Evidence map›Paper›PMID 26792662›Full record

ArticleThe journal of headache and pain2015

A two years open-label prospective study of OnabotulinumtoxinA 195 U in medication overuse headache: a real-world experience.

Andrea Negro, Martina Curto, Luana Lionetto, Paolo Martelletti

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Article in The journal of headache and pain, 2015. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 66 papers, 3 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
66citing papers in PubMed, 3 pooled it
–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

66 citing papers in PubMed, 3 syntheses or guidelines pooled it.

  1. Pooled it
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  6. The Use of Botulinum Toxin in the Management of Headache Disorders.Handbook of experimental pharmacology · 2021
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  10. Botulinum toxin for chronic migraine.Journal of neural transmission (Vienna, Austria : 1996) · 2026
    Review
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  15. Observational
  16. Observational
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6 more citing papers are in PubMed but not listed here.

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

4 authors.

Andrea NegroDepartment of Clinical and Molecular Medicine, Sapienza University, Rome, Italy. andrea.negro@uniroma1.it.
Martina CurtoRegional Referral Headache Centre, Sant'Andrea Hospital, Rome, Italy.
Luana LionettoAdvanced Molecular Diagnostics Unit, IDI Istituto Dermopatico dell'Immacolata-IRCSS, Rome, Italy.
Paolo MartellettiDepartment of Clinical and Molecular Medicine, Sapienza University, Rome, Italy.

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

backgroundThe efficacy and safety of OnabotulinumtoxinA (BOTOX®) in adults with chronic migraine (CM) were demonstrated in the PREEMPT program. However, the dosage used in this study was flexible from 155 U to 195 U at the physician's discretion. Therefore, the objective of this prospective study was to compare the efficacy and safety of OnabotulinumtoxinA 195 U vs. 155 U for the treatment of CM and medication overuse headache (MOH) during a 2-year period.

methodsWe prospectively evaluated the mean reduction in headache days, migraine days, acute pain medication intake days and Headache Impact Test (HIT)-6 score in 172 patients injected with OnabotulinumtoxinA 195 U. Successively, we compared the efficacy measures with data of 155 patients injected with OnabotulinumtoxinA 155 U and followed up for 2 years. All patients were affected by CM and MOH, and failed one or more previous detoxification and preventative therapies.

resultsBoth OnabotulinumtoxinA 195 U and 155 U reduced significantly the number of headache and migraine days, acute pain medication intake days and HIT-6 score, when compared with the baseline measures. Nevertheless, OnabotulinumtoxinA 195 U proved to be superior of 155 U in all efficacy measures since the first injection and for all the 2 years of treatment, with the exception of the reduction in pain medication intake days that resulted significantly larger with 195 U only after the 4th injection. The safety and tolerability of the two doses were similar and treatment related adverse events were transient and mild-moderate.

conclusionsThis study represents the largest and longest post-marketing studies of doses comparison with OnabotulinumtoxinA in a real-life clinical setting. Here, we demonstrate the superior efficacy of OnabotulinumtoxinA 195 U compared to 155 U in CM patients with MOH during a 2-year treatment period with similar safety and tolerability profile.

Indexed as

Acetylcholine Release InhibitorsAdolescentAdultAgedBotulinum Toxins, Type AFemaleHeadache Disorders, SecondaryHumansMaleMiddle AgedMigraine DisordersPrescription Drug OveruseProspective StudiesTreatment OutcomeYoung AdultAcetylcholine Release InhibitorsBotulinum Toxins, Type AChronic migraineMedication overuse headacheMigraine abuseOnabotulinumtoxinAPreventative therapy

Identifiers

PMID26792662
PMCPMC4720620

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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.