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Effectiveness of St John's wort in major depression: a randomized controlled trial.
JAMA 2001; 285(15):1978-86JAMA

Abstract

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.

Authors+Show Affiliations

Department of Psychiatry, Vanderbilt University, Nashville Tennessee, USA. richard.shelton@mcmail.vanderbilt.eduNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info available

Pub Type(s)

Clinical Trial
Journal Article
Multicenter Study
Randomized Controlled Trial
Research Support, Non-U.S. Gov't
Research Support, U.S. Gov't, P.H.S.

Language

eng

PubMed ID

11308434

Citation

Shelton, R C., et al. "Effectiveness of St John's Wort in Major Depression: a Randomized Controlled Trial." JAMA, vol. 285, no. 15, 2001, pp. 1978-86.
Shelton RC, Keller MB, Gelenberg A, et al. Effectiveness of St John's wort in major depression: a randomized controlled trial. JAMA. 2001;285(15):1978-86.
Shelton, R. C., Keller, M. B., Gelenberg, A., Dunner, D. L., Hirschfeld, R., Thase, M. E., ... Halbreich, U. (2001). Effectiveness of St John's wort in major depression: a randomized controlled trial. JAMA, 285(15), pp. 1978-86.
Shelton RC, et al. Effectiveness of St John's Wort in Major Depression: a Randomized Controlled Trial. JAMA. 2001 Apr 18;285(15):1978-86. PubMed PMID: 11308434.
* Article titles in AMA citation format should be in sentence-case
TY - JOUR T1 - Effectiveness of St John's wort in major depression: a randomized controlled trial. AU - Shelton,R C, AU - Keller,M B, AU - Gelenberg,A, AU - Dunner,D L, AU - Hirschfeld,R, AU - Thase,M E, AU - Russell,J, AU - Lydiard,R B, AU - Crits-Cristoph,P, AU - Gallop,R, AU - Todd,L, AU - Hellerstein,D, AU - Goodnick,P, AU - Keitner,G, AU - Stahl,S M, AU - Halbreich,U, PY - 2001/4/20/pubmed PY - 2001/5/22/medline PY - 2001/4/20/entrez SP - 1978 EP - 86 JF - JAMA JO - JAMA VL - 285 IS - 15 N2 - 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. SN - 0098-7484 UR - https://www.unboundmedicine.com/medline/citation/11308434/Effectiveness_of_St_John's_wort_in_major_depression:_a_randomized_controlled_trial_ L2 - https://jamanetwork.com/journals/jama/fullarticle/vol/285/pg/1978 DB - PRIME DP - Unbound Medicine ER -