The efficacy of steroids in the treatment of idiopathic sudden hearing loss. A double-blind clinical study. Steroids, carbogen or placebo for sudden hearing loss: a prospective double-blind study. Treatment of sudden sensorineural hearing loss with systemic steroids and valacyclovir. Treatment of idiopathic sudden sensorineural hearing loss with antiviral therapy: a prospective, randomized, double-blind clinical trial. Antiviral treatment of idiopathic sudden sensorineural hearing loss: a prospective, randomized, double-blind clinical trial. Corticosteroid treatment of idiopathic sudden sensorineural hearing loss: randomized triple-blind placebo-controlled trial. Effect of prostaglandin E1 on idiopathic sudden sensorineural hearing loss: a double-blinded clinical study. Acyclovir in the treatment of idiopathic sudden sensorineural hearing loss. Should hyperbaric oxygen be added to treatment in idiopathic sudden sensorineural hearing loss?
Double-blind studies were conducted for the treatment of idiopathic sudden hearing loss (ISHL) with oral steroids. The condition was defined as not less than a 30-dB loss over three contiguous frequencies in three days or less. Follow-up audiograms were obtained four weeks and three months later. Specific audiologic guidelines for the assessment of hearing recovery were used to ensure objectivity. Steroids had a statistically significant effect on the recovery of hearing in patients with moderate hearing losses. The nature of the hearing loss and its susceptibility to improvement with steroid therapy lend support to the hypothesis that viral cochlitis is the primary cause of ISHL. There is no consensus regarding treatment modalities for idiopathic sudden sensorineural hearing loss (SNHL). In order to evaluate the effectiveness of steroid or carbogen inhalation therapies, a prospective double-blind placebo controlled study was designed. All 41 patients enrolled in the study had unilateral SNHL with no prior history of SNHL, otological pathological history or otoscopic findings. Patients were assigned to four treatment groups: prednisone tablets, placebo tablets, carbogen inhalation or room air inhalation. All were treated for 5 days. The audiometric data at admission was compared to that at day 6 and to data collected at follow-up (average 33 days). Results revealed no significant difference between the groups for early or late audiometric outcome. Age, time from onset of symptoms to initiation of treatment, tinnitus, audiogram configuration, and the presence of vertigo at onset did not significantly affect the outcome. The discrimination scores that were poor in all patient groups on admission improved within days in all groups. These findings suggest that steroids or carbogen inhalation have no therapeutic advantage over placebo. Also, regardless of treatment modality, hearing continued to improve for at least a month after treatment was stopped. To determine if the addition of an antiviral medication to systemic steroids improves recovery in the treatment of idiopathic sudden sensorineural hearing loss.
                Randomized, double-blind, placebo-controlled prospective multicenter clinical trial.
                The study was administrated from a tertiary care center and clinical research institute; patients were enrolled by otolaryngologists in academic and private practice outpatient settings.
                Inclusion criteria included 1) loss of at least 30 dB in 3 contiguous frequencies over <3 days in patients with previous audiometry, 2) marked loss of hearing in patients with prior subjectively normal hearing and no previous audiometry, with contralateral hearing taken as baseline, and 3) patients seen within 10 days of onset of hearing loss. Pretreatment evaluation included audiometry and complete blood cell count, complete blood chemistry, and fluorescent treponemal antibody absorption test. Auditory brainstem-evoked response or magnetic resonance imaging was recommended.
                Patients received prednisone (80 mg/d for 4 d, then tapered over 8 d) with placebo or prednisone with valacyclovir (1 g, 3 times a day for 10 days).
                1) Audiometric assessment at presentation, Week 2, and Week 6; 2) Hearing Screening Inventory questionnaire twice weekly for 6 weeks; and 3) acute Short Form-12 questionnaire at presentation and Week 2.
                Of 105 subjects enrolled in the study, 84 subjects were evaluable. There were no significant differences between placebo and valacyclovir treatment groups in terms of hearing recovery or symptom recovery on the basis of the Hearing Screening Inventory or Short Form-12 questionnaires. No adverse events were related to the use of valacyclovir.
