Posted By Clod on May 23, 2012
However, despite all the encouraging news about St. John’s wort, there is also cause for concern. For one thing, the safety and efficacy of this herbal medicine is still in doubt. That’s because, unlike the German system, St. John’s wort is not regulated as a drug in the United States.
Instead, it is classified as a dietary supplement under the Dietary Supplement Health and Education Act of 1994. As such, the Food and Drug Administration does not have the same regulatory authority over St. John’s wort as it does over prescription drugs. Unlike the pharmaceutical industry, manufacturers of herbal remedies can put their products on the market without first obtaining FDA approval of their safety and efficacy.
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Also, despite evidence from European studies, critics point to a lack of data comparing the efficacy of St. John’s wort with clinically proven pharmaceutical antidepressants. To this end, the National Institute of Mental Health is conducting a three-year clinical trial comparing St.
John’s wort to a modern antidepressant drug (containing the same active ingredient as Zoloft) and a placebo.Finally, reports of dangerous drug interactions involving St. John’s wort are beginning to surface in the medical literature. In the Feb. 12, 2012, issue of the Lancet, researchers report that St. John’s wort caused heart transplant rejections in two patients by interacting negatively with Cyclosporin, a transplant rejection medication. Also in February, the National Institutes of Health (NIH) concluded that St. John’s wort significantly diminishes the effectiveness of the anti-retroviral drug indinavir, which is used to treat AIDS.
Aaron Burstein is one of the clinical pharmacokineticists who worked on the NIH study. He says that researchers are still trying to determine exactly how St. John’s wort works on the mind. Older studies, including the German Commission E monograph, classify it as a monoamine oxidase inhibitor, but Burstein said newer research indicates it may “work through serotonin with effects similar to…Prozac or Zoloft.” According to
While questions remain about the safety, effectiveness and mechanism of St. John’s wort, the American Psychiatric Association advises consumers that while St. John’s wort could be a “promising alternative” to conventional antidepressant drugs, it “needs to be subjected to testing that follows rigorous clinical guidelines” before taking its place alongside clinically proven prescription drugs.