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THIS WEEK'S CONTENTS
ARCHIVES OF INTERNAL MEDICINE NEWS RELEASES
Embargoed Until: 3 P.M. (CT), Monday, July 25, 2005
HORMONE PATCH MAY PROVIDE SOME INCREASE IN SEXUAL DESIRE IN MENOPAUSAL WOMEN
BREAST BIOPSY RATES REMAIN STEADY DESPITE INTRODUCTION OF NEW TECHNOLOGY
VITAMIN D SUPPLEMENTS NOT EFFECTIVE IN PRESERVING BONE MINERAL DENSITY IN BLACK WOMEN
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EMBARGOED FOR RELEASE UNTIL 3 P.M. (CT), MONDAY, July 25, 2005
Media Advisory: To contact Glenn D. Braunstein, M.D., call Kelli Hanley at 310-423-3674.
To contact editorial author Robert A. Vigersky, M.D., e-mail: robert.vigersky{at}na.amedd.army.mil.
HORMONE PATCH MAY PROVIDE SOME INCREASE IN SEXUAL DESIRE IN MENOPAUSAL WOMEN
CHICAGO—A testosterone patch may produce modest increases in sexual desire and frequency of satisfying sexual experiences in women who develop distressful, low sexual desire following hysterectomy and removal of the fallopian tubes and ovaries, according to a study in the July 25 issue of the Archives of Internal Medicine, one of the JAMA/Archives journals.
Diminished sexual desire has been reported by 30 to 50 percent of women who undergo surgical menopause (menopause induced by the surgical removal of both ovaries), according to background information in the article. In one form of female sexual dysfunction, hypoactive sexual desire disorder, a chronic absence of desire for sexual activity results in personal distress. When the ovaries are removed (oophorectomy), blood levels of sex hormones, including testosterone, drop. Although some women see improvements in sexual functioning with estrogen therapy alone, previous studies suggest that the combination of estrogen and testosterone is more effective in preserving sexual desire.
Glenn D. Braunstein, M.D., of Cedars-Sinai Medical Center, Los Angeles, and colleagues conducted a 24-week, randomized, double blind, multicenter clinical trial in women who developed distressful low sexual desire after surgical menopause and were receiving oral estrogen therapy. The 447 women (aged 24 to 70 years) were randomized to receive placebo or testosterone patches twice weekly in one of three progressively higher doses. Testosterone levels were checked at baseline, 12 and 24 weeks. Changes in sexual desire and frequency of satisfying sexual activity were determined on the basis of a woman's reports on standardized questionnaire and sexual function activity log.
The researchers found that compared with women receiving placebo, women receiving the middle dosage (300 micrograms per day) had greater increases from baseline in questionnaire scores for sexual desire (67 percent increase over baseline compared with 48 percent increase over baseline for placebo) and in reported frequency of satisfying sexual activity (79 percent over baseline compared with 43 percent over baseline for the placebo group). The low dosage group showed no evidence of a treatment effect. The women in the high dosage group had increases in baseline sexual desire similar to the middle dosage group, but were no different from the placebo group in changes in frequency of satisfying sexual activity.
"Testosterone, 300 µg/d [microgram per day] administered by a patch, significantly improved sexual desire and the frequency of total satisfying sexual activity in surgically menopausal women with hypoactive sexual desire disorder," the authors conclude. "These findings were generally consistent across all sexual function instruments [questionnaires and logs], end points, and time points, and highlight the important role that testosterone may play in women's sexual health. Additional studies should be undertaken to further assess the efficacy and safety of this treatment."
(Arch Intern Med.
2005;165:1582-1589. Available pre-embargo to the media at www.jamamedia.org)
Editor's Note: This study was funded by research grants from Procter & Gamble Pharmaceuticals, Mason, Ohio. Dr. Braunstein is a consultant for Procter & Gamble Pharmaceuticals. Co-author Jan L. Shifren, M.D., is a consultant for and receives research support from Procter & Gamble Pharmaceuticals. Co-author James A. Simon, M.D., is a consultant for and receives research support from a number of firms including Procter & Gamble Pharmaceuticals. Co-author Gloria Bachman, M.D., is a consultant for Procter & Gamble Pharmaceuticals and is on their speaker's bureau. Co-author Nelson B. Watts, M.D., receives consultant fees, honoraria, and research support from Procter & Gamble Pharmaceuticals.
