Chromium Supplements

The American College of Sports Medicine (ACSM) has issued a statement on the use of chromium supplements to increase muscle mass, reduce body fat and improve blood glucose levels and lipid levels. The ACSM believes that chromium supplementation is not necessary. A diet high in unrefined foods, including a wide variety of foods to obtain adequate amounts of chromium, is recommended. According to the ACSM, the diet should provide enough chromium to meet the needs of most people, including those who exercise regularly.

The ACSM does not believe that supplemental chromium will enhance muscle mass development and loss of body fat in persons who ingest sufficient amounts of chromium. The evidence supporting beneficial effects of chromium supplementation on blood lipid levels and glucose levels is inconclusive. More research is needed before a final verdict can be issued.

The mailing address of the ACSM is P.O. Box 1440, Indianapolis, IN 46206-1440; telephone: 317-637-9200; fax: 317-634-7817.

Bone Mineral Density Assessment System

The U.S. Food and Drug Administration has approved accuDEXA Bone Mineral Density Assessment System, a relatively low-cost diagnostic tool for use in assessing bone mineral density in the physician's office. The system utilizes dual energy x-ray absorptiometry (DEXA) technology to evaluate the phalange, a proven testing site that has been used to assess bone density.

According to the manufacturer, the system is small, requires little technical training and produces test results in just 30 seconds. The cost of the system is around $11,000.

Report on Alcohol Consumption and Violence

A report on alcohol and violence (Alcohol Alert No. 38), published by the National Institute on Alcohol Abuse and Alcoholism (NIAAA), explores the association between alcohol consumption, violence and aggression, and the role of the brain in regulating these behaviors. According to the NIAAA, intoxication alone does not cause violence. Alcohol apparently may increase the risk of violent behavior only for certain individuals or subpopulations and only under some situations and social/cultural influences. It appears to weaken brain functions that restrain inappropriate aggression. By impairing the processing of information, alcohol may also cause a person to misjudge social cues.

Some violent behavior may be amenable to treatment, and some may be preventable. One study found decreased levels of marital violence in couples who completed behavioral therapy for alcoholism. In addition, some medications have been identified that have the potential to reduce violent behavior. These medications include certain anticonvulsants, mood stabilizers and antidepressants, especially those that increase serotonin activity. Decreased serotonin activity is associated with aggression and alcoholism, according to the report.

To obtain a free copy of “Alcohol, Violence, and Aggression,” or to add your name to the mailing list to receive future Alcohol Alert bulletins, write the NIAAA, Publications Distribution Center, P.O. Box 10686, Rockville, MD 20849-0686. Full text of the publication is available on the NIAAA Web site at http://www.niaaa.nih.gov.

Warning on Terbutaline Sulfate in Preterm Labor

The U.S. Food and Drug Administration (FDA) has issued a warning to health care professionals about the subcutaneous administration of terbutaline sulfate via infusion pump for the treatment and prevention of preterm labor. Terbutaline sulfate is approved by the FDA for the treatment of asthma, but adequate data establishing the safety and effectiveness of the use of terbutaline as a tocolytic agent have not been provided to the FDA.

Women receiving continuous subcutaneous terbutaline sulfate infusions may have side effects and complications similar to those experienced by women receiving terbutaline and other beta-sympathomimetics intravenously, according to the FDA. Complications include chest pain, tachycardia, dyspnea and pulmonary edema. The FDA reports that at least one maternal death occurred during outpatient use of a continuous infusion of terbutaline sulfate by subcutaneous pump. In addition, the impact of prolonged exposure of terbutaline to the fetus is unknown.

The only drug currently approved for tocolytic therapy is ritodrine hydrochloride injection (Yutopar Intravenous Injection). Adverse events associated with the use of terbutaline sulfate as a tocolytic agent should be reported to the MedWatch program of the FDA at 800-FDA-1088; fax: 800-FDA-1078.

New Drug for Treatment of Parkinson's Disease

The first drug in a new class of drugs to treat Parkinson's disease has been approved by the U.S. Food and Drug Administration. Tolcapone (Tasmar), the first catechol-O-methyltransferase (COMT) inhibitor, has been shown to improve a patient's ability to function and perform basic daily activities when used as an adjunct to levodopa/carbidopa. According to the manufacturer of tolcapone, COMT inhibitors are believed to work to enhance the effectiveness of levodopa by blocking one of the main enzymes (COMT) responsible for the breakdown of levodopa in the blood before it reaches the brain.

In clinical trials including more than 1,500 patients, tolcapone was shown to enhance and extend the pharmacologic actions and clinical benefits of levodopa/carbidopa. Patients whose response to levodopa was relatively stable had statistically significant improvements in activities of daily living as assessed by the Unified Parkinson's Disease Rating Scale, which measures such activities as speech, handwriting, walking and dressing. These patients also experienced improved motor function. In the studies, patients with a deteriorating response to levodopa showed significant improvement in their symptoms, overall, as measured by the investigator's assessment of change. These patients gained a daily average of 1.7 to 2.9 hours of “on time”—periods of relatively good functioning.

The most common side effects in clinical trials were dyskinesias, nausea, sleep disorders, dystonia, anorexia, diarrhea, somnolence, excessive dreaming, muscle cramps, ortho-static complaints/syncope, dizziness, headache, hallucination and confusion. Liver transaminases should be monitored for the first six months.

All-Time Low for Infant Mortality Rate

According to an annual summary of statistics published in the December 1997 issue of Pediatrics, the infant mortality rate for children born in 1996 in the United States was at an all-time low and their life expectancy was at an all-time high. The summary of vital statistics reports the previous year's birth and death rates and fertility levels as well as statistics on prenatal care, births to teenage mothers and unwed mothers, multiple birth rates and rates of low-birth-weight infants.

The preliminary infant mortality rate for 1996 nationwide was 7.2 per 1,000 live births, 5.0 percent lower than the 1995 rate and the lowest rate ever recorded. Massachusetts had the lowest rates at 5.2 deaths per 1,000 live births; the District of Columbia had the highest rate at 16.2 deaths per 1,000 live births. The four leading causes of infant mortality were congenital anomalies, disorders relating to short gestation and unspecified low birth weight, sudden infant death syndrome and respiratory distress syndrome.

Life expectancy for a child born in 1996 reached a new record high of 76.1 years. Death rates for children have declined 40 to 50 percent since 1979. The summary notes that a large proportion of childhood deaths continue to occur as a result of unintentional injury, which was the leading cause of death for children in 1996, followed by homicide and suicide.

Finasteride for Treatment of Male Pattern Hair Loss

Finasteride (Propecia) has been approved by the U.S. Food and Drug Administration as an oral treatment for male pattern hair loss (androgenetic alopecia). Finasteride is for use by men only and should not be used in women or children.

The approval was based on data from three one-year, double-blind, placebo-controlled, multicenter trials involving 1,879 men aged 18 to 41 years with mild to moderate hair loss of the vertex and anterior mid-scalp areas. In addition, 1,215 of the men who had hair loss at the vertex were studied for another year. Results showed that finasteride either promoted the growth of hair or stopped hair loss in 83 percent of the men.

Side effects were uncommon in the studies. Less than 2 percent of men reported a decreased desire for sex, difficulty in achieving an erection and/or a decrease in the amount of semen. These side effects disappeared when the drug was discontinued and eventually disappeared in 58 percent of the men who continued taking the product. The product label notes that if the drug does not work within 12 months, further treatment is unlikely to be of benefit.

The safety and efficacy of finasteride have not been studied in women. Women of child-bearing age should not use the drug because of the potential for birth defects. In addition, pregnant women should not handle crushed or broken tablets.