sensations.
J Rheumatol. 2011 Sep 1. [Epub ahead of print]
Effects of Bedtime Very Low Dose Cyclobenzaprine on Symptoms and Sleep
Physiology in Patients with Fibromyalgia Syndrome: A Double-blind
Randomized Placebo-controlled Study.
Moldofsky H, Harris HW, Archambault WT, Kwong T, Lederman S.
From the Sleep Disorders Clinics of the Centre for Sleep and
Chronobiology, University of Toronto, Toronto, Ontario, Canada.
Abstract
OBJECTIVE:
To determine the effects of bedtime very low dose (VLD)
cyclobenzaprine (CBP) on symptoms and sleep physiology of patients
with fibromyalgia (FM), unrefreshing sleep, and the =CE=B1-nonREM sleep
electroencephalographic (EEG) anomaly at screening.
METHODS:
Of 37 patients with FM in the screened population, 36 were randomized
and treated in this 8-week, double-blind, placebo-controlled,
dose-escalating study of VLD CBP 1-4 mg at bedtime. We evaluated
changes in subjective symptoms including pain, tenderness, fatigue,
mood [Hospital Anxiety and Depression Scale (HAD)], and objective EEG
sleep physiology (at screening, baseline, and Weeks 2, 4, and 8).
RESULTS:
In the VLD CBP-treated group (n =3D 18) over 8 weeks, musculoskeletal
pain and fatigue decreased, tenderness improved; total HAD score and
the HAD depression subscore decreased; patient-rated and
clinician-rated fatigue improved.
In the placebo-treated group (n =3D 18), none of these outcome measures
changed significantly.
Compared to placebo at 8 weeks, VLD CBP significantly improved pain,
tenderness, and the HAD Depression subscore. Analysis of cyclic
alternating pattern (CAP) sleep EEG revealed that significantly more
subjects in the VLD CBP group than the placebo group had increased
nights of restorative sleep in which CAP(A2+A3)/CAP(A1+A2+A3) =3D
CAP(A2+A3(Norm)) =E2=89=A4 33%. For VLD CBP-treated subjects, the increase =
in
nights with CAP(A2+A3(Norm)) =E2=89=A4 33% was correlated to improvements i=
n
fatigue, total HAD score, and HAD depression score.
CONCLUSION:
Bedtime VLD CBP treatment improved core FM symptoms. Nights with
CAP(A2+A3(Norm)) =E2=89=A4 33% may provide a biomarker for assessing treatm=
ent
effects on nonrestorative sleep and associated fatigue and mood
symptoms in persons with FM.
---------------------------------------------
Send posts to CO-CURE@listserv.nodak.edu
Unsubscribe at http://www.co-cure.org/unsub.htm
---------------------------------------------
Co-Cure's purpose is to provide information from across the spectrum of
opinion concerning medical, research and political aspects of ME/CFS and/or
FMS. We take no position on the validity of any specific scientific or
political opinion expressed in Co-Cure posts, and we urge readers to
research the various opinions available before assuming any one
interpretation is definitive. The Co-Cure website <www.co-cure.org> has a
link to our complete archive of posts as well as articles of central
importance to the issues of our community.
---------------------------------------------
