Acta Neurol Scand 2014: 130: 360–367 DOI: 10.1111/ane.12275

© 2014 John Wiley & Sons A/S. Published by John Wiley & Sons Ltd ACTA NEUROLOGICA SCANDINAVICA

Factors affecting epilepsy treatment outcomes in Nigeria Obiako OR, Sheikh TL, Kehinde JA, Iwuozo EU, Ekele N, Elonu CC, Amaechi AU, Hayatudeen N. Factors affecting epilepsy treatment outcomes in Nigeria. Acta Neurol Scand: 2014: 130: 360–367. © 2014 John Wiley & Sons A/S. Published by John Wiley & Sons Ltd. Objectives – Epilepsy is a complex chronic illness with variable treatment outcomes determined by factors specific to each affected person. We investigated prognostic factors for epileptic seizure outcome after 2 years of anti-epileptic drug (AED) monotherapy. Materials and methods – Two hundred and thirty-four AED na€ıve epilepsy patients were started on AED monotherapy and monitored for 2 years for seizure control. Patients on AED polytherapy were excluded. Prognostic factors investigated were socio-demographics characteristics, age of onset of epilepsy, etiology and precipitants of seizures, presenting seizure types, duration of epilepsy before initiation of AED, family support for treatment, compliance to AED, and clinic attendance. Results – Patients were 160 (68.4%) males and 74 (31.6%) females, with mean ages of 26.2  10.4 and 30.7  16.0 years, respectively. Mean age of onset of epilepsy was 19.0  15.0 years. None of the patients was treated with AED for first seizures, although 75% received traditional and spiritual therapy. Majority were single and of low socioeconomic background, and treatment was funded mainly by parents/guardians. About 88% presented with partial seizures, and carbamazepine was the commonest AED used followed by phenytoin sodium. At the end of 2 years of AED, 147 (63%) achieved complete seizure control, and significant prognostic factors were female sex, age older than 20 years at presentation, secondary and tertiary education attainment, being employed, family support, regular clinic attendance, AED compliance, and generalized epilepsy. Conclusions – Patients with epilepsy are more likely to achieve complete seizure control when they are older, educated, and employed or supported by family members to buy their AEDs and attend clinics regularly.

Introduction

Epilepsy is a complex chronic illness characterized by recurrent unprovoked seizures (1). It affects persons of all races, ages, and socioeconomic background, and as a result, its management and treatment outcome can be affected by many factors (2). The goals of epilepsy treatment are the control of seizures and the achievement of seizure remission with the aim of reducing psychosocial problems associated with uncontrolled attacks and ultimately improving the quality of life of affected persons (3). In Nigeria 360

O. R. Obiako1, T. L. Sheikh2, J. A. Kehinde1, E. U. Iwuozo1, N. Ekele2, C. C. Elonu2, A. U. Amaechi2, N. Hayatudeen2 1 Neurology Unit, Department of Medicine, Ahmadu Bello University Teaching Hospital (ABUTH)/Ahmadu Bello University Zaria, Zaria, Nigeria; 2Epilepsy Unit, Federal Neuropsychiatry Hospital (FNPH) Barnawa, Kaduna, Nigeria

Key words: anti-epileptic drugs; epilepsy; prognostic factors; seizure control O. R. Obiako, Neurology Unit, Department of Medicine, Ahmadu Bello University Teaching Hospital (ABUTH)/ Ahmadu Bello University Zaria, Zaria, Nigeria. PMB 06 Shika-Zaria Kaduna State, Nigeria Tel.: +234 802 373 5832; 706 483 6233 e-mail: [email protected] Accepted for publication June 10, 2014

and other developing countries, many predisposing factors have been reported for epilepsy (4, 5) but failure of healthcare givers to identify and control these adverse sociocultural, psychosocial, and environmental factors has been a major reason for failure of many epilepsy treatment programs to achieve seizure control in patients (3, 6). Therefore, to manage epilepsy successfully, healthcare givers must provide comprehensive information about epilepsy to patients and their family members and discuss all the issues that affect the long-term prognosis of the condition (6–9).

