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

• Published in: The international journal of neuropsychopharmacology Vol. 8; no. 2; pp. 215 - 221
• Main Authors: Murck, Harald, Fava, Maurizio, Alpert, Jonathan, Nierenberg, Andrew A., Mischoulon, David, Otto, Michael W., Zajecka, John, Mannel, Marcus, Rosenbaum, Jerrold F.
• Format: Journal Article
• Language: English
• Published: Cambridge, UK Cambridge University Press 01.06.2005; Oxford University Press
• Subjects: Analysis of Variance; Depressive Disorder, Major - drug therapy; Depressive Disorder, Major - physiopathology; Double-Blind Method; Fluoxetine - therapeutic use; Humans; Hypericum; Phytotherapy; Placebos - therapeutic use; Plant Extracts - therapeutic use; Psychiatric Status Rating Scales; Time Factors; Treatment Outcome; Atypical depression; reversed vegetative signs; major depression; St. John's wort
• ISSN: 1461-1457; 1469-5111
• DOI: 10.1017/S1461145704004717

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 χ2 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.