Abstract
A randomized, double-blind, placebo-controlled trial was conducted to determine the
benefit of nabilone in pain management and quality of life improvement in 40 patients
with fibromyalgia. After a baseline assessment, subjects were titrated up on nabilone,
from 0.5 mg PO at bedtime to 1 mg BID over 4 weeks or received a corresponding placebo.
At the 2- and 4-week visits, the primary outcome measure, visual analog scale (VAS)
for pain, and the secondary outcome measures, number of tender points, the average
tender point pain threshold, and the Fibromyalgia Impact Questionnaire (FIQ), were
evaluated. After a 4-week washout period, subjects returned for reassessment of the
outcome measures. There were no significant differences in population demographics
between groups at baseline. There were significant decreases in the VAS (−2.04, P < .02), FIQ (−12.07, P < .02), and anxiety (−1.67, P < .02) in the nabilone treated group at 4 weeks. There were no significant improvements
in the placebo group. The treatment group experienced more side effects per person
at 2 and 4 weeks (1.58, P < .02 and 1.54, P < .05), respectively. Nabilone appears to be a beneficial, well-tolerated treatment
option for fibromyalgia patients, with significant benefits in pain relief and functional
improvement.
Perspective
To our knowledge, this is the first randomized, controlled trial to assess the benefit
of nabilone, a synthetic cannabinoid, on pain reduction and quality of life improvement
in patients with fibromyalgia. As nabilone improved symptoms and was well-tolerated,
it may be a useful adjunct for pain management in fibromyalgia.
Key words
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Article info
Publication history
Published online: November 02, 2007
Accepted:
September 26,
2007
Received in revised form:
August 27,
2007
Received:
April 19,
2007
Footnotes
Supported by an unrestricted research grant provided by Valeant Canada Limited and an HSC Medical Staff Council Fellowship Fund. Valeant Canada Limited had no involvement in study design, interaction with patients, patient assessments, data analysis, or the authorship of this paper.
Identification
Copyright
© 2008 American Pain Society. Published by Elsevier Inc. All rights reserved.
