Treatment of somatoform disorders with St. John's wort: A randomized, double-blind and placebo-controlled trial

Psychosomatic Medicine

Volumn 66, Issue 4, 2004, Pages 538-547

  Müller, Thomas ^a,e   Mannel, Marcus ^b   Murck, Harald ^c   Rahlfs, Volker W ^d  

^a RUHR UNIVERSITY BOCHUM   (Germany)

^b Ad libitum Medical Services   (Germany)

^c Lichtwer Pharma GmbH   (Germany)

^d IDV Datenanalyse/Versuchsplanung   (Germany)

^e ST JOSEF HOSPITAL   (Germany)

Author keywords

Clinical trial; Depression; Hypericum; LI 160; Somatoform disorders; St. John's wort

Indexed keywords

HYPERICUM PERFORATUM EXTRACT; PLACEBO;

ADULT; AGED; ARTICLE; AUTONOMIC DYSFUNCTION; CLINICAL TRIAL; CONTROLLED CLINICAL TRIAL; CONTROLLED STUDY; DOUBLE BLIND PROCEDURE; DRUG EFFICACY; DRUG SAFETY; DRUG TOLERABILITY; FEMALE; HUMAN; MAJOR CLINICAL STUDY; MAJOR DEPRESSION; MALE; MENTAL PATIENT; NIGHTMARE; OUTCOMES RESEARCH; POPULATION; PRIORITY JOURNAL; PROSPECTIVE STUDY; SCORING SYSTEM; SCREENING TEST; SIDE EFFECT; SOMATIZATION; SOMATOFORM DISORDER; TABLET FORMULATION;

EID: 3242744348     PISSN: 00333174     EISSN: None     Source Type: Journal    
DOI: 10.1097/01.psy.0000128900.13711.5b     Document Type: Article

References (72)

