Article

A European Multicenter Randomized Double-blind Placebo-controlled Monotherapy Clinical Trial of Milnacipran in Treatment of Fibromyalgia

Faculdade Ciências Médicas, Universidade Nova de Lisboa, Serviço de Reumatologia, CHLO, EPE-Hospital Egas Moniz, Lisboa, Portugal.
The Journal of Rheumatology (Impact Factor: 3.17). 02/2010; 37(4):851-9. DOI: 10.3899/jrheum.090884
Source: PubMed

ABSTRACT This randomized, double-blind, placebo-controlled, multicenter study investigated the efficacy and safety of milnacipran in the treatment of fibromyalgia (FM) in a European population.
Outpatients diagnosed with FM according to 1990 American College of Rheumatology criteria (N = 884) were randomized to placebo (n = 449) or milnacipran 200 mg/day (n = 435) for 17 weeks (4-week dose escalation, 12-week stable dose, 9-day down-titration), followed by a 2-week posttreatment period. The primary efficacy criterion was a 2-measure composite responder analysis requiring patients to achieve simultaneous improvements in pain (>or= 30% improvement from baseline in visual analog scale, 24-hour morning recall) and a rating of "very much" or "much" improved on the Patient Global Impression of Change scale. If responder analysis was positive, Fibromyalgia Impact Questionnaire (FIQ) was included as an additional key primary efficacy measure.
At the end of the stable dose period (Week 16), milnacipran 200 mg/day showed significant improvements from baseline relative to placebo in the 2-measure composite responder criteria (p = 0.0003) and FIQ total score (p = 0.015). Significant improvements were also observed in multiple secondary efficacy endpoints, including Short-Form 36 Health Survey (SF-36) Physical Component Summary (p = 0.025), SF-36 Mental Component Summary (p = 0.007), Multidimensional Fatigue Inventory (p = 0.006), and Multiple Ability Self-Report Questionnaire (p = 0.041). Milnacipran was safe and well tolerated; nausea, hyperhidrosis, and headache were the most common adverse events.
Milnacipran is an effective and safe treatment for pain and other predominant symptoms of FM. Registered as trial no. NCT00436033.

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    • "While a diagnosis according to the earlier criteria of the American College of Rheumatology required the presence of a specific number of tender points, more recent guidelines did not define tender points but focused on the presence of widespread pain locations [1] [2]. It was estimated that between 2.9 and 3.8% of the general population in Europe and the US are affected [3] [4] [5], with the majority of patients in clinical settings being female [2]. Many patients with fibromyalgia utilize complementary and alternative therapies in addition to conventional medicine. "
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    ABSTRACT: Objectives. This systematic overview of reviews aimed to summarize evidence and methodological quality from systematic reviews of complementary and alternative medicine (CAM) for the fibromyalgia syndrome (FMS). Methods. The PubMed/MEDLINE, Cochrane Library, and Scopus databases were screened from their inception to Sept 2013 to identify systematic reviews and meta-analyses of CAM interventions for FMS. Methodological quality of reviews was rated using the AMSTAR instrument. Results. Altogether 25 systematic reviews were found; they investigated the evidence of CAM in general, exercised-based CAM therapies, manipulative therapies, Mind/Body therapies, acupuncture, hydrotherapy, phytotherapy, and homeopathy. Methodological quality of reviews ranged from lowest to highest possible quality. Consistently positive results were found for tai chi, yoga, meditation and mindfulness-based interventions, hypnosis or guided imagery, electromyogram (EMG) biofeedback, and balneotherapy/hydrotherapy. Inconsistent results concerned qigong, acupuncture, chiropractic interventions, electroencephalogram (EEG) biofeedback, and nutritional supplements. Inconclusive results were found for homeopathy and phytotherapy. Major methodological flaws included missing details on data extraction process, included or excluded studies, study details, and adaption of conclusions based on quality assessment. Conclusions. Despite a growing body of scientific evidence of CAM therapies for the management of FMS systematic reviews still show methodological flaws limiting definite conclusions about their efficacy and safety.
    Evidence-based Complementary and Alternative Medicine 01/2015; 2015:610615. DOI:10.1155/2015/610615 · 1.88 Impact Factor
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    • "Milnacipran, an SNRI, elicits an antinociceptive or antiallodynic effect in rodent models with neuropathic pain following intrathecal administration (Obata et al., 2005; King et al., 2006; Suzuki et al., 2008; Ikeda et al., 2009; Takeda et al., 2009) or systemic administration (Yokogawa et al., 2002; Önal et al., 2007; Berrocoso et al., 2011). In addition, the effect of milnacipran on patients with fibromyalgia as well as depression has been clinically evaluated (Clauw et al., 2008; Mease et al., 2009; Branco et al., 2010; Matthey et al., 2013). The antiallodynic effects of SNRIs have been mainly evaluated by examining the change of the threshold of the withdrawal response to mechanical stimulation. "
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    BMC Psychiatry 04/2013; 13(1):121. DOI:10.1186/1471-244X-13-121 · 2.24 Impact Factor
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