Evidence map›Paper›PMID 29255444›Full record

ArticleFrontiers in neurology2017

Stopping Onabotulinum Treatment after the First Two Cycles Might Not Be Justified: Results of a Real-life Monocentric Prospective Study in Chronic Migraine.

Paola Sarchielli, Michele Romoli, Ilenia Corbelli, Laura Bernetti, Angela Verzina, Elona Brahimi, Paolo Eusebi, Stefano Caproni, Paolo Calabresi

Abstract read
In one paragraph

Article in Frontiers in neurology, 2017. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 12 papers, 1 of them a synthesis that pooled it.

0numbers the graph read from it
0cells of the map it votes in
12citing papers in PubMed, 1 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

12 citing papers in PubMed, 1 synthesis or guideline pooled it.

  1. Pooled it
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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

9 authors.

Paola SarchielliNeurology Clinic, University of Perugia-Perugia General Hospital, Perugia, Italy.
Michele RomoliNeurology Clinic, University of Perugia-Perugia General Hospital, Perugia, Italy.
Ilenia CorbelliNeurology Clinic, University of Perugia-Perugia General Hospital, Perugia, Italy.
Laura BernettiNeurology Clinic, University of Perugia-Perugia General Hospital, Perugia, Italy.
Angela VerzinaNeurology Clinic, University of Perugia-Perugia General Hospital, Perugia, Italy.
Elona BrahimiNeurology Clinic, University of Perugia-Perugia General Hospital, Perugia, Italy.
Paolo EusebiRegional Health Authority, Public Health Regional Department, Perugia, Italy.
Stefano CaproniNeurology Clinic, University of Perugia-Perugia General Hospital, Perugia, Italy.
Paolo CalabresiNeurology Clinic, University of Perugia-Perugia General Hospital, Perugia, Italy.

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

introductionOnabotulinum toxin A (OnabotA) cyclic treatment is approved for the prophylactic treatment of chronic migraine (CM), a highly disabling disorder. Although treatment response varies among patients, current guidelines suggest to stop treatment after cycle 2 if no response is achieved. This prospective study aimed to define, in real-life setting, the evolution of the response to OnabotA over five cycles of treatment among patients non-responding to cycle 1. The results of this study might help in decision-making, in particular whether prosecuting OnabotA further or not, when facing a patient not responding to cycle 1.

methodsPatients failing to respond at cycle 1 were recruited to complete five cycles. Key outcomes were: (i) a ≥50% reduction in headache days, (ii) a ≥50% reduction in total cumulative hours of headache on headache days and (iii) a ≥5-point improvement in Headache Impact Test-6 (HIT-6) scores.

resultsOverall, 56 patients were included. Mean age was 45.7 years (female 83.9%). Severe (≥60) HIT-6 score was reported at baseline by 95.8% of patients. Responders (headache days reduction of more than 50%) progressively increased cycle after cycle, doubling from cycle 2 to cycle 5 (from 27 to 48%). In addition, patients regressed from CM to episodic migraine moving on with each cycle, with 78% of them reaching less than nine migraine days/month after cycle 5. The headache days per month decreased significantly from cycle 1 to cycle 5 (overall from 23.3 ± 5.7 to 9.2 ± 3.6;

conclusionThe positive effect of OnabotA treatment spreads over the course of the treatment and might also manifest late in treatment course among patients with no benefit after the first two cycles. Thus, the results of this real-life study suggest to extend OnabotA treatment further, beyond cycle 2, to avoid premature withdrawal in patients who would have become responders at cycle 3, 4, or 5.

Indexed as

botoxchronic migrainemigrainemigraine treatmentonabotulinum toxin A

Identifiers

PMID29255444
PMCPMC5723003

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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.