EDITORIAL: GOLDILOCKS AND MENOPAUSE
In an editorial accompanying the article, Robert A. Vigersky, M.D., of Walter Reed Army Medical Center, Washington, D.C., writes, "The benefits found by Braunstein and colleagues are modest and not clearly dose related. Using the Profile of Female Sexual Function (PFSF) ...they found a statistically significant increase in only two of the seven domains of sexual function at the 300-µg/d dose but not at the 450-µg/d dose of a transdermal testosterone patch. ...Despite this apparent robust increase [in the sexual desire and sexual arousal scores], when put in the descriptive terms of the questionnaire, the testosterone treatment only raised the level of sexual function from 'seldom' to 'sometimes.' Similarly, the frequency of satisfying sexual activity increased by 79 percent in the testosterone-treated group compared with 43 percent in the placebo group, but on a monthly basis this was an absolute increase from three to five episodes."
"Goldilocks has been around for almost 200 years," Dr. Vigersky concludes. "Should she ever develop HSDD [hypoactive sexual desire disorder], it is still not clear if a 300-µg transdermal testosterone patch is 'just right' for her. Hopefully, further studies will be available when and if she needs to be treated.
(Arch Intern Med.
2005;165:1571-1572. Available pre-embargo to the media at www.jamamedia.org)
For more information, contact JAMA/Archives media relations at 312/464-JAMA (5262) or e-mail mediarelations{at}jama-archives.org.
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EMBARGOED FOR RELEASE UNTIL 3 P.M. (CT), MONDAY, July 25, 2005
Media Advisory: To contact Karthik Ghosh, M.D., M.S., call Elizabeth Zimmermann at 507-284-5005.
BREAST BIOPSY RATES REMAIN STEADY DESPITE INTRODUCTION OF NEW TECHNOLOGY
CHICAGO—Rates of breast biopsy (removal of tissue for diagnostic evaluation) remained stable over a 12 year period even as mammogram use increased and new and less invasive biopsy techniques were introduced, according to a study in the July 25 issue of the Archives of Internal Medicine, one of the JAMA/Archives journals.
Changes in the guidelines for breast cancer screening have resulted in increased use of mammography. However, some women screened by mammography may have a false positive result, requiring further tests, including biopsy, resulting in anxiety, inconveniences and trauma for the patient as well as increased costs, according to background information in the article. Further, the authors suggest, the advent of less invasive breast biopsy techniques might also contribute to an increase in the use of biopsy, but there is little information on the actual frequency of biopsy in the general community.
Karthik Ghosh, M.D., M.S., of the Mayo Clinic, Rochester, Minn., and colleagues, reviewed the medical records of women 18 years and older from January 1, 1988 through December 31, 1999, using the resources of the Rochester Epidemiology Project which indexes all inpatient and outpatient medical care provided to residents of Olmsted County, Minn. The rate of utilization of biopsy was calculated as the number of biopsies performed (except when multiple biopsies were performed on the same breast at one time) compared with the number of women in Olmsted County.
The researchers identified 2,878 biopsies performed on 2,521 women residing in Olmsted County during the study period. "The overall, age-adjusted, annual utilization rate of breast biopsies was 62.6 percent per 10,000 women and remained fairly constant throughout the study period," the authors write. "There was no significant change in the trends in breast biopsy utilization before or after the introduction of the core-needle breast biopsy procedure in 1992. Utilization rates for women aged 18 to 39 years, 40 to 49 years, and 50 years and older remained stable throughout the study period. ...The rate of utilization did not change in the 40- to 49-year age group despite the introduction of regular screening mammography guidelines in this group in 1997." The researchers found that the ratio between results that indicated a malignancy [cancer] and those that did not [benign] remained stable throughout the study at one malignancy for every 2.2 benign results.
