What question did this study set out to answer?

This study aims to evaluate long-term quality of life in TBI survivors treated with biperiden and identify predictors of QoL.

June 3, 2026Open Access

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

Key Points

This study aims to evaluate long-term quality of life in TBI survivors treated with biperiden and identify predictors of QoL.
Analyzed QoL data from a randomized, double-blind, placebo-controlled trial involving 48 adults with TBI.
QoL was measured using the EQ-5D-3L questionnaire, assessed on average 32 months post-injury.
Analyzed predictors of QoL through Generalized Linear Models and changes over time using a paired t-test in a subgroup.
Treatment with biperiden did not significantly alter QoL compared to placebo.
QoL scores improved significantly from 11.6 months (0.457) to 27.1 months (0.678) post-TBI (p = 0.004).
Negative predictors identified include the presence of PTE (β = -0.23, p = 0.02), temporal lobe lesions (β = -0.22, p = 0.006), and beneficiary status (p = 0.002).

Abstract

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.

Mark Helpful

Bookmark

Relay

View Full Paper