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From the Department of Neurology, Ruhr-University Bochum, Germany (T.M.); Ad libitum Medical Services, Berlin, Germany (M.M.); Lichtwer Pharma GmbH, Berlin, Germany (H.M.); and idv – Datenanalyse und Versuchsplanung, Gauting, Germany (V.W.R).
Address correspondence and reprint requests to Dr. Thomas Müller, Department of Neurology, St. Josef-Hospital Bochum, Ruhr-University of Bochum, Gudrunstr. 56, D-44791 Bochum, Germany. E-mail: thomas.mueller{at}ruhr-uni-bochum.de
OBJECTIVE: To investigate efficacy and safety of St. John’s wort (SJW) LI 160 in somatoform disorders.
METHODS: In a prospective, randomized, placebo-controlled, and double-blind parallel group study, 184 outpatients with somatization disorder (ICD-10 F45.0), undifferentiated somatoform disorder (F45.1), and somatoform autonomic dysfunction (F45.3), but not major depression, received either 300 mg of SJW extract LI 160 twice daily or matching placebo for 6 weeks. Six outcome measures were evaluated as a combined measure by means of the Wei Lachin test: Somatoform Disorders Screening Instrument – 7 days (SOMS-7), somatic subscore of the HAMA, somatic subscore of the SCL-90-R, subscores "improvement" and "efficacy" of the CGI, and the global judgment of efficacy by the patient.
RESULTS: In the intention to treat population (N=173), for each of the six primary efficacy measures as well as for the combined test, statistically significant medium to large-sized superiority of SJW treatment over placebo was demonstrated (p <.0001). Of the SJW patients, 45.4% were classified as responders compared with 20.9% with placebo (p = .0006). Tolerability of SJW treatment was equivalent to placebo.
CONCLUSIONS: Administration of 600 mg of SJW extract LI 160 daily is effective and safe in the treatment of somatoform disorders, thereby confirming results from a previous study.
Key Words: somatoform disorders, • depression, • hypericum, • St. John’s wort, • LI 160, • clinical trial.
Abbreviations: SJW = St. John’s wort;; SSRI = selective serotonin reuptake inhibitor;; CBT = cognitive behavioral therapy;; GCP = good clinical practice;; GMP = good manufacturing practice;; IDCL = international diagnostic checklists;; ICD = international classification of diseases;; DSM = Diagnostic and Statistical Manual for Mental Disorders;; SOMS = Somatoform Disorders Screening Instrument;; HAMA-SOM = Hamilton Anxiety Scale, somatic subscore;; HAMA-PSY = Hamilton Anxiety Scale, psychic subscore;; HAMD = Hamilton Depression Rating Scale;; SAD = somatoform autonomic dysfunction;; SD = somatization disorder;; SCL-90-R-SOM = Symptom Check List 90 Revised, somatization subscore;; CGI = clinical global impression;; ITT = intention to treat (population/analysis);; PP = treated per protocol (population/analysis);; LVCF = last value carried forward;; MW = Mann-Whitney estimator;; CI = confidence interval.
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