Effect of Alprostadil Plus Ginkgo Biloba Extract on Hearing and Quality of Life in Sudden Sensorineural Hearing Loss: Retrospective Comparative Study

Summary

Using a single-center retrospective comparative design, this study showed that alprostadil combined with Ginkgo biloba extract improved PTA-4 recovery, hearing-loss distribution, SF-36 domains, and HHIA scores in sudden sensorineural hearing loss patients compared with alprostadil alone, without increasing adverse reactions, suggesting the short-term potential of early combination therapy.

Abstract

Sudden sensorineural hearing loss is associated with inner-ear microcirculatory disturbance and oxidative stress, which can damage auditory cells and cause permanent hearing impairment without timely treatment. Current management targets blood supply and inflammation, but single-agent efficacy remains unstable. This retrospective study explored whether alprostadil combined with Ginkgo biloba extract is associated with improved audiological outcomes and quality of life. Patients treated from January 2024 to December 2024 at a single center were included. A total of 100 patients who met the eligibility criteria were identified and divided into two groups based on their actual treatment: 50 who received alprostadil alone (control group) and 50 who received alprostadil plus Ginkgo biloba extract (combination therapy group). Primary outcomes were changes in affected-ear pure-tone average threshold [four-frequency pure-tone average (PTA-4)] and quality-of-life scales [36-Item Short Form Health Survey (SF-36); Hearing Handicap Inventory for Adults (HHIA)]. Assessments were performed before treatment and at follow-up as documented in the medical records. Statistical analyses included repeated-measures analysis of variance and independent-samples t-tests, with Bonferroni correction when required (α = 0.05/k), and adverse events (AE) were compared using the χ² test or Fisher’s exact test. The PTA-4 group × time interaction was significant (P = 0.002). On day 90, PTA-4 improvement was greater in the combination therapy group than in the control group (P = 0.002). After 90 days, the proportion of mild hearing loss differed between groups (P = 0.040), whereas the proportions for other grades did not. Significant group × time interactions were observed for all SF-36 dimensions (all P < 0.05) and HHIA scores (P = 0.007). On days 10, 30, and 90, HHIA improved more in the combination therapy group; SF-36 scores were also higher at follow-up. All included patients had completed treatment and 90-day follow-up per medical records and were included in the efficacy and safety analyses. Alprostadil plus Ginkgo biloba extract improved short-term audiological and quality-of-life outcomes without increasing adverse reactions, supporting the short-term potential of early combination therapy.

Introduction

Sudden sensorineural hearing loss is a hearing impairment that develops within a short period of time; common clinical symptoms include tinnitus, aural fullness, and hearing loss. Some patients can recover spontaneously, while a considerable proportion may develop irreversible hearing loss, thereby affecting social interaction and emotional stability^1,2. Current therapy mainly focuses on improving microcirculation in the inner ear and alleviating inflammatory damage, with commonly used drugs including glucocorticoids, vasodilators, and neurotrophic agents; however, efficacy is variable, and relapses are not un....

Protocol

The retrospective study was reviewed and approved by the Medical Ethics Committee of Tianjin First Central Hospital (approval No. (2025) No. 49). The medical records used for this retrospective analysis were derived from patients treated between January 2024 and December 2024. The present retrospective comparative analysis was conducted on de-identified routinely collected clinical data. All subjects had provided written informed consent for the use of their clinical data for research purposes at the time of their initial treatment, and the ethics committee approved the use of these data for this retrospective study.

Study design

Results

General data and baseline characteristics

A total of 149 patients were assessed for eligibility from the medical records, of whom 49 were excluded. Ultimately, 100 patients were included in the analysis, with 50 in each group. All patients were included in the final efficacy and safety analyses (Figure 1). There were no statistically significant differences between the control group and the combination therapy group in age, sex, time from onset to.......

Discussion

This study evaluated the auditory outcomes and quality of life of patients with sudden sensorineural hearing loss, and the results showed that patients who received a combination of alprostadil and Ginkgo biloba extract showed more significant improvements in pure-tone thresholds, especially at 90 days after treatment, with a more pronounced decrease in average hearing threshold and a markedly higher proportion of mild hearing loss than with alprostadil alone. By day 90, PTA-4 decreased from 70.16 ± 7.32 to 48.79 &#.......

