prostate cancer."
(JAMA. 2009;301[1]:102-103. Available pre-embargo to the media at www.jamamedia.org)
Editor's Note: Please see the article for additional information, including financial disclosures, funding and support, etc.
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Previously Released Early Online, December 9, 2008
Media Advisory: To contact J. Michael Gaziano, M.D., M.P.H., call Lori Shanks at 617-534-1604 or email ljshanks{at}partners.org.
NEITHER VITAMIN C OR E ASSOCIATED WITH REDUCED RISK OF PROSTATE CANCER, OR OTHER CANCERS
CHICAGO—In a major cancer prevention study, long-term supplementation with vitamin E or C did not reduce the risk of prostate or other cancers for nearly 15,000 male physicians. This study, along with another cancer prevention study, will be published in the January 7 issue of JAMA, and both reports were released early online because of public health implications.
In some observational studies, intake or blood levels of vitamins E and C have been associated with reduced risk of certain cancers. "However, definitive proof that vitamins E and C can reduce the risk of overall or site-specific cancers must rely on large-scale randomized trials," the authors write. "A number of trials have addressed the potential role of vitamins in the prevention of cancer; however, the results from these trials have not been consistent." Despite uncertainty about the long-term health effects or benefits, more than half of U.S. adults take vitamin supplements, and vitamins E and C are among the most popular individual supplements, according to background information in the article.
J. Michael Gaziano, M.D., M.P.H., of Brigham and Women's Hospital and VA Boston Healthcare System, Boston, and colleagues conducted the Physicians' Health Study II, a randomized, placebo-controlled trial to examine the effects of vitamin E and vitamin C on prostate cancer and total cancer. The study included 14,641 male physicians in the United States, age 50 years or older at the time of entering the trial, of whom 1,307 had a prior history of cancer. Participants were randomized to receive individual supplements of 400 IU of vitamin E every other day and 500 mg. of vitamin C daily.
During an average follow-up of 8.0 years, there were 1,943 confirmed total cancer cases and 1,008 prostate cancer cases. Compared with placebo, vitamin E had no effect on the incidence of prostate cancer or total cancer. The researchers also found no significant effect of vitamin C on total cancer or prostate cancer. Neither vitamin E nor vitamin C had a significant effect on site-specific cancers, including colorectal, lung, bladder and pancreatic. Stratification by various cancer risk factors demonstrated no significant modification of the effect of vitamin E on prostate cancer risk or either agent on total cancer risk.
"These data provide no support for the use of these supplements in the prevention of cancer in middle-aged and older men," the authors conclude.
(JAMA. 2009;301[1]:52-62. 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 THAT DEEP BRAIN STIMULATION OFFERS PATIENTS WITH ADVANCED PARKINSON DISEASE MORE BENEFIT THAN BEST MEDICAL THERAPY
INTRO:
The United States' aging population has made Parkinson Disease an increasingly prevalent disease, with symptoms that can include tremors, muscle stiffness and an inability to move. A new study compares two widely accepted forms of treatment for the disease, and measures the benefits and risks of each, even for older patients. Haley Weldon explains in this week's JAMA Report.
VIDEO:
B-ROLL
Richard walks out his front door, down to his mailbox
AUDIO:
RICHARD SEEGER WAS DIAGNOSED WITH PARKINSON DISEASE IN 1991, AND IN THE FOLLOWING YEARS, SAW HIS MOVEMENT ABILITY RAPIDLY DETERIORATE.
VIDEO:
SOT/FULL
Super @ :10
Richard Seeger
Has Parkinson Disease
Runs :08
I couldn't get up from the seat – I'd have to bounce and bounce and bounce until I finally got my legs, my knees locked.
AUDIO:
HE VOLUNTEERED TO PARTICIPATE IN A STUDY COMPARING TWO FORMS OF TREATMENT - A SURGICAL PROCEDURE CALLED DEEP BRAIN STIMULATION AND "BEST MEDICAL THERAPY", DEFINED AS TREATMENT BY A MOVEMENT DISORDERS SPECIALIST, INCLUDING A COMBINATION OF MEDICATION AND THERAPIES.
VIDEO:
SOT/FULL
Super @ :34
Frances M. Weaver, Ph.D.
Director – Center for Mgmt. of Complex Chronic Care
Hines VA Hospital
Runs:14
AUDIO:
"What is unique about this study was that we included older people – Parkinson's patients are often older, but older people are often excluded from research studies. 25% of our population in our study were aged 70 and older.."
VIDEO:
B-ROLL
Richard doing yard work
AUDIO:
RICHARD WAS CHOSEN AT RANDOM TO UNDERGO SURGERY, IN WHICH VERY SMALL ELECTRODES WERE PLACED IN HIS BRAIN. THE ELECTRIC STIMULATION WAS THEN ADJUSTED TO BEST CONTROL HIS SYMPTOMS.
VIDEO:
SOT FULL
Richard Seeger
Runs: 08
AUDIO:
"...They turned it on and I tell you what, they couldn't hardly believe it, I was walking around, not shaking."
GXF/JAMA COVER:
STUDY RESULTS AT 6 MONTHS
DEEP BRAIN STIMULTION (DBS) VS. BEST MEDICAL THERAPY (BMT)
4.6 Hours of Improved Functioning
No Improved Functioning
DBS PATIENTS
SIGNIFICANT IMPROVEMENTS
Most Movement Functions
Quality of Life
Benefits Roughly the Same, Regardless of Age
AUDIO:
THE STUDY, FEATURED IN THIS WEEK'S ISSUE OF JAMA, THE JOURNAL OF THE AMERICAN MEDICAL ASSOCIATION, FOUND THAT AT SIX MONTHS, PATIENTS WHO RECEIVED DEEP BRAIN STIMULATION INCREASED THE AMOUNT OF TIME PER DAY THAT THEY WERE ABLE TO FUNCTION NORMALLY BY 4.6 HOURS COMPARED WITH PATIENTS RECEIVING BEST MEDICAL THERAPY.
SIGNIFICANT IMPROVEMENTS IN MOST MOVEMENT FUNCTIONS AND QUALITY OF LIFE WERE ALSO MEASURED AND IT WAS FOUND THAT THE EXTENT OF BENEFIT WAS ROUGHLY THE SAME FOR ALL SURGICAL PATIENTS, REGARDLESS OF AGE.
VIDEO:
SOT/FULL
Frances M. Weaver, Ph.D.
Runs: :07
AUDIO:
"The fact that our older patients did almost as well was a very surprising and positive finding for us."
VIDEO:
B-ROLL
Dr. Weaver at computer, referring to PD book
AUDIO:
HOWEVER, THE STUDY ALSO FOUND A HIGHER RATE OF COMPLICATIONS FOR PATIENTS WHO UNDERWENT DEEP BRAIN STIMULATION.
VIDEO:
Continue B-ROLL
SOT/FULL
Frances M. Weaver, PhD
Runs: :15
AUDIO:
The take home message from this study is that each patient should weigh the benefits and risks of undergoing Deep Brain Stimulation but that being older and having Parkinson's does not exclude a person from being appropriate for receiving this treatment.
VIDEO:
B-ROLL
Richard and his wife walking down the street
AUDIO:
RICHARD SEEGER WOULD BE THE FIRST TO AGREE WITH THAT. HALEY WELDON, THE JAMA REPORT.
TAG:
Phase two of this study will focus on the placement of the Deep Brain Stimulation implant, and compare which of two different sites provides better control of symptoms of Parkinson Disease. For more information about phase one, you can log on to www.jama.com.
Please see the complete study for additional information, including other authors, author contributions and affiliations, financial disclosures, funding and support, etc.
