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

International Clinical Psychopharmacology

Volumn 25, Issue 4, 2010, Pages 204-213

  Kasper, Siegfried ^a   Gastpar, Markus ^b   Möller, Hans Juergen ^c   Müller, Walter E ^d   Volz, Hans Peter ^e   Dienel, Angelika ^f   Kieser, Meinhard ^g  

^a MEDICAL UNIVERSITY OF VIENNA   (Austria)

^b Rheinische Kliniken Essen   (Belgium)

^c UNIVERSITY OF MUNICH   (Germany)

^d GOETHE UNIVERSITY   (Germany)

^e Schloss Werneck   (Germany)

^f DR WILLMAR SCHWABE GMBH AND CO KG   (Germany)

^g UNIVERSITY OF HEIDELBERG   (Germany)

Author keywords

Adverse events; Depression; Meta analysis; Safety; St John's wort; Tolerability

Indexed keywords

FLUOXETINE; FLUVOXAMINE; HYPERICUM PERFORATUM EXTRACT; PAROXETINE; PLACEBO; SERTRALINE; UNCLASSIFIED DRUG; WS 5570;

ABDOMINAL PAIN; AGITATION; ANOREXIA; ANTICHOLINERGIC SYNDROME; ANXIETY; ARTICLE; ATTRIBUTABLE RISK; CLINICAL TRIAL; CONFUSION; CONSTIPATION; CONTROLLED CLINICAL TRIAL; CONTROLLED STUDY; DIAGNOSTIC AND STATISTICAL MANUAL OF MENTAL DISORDERS; DIARRHEA; DIZZINESS; DROWSINESS; DRUG EFFICACY; DRUG SAFETY; DRUG TOLERABILITY; DYSMENORRHEA; DYSPEPSIA; FATIGUE; FLATULENCE; GASTROENTERITIS; GASTROINTESTINAL DISEASE; GASTROINTESTINAL SYMPTOM; HEADACHE; HEART ARRHYTHMIA; HEART PALPITATION; HUMAN; HYPERSENSITIVITY REACTION; HYPOTENSION; INSOMNIA; MAJOR CLINICAL STUDY; MAJOR DEPRESSION; MIGRAINE; NAUSEA; NERVOUSNESS; PRIORITY JOURNAL; PRURITUS; RANDOMIZED CONTROLLED TRIAL; RASH; SEDATION; SEROTONIN UPTAKE; SEXUAL DYSFUNCTION; SIDE EFFECT; SWEATING; TACHYCARDIA; TREMOR; VERTIGO; XEROSTOMIA;

DEPRESSIVE DISORDER, MAJOR; DOUBLE-BLIND METHOD; FEMALE; HUMANS; HYPERICUM; MALE; PAROXETINE; PLANT EXTRACTS; RANDOMIZED CONTROLLED TRIALS AS TOPIC; SEROTONIN UPTAKE INHIBITORS; TREATMENT OUTCOME;

EID: 77953697547     PISSN: 02681315     EISSN: None     Source Type: Journal    
DOI: 10.1097/YIC.0b013e328335dc1a     Document Type: Article

References (51)

