Oc027—Dual Reuptake Inhibitor Milnacipran And Spinal Pain Pathways In Fibromyalgia Patients: A Randomized Double-Blind Placebo-Controlled Trial

Matthey, Alain; Cedraschi, C.; Piguet, Vincent; Besson, Marie‐Jo; Chabert, Jocelyne; Daali, Youssef; Courvoisier, D.; Montagne, Agnès; Dayer, P.; Desmeules, Jules Alexandre

doi:10.1016/j.clinthera.2013.07.026

Cited by 12 publications

(33 citation statements)

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“…We included eight new studies (nine reports) (Arnold 2012a; Bateman 2013; Clauw 2013; Leombruni 2015; Matthey 2013; Murakami 2015; NCT00697787; Staud 2015). …”

Section: Resultsmentioning

confidence: 99%

“…We included eight studies with duloxetine (Arnold 2004; Arnold 2005; Arnold 2010a; Arnold 2012a; Chappell 2009a; Leombruni 2015; Murakami 2015; Russell 2008), nine studies with milnacipran (Arnold 2010b; Bateman 2013; Branco 2010; Clauw 2008; Clauw 2013; Matthey 2013; Staud 2015; Mease 2009b; Vitton 2004) and one study with desvenlafaxine (NCT00697787) in the analysis of placebo controlled trials. The eight studies with duloxetine included 11 study arms with different dosages of duloxetine.…”

Section: Resultsmentioning

confidence: 99%

“…Eight studies were conducted in the USA (Arnold 2004; Arnold 2005; Clauw 2008; Mease 2009b; Clauw 2013; NCT00697787; Staud 2015, Vitton 2004), two studies each in the USA and Puerto Rico (Arnold 2010a; Russell 2008) and in more than one continent (Arnold 2012a; Bateman 2013), one study each in the USA and Western Europe (Chappell 2009a), in the USA and Canada (Arnold 2010b) and in Japan (Murakami 2015), and three studies in Europe (Branco 2010; Leombruni 2015; Matthey 2013). All studies had a parallel design except one with an EERW design (Clauw 2013).…”

Section: Resultsmentioning

confidence: 99%

“…We conducted a systematic review on SNRIs in fibromyalgia which included randomized controlled trials that had not been evaluated by the FDA and EMA in 2013 (Häuser 2013 b). Meanwhile, new randomized controlled trials with duloxetine (Leombruni 2015; Murakami 2015), and milnacipran (Bateman 2013; Matthey 2013; Staud 2015), were published that had not been evaluated by the FDA and EMA and by the previous version of this review (Häuser 2013 b). With new data available, and in the light of the divergent appraisals of duloxetine and milnacipran by the FDA and EMA, we saw the need to evaluate the efficacy and safety of SNRIs according to recently established methodological standards of pain medicine (Moore 2010a), in order to assist people with fibromyalgia and doctors in shared decision making on pharmacological treatment options.…”

Section: Introductionmentioning

confidence: 99%

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Serotonin and noradrenaline reuptake inhibitors (SNRIs) for fibromyalgia

Welsch

Üçeyler

Klose

et al. 2018

Cochrane Database of Systematic Reviews

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Background Fibromyalgia is a clinically defined chronic condition of unknown etiology characterized by chronic widespread pain that often co‐exists with sleep disturbances, cognitive dysfunction and fatigue. People with fibromyalgia often report high disability levels and poor quality of life. Drug therapy, for example, with serotonin and noradrenaline reuptake inhibitors (SNRIs), focuses on reducing key symptoms and improving quality of life. This review updates and extends the 2013 version of this systematic review. Objectives To assess the efficacy, tolerability and safety of serotonin and noradrenaline reuptake inhibitors (SNRIs) compared with placebo or other active drug(s) in the treatment of fibromyalgia in adults. Search methods For this update we searched CENTRAL, MEDLINE, Embase, the US National Institutes of Health and the World Health Organization (WHO) International Clinical Trials Registry Platform for published and ongoing trials and examined the reference lists of reviewed articles, to 8 August 2017. Selection criteria We selected randomized, controlled trials of any formulation of SNRIs against placebo or any other active treatment of fibromyalgia in adults. Data collection and analysis Three review authors independently extracted data, examined study quality, and assessed risk of bias. For efficacy, we calculated the number needed to treat for an additional beneficial outcome (NNTB) for pain relief of 50% or greater and of 30% or greater, patient's global impression to be much or very much improved, dropout rates due to lack of efficacy, and the standardized mean differences (SMD) for fatigue, sleep problems, health‐related quality of life, mean pain intensity, depression, anxiety, disability, sexual function, cognitive disturbances and tenderness. For tolerability we calculated number needed to treat for an additional harmful outcome (NNTH) for withdrawals due to adverse events and for nausea, insomnia and somnolence as specific adverse events. For safety we calculated NNTH for serious adverse events. We undertook meta‐analysis using a random‐effects model. We assessed the evidence using GRADE and created a 'Summary of findings' table. Main results We added eight new studies with 1979 participants for a total of 18 included studies with 7903 participants. Seven studies investigated duloxetine and nine studies investigated milnacipran against placebo. One study compared desvenlafaxine with placebo and pregabalin. One study compared duloxetine with L‐carnitine. The majority of studies were at unclear or high risk of bias in three to five domains. The quality of evidence of all comparisons of desvenlafaxine, duloxetine and milnacipran versus placebo in studies with a parallel design was low due to concerns about publication bias and indirectness, and very low for serious adverse events due to concerns about...

