Clinical trials with Phyto-Psychopharmacological agents
V Schulz1, W D Hübner, M Ploch
1Lichtwer-Pharma GmbH, Berlin, Germany.
Summary
Phyto-psychopharmacological agents, plant extracts affecting the central nervous system, are widely used. Clinical trials demonstrate their efficacy and safety, with fewer side effects than synthetic options.
Area of Science:
- Pharmacology
- Neuroscience
- Herbal Medicine
Background:
- Phyto-psychopharmacological agents are plant extracts influencing the central nervous system.
- These herbal medicines are frequently prescribed in Germany.
- Established clinical trials support the efficacy and safety of some preparations.
Purpose of the Study:
- To review the clinical evidence for phyto-psychopharmacological agents.
- To compare their efficacy and safety with synthetic psychopharmacological drugs.
- To discuss the impact of increasing clinical trial standards on herbal medicine research.
Main Methods:
- Review of published clinical studies on specific herbal extracts like Ginkgo (EGb 761, LI 1370), St. John's Wort, kava, and valerian.
- Analysis of data from trials involving thousands of patients.
- Consideration of placebo effects and the necessity of control groups.
Main Results:
- Extensive clinical data exists for Ginkgo and St. John's Wort preparations.
- Kava and valerian efficacy has been investigated in controlled studies.
- Phyto-psychopharmacological agents exhibit a low incidence of side effects (<3%) compared to synthetic alternatives.
Conclusions:
- High-quality clinical trials have confirmed the efficacy and safety of certain phyto-psychopharmacological agents.
- The low side-effect profile is a significant advantage over synthetic psychotropic drugs.
- Rising clinical trial standards may hinder further research and development of these valuable herbal medicines.
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