FWD 2 Impact of Medicinal Dose of Kava vs. Benzodiazepine on Safe Driving

HerbalEGram: Volume 10, Number 9, September 2013

New Trial Tests Impact of Medicinal Dose of Kava vs. Oxazepam on Safe Driving


The root of kava (Piper methysticum) has a long history of medicinal and recreational use due to its anxiolytic effects, which previously led some in the scientific community to question whether kava preparations cause inebriation that could impair driving. For example, The German Commission E kava monograph, published in 1990, states on theoretical grounds, “Even when administered within its prescribed dosages, this herb may adversely affect motor reflexes and judgment for driving and/or operating heavy machinery.”1


In early 2013, the journal Traffic Injury Prevention published the results of a three-arm, randomized, placebo-controlled, double-blind trial intended to determine how a medicinal dose of kava affected the cognition and motor skills necessary for safe operation of a motor vehicle compared to benzodiazepines, a group of pharmaceutical drugs typically used to treat anxiety that includes Valium® and Xanax®.2


Twenty-two subjects of both sexes between the ages of 18 and 65 participated in the trial, which was conducted by the Brain and Psychological Sciences Research Centre at the Swinburne University of Technology in Melbourne, Australia, as part of the Kava Anxiety-Lowering Medication (KALM) Project. The patients suffered from mild-to-moderate anxiety, but were not using conventional antidepressants, antipsychotics, mood stabilizers, analgesics, opioids, or cannabis at the time of the trial. Tobacco smokers, individuals with a history of substance abuse/dependency, and those who had an adverse reaction to kava or benzodiazepines or who regularly used either substance in the preceding year were ineligible for participation in the trial. People with abnormal liver function and pregnant or possibly pregnant women (as well as those trying to conceive) also were excluded.

The kava preparation utilized in the study was MediHerb® Kava (Integria Healthcare; Warwick, Australia), which contains 60 mg of kavalactones per tablet and is manufactured as a water-extracted precipitate from Vanuatu noble cultivar peeled rootstock. High-performance liquid chromatography did not reveal the presence of pipermethystine — a kava alkaloid associated with hepatotoxicity — in the preparation.

All participants underwent a driving simulator practice session that lasted for 10 minutes. Then they were divided into three groups that were administered 180 mg kava, 30 mg of the benzodiazepine oxazepam, or placebo, after which they were instructed to relax for an hour-and-a-half. At that point, the patients participated in a 15-minute driving simulation and visual analog assessment.

Once a week for the two weeks that followed, each patient repeated the procedure in a different “arm” of the trial — meaning that by the end of three weeks, each of them had performed the simulation and testing on separate doses of kava, oxazepam, or placebo. On oxazepam, the participants exhibited slower braking time and more instances of lapsed concentration, although crashes occurred with the same frequency in all treatment groups.


“The shortcomings of the trial are that it is a medicinal dose and not the recreational dose employed by some individuals and should not be extrapolated to this,” said Reg Lehmann, PhD, adjunct associate professor of biological and chemical sciences at University of Queensland and
Manufacturing Technical Services Manager at Integria, who was not involved in the study (email, August 15, 2013). “The strengths of the study are also its weakness,” Dr. Lehmann added, “in that the challenges were repetitive rather than the totally unexpected [challenges] that you sometimes experience on the roadways.”

“I think that [this trial] is very significant in that it was a very well-designed double-blind crossover study in a clinical population (anxiety) using appropriate doses of two medicines used to treat the condition,” said Ethan Russo, MD, a neurologist and GW Pharmaceuticals Group Senior Medical Advisor (email, August 15, 2013).

“The population was appropriate,” he continued. “Higher doses could be tested, but that might represent a recreational use of kava vs. therapeutic. At some dose[s], a negative effect could be observed, but this study demonstrates that conventional doses appear to be quite safe, and more safe than a ‘conventional’ pharmaceutical.”

As to what the next logical step in this vein of kava research should be, Dr. Russo said a similar trial “could be done in actual vehicles with a blinded driving instructor, but this really may not contribute too much and would be more subjective than the simulator employed in this study.”

“A larger study using a more varied driving simulation,” said Dr. Lehmann, “would give more robust data than is found in this small 22 patient study under one challenge situation.”


—Ash Lindstrom


References

1. Blumenthal M, Busse WR, Goldberg A, Gruenwald J, Hall T, et al. The Complete German Commission E Monogaphs: Therapeutic Guide to Herbal Medicines. Austin, Texas: American Botanical Council; Boston, MA: Integrative Medicine Communications, 1998.

2. Sarris J, Laporte E, Scholey A, et al. Does a medicinal dose of kava impair driving? A randomized, placebo-controlled, double-blind study. Traffic Inj Prev. 2013;14(1):13-17.