Materials

List of materials used in this article

Name	Company	Catalog Number	Comments
1. Study drugs and infusion solutions
Alprostadil Injection	Beijing Tide Pharmaceutical Co., Ltd.	NMPA Approval No. H10980024	2 mL:10 μg; study drug for intravenous infusion.
Extract of Ginkgo Biloba Leaves Injection	Zhong Hao International Co., Ltd. (marketing authorization holder); Chi Sheng Pharma & Biotech Co., Ltd. (manufacturer)	NMPA Approval No. HC20181022	5 mL:17.5 mg; injection; 10 ampoules/box; add-on study drug.
Glucose Injection, 5%	Chimin Health Management Co., Ltd.	NMPA Approval No. H19994045	100 mL:5 g; used as the intravenous infusion diluent and line-flushing solution.
2. Infusion administration and safety supplies
Disposable sterile intravenous infusion set for gravity infusion	Hospital standard consumable	GB 8368-2018; catalog number N/A	Used for peripheral venous infusion of separately prepared study drugs.
Peripheral intravenous access supplies	Hospital standard consumables	N/A	Infusion needle or indwelling catheter, tourniquet, skin disinfectant, and sterile dressing; used to establish and maintain peripheral venous access.
Medical electronic blood pressure monitor	OMRON Healthcare Co., Ltd.	HBP-1300	Upper-arm medical electronic blood pressure monitoring device; used for blood pressure and pulse monitoring before infusion.
Emergency management supplies for infusion reactions	Hospital emergency cart/standard emergency medicines	N/A	Available in the treatment area for clinically indicated management of infusion reactions or serious adverse events.
3. Audiological assessment equipment and environment
Diagnostic audiometer	Interacoustics A/S	AD629	Used for air-conduction threshold testing and PTA-4 calculation.
Soundproof booth/audiometry room	Department of Otolaryngology, Tianjin First Central Hospital	N/A	Used to provide a controlled testing environment for pure-tone audiometry.
Audiometer calibration record and biological calibration checklist	Study site/certified calibration service	N/A	Used to document professional calibration before study initiation and daily device self-testing/biological calibration.
Original pure-tone audiometry record sheet	Department of Otolaryngology, Tianjin First Central Hospital	N/A	Used to record air-conduction and bone-conduction thresholds and to support PTA-4 calculation and hearing-grade classification.
4. Questionnaires and scoring materials
36-Item Short Form Health Survey (SF-36)	RAND	RAND 36-Item Health Survey 1.0	A 36-item health-related quality-of-life questionnaire covering 8 domains; source instrument and scoring instructions are provided by RAND; scored according to the RAND 36-Item Health Survey 1.0 standard scoring instructions.
SF-36 scoring and verification sheet	Study team, Department of Otolaryngology, Tianjin First Central Hospital	N/A	Used to convert raw SF-36 responses to 0–100 domain scores and verify subject number, assessment date, and raw scores.
Hearing Handicap Inventory for Adults (HHIA)	Original instrument: Newman et al.	N/A	A 25-item self-assessment scale for social and emotional effects of hearing impairment; source instrument originally described by Newman et al. (1990) and psychometrically reevaluated by Cassarly et al. (2020); scored Yes/Sometimes/No = 4/2/0.
HHIA scoring and verification sheet	Study team, Department of Otolaryngology, Tianjin First Central Hospital	N/A	Used to calculate total HHIA scores and verify subject number, assessment date, and raw scores.
5. Study documentation and trial management materials
Case report form (CRF)	Study team, Department of Otolaryngology, Tianjin First Central Hospital	N/A	Used to record screening, informed consent, randomization number, baseline variables, treatment, follow-up, outcomes, and concomitant treatment.
Infusion administration record form	Study team, Department of Otolaryngology, Tianjin First Central Hospital	N/A	Used to record subject ID, drug name, dose, solvent, administration date/time, infusion start/end time, infusion reaction, and completion status.
Follow-up and concomitant treatment record form	Study team, Department of Otolaryngology, Tianjin First Central Hospital	N/A	Used at day 10, day 30, and day 90 to record follow-up completion, audiometry, scale assessment, adverse events, and concomitant or prohibited treatment.
Adverse event record form	Study team, Department of Otolaryngology, Tianjin First Central Hospital	N/A	Used to record adverse reactions, serious adverse events, onset time, management, outcome, and relationship assessment when applicable.
Basic otologic management checklist	Study team, Department of Otolaryngology, Tianjin First Central Hospital	N/A	Used to standardize noise avoidance, discontinuation of headphone use, sleep management, tinnitus explanation, medication-reaction observation, and follow-up reminders; routine vitamin B therapy was not used.
6. Statistical software
IBM SPSS Statistics 26.0	IBM	26	Statistical analysis software.