                Within the paradigm used in the current study, an antiviral medication did not provide more benefit than steroid alone in the treatment of idiopathic sudden sensorineural hearing loss. A subclinical viral labyrinthitis has been postulated in the literature to elicit idiopathic sudden sensorineural hearing loss (ISSHL). An etiologic role for the herpes family is assumed. Corticosteroids possess a limited beneficial effect on hearing recovery in ISSHL. In this study, we evaluated the therapeutic value of the antiherpetic drug acyclovir (Zovirax) on hearing recovery in 91 patients with ISSHL who received prednisolone in a prospective, randomized, double-blind, placebo-controlled, multicenter trial. The audiometric parameters included pure tone and speech audiometry. Subjective parameters studied included hearing recovery, a pressure sensation in the affected ear, vertigo, and tinnitus. A 1-year follow-up was obtained. Hearing recovery for the whole group averaged about 35 dB and was independent of the severity of the initial hearing loss or vestibular involvement. Speech audiometry improved from 49% to 75%. After 12 months, pressure sensation and vertigo decreased to 15.6% (acyclovir) and 10.3% (placebo) and 12.5% (acyclovir) and 10.7% (placebo), respectively. Tinnitus decreased slightly, to 46.9% (acyclovir) and 55.2% (placebo), in the same period (p > .05 for all parameters). We conclude that no beneficial effect from combining acyclovir with prednisolone can be established in patients with ISSHL. A subclinical viral labyrinthitis has been postulated in the literature to elicit Idiopathic Sudden Sensorineural Hearing Loss. An etiological role for the herpes virus family is assumed. Corticosteroids possess a limited beneficial effect on hearing recovery in ISSHL. In this study, the therapeutic value of the antiherpetic drug aciclovir (Zovirax) on hearing recovery in 44 ISSHL patients receiving prednisolone is evaluated in a multicentre clinical trial. The study is designed prospectively, randomized, double-blind and placebo-controlled. Subjective parameters include hearing recovery, a pressure sensation on the affected ear, disequilibrium or vertigo and tinnitus. Audiometric parameters include pure tone and speech audiometry. A one-year follow up is obtained. Both the pressure sensation and disequilibrium or vertigo have a good prognosis, but tinnitus, occurring in most patients, has a poor prognosis. Hearing recovery prognosis depends on the severity of initial hearing loss, and not on vestibular involvement. No beneficial effect from combining aciclovir with prednisolone can be established in ISSHL. To compare the effect of Prednisolone and placebo on the recovery of unilateral idiopathic sudden sensorineural hearing loss.
                Prospective, randomized, triple-blind, placebo-controlled multicenter trial.
                Four tertiary and 10 secondary referral centers.
                Of 103 patients randomly assigned, 93 were included in the modified intention-to-treat analysis. The patients, aged 18 to 80 years, were seeking care within 1 week after onset of acute unilateral sensorineural hearing loss with a mean decrease of 30 dB or greater in the 3 most affected contiguous frequencies.
                Patients were randomly assigned in permuted blocks of 10 to receive Prednisolone or placebo in tapering doses from 60 mg for 3 days and, thereafter, 10 mg less each day until Day 8. If complete recovery, no more medication given, otherwise medication continued at 10 mg per day until Day 30. Final follow-up was after 3 months with audiogram; 47 patients received Prednisolone and 46 placebo.
                The primary endpoint was efficacy of treatment on recovery at Day 90. Secondary endpoints were prognostic factors for hearing recovery. Analyses were by modified intention-to-treat and per protocol.
                Hearing improvement for 47 Prednisolone-treated patients was 25.5 ± 27.1 dB compared to 26.4 ± 26.2 dB for 46 placebo-treated patients at Day 8 and 39 ± 20.1 dB versus 35.1 ± 38.3 dB after 3 months. Vertigo had significant negative effect on hearing improvement and inflammatory signs in the laboratory workup-a positive prognostic effect, irrespective of treatment.
