A randomized, double-blind, placebo-controlled trial of eszopiclone for the
treatment of insomnia in patients with chronic low back pain.
Author(s): Goforth HW(1), Preud'homme XA(2), Krystal AD(1).
Affiliation(s): Author information:
(1)Assistant Professor of Medicine and Psychiatry, Duke Insomnia and Sleep Research
Program, Duke University Medical Center; Attending Physician (GRECC), Durham
Veterans Affairs Medical Center, Durham, NC.
(2)Assistant Professor of Medicine and Psychiatry, Duke Insomnia and Sleep Research
Program, Duke University Medical Center, Durham, NC.
Publication date & source: 2014, Sleep. , 37(6):1053-60
STUDY OBJECTIVES: Insomnia, which is very common in patients with chronic low
back pain (LBP), has long been viewed as a pain symptom that did not merit
specific treatment. Recent data suggest that adding insomnia therapy to
pain-targeted treatment should improve outcome; however, this has not been
empirically tested in LBP or in any pain condition treated with a standardized
pain medication regimen. We sought to test the hypothesis that adding insomnia
therapy to pain-targeted treatment might improve sleep and pain in LBP.
DESIGN: Double-blind, placebo-controlled, parallel-group, 1-mo trial.
SETTING: Duke University Medical Center Outpatient Sleep Clinic.
PATIENTS: Fifty-two adult volunteers with LBP of at least 3 mo duration who met
diagnostic criteria for insomnia (mean age: 42.5 y; 63% females).
INTERVENTIONS: Subjects were randomized to eszopiclone (ESZ) 3 mg plus naproxen
500 mg BID or matching placebo plus naproxen 500 mg twice a day.
MEASUREMENTS AND RESULTS: ESZ SIGNIFICANTLY IMPROVED TOTAL SLEEP TIME (MEAN
INCREASE: ESZ, 95 min; placebo, 9 min) (primary outcome) and nearly all sleep
measures as well as visual analog scale pain (mean decrease: ESZ, 17 mm; placebo,
2 mm) (primary pain outcome), and depression (mean Hamilton Depression Rating
Scale improvement ESZ, 3.8; placebo, 0.4) compared with placebo. Changes in pain
ratings were significantly correlated with changes in sleep.
CONCLUSIONS: The addition of insomnia-specific therapy to a standardized naproxen
pain regimen significantly improves sleep, pain, and depression in patients with
chronic low back pain (LBP). The findings indicate the importance of
administering both sleep and pain-directed therapies to patients with LBP in
clinical practice and provide strong evidence that improving sleep disturbance
may improve pain.
TRIAL REGISTRATION: clinicaltrials.gov identifier: NCT00365976.
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