Pharmacopsychiatry 2012; 45(07): 275-278
DOI: 10.1055/s-0032-1306348
Original Paper
© Georg Thieme Verlag KG Stuttgart · New York

St John’s Wort (Hypericum perforatum) versus Sertraline and Placebo in Major Depressive Disorder: Continuation Data from a 26-Week RCT

J. Sarris
1   Department of Psychiatry, The University of Melbourne, Melbourne, Australia
2   Centre for Human Psychopharmacology, Swinburne University of Technology, Melbourne, Australia
,
M. Fava
3   Depression Clinical and Research Program, Department of Psychiatry, Massachusetts General Hospital, Harvard Medical School, Boston, MA, USA
,
I. Schweitzer
1   Department of Psychiatry, The University of Melbourne, Melbourne, Australia
,
D. Mischoulon
3   Depression Clinical and Research Program, Department of Psychiatry, Massachusetts General Hospital, Harvard Medical School, Boston, MA, USA
› Author Affiliations
Further Information

Publication History

received 16 January 2012
revised 12 February 2012

accepted 21 February 2012

Publication Date:
16 May 2012 (online)

Abstract

Introduction:

Hypericum perforatum (St John’s wort: SJW) has been extensively studied as an antidepressant in short-term trials, however little research has been conducted on longer-term efficacy.

Methods:

Our objective was to analyze the continuation data from a 26-week randomized, double-blind, controlled study of SJW (LI-160) vs. sertraline and placebo in major depressive disorder. 124 participant “responders” continued treatment after week 8, until week 26. They continued randomly assigned SJW (900–1 500 mg), sertraline (50–100 mg) or matching placebo.

Results:

At week 26, on the primary outcome, Hamilton depression rating scale (HAM-D) completer scores were: SJW (6.6±4.5), sertraline (7.1±5.4) and placebo (5.7±5.4) with a significant effect for time (p=0.036). Comparisons between all treatments were however non-significant (p=0.61). This effect was mirrored on the other outcomes: the BDI, CGI-severity, CGI-improvement, and on intention-to-treat analyses.

Conclusion:

While the continuation data revealed an equivocal outcome between treatments at week 26, both SJW and sertraline were still therapeutically effective, with a pronounced “placebo-effect” impeding a significant result at week 26.

 
  • References

  • 1 Muller W-E. Current St John’s wort research from mode of action to clinical efficacy. Pharmacol Res 2003; 47: 101-109
  • 2 Sarris J, Panossian A, Schweitzer I et al. Herbal medicine for depression, anxiety and insomnia: A review of psychopharmacology and clinical evidence. Eur Neuropsychopharmacol 2011; in press
  • 3 Kasper S, Gastpar M, Möller HJ et al. Better tolerability of St. John’s wort extract WS 5570 compared to treatment with SSRIs: a reanalysis of data from controlled clinical trials in acute major depression. Int Clin Psychopharmacol 2010; 25: 204-213
  • 4 Linde K, Berner M, Kriston L. St John’s wort for major depression. Cochrane Database Syst Rev 2008; (04) CD000448
  • 5 Sarris J, Kavanagh D-J. Kava and St John’s wort: current evidence for use in mood and anxiety disorders. J Altern Complement Med 2009; 15: 827-836
  • 6 Fava M, Alpert J, Nierenberg AA et al. A double-blind, randomized trial of St John’s wort, fluoxetine, and placebo in major depressive disorder. J Clin Psychopharmacol 2005; 25: 441-447
  • 7 Shelton R-C, Keller MB, Gelenberg A et al. Effectiveness of St John’s wort in major depression: a randomized controlled trial. JAMA 2001; 285: 1978-1986
  • 8 Hypericum Depression Trial Study Group . Effect of Hypericum perforatum (St John’s wort) in major depressive disorder: a randomized controlled trial. JAMA 2002; 287: 1807-1814
  • 9 Kasper S, Volz HP, Möller HJ et al. Continuation and long-term maintenance treatment with Hypericum extract WS 5570 after recovery from an acute episode of moderate depression – a double-blind, randomized, placebo controlled long-term trial. Eur Neuropsychopharmacol 2008; 18: 803-813
  • 10 Gastpar M, Singer A, Zeller K. Efficacy and tolerability of hypericum extract STW3 in long-term treatment with a once-daily dosage in comparison with sertraline. Pharmacopsychiatry 2005; 38: 78-86
  • 11 Hamilton M. A rating scale for depression. J Neurol Neurosurg Psychiatry 1960; 23: 56-62
  • 12 Beck A-T, Ward C, Mendelson M. Beck Depression Inventory (BDI). Arch Gen Psychiatry 1961; 4: 561-571
  • 13 Endicott J, Spitzer RL, Fleiss JL et al. The global assessment scale. A procedure for measuring overall severity of psychiatric disturbance. Arch Gen Psychiatry 1961; 33: 766-771
  • 14 Guy W, Bonato R-E. CGI: Clinical Global Impressions. Manual for the ECDEU Assessment Battery. 2. Rev ed. Chevy Chase, MD: National Institute of Mental Health; 1970. (12-1-12-6)
  • 15 Trivedi M-H, Fava M, Wisniewski SR et al. Medication augmentation after the failure of SSRIs for depression. N Engl J Med 2006; 354: 1243-1252
  • 16 Fournier J, DeRubeis RJ, Hollon SD et al. Antidepressant drug effects and depression severity: a patient-level meta-analysis. JAMA 2010; 303: 47-53