Bethesda, MD--The National Institutes of Health (NIH) is launching the firstU.S. clinical trial of St. John's wort, an herb widely used in Europe to treatdepression.
The three-year study, sponsored by NIH's Office of Alternative Medicine (OAM),the National Institute of Mental Health (NIMH) and the Office of DietarySupplements (ODS), will include 336 patients with major depression who will berandomly 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 selectiveserotonin reuptake inhibitor (SSRI), a type of antidepressant commonlyprescribed for depression.
"This study will give us definitive answers about whether St. John's wort worksfor clinical depression," said NIMH Director Steven E. Hyman, M.D. "The studywill be the first rigorous clinical trial of the herb that will be large enoughand long enough to fully assess whether it produces a therapeutic effect.""The compilation of research done thus far, although encouraging, still leavessome unanswered questions about exactly how the herb works," said Wayne B.Jonas, M.D., director of OAM, which is funding the study. "The interest andcollaboration among these three NIH components in this clinical trial willprovide the scientific expertise and clinical guidance to rigorously investigatethis herb's benefit or risk in the treatment of depression."
In Germany, where physicians routinely prescribe herbs for a variety of medicalillnesses, millions of doses of St. John's wort, known also by its botanicalname, Hypericum perforatum, are used daily. However, no studies of long-termuse have been conducted and published studies have used several different doses.
This study will use a standardized preparation containing a 900 mg daily doseof the herb. In addition, study participants who respond positively will befollowed for another 18 weeks. The goal of the followup is to determine ifpatients given St. John's wort have fewer relapses than patients given placebo.
Depression, a brain disorder that affects more than 17 million adult Americanseach year, costs the nation up to $44 billion in treatment, disability, and lostproductivity-a figure comparable to the cost of heart disease. Worldwide,depression is also a leading cause of disability. The illness, often chronic orrecurrent, affects mood, thoughts, body and behavior. Common symptoms includesadness, 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 surethat 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 theBritish Medical Journal, found that the herb may be useful in cases of mild tomoderate depression. The NIH study will examine patients with the moderate formof 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-yearcontract to conduct the $4.3 million study. Patient enrollment is expected tostart next spring.
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The National Institute of Mental Health's mission is to conduct and supportresearch on mental illnesses and mental health, including studies of the brain,behavior, and mental disorders. For information, call NIMH (301) 443-4536 orvisit the NIMH Website at http://www.nimh.nih.gov.
The Office of Alternative Medicine's mission is to identify and evaluateunconventional health care practices. The Office supports, coordinates andconducts research and research training on these practices and disseminatesinformation. For information, call OAM Clearinghouse 1-888-644-6226 or visitthe OAM website at http://altmed.od.nih.gov.
The Office of Dietary Supplements's mission is to explore the potential role ofdietary supplements to improve health care. The ODS promotes the scientificstudy of dietary supplements through conducting and coordinating scientificresearch and compiling and disseminating research results. Watch for the newODS website in late Fall at http://dietary-supplements.info.nih.gov. For moreinformation call ODS: 301-435-2920.
The National Institutes of Health is an agency of the U.S. Department of Healthand Human Services.
Materials provided by NIH-National Institute of Mental Health. Note: Content may be edited for style and length.
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