Summary of: Kava-Kava Extract LI 150 Is as Effective as Opipramol and Buspirone in Generalized Anxiety Disorder: An 8-Week Randomized, Double-Blind Multi-Centre Clinical Trial in 129 out-Patients. Boerner et al. 2003
Citation: Boerner, R. J., H. Sommer, W. Berger, U. Kuhn, U. Schmidt, and M. Mannel. 2003. “Kava-Kava Extract LI 150 Is as Effective as Opipramol and Buspirone in Generalized Anxiety Disorder–an 8-Week Randomized, Double-Blind Multi-Centre Clinical Trial in 129 out-Patients.” Phytomedicine: International Journal of Phytotherapy and Phytopharmacology 10 Suppl 4: 38–49. https://doi.org/10.1078/1433-187x-00309.
Fast Summary:
- The document presents a randomized, double-blind, parallel-group, 8-week active phase multi-center outpatient trial to assess the efficacy and safety of Kava extract LI 150 in comparison with Buspirone and Opipramol in Generalized Anxiety Disorder (GAD). The study was conducted between August 1998 and July 1999 and involved 18 community doctors throughout Germany.
Full Summary:
Introduction
The study titled “Kava-Kava Extract LI 150 Is as Effective as Opipramol and Buspirone in Generalized Anxiety Disorder: An 8-Week Randomized, Double-Blind Multi-Centre Clinical Trial in 129 out-Patients” by Boerner et al. 2003 is a landmark research in the field of herbal medicine, particularly focusing on the treatment of Generalized Anxiety Disorder (GAD).
Background
Generalized Anxiety Disorder is a prevalent mental health condition characterized by persistent and excessive worry. Traditional treatments include pharmaceutical drugs like Opipramol and Buspirone. However, there has been a growing interest in herbal remedies, such as Kava extract, known for its calming effects.
Study Design
The study was meticulously designed as a randomized, double-blind, parallel-group, 8-week active phase multi-center outpatient trial. It aimed to assess the efficacy and safety of Kava extract LI 150 in comparison with Buspirone and Opipramol in treating GAD. Conducted between August 1998 and July 1999, it involved 18 community doctors throughout Germany.
Patients
A total of 138 subjects underwent screening procedures, out of which 129 met all the inclusion criteria and were randomized. The study specifically included patients diagnosed with GAD according to ICD-10 criteria.
Methodology
The methodology was comprehensive, involving various rating scales, adverse events assessments, concomitant therapies, vital signs, physical exams, blood chemistry, and hematology. Efficacy rating scales were assessed at all visits from week 0 to week 9, ensuring a thorough evaluation of the treatment’s impact.
Results
Efficacy
The study found that Kava extract LI 150 was not only effective in treating GAD but also showed positive results in alleviating anxiety symptoms. This finding is significant as it places a herbal extract on par with established pharmaceutical treatments.
Safety
One of the critical aspects of the study was the safety assessment. No significant hepatotoxic reactions were reported in about 330 treatment weeks with Kava LI150. This is vital, considering previous concerns about liver damage possibly related to Kava intake.
Comparison with Other Treatments
The study went further to compare Kava extract with Buspirone and Opipramol, providing valuable insights into the relative efficacy and safety of these treatments. The comparison is essential for clinicians to make informed decisions about treatment options.
Conclusion
The study concludes with valuable evidence that patients suffering from GAD may benefit from acute treatment with Kava. The positive attitude of the majority of patients towards the herbal drug should be considered in future benefit/risk assessments, emphasizing the potential role of herbal medicine in mental health treatment.
Notes
Hepatotoxicity Concerns
The study explicitly addresses concerns about liver damage possibly related to Kava intake, emphasizing that no significant hepatotoxic reactions were reported in this trial. This finding is reassuring for both patients and practitioners.
Clinical Relevance
The study’s findings contribute significantly to the understanding of Kava’s potential therapeutic effects in the context of anxiety disorders. It provides valuable insights for clinicians and researchers, paving the way for more extensive acceptance and usage of herbal remedies.
Funding
The study was funded by a grant from Lichtwer Pharma AG, Berlin, Germany, reflecting the growing interest and investment in herbal medicine research.
Final Thoughts
The Boerner et al. study is a significant contribution to the field of herbal medicine, particularly in the treatment of Generalized Anxiety Disorder. By demonstrating the efficacy and safety of Kava extract, it opens new avenues for treatment and underscores the importance of considering herbal remedies as viable options in mental health care. It also sets a precedent for future research, encouraging a more holistic approach to mental health treatment that includes traditional medicine alongside pharmaceutical options.
