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Drug Res (Stuttg) 2021; 71(02): 83-93
DOI: 10.1055/a-1268-7135
Original Article

Kava (Piper methysticum) Extract for the Treatment of Nervous Anxiety, Tension and Restlessness

Results of an Open, Observational Study
Kenny Kuchta
1   Forschungsstelle für fernöstliche Medizin, Department of Vegetation Analysis and Phytodiversity, Albrecht von Haller Institute of Plant Sciences, Georg August University, Göttingen, Germany
,
Marie Hladikova
2   Department of Medical Informatics, 2nd Faculty of Medicine. Charles University, Prague, Czech Republic
,
Michael Thomsen
3   Discipline of Pharmacology, The University of Sydney Medical School, Sydney, New South Wales, Australia
,
Adolf Nahrstedt   *
4   Institute of Pharmaceutical Biology and Phytochemistry, University of Münster, Münster, Germany
,
Mathias Schmidt 
5   Herbresearch Germany, Tussenhausen, Germany
› Author Affiliations Funding The performance of the clinical study was supported by funds from Redinomedica AG and Harras Pharma Curarina Arzneimittel, who at the time of the study were the marketing authorization holders of the study preparation.
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Abstract

Aim Prior to the kava ban of 2002, the indication for kava (Piper methysticum) extracts defined by the German Commission E was “nervous anxiety, tension and restlessness”. In 2000, an observational trial was started in Germany with the aim of defining symptoms of these indications best treated with kava extract. The trial was interrupted and archived “unevaluated” in 2001 due to the upcoming safety debate on kava. The data from this study has now been analyzed in order to identify symptoms best treated with kava.

Methods Documentation was available from 156 patients. Twelve typical symptoms of nervous anxiety, tension and restlessness were assessed on a five-item rating scale, together with the therapeutic context, the perceived time of onset of effects and the safety of application.

Results The median duration of treatment was 28 days. All individual symptoms showed significant and clinically relevant improvements. The most effective results were seen for nervous tension and restlessness, with better effects in patients with acute versus chronic complaints. The safety of the treatment was found to be excellent, which included the assessment of laboratory data.

Conclusions Overall, the study confirms the effective and safe short-term use of kava in the Commission E-defined indication of “nervous anxiety, tension and restlessness”, especially in other than chronic cases. The clinical use of kava might be translated into context-related phobias according to ICD-10 F40, or to nervous tension (ICD10 R45.0) or restlessness and excitation (ICD-10 R45.1).

Key words

anxiolytic drugs - clinical trials - adverse drug reactions

* Since this trial, Prof. Dr. Nahrstedt has passed away. This study is dedicated to his memory.




Publication History

Received: 17 July 2020

Accepted: 07 September 2020

Article published online:
18 November 2020

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