Strengths and limitations of the study
The prevalent use and scarcity of reliable publications on this drug support the need for rigorous studies.3 In response, we are presenting a trial that strictly followed SPIRIT guidelines and CONSORT statements. Therefore, we had certain strengths as an adequate sample, randomized, triple blinding, placebo-controlled design, participants retention, a standard betahistine posology and tinnitus endpoint. In addition, the broad recruitment of a general population increased the representativeness of our sample, improving the external validity of the study.
The small sample size limits the results’ generalizability and made it impossible to explore the heterogeneity of performance between specific subgroups of the study population (such as those with migraine, psychiatric disorders, and hearing loss). Furthermore, the absence of anxiety and quality of life questionnaires reduced outcome inferences, and protocol changes (mainly sample size reduction) could have affected the accuracy of the study.