Maschio, M., Dinapoli, L., Sperati, F., Pace, A., Fabi, A., Vidiri, A., . . . Carapella, C.M. (2012). Effect of pregabalin add-on treatment on seizure control, quality of life, and anxiety in patients with brain tumour-related epilepsy: A pilot study. Epileptic Disorders, 14, 388–397. 

DOI Link

Study Purpose

To evaluate the effect of pregabalin as an add-on therapy on seizure control, quality of life, and anxiety in patients with brain tumor–related epilepsy.

Intervention Characteristics/Basic Study Process

Pregabalin was added as a first or second add-on drug at 75 mg/day to a maximum of 600 mg/day for specific drugs (i.e., clobazan, lamorigine, levetiracetam, oxcarbazepine, phenobarbital, valproate, and topiramate).

Sample Characteristics

  • N = 25 (final sample); 12 patients completed six-month follow-up
  • AGE RANGE: 19–72 years
  • MALES: 72%, FEMALES: 28%
  • KEY DISEASE CHARACTERISTICS: Patients with brain tumor–related epilepsy
  • OTHER KEY SAMPLE CHARACTERISTICS: Patients with brain tumor–related epilepsy who had received standard antiepileptic drugs (AED) and who had at least one seizure in the month preceding recruitment  despite AEDs being at the maximum tolerable dose

Setting

  • SITE: Single site  
  • SETTING TYPE: Not specified  
  • LOCATION: Center for tumor-related epilepsy

Phase of Care and Clinical Applications

  • PHASE OF CARE: Active antitumor treatment

Study Design

  • Descriptive

Measurement Instruments/Methods

  • Quality of Life in Epilepsy Inventory
  • Quality of Life in Cancer
  • Hamilton Anxiety Rating Scale
  • Zung Self-Rating Depression Scale
  • Karnofsky Performance Status
  • Seizure diary

Results

The mean dose of pregabalin was 279 mg/day, and the mean follow-up period was 4.1 months. At the end of the follow-up, in the whole intention-to-treat population, nine patients were seizure free, 10 patients had a seizure reduction, and two patients were unchanged. There was a significant difference in the presence or absence of seizure between the baseline and the follow-up visit. There was a significant decrease in anxiety score (p = 0.002) between baseline and last available follow-up visit.

Conclusions

The study showed improvement in anxiety scores with pregabalins, but this is a pilot study with small sample size and a short follow-up period. Future studies with larger sample size and minimum dropout are indicated.

Limitations

  • Small sample (< 30)
  • Risk of bias (no control group)
  • Risk of bias (no blinding)
  • Risk of bias (no random assignment) 
  • Risk of bias (no appropriate attentional control condition) 
  • Findings not generalizable
  • Questionable protocol fidelity
 

Nursing Implications

Larger sample size is needed to evaluate the true impact of pregabalin on anxiety among patients with brain tumor–related epilepsy. There are not many implications for nursing because the intervention is drug related.