Evidence map›Paper›PMID 31213753›Full record

ArticleHippokratia

The first comparative double-blind trial on efficacy and safety of ergotamine based five-component combination and sumatriptan in migraine without aura.

S Miljković, Dz Smajlović, M Tirić Campara, R Jurina, L Duranović Vinković, S M Janković, B Begović, M Ćeranić

Abstract read
In one paragraph

Article in Hippokratia. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 2 papers, 1 of them a synthesis that pooled it.

0numbers the graph read from it
0cells of the map it votes in
2citing papers in PubMed, 1 pooled it
0.3field-weighted citation impact, top 36% 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

2 citing papers in PubMed, 1 synthesis or guideline pooled it, 8 citations in OpenAlex.

  1. Pooled it
  2. Article
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

8 authors at 2 institutions in 2 countries.

S MiljkovićDepartment of Neurology, University Clinical Center Banja Luka, Bosnia and Herzegovina.
Dz SmajlovićDepartment of Neurology, University Clinical Center Tuzla, Bosnia and Herzegovina.
M Tirić CamparaDepartment of Neurology, University Clinical Center Sarajevo, Bosnia and Herzegovina.
R JurinaDepartment of Neurology, University Clinical Hospital Mostar, Bosnia and Herzegovina.
L Duranović VinkovićDepartment of Neurology, Cantonal Hospital "Dr. Safet Mujić" Mostar (Regional Medical Center), Bosnia and Herzegovina.
S M JankovićFaculty of Medical Science, University of Kragujevac, Serbia.
B BegovićSociety for Pharmacoeconomics and Outcomes Research in Bosnia and Herzegovina, ISPOR Regional Chapter, Bosnia and Herzegovina.
M ĆeranićBosnalijek dd, Sarajevo, Bosnia and Herzegovina.
University Clinical Center Tuzla · BAUniversity of Kragujevac · RS

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

backgroundDihydroergotamine or ergotamine are the most effective preparations for aborting acute attacks of migraine without aura.

objectiveThe aim of our study was to compare the efficacy and safety of ergotamine based five-component drug combination and sumatriptan in the treatment of moderate to severe acute attacks of migraine without aura.

methodsThe study was designed as a randomized, double-blind, double-dummy, placebo-controlled, parallel arm, multi-center clinical trial. The enrolled patients having migraine without aura were randomized to one of the study arms, ergotamine based five-component drug combination or sumatriptan.

resultsIn total, 201 patients were randomized to one of the treatment arms. Higher percentage of patients was completely free of the headache two hours after dose administration in the ergotamine-based medication group compared to the sumatriptan group, regardless whether all (51.12 % vs 33.70 %) or only repeated attacks were taken into account (50.91 % vs 23.73 %); the salvage therapy (diclofenac) utilization rate was also lower in the ergotamine-based medication group (relative risk 0.61). Photophobia, phonophobia, and osmophobia were reversed more frequently in the ergotamine-based medication group (51.12 % vs 33.70 %), and failure to abort an attack of the migraine without aura occurred more frequently in the group treated with sumatriptan (1.1 % vs 4.9 %). The headache intensity two hours after ingestion of the study medication increased more frequently with sumatriptan, while other adverse events were rare in both groups.

conclusionsThis study demonstrated higher efficacy and similar safety of ergotamine based fixed drug combination in comparison to sumatriptan, when used in the treatment of an acute attack of the migraine. HIPPOKRATIA 2018, 22(1): 17-22.

Indexed as

efficacyergotamine based fixed drug combinationsmigraine without aurasafetysumatriptan

Identifiers

PMID31213753
PMCPMC6528700
OpenAlexW2952449404

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.