A Two-Year Randomized Trial of Interventions to Decrease Stress Hormone Vasopressin Production in Patients with Meniere’s Disease—A Pilot Study

Kitahara, Tadashi; Okamoto, Hidehiko; Fukushima, Munehisa; Sakagami, Masaharu; Ito, Taeko; Yamashita, Akinori; Ota, Ichiro; Yamanaka, Toshiaki

doi:10.1371/journal.pone.0158309

Cited by 30 publications

(39 citation statements)

References 39 publications

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“…Six studies were non-industry funded [ 35 , 36 , 38 , 39 , 41 , 47 ], five declared no funding [ 40 , 42 – 44 , 57 ], and seven did not report funding source [ 37 , 45 , 46 , 48 – 51 ]. Country of conduct and/or the corresponding authors’ locations varied across the studies, and included the United States [ 35 ], Canada [ 57 ], Brazil [ 45 ], Egypt [ 51 ], Germany [ 41 ], India [ 37 ], Iran [ 36 ], Italy [ 44 ], Italy and Romania [ 40 , 42 ], Japan [ 39 , 47 ], Mexico [ 48 , 49 ], the Netherlands [ 43 , 46 , 50 ], and the United Kingdom [ 38 ].…”

Section: Resultsmentioning

confidence: 99%

“…Findings, tympanic ventilation + oral medication (including diuretics, betahistine, diphenidol, dimenhydrinate, and diazepam) versus the same oral medication alone. One trial [39] demonstrated a statistically significant difference favoring tympanic ventilation combined with oral medication against the same medication alone for complete vertigo control (RR 1.55, 95% CI 1.22 to 1.97; n = 133) demonstrated in SA7 Fig. Findings, IT steroid versus low-dose Betahistine + cinnarizine + diet restrictions. There was no difference between IT steroid (dexamethasone) and conventional therapy comprising of salt and caffeine-restricted diet, nicotine and alcohol restrictions, cinnarizine (75 mg/day) for acute episodes and low-dose betahistine (48 mg/day) for maintenance therapy in terms of excellent and good vertigo control measured based on Sakata's criteria [58] (RR 1.13, 95% CI 0.55 to 2.32; n = 40) based on a single trial [37] demonstrated in SA7 Fig in S4 Text.…”

Section: Plos Onementioning

confidence: 99%

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Pharmacologic and surgical therapies for patients with Meniere’s disease: A systematic review and network meta-analysis

et al. 2020

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Background Meniere's disease (MD) is a chronic condition of the inner ear consisting of symptoms that include vertigo attacks, fluctuating sensorineural hearing loss, tinnitus and aural fullness. Despite availability of various interventions, there is uncertainty surrounding their relative efficacy, thus making it difficult to select the appropriate treatments for MD. The objective of this systematic review was to assess the relative effects of the available pharmacologic and surgical interventions in patients with MD with regard to vertigo and other key patient outcomes based on data from randomized clinical trials (RCTs). Methods Our published protocol registered with PROSPERO (CRD42019119129) provides details on eligibility criteria and methods. We searched various databases including MEDLINE, Embase and the Cochrane Library from inception to December 10 th , 2018. Screening at citation and full-text levels and risk of bias assessment were performed by two independent reviewers in duplicate, with discrepancies resolved by consensus or third-party adjudication. Bayesian network meta-analyses (NMA) were performed for hearing change and vertigo control outcomes, along with pairwise meta-analyses for these and additional outcomes. Results We identified 2,889 unique citations, that yielded 23 relevant publications describing 18 unique RCTs (n = 1,231 patients). Overall, risk-of bias appraisal suggested the evidence base to be at unclear or high risk of bias. Amongst pharmacologics, we constructed treatment networks of five intervention groups that included placebo, intratympanic (IT)

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Section: Resultsmentioning

confidence: 99%

Section: Plos Onementioning

confidence: 99%

Pharmacologic and surgical therapies for patients with Meniere’s disease: A systematic review and network meta-analysis

et al. 2020

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“…). The remaining 88 patients with intractable idiopathic BPPV were randomly assigned through computer‐generated block randomization organized by the clinical study section at Nara Medical University Hospital to one of the two treatment groups . Patients received head‐position management when lying down at home and continuous medication with antivertigo and antinausea drugs as needed.…”

Section: Methodsmentioning

confidence: 99%

Head‐Up Sleep May Cure Patients With Intractable Benign Paroxysmal Positional Vertigo: A six‐Month Randomized Trial

