What's new

Kava Fact of the Day Kava fact of the day: Another note to kava's safety.

The Kap'n

The Groggy Kaptain (40g)
KavaForums Founder
"Kava was shown in the clinical trials to be exceptionally safe. There was no major adverse event, and especially no hint to hepatic adverse events in 14,114 patients and healthy subjects exposed to kava preparations. The observation of gamma-glutamyl transaminase (GGT) and alkaline phosphatase (AP) elevations reported in heavy kava drinkers (Cairney et al., 2003a, 2003b) does not count as hepatotoxicity, as firstly a high percentage of the non-kava drinkers also showed elevations, and secondly the indicators of hepatotoxicity, i.e., the transaminases alanine aminotransferase (ALT) and aspartate aminotransferase (AST) were not elevated. Overall, the safety profile deducible from clinical studies is benign and certainly does not confirm a hepatic risk."

Thomsen M, Schmidt M. Health policy versus kava (Piper methysticum): Anxiolytic efficacy may be instrumental in restoring the reputation of a major South Pacific crop. J Ethnopharmacol. 2020 Nov 12:113582. doi: 10.1016/j.jep.2020.113582. Epub ahead of print. PMID: 33189846.
 

kavakarma

Kava Enthusiast
"no hint to hepatic adverse events in 14,114 patients and healthy subjects exposed to kava preparations.
Sounds like water extract. Is this the same reference? https://pubmed.ncbi.nlm.nih.gov/33189846/
1-s2.0-S037887412033470X-fx1_lrg.jpg

.
Aim of the study: The correlation between clinical benefits and the type of extract preparation was examined.
Methods: In order to identify the types of kava material and extracts used in clinical trials, the respective publications were compared with regulatory databases and protocols of a German regulatory advisory board.
Results and conclusions: The comparison reveals inconsistencies in the regulatory decisions. In all studies with WS 1490, the evidence points to the use of an ethanolic extract. The efficacy of kava extract for the approved indication was clearly demonstrated. The HMPC report and the recent renewed German regulatory ban of kava therefore require major revision, which should include the impact of the use of "two-day kava" on drug safety. Such a revision could contribute to restoring the reputation of "noble kava" on the international markets.
Keywords: Efficacy; Noble kava; Piper methysticum; Quality; Two-day kava.
 

The Kap'n

The Groggy Kaptain (40g)
KavaForums Founder
Sounds like water extract. Is this the same reference? https://pubmed.ncbi.nlm.nih.gov/33189846/
View attachment 10979
.
Aim of the study: The correlation between clinical benefits and the type of extract preparation was examined.
Methods: In order to identify the types of kava material and extracts used in clinical trials, the respective publications were compared with regulatory databases and protocols of a German regulatory advisory board.
Results and conclusions: The comparison reveals inconsistencies in the regulatory decisions. In all studies with WS 1490, the evidence points to the use of an ethanolic extract. The efficacy of kava extract for the approved indication was clearly demonstrated. The HMPC report and the recent renewed German regulatory ban of kava therefore require major revision, which should include the impact of the use of "two-day kava" on drug safety. Such a revision could contribute to restoring the reputation of "noble kava" on the international markets.
Keywords: Efficacy; Noble kava; Piper methysticum; Quality; Two-day kava.
You're correct, that's the reference article.
 
Top