CHICAGO—Patients with bipolar disorder who take divalproex, the most commonly prescribed mood- stabilizinger drug in the United States, have about a 2.5 times higher risk of suicide death, than if they take lithium, according to an article in the September 17 issue of The Journal of the American Medical Association (JAMA).

Bipolar disorder (a psychiatric disorder characterized by extreme mood swings, ranging between episodes of elevated mood and severe depression) is a major public health problem, in any given year affecting, in any given year approximately 1.3 percent to 1.5 percent of the U.S. population, according to background information in the article. In the WHOWorld Health Organization's Global Burden of Disease study, bipolar disorder ranked sixth among all medical disorders in years of life lost to death or disability. Estimates of the lifetime risk of suicide in patients with bipolar disorder range from 8 percent to 20 percent, ten 10 to twenty 20 times that in the U.S. general population.

Several studies have suggested that lithium treatment reduces risk of suicide in bipolar disorder, but no research has examined suicide risk during treatment with divalproex. Frederick K. Goodwin, M.D., of George Washington University Medical Center, Washington, D.C., and colleagues compared the risk of suicide attempt and completed suicide death during periods of treatment with lithium withto that during periods of treatment with divalproex.

The study included a population-based sample of 20,,638 people from 2 large integrated health plans in California and Washington, aged 14 years or olderver who had at least one 1 outpatient diagnosis of bipolar disorder and at least one 1 filled prescription for lithium, divalproex, or carbamazepine between January 1, 1994, and December 31, 2001. Follow-up for each individual began with first qualifying prescription and ended with death, disenrollment from the health plan, or end of the study period.

"In both health plans, unadjusted rates were greater during treatment with divalproex than during treatment with lithium offor ERemergency department suicide attempt (31.3 vs. 10.8 per 1000 person-years), hospitalized suicide attempt resulting in hospitalization (10.5 vs. 4.2 per 1000 person-years), and suicide death (1.7 vs. 0.7 per 1000 person-years)," the authors write were all greater during periods of treatment with divalproex than during treatment with lithium. "After adjustment for age, gendersex, health plan, year of diagnosis, comorbid medical or psychiatric conditions, and concomitant use of other psychotropic drugs, risk of completed suicide death was 2.7 times higher during treatment with divalproex than during treatment with lithium."

The researchers found that patients taking divalproex had a 70 percent increased risk for attempts resulting in hospitalization and a 80 percent increased risk for attempts diagnosed in the emergency departmentER, compared to patients taking lithium.

CHICAGO—Magnetic shoe inserts provided the same pain relief for patients with plantar heel pain as inserts with no magnetic properties, according to an article in the September 17 issue of The Journal of the American Medical Association (JAMA).

According to background information in the article, the use of magnets for pain relief has increased dramatically in the past decade, despite little scientific evidence supporting their effectiveness, and lack of approval by the U.S. Food and Drug Administration, according to background information in the article. An estimated $5 billion has been spent worldwide on magnet devices purchased to treat pain, with annual U.S. sales estimated at $500 million. Magnets purchased to reduce pain are considered safe when applied to the skin, but the physiologic effects of magnets on pain are unknown.

Mark H. Winemiller, M.D., of the Mayo Clinic, Rochester, Minn., and colleagues investigated whether magnetic shoe insoles could improve heel pain in adults with plantar heel pain more than similar shoe inserts with no magnetic layer.

The researchers conducted a randomized, double-blind, placebo-controlled trial from February 12, 2001 to November 9, 2001. A volunteer sample of 101 adults with diagnoses of plantar heel pain for at least 30 days were enrolled in the study. Participants were randomly given a pair of shoe insoles that either contained an active magnetic foil, or similar foil with no magnetic properties (sham magnets) and were instructed to wear the shoe inserts for at least four hours a day, four days a week, for eight weeks. The participants kept daily pain diaries, and rated their pain based on a 10 point scale with 10 being the worst pain.

The researchers found that there were no significant differences in pain outcomes between the group assigned to the magnetic inserts vs. the group that received sham magnetic inserts. Both groups reported significant improvements in morning foot pain intensity, with average pain scores decreasing from 6.9 for the nonmagnetic and 6.7 for the magnetic group at the beginning of the study, to 3.9 for each group at 8 weeks. At the end of the study, 33 percent of the nonmagnetic group and 35 percent of the magnetic group reported being all or mostly better.

The researchers also found that participants reported that their pain interfered moderately with their enjoyment of their jobs, and that this improved in both groups by the end of the study.

"Both groups used cushioned insoles and both reported subjective improvement in their symptoms; however, static magnets imbedded within these insoles did not provide additional relief," the authors write.

"Our results only marginally support the secondary hypothesis that participants believing magnets have a significant potential to relieve pain would be more likely to have a response to either intervention," the researchers explain. "Because participants were blinded, the magnitude of this placebo effect could be understated compared with devices purchased independently and known to be magnetic."

CHICAGO—Performance scores on most indicators for quality of care for children and adolescents enrolled in Medicaid managed care programs are significantly lower than performance scores for children enrolled in commercial plans, according to an article in the September 17 issue of The Journal of the American Medical Association (JAMA).

According to background information in the article, many states have turned to commercial health plans to serve Medicaid beneficiaries and to achieve cost-containment goals. Assumptions that the quality of care provided to Medicaid beneficiaries through these programs is acceptable have not been tested.

