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.