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.

JAMA NEWS RELEASES
(Embargoed for Release: 3 p.m. CT, Tuesday, February 22, 2005)

JAMA NEWS RELEASES

   HORMONE THERAPY INCREASES RISK OF URINARY INCONTINENCE

   SCREENING FINDS BIPOLAR DISORDER TO BE COMMON IN AN URBAN PRIMARY CARE PRACTICE

   STUDY EXAMINES THREE-DAY ANTIBIOTIC REGIMENS FOR TREATING BLADDER INFECTION IN WOMEN

JAMA REPORT (VIDEO NEWS RELEASE SCRIPT)

   HORMONE THERAPY INCREASES WOMEN'S RISK OF URINARY INCONTINENCE

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Embargoed for Release: 3 p.m. CT, TUESDAY, February 22, 2005
Media Advisory: To contact Susan L. Hendrix, D.O., call Jennifer Day at 313-577-1429. To contact editorialist Catherine E. DuBeau, M.D., call John Easton at 773-702-6241.

CHICAGO—What has been considered a treatment for urinary incontinence—estrogen alone or with progestin—has been found to increase the incidence of incontinence in postmenopausal women, according to a study in the February 23 issue of JAMA.

Menopausal hormone therapy (MHT) consisting of oral estrogen plus progestin or estrogen alone has long been used to treat postmenopausal women and, until recently, was credited with many benefits well beyond the indications for symptomatic relief of hot flashes, night sweats, and vaginal dryness, according to background information in the article. One of the purported benefits of MHT was to improve the symptoms of urinary incontinence (UI), and it has often been prescribed to treat UI.

Susan L. Hendrix, D.O., of the Wayne State University School of Medicine and Hutzel Women's Hospital, Detroit, and colleagues conducted a study to determine the effects of MHT (estrogen and progestin or estrogen alone) on the 1-year incidence and severity of symptoms of stress (incontinence that occurs when involuntary pressure is put on the bladder by coughing or laughing or sneezing or lifting or straining), urge (incontinence that is generally attributable to involuntary contracts of the bladder muscle), and mixed UI (involuntary leakage associated with urgency and also with exertion, effort, sneezing, or coughing) in healthy postmenopausal women. The researchers analyzed data from the Women's Health Initiative (WHI): multicenter double-blind, placebo-controlled, randomized clinical trials of menopausal hormone therapy in 27,347 postmenopausal women aged 50 to 79 years enrolled between 1993 and 1998. Existence of any UI symptoms was known for 23,296 participants at baseline and 1 year. Women were randomized to receive estrogen alone (conjugated equine estrogen, [CEE]), estrogen plus progestin (CEE plus medroxyprogesterone acetate [MPA]), or placebo.

The WHI trials were designed to evaluate the effects of MHT using estrogen and progestin or estrogen alone in preventing coronary heart disease and hip fractures in postmenopausal women. Both trials ended prematurely because more harm than benefit was observed.

The researchers found that menopausal hormone therapy increased the incidence of all types of UI at 1 year among women who were continent at baseline. The risk was highest for stress UI (1.87-fold increased risk with CEE + MPA; CEE alone, 2.15-fold increased risk), followed by mixed UI (1.49-fold increased risk with CEE + MPA; CEE alone, 1.79-fold increased risk). The combination of CEE + MPA had no significant effect on developing urge UI, but CEE alone increased the risk by 1.32 fold. Among women who reported having UI at baseline, both frequency and amount of UI worsened in both trials. Women receiving menopausal hormone therapy were more likely to report that UI limited their daily activities and bothered or disturbed them at 1 year.

"In conclusion, these results from a large, double-blind, placebo-controlled, randomized clinical trial, conducted in multiple centers with an ethnically diverse group of healthy postmenopausal women, indicate that MHT use does not confer protection against any type of UI. On the contrary, both CEE alone and CEE + MPA increased risk of new onset UI among continent women and worsened the characteristics of UI among symptomatic women. Considerations regarding the use of hormone therapy by postmenopausal women for any duration should incorporate the current findings into the established risks and benefits of these agents," the authors conclude.
(JAMA. 2005;293:935-948. Available post-embargo at jama.com)

Editor's Note: The National Heart, Lung, and Blood Institute funds the Women's Health Initiative program. Wyeth-Ayerst provided the study pills (active and placebo). Dr. Hendrix has received research funding from Lilly. None of the other authors reported any disclosures.

