RT Journal Article
SR Electronic
T1 Effect of Milnacipran on Pain in Patients with Rheumatoid Arthritis with Widespread Pain: A Randomized Blinded Crossover Trial
JF The Journal of Rheumatology
JO J Rheumatol
FD The Journal of Rheumatology
SP 38
OP 45
DO 10.3899/jrheum.150550
VO 43
IS 1
A1 Yvonne C. Lee
A1 Elena Massarotti
A1 Robert R. Edwards
A1 Bing Lu
A1 ChihChin Liu
A1 Yuanyu Lo
A1 Alyssa Wohlfahrt
A1 Nancy D. Kim
A1 Daniel J. Clauw
A1 Daniel H. Solomon
YR 2016
UL http://www.jrheum.org/content/43/1/38.abstract
AB Objective. Clinical trials have shown that serotonin norepinephrine reuptake inhibitors, such as milnacipran, decrease pain in noninflammatory pain conditions such as fibromyalgia and osteoarthritis. We examined the effect of milnacipran on self-reported pain intensity and experimental pain sensitivity among patients with rheumatoid arthritis (RA) with widespread pain and stable RA disease activity.Methods. In this double-blind, crossover study, patients with RA with widespread pain, receiving a stable treatment regimen, were randomized (by a random number generator) to receive milnacipran 50 mg twice daily or placebo for 6 weeks, followed by a 3-week washout and crossed over to the other arm for the remaining 6 weeks. The primary outcome was change in average pain intensity, assessed by the Brief Pain Inventory short form. The sample size was calculated to detect a 30% improvement in pain with power = 0.80 and α = 0.05.Results. Of the 43 randomized subjects, 41 received the study drug, and 32 completed the 15-week study per protocol. On a 0–10 scale, average pain intensity decreased by 0.39 (95% CI −1.27 to 0.49, p = 0.37) more points during 6 weeks of milnacipran treatment compared with placebo. In the subgroup of subjects with swollen joint count ≤ 1, average pain intensity decreased by 1.14 more points during 6 weeks of milnacipran compared with placebo (95% CI −2.26 to −0.01, p = 0.04). Common adverse events included nausea (26.8%) and loss of appetite (9.7%).Conclusion. Compared with placebo, milnacipran did not improve overall, self-reported pain intensity among subjects with widespread pain receiving stable RA medications. Trial registration: ClinicalTrials.gov NCT01207453.