CHICAGO—Although many physicians and patients prefer a rapid MRI than an x-ray for the evaluation of low back pain, there is no significant difference at one year later in pain, disability or general health status between the two imaging procedures, and MRIs appear to increase the number of spine operations and increase costs, according to a study in the June 4 issue of The Journal of the American Medical Association (JAMA).

According to background information in the article, rapid magnetic resonance imaging (MRI) scanning has made MRI a potential cost-effective replacement for radiographs (x-rays) for patients with low back pain. But whether rapid MRI scanning results in cost effectiveness or better patient outcome than radiographic evaluation has been unknown.

Jeffrey G. Jarvik, M.D., M.P.H., of the Department of Radiology, University of Washington, Seattle, and colleagues conducted a study to determine the clinical and economic consequences of replacing spine radiographs with rapid MRI for primary care patients. The study was a randomized controlled trial of 380 patients aged 18 years or older whose primary physicians had ordered that their low back pain be evaluated by x-rays. The patients were recruited between November 1998 and June 2000 from 1 of 4 imaging centers in the Seattle area: a university-based teaching program, a nonuniversity-based teaching program, and two private clinics. Patients were randomly assigned to receive lumbar spine evaluation by rapid MRI or by radiograph.

At 12 months, primary outcomes of functional disability were obtained from 337 (89 percent) of the 380 patients enrolled. The average back-related disability modified Roland score (based on a questionnaire about back pain disability and how back pain affects common daily activities; higher scores indicate worse function) for the 170 patients assigned to the radiograph evaluation group was 8.75 vs. 9.34 for the 167 patients assigned the rapid MRI evaluation group. The mean difference between the two groups in the secondary outcomes concerning pain bothersomeness, pain frequency, subscales of bodily pain and physical functioning were not statistically significant. Ten patients in the rapid MRI group vs. four in the radiograph group had lumbar spine operations. The rapid MRI strategy had a mean cost of $2,380 vs. $2,059 for the radiograph strategy.

"A major impetus for this work was the concern that substituting radiographs with rapid MRI scans would result in worse patient outcomes because incidental abnormalities would foster increased interventions and unnecessary morbidity. Our study suggests that substituting rapid MRI scan for radiographs is likely safe but may in fact result in more specialist consultations and operations. Despite the higher rate of surgery, average outcomes were not better among those in the rapid MRI group," the authors write.

CHICAGO—Use of the nonsteroidal anti-inflammatory drugs (NSAIDs) rofecoxib or naproxen does not slow the cognitive decline of patients with mild-to-moderate Alzheimer Disease (AD), according to a study in the June 4 issue of The Journal of the American Medical Association (JAMA).

Laboratory evidence that inflammatory mechanisms contribute to neural injury in AD, along with evidence from epidemiological studies, suggest that NSAIDs may favorably influence the clinical course of the disease, according to background information in the article. Alzheimer disease is among the most important health problems of elderly persons, affecting more than 4 million people in the United States.

Paul S. Aisen, M.D., of the Department of Neurology, Georgetown University Medical Center, Washington, D.C., and colleagues tested the hypothesis that NSAID treatment would slow the rate of cognitive decline in individuals with mild to moderate AD. The study was a multicenter, randomized, double-blind, placebo-controlled trial with 1-year exposure to study medications, conducted at 40 ambulatory treatment centers affiliated with the Alzheimer's Disease Cooperative Study consortium. The study included 351 participants, recruited from December 1999 to November 2000, with mild to moderate AD. Participants were randomized to take rofecoxib (n=122) once-daily, 25 mg, or twice-daily naproxen sodium (n=118), 220 mg, or placebo (n=111).

The researchers found that the one year average change in Alzheimer Disease Assessment Scale-cognitive subscale (ADAS-Cog, an instrument that evaluates memory, attention, reasoning, language, orientation and established practice, with a range of scores from zero to seventy) scores in participants treated with naproxen (5.8) or rofecoxib (7.6 ) was not significantly different from the change in participants treated with placebo (5.7 ). Results of secondary analyses showed no consistent benefit with either treatment. Fatigue, dizziness, and hypertension were more commonly reported in the active drug groups, and more serious adverse events were found in the active treatment group than in the placebo group, although that difference was not significant.

CHICAGO—Menopausal hot flash symptoms may be reduced by taking a selective serotonin reuptake inhibitor (SSRI) antidepressant medication as an alternative to hormone replacement and other therapies, according to a study in the June 4 issue of The Journal of the American Medical Association (JAMA).

