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2 Department of Neurology and Psychiatry, AL-Azhar University Hospital, Assiut, Egypt.

3 Department of Clinical Pathology, Assiut University Hospital, Assiut, Egypt. *Corresponding Author: Sherifa Ahmed Hamed M.D, Department of Neurology and Psychiatry, Assiut University Hospital, Assiut, Egypt Telephone: +2 088 2374904 Fax: +2 088 23333227 E-mail: [email protected] Abstract.

We aimed to determine the frequency of ED in epileptic adults and its related variables. Included were 100 epileptic men treated with conventional antiepileptic drugs (AEDs). Patients were assessed using International Index of Erectile Function questionnaire-5 items version (IIEF-5), psychiatric interview, Beck Depression Inventory (2nd edition) (BDI-II) and Hamilton Anxiety Rating Scale (HAM-A). Free testosterone and sex hormone binding globulin (SHBG) were measured to assess endocrinal status. Compared to controls (n=50), patients had higher rates of ED (37%), lower IIEF-5 scores (P=0.053), particularly with frontal lobe epilepsy, left foci, carbamazepine (CBZ) and uncontrolled seizures. A high frequency of depression (51%) and scores of BDI-II were reported with frontal lobe epilepsy, right foci, CBZ, polytherapy and lack of control on AEDs.

Lower free testosterone and higher SHBG levels were also reported. Patients with ED were older in age, had higher rates of uncontrolled seizures (58.19%) and higher scores of BDI-II and HAM-A.

A significant negative correlations were identified between ED and age, age at onset, scores of BDII and HAM-A. We concluded that psychiatric comorbidity and endocrine abnormalities appear to be related to ED and seizure intractability to AED medications. Attention should be paid to optimize seizure control.

In addition, psychotherapy and modalities such as medications for ED are sometimes needed.

Erectile dysfunction; epilepsy; antiepileptic drugs; depression; anxiety.

GTC: Generalized tonic-clonic; AEDs, antiepileptic drugs; CBZ: carbamazepine; VPA: valproate; EI-AEDs: enzyme inducer antiepileptic drugs; TLE: temporal lobe epilepsy; SHBG: sex hormone binding globulin; IIEF-5: International Index of Erectile Function questionnaire – 5 items version; BDI-II: Beck

Depression

Erectile dysfunction (ED) is defined as a failure to persistent or recurrent partial or complete obtaining and/or maintaining penile erections until the end of sexual activity.

The etiology of ED in patients with epilepsy is multifactorial, involving neurological, endocrine, iatrogenic and psychosocial. ED may be due to disturbance of sex hormones, hypothalamic-pituitary axis and testicular function by epileptic discharges [3, 8,9], or may result as adverse effect of antiepileptic drugs (AEDs) [10-12].

Reduced serum levels of free testosterone and/or albumin bound testosterone and free androgen index (FAIs) and increased levels of estradiol (E2), sex hormone binding globulin (SHBG), follicle stimulating hormone (FSH), luteinizing hormone (LH) and prolactin were reported in men with epilepsy [3-6]. Enzyme inducer AEDs (EI-AEDs) as carbamazepine (CBZ), phenytoin (PHT) and phenobarbitone (PB) elevate SHBG and reduce bioactive testosterone levels and may result in impotence in men [13, 14]. Epilepsy signifies anxiety and depression, low self-esteem and immaturity and this could lead to avoid situations that call for affective sexual involvement [15-18].

In this work, we aimed to determine the frequency rate of ED in a cohort of adult men with epilepsy and its relation to demographic-, clinical-, epilepsy-, psychosocial- hormonaland treatment- related variables.

This study was conducted on 100 adult males with epilepsy, with age ranges between 20 to 48 years and total time of illness ranged from 3 to 35 years.

Patients were on regular treatment with one or combined therapy of the conventional AED(s) for at least 6 months before participation in our study.

Patients were free from other neurological or medical diseases and had normal computer tomography (CT) or rx coupons sildenafil magnetic resonance imaging (MRI) of the brain.

Their seizure types’ were

diagnosed

Patients were recruited from the out-patient epilepsy clinics of the departments of Neurology and Psychiatry of Assiut and Al-Azhar University Hospitals, Assiut, Egypt.

Fifty healthy males matched for age, sex, educational level and socioeconomic status were included as controls for comparison.

Controls were recruited from the healthy general population matched for age- (range: 20-48 years; mean: 30.36±7.59), sex-, educational level and socioeconomic status. Excluded were subjects (patients and controls) with: 1) history of neurological disorder other than epilepsy, 2) history of clinically significant genitourinary disease, pelvic trauma, pelvic surgery, or radiation therapy, 3) concomitantly known vascular risks (e.g., heavy smoking, diabetes mellitus (DM), coronary artery disease) , systemic illness (e.g. gout, active gastrointestinal disease, renal failure, serum creatinine concentration >150 mmol/l, chronic hepatic illness) likely to affect erectile function, 4) alcoholism or diagnosed substance abuse and/or previous hospitalization for substance abuse), 5) use of regular medication(s) in addition to AEDs (e.g.

drugs for high blood pressure, heart medications, antidepressants, tranquilizers, and sedatives), and 6) current or recent treatment of ED with intracorporeal injection or application of vasoactive drugs.

