Evidence map›Paper›PMID 30225735›Full record

Observational studyThe journal of headache and pain2018

Sustained onabotulinumtoxinA therapeutic benefits in patients with chronic migraine over 3 years of treatment.

Michail Vikelis, Andreas A Argyriou, Emmanouil V Dermitzakis, Konstantinos C Spingos, Nikolaos Makris, Evangelia Kararizou

Abstract readObservational Study
In one paragraph

Observational study in The journal of headache and pain, 2018. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 16 papers.

0numbers the graph read from it
0cells of the map it votes in
16citing 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

16 citing papers in PubMed.

  1. Article
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  5. Article
  6. Article
  7. Review
  8. Article
  9. Article
  10. Article
  11. Article
  12. Article
  13. Approach to Pediatric Intractable Migraine.Current neurology and neuroscience reports · 2021
    Review
  14. Article
  15. Chronic migraine long-term regular treatment with onabotulinumtoxinA: a retrospective real-life observational study up to 4 years of therapy.Neurological sciences : official journal of the Italian Neurological Society and of the Italian Society of Clinical Neurophysiology · 2020
    Observational
  16. Botulinum Toxin Application in Facial Esthetics and Recent Treatment Indications (2013-2018).Journal of International Society of Preventive & Community Dentistry
    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.

Michail VikelisHeadache Clinic, Mediterraneo Hospital, Glyfada, Greece. mvikelis@headaches.gr.
Andreas A ArgyriouNeurology Department, Saint Andrew's State General Hospital of Patras, Patras, Greece.
Emmanouil V DermitzakisDepartment of Neurology, "Geniki Kliniki" Euromedica, Thessaloniki, Greece.
Konstantinos C SpingosCorfu Headache Clinic, Corfu, Greece.
Nikolaos MakrisNeurology Department, Saint Andrew's State General Hospital of Patras, Patras, Greece.
Evangelia KararizouHeadache Outpatient Clinic, 1st Department of Neurology, National and Kapodistrian University of Athens, Athens, Greece.

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

backgroundEvidence on whether the therapeutic effect and good safety profile of onabotulinumtoxinA (Botox®) in chronic migraine (CM) patients is maintained over long term treatment is still limited. We herein aimed at assessing whether there is a sustained benefit and good safety with repeated onabotulinumtoxinA sessions in CM over more than three years of treatment.

methodsWe prospectively enrolled 65 CM patients, who were classified as responders after three sessions of onabotulinumtoxinA and were eligible to further continue treatment. Data documenting longitudinal changes from the trimester after the third onabotulinumtoxinA administration (T1) to the trimester after completing two years of treatment (T2) and eventually to the trimester after completing three years of treatment (T3) in (i) mean number of monthly headache days (ii) migraine severity as expressed by the mean number of days with peak headache intensity of > 4/10, and (iii) mean number of days with use of any acute headache medication, were prospectively collected from patients' headache diaries.

resultsA total of 56 (86.1%) of 65 patients achieved to attain onabotulinumtoxinA over three years. At T3, a significant reduction in mean monthly headache days was evident, compared to T1 (3.4 ± 1.7 vs 7.2 ± 3.8; P < 0.001) with diminished mean number of monthly days with peak headache intensity of more than 4/10 and a significant change in days using acute headache medications per month between T1 and T3 (2.8 ± 1.3 vs 4.7 ± 3.2; P < 0.001). Significant changes were also noticed in all efficacy variables from T2 to T3. Therapy was safe and well tolerated with low rates of adverse events or drop-outs.

conclusionThe long -term treatment with onabotulinumtoxinA proved effective, safe and well tolerated over three years. Our findings support the strategy to consistently deliver sessions of use of onabotulinumtoxinΑ over long time in CM patients (Trial registration NTC03606356, registered retrospectively, 28 July 2018).

Indexed as

Acetylcholine Release InhibitorsAdultBotulinum Toxins, Type AChronic DiseaseFemaleHumansMaleMiddle AgedMigraine DisordersProspective StudiesRetrospective StudiesTime FactorsTreatment OutcomeYoung AdultAcetylcholine Release InhibitorsBotulinum Toxins, Type ABotox®Chronic migraineLong term treatmentMigraineonabotulinumtoxinASustained efficacy

Identifiers

PMID30225735
PMCPMC6755578

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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.