Bromide treatment of pharmaco-resistant epilepsies with generalized tonic-clonic seizures: a clinical study.

In a retrospective controlled clinical study we investigated the efficacy of bromides (BR) as to the frequency of generalized tonic-clonic seizures (GTCS) as a monotherapy (n = 5) or combined with other antiepileptic drugs (AEDs) (n = 55), and compared the results statistically with those achieved with a treatment based on phenobarbitone (PB) and/or phenytoin (PHT) in a very similar group of another 60 patients. All patients treated with BR had previously proved to be pharmaco-resistant. In most of the cases the epilepsies were based on early cerebral lesions, and were partly associated with severe mental and physical handicaps. Most of the patients were between three and 14 years old. The percentage of responders was 58%, which means a reduction in the GTCS-frequency of more than 50%. The positive result was observed for 28 months on the average. 27% of all patients became free of GTCS for 18 months on the average (range, 44 days to 62 months), and 32% were improved (reduction in GTCS-frequency of more than 50% while not GTCS-free) for nearly three years on the average (range, 79 days to 110 months). Compared to PHT or PB, BR were slightly more efficient and similarly tolerable, but no statistically significant difference was seen (48% responders in the control group versus 58% responders in the BR-group). Thus, the statistical correlation with competitive therapies confirmed the good efficacy of BR against GTCS, which was previously demonstrated by clinical tests without control studies. We recommended BR in the case of every pharmaco-resistant epilepsy with GTCS as a therapeutic alternative.

RCT Entities:   Population Interventions Outcomes