Barton DL, et al. 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). J Support Oncol. 2011;9:24-31.
In this RCT, a total of 227 patients with various cancers who reported difficulty sleeping were randomized to receive either valerian 450 mg or placebo 1 hour prior to bedtime for 8 weeks. Although single doses in studies have ranged from 400–900 mg at bedtime, investigators chose to evaluate 450 mg because of older dose-finding trials that suggested 900 mg was not significantly better than 450 mg (52) (53). The primary endpoint was the averaged area under the curve (AUC) of the overall Pittsburgh Sleep Quality Index (PSQI) score. Secondary endpoints included the Functional Outcomes of Sleep Questionnaire, the Brief Fatigue Inventory (BFI), and the Profile of Mood States (POMS). Toxicity was evaluated with self-reported numeric analogue scale questions and the Common Terminology Criteria for Adverse Events (CTCAE), version 3.0. Questionnaires were completed at baseline and 4 and 8 weeks. In 119 patients evaluable for the primary endpoint over 8 weeks, valerian AUC was nonsignificant compared with placebo (51.4 vs 49.7; P=.6957). However, BFI and POMS analysis indicated that several secondary endpoints were significantly better for those taking valerian vs placebo including fatigue, sleep problems, sleep latency, and amount of sleep per night. The intervention group also reported less drowsiness. There were no significant differences in toxicities except for mild alkaline phosphatase increases, which were slightly more common in the placebo group. Although this study does not support that nighttime valerian 450 mg could improve sleep as measured by the PSQI, secondary endpoint results using other validated scales did indicate some beneficial effects, and only 52% of initial participants were fully evaluable. Further research to evaluate the possible physiologic effects and safety of valerian in oncology symptom management may be warranted.
Mirabi P, Mojab F. The effects of valerian root on hot flashes in menopausal women. Iran J Pharm Res. 2013;12:217-222.
In this randomized double-blind study, 68 menopausal women with the main complaint of hot flashes received either valerian capsules 255 mg 3 times daily for 8 weeks or placebo. Severity and frequency of hot flashes were measured and recorded through questionnaires and information forms at 3 time points: 2 weeks pre-intervention and 4 and 8 weeks post-intervention. There was a statistically significant reduction in severity of hot flashes post-valerian treatment (P<.001) with significant between-group differences (P<.001). Valerian also reduced the number of hot flashes at 4 and 8 weeks post-treatment (P<.001) with no between-group difference in side effects. Investigators concluded that valerian may be useful to treat hot flashes in menopausal women and as a potential alternative to hormone therapy.
Taavoni S, et al. Effect of valerian on sleep quality in postmenopausal women: a randomized placebo-controlled clinical trial. Menopause. 2011;18:951-955.
This randomized, triple-blind, controlled trial evaluated valerian extract on the improvement of sleep quality in 100 postmenopausal women experiencing insomnia. Women aged 50–60 years received either valerian extract 530 mg or placebo twice daily for 4 weeks. Demographic data and the Pittsburgh Sleep Quality Index were used in evaluation. Change in sleep quality with valerian versus placebo was statistically significant (P<.001), with approximately 30% of intervention participants showing an improvement. Investigators concluded that valerian may be useful in the clinical management of insomnia in postmenopausal women.
Oxman AD, et al. A televised, web-based randomised trial of an herbal remedy (valerian) for insomnia. PLoS One. 2007;2:e1040.
In this randomized double-blind placebo-controlled study, 405 participants with insomnia were recruited via television and the internet. Participants were mailed valerian 200-mg tablets or placebo and instructed to take 3 tablets 1 hour before bedtime for 2 weeks. Although no differences in self-reported sleep quality were detected, participants using the intervention reported better outcomes on the global self-assessment question. Trends toward improved sleep duration and reduced night awakening were also observed. The authors concluded that valerian had modest effects on sleep quality compared with placebo. Because the optimal dose of valerian is unknown, whether larger dosages could safely increase benefits also requires further study.