Evidence map›Paper›PMID 38265679›Full record

Trial reportNaunyn-Schmiedeberg's archives of pharmacology2024

Safety and efficacy of levetiracetam and carbamazepine monotherapy in the management of pediatric focal epilepsy: a randomized clinical trial.

Hadi Montazerlotfelahi, Arsh Haj Mohamad Ebrahim Ketabforoush, Marzieh Tavakol, Mahmoudreza Ashrafi, Mahdieh Dehghani, Keihan Mostafavi, Shayan Mardi, Sanaz Tajfirooz

Abstract readRandomized Controlled TrialComparative Study
PubMed Publisher
In one paragraph

Trial report in Naunyn-Schmiedeberg's archives of pharmacology, 2024. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 3 papers, 1 of them a synthesis that pooled it.

0numbers the graph read from it
0cells of the map it votes in
3citing 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

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

  1. Pooled it
  2. Review
  3. Observational
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.

Hadi MontazerlotfelahiDepartment of Pediatric Neurology, Faculty of Medicine, Imam Ali Hospital, Alborz University of Medical Sciences, Karaj, Iran.
Arsh Haj Mohamad Ebrahim KetabforoushStudent Research Committee, Alborz University of Medical Sciences, Karaj, Iran.
Marzieh TavakolNon-Communicable Diseases Research Center, Alborz University of Medical Sciences, Karaj, Iran.
Mahmoudreza AshrafiDepartment of Pediatric Neurology, Children's Medical Center, Tehran University of Medical Sciences, Tehran, Iran.
Mahdieh DehghaniDepartment of Oral and Maxillofacial, Faculty of Dentistry, Tehran Medical Sciences of Islamic Azad University, Tehran, Iran.
Keihan MostafaviDepartment of the Pediatrics, Faculty of Medicine, Iran University of Medical Sciences, Tehran, Iran.
Shayan MardiStudent Research Committee, Arak University of Medical Sciences, Arak, Iran.
Sanaz TajfiroozDepartment of the Pediatrics, Faculty of Medicine, Imam Ali Hospital, Alborz University of Medical Sciences, Vali-Asr St., Shora Ave, Karaj, Iran. sanaztajfirooz@gmail.com.

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

Due to the limited number of studies in children with focal epilepsy and the importance of choosing the most suitable drug to control seizures in children, the administration of the most effective medication with the most negligible adverse events is vital. This study aimed to evaluate the effectiveness and adverse events of carbamazepine vs. levetiracetam monotherapy in children with focal seizures. A monocentric, randomized, controlled, double-blind, parallel-group clinical trial was designed. This study was approved by the Iranian Registry of Clinical Trials (registration number: IRCT20170216032603N2) on June 19, 2020, and conducted at the neurology department of Imam Ali Hospital, Karaj, Iran, from February 2020 to March 2021. This study assessed 120 patients with recently diagnosed focal seizures aged 2 to 14. Patients were randomly divided into two groups, who received carbamazepine (CBZ) 15 to 20 mg/kg and levetiracetam (LEV) 20 to 40 mg/kg daily, respectively. Patients were evaluated for improvement and complications at weeks 4, 12, and 24. Out of 120 patients included in the study, six patients were excluded due to various complications of CBZ. The mean number of seizures at the end of the fourth, twelfth, and twenty-fourth weeks were 1.09 ± 0.75, 0.62 ± 0.27, and 0.39 ± 0.12 in the carbamazepine group and 1.11 ± 0.63, 0.52 ± 0.21, and 0.37 ± 0.11 in the LEV group, respectively (P > 0.05). Similarly, the number of seizure-free patients was 34, 44, and 48 in the CBZ group compared to 41, 50, and 54 in the LEV group, respectively (P > 0.05). On the other hand, the frequency of somnolence, dermatologic complications, and agitation was considerably higher in the CBZ group (P < 0.05). Although both medicines were equally effective in seizure control, CBZ was associated with considerably more adverse events and less patient compliance. Physicians should be aware of this difference to prevent unwanted consequences.

Indexed as

AnticonvulsantsCarbamazepineEpilepsies, PartialLevetiracetamAdolescentChildChild, PreschoolDouble-Blind MethodFemaleHumansIranMaleTreatment OutcomeAnticonvulsantsCarbamazepineLevetiracetamCarbamazepineFocal epilepsyFocal seizuresLevetiracetamPediatric neurology

Identifiers

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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.