Oxazepam

Recent publications appear to have answered several important questions for valerian root:

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* Does valerian impair cognitive function or cause excessive sedation?

* How does its efficacy compare to benzodiazepine drugs?

* Is valerian safe and effective for children?

In an Australian study, nine healthy volunteers received single doses of either valerian root (1000mg or 500mg), the drug triazolam (0.25mg) or placebo in a double-blind, placebo-controlled, crossover trial. (1) Results confirmed that while triazolam had a detrimental effect on cognitive processes, the valerian was without effect. Another study compared even higher doses of valerian (600, 1200 and 1800mg of a 5:1 extract) with 10mg diazepam and placebo in a clinical trial of similar design. (2) Again an impairment of performance occurred for the benzodiazepine drug whereas the valerian had no impact on any parameters tested. A third study found that valerian (400mg and 800mg) was not different from placebo on any measure used of psychomotor performance or sedation. (3)

Patients aged 18 to 73 years and diagnosed with non-organic insomnia were treated in a multicentre, double-blind, randomized parallel group comparison with either 600 mg/day of valerian extract (5:1) or 10 mg/day oxazepam taken for 6 weeks. (4) A total of 202 outpatients with a mean duration of insomnia of 3.5 months at baseline were included. Sleep quality after 6 weeks showed that valerian extract was at least as efficacious as treatment with oxazepam. Both treatments markedly increased sleep quality compared with baseline (p<0.01). Adverse events occurred in 29 patients (28.4%) receiving valerian extract and 36 patients (36.0%) under oxazepam, and were all rated mild to moderate. No serious adverse reactions were reported in either group. Most patients assessed their respective treatment as very good (82.8% in the valerian group, 73.4% in the oxazepam group).

Another smaller trial of similar design compared the effect of the same dose of valerian with 10mg oxazepam over 4 weeks in 75 patients with non-organic insomnia. (5) The study showed no differences between the efficacy of valerian and oxazepam.

The efficacy and tolerability of a valerian extract preparation were investigated in an open, observational study on children aged to 6 to 12 years. (6) An average daily dosage of 2 tablets (range 1 to 4) tablets containing 300mg of 5:1 extract was administered to 130 children suffering from nervous sleep disturbances and/or nervous tension over a period of 4 weeks. Therapeutic efficacy was estimated by parents and physicians as good to very good in 95% of cases. A side effect (tiredness in the morning) was reported in only one case, which disappeared after dose adjustment.

Commentary

Unlike the benzodiazepine drugs, valerian clearly does not cause sedation or impairment of functioning in healthy volunteers. But this could be attributed to valerian having no activity on the nervous system (as detractors of phytotherapy would no doubt assert). Hence, it is pertinent that a well-designed trial found valerian to be just as effective as a benzodiazepine drug in the alleviation of non-organic insomnia. (Non-organic insomnia is characterized by a chronic, psychological impairment of the ability to initiate or maintain sleep which leads to a preoccupation with insomnia and impairment of functioning during the day.) The open trial in children also provides proof of safety here, but its efficacy should now be established in a randomized, controlled trial.

References

1. Hallam KT, Olver JS, McGrath C et al. Comparative cognitive and psychomotor effects of single doses of Valeriana officinalis and triazolam in healthy volunteers. Hum Psychopharmacol 2003; 18(8):619-625

2. Gutierrez S, Ang-Lee MK, Walker DJ et al. Assessing subjective and psychomotor effects of the herbal medication valerian in healthy volunteers. Pharmacol Biochem Behav 2004; 78(1):57-64

3. Glass JR, Sproule BA, Herrmann N et al. Acute pharmacological effects of temazepam, diphenhydramine, and valerian in healthy elderly subjects. J Clin Psychopharmacol 2003; 23(3):260-268

4. Ziegler G, Ploch M., Miettinen-Baumann A et al. Efficacy and tolerability of valerian extract LI 156 compared with oxazepam in the treatment of non-organic insomnia--a randomized, double-blind, comparative clinical study. Eur J Med Res 2002; 7(11):480-486

5. Dorn M. Wirksamkeit und vertr[per thousand]glichkeit von baldrian versus oxazepam bei nichtorganischen und nichtpsychiatrischen insomnien: Eine randomisierte, doppelblinde, klinische vergleichsstudie. Forsch Komplementarmed Klass Naturheilkd 2000; 7: 79-84.

6. Hintelmann C. Einschlafstorungen bei kindern unter 12 jahren. Z Phytother 2002; 23:60-61

by Kerry Bone, FNIMH, FNHAA

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