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“…We included eight new studies (nine reports) (Arnold 2012a; Bateman 2013; Clauw 2013; Leombruni 2015; Matthey 2013; Murakami 2015; NCT00697787; Staud 2015). …”

Section: Resultsmentioning

confidence: 99%

Section: Resultsmentioning

confidence: 99%

Section: Resultsmentioning

confidence: 99%

Section: Introductionmentioning

confidence: 99%

See 2 more Smart Citations

Serotonin and noradrenaline reuptake inhibitors (SNRIs) for fibromyalgia

Welsch

Üçeyler

Klose

et al. 2018

Cochrane Database of Systematic Reviews

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“…One possible explanation for this discrepancy is lack of statistical power. In a recent 15,20 . Similar to our study, these prospective FM trial for >12 weeks failed to demonstrate significant treatment effects of milnacipran (200 mg/day) on mechanical hyperalgesia.…”

Section: Milnacipran Effects On Fm Pain and Hyperalgesiamentioning

confidence: 97%

Effects of Milnacipran on Clinical Pain and Hyperalgesia of Patients With Fibromyalgia: Results of a 6-Week Randomized Controlled Trial

Staud¹,

Lucas²,

Price³

2015

The Journal of Pain

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Resting state connectivity correlates with drug and placebo response in fibromyalgia patients

Schmidt‐Wilcke

Ichesco

Hampson

et al. 2014

NeuroImage: Clinical

104

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Fibromyalgia is a chronic pain syndrome characterized by widespread pain, fatigue, and memory and mood disturbances. Despite advances in our understanding of the underlying pathophysiology, treatment is often challenging. New research indicates that changes in functional connectivity between brain regions, as can be measured by magnetic resonance imaging (fcMRI) of the resting state, may underlie the pathogenesis of this and other chronic pain states. As such, this parameter may be able to be used to monitor changes in brain function associated with pharmacological treatment, and might also be able to predict treatment response.We performed a resting state fcMRI trial using a randomized, placebo-controlled, cross-over design to investigate mechanisms of action of milnacipran (MLN), a selective serotonin and norepinephrine reuptake inhibitor (SNRI), in fibromyalgia patients. Our aim was to identify functional connectivity patterns at baseline that would differentially predict treatment response to MLN as compared to placebo. Since preclinical studies of MLN suggest that this medication works by augmenting antinociceptive processes, we specifically investigated brain regions known to be involved in pain inhibition.15 fibromyalgia patients completed the study, consisting of 6 weeks of drug and placebo intake (order counterbalanced) with an interspersed 2 week wash out period. As a main finding we report that reductions in clinical pain scores during MLN were associated with decreased functional connectivity between pro-nociceptive regions and antinociceptive pain regions at baseline, specifically between the rostral part of the anterior cingulate cortex (ACC) and the insular cortex (IC), as well as between the periaqueductal gray (PAG) and the IC: patients with lower preexisting functional connectivity had the greatest reduction in clinical pain. This pattern was not observed for the placebo period. However a more robust placebo response was associated with lower baseline functional connectivity between the ACC and the dorsolateral prefrontal cortex.This study indicates that ACC–IC connectivity might play a role in the mechanism of action of MLN, and perhaps more importantly fcMRI might be a useful tool to predict pharmacological treatment response.

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Oc027—Dual Reuptake Inhibitor Milnacipran And Spinal Pain Pathways In Fibromyalgia Patients: A Randomized Double-Blind Placebo-Controlled Trial

Cited by 12 publications

References 0 publications

Serotonin and noradrenaline reuptake inhibitors (SNRIs) for fibromyalgia

Serotonin and noradrenaline reuptake inhibitors (SNRIs) for fibromyalgia

Effects of Milnacipran on Clinical Pain and Hyperalgesia of Patients With Fibromyalgia: Results of a 6-Week Randomized Controlled Trial

Resting state connectivity correlates with drug and placebo response in fibromyalgia patients

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