Hypericum extract in patients with MDD and reversed vegetative signs: re-analysis from data of a double-blind, randomized trial of hypericum extract, fluoxetine, and placebo

Abstract

Hypericum extract (HE) might be favourably active in depressed patients with reversed vegetative signs (RVS). Therefore, we performed an exploratory subgroup analysis of a three-armed study to compare HE, fluoxetine, and placebo in patients with major depressive disorder (MDD) in a 12 wk trial. A total of 135 patients were randomized to 12 wk treatment with HE LI 160 (900 mg/d), fluoxetine (20 mg/d), or placebo. Patients with RVS were defined in two steps, according to DSM-IV. First, patients with melancholy-related vegetative signs were excluded. Secondly, patients had to have at least one score of 2 for the items 22-26 of the HAMD-28 scale, which are related to hypersomnia and hyperphagia. Twenty-seven patients remained in the group. Analysis of covariance (ANCOVA) was applied using the HAMD-17 score. Secondly a chi2 test for response was performed, using the same and further an adapted criterium as in recently published studies. ANCOVA revealed a trend to a global difference. Post-hoc analysis showed a trend to superiority of HE compared to placebo and to fluoxetine, but a very large effect size for both differences. Fluoxetine was not different from placebo. The adapted response criterium showed a significant global difference as well as a significant superiority of HE over placebo and over fluoxetine. These data are based on a small sample size and must be considered tentative. A characterization of vegetative features of patients with depression could lead to an overall increased effect size in the treatment with HE.

Clinical efficacy and safety of the Shugan Jieyu capsule in patients with acute myocardial infarction and depression

“…21,22 Many foreign studies on Hypericum perforatum extract showed that the drug has an antidepressant effect and is especially suitable for patients with mild-to-moderate depression. 23–30 Consistently, our study proved the Shugan Jieyu capsule has a definite curative effect in treatment of acute MI patients with depression.…”

Atypical depression spectrum disorder – neurobiology and treatment

“…A study in patients with mild to moderate depression comparing the effect of hypericum extract LI 160 with fluoxetine and placebo (48) found a significant superiority of hypericum compared with fluoxetine and a trend to a superiority compared with placebo. Interestingly, a subgroup analysis including patients with reversed vegetative signs, but after the exclusion of melancholic features, found the same pattern in this subgroup with a much more pronounced effect size, but no efficacy of any drug compared with placebo in the non‐atypical patients (49). Open studies demonstrated the efficacy of hypericum in seasonal affective disorder (SAD) (50–52), which is a subgroup of AD with fatigue as one main symptom.…”

Herbal medicines in the treatment of psychiatric disorders: a systematic review

“…Four studies demonstrated that SJW had similar (Behnke et al, 2002;Bjerkenstedt et al, 2005) or superior Schrader, 2000) effects to fluoxetine. An analysis of the sub-sample of a 12-week 3-arm study discovered that SJW (LI 160 900 mg/day) ameliorated depression-based vegetative presentations, while fluoxetine (20 mg/day) was statistically equivalent to placebo (Murck et al, 2005). A 2006 study found lower remission rates for SJW in comparison with fluoxetine, although intention-to-treat analysis (ITT) showed no difference between the groups (Moreno et al, 2006).…”