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Sugar Pill is Better and St. John’s Wort as good as Zoloft
The April 10, 2002 issue of JAMA, Vol. 287 No. 14, reported on a study conducted to determine the efficacy of St. John’s Wort (Hypericum perforatum) in major depressive disorder. The study was a double blind, randomized, placebo-controlled trial conducted in 12 academic and community psychiatric research clinics in the United States. Patients were randomly assigned to receive H perforatum, placebo, or sertraline (Zoloft – as an active comparator) for 8 weeks. Based on clinical response, the daily dose of H perforatum could range from 900 to 1500 mg and that of sertraline from 50 to 100 mg. Responders at week 8 could continue blinded treatment for another 18 weeks.
The findings of the study reported that “Full response occurred in 31.9% of the placebo-treated patients vs 23.9% of the (St. John’s Wort) H perforatum-treated patients and 24.8% of (Zoloft) sertraline-treated patients.”
However, the conclusion of the study failed to mention that Zoloft was used in the study, and simply stated that St. John’s Wort was ineffective.
In a communication to several FDA officials, the Alliance for Human Research Protection (AHRP) questioned the motives behind the researchers’ failure to mention in the conclusion that not only was Zoloft part of the trial, but was also found to be less effective than the placebo – and only slightly more effective than St. John’s Wort.
According to the AHRP, this omission in the conclusion is especially suspect since the authors of the study also acknowledged that “An increasing number of studies have failed to show a difference between active antidepressants and placebo. Many of the presumed factors underlying this phenomenon were carefully attended to in this study, e.g., adherence to quality control by rater training, treatment adherence monitoring, inclusion of experienced investigators, and carefully defined entry criteria. Despite all of this, Zoloft failed to separate from placebo on the 2 primary outcome measures.”
Seattle psychiatrist Arif Khan, who has studied the placebo effect in trials submitted to the FDA, conducted an analysis of 96 antidepressant trials between 1979 and 1996. He analyzed trials that were made public in the medical literature, which tend to show positive results, and those that were not. The results showed that in 52 percent of the studies, the effect of the antidepressant could not be distinguished from that of the placebo. Khan said the makers of Prozac had to run five trials to obtain two that were positive, and the makers of Paxil and Zoloft had to run even more.
Additionally, it has been found that the placebos affect parts of the brain in a manner similar to selective serotonin reuptake inhibitors (SSRIs). Andrew Leuchter, a professor of psychiatry at UCLA, published a study in the American Journal of Psychiatry (January 2002) in which he tracked some of the brain changes associated with drugs such as Prozac and Effexor. When Leuchter compared the brain changes on placebos, he found that many of the patients had changes in the same parts of the brain that are thought to control important facets of mood.
Thomas Laughren, who heads the group of scientists at the FDA that evaluates these drugs, recently commented on these issues in the article entitled “Against Depression, a Sugar Pill Is Hard to Beat”, published in the Washington Post on May 7, 2002. “It speaks to the difficulty we have in classifying and identifying the disorders we deal with,” said Mr. Laughren. “Psychiatric diagnosis is descriptive. We don’t really understand psychiatric disorders at a biological level.”
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