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June 22/29, 2004

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, June 22, 2004)


JAMA NEWS RELEASES

>   USE OF ESTROGEN DOES NOT REDUCE RISK OF DEMENTIA IN OLDER WOMEN

>   WEIGHT LOSS, LIFESTYLE CHANGES ASSOCIATED WITH IMPROVED SEXUAL FUNCTION IN OBESE MEN WITH ERECTILE DYSFUNCTION

>   MANY U.S. WOMEN WHO HAVE HAD A HYSTERECTOMY ARE UNNECESSARILY SCREENED FOR CERVICAL CANCER


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 the use of hormone therapy and the incidence of dementia in older women. The release will be fed Tuesday, June 22, from 9:00 - 9:30 a.m. ET on Telstar 6, Transponder 11 (C-Band) and from 2:00 - 2:30 p.m. ET on Telstar 6, Transponder 11 (C-Band). For more information, call 312/464-JAMA (5262).

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Please Note: JAMA DOES NOT PUBLISH ON THE 5TH WEDNESDAY OF A MONTH, THERE WILL BE NO JAMA OR NEWS RELEASES FOR JUNE 30.

SAVE THE DATE: New research from JAMA's theme issue on HIV/AIDS will be presented at the 15th International AIDS Conference in Bangkok, Thailand, on Sunday, July 11, from 9 a.m. to 11 a.m., at the Oriental Hotel in Bangkok. A program and registration form will be included in a future email.

Embargoed for Release: 3 p.m. CT, TUESDAY, June 22, 2004
Media Advisory: To contact Sally A. Shumaker, Ph.D., or Mark A. Espeland, Ph.D., call Karen Richardson at 336-716-4453. To contact editorialist Lon S. Schneider, M.D., call Jon Weiner at 323-442-2830.

USE OF ESTROGEN DOES NOT REDUCE RISK OF DEMENTIA IN OLDER WOMEN

CHICAGO—Contrary to findings in several previous studies, estrogen therapy does not decrease, but may increase, the risk for dementia in older, postmenopausal women, according to a study in the June 23/30 issue of the Journal of the American Medical Association (JAMA).

Dementia is an age-associated illness that imposes severe functional impairment on individuals, according to background information in the article. In the year 2000, more than 4 million people in the United States had Alzheimer disease (AD), and that number is expected to increase to 13 million by 2050. Milder cognitive impairment affects between one-fifth and one-third of older adults and strongly predicts dementia and subsequent institutionalization. Previous studies have reported an association between lower risk of dementia and postmenopausal estrogen use.

In this study, Sally A. Shumaker, Ph.D., of the Wake Forest University School of Medicine, Winston-Salem, N.C., with investigators from the Women's Health Initiative Memory Study (WHIMS) sought to determine whether conjugated equine estrogens (CEE) alone decreased an older woman's risk for dementia or mild cognitive impairment (MCI). The WHIMS previously found an increased risk for dementia and no effect on MCI in women treated with CEE plus medroxyprogesterone acetate (MPA).

The WHIMS is an ancillary study to the larger Women's Health Initiative (WHI) randomized clinical trials of hormone therapy that include a geographically diverse group of approximately 27,000 women. The estrogen plus progestin trial of the WHI was terminated in July 2002 due to significantly more noncognitive adverse events associated with CEE plus MPA compared with placebo. The WHI estrogen-alone trial was terminated on February 29, 2004, because the National Institutes of Health considered the excess risk of stroke in the active hormone group to be unacceptable in healthy women in the absence of benefit for coronary heart disease, the primary outcome.

The WHIMS consisted of randomized, double-blind, placebo-controlled clinical trials of CEE or CEE plus MPA (estrogen plus progestin trial) in community-dwelling women aged 65 to 79 years, conducted from June 1995 to July 8, 2002 (estrogen plus progestin; n=4,532), or to February 29, 2004 (estrogen-alone; n=2,947) in 39 of the 40 WHI clinical centers. Participants in the estrogen-alone trial received either 1 daily tablet containing 0.625 mg/d of CEE or matching placebo; in the estrogen plus progestin trial, they received either 1 daily tablet containing CEE (0.625 mg/d) plus MPA (2.5 mg/d) or matching placebos.

