What is the evidence for Mirtazapine for adults with fibromyalgia?
AMSTAR Rating
Summary
Patient Population:
3 RCTs of 606 participants with fibromyalgia.
Intervention:
Mirtazapine (a tetracyclic piperazino-azepine antidepressant agent) was givenat 15 mg to 45 mg daily for 7 – 13 weeks.
Comparison:
All 3 RCTs compared Mirtazapine to control groups (placebo treatment).
Outcome:
Major outcomes of participant-reported pain relief of > 50%, patient global impression of change, safety and tolerability were measured.
- 22% of the Mirtazapine group reported a pain relief of > 50% compared to 16% of the placebo group (Risk Difference (RD) was 0.05, indicating no clinical benefit, 95% CI -0.01 – 0.12, 3 pooled studies)
- Patient global impression of change was only reported by 1 of the 3 studies, and there were no reported changes to be much or very much improved.
- 3% of the Mirtazapine group compared to 0% of the placebo group experienced a serious adverse event (RD was -0.00, indicating no clinically relevant difference in harm, 95% CI -0.01 – 0.02, 3 pooled studies)
- 3% of the Mirtazapine group withdrew due to non-serious adverse events compared to 2.2% in the placebo group (RD was 0.00, indicating no clinically relevant harm, 95% CI -0.02 – 0.03, 3 pooled studies)
Guideline Recommendations
| Source | Recommendation |
|---|---|
| CRA | Support (Level 1/Grade A) |
Outcomes Assessed
- Benefit
- Harm
- Inconclusive
Pain
Self reported >50% reduction
Global Impression
Patient assessment
Other outcomes
Safety
Tolerability
Relevant Clinical Info
The quality of evidence was low or very low, with two of the three studies of questionable quality and raising issues surrounding indirectness and risk of publication bias.
Participant Information
the sample size was 606
Mean age of 44 years.
their were 3 studies used.