EDITORIAL: ESTROGEN TREATMENT FOR URINARY INCONTINENCE - NEVER, NOW, OR IN THE FUTURE?

In an accompanying editorial, Catherine E. DuBeau, M.D., of the University of Chicago, examines the conclusions that can be derived from the findings by Hendrix et al.

"First, clinicians should no longer prescribe long-term oral conjugated equine estrogens for treatment of urge, stress, or mixed UI in postmenopausal women aged 50 years or older. Hendrix et al have performed an important service by placing UI among the ranks of other significant women's health problems that warrant formidable organizational, funding, and analysis efforts. Such trials carry enormous impact among both physicians and the public, which can lead to fruitful, if complicated, dialogues about the specific health problems investigated. It would be extremely positive if these trial results prompted women with UI -- half of whom never discuss their condition with a physician -- to ask their physicians about the many other available treatments for UI."

"Second, this trial is not the final word on using estrogens to treat UI. Whether topical estrogens might prove beneficial remains unknown, especially on a short-term basis and/or in combination with other therapies," Dr. DuBeau writes.
(JAMA. 2005;293:998-1001. 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, February 22, 2005
Media Advisory: To contact Amar K Das, M.D., Ph.D., call Dacia Morris at 212-543-5421 or Craig Lemoult at 212-305-0820.

SCREENING FINDS BIPOLAR DISORDER TO BE COMMON IN AN URBAN PRIMARY CARE PRACTICE

CHICAGO—Nearly 10 percent of patients screened at a general medicine clinic in an urban area were found to have a history of bipolar disorder, according to a study in the February 23 issue of JAMA.

Bipolar disorder consists of episodes of manic and depressive symptoms, according to background information in the article. One or more episodes of manic or hypomanic symptoms such as elevated or irritable mood, racing thoughts, a decreased need for sleep, talkativeness, and excessive involvement in risk-taking activities are necessary to diagnose a bipolar disorder. Hypomania and mania share the same symptoms, but hypomania is less severe. Patients with bipolar disorders are more likely to seek treatment during an episode of depression than hypomania or mania.

Determining whether depression is part of a bipolar disorder is essential for appropriate pharmacological management, because treating patients with bipolar disorder with an antidepressant alone (that is, without a mood-stabilizing drug such as lithium) risks triggering mania, hypomania and rapid cycling between depression and mania.

Amar K Das, M.D., Ph.D., of the New York State Psychiatric Institute and Columbia University, New York, and colleagues conducted a study to estimate the lifetime prevalence of bipolar disorder for patients in an urban general medicine clinic and to compare demographic, clinical, and treatment characteristics of patients who screen positive for a history of bipolar disorder with those who do not.

The study included 1,157 patients between 18 and 70 years of age who were seeking primary care at an urban general medicine clinic serving a low-income population. The study was conducted between December 2001 and January 2003. Diagnosis of bipolar disorder was determined by various questionnaires and surveys and reviewing data on past mental health treatments and records.

The researchers found that the prevalence of positive screening results for lifetime bipolar disorder was 9.8 percent and did not differ significantly by age, sex, or race/ethnicity. Eighty-one patients (72.3 percent) who screened positive for bipolar disorder sought professional help for their symptoms, but only 9 (8.4 percent) reported receiving a diagnosis of bipolar disorder. Seventy-five patients (68.2 percent) who screened positive for bipolar disorder had a current major depressive episode or an anxiety or substance use disorder. Of 112 patients, only 7 (6.5 percent) reported taking a mood-stabilizing agent in the past month. Primary care physicians recorded evidence of current depression in 47 patients (49 percent) who screened positive for bipolar disorder, but did not record a bipolar disorder diagnosis either in administrative billing or the medical record of any of these patients. Patients who screened positive for bipolar disorder reported worse health-related quality of life as well as increased social and family life impairment compared with those who screened negative.

"The high estimated prevalence in this clinical setting (9.8 percent) may be related to the low socioeconomic status of the population. In a national study, lifetime prevalence of bipolar disorder was highest (5.7 percent) among participants with the lowest annual household income (less than $20,000/year). In our clinical sample, nearly nine in ten participants reported a household income below $18,000 per year, and the rate of screening positive for lifetime bipolar disorder was inversely associated with household income. These findings are consistent with community-based studies that have shown that economically disadvantaged individuals have higher rates of mental disorders than their more affluent counterparts," the authors write.

