Abstract
Objectives
It was aimed to investigate the necessity of antiviral agents in the ISSHL treatment.
Methods
In this study, the patients, diagnosed with sudden hearing loss and admitted in the first 7 days of hearing loss were divided into two groups; a combination therapy was administered to one of the groups, and famciclovir was administered to the other group as an antiviral treatment in addition to the combined therapy. Both groups were compared in terms of levels of recovery.
Results
No statistically significant difference was found in the recovery rates between the two groups ( p = 0.7).
Conclusion
In this study, the additional antiviral treatment was found to have no effect on the remission rates in patients with ISSHL treated with combined therapy.
1
Introduction
Idiopathic sudden sensorineural hearing loss (ISSNHL) is one of the most controversial issues of otolaryngology since its etiology and treatment cannot be elucidated fully. Sudden hearing loss is defined as development of more than 30 dB of sensorineural hearing loss at three sequential frequencies in less than three days . Since it was described by De Kleyn in 1944 for the first time, its etiopathogenesis has not been fully clarified. Theories such as viral infection, vascular occlusion, perforation of the labyrinthine membranes, immune-mediated mechanisms and abnormal stress response in the cochlea have been proposed to explain the etiopathogenesis of ISSHL .
Although a variety of treatment protocols have been applied in ISSNHL, no consensus has been formed yet . Although vasodilators, diuretics, anticoagulants, plasma expanders, CO 2 and various other methods are proposed for treatment, all these treatment modalities are applied empirically in many cases, without revealing the cause clearly. Hence, all these treatment modalities need a proper explanation . Only the steroid therapy has been shown to be effective on good prognosis, albeit to a certain extent . Spontaneous healing rate of ISSNHL has been shown as 32–65% in various studies, and the healing rates in ISSNHL have been reported as 49–89% with the use of steroids .
The insufficiently understood pathophysiology, spontaneous recovery in the course of the disease, and its low incidence makes it difficult to choose the treatment modalities . In recent studies, viral agents were considered responsible in a significant number of patients with ISSNHL, and antiviral-agent acyclovir has been proposed as an effective treatment option in cases with a viral etiology . After some histopathological studies, many clinicians started to consider viral factors’ role in the etiopathogenesis. The results of some of the histopathological studies were interpreted in favor of viral etiology, and antiviral therapy has recently started to be adopted . On the other hand, many clinicians have started to add antiviral therapy to their treatment by considering viral etiology, albeit improvable . However, the efficacy of antiviral therapy could not be demonstrated clearly, and, there is a debate on how and by which ways the viruses cause ISSHL as well.
The aim of this study is to determine whether the patients with ISSNHL benefit from early treatment with famciclovir antiviral-agent. Thus, the efficacy of antiviral therapy in patients with ISSHL will be studied. Famciclovir is a drug that is rapidly absorbed orally and metabolized to penciclovir. Its bioavailability is high and plasma concentration reaches its peak in an hour. Routine famciclovir use for sudden hearing loss (ISSNHL) has not been found in the literature. This is the first study in the literature on the use of famciclovir in sudden sensorineural hearing loss.
2
Materials and methods
The patients admitted within 7 days from the onset of the symptoms were included in this study. Detailed histories of the patients were taken first, and then the systemic ENT and vestibular system examinations were performed. All patients were evaluated for the fasting blood glucose, liver function tests (ALT, AST, GGT, total bilirubin), renal function tests (Na, K, Cl, urea, creatinine clearance), bleeding profiles (aPTT, PTZ), and contrast-enhanced magnetic resonance imaging (MRI) of the cranial. The patients with hypertension, diabetes, autoimmune, collagen and renal diseases and the patients with a previous history of ear disease or the ones that have a known hearing loss, and the patients diagnosed as fluctuating hearing loss at the follow-up and the patients with cerebellopontine angle tumor were not included in the study. In total, 41 patients were included in the study, according to the inclusion criteria. In this study, the patients that were administered with a combined treatment and the patients administered with famciclovir in addition to the combined therapy were divided into groups according to their hearing loss treatments. The Group 1 patients consisted of the patients administered with a combined therapy, and the Group 2 consisted of the patients administered with the additional famciclovir treatment. The Group 1 patients were administered with steroid (methylprednisolone, 250 mg on the first day, 150 mg on the second day, 100 mg on the third day, and this continued by 20 mg reduction in every three days beginning from the fourth day), rheomarodex (500 cc, as to continue for 8 hours, for 5 days) and piracetam (3 × 2 g ampule for 5 days), lansoprol capsule (1 × 1 for stomach protection). Patients in the Group 2 were administered with famciclovir 3 × 250 mg orally, for 7 days, in addition to the combined treatment in the Group 1. During the treatment, the blood pressure and blood glucose levels of all patients were monitored.
