DefinePK

Research Objective

To evaluate vertigo control and auditory rescue in patients with Meniere's disease treated with intratympanic Gentamicin and Dexamethasone.

Methodology

Randomized Control Trial (Clinical Trials.gov Identifier: NCT05355610) conducted in ENT Departments CMH Quetta and Benazir Bhutto Hospital Rawalpindi Pakistan from April 2020 to March 2022. Ninety-three cases of unilateral Meniere's disease meeting inclusion criteria were treated with intratympanic Gentamicin and Dexamethasone. Pre and post-treatment vertigo was assessed on Vestibular Deficit Index, and speech discrimination scores were recorded for auditory impact. Data was analyzed using SPSS version 24 with paired sample t-test for statistical significance.

Methodology Flowchart

                        graph TD;
    A["Recruit Patients with Unilateral Meniere's Disease"] --> B["Obtain Institutional Review Board Approval"];
    B --> C["Pre-treatment Assessment: Vestibular Deficit Index & Speech Discrimination Score"];
    C --> D["Administer Intratympanic Gentamicin and Dexamethasone via Grommet 3 courses, weekly"];
    D --> E["Post-treatment Assessment: Vestibular Deficit Index & Speech Discrimination Score"];
    E --> F["Data Analysis using SPSS v24"];
    F --> G["Statistical Significance Testing"Paired Sample t-test""];
    G --> H["Draw Conclusions"];                    

Discussion

The Vestibular Deficit Index is considered a more realistic approach to gauge vertigo due to its incorporation of objective and subjective symptomatic elements. Using a grommet facilitates repeated intratympanic drug administration without repeated surgical intervention. Concomitant use of Dexamethasone with ototoxic drugs like Gentamicin can dampen collateral auditory damage. The study suggests that intratympanic Gentamicin effectively controls vestibular symptoms, while Dexamethasone helps rescue the auditory system.

Key Findings

A statistically significant improvement in the Vestibular Deficit Index was observed in the ninety-three treated cases (p-value = 0.001). Although all patients had a reduced speech discrimination score, this reduction was not statistically significant (p-value = 0.08).

Conclusion

Control of vestibular symptoms can be achieved with intratympanic Gentamicin in Meniere's disease, and at the same time, the auditory system can be rescued with intratympanic Dexamethasone.

Fact Check

1. The study was conducted from April 2020 to March 2022. (Confirmed by text)
2. Ninety-three cases of unilateral Meniere's disease were treated. (Confirmed by text)
3. The Vestibular Deficit Index showed a statistically significant improvement with a p-value of 0.001. (Confirmed by text)

Mind Map