Horinaka

Kitahara

Shiozaki

et al. 2019

Laryngoscope Investig Oto

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Objectives The aim of the present study was to assess head‐position management for intractable idiopathic benign paroxysmal positional vertigo (BPPV) when lying down. We hypothesized that head‐up sleep (HUS) could prevent free‐floating otoliths from entering the semicircular canals. Study Design A prospective two‐arm multicenter randomized controlled trial. Methods BPPV was diagnosed in 611 patients (611/1,520; 40.2%) according to the 2015 diagnostic guidelines issued by the International Classification of Vestibular Disorders. Among them, 201 patients were intractable (201/611; 32.9%), 88 of whom were idiopathic and subsequently enrolled in the study. Patients randomly received intervention with HUS at greater than 45° (n = 44) or head‐down sleep (HDS; n = 44) when lying down. Before treatment, they completed several examinations, including subjective visual vertical (SVV). The specific diagnoses for the 88 patients with BPPV included horizontal type cupula (n = 40), horizontal type canal (n = 13), posterior type (n = 26), and probable and/or atypical BPPV (n = 9). Results Patient backgrounds did not differ significantly between the HUS and HDS groups. Visual analog scale (VAS) scores of vertiginous sensation were significantly lower in the HUS group than in the HDS group at both the third month and sixth month post‐treatment. Positional/positioning nystagmus observed just before treatment disappeared significantly more often in the HUS group than in the HDS group until the sixth post‐treatment month. Further, especially in HUS group, VAS scores in SVV− group (n = 24) were significantly lower than those in the SVV+ group (n = 20) sixth month post‐treatment. Conclusions Controlling free‐floating otoliths is not easy due to aging of the otolith organs. Repeatedly returning the endless free‐floating debris from the canals to the utricle through physical means is not a good strategy. Therefore, HUS when lying down at home could be recommended as an initial treatment for patients with intractable idiopathic BPPV. Level of Evidence 1b

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“…Besides, VTI has been proposed to modify the vasopressin-secretion from the hypothalamic-pituitary system mediated by vestibulo-hypothalamic neural interactions. 27 Final Comments There are no RCTs that directly assess the efficacy of VTI on the number of vertiginous attacks in patients with definite or probable MD. Current data are suggestive of a considerable positive effect on the number of vertiginous attacks in patients with MD.…”

Section: International Archives Of Otorhinolaryngologymentioning

confidence: 99%

Vertiginous Episodes in Menière Disease following Transmyringeal Ventilation Tube Insertion: A Systematic Review on the Current State of Evidence

Grønlund

Devantier

Edemann-Callesen

et al. 2020

Int Arch Otorhinolaryngol

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Introduction Menière disease (MD) is a disorder characterized by episodes of vertigo, sensorineural hearing loss, tinnitus and aural fullness. Objectives To assess the effect of ventilation tube insertion (VTI) on vertiginous episodes in patients (≥ 18 years old) with MD. Data Synthesis A systematic literature search on randomized clinical trials (RCTs), nonrandomized trials and other systematic reviews was performed. The Grades of Recommendation, Assessment, Development, and Evaluation (GRADE) approach was used to assess the overall certainty of evidence.Two RCTs and four nonrandomized studies were identified. Data extraction was only possible for one RCT. Results showed that the number of patients with no vertigo attacks significantly increased following active treatment (relative risk 1.52; [95% confidence interval: 1.19–1.94]). The quality of evidence was rated as low. None of the nonrandomized trials included a proper control group, which hindered data extraction and quality assessment. Conclusion There are currently no RCTs that specifically assess the efficacy of VTI in patients with MD. Current limited data suggest a considerable positive effect on the number of vertiginous episodes in patients with MD. However, due to poor evidence, a fluctuating course and a substantial placebo-effect associated with MD-treatment, no solid conclusion(s) regarding the efficacy of VTI can be made. There is a need for high-quality RCTs.

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A Two-Year Randomized Trial of Interventions to Decrease Stress Hormone Vasopressin Production in Patients with Meniere’s Disease—A Pilot Study

Cited by 30 publications

References 39 publications

Pharmacologic and surgical therapies for patients with Meniere’s disease: A systematic review and network meta-analysis

Pharmacologic and surgical therapies for patients with Meniere’s disease: A systematic review and network meta-analysis

Head‐Up Sleep May Cure Patients With Intractable Benign Paroxysmal Positional Vertigo: A six‐Month Randomized Trial

Vertiginous Episodes in Menière Disease following Transmyringeal Ventilation Tube Insertion: A Systematic Review on the Current State of Evidence

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