According to background information in the article, "for many years, hormone replacement therapy (HRT) with combined estrogen/progestin has been the standard therapy for women experiencing menopausal symptoms," the authors write. "However, increased risks of long-term adverse clinical outcomes in a recent prospective study conducted by the Women's Health Initiative (WHI) on long-term HRT use, are likely to change clinical practice significantly." The authors write that alternative treatments are now needed. They report that hot flashes are the most common complaint among women entering menopause and may continue for five years or longer. About 75 percent women will experience some hot flashes around the time of menopause. This translates into more than 25 million women in the United States.

Vered Stearns, M.D., from the Sidney Kimmel Comprehensive Cancer Center at the Johns Hopkins School of Medicine, Baltimore, and colleagues evaluated a SSRI (paroxetine controlled release [CR]) in treating menopausal hot flash symptoms. A total of 165 menopausal women aged 18 years or older, who were experiencing 2 to 3 daily hot flashes participated in the study. The participants had to have discontinued any hormone therapy for at least six weeks and women were excluded if they had any signs of active cancer of were undergoing chemotherapy or radiation therapy.

The participants were randomly assigned to received a placebo or the SSRI. Fifty-one women were assigned to receive 12.5 mg/daily of paroxetine CR; 58 were assigned to received 25.0 mg/daily of paroxetine CR and 56 women were assigned to receive the placebo. The participants were evaluated at baseline, and at 1, 3, and 6 weeks. They kept daily hot flash diaries to document the frequency and severity of hot flashes. A number was assigned to the severity of the hot flash and that number was multiplied by the daily number of hot flashes experienced at that severity level to reach a composite score.

"The mean (average) reductions in the hot flash frequency composite score from baseline to week 6 were statistically significantly greater for those receiving paroxetine CR than for those receiving placebo," the authors report. "By week 6, the mean daily hot flash frequency went from 7.1 to 3.8 (mean reduction, 3.3) for those in the 12.5 mg/daily and from 6.4 to 3.2 (mean reduction, 3.2) for those in the 25-mg/daily paroxetine CR groups and from 6.6 to 4.8 (mean reduction, 1.8) for those in the placebo group."

The most common adverse effects experienced by women receiving paroxetine CR were headache, dizziness, and nausea, with fewer reports of such effects from women receiving the lower dose.

"At study end, 63 (60.5 percent) of 104 women who received paroxetine CR achieved a 50 percent or greater reduction in their hot flash composite scores," the authors note.

CHICAGO—Belt-positioning booster seats are associated with a reduced risk of injury compared with seat belts alone in children four to seven years of age, according to a study in the June 4 issue of The Journal of the American Medical Association (JAMA).

Dennis R. Durbin, M.D., M.S.C.E., from Children's Hospital of Philadelphia, and colleagues assessed the association between belt-positioning booster seats compared with seat belts alone and risk of injury among children.

"Advocates have long recommended belt-positioning booster seats for children who have outgrown their child safety seats," the authors provide as background information. "A belt-positioning booster, either with or without a high back, raises the child up to improve the fit of both the lap and shoulder portions of the seat belt." The authors write that poorly positioned vehicle seat belts increase the risk of intra-abdominal and spinal cord injuries (also know as "seat belt syndrome"), as well as injuries to the face and brain that might occur on impact of the head with the child's knees or the interior of the vehicle.

The authors evaluated data of children aged four to seven years who were involved in crashes of insured vehicles in 15 states. The data were collected through insurance claims records and a telephone survey. The sample of 3,616 crashes involving 4,243 children was weighted to represent 56,593 children in 48,257 crashes and collected between December 1, 1998 and May 31, 2002.

"Injuries occurred among 1.81 percent of all four-to-seven-year olds, including 1.95 percent of those in seat belts and 0.77 percent of those in belt-positioning booster seats," the authors report. "The odds of injury, adjusting for child, driver, crash, and vehicle characteristics, were 59 percent lower for children aged four to seven years in belt-positioning boosters than in seat belts. Children in belt-positioning booster seats had no injuries to the abdomen, neck/spine/back, or lower extremities, while children in seat belts alone had injuries to all body regions."

BELT-POSITIONING BOOSTER SEATS DRAMATICALLY REDUCE RISK OF INJURY TO YOUNG CHILDREN