Trial reportTrials2020
Randomized placebo-controlled clinical trial investigating the effect of antioxidants and a vasodilator on overall safety and residual hearing preservation in cochlear implant patients.
Trial report in Trials, 2020. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 8 papers.
What it found
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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.
Who cites it
8 citing papers in PubMed.
- Pharmacotherapeutic Interventions for Sensorineural Hearing Loss: A Scoping Review.Audiology research · 2026Review
- Dexamethasone-eluting cochlear implants reduce inflammation and foreign body response in human and murine cochleae.Scientific reports · 2025Article
- Efficacy and Mechanisms of Antioxidant Compounds and Combinations Thereof against Cisplatin-Induced Hearing Loss in a Rat Model.Antioxidants (Basel, Switzerland) · 2024Article
- Noise-induced hearing disorders: Clinical and investigational tools.The Journal of the Acoustical Society of America · 2023Article
- Cochlear implants: Causes, effects and mitigation strategies for the foreign body response and inflammation.Hearing research · 2022Review
- Enhanced Antioxidant Ability of PEG-Coated CeACS omega · 2022Article
- Correlation of Electrically Evoked Compound Action Potential Amplitude Growth Function Slope and Anamnestic Parameters in Cochlear Implant Patients-Identification of Predictors for the Neuronal Health Status.Life (Basel, Switzerland) · 2021Article
- Impact of the ACEMg Biomedicine on Sensorineural Hearing Loss and Auditory Function: Analysis of Real-World Clinical Data.Global advances in integrative medicine and healthArticle
Corrections and comments
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Authors and funding
9 authors.
Funding
Abstract
backgroundThe standard therapy for patients suffering from sensorineural hearing loss is cochlear implantation. The insertion of the electrode array into the cochlea, with potential mechanical trauma and the presence of this foreign body inside the cochlea, may lead to free radical formation and reduced blood perfusion of the cochlea which can result in a loss of residual hearing. Studies have suggested that a particular combination of the antioxidants vitamins A, C and E as well as the vasodilator magnesium (together: ACEMg) may protect the residual hearing.
methodsThe potential protective effect of ACEMg on residual hearing preservation in cochlear implant (CI) patients was investigated in a single-centre, randomized, placebo-controlled, double-blind phase II clinical trial. CI candidates with some residual hearing in low frequencies receiving MED-EL implants of different FLEX electrode array lengths were treated with ACEMg tablets or placebo respectively 2 days preoperatively and up to 3 months postoperatively. The study objective was to demonstrate that ACEMg is more efficacious than placebo in preserving residual hearing during cochlear implantation by comparing the hearing loss (change in hearing thresholds at 500 Hz from baseline) 3 months after the first fitting between the two treatment groups and to investigate the treatments' safety.
resultsFifty-one patients were included in the study, which had to be terminated before the recruitment goal was reached because of IMP-resupply mismanagement of one partner. In the intention-to-treat population, 25 patients were treated with ACEMg and 24 patients with placebo. The mean hearing loss at 500 Hz was (± 15.84) 30.21 dB (placebo) or (± 17.56) 26.00 dB (ACEMg) 3 months after the initial fitting. Adjusting the postoperative hearing loss for the baseline residual hearing, planned electrode length and surgeon results in 8.01 dB reduced hearing loss in ACEMg-treated patients compared to placebo-treated ones. The safety analysis revealed that ACEMg was generally well-tolerated with adverse event frequencies below the placebo level.
conclusionThis is the first clinical trial investigating a drug effect on residual hearing in CI patients. These first-in-man data may suggest that a perioperative oral administration of ACEMg is safe and may provide protection of residual hearing in CI patients.
trial registrationEU Clinical Trial Register No. 2012-005002-22 . Registered on 6 December 2013.
fundingEuropean Commission FP7-HEALTH-2012-INNOVATION-2.
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