Evidence map›Paper›PMID 33009629›Full record

Trial reportPsychopharmacology2020

Etifoxine is non-inferior than clonazepam for reduction of anxiety symptoms in the treatment of anxiety disorders: a randomized, double blind, non-inferiority trial.

Benjamín Vicente, Sandra Saldivia, Naín Hormazabal, Claudio Bustos, Patricia Rubí

Abstract readComparative StudyEquivalence TrialMulticenter Study
PubMed Publisher
In one paragraph

Trial report in Psychopharmacology, 2020. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 7 papers.

0numbers the graph read from it
0cells of the map it votes in
7citing papers in PubMed
1.6field-weighted citation impact, top 16% 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

7 citing papers in PubMed, 17 citations in OpenAlex.

  1. Local and global effects of sedation in resting-state fMRI: a randomized, placebo-controlled comparison between etifoxine and alprazolam.Neuropsychopharmacology : official publication of the American College of Neuropsychopharmacology · 2024
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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

5 authors at 1 institution in 1 country.

Benjamín VicenteDepartment of Psychiatry and Mental Health, Universidad de Concepción, Av. Juan Bosco s/n, Casilla 160-C, Concepción, Chile. bvicent@udec.cl.ORCID http://orcid.org/0000-0001-8903-6170
Sandra SaldiviaDepartment of Psychiatry and Mental Health, Universidad de Concepción, Av. Juan Bosco s/n, Casilla 160-C, Concepción, Chile.
Naín HormazabalÑuble Health Service, Bulnes 502, Chillán, Chile.
Claudio BustosDepartment of Psychiatry and Mental Health, Universidad de Concepción, Av. Juan Bosco s/n, Casilla 160-C, Concepción, Chile.
Patricia RubíDepartment of Psychiatry and Mental Health, Universidad de Concepción, Av. Juan Bosco s/n, Casilla 160-C, Concepción, Chile.
University of Concepción · CL

Funding

Universidad de Concepción UR 2623256401
6 · The paper itself

Abstract

objectiveTo determine whether etifoxine, a non-benzodiazepine drug of the benzoxazine family, is non-inferior compared with clonazepam in the treatment of anxiety disorders.

methodA randomized controlled double blind trial with parallel groups was conducted. A total of 179 volunteer patients with a diagnosis of anxiety disorder (DSM-IV), between 18 and 64 years of age, participated in this study. The experimental group received 150 mg/day of etifoxine and the control 1 mg/day of clonazepam, both in three daily doses for 12 weeks. This treatment was completed by 87 participants, and 70 were available for follow-up at 24 weeks from start of treatment. The primary objective was a non-inferiority comparison between etifoxine and clonazepam in the decrease of anxiety symptoms (HAM-A) at 12 weeks of treatment. Secondary outcomes included the evaluation of medication side effects (UKU), anxiety symptoms at 24 weeks of treatment, and clinical improvement (CGI). Data analysis included multiple imputation of missing data. The effect of etifoxine on the HAM-A, UKU, and CGI was evaluated with the intention of treatment, and a sensitivity analysis of the results was conducted. Non-inferiority would be declared by a standardized mean difference (SMD) between clonazepam and etifoxine not superior to 0.31 in favour of clonazepam.

resultsUsing imputed data, etifoxine shows non-inferiority to clonazepam on the reduction of anxiety symptoms at the 12-week (SMD = 0.407; 95% CI, 0.069, 0.746) and 24-week follow-ups (SMD = 0.484; 95% CI, 0.163, 0.806) and presented fewer side effects (SMD = 0.58; 95% CI, 0.287, 0.889). LOCF analysis shows that etifoxine is non-inferior to clonazepam on reduction of anxiety symptoms and adverse symptoms even when no change was assigned as result to participant whom withdrew. Non-inferiority could be declared for clinical improvement (SMD = 0.326; 95% CI, - 0.20, 0.858).

conclusionEtifoxine was non-inferior to clonazepam on reduction of anxiety symptoms, adverse effects, and clinical improvement.

Indexed as

AdolescentAdultAgedAnti-Anxiety AgentsAnxiety DisordersClonazepamDouble-Blind MethodFemaleFollow-Up StudiesHumansMaleMiddle AgedOxazinesTreatment OutcomeYoung AdultAnti-Anxiety AgentsClonazepametifoxineOxazinesAnxietyBenzodiazepinesClonazepamEtifoxineNon-inferiority trial

Identifiers

PMID33009629
OpenAlexW3091648548

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.