1. Anghelescu IG, Kohnen R, Szegedi A, Klement S, Kieser M (2006). Comparison of Hypericum extract WS 5570 and paroxetine in ongoing treatment after recovery from an episode of moderate to severe depression: results from a randomized multicenter study. Pharmacopsychiatry 39:213-219.
2. Bailly D (2006). Safety of selective serotonin reuptake inhibitor antidepressants in children and adolescent. Presse Med 35:1507-1515.
3. Behnke K, Jensen GS, Graubaum HJ, Grünwald J (2002). Hypericum perforatum versus fluoxetine in the treatment of mild to moderate depression. Adv Ther 19:43-52.
4. Breggin PR (2003/2004). Suicidality, violence and mania caused by selective serotonin reuptake inhibitors (SSRIs): a review and analysis. Int J Risk Safety Med 16:31-49.
5. Brenner R, Azbel V, Madhusoodanan S, Pawlowska M (2000). Comparison of an extract of hypericum (LI 160) and sertraline in the treatment of depression: a double-blind, randomized pilot study. Clin Ther 22:411-419.
6. Bryant TN (2000). Computer software for calculating confidence intervals. In: Altman DG, Machin D, Bryant TN, Gardner MJ, editors. Statistics with confidence. London: BMJ Books; pp. 208-213.
7. Cascade EF, Kalali AH (2006). Generic conversion of the SSRI market and the impact on branded products. Psychiatry 3:34-35.
8. Cooper GL (1988). The safety of fluoxetine-an update. Br J Psychiatry 3 (Suppl):77-86.
9. De Smet PA, Nolen WA (1996). St John's wort as an antidepressant. Br Med J 313:241-242.
10. Dechant KL, Clissold SP (1991). Paroxetine. A review of its pharmacodynamic and pharmacokinetic properties, and therapeutic potential in depressive illness. Drugs 41:225-253.
11. Donovan S, Dearden L, Richardson L (1994). The tolerability of dothiepin: a review of clinical studies between 1963 and 1990 in over 13000 depressed patients. Prog Neuropsychopharmacol Biol Psychiatry 18:1143-1162.
12. Doogan DP (1991). Toleration and safety of sertraline: experience worldwide. Int Clin Psychopharmacol 6 (Suppl 2):47-56.
13. Dürr D, Steiger B, Kullak-Ublik GA, Rentsch KM, Steinert HC, Meier PJ, Fattinger K (2000). St John's wort induces intestinal P-glycoprotein/MDRI and intestinal and hepatic CYP3A4. Clin Pharmacol Ther 68:598-604.
14. Ernst E (1999). Second thoughts about safety of St John's wort. Lancet 354:2014-2016.
15. Ernst E, Rand JI, Barnes J, Stevinson C (1998). Adverse effects profile of the herbal antidepressant St John's wort (Hypericum perforatum L.). Eur J Clin Pharmacol 54:589-594.
16. Fava M, Judge R, Hoog SL, Nilsson ME, Koke SC (2000). Fluoxetine versus sertraline and paroxetine in major depressive disorder: changes in weight with long-term treatment. J Clin Psychiatry 61:863-867.
17. Gastpar M, Singer A, Zeller K (2005). Efficacy and tolerability of hypericum extract STW3 in long-term treatment with a once-daily dosage in comparison with sertraline. Pharmacopsychiatry 38:78-86.
18. Gastpar M, Singer A, Zeller K (2006). Comparative efficacy and safety of a once-daily dosage of hypericum extract STW3-VI and citalopram in patients with moderate depression: a double-blind, randomised, multicentre, placebo-controlled study. Pharmacopsychiatry 39:66-75.
19. Grimsley SR, Jann MW (1992). Paroxetine, sertraline, and fluvoxamine: new selective serotonin reuptake inhibitors. Clin Pharm 11:930-957.
20. Harrer G, Schmidt U, Kuhn U, Biller A (1999). Comparison of equivalence between the St John's wort extract LoHyp-57 and fluoxetine. Arzneimittel- forschung/Drug Res 49:289-296.
21. Hippius H (1998). St John's Wort (Hypericum perforatum)-a herbal antidepressant. Curr Med Res Opin 14:171-184.
22. Hirschfeld RM, Vornik LA (2004). Newer antidepressants: review of efficacy and safety of escitalopram and duloxetine. J Clin Psychiatry 65 (Suppl 4):46-52.
23. Hypericum Depression Trial Study Group (2002). Effect of Hypericum perforatum (St John's wort) in major depressive disorder. JAMA 287:1807-1814.
24. Kasper S, Anghelescu I, Szegedi A, Dienel A, Kieser M (2006). Superior efficacy of St John's wort extract WS 5570 compared to placebo in patients with major depression: a randomized, double-blind, placebo-controlled, multi-center trial. BMC Med 4:14.
25. Kasper S, Volz HP, Möller HJ, Dienel A, Kieser M (2008). 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 18:803-813.
