Evidence map›Paper›PMID 24306002›Full record

Trial reportNeurology2014

Effects of Bacille Calmette-Guerin after the first demyelinating event in the CNS.

Giovanni Ristori, Silvia Romano, Stefania Cannoni, Andrea Visconti, Emanuele Tinelli, Laura Mendozzi, Pietro Cecconi, Roberta Lanzillo, Mario Quarantelli, Carla Buttinelli and 8 more

Abstract readRandomized Controlled Trial
PubMed Full text at PMC Publisher
In one paragraph

Trial report in Neurology, 2014. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 72 papers, 3 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
72citing papers in PubMed, 3 pooled it
5.3field-weighted citation impact, top 4% 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

72 citing papers in PubMed, 3 syntheses or guidelines pooled it, 153 citations in OpenAlex.

  1. Pooled it
  2. Pooled it
  3. Pooled it
  4. Trial
  5. Review
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  10. Unmasking a Paradox: Roles of the PD-1/PD-L1 Axis in Alzheimer's Disease-Associated Neuroinflammation.Journal of neuroimmune pharmacology : the official journal of the Society on NeuroImmune Pharmacology · 2025
    Review
  11. Review
  12. Article
  13. Article
  14. Review
  15. Review
  16. Article
  17. BCG vaccination and multiple sclerosis risk: A Norwegian cohort study.Multiple sclerosis (Houndmills, Basingstoke, England) · 2024
    Article
  18. Review
  19. Review
  20. Article

12 more citing papers are in PubMed but not listed here.

4 · The record

Corrections and comments

5 · Who and what money

Authors and funding

18 authors at 1 institution in 1 country.

Giovanni RistoriFrom the Center for Experimental Neurological Therapies (G.R., S.R., S.C., A.V., C.B., G.C., M.S.), S. Andrea Hospital-site, Neurosciences, Mental Health, and Sensory Organs (NESMOS) Department and Department of Neurology and Psychiatry (E.T., M.F., C.P.), "Sapienza" University of Rome, Department of Neurological Sciences (C.G.), Azienda Ospedaliera S Camillo-Forlanini, Rome; MSCenter (L.M., D.C.) and Neuroradiology Unit (P.C.), Fondazione don Carlo Gnocchi, IRCCS, Milan; Department of Neurological Sciences (R.L., V.B.), Federico II University, and Biostructure and Bioimaging Institute (M.Q.), CNR, Naples; and National Centre of Epidemiology (N.V.), National Institute of Health, Rome, Italy.
Silvia Romano
Stefania Cannoni
Andrea Visconti
Emanuele Tinelli
Laura Mendozzi
Pietro Cecconi
Roberta Lanzillo
Mario Quarantelli
Carla Buttinelli
Claudio Gasperini
Marco Frontoni
Giulia Coarelli
Domenico Caputo
Vincenzo Bresciamorra
Nicola Vanacore
Carlo Pozzilli
Marco Salvetti
Institute of Biostructure and Bioimaging · IT

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

objectiveTo evaluate Bacille Calmette-Guérin (BCG) effects after clinically isolated syndromes (CIS).

methodsIn a double-blind, placebo-controlled trial, participants were randomly assigned to receive BCG or placebo and monitored monthly with brain MRI (6 scans). Both groups then entered a preplanned phase with IM interferon-β-1a for 12 months. From month 18 onward, the patients took the disease-modifying therapies (DMTs) that their neurologist considered indicated in an open-label extension phase lasting up to 60 months.

resultsOf 82 randomized subjects, 73 completed the study (33 vaccinated and 40 placebo). During the initial 6 months, the number of cumulative lesions was significantly lower in vaccinated people. The relative risks were 0.541 (95% confidence interval [CI] 0.308-0.956; p = 0.03) for gadolinium-enhancing lesions (the primary endpoint), 0.364 (95% CI 0.207-0.639; p = 0.001) for new and enlarging T2-hyperintense lesions, and 0.149 (95% CI 0.046-0.416; p = 0.001) for new T1-hypointense lesions. The number of total T1-hypointense lesions was lower in the BCG group at months 6, 12, and 18: mean changes from baseline were -0.09 ± 0.72 vs 0.75 ± 1.81 (p = 0.01), 0.0 ± 0.83 vs 0.88 ± 2.21 (p = 0.08), and -0.21 ± 1.03 vs 1.00 ± 2.49 (p = 0.02). After 60 months, the cumulative probability of clinically definite multiple sclerosis was lower in the BCG + DMT arm (hazard ratio = 0.52, 95% CI 0.27-0.99; p < 0.05), and more vaccinated people remained DMT-free (odds ratio = 0.20, 95% CI 0.04-0.93; p = 0.04).

conclusionsEarly BCG may benefit CIS and affect its long-term course. CLASSIFICATION OF EVIDENCE: BCG, as compared to placebo, was associated with significantly reduced development of gadolinium-enhancing lesions in people with CIS for a 6-month period before starting immunomodulating therapy (Class I evidence).

Indexed as

AdultBCG VaccineBrainDemyelinating DiseasesDouble-Blind MethodFemaleFollow-Up StudiesHumansMaleMultiple SclerosisTreatment OutcomeYoung AdultBCG Vaccine

Identifiers

PMID24306002
PMCPMC3873620
OpenAlexW2144448602

What OpenQuestion holds

Textmetadata
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.