The study protocol was approved by the ethical committee of the faculties of medicine of Assiut and Al-Azhar, Assiut, Egypt and all patients and control subjects gave their informed consent to participate in this study as follow: Methods. All patients and healthy control subjects underwent the same research protocol.

Patients’ evaluation was done interictally, 1) Medical, neurological, endocrinological, psychiatric, vascular and urological history and examination: Seizure variables included age at onset, precipitating factors, duration of illness, type, frequency, family history of epilepsy, type of utilized AED(s) (monotherapy or polytherapy), duration of treatment, degree of patients’ control on AED(s) and side effects from medications. The frequencies of seizures were defined as described before [20] into: a) very frequent: occuring several times a day or at intervals shorter than 7 days, b) frequent: occuring at intervals longer than 7 days but shorter than 30 days, c) occasional: occuring at intervals longer than 30 days but shorter than one year, and d) rare: occuring at intervals longer than one year.

Regarding the degree of control on AEDs, patients were considered controlled on AEDs treatment, when seizure free for ?1 year, partially controlled when seizure frequencies were occasional and uncontrolled when seizures were frequent or very frequent.

Physical and urological examinations included examination for the presence of secondary sexual character, genitalia, other tissues of the penis and pelvic region, rectal and prostate examination and examination of perianal and penile sensation. Bulbocavernosal reflex was done to test the integrity of the sacral arc, performed by squeezing the glans (head) of the penis, which immediately cause the anus to contract if nerve function is normal.

The latency between squeeze and contraction was assessed by observing the anal sphincter or by filling it with a gloved finger inserted past the anus.

All patients underwent standard electroencephalography (EEG) and neuroimaging [as computed tomography (CT) or magnetic resonance imaging (MRI)].

2) Assessment of erectile function: Assessment of erectile function was done using the Arabic translated version [21] of International Index of Erectile Function questionnaire 5-items version or IIEF-5 [22].

Each item of IIEF-5 is scored from 0 to 5 on 4 items and 1 to 5 on 1 item. The 4 of the 6 items

includes

A cutoff value of 21 is chosen so that patients with IIEF-5 scores of ?21 are classified as having ED while scores >21 are not. According to this scale, ED is classified into four categories: severe ED (1–7), moderate ED (8–11), mild-to-moderate ED (12–16), mild (17–21), and no ED (22–25). 3) Psychiatric evaluation: Standardized psychiatric interview was done by applying the Diagnostic and Statistical Manual of Mental Health Disorders, fourth edition (DSM–IV) criteria for the diagnosis of depression and anxiety [23].

A standardized psychiatric interview was chosen as the primary method for obtaining data. A differentiation between behavioral disorders and behavioral symptoms was made throughout the work. In patients with coexisting symptoms, assessment of the severity of the symptoms was undertaken by an experienced psychologist using the Arabic translated versions of Beck Depression Inventory (2nd edition) (BDI-II) [24, 25] and Hamilton Anxiety Rating Scale (HAM-A) [26,27]. BDI-II is the revised version of the original BDI (1st edition) [28].

In BDI-II, the items reflecting somatic disease and consequences of a medical illness which overlap with depressive symptoms were eliminated (as fatigue, work disability, weight loss, loss of energy, sleep loss, appetite loss, changes in body image, and somatic preoccupation).

The BDI–II consists of 21 items to assess the intensity of depression.

Each of the 21 items corresponding to a symptom of depression is summed to give a single score for the BDI-II. According to summation of scores from all 21 parameters, the score of 0-13 is considered minimal range, 14-19 is mild, 20-28 is moderate, and 29-63 is severe. The HAM-A consists of 14 items to measure the severity of a patients’ anxiety. Each of the 14 items is scored on a 5-point scale, ranging from 0 = not present to 4 = severe. According to summation of scores from all 14 parameters, the total score of 14-17 is considered as mild in range 18-24 as moderate while 25-30 as severe. 15-20 minutes to complete the interview and score the result.

4) Laboratory investigations: Standard laboratory tests included: complete blood count (CBC), measurement of serum creatinine, liver enzymes and fasting blood glucose level.

For analysis of serum free testosterone, prolactin, free thyroxin (FT4), thyroid stimulating hormone (TSH) and sex hormone binding globulin (SHBG), blood samples were drawn at (8.00-10.00 am) after an overnight fast and patients were seizure free for at least 72 hours, as any postictal central hormonal dysfunction is recognized to reverse within hours.

Assessment protocols were done according to the recommendations of the manufacturers.

The concentrations of serum prolactin, FT4 and TSH were measured by IMMULITE reproductive hormone assays from Diagnostic Product Cooperation (Los Angeles, USA).

The concentrations of free testosterone were measured by enzyme immunoassay method (ELISA) (BioSource Europe S.A.

Rue de I`Industrie, 8 – B-1400 Nivelles – Belgium) and SHBG concentrations were measured by ELISA kits (IBL international GMBH, Hamburg, Germany).