Mirtazapine harms outweigh benefits in fibromyalgia

  • Welsch P & al.
  • Cochrane Database Syst Rev
  • 6 Aug 2018

  • curated by Emily Willingham, PhD
  • Clinical Essentials
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Takeaway

  • The benefits of mirtazapine (Remeron) for fibromyalgia do not outweigh the harms, according to the findings of this Cochrane review.
  • A small subset of patients might experience benefit without adverse events. 

Why this matters

  • Fibromyalgia remains elusive in terms of pathophysiology and treatment.
  • Some studies have hinted at a benefit from the tricyclic antidepressant mirtazapine.

Key results

  • Bias risk was high or unclear in 2 of the studies.
  • Evidence was low or very low quality.
  • Placebo and mirtazapine did not differ for any primary outcomes reported: 
    • Participant‐reported pain relief of 50% or greater. 
    • Patient Global Impression of Change (PGIC): no data available; and  
    • Tolerability.
  • For some participant-reported secondary outcomes, mirtazapine bested placebo:
    • Pain relief of ≥30% (47% vs 34%; risk difference, 0.13; 95% CI, 0.05-0.21); 
    • Pain intensity (standardized mean difference [SMD], −0.29; 95% CI, −0.46 to −0.13); and 
    • Sleep problems (SMD −0.23; 95% CI, −0.39 to −0.06). 
  • No improvements in other participant-reported measures (e.g., health-related QoL, fatigue, negative mood).
  • Clinically relevant harm vs placebo for somnolence, weight gain, elevated liver enzymes.

Study design

  • 3 randomized controlled trials, n=606, 7-13 weeks. 
  • Funding: National Institute for Health Research.

Limitations

  • Limitations of included studies, generally of low quality, according to the authors.

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