Joseph W. Thompson, M.D., M.P.H., of the University of Arkansas for Medical Sciences, Little Rock, Ark., and colleagues conducted a study to determine if the quality of care (QOC) provided to children in Medicaid managed care organizations (MCOs) is equivalent to the QOC provided to children in commercial MCOs.

The researchers used 1999 data collected through the Health Plan Employer Data and Information Set (HEDIS) and examined quality-of-care indicators for children and adolescents. Results from 423 commercial and 169 Medicaid plans were compared. Matched pairs analyses were performed using data from each of the 81 companies serving both populations to control for corporate differences. The quality indicators included Pprenatal care, childhood immunizations, well-child visits, adolescent immunizations, and myringotomy (procedure involving the eardrum to relieve pressure or release pus from the middle ear) and tonsillectomy rates.

Using these indicators of clinical performance, children and adolescents enrolled in Medicaid received worse care compared with their commercial counterparts. "For most of the 81 health plans serving both populations, Medicaid enrollees had statistically significantly pœ0lower rates than commercial plans for clinical quality indicators (e.g., childhood immunization rates of 69 percent vs. 54 percent, respectively); for clinical access indicators (e.g., well-child visits in the first 15 months of life, 53 percent vs. 31 percent); and for common procedures (e.g., myringotomies for children aged 0-4 years, 35 vs. 2 per 1000 members). Conversely, some plans demonstrated equal and high-quality care for both populations," the authors write.

"Our study is the first to our knowledge to document that children enrolled in Medicaid served by commercial MCOs frequently receive lower QOC than their commercially enrolled counterparts in the same MCO on a number of performance indicators. A few select MCOs do achieve high-quality and equivalent care for both Medicaid and commercially enrolled children," they add.

CHICAGO—Use of St. John's wort may result in reduced clinical efficacy or increased dosage requirements for a large and diverse group of medications, according to an article in the September 17 issue of The Journal of the American Medical Association (JAMA).

According to background information in the article, St. John's wort is a popular herbal product available without prescription and used to treat depression. Previous . Itresearch has indicated that this agent may cause as a participant clinically significant, and perhaps dangerous drug interactions.

John S. Markowitz, Pharm.D., and colleagues from the Medical University of South Carolina, Charleston, conducted a study to assess the potential of chronic St. John's wort to alter the activity of the cytochrome P450 (CYP) enzyme systems, which are extensively involved in drug metabolism.

The study, conducted from March 2002 to February 2003, involved 12 healthy volunteers individuals (6M, 6F6 men and 6 women) aged 22 to 38 yearsstudied treatment with. Participants were given "probe" drugs (30 mg of dextromethorphan (a cough suppressant) and 2 mg of alprazolam (an antianxiety medication) to establish baseline CYP 2D6 and CYP 3A4 (enzymes) activity. After a minimum 7-day washout period, participants began taking one 300-mg tablet of St. John's wort 3 times per day. After 14 days of St. John's wort administration, participants were given the probe drugs along with one St. John's wort tablet to establish postadministration CYP activity; the St. John's wort dosing regimen was continued for 48 hours.

The results indicated that alprazolam was eliminated from plasma twice as fast following St. John's wort administration (elimination half-life decreased from 12.4 hours to 6.0 hours). After 36 hours, only 7 of 12 St John 's worttreated participantsubjects had measurable alprazolam concentrations after St. John's wort administration vs.versus all 12 participantsubjects at baseline. At the 48 hours time point, no participantsubject had measurable alprazolam concentrations after St. John's wort administrationtreatment compared withto 11 of 12 participantsubjects during the baseline phase.

CHICAGO—Herbal products sold on the Internet may have misleading claims that they can treat, prevent, diagnose, or cure specific diseases despite regulations prohibiting these types of statements, according to an article in the September 17 issue of The Journal of the American Medical Association (JAMA).

Charles A. Morris, M.D., and Jerry Avorn, M.D., from the Brigham and Women's Hospital, Boston, analyzed Internet Web sites to assess the nature of marketing claims for eight best selling herbal products (ginkgo biloba, St. John's wort, echinacea, ginseng, garlic, saw palmetto, kava kava, and valerian root). The eight products were chosen because they were the best-sellers in 2000.

"The Dietary Supplement Health and Education Act passed in 1994 restricted the Food and Drug Administration's (FDA's) control over dietary supplements, leading to enormous growth in their promotion," the authors write. "Between 1990 and 1997, use of herbal remedies increased 380 percent in the United States." The authors quote a 1998 - 1999 survey that shows an estimated 14 percent of U.S. adults took herbal supplements and approximately one in five adults take herbal or dietary supplements in addition to prescription medications. In 2001, the dietary supplement industry grossed nearly $18 billion according to information provided by the authors.

The authors identified 443 Web sites pertaining to health-related uses of oral herbal products. "A total of 338 (76 percent) of the Web sites either sold product or directly linked to a vendor," the authors report. "A total of 273 (81 percent) of the 338 retail Web sites made one or more health claims; of these, 149 (55 percent) claimed to treat, prevent, diagnose, or cure specific diseases." The authors also report that important clinical information was often omitted, and among all sites with health claims, the standard FDA disclaimer ["This statement has not been evaluated by the Food and Drug Administration. This product is not intended to diagnose, treat, cure, or prevent any disease."] was omitted in more than half of the sites.

MAGNETIC INSOLES NO MORE EFFECTIVE AT RELIEVING HEEL PAIN THAN REGULAR INSOLES