Trial reportEuropean journal of medical research2025
Efficacy of methylprednisolone sodium succinate combined with acoustic resonance therapy on inflammatory response indicators and cerebral microcirculation in patients with sudden sensorineural hearing loss.
Trial report in European journal of medical research, 2025. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 1 paper.
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Abstract
backgroundSudden sensorineural hearing loss (SSNHL), is associated with significant inflammatory responses that can impair auditory function. Methylprednisolone sodium succinate (MPSS) is commonly used for its anti-inflammatory properties, while acoustic resonance therapy may enhance healing through improved microcirculation. This study aims to evaluate the combined effects of MPSS and acoustic resonance therapy on inflammatory response indicators and cerebral microcirculation in patients with SSNHL.
methodsA double-blind, randomized, placebo-controlled trial was conducted with 256 participants aged 18 to 65 diagnosed with unilateral SSNHL. The study included three groups of patients: the MPSS group (n = 85), the combination therapy group (n = 86), and the placebo group (n = 85). Severe cases comprised 54.1% of the MPSS group, 57.0% of the combination therapy group, and 52.9% of the placebo group, while profound hearing loss was observed in 45.9%, 43.0%, and 47.1%, respectively. Word recognition scores at 80 dB varied, with median values of 16% (0-60) in the MPSS group, 22.5% (0-50) in the combination group, and 30% (0-70) in the placebo group. While the MPSS and placebo injections were administered under double-blind conditions, the acoustic resonance therapy component was not blinded due to the nature of the intervention. Key endpoints included changes in inflammatory markers [C-reactive protein (CRP), Interleukin 6 (IL-6), tumour necrosis factor alpha (TNF-a), and fibrinogen)], assessments of cerebral microcirculation, and hearing outcomes measured by pure-tone average (PTA) and word recognition scores (WRS).
resultsTreatment effectiveness was assessed via PTA, hearing recovery, tinnitus severity, WRS, and inflammatory markers. At baseline, PTA values were similar (p = 0.802). By Day 30, PTA improved significantly (p = 0.022), with the greatest gains in the combination therapy group. By Day 60, PTA values were 45.0 ± 9.8 dB (MPSS), 48.0 ± 8.3 dB (combination therapy), and 31.0 ± 10.0 dB (placebo) (p = 0.031). The combination therapy group showed the most PTA improvement (16.0 ± 5.1 dB, p = 0.046) and highest complete recovery rate (46.5% vs. 29.4% MPSS, 9.4% placebo, p = 0.005). Tinnitus severity was similar at baseline (p = 0.236) but decreased significantly by Day 30. MPSS reduced to 4.0 ± 1.0, while combination therapy improved to 2.5 ± 0.9 (p < 0.001). By Day 60, combination therapy had the lowest severity (1.8 ± 0.7), confirming superior efficacy. WRS improved significantly, with combination therapy showing the most gains. By Day 60, WRS reached 45.0% ± 11.0% (MPSS), 60.0% ± 8.5% (combination therapy), and 42.0% ± 14.5% (placebo) (p < 0.001), supporting combination therapy's advantage. Inflammatory markers (CRP, IL-6, TNF-α, fibrinogen) dropped significantly in treatment groups. By Day 60, CRP fell to 5.2 ± 0.9 mg/L (MPSS) and 3.5 ± 0.8 mg/L (combination therapy) (p < 0.001). IL-6 dropped to 10.0 ± 2.0 pg/mL (MPSS) and 8.5 ± 1.8 pg/mL (combination therapy) (p < 0.001). TNF-α decreased to 38.5 ± 1.5 pg/mL (MPSS) and 34.0 ± 1.3 pg/mL (combination therapy), while fibrinogen was lowest in combination therapy (3.0 ± 0.2 g/L) (p < 0.001), demonstrating strong anti-inflammatory effects. Cerebral circulation improved significantly in all groups, with the greatest increase in blood flow (Qm) in combination therapy (9.00 ± 1.75 mL/s by Day 60) and enhanced cerebral perfusion (p < 0.05). While the placebo group showed moderate improvement, combination therapy consistently yielded the most substantial benefits in hearing, inflammation reduction, and circulation.
conclusionThe findings suggest that the synergistic application of MPSS and acoustic resonance therapy effectively reduces inflammation and improves cerebral blood flow, leading to better auditory outcomes in patients with SSNHL. This research underscores the potential of integrated treatment approaches in managing SSNHL.
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