Factual errors in the Cochrane review (Webster et al, 2023) on betahistine in Menière's Disease

Gürkov, Robert (2026): Factual errors in the Cochrane review (Webster et al, 2023) on betahistine in Menière's Disease.

Abstract

The Cochrane review (Webster et al, 2023) on betahistine in Menière’s Diseae (Hydropic Ear Disease) represents a problematic handling of evidence. The existing clinical trials in this field are extremely heterogenous. Furthermore, there is a clear correlation between the quality of trial and its result: low-quality trials typically claim to find a significant therapeutic effect of betahistine in Hydropic Ear Disease. High-quality trials usually do not find a therapeutic effect. When summarizing the evidence from such extremely heterogeneous trials, it is obvious at first sight that a meta-analysis of several trials is neither feasible nor useful. Therefore, a narrative systematic review is warranted. It allows to clearly assess individual trial quality and preserves the informational content of the original studies and hence is the most valuable and useful approach to provide the decision-makers (physicians, healthcare providers, guideline developers) with the best available evidence as a basis for their decisions. However, the Cochrane 2023 review chose another path: it chose to blend extremely heterogeneous studies into one melting pot and transformed the original data structure by an analysis method using aggregation of primary data. This aggregation leads to a substantial alteration of the primary data structure and a significant loss of information. For example, the longitudinal data which have been collected daily during 9 months (!) of continuous treatment in the BEMED trial have been truncated to a single cross-sectional data point at one single time point. Furthermore, this aggregation of primary data fails to yield the desired positive effect of enabling a meta-analysis because the data are still too heterogenous across trials. It merely leads to an artificial weakening of very robust and precise results with a high statistical power and consequently to a misleading perpetuation of “uncertainty” where in fact clarity exists. Apart from this unsuitable method of analysis which distorts the extremely valuable primary data, this Cochrane review suffers from numerous factual errors. The amount and severity of these errors warrant a major revision of the Cochrane review. These errors are explained here in order to provide decision makers with the necessary information for interpretation of this problematic review.

• Item Type: Paper
• Keywords: Betahistine; Hydropic Ear Disease; Menière's Disease; Systematic Review; Cochrane review; Research integrity; Evidence synthesis; Clinical trials
• Faculties: Medicine > Medical Center of the University of Munich > Clinic and Polyclinic for Otorhinolaryngology and Otolaryngology
• Subjects: 500 Science > 570 Life sciences; biology; 600 Technology > 610 Medicine and health