Morales‐Luckie 2005.

Study characteristics
Methods	Parallel‐group RCT with 18 weeks duration of treatment and tapering of dose (timing not specified). Further follow‐up for 1 year after discontinuation of steroids.
Participants	Setting:  Single‐centre trial from Mexico. Participants were recruited from a tertiary care hospital in Mexico. Managed as outpatients. Study recruitment dates were not reported.  Sample size: Number randomised: 16 participants Number completed: 16 participants Participant baseline characteristics Age:  Prednisolone group: mean 40.8 years (range 33 to 47 years) Control group: mean 38.8 years (range 32 to 49 years) Gender: Not reported   Probable/definite Ménière's disease:  Not reported  Duration of disease:  Prednisolone group: mean 3.6 years  Control group: mean 3.3 years Attack frequency at baseline:  Prednisolone group: mean 1.27 attacks per day at baseline (95% CI 0.73 to 1.81 attacks) Control group: mean 1.01 attacks per day at baseline (95% CI 0.71 to 1.31 attacks) Hearing loss at baseline:  Not reported  Measure of tinnitus at baseline:  Not reported  Number of participants with bilateral disease: Not reported  Inclusion criteria: Ménière's disease, apparently according to the AAO‐HNS criteria, although not explicit: "According to Pearson‐Brackmann criteria [Pearson 1985] and the amended 1995 version [AAO‐HNS 1995 criteria], all patients included in this study had severe disability (Scale 3) and limited vertigo control (Class C), and rejected any surgical management." Vertigo under poor control by maintenance treatment (diphenidol 25 mg/day, acetazolamide 250 mg/48 hours orally and a low‐sodium diet (< 1500 mg/day), with advised reductions in consumption of alcohol, caffeine, nicotine and stress). Exclusion criteria: Peptic acid disease; diabetes mellitus; hypertension; glaucoma. Other clinical conditions for which glucocorticoid therapy is contraindicated. Diagnosis of Ménière's disease: Not stated. Only AAO‐HNS 1995 criteria for grading disability and vertigo control in response to treatment were reported.
Interventions	Intervention (n = 8 randomised, n = 8 completed) Oral prednisolone 0.35 mg/kg/day was administered for 18 weeks, in addition to maintenance treatment. "The [prednisolone] administered was gradually reduced by a 50% dose reduction every 5 days. The drug was definitively withdrawn when a total dose of 2.5 mg was reached." Duration of intervention will therefore vary depending on body weight.  Comparator (n = 8 randomised, n = 8 completed) No intervention; maintenance treatment only  Background interventions administered to all participants All patients received maintenance treatment: diphenidol 25 mg/day, acetazolamide 250 mg/48 hours orally and a low‐sodium diet (< 1500 mg/day), with advised reductions in consumption of alcohol, caffeine, nicotine and stress
Outcomes	Primary outcomes relevant to this review: Improvement in vertigo Improvement was assessed according to the AAO‐HNS 1995 control of vertigo (frequency) scale as complete, substantial, limited or insignificant improvement or worsening of vertigo  Change in vertigo Assessed with daily frequency of vertigo episodes  Serious adverse events There is no report on how adverse events were assessed. Some other (non‐serious) adverse events are specifically reported.  Secondary outcomes relevant to this review: Disease‐specific health‐related quality of life Reported as a change in disability status as assessed with a variant of the AAO‐HNS 1995 Functional Level Scale. Scale used in this article ranges from 0 to 3: 0 = No disability 1 = Mild disability: mild unsteadiness or dizziness that precludes working in a hazardous environment 2 = Moderate disability: moderate unsteadiness or dizziness that results in necessity for a sedentary occupation 3 = Severe disability: symptoms exclude gainful employment Hearing Assessed with pure tone audiometry and speech discrimination scores. Not fully reported ‐ no numeric data suitable for meta‐analysis.  Tinnitus  No data from a validated questionnaire. Only assessed as frequency of tinnitus.  Other adverse effects Narrative statement regarding a variety of adverse effects. It is not clear whether these were systematically assessed and reported.  Other outcomes reported in the study: Aural fullness Duration of vertigo attacks Relapse in symptoms from week 18 to end of follow‐up Change in frequency of tinnitus Number of participants with severe disability and limited vertigo control
Funding sources	None reported
Declarations of interest	No declaration is made
Notes	Research integrity checklist: No retractions/expression of concern were identified  Trial registration is not applicable (published prior to 2010) Baseline characteristics of the 2 groups are not excessively similar No loss to follow‐up occurred and no reason is given for this The treatment appears to have a strong effect on vertigo, despite the small sample size  Equal numbers were recruited to each group. Minimisation was used to maintain balance across group of known potential confounding characteristics.
Risk of bias
Bias	Authors' judgement	Support for judgement
Random sequence generation (selection bias)	Unclear risk	Quote: "Two groups (n = 8 per group) were assembled by the method of minimization to accomplish the balance between groups". Comment: although minimisation is a valid alternative to randomisation, there are no further details provided regarding the prognostic factors used for minimisation, any statistical software that was employed for the process etc. This process may have been conducted by the investigators themselves, and could therefore not be viewed as equivalent to randomisation.
Allocation concealment (selection bias)	Unclear risk	Comment: as above, no information is provided. If investigators were involved in the process of minimisation then group allocation may have been foreseeable.
Blinding of participants and personnel (performance bias) All outcomes	High risk	Comment: no placebo was used. Although this is described as a "double‐blind trial" no description of blinding is present, and no placebo was used.
Blinding of outcome assessment (detection bias) All outcomes	High risk	Comment: as above, participants would have been aware of their group allocation. Most outcomes are reported by (unblinded) participants, therefore detection bias is a risk.
Incomplete outcome data (attrition bias) All outcomes	Low risk	Comment: no patient withdrawals from the trial were reported.
Selective reporting (reporting bias)	High risk	Comment: no protocol is reported. Different vertigo outcomes are reported at different time points (attacks per day at 18 weeks, control of vertigo at > 12 months). Number of vertigo attacks per day is not reported at complete follow‐up. Hearing outcomes are not reported in a way that enables meta‐analysis.
Other bias	Unclear risk	Comment: the timing of follow‐up for those in the control arm is not clear, which may lead to a difference between the groups.