FDA Approves Photodynamic Therapy Illuminator

The U.S. Food and Drug Administration (FDA) has approved the use of the BLU-U Blue Light Photodynamic Therapy (PDT) Illuminator for the treatment of nonhyperkeratotic actinic keratoses of the face or scalp. The illuminator is a nonlaser fluorescent light source that is used in combination with aminolevulinic acid in the Levulan PDT system.

A physician applies the aminolevulinic acid for topical solution, 20 percent, to the affected area of skin. Approximately 14 to 18 hours later, the patient must return to the physician's office and the affected area is then exposed to the PDT illuminator. When the solution reacts to the visible blue light, the skin lesion is destroyed. Healthy skin is unharmed. According to the manufacturer, a typical candidate for this type of therapy is a patient at least 40 years of age with fair skin and more than seven lesions.

Possible adverse effects of treatment with the Levulan PDT system include stinging, burning, itching, erythema and edema. During clinical trials, fewer than 3 percent of patients discontinued therapy because of stinging and/or burning.

In clinical trials, more than 70 percent of patients were completely cleared of all lesions 12 weeks after treatment with the Levulan PDT system. Ninety-four percent of patients rated the way the appearance of their lesions responded to treatment as good or excellent.

ACSM Statement on Exercise in Health Clubs

The American College of Sports Medicine (ACSM) has released an official statement on exercise in health clubs. The statement appears in the ACSM's Current Comments, September 2000.

According to the ACSM, the aging population and the tendency of health clubs to enroll persons who have just completed heart disease rehabilitation programs are cause for concern regarding the safety and staffing of health clubs. Recent surveys also have shown generally inadequate pre-exercise screening and safety programs in a high percentage of clubs.

To alleviate this concern, the ACSM believes that guidelines on fitness standards from major medical organizations such as the American Medical Association, the American Heart Association (AHA) and the ACSM should be used to guide physicians and health clubs in making the fitness environment safe for everyone.

Several major fitness guidelines, including those of the AHA and ACSM, recommend that all persons be screened before participation in fitness activities. The goal is to risk-stratify participants by identifying those who should see their physician before beginning an exercise program. This will also allow for communication between the participant's physician and the health club staff about persons who might be less than healthy.

The ACSM stresses that because the public health benefits of exercise are so great, there is widespread agreement in the medical community that any screening process should not be so intensive that it serves to discourage participation. Simple questionnaires from organizations such as the AHA can identify within moments any problems that might contraindicate exercise.

Current Comments are official statements by the ACSM concerning topics of interest to the public at large. More information may be obtained by calling 317-637-9200 or by writing to the ACSM, P.O. Box 1440, Indianapolis, IN 46206-1440.

AHRQ Report on the Effects of Dietary Garlic

According to an evidence-based report from the Agency for Healthcare Research and Quality (AHRQ), dietary consumption of garlic may lower some types of cholesterol levels in the short term, but does not appear to offer long-term protection against cardiovascular disease.

The AHRQ states that garlic may help to reduce low-density lipoprotein (LDL) cholesterol levels, but the evidence is only for short-term effects of one to three months. The long-term effects are currently unknown. The report showed that the levels of high-density cholesterol were unaffected by garlic use. After six months of garlic consumption, no further reductions in triglyceride levels or LDL levels were apparent. The AHRQ calls for further research to compare the short-term and long-term benefits of garlic use.

Garlic was not found to have a beneficial effect on conditions such as blood pressure or diabetes, and the evidence was inconclusive about its role in cancer prevention. While garlic may be associated with a decreased likelihood of some types of cancer, the number of available studies was not sufficient to draw conclusions. Also, the current research does not address the wide variations in garlic preparation.

The AHRQ report was based on a systematic review and analysis of scientific evidence from clinical studies of garlic use in humans. For a copy of “Garlic: Effects on Cardiovascular Risks and Disease, Protective Effects Against Cancer, and Clinical Adverse Effects” (Evidence Report No. 20), write to the AHRQ Publications Clearinghouse, P.O. Box 8547, Silver Spring, MD 20907-8547, or call 800-358-9295. The report is also available on the AHRQ Web site athttp://www.ahrq.gov/clinic/epcix.htm.

FDA Approval of Extended-Release Divalproex

The U.S. Food and Drug Administration (FDA) has approved divalproex extended release (Depakote ER) for once-a-day dosing to prevent migraine in adults. The medication is available in 500-mg tablets.

The manufacturer reports that divalproex extended release was well tolerated in clinical trials. A small percentage of patients are affected by side effects such as nausea, dyspepsia, diarrhea, vomiting, abdominal pain, somnolence and infection

According to the manufacturer, divalproex extended release should not be used in patients with hepatic disease or significant hepatic dysfunction. Valproic acid and its derivatives can cause death from hepatic failure and pancreatitis. Valproate may also cause teratogenic effects in the children of women who use the drug during pregnancy. Because of the potential hazard to the fetus, divalproex extended release should be considered for women of childbearing age only after this risk has been discussed with the patient and weighed against the potential benefits of treatment. The safety and effectiveness of divalproex extended release and prophylaxis of migraine in patients older than 65 years have not been established.

NIDA Clinical Toolbox for Drug Treatment Strategies

The National Institute on Drug Abuse (NIDA) has released the “NIDA Clinical Toolbox: Science-Based Materials for Drug Abuse Counselors,” a compilation of its research on drug abuse and addiction, to provide drug treatment professionals with new and effective approaches to addiction therapy. The comprehensive toolbox was created for distribution to nearly 12,000 drug treatment programs in the United States.

The toolbox features NIDA research reports on anabolic steroid abuse, cocaine abuse and addiction, methamphetamine abuse, nicotine addiction, inhalant abuse, and heroin abuse and addiction. Three therapy manuals on the treatment of cocaine addiction are also included. The manuals highlight three approaches to treatment: cognitive-behavioral, community reinforcement plus vouchers and individual counseling.

The toolbox contains information on approaches to drug abuse counseling, principles of drug addiction treatment, a catalog of NIDA publications and a chart listing commonly abused drugs. As additional reports and materials are developed, they can be added to the toolbox.

The NIDA Clinical Toolbox is available for a small shipping fee by calling the National Clearinghouse for Drug and Alcohol Information at 800-729-6686. The publications included in the toolbox are also available online athttp://www.drugabuse.gov.