Yvonne C Lee1, Elena Massarotti2, Robert R Edwards2, Bing Lu2, ChihChin Liu2, Yuanyu Lo2, Alyssa Wohlfahrt2, Nancy D Kim2, Daniel J Clauw2, Daniel H Solomon2. 1. From the Division of Rheumatology, Immunology and Allergy, and Department of Anesthesiology, Brigham and Women's Hospital; Division of Rheumatology, Immunology and Allergy, Massachusetts General Hospital, Boston, Massachusetts; Department of Anesthesiology, University of Michigan Medical Center, Ann Arbor, Michigan, USA.Y.C. Lee, MD, MMSc, Division of Rheumatology, Department of Medicine, Brigham and Women's Hospital; E. Massarotti, MD, Division of Rheumatology, Brigham and Women's Hospital; R.R. Edwards, PhD, Pain Management Center, Brigham and Women's Hospital; B. Lu, MD, DrPH, Division of Rheumatology, Brigham and Women's Hospital; C. Liu, PhD, Division of Rheumatology, Brigham and Women's Hospital; Y. Lo, MPH, Division of Rheumatology, Brigham and Women's Hospital; A. Wohlfahrt, BA, Division of Rheumatology, Brigham and Women's Hospital; N.D. Kim, MD, Division of Rheumatology, Immunology and Allergy, Massachusetts General Hospital; D.J. Clauw, MD, University of Michigan; D.H. Solomon, MD, MPH, Division of Rheumatology, Brigham and Women's Hospital. ylee9@partners.org. 2. From the Division of Rheumatology, Immunology and Allergy, and Department of Anesthesiology, Brigham and Women's Hospital; Division of Rheumatology, Immunology and Allergy, Massachusetts General Hospital, Boston, Massachusetts; Department of Anesthesiology, University of Michigan Medical Center, Ann Arbor, Michigan, USA.Y.C. Lee, MD, MMSc, Division of Rheumatology, Department of Medicine, Brigham and Women's Hospital; E. Massarotti, MD, Division of Rheumatology, Brigham and Women's Hospital; R.R. Edwards, PhD, Pain Management Center, Brigham and Women's Hospital; B. Lu, MD, DrPH, Division of Rheumatology, Brigham and Women's Hospital; C. Liu, PhD, Division of Rheumatology, Brigham and Women's Hospital; Y. Lo, MPH, Division of Rheumatology, Brigham and Women's Hospital; A. Wohlfahrt, BA, Division of Rheumatology, Brigham and Women's Hospital; N.D. Kim, MD, Division of Rheumatology, Immunology and Allergy, Massachusetts General Hospital; D.J. Clauw, MD, University of Michigan; D.H. Solomon, MD, MPH, Division of Rheumatology, Brigham and Women's Hospital.
Abstract
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.
RCT Entities:
OBJECTIVE: Clinical trials have shown that serotoninnorepinephrine 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.
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