Epilepsy treatment outcomes Many studies had shown that ignorance, illiteracy, poverty, low self-esteem, poorly developed health services, and drug distribution systems were associated with anti-epileptic drug (AED) non-compliance, high clinic default, and suboptimal seizure control (9–11). Conversely, other studies had also shown that well-informed and motivated patients achieved optimal seizure control within 5 years of diagnosis because they were more likely to avoid seizure precipitants, adopt less seizure-prone life styles, and attain satisfactory AED compliance and regular clinic attendance (8, 12, 13). However, despite regular clinic attendance and/or AED compliance, some studies have shown that about 20–30% of patients will continue to experience recurrent seizures (14, 15). Although some of these patients will experience significant reductions in the frequency, severity, and duration of seizures, seizure control may remain incomplete and unpredictable (15). This study therefore investigated prognostic factors for treatment outcomes among patients with epilepsies (PWEs) who were commenced on AEDs and monitored for over 2 years at two tertiary hospitals in northern Nigeria. The primary outcome was achievement of complete seizure control defined as ‘being seizure-free for a period of two or more years of AED monotherapy’ (15). It is hoped that the result of this study will assist healthcare providers and others involved in caring for PWE to manage them successfully. Materials and methods Study site and setting

The research was carried out among 220 adult and 14 adolescent AED na€ıve PWEs who were referred to the epilepsy outpatient clinics of Ahmadu Bello University Teaching Hospital (ABUTH) Shika Zaria (between October 2008 and May 2011) and the Federal Neuro-Psychiatry Hospital (FNPH) Barnawa, Kaduna (between June 2011 and June 2013), respectively. These tertiary health centers are located 125 km apart in Kaduna State, northwestern Nigeria. Patients travelled a median distance of 54 km from their various homes to either of the hospitals to access care and prescriptions, as well as procure medications. Epilepsy in this study was defined as the occurrence of at least one epileptic seizure with an enduring predisposition to generate future seizures (1) or the occurrence of two or more stereotyped seizures not provoked by fever, acute neurologic insult, metabolic disorder, or drug/ alcohol withdrawal on different days in a lifetime

(4, 5, 16). The occurrence of at least one of the seizures must be confirmed by an eye witness account (4, 5). Thus, persons with either of these criteria were accepted as PWE. Ethical approval was obtained from ethical committee of each hospital, and all patients gave their consent after the objectives of the study were explained to them. Study protocol

Research instrument design – The research was a prospective interventional study, which was designed using an epilepsy-specific protocol modified from the World Health Organisation (WHO) protocol for detection of neurologic diseases in the community (16) and health-related quality of life questionnaire (17). The epilepsy protocol comprised information on socio-demographic characteristics of patients, clinical features, etiological, predisposing and precipitating factors of seizures, seizure frequency, severity and duration, and source of support for treatment. The protocol was translated to Hausa (the indigenous language) by a bilingual expert and back-translated to English by another bilingual expert who was blind to the first translation. To reduce ambiguity, misinterpretation, or misunderstanding of any question or item in the protocol, each version (Hausa and English) was administered independently on 20 AED-experienced PWE by two of the investigators (ORO, NH) who assigned the appropriateness of each question or item to one of the four groups. When a question or item was assigned to a group, that group received a score of 1, while the other groups received a score of 0 each (the sample protocol is available on request). The groups were defined by the following criteria: 1. When the question or item was unambiguous and understood by both investigator and subject, it was defined as a true positive. 2. When the question or item was unambiguous but misunderstood or misinterpreted by either investigator or subject, it was defined as a false positive. 3. When the question or item was unambiguous but misunderstood or misinterpreted by both investigator and subject, it was defined as a false negative. 4. When the question or item was ambiguous and misunderstood or misinterpreted by both investigator and subject, it was defined as a true negative.

The pilot data were subjected to Wilcoxon rank sum test, which yielded mean scores of 1.01, 361

Obiako et al. 1.1, 0.0, and 0.0 for the respective groups. This gave the instrument a sensitivity of 100% [formula: true positives (1.01)/true positives (1.01) + false negatives (0.0) 9 100] and specificity of 90% [formula: true negative (0.0)/true negative (0.0) + false positive (1.1) 9 100]. Patients’ clinical evaluations and classification of seizures – Consecutive AED na€ıve patients who satisfied guidelines for AED monotherapy (18) were recruited for the study. Therefore, patients on prior AED monotherapy, AED polytherapy or concomitant antipsychotics were excluded because their inclusion might affect AED compliance and introduce bias, which may affect the outcome of study. Selected patients were interviewed in Hausa or English (depending on choice or proficiency) by senior residents in neurology and neuropsychiatry, in the presence of caregivers (usually parents or guardians). The following information was documented: 1. Socio-demographic characteristics: sex, age, marital status, educational attainment, employment status, residential addresses, and mobile phones of patients and caregivers. 2. Details of seizures: age of onset, etiology and precipitants, presence or absence of aura/body jerks/altered consciousness/post-ictal sleep and amnesia, mode of treatment of first seizures, duration of epilepsy before commencement of AED, seizure frequency, severity, and duration. 3. Any other relevant medical history (such as hypertension, diabetes mellitus, HIV, head injury, stroke) and relevant laboratory investigations (such as brain imaging, electroencephalography [EEG], blood glucose and HIV serology).

