St. John’s Wort: NIH study failed On 10th April, 2002, the American medical journal JAMA (287: 1840 – 47) published a controlled clinical study with St. John’s Wort extract. In the following, the members of the “St. John’s Wort” International Consensus Conference comment on the published data.
The authors treated 340 patients with moderately severe depression for eight weekswith placebo, 900 to 1500 mg St. John’s Wort (LI160) or 50 to 100 mg sertraline(Zoloftâ). The aim of this study was to confirm the efficacy of the therapy by means
of changes in the Hamilton scale (HAMD) and – as secondary parameter – with thehelp of the clinical global impression (CGI). At the end of the study, neither thechanges in HAMD nor in the CGI showed a significant difference between patientstreated with placebo, sertraline or St. John’s Wort. How can these results be interpreted?
To begin with, it should be stated that the improvement in the placebo patients of 31percent corresponds with the general results of other studies. In an analysis of 75studies this was 29.7 percent (Journal for Phytotherapy 2002; 23: 11-15). Undersertraline – a wel -documented so-called SSRI – the condition had improved in only24.8 percent of patients, under St. John’s Wort (LI160) an improvement occurred in23.9 percent. Since no differences were obtained between the three very differenttreatment alternatives in this study, only one conclusion may be drawn: It is notsuitable for evaluating the efficacy of either sertraline or St. John’s Wort.
With the clinical picture of depression, it is not unusual that studies are withouttangible results. Due to the important role that caring plays for these patients, it isoften the case that additional effects of the medication cannot be statisticallydemonstrated. For this reason, careful y performed meta-analyses are particularlyimportant, especially in the evaluation of the efficacy of a therapy for depression, asthe individual results are thereby placed in a larger context.
The study is a failure, it could document the efficacy of neither the standardantidepressant sertraline nor St. John’s Wort. It is unfortunate that a study which cost4 million dollars produced such disappointing results. However, these high researchcosts should not induce one to attach an importance to the data which is not justifiedby objective standards. This study does not call the proven efficacy of sertraline norof St. John’s Wort extracts into question.
Prof. Siegfried KasperDepartment of General Psychiatry,University of Vienna, Vienna, Austria
Prof. Walter E. MüllerDepartment of Pharmacology, Biocenter Niederursel,University of Frankfurt, Frankfurt/Main, Germany
Prof. Ivar RootsInstitut for clinical Pharmacology and ToxicologyUniversity Hostpital CharitéBerlin, Germany
Prof. Hilke WinterhoffInstitute of PharmacologyUniversity of Münster, Germany
Source: Komitee Forschung Naturmedizin KFN 7/2002
The complete text of the English publication in the journal JAMA can be found under:
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