Theodore R Brown1, April Slee1. 1. MS Center at Evergreen, Evergreen Health, Kirkland, WA, USA (TRB); and Axio Research, LLC, Seattle, WA, USA (AS).
Abstract
BACKGROUND: Pain is common in multiple sclerosis (MS). Duloxetine has a potential therapeutic role in treating MS-related pain. METHODS:Thirty-eight MS patients were randomized 1:1 to receive duloxetine (n = 18) or matched placebo (n = 20). The dosing regimen was 30 mg daily for 1 week, then 60 mg daily for 5 weeks. The primary outcome measure was change in worst pain for week 6 relative to baseline recorded on a daily pain diary. RESULTS: Of 38 randomized patients, 14 (78%) patients randomized to duloxetine and 18 (90%) randomized to placebo completed treatment per protocol. These participants had an average age of 55.5 years, 25% were male, and 66% had relapsing-remitting MS (RRMS). Baseline characteristics were similar. Discontinuations were due primarily to drug intolerance. Among those who completed treatment, worst pain at 6 weeks was reduced by 29% (±20%) for duloxetine versus 12% (±18%) for placebo (P = .016). Average daily pain at 6 weeks was reduced by 39% (±29%) in the duloxetine group compared to 10% (±18.8%) in the placebo group (P = .002). There were no significant changes (week 6 vs. baseline) or between-group differences for subject global impression, Beck Depression Inventory, 36-item Short Form Health Status Survey (SF-36), or sleep quality score. CONCLUSIONS: Fewer patients could tolerate duloxetine compared to placebo. Among patients who completed 6 weeks of treatment, there were significant reductions in average and worst daily pain scores with duloxetine compared to placebo. This study suggests that duloxetine has a direct pain-relieving effect in MS.
RCT Entities:
BACKGROUND:Pain is common in multiple sclerosis (MS). Duloxetine has a potential therapeutic role in treating MS-related pain. METHODS: Thirty-eight MS patients were randomized 1:1 to receive duloxetine (n = 18) or matched placebo (n = 20). The dosing regimen was 30 mg daily for 1 week, then 60 mg daily for 5 weeks. The primary outcome measure was change in worst pain for week 6 relative to baseline recorded on a daily pain diary. RESULTS: Of 38 randomized patients, 14 (78%) patients randomized to duloxetine and 18 (90%) randomized to placebo completed treatment per protocol. These participants had an average age of 55.5 years, 25% were male, and 66% had relapsing-remitting MS (RRMS). Baseline characteristics were similar. Discontinuations were due primarily to drug intolerance. Among those who completed treatment, worst pain at 6 weeks was reduced by 29% (±20%) for duloxetine versus 12% (±18%) for placebo (P = .016). Average daily pain at 6 weeks was reduced by 39% (±29%) in the duloxetine group compared to 10% (±18.8%) in the placebo group (P = .002). There were no significant changes (week 6 vs. baseline) or between-group differences for subject global impression, Beck Depression Inventory, 36-item Short Form Health Status Survey (SF-36), or sleep quality score. CONCLUSIONS: Fewer patients could tolerate duloxetine compared to placebo. Among patients who completed 6 weeks of treatment, there were significant reductions in average and worst daily pain scores with duloxetine compared to placebo. This study suggests that duloxetine has a direct pain-relieving effect in MS.
Authors: Dawn M Ehde; George H Kraft; Lydia Chwastiak; Mark D Sullivan; Laura E Gibbons; Charles H Bombardier; Rohini Wadhwani Journal: Gen Hosp Psychiatry Date: 2008 Jan-Feb Impact factor: 3.238
Authors: Brenda Breuer; Marco Pappagallo; Helena Knotkova; Nilufer Guleyupoglu; Sylvan Wallenstein; Russell K Portenoy Journal: Clin Ther Date: 2007-09 Impact factor: 3.393
Authors: Daniel Bates; B Carsten Schultheis; Michael C Hanes; Suneil M Jolly; Krishnan V Chakravarthy; Timothy R Deer; Robert M Levy; Corey W Hunter Journal: Pain Med Date: 2019-06-01 Impact factor: 3.750