The patients were examined by neurologists who also performed EEG on them. The presenting seizure types were classified according to the clinical criteria of the 1993 International League Against Epilepsy (ILAE) (19) supported by epileptiform abnormalities on EEG. These waves were recognized as spikes, polyspikes, sharp waves, spikes, and wave complexes on EEG (20). Commencement of anti-epileptic therapy – Each patient and caregiver was educated about epilepsy and its predisposing and precipitating factors. They were counseled about the importance of AED compliance, regular clinic attendance, and avoiding seizure precipitants. Measures to ameliorate stigma and discrimination in the community

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were usually discussed. In addition, each patient was given an outpatient appointment card and two exercise books: one for recording daily AED ingestion (AED log book) and one for recording seizure frequency, severity and duration (seizure dairy). Thereafter, each patient was commenced on a standard minimum dose of AED monotherapy for specific presenting seizure type (18–20) and advised to report back to the clinics 1–2 monthly for medication prescriptions, AED refill, and seizure monitoring. Monitoring of patients – At the 1–2 monthly clinic visits or at emergency visits, the patients gave reports of clinic attendance, AED compliance, and seizure control, which were usually corroborated by inspecting the appointment card, exercise books, and remnants of AEDs. Self-report of sources of financial support for treatments, AED procurement and adherence (21), and the effect of AED on activities of daily living were also assessed on such visits. Patients who missed 1–2 clinic appointments (regarded as ‘defaulters’) (10), or those who failed to take AED as prescribed (regarded as ‘non-compliants’) (9, 10), were visited at home or contacted through mobile phones to find out reasons for default and noncompliance. During such visits, epilepsy-specific health education was re-enforced and patients were offered psychological and social support. When seizures persisted despite compliance, dosage of an AED was gradually increased until seizures were controlled or the frequency, severity, and duration were significantly reduced. The dosage ranges of AEDs prescribed for PWEs during the 2-year period of study is shown in Table 3. At 2–3 monthly intervals, blood counts were performed on all patients, while serum calcium and liver function tests were limited to patients on phenytoin and valproate. After 2 years of AEDs, EEG was repeated on 147 (63%) patients who achieved complete seizure control. Statistical analysis

Data were analyzed with the electronic database of the Statistical Package for Social Sciences (SPSS) version 17 (Chicago, IL, USA). Continuous variables were expressed as means and standard deviations, while categorical variables were expressed in percentages and proportions. Stepwise linear regression analysis was performed to determine predictors of complete seizure control at 2 years of AED. Level of significance was set at 5% (P < 0.05, two-sided) within 95% confidence interval.

Epilepsy treatment outcomes Table 1 Socio-demographic characteristics of patients S. No. 1.

2.

3.

4.

Variables Age (years) Mean  SD Range Marital status Single Married Divorced/separated Widower Total Educational attainment None Completed primary school Completed secondary school Completed tertiary education Total Occupational status None Self-employed Paid employment Student Total

Number of males (%)

Number of females (%)

Total number of PWE (%)

26.2  10.4 16–75

30.7  16.0 years 15–70

29.8  13.6 15–75

118 34 4 2 160

(50.4) (14.5) (1.7) (0.8) (68.4)

40 14 20 0 74

(17.1) (6.0) (8.5) (0.0) (31.6)

158 48 24 2 234

(67.5) (20.5) (10.2) (0.8) (100)

16 52 86 6 160

(6.8) (22.2) (36.8) (2.6) (68.4)

6 58 10 0 74

(2.6) (24.8) (4.2) (0.0) (31.6)

22 110 96 6 234

(9.4) (47.0) (41.0) (2.6) (100)

118 16 20 6 160

(50.4) (6.8) (8.5) (2.6) (68.4)

62 2 2 8 74

(26.5) (0.9) (0.9) (3.4) (31.6)

180 18 22 14 234

(76.9) (7.7) (9.4) (6.0) (100)

PWE, patients with epilepsies.

Results Socio-demographic characteristics of patients

The patients comprised 160 (68.1%) males and 74 (31.9%) females, with respective mean ages of 26.2  10.4 and 30.7  14.0 years (P < 0.05). More than two-thirds were unmarried and unemployed. Twenty-two (9.4%) had no formal western education; 110 (47%) and 96 (41%) completed primary and secondary schools, respectively, while only 6 (2.6%) attended tertiary education (Table 1). Characteristics of epileptic seizures

Mean age for onset of epilepsy was 19.0  15.0 years. Seventy-five percent of patients were treated initially by traditional and spiritual healers, while 25% did not receive any treatment for first seizures. The median duration of epilepsy before presentation was 4 years; as 178 (76.1%) patients presented

Factors affecting epilepsy treatment outcomes in Nigeria.

Epilepsy is a complex chronic illness with variable treatment outcomes determined by factors specific to each affected person. We investigated prognos...
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