The researchers found that in the estrogen-alone trial, 47 participants were diagnosed with probable dementia, of whom 28 were assigned to receive CEE and 19 to receive matching placebo. During follow-up, the incidence of probable dementia was 49 percent higher among women assigned to receive CEE compared with those receiving placebo, but this difference was not significant. Incidence rates for probable dementia in the estrogen-alone trial were statistically similar to those in the estrogen plus progestin trial. When data from the 2 trials were pooled, the overall risk for probable dementia was significantly increased by 76 percent. After excluding participants with certain baseline scores at or below the cut point, suggesting early cognitive decline, risk for probable dementia increased a nonsignificant 77 percent in the estrogen-alone trial and a significant 2.19 times in the pooled trials.

The risk of being diagnosed with MCI in the CEE group was increased a nonsignificant 34 percent compared with the placebo group. In the combined trials, the risk was similar. The women assigned to CEE had a significant 38 percent increased risk of having either MCI or probable dementia at some time during the trial, compared to the women assigned to placebo.

"Use of hormone therapy to prevent dementia or MCI in women 65 years of age or older is not recommended," the authors conclude.
(
JAMA. 2004;291:2947-2958. Available post-embargo at jama.com)

Editor's Note: For funding and disclosure information, please see the JAMA article.

HORMONE THERAPY ADVERSELY EFFECTS OVERALL COGNITIVE ABILITIES FOR OLDER WOMEN

Additional results from the WHIMS indicate that women aged 65 years and older who took hormone therapy had a greater decline in cognitive function than women taking placebo.

Mark A. Espeland, Ph.D., from Wake Forest University School of Medicine, Winston-Salem, N.C., and investigators with the WHIMS evaluated the effect of postmenopausal hormone therapy on global (overall) cognition in the estrogen-alone trial and in the pooled estrogen-alone and estrogen plus progestin cohorts. The cognitive areas measured included temporal and spatial orientation, immediate and delayed recall, naming, verbal fluency, abstract reasoning (similarities), praxis (obeying command, sentence writing), writing, and visuoconstructional abilities (copying).

Of the 2,947 women enrolled in WHIMS, analyses were conducted on the 2,808 women with a baseline and at least 1 follow-up measure of global cognitive function before the trial's termination.

"We found that women aged 65 years or older assigned to CEE therapy had a slightly but significantly lower average cognitive function compared with women assigned to placebo, as measured … during 5 to 7 years of follow-up," the authors write. "These differences appeared to emerge 1 to 2 years after initiation of therapy and persisted throughout the trial."

"Our results suggest that neither CEE nor CEE plus MPA should be initiated in older women for the purpose of protecting cognitive function. Furthermore, at least 1 subgroup of women was at particularly high risk for the adverse effects of hormone therapy on cognition-women with relatively low baseline cognitive function," the researchers conclude.
(JAMA. 2004;291:2959-2968. Available post-embargo at jama.com)

Editor's Note: For funding and disclosure information, please see the JAMA article

EDITORIAL: ESTROGEN AND DEMENTIA - INSIGHTS FROM THE WOMEN'S HEALTH INITIATIVE MEMORY STUDY

In an accompanying editorial, Lon S. Schneider, M.D., from the University of Southern California, Los Angeles, writes that some important questions regarding estrogen therapy remain.

"Most important is whether short-term use of estrogen over several years in early postmenopause is effective in reducing dementia 2 or 3 decades later. This is the crux of the observational data, suggesting that previous hormone therapy during a critical period is protective while recent or current use is not. By initiating hormone therapy at an approximate mean age of 71 years and following up patients to 4 to 5 years, WHIMS is intervening fairly late in life while seeking to identify relatively infrequent earlier-onset AD cases around age 75 years."