"In an urban general medicine practice, screening positive for bipolar disorder is relatively common but frequently under recognized and is associated with poor health-related quality of life, impairment in social activities and family life, and current suicidal ideation. A significant proportion of primary care participants who screened positive for bipolar disorder present with major depression or an anxiety or substance use disorder. These participants are at risk for adverse events if prescribed antidepressant monotherapy," the authors write. "To improve the recognition and reduce the morbidity of bipolar disorders in primary care, further efforts are needed by primary care physicians to screen selectively for past hypomania or mania among participants with known depression, anxiety, or substance use conditions."
(JAMA. 2005;293:956-963. Available post-embargo at jama.com)

Editor's Note: This project was supported by an investigator-initiated grant from Eli Lilly & Co (co-author Dr. Weissman), and a National Research Service Award Institutional Research Training Grant from the National Institute of Mental Health (Dr. Das).

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, February 22, 2005
Media Advisory: To contact Thomas M. Hooton, M.D., call Susan Gregg-Hanson at 206-731-4097.

STUDY EXAMINES THREE-DAY ANTIBIOTIC REGIMENS FOR TREATING BLADDER INFECTION IN WOMEN

CHICAGO—A three-day regimen of the antibiotic amoxicillin-clavulanate is not as effective as ciprofloxacin at treating an uncomplicated bladder infection in women, according to a study in the February 23 issue of JAMA.

Acute uncomplicated urinary tract infections (UTIs) are among the most commonly encountered bacterial infections in women, according to background information in the article. Management of these infections has been made more complicated in recent years by increasing antimicrobial resistance, which has led to increased use of alternative antibiotics. There have been no published studies on the efficacy of one such antibiotic, amoxicillin-clavulanate, in the treatment of acute cystitis (inflammation of the urinary bladder) in the current era of high-level amoxicillin resistance.

Thomas M. Hooton, M.D., of the University of Washington and Harborview Medical Center, Seattle, and colleagues conducted a randomized trial that compared 3-day regimens of amoxicillin-clavulanate and ciprofloxacin for treatment of women with acute uncomplicated cystitis and used follow-up to evaluate the women for recurrent infection. Ciprofloxacin is in the fluoroquinolone class of antibiotics, a potent and frequently prescribed group that has shown increasing resistance. The trial included 370 women, aged 18 to 45 years. Subjects were randomly assigned to receive amoxicillin-clavulanate (500 mg/125 mg twice daily) or ciprofloxacin (250 mg twice daily) for 3 days and were followed for 4 months.

The researchers found that clinical cure resolution of the symptoms associated with UTI was observed in 93 (58 percent) of 160 women treated with amoxicillin-clavulanate compared with 124 (77 percent) of 162 women treated with ciprofloxacin. Amoxicillin-clavulanate was not as effective as ciprofloxacin even among women infected with bacterial strains susceptible to amoxicillin-clavulanate (65 [60 percent] of 109 women in the amoxicillin-clavulanate group vs. 114 [77 percent] of 149 women in the ciprofloxacin group. The difference in clinical cure rates occurred almost entirely within the first 2 weeks after therapy. Microbiological cure (determine by follow-up urine culture) at 2 weeks was observed in 118 (76 percent) of 156 women treated with amoxicillin-clavulanate compared with 153 (95 percent) of 161 women treated with ciprofloxacin.

"Trimethoprim-sulfamethoxazole should continue to be the first-line treatment for acute cystitis if the woman has no history of allergy to the drug and if the likelihood of trimethoprim-sulfamethoxazole resistance is low. In areas where the likelihood of trimethoprim-sulfamethoxazole resistance is high (greater than 20 percent) or in women who have risk factors for trimethoprim-sulfamethoxazole resistance, nitrofurantoin or a fluoroquinolone [ciprofloxacin] is an appropriate choice. Amoxicillin-clavulanate in a 3-day regimen is not as effective as a fluoroquinolone for the treatment of acute uncomplicated cystitis, even in those women with UTIs caused by susceptible uropathogens, and should be considered only when use of other first- and second-line antibiotics is not feasible," the authors write.
(JAMA. 2005;293:949-955. Available post-embargo at jama.com)

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

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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