In order to ensure standardization of the groups, the patients were proportionally divided into the groups in terms of the factors (degree of loss, the shape of the audiogram, presence of vertigo and/or tinnitus, age) that may affect prognosis ( Table 1 ).
| Group 1 | Group 2 | |||||
|---|---|---|---|---|---|---|
| n | % | Recovery | n | % | Recovery | |
| Hearing loss | ||||||
| Mild | 2 | 10 | 2 (100%) | 3 | 14 | 3 (100%) |
| Moderate | 8 | 40 | 7 (88%) | 7 | 33 | 6 (85%) |
| Moderately severe | 5 | 25 | 2 (40%) | 5 | 24 | 3 (60%) |
| Severe | 5 | 25 | 2 (40%) | 6 | 29 | 3 (50%) |
| Tinnitus | 11 | 55 | 6 (55%) | 13 | 62 | 8 (62%) |
| Vertigo | 5 | 25 | 2 (40%) | 3 | 14 | 3 (100%) |
| Shape of the audiogram | ||||||
| Upwards | 9 | 45 | 6 (66%) | 8 | 38 | 6 (75%) |
| Flat | 7 | 35 | 5 (71%) | 7 | 33 | 6 (85%) |
| Downwards | 4 | 20 | 2 (50%) | 6 | 29 | 3 (50%) |
Before and after the treatment, the patients were evaluated by audiometric examinations on the 7th day, 10th day, 1st month and 6th month. The pure tone audiometry, speech reception thresholds (SRT), discrimination, the stapes reflex and tympanometric examinations were performed on the patients. The differences between pure tone averages taken before the treatment and on the 6th month after treatment were calculated for the two groups and the differences were assessed for a statistical significance. The patients with more than 15 dB gain were considered to have benefited from the treatment. The difference between the two groups evaluated to investigate the therapeutic efficacy of famciclovir in sudden hearing loss.
2.1
Statistical analysis
Fisher’s exact test was used in 2 × 2 tables, and non-parametric Mann-Whitney U test was used for the comparison of binary groups that lack the normal distribution. p < 0.05 was considered as statistically significant. SPSS for Windows 10.0 was used in the statistical analysis.
2
Materials and methods
The patients admitted within 7 days from the onset of the symptoms were included in this study. Detailed histories of the patients were taken first, and then the systemic ENT and vestibular system examinations were performed. All patients were evaluated for the fasting blood glucose, liver function tests (ALT, AST, GGT, total bilirubin), renal function tests (Na, K, Cl, urea, creatinine clearance), bleeding profiles (aPTT, PTZ), and contrast-enhanced magnetic resonance imaging (MRI) of the cranial. The patients with hypertension, diabetes, autoimmune, collagen and renal diseases and the patients with a previous history of ear disease or the ones that have a known hearing loss, and the patients diagnosed as fluctuating hearing loss at the follow-up and the patients with cerebellopontine angle tumor were not included in the study. In total, 41 patients were included in the study, according to the inclusion criteria. In this study, the patients that were administered with a combined treatment and the patients administered with famciclovir in addition to the combined therapy were divided into groups according to their hearing loss treatments. The Group 1 patients consisted of the patients administered with a combined therapy, and the Group 2 consisted of the patients administered with the additional famciclovir treatment. The Group 1 patients were administered with steroid (methylprednisolone, 250 mg on the first day, 150 mg on the second day, 100 mg on the third day, and this continued by 20 mg reduction in every three days beginning from the fourth day), rheomarodex (500 cc, as to continue for 8 hours, for 5 days) and piracetam (3 × 2 g ampule for 5 days), lansoprol capsule (1 × 1 for stomach protection). Patients in the Group 2 were administered with famciclovir 3 × 250 mg orally, for 7 days, in addition to the combined treatment in the Group 1. During the treatment, the blood pressure and blood glucose levels of all patients were monitored.
In order to ensure standardization of the groups, the patients were proportionally divided into the groups in terms of the factors (degree of loss, the shape of the audiogram, presence of vertigo and/or tinnitus, age) that may affect prognosis ( Table 1 ).
