Bethesda, MD--The National Institutes of Health (NIH) is launching the first U.S. clinical trial of St. John's wort, an herb widely used in Europe to treat depression.
The three-year study, sponsored by NIH's Office of Alternative Medicine (OAM), the National Institute of Mental Health (NIMH) and the Office of Dietary Supplements (ODS), will include 336 patients with major depression who will be randomly assigned to one of three treatment arms for an eight-week trial. One-third of the patients will receive a uniform dose of St. John's wort, another third will be given placebo, and the final third will take a selective serotonin reuptake inhibitor (SSRI), a type of antidepressant commonly prescribed for depression.
"This study will give us definitive answers about whether St. John's wort works for clinical depression," said NIMH Director Steven E. Hyman, M.D. "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." "The compilation of research done thus far, although encouraging, still leaves some unanswered questions about exactly how the herb works," said Wayne B. Jonas, M.D., director of OAM, which is funding the study. "The interest and collaboration among these three NIH components in this clinical trial will provide the scientific expertise and clinical guidance to rigorously investigate this herb's benefit or risk in the treatment of depression."
In Germany, where physicians routinely prescribe herbs for a variety of medical illnesses, millions of doses of St. John's wort, known also by its botanical name, Hypericum perforatum, are used daily. However, no studies of long-term use have been conducted and published studies have used several different doses.
This study will use a standardized preparation containing a 900 mg daily dose of the herb. In addition, study participants who respond positively will be followed for another 18 weeks. The goal of the followup is to determine if patients given St. John's wort have fewer relapses than patients given placebo.
Depression, a brain disorder that affects more than 17 million adult Americans each year, costs the nation up to $44 billion in treatment, disability, and lost productivity-a figure comparable to the cost of heart disease. Worldwide, depression is also a leading cause of disability. The illness, often chronic or recurrent, affects mood, thoughts, body and behavior. Common symptoms include sadness, loss of interests, decreased energy, disturbed sleep and hopelessness. When severe, depression can lead to suicide.
"Depression is a serious and sometimes fatal medical illness and we must be sure that the treatments people receive have been proven to be effective," said Dr. Hyman.
An overview of 23 clinical studies in Europe, published August 3, 1996, in the British Medical Journal, found that the herb may be useful in cases of mild to moderate depression. The NIH study will examine patients with the moderate form of the disorder.
NIH officials said the clinical trial will be coordinated by Jonathan Davidson, M.D., at Duke University Medical Center, which has received a three-year contract to conduct the $4.3 million study. Patient enrollment is expected to start next spring.
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The National Institute of Mental Health's mission is to conduct and support research on mental illnesses and mental health, including studies of the brain, behavior, and mental disorders. For information, call NIMH (301) 443-4536 or visit the NIMH Website at http://www.nimh.nih.gov.
The Office of Alternative Medicine's mission is to identify and evaluate unconventional health care practices. The Office supports, coordinates and conducts research and research training on these practices and disseminates information. For information, call OAM Clearinghouse 1-888-644-6226 or visit the OAM website at http://altmed.od.nih.gov.
The Office of Dietary Supplements's mission is to explore the potential role of dietary supplements to improve health care. The ODS promotes the scientific study of dietary supplements through conducting and coordinating scientific research and compiling and disseminating research results. Watch for the new ODS website in late Fall at http://dietary-supplements.info.nih.gov. For more information call ODS: 301-435-2920.
The National Institutes of Health is an agency of the U.S. Department of Health and Human Services.