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Published on: December 26, 2015
A randomized placebo-controlled trial of duloxetine for central pain in multiple sclerosis
Theodore R Brown1, April Slee1
1MS Center at Evergreen, Evergreen Health, Kirkland, WA, USA (TRB); and Axio Research, LLC, Seattle, WA, USA (AS).
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.
Insights
Duloxetine significantly reduced pain in multiple sclerosis (MS) patients completing the study. While fewer patients tolerated duloxetine due to side effects, it offered a direct pain-relieving effect for those who completed treatment.
Area of Science:
- Neurology
- Clinical Pharmacology
Background:
- Pain is a prevalent and debilitating symptom in multiple sclerosis (MS).
- Duloxetine, a serotonin-norepinephrine reuptake inhibitor, is being investigated for its efficacy in managing MS-related pain.
Purpose of the Study:
- To evaluate the effectiveness of duloxetine in reducing pain in patients with multiple sclerosis.
- To compare the efficacy of duloxetine versus placebo in a randomized controlled trial.
Main Methods:
- A randomized, double-blind, placebo-controlled trial involving 38 MS patients.
- Patients received either duloxetine (60 mg daily) or placebo for 6 weeks.
- Pain was assessed using daily pain diaries, measuring worst and average pain levels.
Main Results:
- Among completers, duloxetine significantly reduced worst pain by 29% and average daily pain by 39% compared to 12% and 10% for placebo, respectively (P < .05).
- Drug intolerance led to higher discontinuation rates in the duloxetine group.
- No significant improvements were observed in depression, health status, or sleep quality.
Conclusions:
- Duloxetine demonstrates a direct pain-relieving effect in patients with MS who tolerate the medication.
- Despite tolerability issues, duloxetine offers a potential treatment option for MS-associated neuropathic pain.