"The WHIMS results do not prove that estrogen therapy has no effect on AD or dementia, but they do clearly indicate that women older than 65 years should not be treated with CEE with or without MPA to attempt to prevent dementia or enhance cognition. Whether with different populations, lower doses of CEE, other forms of estrogen or receptor modulators, or delivered in lower more physiological doses, estrogen therapy could eventually be proven beneficial remains to be seen. However, the harmful to neutral effects of estrogen in the WHI and WHIMS trials will make further development of and research with estrogen therapy a daunting task," writes Dr. Schneider.
(JAMA. 2004;291:3005-3007. Available post-embargo at jama.com)

Editor's Note: For Dr. Schneider's financial disclosure, please see the JAMA editorial.

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, June 22, 2004
Media Advisory: To contact Katherine Esposito, M.D., email: katherine.esposito{at}unina2.it. To contact editorialist Christopher S. Saigal, M.D., M.P.H., call Rachel Champeau at 310-794-0777.

WEIGHT LOSS, LIFESTYLE CHANGES ASSOCIATED WITH IMPROVED SEXUAL FUNCTION IN OBESE MEN WITH ERECTILE DYSFUNCTION

CHICAGO—Obese men with erectile dysfunction may be able to improve their sexual function with exercise and weight loss, according to a study in the June 23/30 issue of the Journal of the American Medical Association (JAMA).

Erectile dysfunction (ED) is an important cause of decreased quality of life in men, and may affect an estimated 30 million men in the United States, according to background information in the article. In a previous study, moderate-to-severe erectile dysfunction was reported by 12 percent of men younger than 59 years; 22 percent of men aged 60 to 69 years; and 30 percent of men older than 69 years.

Katherine Esposito, M.D., of the Center for Obesity Management, Second University of Naples, Italy, and colleagues conducted a study to determine if lifestyle changes designed to obtain a sustained and long-term reduction in body weight and an increase in physical activity would improve erectile function and endothelial (cells lining the inside of blood vessels) function in obese men.

The randomized trial included 110 obese men (body mass index 30 or greater) aged 35 to 55 years, without diabetes, hypertension, or hyperlipidemia, who had erectile dysfunction that was determined by having a score of 21 or less on the International Index of Erectile Function (IIEF). The study was conducted from October 2000 to October 2003 at a university hospital in Italy.

The 55 men randomly assigned to the intervention group received detailed advice about how to achieve a loss of 10 percent or more in their total body weight by reducing caloric intake and increasing their level of physical activity. Men in the control group (n = 55) were given general information about healthy food choices and exercise.

The researchers found that after 2 years, weight and body mass index decreased significantly more in the intervention group than in the control group. The average level of physical activity increased more in the intervention group (from 48 to 195 min/wk) than in the control group (from 51 to 84 min/wk). The average IIEF score improved in the intervention group (from 13.9 to 17), but remained stable in the control group (from 13.5 to 13.6). Seventeen men in the intervention group and 3 in the control group reported an IIEF score of 22 or higher. In multivariate analyses, reductions in body mass index and increases in physical activity were independently associated with changes in IIEF score.

"Our data demonstrate that lifestyle changes, including a reduced calorie diet and increased exercise, improve erectile function in obese men and resulted in about one-third of men with erectile dysfunction regaining sexual function after treatment. This improvement was associated with amelioration of both endothelial function and markers of systemic vascular inflammation. Interventions focused on modifiable health behaviors may represent a safe strategy to improve erectile function and reduce cardiovascular risk in obese patients," the authors conclude.
(
JAMA. 2004;291:2978-2984. Available post-embargo at jama.com)

Editor's Note: Financial support for the research presented in this article was provided by the Second University of Naples, Italy.

EDITORIAL: OBESITY AND ERECTILE DYSFUNCTION - COMMON PROBLEMS, COMMON SOLUTION?

In an accompanying editorial, Christopher S. Saigal, M.D., M.P.H., of the University of California, Los Angeles, writes that the findings from the study by Esposito et al are provocative but come with some caveats.

"The population studied may differ from obese patients typically seen in primary care clinics in that these patients did not have known coronary heart disease, diabetes, or hypertension, all commonly seen in obese patients in practice. The presence of these comorbid diseases may lessen the impact of the effect of exercise and weight loss on ED. Another limitation to the generalizability of the findings is these obese patients were seeking treatment for weight loss at a specialized clinic. Counseling overweight patients to begin and sustain effective weight-reducing behaviors can be a daunting challenge for clinicians. Some obese patients may lack the motivation demonstrated by the patients in this study. Even among these motivated patients, benefit was evident only in those who were entered into an intensive program, which may be difficult to replicate in many practices."

