Combinations of tiagabine (TGB), carbamazepine (CBZ), and phenytoin (PHT) w
ere compared for their impact on health-related quality of life (HRQOL) and
adverse effects related to treatment efficacy for people with frequent com
plex partial seizures, Two independent, randomized, double-blind clinical t
rials for efficacy and safety were conducted simultaneously with treatment
groups: CBZ+PHT versus CBZ+TGB, and PHT+CBZ versus PHT+TGB. Treatment was i
nitiated at week 0 and continued through week 16. HRQOL was evaluated with
the QOLIE-89. Treatment success was defined as greater than or equal to 50%
reduction in complex partial seizures. Among patients who achieved a 50% r
eduction in seizures, addition of TGB to baseline PHT enhanced patient perc
eptions of attention/concentration (13%; p = 0.002), memory (17%; p = 0.042
), and language subscales (22%; p = 0.004). Addition of CBZ to PHT led to p
ositive change in the work/driving/social relations subscale (14%; p = 0.00
4). These improvements were significantly different only between visits, no
t between the two treatment groups. Seizure worry subscale scores showed im
provement among all treatment groups and was probably related to participat
ion in the clinical trial. These exploratory analyses suggest a possible ea
rly positive effect of TGB on patient-perceived cognitive domains using the
QOLIE-89 These findings are limited by the small sample size and could be
related to reduction in seizures.