Barton, D. L., Atherton, P. J., Bauer, B. A., Moore, D. F., Jr., Mattar, B. I., Lavasseur, B. I., . . . Loprinzi, C. L. (2011). The use of Valeriana officinalis (Valerian) in improving sleep in patients who are undergoing treatment for cancer: a phase III randomized, placebo-controlled, double-blind study (NCCTG Trial, N01C5). Journal of Supportive Oncology, 9, 24–31.doi: 10.1016/j.suponc.2010.12.008
To assess the effect of a standardized preparation of valerian in improving sleep in patients undergoing therapy for cancer.
Patients receiving therapy for cancer who reported sleep difficulty of 4 or greater on a scale of 0 to 10 with a life expectancy of more than six months and an Eastern Cooperative Oncology Group (ECOG) performance score of 0 or 1 were included. Patients were randomized to receive 450 mg of oral valerian or placebo to be taken one hour before bed for eight weeks. Valerian capsules used contained 0.8% of valerenic acid. Valerian and placebo capsules were stored together so the placebo capsules would have a similar smell to the valerian capsules. Study measures were completed at baseline and four and eight weeks. Toxicity was assessed every two weeks using the Common Terminology Criteria for Adverse Events (CTCAE).
Patients were undergoing the active treatment phase of care.
The study was a randomized, controlled trial.
Total PSQI scores were not significantly different between the two groups over time. Although fewer patients in the valerian group reported sleep problems at week 8 than patients in the placebo group (64% versus 80%), no statistically significant changes in sleep problems were observed from baseline to week 8 in either group. Amount of sleep was significantly improved in the valerian group from baseline to week 4 (p = 0.008), but not from week 4 to week 8. Statistically significant improvement was observed in the valerian group in sleep latency, and 43% of patients reported reduced time to fall asleep compared to 32% of patients in the placebo group.
The Fatigue Inertia subscale of the POMS was significantly different from weeks 4 (p = –0.004) and 8 (p = 0.02), with better scores reported in the valerian group. The valerian group also scored significantly better from baseline to weeks 4 and 8 on the Fatigue Now subscale (p = 0.003 and p = 0.01, respectively) and the Usual Fatigue subscale (p = 0.02 and p = 0.046, respectively) of the BFI.
No significant differences were observed between groups for self-reported side effects at any of the data collection points. The placebo arm reported a significantly higher incidence of grade 1 alkaline phosphatase toxicity (p = 0.049).
The study showed that valerian provides no statistically significant improvement in sleep quality in patients undergoing treatment for cancer. Additional study on the effects of valerian on daytime fatigue may be warranted.
The study findings do not support the use of valerian in patients with cancer and insomnia. Additional study is needed to determine the effects of valerian on fatigue in this patient population.