Evidence map›Paper›PMID 41047726›Full record

SynthesisPain management2025

Efficacy and safety of TNX-102 SL in patients with fibromyalgia: a systematic review and meta-analysis.

Bárbara Ghizoni Maggi, Natan Lucca Lima, Luís Henrique Correa de Lara, Maria Júlia Hallack Moura, Davi Orli Machado Grüdtner, José Pedro Duarte Hillal

Abstract readSystematic ReviewMeta-Analysis
In one paragraph

Synthesis in Pain management, 2025. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 1 paper.

0numbers the graph read from it
0cells of the map it votes in
1citing papers in PubMed
–field-weighted citation impact
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

1 citing paper in PubMed.

  1. Review
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

6 authors.

Bárbara Ghizoni MaggiFaculty of Medicine, Federal University of Santa Catarina (UFSC), Araranguá, Brazil.ORCID 0009-0008-5001-9291
Natan Lucca LimaFaculty of Medicine, Federal University of Santa Catarina (UFSC), Araranguá, Brazil.ORCID 0009-0004-7595-7082
Luís Henrique Correa de LaraFaculty of Medicine, Federal University of Santa Catarina (UFSC), Araranguá, Brazil.ORCID 0009-0006-0908-7351
Maria Júlia Hallack MouraFaculty of Medicine, Federal University of Santa Catarina (UFSC), Araranguá, Brazil.ORCID 0009-0002-9236-7549
Davi Orli Machado GrüdtnerFaculty of Medicine, Federal University of Santa Catarina (UFSC), Araranguá, Brazil.ORCID 0009-0008-6412-1668
José Pedro Duarte HillalDepartment of Rheumatology, Hospital São Lucas da PUCRS, Porto Alegre, Brazil.ORCID 0000-0002-1134-164X

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

objectiveTNX-102 SL is a new sublingual tablet formulation of cyclobenzaprine (CBP) for rapid transmucosal absorption. We aimed to evaluate the efficacy and safety of TNX-102 SL in improving pain and sleep quality in patients with fibromyalgia (FM).

methodsSearches were conducted in Embase, PubMed, Cochrane Library, and Web of Science databases. The primary endpoint was the reduction in daily diary pain score. Secondary outcomes included Fibromyalgia Impact Questionnaire (FIQ-R) Function and Symptoms, daily diary sleep score, and adverse effects. Four studies met eligibility criteria and a random-effect meta-analysis was performed to combine data.

resultsThe analyses of 1,993 patients yielded statistically significant differences in the TNX-102 SL group versus the control group on daily diary pain intensity (SMD = -0.25; 95% CI [-0.34, -0.16];

conclusionsPooled data show TNX-102 SL significantly reduces pain, improves sleep quality, and enhances quality of life in FM patients. PROTOCOL REGISTRATION: www.crd.york.ac.uk/prospero identifier is CRD42024588069.

Indexed as

FibromyalgiaAmitriptylineHumansAmitriptylinecyclobenzaprineCyclobenzaprinefibromyalgiameta-analysispain managementsublingual administration

Identifiers

PMID41047726
PMCPMC12674253

What OpenQuestion holds

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Read underepoch 390

Registered trials

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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.