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762 S. Kasper et al. terms of tolerability and compliance (Linde et al., 2008; Rahimi et al., 2009). 6. Drug interactions with Hypericum extract Several systematic reviews have examined the published literature on Hypericum extract-mediated drug interactions (Henderson et al., 2002; Izzo, 2004; Mills et al., 2004; Whitten et al., 2006). Izzo (2004) published a review of the clinical evidence related to drug interactions with Hypericum extracts which pulls together many small studies and case reports. Interactions of clinical relevance often relate to the potential of Hypericum extracts for inducing cytochrome P450 enzymes (particularly CYP 3A4) and also increasing expression of Pglycoprotein (Pgp). Current evidence suggests that these effects can be due to hyperforin, one of the main constituents of Hypericum extract, which increases the expression of the pregnane X receptor, and then induces Pgp expression as well as CYP 3A4 activity (Moore et al., 2000). Moreover pharmacodynamic interactions have been described between Hypericum extract and other antidepressants (e.g. serotonin reuptake inhibitors such as paroxetine and sertraline) with the possible occurrence of a serotonin syndrome (Zhou and Lai, 2008). Izzo (2004) have reviewed the data relating to interactions with oral contraceptives (OCs); several cases have been reported in which women have had breakthrough bleeding while taking Hypericum extract with OCs. In two open-label post-marketing surveillance studies (Hall et al., 2003; Pfrunder et al., 2003) of concomitant OC and Hypericum extract use over 3 months, there was no loss of contraceptive control; endogenous hormone levels showed an absence of ovulation in all patients taking Hypericum extract throughout the study period. A systematic review was conducted by Whitten et al. (2006) to examine the quality and outcomes of clinical trials analyzing the effect of St. John's wort extracts on the metabolism of drugs by CYP3A. All of the 19 studies that used high-dose hyperforin extracts (N10 mg =day) had outcomes consistent with CYP3A induction, while the three studies using low-dose hyperforin extracts (b4 mg=day) demonstrated no significant effect on CYP3A (Whitten et al., 2006). 7. Conclusion Whether examined individually or combined in quantitative meta-analyses, the results of numerous clinical studies strongly support the effectiveness of some Hypericum extracts for the treatment of mild to moderate depression. Study methodology and quality of reporting have increased in recent years, which should make prescribers and patients more confident in choosing Hypericum extract over conventional antidepressants. Although a small number of comparative trials have shown Hypericum extract to be effective in severe depression, the majority do not support this view, and, therefore, weighing current evidence, Hypericum extract is not recommended for patients with severe depression. There is some evidence that Hypericum extract is effective in controlling symptoms in patients with disorders associated with or related to depression such as anxiety (Muller et al., 2003), somatoform disorders (Muller et al., 2004; Volz et al., 2002; Woelk, 2000), and obsessive compulsive disorder (Taylor and Kobak, 2000). Overall, current evidence appears to support the efficacy of Hypericum extract for the treatment of mild to moderate depression; meta-analyses of clinical trials suggest that Hypericum extract is significantly more effective than placebo and at least as effective as standard antidepressants. Those extracts which demonstrate efficacy in clinical trials can and should be recommended for the treatment of mild to moderate depression. Based on our review of individual clinical trials, WS 5572, LI 160, WS 5570 and ZE 117 Hypericum extracts have been shown to be significantly more effective than placebo with similar efficacy to standard antidepressants. Initial studies of extracts LoHyp-57, psychotonin, calmigen, Swiss Herbal Remedies, STW3, STEI 300 and esbericum have produced promising results but further clinical data are needed to confirm their effectiveness in mild to moderate depression. Considering the favourable safety profile of all extracts studied (equivalent to placebo and better tolerated than standard antidepressants), which also correlated with a lower frequency of dropouts in clinical studies than seen with standard antidepressants, Hypericum extract is a valid therapeutic approach in patients with mild to moderate depression. For these patients, for whom adverse effects of treatment may be difficult to accept, Hypericum extracts provide a high rate of pharmacological compliance. They provide an effective and well tolerated alternative to standard tricyclic and SSRI antidepressants and are advocated for first line therapy of mild to moderate depression. Role of the funding source This study was not supported by external funding. Contributors All authors have been actively involved in the construction of the paper from the outset and have had full editorial control over its content. Conflict of interest Siegfreid Kasper has received grant/research support from Eli Lilly, Lundbeck, Bristol-Myers Squibb, GlaxoSmithKline, Organon, Sepracor and Servier; has served as a consultant or on advisory boards for AstraZeneca, Bristol-Myers Squibb, GlaxoSmithKline, Eli Lilly, Lundbeck, Pfizer, Organon, Schwabe, Sepracor, Servier, Janssen, and Novartis; and has served on speakers' bureaus for AstraZeneca, Eli Lilly, Lundbeck, Schwabe, Sepracor, Servier and Janssen. Filippo Caraci has received grants or honoraria as a consultant from Eli Lilly, Janssen, and Innova Pharma. Bruno Forti and Eugenio Aguglia declare that they have no conflict of interests. Filippo Drago has served as a consultant or on advisory boards for Eli Lilly, GlaxoSmithKline, AstraZeneca, Novartis, Pfizer, SIFI, Amdipharm, Grunenthal.
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