CLINICAL RESEARCH POSTER PRESENTATION ABSTRACTS
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Salons 10-12.
THURSDAY, 5:30-6:15 PM
Taibi DM, Bourguignon C, Taylor AG.
A randomized clinical trial of the effects of Valerian
on sleep disturbances in persons with arthritis.
University of Washington School of Nursing dmtaibi@u.washington.edu
PURPOSE: This pilot study was a double-blind,
placebo-controlled, randomized clinical trial to investigate whether
or not the valerian root extract, an herbal supplement, reduced sleep
disturbances in persons with arthritis.
METHODS: Participants were randomly assigned
to receive either valerian extract (600 mg) or a placebo (600 mg vegetable
oil). Sleep outcomes were measured for eight days, including three days
of baseline measurement and five days using the intervention one hour
before bedtime. Objective sleep outcomes (sleep efficiency, number of
awakenings, and sleep latency) were measured wrist actigraphs. Subjective
sleep outcomes (sleep quality and estimated sleep latency) and daily
pain were measured using daily diaries. Serum was collected for liver
function tests and C-reactive protein (to measure general inflammation)
at baseline and follow-up.
RESULTS: Fifteen participants were recruited
from physicians' offices and the community in central Virginia. Primary
analyses did not demonstrate significant effects on sleep efficiency,
awakenings, subjective sleep latency, or sleep quality. Significant
differences were found over time in objective sleep latency (p=.03),
but latency was higher in the valerian group. This result may have occurred
due to low baseline sleep latency. No clinically important changes occurred
in the primary sleep outcomes. However, a greater proportion of persons
in the valerian group than the placebo group believed that they received
the valerian or were unsure (71.6% versus 50%), indicating that valerian
may have exerted perceivable effects that were not evident on the outcomes
used in this study. Secondary analyses supported the safety of valerian.
Side effects were infrequent and mild. Liver function tests and C-reactive
protein were unchanged by valerian.
CONCLUSIONS: Overall, these findings did not
demonstrate that valerian effectively reduced sleep disturbances in
the current sample of persons with arthritis. Various study limitations,
particularly high intra-individual variability in sleep outcomes and
use of a short supplementation period, may have reduced the sensitivity
of the analyses in detecting potential treatment effects. However, the
study supported the safety and tolerability of valerian and the feasibility
of the study design. It remains possible that valerian could be useful
as a mild sleep aid in this population, but further research is needed
to support use of this herbal supplement as a sleep aid and to guide
clinical recommendations.
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