1. American Psychiatric Association. Diagnostic and statistical manual of mental disorders, 4th ed. (DSM-IV). Washington, DC: American Psychiatric Association; 1994.
2. World Health Organization. The ICD-10 classification of mental and behavioural disorders. Clinical descriptions and diagnostic guidelines. Geneva: WHO; 1992.
3. Hiller W, Rief W, Fichter M. How disabled are patients with somatoform disorders? Gen Hosp Psychiatry 1997;19:432-8.
4. Smith GR, Monson RA, Ray DC. Patients with multiple unexplained symptoms. Their characteristics, functional health, and health care utilisation. Arch Intern Med 1986;146:69-72.
5. Bhui K, Hotopf M. Somatization disorder. Br J Hosp Med 1997;58:145-9.
6. Escobar JI, Rubio-Stipec M, Canino G, Kamo M. Somatic symptom index (SSI): a new and abridged somatization construct. Prevalence and epidemiological correlates in two large community samples. J Nerv Ment Dis 1989;177:140-6.
7. Kroenke K, Spitzer RL, deGruy FV 3rd, Hahn SR, Linzer M, Williams JB, Brody D, Davies M. Multisomatoform disorder. An alternative to undifferentiated somatoform disorder for the somatizing patient in primary care. Arch Gen Psychiatry 1997;54:352-8.
8. Rief W, Hessel A, Braehler E. Somatization symptoms and hypochondriacal features in the general population. Psychosom Med 2001;63:595-602.
9. Bass C, Peveler R, House A. Somatoform disorders: severe psychiatric illnesses neglected by psychiatrists. Br J Psychiatry 2001;179:11-4.
10. Kroenke K, Swindle R. Cognitive-behavioral therapy for somatization and symptom syndromes: a critical review of controlled clinical trials. Psychother Psychosom 2000;69:205-15.
11. Volz HP, Stieglitz RD, Menges K, Möller HJ. Somatoform disorders-diagnostic concept, controlled clinical trials, and methodological issues. Pharmacopsychiat 1994;27:231-7.
12. Ferreri M, Florent C, Gerard D. Sulpiride: study of 669 patients presenting with pain of psychological origin. Encephale 2000;26:58-66.
13. Turkington D, Grant JB, Ferrier IN, Rao NS, Linsley KR, Young AH. A randomized controlled trial of fluvoxamine in prostatodynia, a male somatoform pain disorder. J Clin Psychiatry 2002;63:778-81.
14. Garcia-Campayo J, Sanz-Carillo C. Topiramate as a treatment for pain in multisomatoform disorder patients: an open trial. Gen Hosp Psychiatry 2002;24:417-21.
15. Fallon BA, Liebowitz MR, Salman E, Schneier FR, Jusino C, Hollander E, Klein DF. Fluoxetine for hypochondriacal patients without major depression. J Clin Psychopharmacol 1993;13:438-41.
16. Kjernisted KD, Enns MW, Lander M. An open-label clinical trial of nefazodone in hypochondriasis: Psychosomatics 2002;43:290-4.
17. Perugi G, Giannotti D, Di Vaio S, Frare F, Saettoni M, Cassano GB. Fluvoxamine in the treatment of body dysmorphic disorder (dysmorphophobia). Int Clin Psychopharmacol 1996;11:247-54.
18. Hollander E, Allen A, Kwon J, Aronowitz B, Schmeidler J, Wong C, Simeon D. Clomipramine vs desipramine crossover trial in body dysmorphic disorder: selective efficacy of a serotonin reuptake inhibit or in imagined ugliness. Arch Gen Psychiatry 1999;56:1033-9.
19. Phillips KA, Albertini RS, Rasmussen SA. A randomized placebo-controlled trial of fluoxetine in body dysmorphic disorder. Arch Gen Psychiatry 2002:59:381-8.
20. Noyes R Jr., Happel RL, Muller BA, Holt CS, Kathol RG, Sieren LR, Amos JJ. Fluvoxamine for somatoform disorders: an open trial. Gen Hosp Psychiatry 1998;20:339-44.
21. Menza M, Lauritano M, Allen L, Warman M, Ostella F, Hamer RM, Escobar J. Treatment of somatization disorder with nefazodone: a prospective open-label study. Ann Clin Psychiatry 2001;13:153-8.
22. Volz HP, Möller HJ, Reimann I, Stoll KD. Opipramol for the treatment of somatoform disorders - results from a placebo-controlled trial. Eur Neuropsychopharmacol 2000;10:211-7.
23. Dwight MM, Arnold LM, O'Brien H, Metzger R, Morris-Park E, Keck PE. An open clinical trial of Venlafaxine treatment of fibromyalgia. Psychosomatics 1998;39:14-7.
