St. John's Wort at Least as Effective as Paroxetine in the Treatment of Depression, latest research shows

Main Category: Depression
Article Date: 12 Feb 2005 - 1:00 PDT

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According to latest research, Dr. Willmar Schwabe Pharmaceuticals' proprietary St. John's Wort extract WS® 5570 is at least as effective and better tolerated than standard treatment with prescription antidepressant paroxetine in the treatment of moderate to severe major depression[1]. The randomised, double-blind, reference-controlled, multicentre Phase III clinical trial investigated the antidepressant efficacy of WS® 5570 and paroxetine in 251 patients with acute major depression and was published online in the British Medical Journal (http://bmj.bmjjournals.com/) today.

Depression is the most common mental disorder worldwide. It is estimated that 5.8% of men and 9.5% of women will experience a depressive episode in any given year. The lifetime risk of developing major depression is 10 - 25% for women and 5 - 12% for men. Globally, around 120 million people suffer from depression[2].

In the new study, 251 patients with moderate to severe forms of depression were divided into two groups: one receiving 900 mg/day of WS® 5570, and the other 20 mg/day of paroxetine, for six weeks. Any patients not responding after two weeks had their dose doubled at that time. The higher dose was not associated with any relevant increase in adverse events for either drug.

WS® 5570 produced a significantly better improvement in patients as measured by internationally accepted diagnostics such as the Hamilton Depression Rating Scale (HAMD). When compared to paroxetine, treatment with WS® 5570 shows an average advantage of 3 points for HAMD total score decrease versus baseline. This clinically relevant superiority was additionally supported by a responder rate of 70% versus 60% and a remission rate of 50% versus 35% for WS® 5570 and paroxetine, respectively. All secondary efficacy measures showed moderate to large advantages in favour of WS® 5570.

WS® 5570 was well tolerated. The average incidence densities were 0.035 adverse events per day of exposure for WS® 5570 and 0.060 for paroxetine so that the adverse event incidence was 71% lower for WS® 5570.

These results are in line with the findings of another recent clinical trial in 375 patients, showing a significant advantage of WS® 5570 over placebo[3].

"This study shows that WS® 5570 is at least equally effective and much better tolerated than one of the leading synthetic antidepressants" says Prof. A. Szegedi, principal investigator of the study and managing senior physician at the Department of Psychiatry and Psychotherapy of the Charité-Universitätsmedizin Berlin. "WS® 5570 therefore represents a real alternative in the treatment of depression."

Paroxetine is a potent SSRI (selective serotonin reuptake inhibitor) with proven efficacy in patients suffering from depression of any severity.

WS® 5570 is a uniquely standardised extract of St. John's Wort. A patent-protected formulation guarantees stability of the active anti-depressive ingredients. WS® 5570 was developed and is produced by Dr. Willmar Schwabe Pharmaceuticals, Karlsruhe, Germany, the leading research-based phytomedicine company worldwide.

Contact:
Dr. Willmar Schwabe Pharmaceuticals
Willmar-Schwabe-Str. 4
76227 Karlsruhe

Dr. Jochen Muehlhoff
Email: jochen.muehlhoff@schwabe.de

[1] Szegedi A, Kohnen R, Dienel A, Kieser M. Acute treatment of moderate to severe depression with hypericum extract WS 5570 (St John's wort): randomised controlled double blind non-inferiority trial versus paroxetine. BMJ, doi:10.1136/bmj.38356.655266.82 (published 11 February 2005).

[2] The World health report 2001: Mental health: new understanding, new hope; World Health Organization, 2001.

[3] Lecrubier Y, Clerc G, Didi R, Kieser M: "Efficacy of St. John's Wort Extract WS 5570 in Major Depression: A Double-Blind, Placebo-Controlled Trial", American Journal of Psychiatry 2002 (159/8): 1361-1366.

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