Evidence map›Paper›PMID 40515518›Full record

Trial reportThe Laryngoscope2025

Optimal Dosing of Nortriptyline-Topiramate and Verapamil-Paroxetine Combinations in Tinnitus Treatment.

Ella J Lee, Karen Tawk, Martha Lucía Gutiérrez Pérez, Cynthia Tsang, Mehdi Abouzari, Hamid R Djalilian

Abstract readRandomized Controlled Trial
PubMed Full text at PMC Publisher
In one paragraph

Trial report in The Laryngoscope, 2025. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 1 paper.

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

1 citing paper in PubMed.

  1. Review
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

6 authors.

Ella J LeeDepartment of Otolaryngology-Head and Neck Surgery, University of California, Irvine, California, USA.
Karen TawkDepartment of Otolaryngology-Head and Neck Surgery, University of California, Irvine, California, USA.
Martha Lucía Gutiérrez PérezDepartment of Otolaryngology-Head and Neck Surgery, University of California, Irvine, California, USA.
Cynthia TsangDepartment of Otolaryngology-Head and Neck Surgery, University of California, Irvine, California, USA.
Mehdi AbouzariDepartment of Otolaryngology-Head and Neck Surgery, University of California, Irvine, California, USA.ORCID 0000-0002-3585-698X
Hamid R DjalilianDepartment of Otolaryngology-Head and Neck Surgery, University of California, Irvine, California, USA.ORCID 0000-0003-2270-5207

Funding

University of California Health Participation in the National COVID Cohort Collaborative (N3C)UL1TR001414 · NCATS · UNIVERSITY OF CALIFORNIA-IRVINE · PI COOPER, DAN M, VILAIN, ERIC J. · 2015 to 2023
$35.1M
Institute for Clinical and Translational ScienceUM1TR004927 · NCATS · UNIVERSITY OF CALIFORNIA-IRVINE · PI DAN M COOPER, Eric J. Vilain · 2024 to 2026
$12.2M
NRSA Training CoreTL1TR001415 · NCATS · UNIVERSITY OF CALIFORNIA-IRVINE · PI CAIOZZO, VINCENT JAMES, HEAD, ELIZABETH · 2015 to 2023
$4.2M
NCATS NIH HHS TL1 TR001415NCATS NIH HHS TL1TR001415NCATS NIH HHS UL1 TR001414NCATS NIH HHS UM1 TR004927NCRR NIH HHS TL1TR001415NIH HHS
6 · The paper itself

Abstract

objectiveTo determine effective dose strategies for nortriptyline-topiramate (NT) and verapamil-paroxetine (VP) combinations for tinnitus treatment.

methodsThis secondary analysis examined data from an 8-week, randomized, double-blind, placebo-controlled trial (RCT) evaluating treatment outcomes in 41 patients. Tinnitus Functional Index (TFI) scores were used as the primary outcome measure, administered at baseline, Week 4, and Week 8 to assess achievement of minimal clinically important differences (MCID) of 13-point reduction. Descriptive statistics were employed to characterize treatment responses and assess dose-response relationships.

resultsIn the NT group (n = 19), 42% of the participants achieved a reduction in TFI scores meeting MCID with a mean dose of 44 ± 12 mg nortriptyline plus 59 ± 16 mg topiramate, all showing greater than 15% improvement. In the VP group (n = 22), 41% reached MCID with a mean of 207 ± 36 mg verapamil plus 28 ± 5 mg paroxetine. Of these, 88.9% showed at least a 15% improvement in TFI. Early responders who achieved MCID by the midpoint of the trial required continued dose escalations due to limited improvement in weekly VAS scores afterward. However, subsequent TFI changes were not statistically significant.

conclusionsBoth NT and VP regimens effectively reduce tinnitus severity in approximately half of the patients at moderate doses within 8 weeks. However, long-term effects may not have been fully captured, particularly among late improvers. LEVEL OF EVIDENCE: 2:

Indexed as

NortriptylineParoxetineTinnitusTopiramateVerapamilAdultAgedDose-Response Relationship, DrugDouble-Blind MethodDrug CombinationsDrug Therapy, CombinationFemaleHumansMaleMiddle AgedTreatment OutcomeDrug CombinationsNortriptylineParoxetineTopiramateVerapamilmigraineminimal clinically important differencenortriptyline–topiramateoptimal dosetinnitusverapamil–paroxetine

Identifiers

PMID40515518
PMCPMC12867007

What Socratic holds

Textmetadata
LicenceTDM
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 Socratic graph.