DATE: Friday, October 3, 1997 TAG: 9710030646 SECTION: LOCAL PAGE: B3 EDITION: NORTH CAROLINA SOURCE: ASSOCIATED PRESS DATELINE: DURHAM LENGTH: 57 lines
A small plant with yellow flowers and a strange name will undergo the first U.S. clinical trials to determine its effectiveness for treating depression.
Duke University announced Wednesday that it will conduct the three-year study of Saint Johnswort, which has grown so popular in Europe that the herb is the leading antidepressant treatment in Germany. Duke has received a $4.3 million grant from the National Institutes of Health for the work.
``The study will be the first rigorous clinical trial of the herb that will be large enough and long enough to fully assess whether it produces a therapeutic effect,'' said Dr. Steven Hyman, director of the National Institute of Mental Health.
Duke will work with 336 patients across the country suffering major depression to determine the herb's safety and effectiveness.
``The clinical trials done in Europe have all been small,'' said Dr. Robert Califf, director of Duke's clinical research institute. ``They look promising, but the information is not up to the standards we require to put something on the market as a drug.''
For several years in Germany, the herb has far outsold the antidepressant drug Prozac as a treatment.
About a year ago the British Medical Journal published a review of 23 controlled studies of depressed patients. In that analysis, researchers from the United States and Germany found that Saint Johnswort worked nearly three times better than a placebo.
Despite the promising studies, researchers still know little about the herb's active ingredients or how it works. They also aren't sure whether Saint Johnswort can help the severely depressed or whether it is safe for long-term use.
The NIH said depression affects more than 17 million adult Americans each year.
The three-year study is sponsored by the NIH's Office of Alternative Medicine, the National Institute of Mental Health and the Office of Dietary Supplements.
Patients will be randomly assigned to one of three treatments for an eight-week trial. One-third will receive Saint Johnswort, another third a sugar pill and the rest antidepressants commonly prescribed for depression.
This study calls for a 900-milligram dose of the herb daily. Study participants who respond positively will be followed for another 18 weeks.
The goal of the follow-up is to determine whether patients given Saint Johnswort have fewer relapses than patients given the placebo.
Advocates report that millions of Germans have used the herb extensively without any reported deaths. One side effect that some patients have noted is a heightened sensitivity to sunlight.
``Very few alternative medicines have reached such a high level of interest,'' said Dr. Ranga Krishnan, a Duke psychiatry professor who will work with Dr. Jonathan Davidson, the project's lead coordinator. ``The time has come to take a closer look to see if it is effective and safe, and how it compares to standard antidepressants. In reality, we really don't know how well it works.''
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