Impacto de la intervención farmacéutica en el tratamiento y calidad de vida de la mujer con epilepsiaEnsayo clínico

Résumé

Introduction Epilepsy is a chronic neurological disorder, involving complex or simple seizures, affecting the health-related quality of life (HRQOL) of those suffering it, especially women. Pharmaceutical care (PC) facilitates direct interaction between a pharmacist and a patient and with other members of a healthcare team to optimise treatment aimed at reducing negative outcomes associated with medication and help improve HRQOL, this being a therapeutically relevant humanistic outcome (i.e. quantifying a patient¿s experience of such treatment without others¿ interpretation). This study was aimed at ascertaining the impact of a PC programme on HRQOL, adverse reactions, depression, HRQOL programme adherence and seizure frequency regarding epileptic women. Methods: This was a pragmatic randomised controlled trial, involving parallel groups of women aged over 18 years-old who were suffering epilepsy (WWE) and who were attending a third-level institution which specialises in managing epilepsy in Bogotá, Colombia. The intervention group (IG) followed a six-month long PC programme; this consisted of pharmacotherapeutic follow-up (PF) following Dáder¿s method, health education, promoting adherence to the PC programme and monitoring anticonvulsant drugs. The control group (CG) received the usual care provided by the institution. The PC programme¿s impact was evaluated by changes in seizure frequency; the following self-administered questionnaires were used: the Quality of Life in Epilepsy Inventory-31 (QOLIE-31), the Liverpool Adverse Events Profile (AEP), the Center for Epidemiologic Studies Depression Scale (CES-D) and the Haynes-Sackett and Morisky-Green tests between the first interview and the end of the six-month follow-up. A t-test was used for comparing final QOLIE-31 score between groups and a paired t-test was used for determining any change in each group between the start and the end of follow-up. A Chi-squared test was used when no suppositions for t were met. Results and Discussion: One hundred and eighty-two WWE were enrolled in the study but only 144 (79.1%) completed it. Increased QOL was evident due to implementing the PC programme, The t-test for comparing final QOLIE-31 scores between groups gave t = -2.166 (-10.125, -0.4625 95%CI; p = 0.0319). The IG change (¿) regarding 3 QOLIE-31 score was 12.44 points (p < 0.001), this being much greater than that for the CG (2.61; p = 0.072). Regarding clinical significance, a 10.7 minimally important change gave a relative risk (RR) of 2.17 (1.37-3.43 95%CI) and 3.54 as the number needed to treat (NNT), showing that, for every four people who received the PC programme, one obtained an additional beneficial result. Change regarding AEP was 5.11 for the IG and 0.70 for the CG (p <0.001), emphasising a statistically significant difference between adverse reactions. An improvement was observed for the IG which was attributable to them receiving the PC programme. Depression became reduced by 4.45 points for the IG and by 0.82 for the CG, this being a significant difference (p = 0.018). Multivariate analysis revealed a clear association between changes in depression and changes in QOL. Adherence to the programme increased by 30.6% (p <0.001) in the IG, highlighting the PC programme¿s positive effect. Plasma levels had to be monitored in 56% of the IG patients; 65% of the levels were outside the reference range. 82.4% of the interventions were accepted. Conclusions: The study showed that the PC programme significantly improved WWE¿s HRQOL, lessened their adverse reactions, lowered depression rates and improved their adherence to the PC programme. The NNT given by this study strengthens recommendations for running a PC programme regarding the additional benefit for patients¿ HRQOL. A pharmacist should be included in any healthcare team attending WWE in an attempt to optimise their treatment. Keywords: Pharmaceutical care, Quality of life, Controlled Clinical trial, Epilepsy, Women, Patient Reported Outcome.