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News Stories on Human ResearchProtection and April 12, 2002 If Placebo Works Without Risk,Side-Effects or Cost — Why Prescribe Anti-Depressant Drugs? FYI As we reported in yesterday’s Infomail, a major governmentfunded study found that neither Zoloft nor St. John’s wort were any moreeffective than placebo in patients with "moderately severe majordepression." http://jama.ama-assn.org/issues/v287n14/rfull/joc11936.html This finding raises serious questions about why psychiatryclings to drugs as the "treatment of choice" for depression? Sinceplacebo poses no risk and no cost, and research findings have demonstratedrepeatedly that placebo works as well as antidepressants, why do psychiatristsprescribe these expensive drugs despite the serious risks and side-effects? The risks associated with highly prescribedantidepressants (such as Zoloft, Prozac, Paxil, Effexor, Serzone) can be severe:in some patients they induce mania and suicidal thoughts. [See, for example,Thomas J. Moore, author, Prescription for Disaster, 1998 http://www.washingtonian.com/health/hardtoswallow.html See also, David Healy, MD, "Emergence ofantidepressant induced suicidality, Primary Care Psych. 2000, vol6 pp. 25-28] This NIMH-funded study is significant because prominentAmerican researchers (who are funded by pharmaceutical companies) tried hard torefute the 20 German studies showing St. John’s wort to be superior to placeboin mildly depressed patients. The U.S. trial pitted St. John’s and Zoloftagainst placebo in severely depressed patients–although St. John’s was neverclaimed to be effective in this patient population. They found that even in severely depressed patients, theantidepressant drug, Zoloft, was no better than placebo. Although their ownfindings show that neither the drug nor the herb works better than placebo, theinvestigators are not even handed in how they portray their findings the press.They ONLY point to the poor showing of St. John’s to placebo and not to theequally poor showing of the drug, Zoloft. ~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~ Study: Sugar pills offer more relief than St. John’s wort,Zoloft Millions of Americans take St. John’s wort for depression,but a new study questions the herb’s effectiveness. NBC’s Robert Bazell reports.~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~ REUTERS http://story.news.yahoo.com/news?tmpl=story&cid=571&571&e=2&u=/nm/20020409/hl_nm/depression_herb Herb Found Ineffective for Moderate Depression Reuters Health April 9, 2002 Although promoted as an alternative therapy fordepression, the herbal supplement St. John’s wort appears ineffective for peoplewith moderate clinical depression, findings from a US study suggest. In the study of 340 patients diagnosed with moderatedepression, St. John’s wort proved no more effective than inactive treatmentwith a placebo in alleviating symptoms. Active treatment with the antidepressantdrug sertraline (Zoloft) worked somewhat better than placebo, according tofindings published in the April 10th issue of The Journal of the AmericanMedical Association (news – web sites). A body of evidence suggests that St. John’s wort (Hypericumperforatum), used for more than 2,000 years to quell mood problems, does helpsymptoms of depression. In Germany, where many of the positive studies have beenconducted, St. John’s wort is available as a prescription antidepressant. But the quality of much of this research has beencriticized–including the lack of studies using a placebo and a selectiveserotonin reuptake inhibitor (SSRI) like sertraline, according to the authors ofthe new study. SSRIs are a newer class of drugs commonly used to treatdepression. To address these concerns about earlier studies,researchers led by Dr. Jonathan R. T. Davidson of Duke University in Durham,North Carolina, randomly assigned patients to take St. John’s wort, sertralineor placebo for up to 26 weeks. At the study’s end, the researchers found that neither theherb nor the drug was better than placebo in improving patients’ scores on astandard scale of depressive symptoms. Overall, nearly one third of placebopatients showed a full response to treatment, compared with roughly 24% in boththe St. John’s wort and sertraline groups. Patients on sertraline did, however, do better thanplacebo patients on a secondary test used to gauge a person’s daily functioningand levels of distress. The sertraline group also had a higher percentage ofso-called "partial responders" to treatment than either the placebo orSt. John’s wort groups. Still, the findings do not indicate whether the herb canhelp people with mild depressive symptoms–a question additional research willhave to address, Davidson told Reuters Health. St. John’s wort is marketed forthe treatment of mild to moderate depression, but Davidson noted that it’slikely people with a range of depressive disorders try the herb. "If someone is suffering from depression for weeks,they’re much better off going to a healthcare professional…than trying toself-treat," he said. And because St. John’s wort can interact with a range ofdrugs, including some used to treat cancer and HIV (news – web sites), peoplewho do use the herb "should always tell their doctor they’re usingit," Davidson added. As for the findings on sertraline, the researcher saidthat dosing "had a lot to do with" the lack of full response amongpatients on the drug. The study design permitted sertraline to be given only upto half of its highest recommended dose, and fewer patients on the drug hadtheir doses "maximized," compared with those on St. John’s wort orplacebo. Dosing "almost certainly contributed" tosertraline’s less-than-stellar performance in the study, according to anaccompanying editorial by Drs. David J. Kupfer and Ellen Frank of the Universityof Pittsburgh Medical School in Pennsylvania. They also stress that this study–along with a second onein the same journal issue documenting the rise of the "placebo effect"in recent research on depression drugs–highlight the importance of using aplacebo and an active comparison drug in studies of unproven antidepressantagents. The New York-based drug company Pfizer Inc. provided thesertraline for the study, and Lichtwer Pharma of Berlin, Germany, supplied theSt. John’s wort product. Davidson holds stock in Pfizer, and has receivedspeaker fees from both Pfizer and Lichtwer. Co-authors on the study havereceived funding from a number of pharmaceutical companies. The study itself was funded by the US National Institutesof Health. FAIR USE NOTICE: This may contain copyrighted (© )material the use of which has not always been specifically authorized by thecopyright owner. 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