PMID- 11308434
OWN - NLM
STAT- MEDLINE
DCOM- 20010510
LR  - 20190701
IS  - 0098-7484 (Print)
IS  - 0098-7484 (Linking)
VI  - 285
IP  - 15
DP  - 2001 Apr 18
TI  - Effectiveness of St John's wort in major depression: a randomized controlled 
      trial.
PG  - 1978-86
AB  - CONTEXT: 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. DESIGN AND 
      SETTING: Randomized, double-blind, placebo-controlled clinical trial conducted 
      between November 1998 and January 2000 in 11 academic medical centers in the 
      United States. PARTICIPANTS: 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. 
      INTERVENTION: 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. MAIN OUTCOME MEASURES: 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). CONCLUSION: In 
      this study, St John's wort was not effective for treatment of major depression.
FAU - Shelton, R C
AU  - Shelton RC
AD  - Department of Psychiatry, Vanderbilt University, Nashville Tennessee, USA. 
      richard.shelton@mcmail.vanderbilt.edu
FAU - Keller, M B
AU  - Keller MB
FAU - Gelenberg, A
AU  - Gelenberg A
FAU - Dunner, D L
AU  - Dunner DL
FAU - Hirschfeld, R
AU  - Hirschfeld R
FAU - Thase, M E
AU  - Thase ME
FAU - Russell, J
AU  - Russell J
FAU - Lydiard, R B
AU  - Lydiard RB
FAU - Crits-Cristoph, P
AU  - Crits-Cristoph P
FAU - Gallop, R
AU  - Gallop R
FAU - Todd, L
AU  - Todd L
FAU - Hellerstein, D
AU  - Hellerstein D
FAU - Goodnick, P
AU  - Goodnick P
FAU - Keitner, G
AU  - Keitner G
FAU - Stahl, S M
AU  - Stahl SM
FAU - Halbreich, U
AU  - Halbreich U
LA  - eng
GR  - U01 MH061590/MH/NIMH NIH HHS/United States
GR  - K24-MH01741/MH/NIMH NIH HHS/United States
PT  - Clinical Trial
PT  - Journal Article
PT  - Multicenter Study
PT  - Randomized Controlled Trial
PT  - Research Support, Non-U.S. Gov't
PT  - Research Support, U.S. Gov't, P.H.S.
PL  - United States
TA  - JAMA
JT  - JAMA
JID - 7501160
RN  - 0 (Plant Extracts)
SB  - IM
CIN - ACP J Club. 2001 Nov-Dec;135(3):103
CIN - JAMA. 2001 Jul 4;286(1):42; author reply 44-5. PMID: 11434815
CIN - JAMA. 2001 Jul 4;286(1):42; author reply 44-5. PMID: 11434816
CIN - JAMA. 2001 Jul 4;286(1):42-3; author reply 44-5. PMID: 11434817
CIN - JAMA. 2001 Jul 4;286(1):43; author reply 44-5. PMID: 11434818
CIN - JAMA. 2001 Jul 4;286(1):43-5. PMID: 11434819
CIN - Evid Based Ment Health. 2002 Feb;5(1):24. PMID: 11915827
MH  - Adult
MH  - Depressive Disorder, Major/diagnosis/*drug therapy
MH  - Double-Blind Method
MH  - Female
MH  - Humans
MH  - *Hypericum
MH  - Male
MH  - Middle Aged
MH  - *Phytotherapy
MH  - Plant Extracts/therapeutic use
MH  - *Plants, Medicinal
MH  - Psychiatric Status Rating Scales
MH  - Regression Analysis
EDAT- 2001/04/20 10:00
MHDA- 2001/05/22 10:01
CRDT- 2001/04/20 10:00
PHST- 2001/04/20 10:00 [pubmed]
PHST- 2001/05/22 10:01 [medline]
PHST- 2001/04/20 10:00 [entrez]
AID - joc02013 [pii]
AID - 10.1001/jama.285.15.1978 [doi]
PST - ppublish
SO  - JAMA. 2001 Apr 18;285(15):1978-86. doi: 10.1001/jama.285.15.1978.