24. Engel CC, Walker EA, Engel AL, Bulls J, Armstrong A. A randomized, double-blind crossover trial of sertraline in women with chronic pelveic pain. J Psychosom Res 1998;44:203-7.
25. Fishbain DA, Cutler RB, Rosomoff HL, Rosomoff RS. Do antidepressants have an analgesic effect in psychogenic pain and somatoform pain disorder? A meta-analysis. Psychosom Med 1998;60:503-9.
26. Freeman EW, Rickels K, Sondheimer SJ, Polansky M. Differential response to antidepressants in women with premenstrual syndrome/premenstrual dysphoric disorder. Arch Gen Psychiatry 1999;56:932-9.
27. Linde K, Mulrow CD. St John's wort for depression (Cochrane Review). In: The Cochrane library. Issue 5. Oxford: Update Software; 2003.
28. Bilia AR, Gallori S, Vincieri FF. St. John's wort and depression. Efficacy, safety and tolerability - an update. Life Sci 2002;70:3077-96.
29. Sommer H, Harrer G. Placebo-controlled double-blind study examining the effectiveness of an hypericum preparation in 105 mildly depressed patients. J Geriatr Psychiatry Neurol 7(suppl 1):9-11, 1994.
30. Woelk H, Burkard G, Grünwald J. Benefits and risks of the hypericum extract LI 160: drug monitoring study with 3,250 patients. J Geriatr Psychiatry Neurol 7(suppl 1):34-8, 1994.
31. Woelk H, for the Remotiv/Imipramine study group. Comparison of St. John's wort and imipramine for treating depression: randomised controlled trial. BMJ 2000;321:536-9.
32. Grube B, Schermuck S, Hopfenmüller W, Michel F. Use of a hypericum extract in mild, transient depressive disorders. Eur J Clin Res 1997;9:293-302.
33. Stevinson C, Dixon M, Ernst E. Hypericum for fatigue - a pilot study. Phytomedicine 1998;5:443-7.
34. Stevinson C, Ernst E. A pilot study of Hypericum perforatum for the treatment of premenstrual syndrome. Br J Obstet Gynaecol 2000;107:870-6.
35. Grube B, Walper A, Wheatley D. St. John's wort extract: efficacy for menopausal symptoms of psychological origin. Adv Ther 1999;16:177-86.
36. Volz HP, Murck H, Kasper S, Möller HJ. St. John's wort extract (LI 160) in somatoform disorders: results of a placebo-controlled trial. Psychopharmacology 2002;164:294-300.
37. Rief W, Hiller W. A new approach to assess treatment effects in somatoform disorders. Psychosomatics 2003;44:492-8.
38. Hiller W, Zaudig M, Mombour W, Bronisch T. Routine psychiatric examinations guided by ICD-10 Diagnostic Checklists (International Diagnostic Checklists). Eur Arch Psychiatry Clin Neurosci 1993;242:218-23.
39. Hiller W, Zaudig M, Mombour W. IDCL: International diagnostic checklists for ICD-10 and DSM-IV. Seattle: Hogrefe & Huber; 1996.
40. Hiller W, von Bose M, Dichtl G, Agerer D. Reliability of checklist-guided diagnoses for DSM-IIIR affective and anxiety disorders. J Affect Disord 1990;20:235-47.
41. Rief W, Heuser J, Mayrhuber E, Stelzer I, Hiller W, Fichter MM. The classification of multiple somatoform symptoms. J Nerv Ment Dis 1996;184:680-7.
42. Rief W, Hiller W, Heuser J. SOMS - Das screening für somatoforme störungen; manual zum fragebogen. [SOMS-the screening for somatoform diaorders] Bern: Verlag Hans Huber; 1997.
43. Rief W, Greitemeyer M, Fichter MM. Die symptom check list SCL-90-R: überprüftmg an 900 psychosomatischen Patienten. Diagnostika 1991;37:58-65.
44. Lehmann EL. Nonparametrics. Statistical methods based on ranks. New Jersey: Prentice Hall; 1998.
45. European Agency for the Evaluation of Medicinal Products (EMEA); Committee for Proprietary Medicinal Products (CPMP). Note for Guidance on Statistical Principles for Clinical Trials (CPMP/ICH/363/96). London: EMEA; 18 March 1998.
46. Wei LJ, Lachin JM. Two-sample asymptotically distribution-free tests for incomplete multivariate observations. J Am Stat Assoc 1984;79:653-61.
47. Thall PF, Lachin JM. Analysis of recurrent events: Nonparametric methods for random interval count data. J Am Stat Assoc 1988;83:339-47.
48. Lachin JM. Some large-sample distribution-free estimators and tests for multivariate partially incomplete data from two populations. Stat Med 1992;11:1151-70.