"At a time in which obesity has become a public health crisis, this study provides evidence of efficacy for what perhaps should be the first-line treatment for obese patients with ED. This treatment strategy produces many benefits for the patient if it is successful and incurs no untoward risk if it is not. Unfortunately, however, this is one treatment for ED that will not be accompanied by free pens, free notepads, and its own Super Bowl commercial," writes Dr. Saigal.
(JAMA. 2004;291:3011-3012. 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, June 22, 2004
Media Advisory: To contact Brenda E. Sirovich, M.D., M.S., call Deborah Kimbell at 603-653-1913.

MANY U.S. WOMEN WHO HAVE HAD A HYSTERECTOMY ARE UNNECESSARILY SCREENED FOR CERVICAL CANCER

CHICAGO—Many women in the United States who have had a hysterectomy are undergoing Papanicolaou (PAP) smear screening even though they are not at risk of cervical cancer, according to a report in the June 23/30 issue of the Journal of the American Medical Association (JAMA).

Pap smear screening for cervical cancer was introduced in the 1940s and has become a widely accepted cancer screening test that has substantially decreased the number of cases and deaths since its introduction, according to background information in the article. In 1996, "based on accumulated evidence from observational studies, the U.S. Preventive Services Task Force recommended that routine Pap smear screening is unnecessary for women who have undergone a complete hysterectomy for benign (non-cancerous) disease." The authors add that most women who have undergone hysterectomy are not at risk of cervical cancer because they no longer have a cervix.

Brenda E. Sirovich, M.D., M.S., and H. Gilbert Welch, M.D., M.P.H., from the VA Outcomes Group, White River Junction, Vt. and Dartmouth Medical School in Hanover, N.H., analyzed data from the Behavioral Risk Factor Surveillance System (1992 - 2002), an annual, population-based telephone survey of U.S. adults conducted by the Centers for Disease Control and Prevention. The authors evaluated the information from 187,670 women who reported having a hysterectomy and answered questions about the timing of their last Pap smear.

"Twenty-two million U.S. women 18 years and older have undergone hysterectomies, representing 21 percent of the population," the authors found. "The proportion of these women who reported a current Pap smear [within the last 3 years] did not change during the 10-year study period. In 1992 (before the U.S. Preventive Services Task Force recommendations), 68.5 percent of women who had undergone hysterectomy reported having had a Pap smear in the past 3 years; in 2002 (6 years after the recommendation), 69.1 percent had had a Pap smear during the same period."

After accounting for Pap smears that may have preceded a recent hysterectomy and hysterectomies that spared the cervix or were performed for cervical neoplasia (tumors), we estimate that approximately 10 million women, or almost half of all women who have undergone hysterectomy, are being screened unnecessarily, the authors report. Although estimates based on patient self-report may over-estimate actual screening rates, these results suggest that millions of women are being screened unnecessarily, and the amount of screening has not declined following the task force recommendation, the authors note.

The authors write there may be several factors contributing to the continued screenings. "It is possible that women who have had a total hysterectomy are not aware that they are no longer at risk for cervical cancer. Or they may simply be so enthusiastic about cancer screening that they continue to have Pap smears regardless of the usefulness of the test. It is also possible that physicians are largely responsible for continuing cervical cancer screening after hysterectomy." The authors also suggest Pap smear performance measures may also be responsible. Although such measures may not be aimed at women who have undergone a hysterectomy, "The net effect may be that all women are encouraged to receive Pap smears in order to meet specified benchmarks for cervical cancer screening." In conclusion the authors write: "The U.S. Preventive Services Task Force recommendations either have not been heard or have been ignored."
(
JAMA. 2004;291:2990-2993. Available post-embargo at jama.com)

Editor's Note: Dr. Sirovich is supported by a Veterans Affairs Career Development Award. This study was supported by a Research Enhancement Award from the U.S. Department of Veterans Affairs to investigate the harms of excessive medical care.

