ArticleTherapeutic advances in musculoskeletal disease2013
Milnacipran combined with pregabalin in fibromyalgia: a randomized, open-label study evaluating the safety and efficacy of adding milnacipran in patients with incomplete response to pregabalin.
Article in Therapeutic advances in musculoskeletal disease, 2013. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 15 papers, 4 of them syntheses that pooled it.
What it found
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The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.
The trial behind it
Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.
Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.
Who cites it
15 citing papers in PubMed, 4 syntheses or guidelines pooled it, 26 citations in OpenAlex.
- Assessing Ethnic Minority Representation in Fibromyalgia Clinical Trials: A Systematic Review of Recruitment Demographics.International journal of environmental research and public health · 2023Pooled it
- Fibromyalgia: an update on clinical characteristics, aetiopathogenesis and treatment.Nature reviews. Rheumatology · 2020Pooled it
- Serotonin and noradrenaline reuptake inhibitors (SNRIs) for fibromyalgia.The Cochrane database of systematic reviews · 2018Pooled it
- Combination pharmacotherapy for the treatment of fibromyalgia in adults.The Cochrane database of systematic reviews · 2018Pooled it
- Article
- The Efficacy and Safety of Crisugabalin (HSK16149) in Fibromyalgia Patients: Protocol for a Prospective Randomized Open Blinded-Endpoint (PROBE) Study.Journal of pain research · 2026Article
- Efficacy and Safety of Adjunctive Therapy Using Single High-Dose S-Ketamine Infusion for Fibromyalgia: A Multicenter, Prospective, Randomized, Controlled, Open-Label, Blinded-Endpoint Study Protocol.Journal of pain research · 2026Article
- Serotonin and Norepinephrine Reuptake Inhibitors (SNRIs) for Treatment of Fibromyalgia: A Comprehensive Clinical Review.Psychopharmacology bulletin · 2025Review
- Melatonin as a Coadjuvant in the Treatment of Patients with Fibromyalgia.Biomedicines · 2023Review
- Non-invasive brain stimulation for fibromyalgia: current trends and future perspectives.Frontiers in neuroscience · 2023Review
- Disentangling Diagnosis and Management of Fibromyalgia.Journal of rheumatic diseases · 2022Review
- Efficacy of acupuncture in the treatment of fibromyalgia.Orthopedic reviews · 2021Review
- Healthcare Costs and Medication Adherence Among Patients with Fibromyalgia: Combination Medication vs. Duloxetine, Milnacipran, Venlafaxine, and Pregabalin Initiators.Pain practice : the official journal of World Institute of Pain · 2018Article
- Treatment of fibromyalgia.Australian prescriber · 2017Review
- Fixed-site high-frequency transcutaneous electrical nerve stimulation for treatment of chronic low back and lower extremity pain.Journal of pain research · 2016Article
Corrections and comments
PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.
Authors and funding
6 authors at 2 institutions in 1 country.
Funding
No grant is acknowledged in the PubMed record.
Abstract
objectiveTo evaluate the safety, tolerability, and efficacy of adding milnacipran to pregabalin in patients with fibromyalgia who have experienced an incomplete response to pregabalin.
methodsIn this randomized, multicenter, open-label study, patients received pregabalin 300 or 450 mg/day during a 4- to 12-week run-in period. Patients with weekly recall visual analog scale (VAS) pain score of at least 40 and up to 90, Patient Global Impression of Severity score of at least 4, and Patient Global Impression of Change (PGIC) score of at least 3 were classified as incomplete responders and randomized to continue pregabalin alone (n = 180) or receive milnacipran 100 mg/day added to pregabalin (n = 184). The primary efficacy parameter was responder status based on PGIC score of up to 2. The secondary efficacy parameter was change from randomization in weekly recall VAS pain score. Safety parameters included adverse events (AEs), vital signs, and clinical laboratory tests.
resultsThe percentage of PGIC responders was significantly higher with milnacipran added to pregabalin (46.4%) than with pregabalin alone (20.8%; p < 0.001). Mean improvement from randomization in weekly recall VAS pain scores was greater in patients receiving milnacipran added to pregabalin (-20.77) than in patients receiving pregabalin alone (-6.43; p < 0.001). During the run-in period, the most common treatment-emergent AEs with pregabalin were dizziness (22.8%), somnolence (17.3%), and fatigue (9.1%). During the randomized period, the most common treatment-emergent AEs with milnacipran added to pregabalin were nausea (12.5%), fatigue (10.3%), and constipation (9.8%).
conclusionsIn this exploratory, open-label study, adding milnacipran to pregabalin improved global status, pain, and other symptoms in patients with fibromyalgia with an incomplete response to pregabalin treatment.
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