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RESEARCHERS TAKE ISSUE WITH
ST. JOHN'S WORT STUDY

A new study examining the efficacy of a popular, natural anti-depressant in treating serious depression has thrown the media into a frenzy. "St. John's Wort is Ineffective" appeared on the Associated Press (AP) wire, while ABCnews.com reported "St. John's Wort, Like a Sugar Pill." However, the herb has repeatedly been proven to treat mild-to-moderate depression in previous studies.

According to research published in the April 17 Journal of the American Medical Association (JAMA) (285, 15:1978-86, 2001), St. John's wort appeared to have no significant effect on patients with severe depression. The study, conducted between November 1998 and January 2000 throughout 11 U.S. academic medical centers, looked at 200 adult outpatients in an eight-week, randomized, double blind, placebo-controlled clinical trial. After all were diagnosed with having major depression, 98 were randomly given 900 mg/d of St. John's wort extract for four weeks and 1,200 mg/d for the remaining four weeks; the other 102 patients received a placebo.

The researchers used various scales to rate depression and anxiety in this study: the Hamilton Rating Scale for Depression (HAM-D) and Anxiety (HAM-A), the Beck Depression Inventory (BDI) the Global Assessment of Function (GAF) scale, and the Clinical Global Impression-Severity and -Improvement (CGI-S and CGI-I) scales.

The researchers, led by Richard Shelton at Vanderbilt University, found that the response rates to the treatments were not significantly different (26.5 percent for the St. John's wort takers compared to 18.6 percent of the placebo group). Headaches were the only adverse events, with more experienced in the herbally supplemented group (41 percent) than the placebo group (25 percent). "The results of this study suggest that persons with significant major depression should not be treated with St. John's wort, given the morbidity and mortality risks of untreated or ineffectively treated major depression," the authors noted. However, the researchers stated that St. John's wort might be a more efficacious treatment for people who commonly use alternative medicine therapies, who may experience more of a benefit.

"This finding [that St. John's wort is ineffective for severe depression] is interesting," said Joseph Betz, vice president of scientific and technical affairs at the American Herbal Products Association (AHPA). "But the study's authors are trying to make waves. If they weren't trying to make waves, they would have just quietly published this study and let it go."

Betz added that the study compares apples with oranges. "St. John's wort isn't intended for major depression," he stated. "No one has looked at its effects on major depression until this study. All of the clinical trials show that St. John's wort is effective in cases of mild to moderate depression."

Other industry organizations agree. In a press release issued by the Council for Responsible Nutrition (CRN), John Cordaro, the president and chief executive officer, stated, "[T]his study will confuse consumers who responsibly use St. John's wort for mild depression. Consumers wouldn't use a throat lozenge for strep throat, but that same lozenge might be just right for a scratchy throat from ... a cold."

Also of concern is an editor's note that accompanied the study that stated that Pfizer participated in the design and preparation of the study. "People seem to be under the impression that this is a Pfizer study, and it is not," said Celeste Torello, manager of pharmaceutical communications at Pfizer. "Pfizer provided an unrestricted educational grant to Dr. Shelton to do with as he pleased." The study was also funded in part by the National Institute of Mental Health. Torello also stated that, contrary to what was stated by the editor's note, Pfizer did not participate in the design of the study.

In addition, the editor's note stated that not only is Pfizer Inc. a manufacturer of prescription antidepressants (Zoloft), but also a maker of St. John's wort extract (after acquiring Warner-Lambert last year). However, according to Torello, the company no longer makes an over-the-counter herbal product line.

Written by: Journal of the American Medical Association (JAMA)


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