title: Effectiveness of St John's wort in major depression: a randomized controlled trial.
abstract: BACKGROUND
  Extracts of St John's wort are widely used to treat depression. Although more than 2 dozen clinical trials have been conducted with St John's wort, most have significant flaws in design and do not enable meaningful interpretation.
  
  
  OBJECTIVE
  To compare the efficacy and safety of a standardized extract of St John's wort with placebo in outpatients with major depression.
  
  
  METHODS
  Randomized, double-blind, placebo-controlled clinical trial conducted between November 1998 and January 2000 in 11 academic medical centers in the United States.
  
  
  METHODS
  Two hundred adult outpatients (mean age, 42.4 years; 67.0% female; 85.9% white) diagnosed as having major depression and having a baseline Hamilton Rating Scale for Depression (HAM-D) score of at least 20.
  
  
  METHODS
  Participants completed a 1-week, single-blind run-in of placebo, then were randomly assigned to receive either St John's wort extract (n = 98; 900 mg/d for 4 weeks, increased to 1200 mg/d in the absence of an adequate response thereafter) or placebo (n = 102) for 8 weeks.
  
  
  METHODS
  The primary outcome measure was rate of change on the HAM-D over the treatment period. Secondary measures included the Beck Depression Inventory (BDI), Hamilton Rating Scale for Anxiety (HAM-A), the Global Assessment of Function (GAF) scale, and the Clinical Global Impression-Severity and -Improvement scales (CGI-S and CGI-I).
  
  
  RESULTS
  The random coefficient analyses for the HAM-D, HAM-A, CGI-S, and CGI-I all showed significant effects for time but not for treatment or time-by-treatment interaction (for HAM-D scores, P<.001, P =.16, and P =.58, respectively). Analysis of covariance showed nonsignificant effects for BDI and GAF scores. The proportion of participants achieving an a priori definition of response did not differ between groups. The number reaching remission of illness was significantly higher with St John's wort than with placebo (P =.02), but the rates were very low in the full intention-to-treat analysis (14/98 [14.3%] vs 5/102 [4.9%], respectively). St John's wort was safe and well tolerated. Headache was the only adverse event that occurred with greater frequency with St John's wort than placebo (39/95 [41%] vs 25/100 [25%], respectively).
  
  
  CONCLUSIONS
  In this study, St John's wort was not effective for treatment of major depression.
authors: Department of Psychiatry, Vanderbilt University, Nashville Tennessee, USA. richard.shelton@mcmail.vanderbilt.edu
authors: R C
authors: RC
authors: Shelton
authors: M B
authors: MB
authors: Keller
authors: A
authors: A
authors: Gelenberg
authors: D L
authors: DL
authors: Dunner
authors: R
authors: R
authors: Hirschfeld
authors: M E
authors: ME
authors: Thase
authors: J
authors: J
authors: Russell
authors: R B
authors: RB
authors: Lydiard
authors: P
authors: P
authors: Crits-Cristoph
authors: R
authors: R
authors: Gallop
authors: L
authors: L
authors: Todd
authors: D
authors: D
authors: Hellerstein
authors: P
authors: P
authors: Goodnick
authors: G
authors: G
authors: Keitner
authors: S M
authors: SM
authors: Stahl
authors: U
authors: U
authors: Halbreich
mesh_terms: D000328:Adult; D003865:Major Depressive Disorder / Q000175:diagnosis / Q000188:drug therapy*; D004311:Double-Blind Method; D005260:Female; D006801:Humans; D020902:Hypericum; D008297:Male; D008875:Middle Aged; D008517:Phytotherapy; D010936:Plant Extracts / Q000627:therapeutic use; D010946:Plants, Medicinal; D011569:Psychiatric Status Rating Scales; D012044:Regression Analysis
chemical_list: D010936:Plant Extracts