St John's wort extract (LI 160) in somatoform disorders: results of a placebo-controlled trial |
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Authors: | Volz Hans-Peter Murck Harald Kasper Siegfried Möller Hans-Jürgen |
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Institution: | Psychiatric Department, University of Jena, Philosophenweg 3, 07740 Jena, Germany. volz.werneck@t-online.de |
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Abstract: | Abstract
Rationale and objective. Preliminary data have shown that St John's wort might possess some specific efficacy in patients with somatoform complaints.
Therefore, the efficacy of the Hypericum extract LI 160 in patients with somatoform disorders should be studied in a double-blind
placebo-controlled fashion.
Methods. This was a multicentre, randomised, placebo controlled, 6-week trial comparing the efficacy of LI 160 (600 mg/day) and placebo
in 151 out-patients suffering from somatization disorder (ICD-10: F45.0), undifferentiated somatoform disorder (F45.1), or
somatoform autonomic dysfunctions (F45.3). The primary outcome measure was the decrease of the Hamilton Anxiety Scale, subfactor
somatic anxiety (HAMA-SOM), during the trial period.
Results. LI 160 was superior effective concerning the primary outcome criterion HAMA-SOM decrease from 15.39 (SD 2.68) to 6.64 (4.32)
in the Hypericum group and from 15.55 (2.94) to 11.97 (5.58) in the placebo group (statistically significant difference, P=0.001)]. This was corroborated by the result of a statistically significant superior efficacy in the outcome criteria additionally
used such as Clinical Global Impression, HAMA-total score, HAMA, subscore psychic anxiety, Hamilton Depression Scale, Self-Report
Symptom Inventory 90 items – revised (SCL-90-R), and SCL-90-R, subscore somatic anxiety. The efficacy of LI 160 was preserved
after splitting the population in those with mild and those with severe depressive symptoms. Tolerability of LI 160 was excellent.
Conclusion. The data from this trial show excellent efficacy and tolerability for LI 160 in somatoform disorders. The efficacy is independent
of an existing depressive mood. This is the first study showing the efficacy of a drug in patients with somatisation disorder
independent of depressive symptomatology.
Electronic Publication |
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Keywords: | Somatoform disorders St John's wort LI 160 Placebo-controlled double blind trial Efficacy Safety |
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