|Date: December 15, 2005||HC# 050253-294|
Re: Safety and Efficacy of Long-term Use of Hypericum Extract STW3
Gastpar M, Singer A, Zeller K. Efficacy and tolerability of Herpicum extract STW3 in long-term treatment with a once-daily dosage in comparison with sertraline. Pharmacopsychiatry. 2005;38:78-86.
Depression is one of the most common psychiatric disorders treated by general practitioners. An estimated 17% of the general European population suffers from depression; however, only 31% of this population receives prescription drugs for this disorder. Despite the proven efficacy of serotonin reuptake inhibitors (SSRIs) in treating depression, as many as 30% of those patients who take SSRIs stop treatment because they experience adverse side effects, such as sexual dysfunction, insomnia, nausea, and vomiting. Thus, there is an obvious need of antidepressants with fewer side effects in order to provide better outcomes for persons with depression. Hypericum extract, derived from St. John's wort (Hypericum perforatum), is one such alternative in the treatment of mild to moderate depression. The safety and efficacy of certain hypericum extracts in treating depression has been confirmed by the World Health Organization and other scientific organizations when used according to recommended instructions. The objective of this study was to determine the efficacy of hypericum extract STW3 relative to sertraline, a commonly prescribed SSRI for treatment of depression.
Men and women with moderate depression were enrolled in this double-blind, randomized, multi-center phase III study, which was conducted at the offices of 21 primary care physicians between July 2000 and April 2001 in Germany. The patients were randomly assigned to receive a once-daily dose of either 612 mg hypericum extract STW3 (n = 123; Laif 600; Steigerwald Arzneimittelwerk GmbH, Germany) or 50 mg sertraline (n = 118; Zoloft; Pfizer, United States) for 12 weeks. After 12 weeks, treatment continued at the same dosage for an additional 12 weeks in those patients in whom it was deemed necessary by the investigators. Three rating scales were used to evaluate depression during the study: the Hamilton Depression Scale (HAMD), Von Zerssen's Adjective Mood Scale (BfS), and Clinical Global Impression (CGI). Patient compliance was monitored by counting the number of returned pills at the designated visits.
The HAMD showed improvements in depression in both study groups after 12 weeks of treatment; scores decreased from 22.0 plus/minus 1.1 points at baseline to 8.3 plus/minus 5.5 points in the hypericum group and from 22.1 plus/minus 1.1 at baseline to 8.1 plus/minus 5.6 points in the sertraline group. Eighty-four percent of the patients in the hypericum group and 81.3% of the patients in the sertraline group were classified as responders (i.e., HAMD score < 10 after treatment or an improvement in the initial HAMD score of at least 50% after treatment). The BfS also showed improvements in depression in both study groups after treatment; scores decreased from 40.5 plus/minus 12.2 points at baseline to 19.8 plus/minus 13.7 points in the hypericum group and from 42.4 plus/minus 12.0 points at baseline to 21.4 plus/minus 16.3 points in the sertraline group. Both the HAMD and BfS showed continued improvements in both study groups after 24 weeks of treatment. Per the CGI, the number of patients considered "moderately, markedly, or severely ill" decreased from 96.0% to 26.4% in the hypericum group and from 96.9% to 34.7% in the sertraline group after 12 weeks of treatment. Adverse effects possibly related to treatment were slightly higher in the sertraline group (13.6%) than in the hypericum group (9.8%). No interactions with other medications taken concomitantly during the study were observed.
The results indicate that a "once-daily dosage of hypericum extract STW3 is therapeutically equivalent to the chemically defined standard antidepressant sertraline" and "may be a beneficial alternative to classic[al] antidepressants in the treatment of outpatients with moderate depression." A single daily dosing regimen offers the advantages of simplicity, better compliance, and minimal side effects, which increase the likelihood of an overall success rate in the treatment of depression.
—Brenda Milot, ELS