49. Maurer W, Hothorn LA, Lehmacher W. Multiple comparisons in drug clinical trials and pre-clinical assays: a-priori ordered hypotheses. In: Vollmar J, editor. Biometrie in der chemisch-pharmazeutischen Industrie 6. Stuttgart: Gustav Fischer; 1995.
50. Colditz GA, Miller JN, Mosteller F. Measuring gain in the evaluation of medical technology. The probability of a better outcome. Int J Technol Assess Health Care 1988;4:637-42.
51. Kroenke K, Mangelsdorff D. Common symptoms in ambulatory care: incidence, evaluation, therapy and outcome. Am J Med 1989;86:262-6.
52. Hypericum Depression Trial Study Group. Effect of Hypericum perforatum (St John's wort) in major depressive Disorder: a randomized controlled trial. JAMA 2002;287:1807-14.
53. Montgomery SA. The failure of placebo-controlled studies. ECNP Consensus Meeting, September 13, 1997, Vienna. European College of Neuropsychopharmacology. Eur Neuropsychopharmacol 1999;9:271-6.
54. Gillespie N, Kirk KM, Heath AC, Martin NG, Hickie I. Somatic distress as a distinct psychological dimension. Soc Psychiatry Psychaitr Epidemiol 1999;34:451-8.
55. Gillespie NA, Zhu G, Heath AC, Hickie IB, Martin NG. The genetic aetiology of somatic distress. Psychol Med 2000;30:1051-61.
56. Murck H. Atypical depression spectrum disorder - neurobiology and treatment. Acta Neuropsychiatrica 2003;15:227-41.
57. Tsigos C, Chrousos GP. Hypothalamic-pituitary-adrenal axis, neuroendocrine factors and stress. J Psychosom Res 2002;53:865-71.
58. Yehuda R. Biology of posttraumatic stress disorder. J Clin Psychiatry 2001;62(suppl 17):41-6.
59. Andreski P, Chilcoat H, Breslau N. Post-traumatic stress disorder and somatization symptoms: a prospective study. Psychiatry Res 1998;79:131-8.
60. Breslau N. Outcomes of posttraumatic stress disorder. J Clin Psychiatry 2001;62(suppl 17):55-9.
61. Rief W, Pilger F, IhIe D, Bosmans E, Egyed B, Maes M. Immunological differences between patients with major depression and somatization syndrome. Psychiatry Res 2001;105:165-74.
62. Holsboer-Trachsler E, Brand S, Hatzinger M, Hemmeter U. Effects on hypericum extract on sleep EEG and Dex/CRH test in patients with depression. Biol Psychiatry 2001;49:9S.
63. Nickel T, Sonntag A, Schill J, Zobel AW, Ackl N, Brunnauer A, Murck H, Ising M, Yassouridis A, Steiger A, Zihl J, Holsboer F. Clinical and neurobiological effects of tianeptine and paroxetine in major depression. J Clin Psychopharmacol 2003;23:155-68.
64. Zobel AW, Nickel T, Sonntag A, Uhr M, Holsboer F, Ising M. Cortisol response in the combined dexamethasone/CRH test as predictor of relapse in patients with remitted depression. A prospective study. J Psychiatr Res 2001;35:83-94.
65. Allen LA, Woolfolk RL, Lehrer PM, Gara MA, Escobar JI. Cognitive behavior therapy for somatization disorder: a preliminary investigation. J Behav Ther Exp Psychiatry 2001;32:53-62.
66. Kendall PC, Pimentel SS. On the physiological symptom constellation in youth with Generalized Anxiety Disorder (GAD). J Anxiety Disord 2003;17:211-21.
67. Looper KJ, Kirmayer LJ. Behavioral medicine approaches to somatoform disorders. J Consult Clin Psychol 2002;70:810-27.
68. Hiller W, Fichter MM, Rief W. A controlled treatment study of somatoform disorders including analysis of healthcare utilization and costeffectiveness. J Psychosom Res 2003;54:369-80.
69. Allen LA, Gara MA, Escobar JI, Waitzkin H, Silver RC. Somatization: a debilitating syndrome in primary care. Psychosomatics 2001;42:63-7.
70. Davidson JR, Connor KM. St. John's wort in generalized anxiety disorder: three case reports. J Clin Psychopharmacol 2001;21:635-6.
71. Friede M, Wüstenberg P. Johanniskraut zur Therapie von Angstsyndromen bei depressiven Verstimmungen. Ztschr Phytother 1998;19:309-17.
72. Kasper S, Dienel A. Cluster analysis of symptoms during antidepressant treatment with Hypericum extract in mildly to moderately depressed out-patients. A meta-analysis of data from three randomized, placebo-controlled trials. Psychopharmacology 2002;164:301-8.