Evidence map›Paper›PMID 26335989›Full record

Trial reportThe journal of pain2015

Effect of Milnacipran Treatment on Ventricular Lactate in Fibromyalgia: A Randomized, Double-Blind, Placebo-Controlled Trial.

Benjamin H Natelson, Diana Vu, Xiangling Mao, Nora Weiduschat, Fumiharu Togo, Gudrun Lange, Michelle Blate, Guoxin Kang, Jeremy D Coplan, Dikoma C Shungu

Open access · bronzeAbstract readRandomized Controlled Trial
In one paragraph

Trial report in The journal of pain, 2015. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 12 papers, 2 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
12citing papers in PubMed, 2 pooled it
1.5field-weighted citation impact, top 19% of its field
1 · What the graph read from it

What it found

Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.

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.

2 · The registry

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.

3 · Its place in the literature

Who cites it

12 citing papers in PubMed, 2 syntheses or guidelines pooled it, 18 citations in OpenAlex.

  1. Pooled it
  2. Serotonin and noradrenaline reuptake inhibitors (SNRIs) for fibromyalgia.The Cochrane database of systematic reviews · 2018
    Pooled it
  3. Trial
  4. Review
  5. Review
  6. Neuropsychiatric Lyme Disease and Vagus Nerve Stimulation.Antibiotics (Basel, Switzerland) · 2023
    Review
  7. Review
  8. Review
  9. Review
  10. Review
  11. Article
  12. Article
4 · The record

Corrections and comments

PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.

5 · Who and what money

Authors and funding

10 authors at 4 institutions in 2 countries.

Benjamin H NatelsonDepartment of Neurology, Mount Sinai Beth Israel, New York, New York. Electronic address: bnatelson@bethisraelny.org.
Diana VuDepartment of Neurology, Mount Sinai Beth Israel, New York, New York.
Xiangling MaoDepartment of Radiology, Weill Medical College of Cornell University, New York, New York.
Nora WeiduschatDepartment of Radiology, Weill Medical College of Cornell University, New York, New York.
Fumiharu TogoEducational Physiology Laboratory, Graduate School of Education, The University of Tokyo, Tokyo, Japan.
Gudrun LangeDepartment of Neurology, Mount Sinai Beth Israel, New York, New York.
Michelle BlateDepartment of Neurology, Mount Sinai Beth Israel, New York, New York.
Guoxin KangDepartment of Radiology, Weill Medical College of Cornell University, New York, New York.
Jeremy D CoplanDepartment of Psychiatry & Behavioral Sciences, State University of New York Downstate Medical Center, Brooklyn, New York.
Dikoma C ShunguDepartment of Radiology, Weill Medical College of Cornell University, New York, New York.
Cornell University · USMount Sinai Beth Israel · USJapan Graduate School of Education University · JPState University of New York · US

Funding

Clinical and Translational Science CenterUL1TR000457 · NCATS · WEILL MEDICAL COLL OF CORNELL UNIV · PI IMPERATO-MCGINLEY, JULIANNE L · 2012 to 2016
$46.0M
Specificity and Validity of Oxidative Stress Model of Chronic Fatigue SyndromeR01MH100005 · NIMH · WEILL MEDICAL COLL OF CORNELL UNIV · PI SHUNGU, DIKOMA C · 2013 to 2016
$2.0M
NCATS NIH HHS UL1 TR000457NIMH NIH HHS R01 MH100005
6 · The paper itself

Abstract

unlabelledMilnacipran, a serotonin/norepinephrine reuptake inhibitor, has been approved by the US Food and Drug Administration for the treatment of fibromyalgia (FM). This report presents the results of a randomized, double-blind, placebo-controlled trial of milnacipran conducted to test the hypotheses that a) similar to patients with chronic fatigue syndrome, patients with FM have increased ventricular lactate levels at baseline; b) 8 weeks of treatment with milnacipran will lower ventricular lactate levels compared with baseline levels and with ventricular lactate levels after placebo; and c) treatment with milnacipran will improve attention and executive function in the Attention Network Test compared with placebo. In addition, we examined the results for potential associations between ventricular lactate and pain. Baseline ventricular lactate measured by proton magnetic resonance spectroscopic imaging was found to be higher in patients with FM than in healthy controls (F1,37 = 22.11, P < .0001, partial η(2) = .37). Milnacipran reduced pain in patients with FM relative to placebo but had no effect on cognitive processing. At the end of the study, ventricular lactate levels in the milnacipran-treated group had decreased significantly compared with baseline and after placebo (F1,18 = 8.18, P = .01, partial η(2) = .31). A significantly larger proportion of patients treated with milnacipran showed decreases in both ventricular lactate and pain than those treated with placebo (P = .03). These results suggest that proton magnetic resonance spectroscopic imaging measurements of lactate may serve as a potential biomarker for a therapeutic response in FM and that milnacipran may act, at least in part, by targeting the brain response to glial activation and neuroinflammation. PERSPECTIVE: Patients treated with milnacipran showed decreases in both pain and ventricular lactate levels compared with those treated with placebo, but, even after treatment, levels of ventricular lactate remained higher than in controls. The hypothesized mechanism for these decreases is via drug-induced reductions of a central inflammatory state.

Indexed as

Adrenergic Uptake InhibitorsAdultAnti-Inflammatory Agents, Non-SteroidalAttentionBiomarkersCerebral VentriclesCyclopropanesDouble-Blind MethodExecutive FunctionFemaleFibromyalgiaHumansLactic AcidMiddle AgedMilnacipranNonlinear DynamicsAdrenergic Uptake InhibitorsAnti-Inflammatory Agents, Non-SteroidalBiomarkersCyclopropanesLactic AcidMilnacipranSelective Serotonin Reuptake Inhibitorsbrain functionmagnetic resonance spectroscopyserotonin-norepinephrine reuptake inhibitorWidespread pain

Identifiers

PMID26335989
PMCPMC4630071
OpenAlexW1955494979

What OpenQuestion holds

Textmetadata
LicenceTDM
Read underepoch 390

Registered trials

None linked

Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.