Advertisement

Hypericum extract LI 160 and fluoxetine in mild to moderate depression

A randomized, placebo–controlled multi–center study in outpatients
  • L. Bjerkenstedt
  • G. V. Edman
  • R. G. Alken
  • M. Mannel
ORIGINAL PAPER

Abstract

Efficacy and tolerability of Hypericum LI 160 was compared to fluoxetine and placebo in mild to moderate Major Depression (DSM–IV) in a 4–week randomized, double–blind trial. One hundred and sixtythree outpatients from 15 general practitioner centers received either 900 mg Hypericum LI 160, 20 mg fluoxetine, or placebo daily. Amelioration was measured by the Hamilton and the Montgomery–Åsberg Depression scales. Response and remission rates and global ratings by investigators and patients were measured. Adverse event reports, laboratory screening, vital signs, physical exams and ECG were collected. No significant differences could be observed regarding efficacy measures except for remission rate (Hypericum 24%; fluoxetine 28%; placebo 7 %). Hypericum was significantly better tolerated than fluoxetine. Hypericum LI 160 or fluoxetine were not more effective in short–term treatment in mild to moderate depression than placebo.

Key words

Hypericum fluoxetine placebo major depression outpatient treatment 

Preview

Unable to display preview. Download preview PDF.

Unable to display preview. Download preview PDF.

