Dexamethasone inner ear perfusion by intratympanic injection in unilateral Ménière's disease: a two-year prospective, placebo-controlled, double-blind, randomized trial. Intratympanic gentamicin therapy for control of vertigo in unilateral Menire's disease: a prospective, double-blind, randomized, placebo-controlled trial. Steroids, carbogen or placebo for sudden hearing loss: a prospective double-blind study. The prognostic importance of detecting mild sensory impairment in leprosy: a randomized controlled trial (TRIPOD 2). Double-blind trial of intravenous methylprednisolone in Guillain-Barré syndrome. Guillain-Barré Syndrome Steroid Trial Group. A randomised controlled trial comparing rehabilitation against standard therapy in multiple sclerosis patients receiving intravenous steroid treatment. A double-blind randomised placebo-controlled trial of topical intranasal corticosteroids in 4- to 11-year-old children with persistent bilateral otitis media with effusion in primary care. Evaluation of booklet-based self-management of symptoms in Ménière disease: a randomized controlled trial. Efficacy of repetitive transcranial magnetic stimulation for the treatment of refractory chronic tinnitus: a randomized, placebo controlled study.
To investigate the efficacy of dexamethasone inner ear perfusion by intratympanic injection in hearing loss, tinnitus, aural fullness, and vertigo in the treatment of unilateral Ménière's disease and compare it with the control group.
                A prospective, randomized, double-blind study with 2-year follow-up comparing changes secondary to dexamethasone inner ear perfusion versus placebo consisting of saline solution.
                Twenty-two patients having definite Ménière's disease as outlined by the 1995 American Academy of Otolaryngology-Head and Neck Surgery Committee on Hearing and Equilibrium. All the patients were older than 18 years of age and were not receiving any other form of treatment with steroids for their Ménière's disease.
                Five consecutive daily intratympanic injections of dexamethasone or placebo to the involved ear.
                In the dexamethasone group at 2-year follow-up, complete control of vertigo (class A) was achieved in 9 of 11 patients (82%) and substantial control of vertigo (class B) in the remaining 2 patients (18%.) In the control group only 7 of 11 patients (64%) finished the 2-year follow-up because in the other 4 patients (36%) we had to give another treatment for the continuing vertigo and thus they were classified as failure (class F.) From the 7 patients who have finished the follow-up of 2 years in the control group, 4 patients (57%) achieved class A, 2 patients (29%) achieved class C, and 1 patient (14%) class F.
                Dexamethasone (4 mg/mL) inner ear perfusion in a group of patients with unilateral Ménière's disease (Shea's stage III) showed 82% of complete control of vertigo over placebo (57%). There was also a subjective improvement in tinnitus (48%), hearing loss (35%), and aural fullness (48%) in the dexamethasone group compared with 20%, 10%, and 20% respectively in the control group. Intratympanic application of gentamicin is a relatively safe and efficient treatment for the reduction of complaints of vertigo attacks associated with Menière's disease. The treatment also reduces the severity of the perceived aural fullness.
                To investigate the effectiveness of intratympanic gentamicin treatment in patients with unilateral Menière's disease.
                In a prospective, double-blind, randomized, placebo-controlled clinical trial subjects scored vertigo complaints, aural fullness and tinnitus, before, during and up to 1 year after treatment. Hearing loss was monitored with pure tone audiometry.
                Gentamicin treatment resulted in a significant reduction of the score for vertigo complaints and the score for perceived aural fullness. A small increase in hearing loss (average 8 dB) was measured in the gentamicin group. 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. This study was designed to investigate whether leprosy patients diagnosed with mild sensory impairment have a better prognosis when treated with steroids than similarly impaired patients treated with placebo. A multi-centre, randomized, double-blind, placebo-controlled trial was conducted in Nepal and Bangladesh. Patients were eligible if they had a confirmed leprosy diagnosis, were between 15 and 50 years old, had mild sensory impairment of the ulnar or posterior tibial nerve of less than 6 months duration and did not require steroids for other reasons. 'Mild impairment' was defined as 'impaired on the Semmes-Weinstein monofilament test, but testing normal on the ballpen sensory test'. Subjects were randomized to either prednisolone treatment starting at 40 mg per day, tapering over 4 months, or placebo. Nerve function was monitored monthly. Any patient who deteriorated was taken out of the trial and was put on full-dose steroid treatment. Outcome assessment was done at 4, 6, 9 and 12 months from the start of the treatment. Outcome measures were the proportion of patients needing full-dose prednisolone and the Semmes-Weinstein sum scores. Each patient contributed only one nerve to the analysis. Seventy-five patients had nerves eligible for analysis, of whom 41 (55%) and 34 (45%) were allocated to the prednisolone and placebo arms, respectively. At 4 months, three patients in the prednisolone arm (7%) and six in the placebo arm (18%) had an outcome event requiring