"In conclusion, this population-based study is an assessment of clinical breast practice across a 12-year period during which there was increasing use of mammography and the introduction of new, less invasive biopsy techniques, presumably increasing breast biopsy utilization," the authors write. "Breast biopsy utilization rates remained stable throughout the study, although the biopsy technique itself changed with increasing utilization of image-guided core-needle biopsies. The benign-malignant ratio also remained stable despite the change in biopsy techniques. A multidisciplinary breast practice, along with established guidelines for breast biopsy, can ensure the appropriate use of new technology and thereby improve patient care."
(Arch Intern Med.
2005;165:1593-1598. Available pre-embargo to the media at www.jamamedia.org)
Editor's Note: This study was supported by a grant from the Department of Defense Breast Cancer Center of Excellence located at Mayo Clinic, Rochester, Minn.
For more information, contact JAMA/Archives media relations at 312/464-JAMA (5262) or e-mail mediarelations{at}jama-archives.org.
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EMBARGOED FOR RELEASE UNTIL 3 P.M. (CT), MONDAY, July 25, 2005
Media Advisory: To contact John F. Aloia, M.D., call John Broder at 516-663-2234.
VITAMIN D SUPPLEMENTS NOT EFFECTIVE IN PRESERVING BONE MINERAL DENSITY IN BLACK WOMEN
CHICAGO—Vitamin D supplementation did not appear to prevent bone loss in postmenopausal black women, according to a study in the July 25 issue of the Archives of Internal Medicine, one of the JAMA/Archives journals.
Although there is general agreement on the optimal calcium intake recommended for reducing postmenopausal bone loss, and it is recognized that vitamin D is important in calcium maintenance, the optimal intake of vitamin D is controversial, according to background information in the article. Blood levels of 25-hydroxyvitamin D (25-OHD) are the best indicator of vitamin D status, with very low levels leading to rickets and osteomalacia (softening of bones). Black women have lower blood levels of 25-OHD because they synthesize less through skin exposure to the sun.
John F. Aloia, M.D., from Winthrop University Hospital, Mineola, N.Y., and colleagues, conducted a randomized, double-blind trial comparing bone loss in postmenopausal black women taking vitamin D3 supplements and those not taking supplements. Two-hundred-eight healthy black women, aged 50 to 75 years, received either placebo or 20 µg/day (micrograms per day) of vitamin D3. All participants received calcium supplements to ensure a total calcium intake of 1,200 to 1,500 mg/day. After two years, the vitamin D3 dose was raised to 50 µg/day. Bone mineral density (BMD) was measured at six-month intervals for three years.
The researchers found that there was no significant difference in BMD in women receiving vitamin D and women receiving placebo. There was also no relationship found between 25-OHD blood levels and bone density change in either group. Both groups experienced an increase in BMD in total body, hip, and mid-radius (forearm bone) at one year (between 1.1 and 1.3 percent). However, BMD declined at these sites over the full three years from 0.26 percent to 0.55 percent. Initial total hip BMD ranged from normal (65 percent) to osteopenic (having reduced bone mass; 33.6 percent) to osteoporotic (severely reduced bone mass, 1.4 percent).
"Our study demonstrated a lack of benefit of vitamin D supplementation on loss of skeletal mass in calcium-sufficient African American women in midlife," the researchers report. "Although this may not be extrapolated to women of other ethnic groups, to elderly women, or to greater degrees of vitamin D insufficiency, it lends support to re-examination of optimal vitamin D nutrition for skeletal health in postmenopausal women of other ethnic groups."
(Arch Intern Med. 2005;165:1618-1623. Available pre-embargo to the media at www.jamamedia.org)
Editor's Note: This research was funded by the National Institute of Aging, National Institutes of Health, Bethesda, Md.
For more information, contact JAMA/Archives media relations at 312/464-JAMA (5262) or e-mail mediarelations{at}jama-archives.org.
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