Mirtazapine Provide No Significant Benefit in Fibromyalgia Treatment

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Mirtazapine Provide No Significant Benefit in Fibromyalgia Treatment

Mirtazapine, an atypical antidepressant provide minimal clinically relevant benefits in fibromyalgia treatment, as per a recent systematic analysis published in the journal, Cochrane Database of Systematic Reviews.

Fibromyalgia is a chronic condition characterized by fatigue, sleep disturbance, widespread pain, and cognitive dysfunction. Patrick Welsch and colleagues evaluated the efficacy, safety, and tolerability of Mirtazapine as compared to other active drug or placebo in managing fibromyalgia among adults.

The RCTs (randomized controlled trials) with comparative information regarding Mirtazapine against other drug or placebo were identified by searching MEDLINE, Embase, CENTRAL, WHO, SCOPUS, International clinical trials registry platform and US national institutes of health for ongoing and published trials along with investigated reference list of selected articles until 9 July 2018. Two review authors individually analyzed the efficacy, safety, and tolerability; extraction of study characteristics; assessment of the risk of bias; examination of issues related to study quality and discussion on resolving discrepancies. The PGIC (Patient Global Impression of Change), participant-reported pain relief, tolerability, and safety were considered as primary outcomes. Fatigue, mean pain intensity, sleep issues, particular adverse effects, negative mood and health-related quality of life ( HRQoL) improved by 20 %, or more were the secondary outcomes analyzed during the trial. The standardized mean difference (SMD), numbers needed to treat (NNT) and risk difference (RD) were determined by using the random-effects model. The GRADE was used to assess evidence and create a 'Summary of findings' table.

Three studies (606 patients) involved the Mirtazapine and placebo comparison. Two studies showed the high risk of bias. The outcomes were of Low or very low-quality due to the risk of publication bias, poor study quality, imprecision and the low number of events. Mirtazapine and placebo exhibited no difference for the primary outcome. However, mirtazapine showed a clinically-relevant benefit for some of the secondary outcomes (sleep issues, mean pain intensity and pain relief of 30% or higher) as compared to placebo. No difference was seen related to adverse events between both groups. Mirtazapine showed side effects like weight gain, increased alanine aminotransferase, and somnolence as compared to placebo.


Cochrane Database of Systematic Reviews



Original title of the article:

Mirtazapine for fibromyalgia in adults


Patrick Welsch et al.

Therapeutic, Mirtazapine, Fibromyalgia, Nerves, Antidepressant, Systemic Review, Efficacy, Safety, Tolerability, HRQoL, SMD, NNT, RD, Weight Gain, Increased Alanine Aminotransferase, Somnolence
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