full dose steroids. At 12 months, these proportions had almost reversed, 11 (27%) and 6 (18%) in the treatment and placebo arms, respectively. In the latter group, 75% had recovered spontaneously after 12 months. Prednisolone treatment of sensory impairment of the ulnar and posterior tibial nerves detectable with the monofilament test, but not with the ballpen test, did not improve the long-term outcome in terms of recovery of touch sensibility, not did it reduce the risk of leprosy reactions or nerve function impairment beyond the initial 4-month treatment phase. Two unexpected main findings were the strong tendency of mild sensory impairment to recover spontaneously and the fact that patients with mild sensory impairment without any other signs or symptoms of reaction or nerve function impairment are relatively rare. Steroids have been beneficial in the treatment of demyelinating diseases with features similar to those of Guillain-Barré syndrome (GBS). However, steroid treatment of GBS has been disappointing; in an earlier trial oral prednisolone was ineffective, although the dose was low and the sample small. We assessed the benefit of a high-dose steroid regimen in a large sample of patients with GBS in a multicentre, randomised, double-blind trial. 242 adult patients were randomised to receive intravenous methylprednisolone (IVMP) 500 mg (124 patients) or a placebo (118) daily for 5 days. Patients were diagnosed by standard clinical criteria and entered the trial within 15 days of onset of neurological symptoms. All patients were too weak to run. Some patients received plasma exchange depending on the practice of their centre. Disability was graded on a scale from 0 (healthy) to 6 (dead) at intervals for 48 weeks. There was no significant difference in any outcome variable between patients treated with IVMP and those given placebo. The most important outcome was the difference between the groups in disability grade 4 weeks after randomisation, which was only a 0.06 grade (95% Cl -0.23 to 0.36) greater improvement in the IVMP than the placebo group. The 39 patients in the IVMP group who required ventilation did so for a median of 18 days, 9 days fewer than the 44 patients who had a placebo and required ventilation (95% Cl -9.6 to 27.6). Median time to walk unaided was 38 days in the IVMP patients and 50 days in the placebo patients (difference 12 days, (95% Cl -21.3 to 45.3). A short course of high-dose IVMP given early in GBS is ineffective. There is evidence to support both the use of intravenous methylprednisolone (IVMP) in multiple sclerosis (MS) relapse and physiotherapy in the management of MS, but no studies have investigated the combination of steroids and rehabilitation together.
                To evaluate the benefits of IVMP with planned, comprehensive multidisciplinary team (MDT) care compared to IVMP with standard care.
                In this randomised controlled trial, patients confirmed to have had a definite MS relapse severe enough to warrant IVMP (1 g daily for three days) were randomised to two groups. The control group was managed according to the standard ward routine; the treatment group received planned coordinated multidisciplinary team assessment and treatment. Baseline assessments, including demographics and Expanded Disability Status Scale (EDSS) were carried out on both groups. The primary outcome measures were Guy's Neurological Disability Scale (GNDS), and Amended Motor Club Assessment (AMCA). The secondary measures were the Barthel Index (BI), Human Activity Profile (HAP), and Short Form Item 36 Health Survey (SF-36). All measures have published data on reliability and validity. Measures were administered at one and three months.
                Forty subjects, including 27 females, completed data collection. There were no significant differences between the two groups at baseline. Results showed statistically significant differences in GNDS (p = 0.03), AMCA (p = 0.03), HAPM (p < 0.01), HAPA (p = 0.02), and BI (p = 0.02) at three months in favour of planned MDT care.
                This study indicates that combining steroids with planned MDT care is superior to administering them in a standard neurology or day ward setting. Further research is necessary in order to confirm this finding. To determine the clinical effectiveness and cost-effectiveness of topical mometasone in children with bilateral otitis media with effusion (OME).
                A double-blind randomised placebo-controlled trial with an intention to treat analysis; the 10.6% of patients lost to follow-up at 1 month were censored in the analysis.
                76 Medical Research Council General Practice Research Framework practices throughout the UK between 2004 and 2007.
                A sample of 217 children aged 4-11 years was selected from those presenting to their GP with one or more episodes of otitis media or ear-related problems in the previous 12 months whom the research nurse confirmed had bilateral glue ear using microtympanometry (B B or B C2 types using a modified Jerger classification) at randomisation.
                Mometasone 50 micrograms in each nostril or placebo spray once daily for 3 months.
                The primary outcome was the proportions of children cleared of OME assessed by tympanometry at 1 month. Secondary outcomes included clearance at 3 months and 9 months; adverse events; OM8-30 scores (a functional health status responsive disease-specific measure); hearing loss; days with otalgia; cost-effectiveness; and health utilities.