26. Katz D, Baptista J, Azen SP, Pike MC (1978). Obtaining confidence intervals for the risk ratio in cohort studies. Biometrics 34:469-474.
27. Knüppel L, Linde K (2004). Adverse effects of St John's Wort: a systematic review. J Clin Psychiatry 65:1470-1479.
28. Lecrubier Y, Clerc G, Didi R, Kieser M (2002). Efficacy of St John's wort extract WS 5570 in major depression: a double-blind, placebo-controlled trial. Am J Psychiatry 159:1361-1366.
29. Levitt AJ, Joffe RT, Esche I, Sherret D (1987). The effect of desipramine on body weight in depression. J Clin Psychiatry 48:27-28.
30. Linde K, Berner MM, Kriston L (2008). St John's wort for major depression. Cochrane Database Syst Rev 4:CD000448.
31. Möller HJ, Baldwin DS, Goodwin G, Kasper S, Okasha A, Stein DJ, et al. (2008). Do SSRIs or antidepressants in general increase suicidality? WPA Section on Pharmacopsychiatry: consensus statement. Eur Arch Psychiatry Clin Neurosci 258 (Suppl 3):3-23.
32. Montgomery SA (1995). Safety of mirtazapine: a review. Int Clin Psychopharma-col 10 (Suppl 4):37-45.
33. Müller WE, Kasper S (1997). Editorial hypericum extract (LI 160) as a herbal antidepressant. Pharmacopsychiatry 30:71.
34. Nelson JC, Lu Pritchett Y, Martynov O, Yu JY, Mallinckrodt CH, Detke MJ (2006). The safety and tolerability of duloxetine compared with paroxetine and placebo: a pooled analysis of 4 clinical trials. Prim Care Companion J Clin Psychiatry 8:212-219.
35. Preskorn SH (1995). Comparison of the tolerability of bupropion, fluoxetine, imipramine, nefazodone, paroxetine, sertraline, and venlafaxine. J Clin Psychiatry 56 (Suppl 6):12-21.
36. Preskorn SH (1996). Clinical pharmacology of selective serotonin reuptake inhibitors. Caddo, OK: Professional Communications.
37. Preskorn SH (1997). Clinically relevant pharmacology of selective serotonin reuptake inhibitors. An overview with emphasis on pharmacokinetics and effects on oxidative drug metabolism. Clin Pharmacokinet 32 (Suppl 1):1-21.
38. Preskorn SH (2000). The adverse effect profiles of the selective serotonin reuptake inhibitors: relationship to in vitro pharmacology. J Psychiatr Pract 6:153-157.
39. Preskorn SH, Baker B (1997). Fatality associated with combined fluoxetine-amitriptyline therapy. JAMA 277:1682.
40. Preskorn SH, Beber JH, Faul JC, Hirschfeld RM (1990). Serious adverse effects of combining fluoxetine and tricyclic antidepressants. Am J Psychiatry 147:532.
41. 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 15:61-68.
42. Schulz V (2006). Safety of St John's Wort extract compared to synthetic antidepressants. Phytomedicine 13:199-204.
43. Stevinson C, Ernst E (1999). Safety of Hypericum in patients with depression. A comparison with conventional antidepressants. CNS Drugs 11:125-137.
44. Szegedi A, Kohnen R, Dienel A, Kieser M (2005). Acute treatment of moderate to severe depression with hypericum extract WS 5570 (St John's wort): randomised controlled double blind non-inferiority trial versus paroxetine. Br Med J 330:503-506.
45. Tollefson GD (1993). Adverse drug reactions/interactions in maintenance therapy. J Clin Psychiatry 54 (Suppl):48-58.
46. Trautmann-Sponsel RD, Dienel A (2004). Safety of Hypericum extract in mildly to moderately depressed outpatients: a review based on data from three randomized, placebo-controlled trials. J Affect Disord 82:303-307.
47. Trindade E, Menon D, Topfer LA, Coloma C (1998). Adverse effects associated with selective serotonin reuptake inhibitors and tricyclic antidepressants: a meta-analysis. CMAJ 159:1245-1252.
48. Van Gurp G, Meterissian GB, Haiek LN, McCusker J, Bellavance F (2002). St John's wort or sertraline? Randomized controlled trial in primary care. Can Fam Physician 48:905-912.
49. Vida S, Looper K (1999). Precision and comparability of adverse event rates of newer antidepressants. J Clin Psychopharmacol 19:416-426.
50. Wheatley D (1998). Hypericum extract. Potential in the treatment of depression. CNS Drugs 9:431-440.
51. Zuckerman ML, Vaughan BL, Whitney J, Dodds A, Yakhkind A, MacMillan C, et al. (2007). Tolerability of selective serotonin reuptake inhibitors in thirty-nine children under age seven: a retrospective chart review. J Child Adolesc Psychopharmacol 17:165-174.