Evaluation of long-term quality of life in traumatic brain injury patients early treated with biperiden - a randomized controlled trial.

BACKGROUND

Traumatic brain injury (TBI) is a leading cause of disability, with post-traumatic epilepsy (PTE) being a major complication. Biperiden has shown experimental potential in preventing epileptogenesis, however its impact on outcomes, such as quality of life (QoL), remains unknown. This study evaluated long-term QoL in TBI survivors treated with biperiden and identified clinical and socioeconomic predictors of their QoL.

METHODS

We analyzed QoL data from a randomized, double-blind, placebo-controlled trial involving 48 adults with moderate to severe TBI, assessed on average 32 months post-injury. QoL was measured using the EQ-5D-3 L questionnaire. A cross-sectional analysis identified predictors of QoL using Generalized Linear Models (GLMs), and a longitudinal analysis of a 14-participant subgroup assessed changes over time using a paired t-test.

RESULTS

Early treatment with biperiden did not significantly alter QoL compared to placebo. However, the study identified significant negative predictors for QoL: the presence of PTE (β = -0.23, p = 0.02), temporal lobe lesion (β = -0.22, p = 0.006), and being a beneficiary (p = 0.002). QoL scores significantly improved between 11.6 months (0.457) and 27.1 months (0.678) post-TBI (p = 0.004). Descriptively, while mobility and self-care were well-preserved, the anxiety/depression dimension was the most affected dimension, with 22.5% of participants reporting extreme problems.

CONCLUSIONS

Biperiden did not impact QoL in TBI survivors. However, improvements were observed in the approximately 2 years following injury. Predictors like PTE, temporal lesions and receiving benefits as income were associated with lower Qol score. These preliminary findings guide future interventions for TBI patients and are particularly important as they fill a data gap for the Brazilian population.

TRIAL REGISTRATION: The trial was registered at ClinicalTrials.gov, a database managed by the U.S. National Library of Medicine (NLM) and National Institutes of Health (NIH), under the identifier NCT01048138 on January 13, 2010.