                Of the topical steroid group, 40.6% (39/96) demonstrated tympanometric clearance (C1 or A type) in one or both ears at 1 month, compared with 44.9% (44/98) of the placebo group. The absolute risk reduction at 1 month was -4.3% (95% CI -18.05% to 9.26%); the odds ratio (OR) was 0.84 (95% CI 0.48 to 1.48). Four covariates were pre-specified for inclusion in logistic regression analysis: age as a continuous variable (p = 0.94), season (p = 0.70), atopy (p = 0.61) and clinical severity (p = 0.006). The adjusted OR (AOR) at 1 month for the main outcome was 0.93 (95% CI 0.50 to 1.75). Secondary analysis at 3 months showed 58.1% of the steroid group had resolved and 52.3% of the placebo group, AOR 1.45 (95% CI 0.74 to 2.84). At 9 months 55.6% of the treated group remained clear in at least one ear and 65.3% of the placebo group, AOR 0.82 (95% CI 0.39 to 1.75). Adverse events (although relatively minor) occurred in 7-22% of children and included nasal stinging, epistaxis, dry throat and cough. The OM8-30 scores (p = 0.55) reported hearing difficulty (p = 0.08), and days with otalgia (p = 0.46) were not significantly different between groups at 3 months. The economic evaluation found the active treatment arm to be dominated by placebo, accruing slightly (but not significantly) higher costs and fewer quality-adjusted life-years (QALYs), with a 24.2% probability that topical steroids are a cost-effective use of NHS resources at a ceiling ratio of 20,000 pounds per QALY gained.
                Use of topical intranasal corticosteroids is very unlikely to be a clinically effective treatment for OME (glue ear) in the primary care setting.
                Current Controlled Trials ISRCTN38988331. This study examined the effectiveness of booklet-based education in vestibular rehabilitation (VR) and symptom control (SC) techniques to manage vertigo and dizziness in Ménière disease.
                Participants (n = 360) were randomized to a waiting list control group or to receive either a VR or an SC self-management booklet. VR involved provoking dizziness in a controlled manner by making repeated head movements in order to promote neurological and psychological habituation. SC involved using applied relaxation, challenging negative beliefs, and lifestyle modification to reduce amplification of dizziness by anxiety. Subjective improvement in health, enablement (ability to understand and cope with symptoms), and adherence were measured at 3 and 6 months. Symptoms, handicap, anxiety and depression, and negative beliefs about symptoms were assessed pretreatment and at 3 and 6 months.
                At 6-month follow-up, 45 (37.5%) of the VR group and 47 (39.2%) of the SC group reported improvement compared with 19 (15.8%) controls; the relative probability of improvement compared with controls was 2.37 (95% confidence interval [CI], 1.48-3.80) for VR and 2.47 (95% CI, 1.55-3.95) for SC. Both intervention groups reported greater enablement than controls (p < .001, d > 0.70). At 3 months, the VR group had reduced symptoms, anxiety, handicap, and negative beliefs about dizziness; the SC group had reduced handicap; but the control group showed no improvement. Reported adherence levels were low and strongly related to outcome.
                Self-management booklets offer an inexpensive and easily disseminated means of helping people with Ménière disease to cope with dizziness symptoms. The pathophysiologic mechanisms of idiopathic tinnitus remain unclear. Low frequency rTMS applied over the auditory cortex has been proposed as a new and causally oriented treatment approach for pathological conditions with abnormal, increased cortical activity including tinnitus with increased activity in the auditory cortex. However available studies are characterized by a positive reports on the therapeutic effects of repetitive transcranial magnetic stimulation (rTMS) for treatment of tinnitus, there are few details about the duration of specific treatment effects.
                The design of the study was randomized, prospective, placebo-controlled. Right-handed patients were treated with either real or sham 1 Hz frequency rTMS over a period of two weeks. Fifty-two patients with chronic, treatment resistant tinnitus and stable medication were enrolled in the study after giving written informed consent and forty-two patients completed the study and were included in data analysis.
                The ability to reduce the symptoms of tinnitus appeared in both randomized groups immediately after the 1 Hz rTMS and sham stimulation phase. There was a significant reduction in both groups of the tinnitus total score on the Tinnitus Handicap Inventory (THI) (real rTMS p=0.005; sham rTMS p=0.049) and Tinnitus Questionnaire (TQ) total score (real rTMS p=0.003; sham rTMS p=0.049). On the THI evaluation scale, in the real rTMS a mild worsening was noted during week 6 in comparison with the state attained in week 2. During the subsequent course of the study a significant reduction of the total score persisted in the case of THI (real rTMS week 14 p=0.033 and borderline week 26 p=0.058). The reduction of symptoms as evaluated using the TQ was significant compared to baseline in the real rTMS group at week 2, 6 and 14 (p=0.003; p=0.024; p=0.022). The group treated with sham stimulation reached significant reduction of symptoms only at week 2 (p=0.049). A comparison of the difference in the recorded values of the total score during follow-up in relation to baseline expressed as a percentage demonstrates the difference in the effect of rTMS and sham stimulation as evaluated by both the basic scales. Graphical analysis of mean patterns of treatment response according to stimulation type shows a similarity between treatment response patterns evaluated by reduction of the total scores using THI and TQ.
                The principal finding of this study is that real 1 Hz rTMS treatment was capable of significantly reducing the total baseline score of basic scales that measure tinnitus severity. This result is important as it proves that significant reduction of symptoms can be achieved even in a group of patients with long-term symptoms resistant to pharmacological treatment.
The results of a single trial provide limited evidence to support the effectiveness of intratympanic steroids in patients with Ménière's disease. This trial demonstrated a statistically and clinically significant improvement of the frequency and severity of vertigo measured 24 months after the treatment was administered. It is important to note that there were a few aspects of the study which we were unable to clarify with the study authors.