                Prednisolone in customary dosage does not seem to influence recovery of idiopathic sudden sensorineural hearing loss. The authors conducted a prospective, randomized, double-blinded clinical trial for the purpose of elucidating the effects of prostaglandin E1 (PGE1) on idiopathic sudden sensorineural hearing loss.
                With the approval of the institute ethics committee, a total of 57 consecutive patients with diagnoses of idiopathic sudden sensorineural hearing loss were included in the study. The patients in the PGE1 group received continuous infusion containing 60 microg PGE1 and 100 mg hydrocortisone for 7 days, and the patients in the placebo group were treated with continuous infusion containing an inactive placebo and 100 mg hydrocortisone.
                No significant differences were observed in the improvements of pure-tone average and subjective symptoms between the PGE1 and the placebo groups. However, the hearing improvement at high frequencies (4 kHz and 8 kHz) was significantly higher in the PGE1 group than in the placebo group, especially in the patients with severe tinnitus.
                These results failed to prove a beneficial effect of PGE1 in the treatment of idiopathic sudden sensorineural hearing loss. Further studies will be needed to clarify the pharmacologic actions of PGE1 in the cochlea. Idiopathic sudden sensorineural hearing loss (ISSNHL) is a vexing problem that continues to pose a diagnostic and therapeutic enigma for the otologist. The aim of the study, adopting the viral theory, was to discover whether patients with ISSNHL would benefit from early treatment with acyclovir and hydrocortisone compared with patients treated by hydrocortisone alone.
                Sixty patients with ISSNHL were treated in a prospective controlled randomized manner. Patients were seen within 7 days of onset and were divided randomly into 2 groups. The study group patients were treated with acyclovir and hydrocortisone, whereas those in the control group were treated with hydrocortisone alone.
                We compared the 2 groups before and after treatment regarding SRT, mean hearing level at each frequency, speech reception threshold improvement, gender, age, tinnitus, and balance complaints. The overall improvement was 78%.
                We conclude that there probably is no benefit from the addition of acyclovir in the treatment of ISSNHL. At present, there is still no agreement about the therapy of idiopathic sudden sensorineural hearing loss (ISSHL). Hyperbaric oxygen (HBO) is used in the therapy of ISSHL to increase the partial oxygen pressure and the oxygen concentration in the inner ear and also to improve the blood profile and the microcirculation. In our prospective randomized study, we aimed to investigate the therapeutic effects of HBO therapy in the 1st 2 weeks of the onset of ISSHL. Fifty-one hospitalized patients with confirmed ISSHL who had received therapy were grouped randomly into two groups. Twenty-one patients (group I) received steroids, plasma expander dextrans (rheomacrodex), diazepam, pentoxiphylline and salt restriction, and 30 patients (group II) received the same basic treatment with the addition of HBO therapy. Audiological assessments of the patients were performed before and after the treatment. The hearing gains at frequencies of 250, 500, 1,000, 2,000 and 4,000 Hz were calculated separately. The level of hearing loss at the five frequencies was assessed in three groups at the first visit: equal or below 60 dB, between 61-80 dB and equal or above 81 dB. The average of the mean hearing gains at the five frequencies of the patients according to the age groups in group II was compared. The mean hearing gains at the five frequencies were compared between the two groups, and statistically significant improvement was detected in all the frequencies except at 2,000 Hz in group II. The mean hearing gains in group II were found to be significantly high in patients with initial hearing levels up to 60 dB in comparison to patients with initial hearing levels below 60 dB. When age groups and mean hearing gains were compared, there was no statistically significant difference in group I. In group II, the mean hearing gains were 39.1+/-18.3 dB in patients younger than 50 years and 22.7+/-11.3 dB in patients older than 50 years ( P=0.044). In conclusion, the addition of HBO therapy to conventional treatment modalities significantly improves the outcome of ISSHL, especially at the frequencies of 250, 500, 1,000 and 4,000 Hz and in hearing loss of above 61 dB. Furthermore, HBO therapy was found to be more effective in patients younger than 50 years.
The value of steroids in the treatment of idiopathic sudden sensorineural hearing loss remains unclear since the evidence obtained from randomised controlled trials is contradictory in outcome, in part because the studies are based upon too small a number of patients.