| PDF (Download) | DepressionSt. John's Wort (Hypericum perforatum)WS(r) 5570/5572 | | Date: October 13, 2006 | HC# 030566-314 |
Re: Study Shows That Early Improvement Predicts Therapeutic Response in Depression Patients Treated with Hypericum Extract
Kielser M, Szegedi A. Predicting stable treatment response in patients with major depression treated with Hypericum extract WS(r) 5570/5572 Pharmacopsychiatry. 2005;38:194-200.
It is a common belief that antidepressant drugs have a delayed onset of action and could take one month or more for effects to become apparent. In other words, one month of treatment is required until it could be determined that a patient is a responder or non-responder to the particular antidepressant. More recently, data has emerged indicating that an improvement in depression observed within the first two weeks of treatment could predict the final treatment response. People who did not have a 20% improvement on the Hamilton depression (HAM-D) rating scale at two weeks of treatment also did not show response after waiting for a delayed onset of action. This finding, which has been shown for various synthetic antidepressants, has initiated re-analyses and meta-analyses of previously published data. The purpose of this study was to evaluate whether early improvement can predict the therapeutic response or non-response to antidepressant treatment with St John's wort (SJW, Hypericum perforatum) extracts WS®5570/5572.
This study included the original patient data from three previously published double-blind, randomized, placebo-controlled trials. The three studies used similar protocols. The studies used standardized SJW extracts: WS5570 (drug-extract ratio 3-7:1, 3-6% hyperforin), WS5572 (drug-extract ratio 2.5-5:1, 5% hyperforin¬), WS5573 (drug-extract ratio 2.5-5:1, 0.5% hyperforin) (Dr. Willmar Schwabe Pharmaceuticals, Karlsruhe, Germany). The patients were evaluated with the HAM-D scales at baseline, and after 7, 14, 28, and 42 days of randomized treatment. The data were reanalyzed separately and the data from the studies using WS5570 and WS5572 were pooled. The pooling of the data was considered appropriate because of the very similar patient selection criteria, treatment, and assessment schedules.
Data from a total of 594 patients with mild to moderate depression was reanalyzed. Patients with at least a 20% improvement at 2 weeks were predicted to become sustained responders rather than transient responders. For the SJW extract, 87% of the patients with a sustained response could have been identified early by showing improvement after 2 weeks of treatment. Of the patients who did not have a sustained response, 78% did not have an improvement at day 14. Only 15% of the patients with a sustained response to SJW did not show an improvement by at least 20% by the end of week 2. At one week, only 43% of the sustained responders to SJW had an improvement of at least 20%. Patients taking placebo also improved at week 2 and had a sustained improvement at week 42; however, the proportion of improvers and responders was substantially higher in patients treated with SJW. (A high placebo response is common for most antidepressant trials.) Comparing these findings to those from synthetic pharmaceuticals suggests that SJW is similar to accepted synthetic pharmaceuticals.
The authors conclude that similar to synthetic pharmaceuticals, the presence or absence of an early improvement from SJW can predict the therapeutic outcome. It is important to note that some patients did have a sustained response to SJW even though the response could not be predicted from their 2 –week data. The reverse is true too, some patients showed an improvement at week 2, but the effect was transient. Overall the data show that SJW demonstrates characteristics similar to synthetic antidepressants. The data also indicate that when a physician observes an early 20% improvement in a depressed patient taking SJW, the physician should recommend that SJW treatment be continued because this early effect likely predicts a sustained effect.
—Heather S. Oliff, PhD
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