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

ESTROGEN ALONE WILL NOT PROTECT ELDERLY WOMEN AGAINST DEMENTIA OR MEMORY LOSS - CAN INCREASE RISK INSTEAD

VIDEO:
NAT SOT UP FULL FOR :05
Nurse questioning older woman


AUDIO:
"Since you've been off your estrogen, have you had any hot flashes?
No."

VIDEO:
B-ROLL
Nurse interviewing woman in exam room


AUDIO:
SOME WOMEN TAKE ESTROGEN HORMONE THERAPY TO HELP WITH THE UNCOMFORTABLE SYMPTOMS OF MENOPAUSE... AND IN THE HOPES THAT THE THERAPY CAN PROTECT AGAINST COGNITIVE DECLINE, SUCH AS DEMENTIA AND MEMORY LOSS. BUT A NEW STUDY HAS BAD NEWS ABOUT ESTROGEN THERAPY.

VIDEO:
SOT/FULL @ :20 Runs :06
Super: Stephen Rapp, Ph.D., Wake Forest Univ. School of Medicine


AUDIO:
"Women who are, who were taking estrogen only, had an increased risk of developing dementia."

VIDEO:
B-ROLL
Dr. Rapp and colleague going over data
GFX/JAMA COVER
Elderly women walking outside
Estrogen pills being counted in pharmacy


AUDIO:
DR. STEPHEN RAPP AND COLLEAGUES AT WAKE FOREST UNIVERSITY SCHOOL OF MEDICINE AND EIGHT OTHER INSTITUTIONS AROUND THE U.S. ANALYZED DATA FROM THE WOMEN'S HEALTH INITIATIVE MEMORY STUDY. THEIR FINDINGS APPEAR IN THE JOURNAL OF THE AMERICAN MEDICAL ASSOCIATION. THEY TRACKED NINE YEARS OF DATA ON ABOUT THREE-THOUSAND WOMEN AGE 65 AND OVER. HALF THOSE WOMEN TOOK ESTROGEN ALONE. HALF TOOK PLACEBO, OR SUGAR PILL.

VIDEO:
SOT/FULL Runs :10
Stephen Rapp, Ph.D., Wake Forest Univ. School of Medicine


AUDIO:
"We found about a 50 percent increased risk in the women taking estrogen compared with the women who were taking placebo."

VIDEO:
Full screen graphic
Title: RISK OF DEMENTIA
Estrogen - 23 per 10,000
Placebo - 12 per 10,000
Difference of 11 per 10,000 per year


AUDIO:
THE RESEARCHERS SAY THAT FOR EVERY TEN-THOUSAND WOMEN TAKING ESTROGEN ALONE, 23 WOULD DEVELOP DEMENTIA EACH YEAR, COMPARED TO 12 PER TEN-THOUSAND EACH YEAR FOR THE PLACEBO GROUP... A DIFFERENCE OF JUST 11 PER TEN-THOUSAND PER YEAR. SO THE RISK TO THE INDIVIDUAL WOMAN IS QUITE SMALL.

VIDEO:
SOT/FULL
Stephen Rapp, Ph.D., Wake Forest Univ. School of Medicine
Runs :15


AUDIO:
"But when we think about the number of women who are taking estrogen therapy at this time, and that number is in the millions, suddenly the impact of the risk of dementia on estrogen therapy becomes quite meaningful."

VIDEO:
B-ROLL
Dr. Rapp at his computer


AUDIO:
THESE FINDINGS MIRROR LAST YEAR'S WOMEN'S HEALTH INITIATIVE MEMORY STUDY FINDINGS ON ESTROGEN PLUS PROGESTIN. DR. RAPP SAYS BOTH STUDIES HAVE THE SAME CONCLUSION.

VIDEO:
SOT/FULL Runs :09
Stephen Rapp, Ph.D., Wake Forest Univ. School of Medicine


AUDIO:
"Women over 65 should not be taking hormone therapy to protect them from developing dementia or to protect them from memory problems."

VIDEO:
B-ROLL
Estrogen pills being counted in pharmacy


AUDIO:
THIS IS MAVIS PRALL REPORTING.

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