References

  1. 1.
    American Psychiatric Association (1994) Diagnostic and Statistical Manual of Mental Disorders (DSM-IV). American Psychiatric Press: Washington DCGoogle Scholar
  2. 2.
    Baker CB, Johnsrud MT,Crismon ML, Rosenheck RA,Woods SW (2003) Quantitative analysis of sponsorship bias in economic studies of antidepressants. Br J Psychiatry 183:498–506CrossRefPubMedGoogle Scholar
  3. 3.
    Brenner R, Azbel V, Madhusoodanan S, Pawlowska M (2000) Comparison of an extract of hypericum (LI 160) treatment of depression: a double-blind, randomized pilot study. Clin Ther 22:411–419CrossRefPubMedGoogle Scholar
  4. 4.
    Brenner R, Bjerkenstedt L, Edman GV (2002) Hypericum perforatum extract (St. John’s wort) for depression. Psychiatr Ann 32:21–26Google Scholar
  5. 5.
    Chilvers C, Dewey M, Fielding K, Gretton V, Miller PR, Palmer BW, Weller D, Churchill R, Williams I, Bedi N, Duggan C, Lee A, Harrison G (2001) Antidepressant drugs and generic counselling for treatment of major depression in primary care: randomised trial with patient preference arms. Br Med J 322:772–775Google Scholar
  6. 6.
    Deltito J,Beyer D (1998) The scientific, quasi-scientific and popular literature on the use of St. John’s Wort in the treatment of depression. J Affective Disord 51:345–351CrossRefGoogle Scholar
  7. 7.
    Doogan DP, Langdon CJ (1994) A double-blind, placebo-controlled comparison of sertraline and dothiepin in the treatment of major depression in general practice. Int Clin Psychopharmacol 9:95–100PubMedGoogle Scholar
  8. 8.
    Ernst E, Rand JI, Barnes J, Stevinson C (1998) Adverse effects profile of the herbal antidepressant St. Johns wort (Hypericum perforatum L.). Eur J Clin Pharmacol 54:589–594CrossRefPubMedGoogle Scholar
  9. 9.
    The European Agency for the Evaluation of Medicinal Products (1998) Concept paper on the revision of the committee for proprietary medicinal products (CPMP) note for guidance on medicinal products for the treatment of depression (CPMP/EWP/ 518/97 concept paper). London: EMEAGoogle Scholar
  10. 10.
    Fabre LF, Putman HPr (1987) A fixed-dose clinical trial of fluoxetine in outpatients with major depression. J Clin Psychiatry 48:406–408PubMedGoogle Scholar
  11. 11.
    Gupta RK, Möller HJ (2003) St. John’s Wort.An option for the primary care treatment of depressive patients? Eur Arch Psychiatry Clin Neurosci 253:140–148PubMedGoogle Scholar
  12. 12.
    Guy W (1976) ECDEU Assessment Manual for Psychopharmacology (76–338) Rockville, Md: US Department of Health, Education, and Welfare publication (ADM)Google Scholar
  13. 13.
    Hamilton M (1967) Development of a rating scale for primary depressive illness. Br J Soc Clin Psychol 6:278–296PubMedGoogle Scholar
  14. 14.
    Harrer G, Schmidt U, Kuhn U, Biller A (1999) Äquivalenzvergleich Johanniskrautextrakt LoHyp-57 versus Fluoxetin. Arzneim Forsch/Drug Res 49:3–10Google Scholar
  15. 15.
    Hoffmann J, Kühl ED (1979) Therapie von depressiven Zuständen mit Hypericin. Zeitschrift für Allgemeinmedizin 55:776–782Google Scholar
  16. 16.
    Hypericum Depression Trial Study Group (2002) Effect of Hypericum perforatum (St. John’s Wort) in major depressive disorder: a randomized controlled trial. JAMA 287:1807–1814CrossRefPubMedGoogle Scholar
  17. 17.
    Khan A, Leventhal RM, Khan SR, Brown WA (2002) Severity of depression and response to antidepressants and placebo: an analysis of the Food and Drug Administration database. J Clin Psychopharmacol 22:40–45PubMedGoogle Scholar
  18. 18.
    Kim HL, Streltzer J, Goebert D (1999) St. John’s wort for depression. A meta-analysis of well-defined clinical trials. J Nerv Ment Dis 187:532–539PubMedGoogle Scholar
  19. 19.
    Kirsch I, Sapirstein G (1998) Listening to Prozac but hearing placebo: a meta-analysis of antidepressant medication. Retrieved from the World Wide Web: http://journals.apa.org/ prevention/volume1/pre0010002a.htmlGoogle Scholar
  20. 20.
    Linde K, Ramirez G, Mulrow CD, Pauls A, Weidenhammer W, Melchart D (1996) St John’s wort for depression – an overview and meta-analysis of randomised clinical trials. Br Med J 313:253–258Google Scholar
  21. 21.
    Linde K, ter Riet G, Hondras M,Vickers A, Saller R,Melchert D (2001) Systematic reviews of complementary therapies – an annotated bibliography. Part 2: Herbal medicine. BMC Complementary Alternative MedicineGoogle Scholar
  22. 22.
    Lingjaerde O, Ahlfors UG, Bech P, Dencker SJ, Elgen K (1987) The UKU side effect rating scale. A new comprehensive rating scale for psychotropic drugs and a cross-sectional study of side effects in neuroleptic-treated patients. Acta Psychiatr Scand 334:1–100Google Scholar
  23. 23.
    Montgomery SA (1999) The failure of placebo-controlled studies. Eur Neuropsychopharmacol 9:271–276Google Scholar
  24. 24.
    Montgomery SA, Åsberg M (1979) A new depression scale designed to be sensitive to change. Br J Psychiatry 133:382–389Google Scholar
  25. 25.
    Müller MJ, Himmerich H, Kienzle B, Szegedi A (2003) Differentiating moderate and severe depression using the Montgomery- Asberg depression rating scale (MADRS). J Affective Disord 77:255–260CrossRefGoogle Scholar
  26. 26.
    Parker G, Anderson IM, Haddad P (2003) Clinical trials of antidepressant medications are producing meaningless results. Br J Psychiatry 183:102–104PubMedGoogle Scholar
  27. 27.
    Schrader E (2000) Equivalence of St John’s wort extract (Ze 117) and fluoxetine: a randomized, controlled study in mild-moderate depression. Int Clin Psychopharmacol 15:61–68PubMedGoogle Scholar
  28. 28.
    Shelton RC, Keller MB, Gelenberg A, Dunner DL, Hirschfeld R, Thase ME, Russell J, Lydiard RB, Crits-Cristoph P, Gallop R, Todd L, Hellerstein D, Goodnick P, Keitner G, Stahl SM, Halbreich U (2001) Effectiveness of St John’s wort in major depression: a randomized controlled trial. JAMA 285:1978–1986CrossRefPubMedGoogle Scholar
  29. 29.
    Stevinson C,Ernst E (1999) Safety of Hypericum in patients with depression. CNS Drugs 11:125–132Google Scholar
  30. 30.
    Stokes PE, Holtz A (1997) Fluoxetine tenth anniversary update: the progress continues. Clin Ther 5:1135–1250CrossRefGoogle Scholar
  31. 31.
    Walsh BT, Seidman SN, Sysko R, Gould M (2002) Placebo response in studies of major depression: variable, substantial, and growing. 287:1840–1847Google Scholar
  32. 32.
    World Health Organisation (1999) Adverse Reactions Terminology (WHO-ART). Uppsala: World Health OrganisationGoogle Scholar
  33. 33.
    WMA (2000) Declaration of Helsinki. World Medical Association, www.wma.net/e/policty/17-c_e.html. Retrieved from the World Wide WebGoogle Scholar
  34. 34.
    Volz HP (1997) Controlled clinical trials of Hypericum extracts in depressed patients – an overview. Pharmacopsychiatry 30:72–76Google Scholar
  35. 35.
    Volz HP, Laux P (2000) Potential treatment for subthreshold and mild depression: a comparison of St. John’s wort extracts and fluoxetine. Compr Psychiatry 41:133–137Google Scholar
  36. 36.
    Vorbach EU, Arnoldt KH, Wolpert E (2000) St. Johns wort.A potential therapy for elderly depressed patients? Drugs Aging 16:189–197PubMedGoogle Scholar

Copyright information

© Steinkopff Verlag 2004

Authors and Affiliations

  • L. Bjerkenstedt
    • 1
  • G. V. Edman
    • 2
  • R. G. Alken
    • 3
  • M. Mannel
    • 4
  1. 1.Dept. of Clinical NeurosciencePsychiatry Section Karolinska HospitalStockholmSweden
  2. 2.Dept. of Psychiatry Research and Development Unit Danderyd’s HospitalDanderydSweden
  3. 3.Cooperative Clinical Drug Research and Development AGNeuenhagenGermany
  4. 4.Lichtwer Pharma GmbHBerlinGermany

Personalised recommendations