Evaluation of reliability and validity of the Persian version of the Neurological Disorders Depression Inventory for Epilepsy (P-NDDI-E).

INTRODUCTION: Major depression is common among people with epilepsy (PWE), but it is underdiagnosed. The aim of the present study was to assess the reliability and validity of the Persian version of the Neurological Disorders Depression Inventory for Epilepsy (P-NDDI-E) as a screening tool for major depression in patients with epilepsy. METHOD: A total of 210 patients suffering from epilepsy have been assessed using the NDDI-E and the Beck Depression Inventory-II (BDI-II) with no difficulty in understanding or answering the Persian version of the questionnaire. Patients identified as depressed under BDI-II underwent a psychiatric evaluation to confirm depression according to 10th revision of the International Statistical Classification of Diseases and Related Health Problems (ICD) criteria. RESULT: According to the BDI-II and the ICD-10 criteria, major depression was diagnosed in 75 patients (32% men, 68% women). Cronbach's α coefficient was 0.826, suggesting a very good internal consistency. The receiver operating characteristic analysis showed an area under the curve of 0.90 (95% confidence interval [CI] = 0.86-0.94, standard error [SE]: 0.02, p < 0.001). A cutoff of ≥14 resulted in an 83% sensitivity, an 80% specificity, a 70.1% positive predictive value, and an 88.6% negative predictive value. A significant and positive correlation between the P-NDDI-E and the BDI-II was shown (Spearman's ρ = 0.604, p < 0.001). DISCUSSION: The P-NDDI-E could be used as a reliable and valid instrument in detecting major depression in PWE.

A randomized double-blind trial of comparative efficacy and safety of Avonex and CinnoVex for treatment of relapsing-remitting multiple sclerosis.

BACKGROUND AND AIM: Interferon beta is currently the first line treatment of relapsing-remitting multiple sclerosis (RRMS). Different formulations of interferon beta are available. Avonex and CinnoVex are two interferon beta-1a being prescribed by neurologists in Iran. The aim of this study was to compare the four and half year outcome of Avonex and CinnoVex in patients with RRMS. METHODS: A total 186 of patients with definite RRMS diagnosis were followed for four and half years. Patients were randomly assigned to receive either Avonex or CinnoVex. Patients were subsequently visited every 6 months, and MRI was also undertaken prior each visit. The efficacy end points were to compare mean scores of expanded disability status scale (EDSS) and the proportion of patients with MRI and clinical activity in follow-up visits between Avonex and CinnoVex. Safety end point was to compare the percentage of adverse events between two groups. RESULTS: One hundred and eighty-two patients completed the study. The population of study experienced a steady increase in EDSS during follow-up with a mean increase of 1.03. Repeated measures ANOVA revealed no statistically significant difference between Avonex and CinnoVex (p = 0.78). The most common adverse events were headache, myalgia, fatigue, fever, flu symptoms, injection site pain, and depression. Direct comparison of each adverse events revealed no meaningful difference between two groups except for only a few adverse events. There was no statistically significant difference in MRI activity and clinical activity between two groups. CONCLUSION: Avonex and CinnoVex showed similar efficacy and safety outcome in patients with RRMS.

Comparison of Pregabalin and Sodium Valproate in Migraine Prophylaxis: A Randomized Double-Blinded Study.

Patients suffering from headache, particularly migraine type, are among the most dissatisfied patients. The aim of this study was comparing the efficacy of pregabalin with valproate sodium, in preventing migraine headache. In a randomized, double-blinded study, adult patients eligible for prophylactic treatment (i.e., patients with 4-15 attacks per month in last two months) were recruited. Patients' demographic data, duration of symptoms, headache frequency (attacks per month) and intensity (based on visual analogue scale) and also drugs used to relief headache were recorded. The patients were randomly assigned to two groups; valproate sodium (200 mg two times daily) and pregabalin (50 mg two times daily). The patients were examined by neurology specialist monthly for three months and the related data were recorded. The Data were analyzed using SPSS version 21, with related statistical tests. Total number of 140 patients with recurrent migraine were entered into the study. Sixty-nine patients were assigned to group A and 71 to group B by the randomizing table. Inter-group analysis of data in two arms of the study showed that two medications were equally effective except that pregabalin was not significantly effective in reducing number of attacks during first month of therapy compared to baseline. This differences were not significant at second and third month of the study. Our study showed that pregabalin, has comparable efficacy with valproate sodium in reducing migraine frequency, intensity, and duration of attacks and could be an alternative for migraine prophylaxis.

MLC601 in vascular dementia: an efficacy and safety pilot study.

BACKGROUND AND AIM: Vascular dementia (VaD) is the second most common cause of dementia and currently there is scarcity of therapies for VaD. We aimed to investigate the efficacy and safety of MLC601 in the treatment of VaD. METHODS: In this multicenter, pilot, randomized, double-blind trial, 82 patients with VaD according to DSM-5 criteria received MLC601 or placebo capsules three times a day for 2 years. The primary efficacy end-point was evaluated by comparing Mini-Mental State Examination (MMSE) and Alzheimer's Disease Assessment Scale-cognitive subscale (ADAS-cog) score between the two groups over 2 years of study. Safety was also assessed by recording adverse events and abnormal laboratory results. RESULTS: Eighty-one patients completed the study and were included in the analysis. One patient was lost to follow-up in the placebo group. After 2 years, mean (±SD) changes in the MMSE score were -3.71 (±4.50) for MLC601 group and -9.33 (±4.80) for placebo group. ADAS-cog score showed (±SD) changes of 7.34 (±9.55) and 19.00 (±11.28) for MLC601 and placebo group, respectively. Repeated measures analyses showed that both MMSE and ADAS-cog scores were significantly better in the treatment group at 24 months (p<0.001). Ten (24.39%) patients reported predominantly transient gastrointestinal adverse events in MLC601 group. No patient left the study due to adverse events. There were no clinically significant abnormalities on laboratory tests. CONCLUSION: Patients treated with MLC601 over the 2 years showed dramatically better cognitive outcome compared with those treated with placebo. MLC601 was devoid of any serious adverse events and was well-tolerated.

Efficacy and Safety of MLC601 in the Treatment of Mild Cognitive Impairment: A Pilot, Randomized, Double-Blind, Placebo-Controlled Study.

BACKGROUND AND AIM: Mild cognitive impairment (MCI) is characterized by declined cognitive function greater than that expected for a person's age. The clinical significance of this condition is its possible progression to dementia. MLC601 is a natural neuroprotective medication that has shown promising effects in Alzheimer disease. Accordingly, we conducted this randomized, double-blind, placebo-controlled study to evaluate the efficacy and safety of MLC601 in MCI patients. METHODS: Seventy-two patients with a diagnosis of MCI were recruited. The included participants were randomly assigned to groups to receive either MLC601 or placebo. An evaluation of global cognitive function was performed at baseline as well as at 3-month and 6-month follow-up visits. Global cognitive function was assessed by Mini-Mental State Examination (MMSE) and Alzheimer's Disease Assessment Scale-cognitive subscale (ADAS-cog) scores. Efficacy was evaluated by comparing global function scores between the 2 groups during the study period. Safety assessment included adverse events (AEs) and abnormal laboratory results. RESULTS: Seventy patients completed the study, 34 in the MLC601 group and 36 in the placebo group. The mean changes (±SD) in cognition scores over 6 months in the MLC601 group were -2.26 (±3.42) for the MMSE and 3.82 (±6.16) for the ADAS-cog; in the placebo group, they were -2.66 (±3.43) for the MMSE and 4.41 (±6.66) for the ADAS-cog. The cognition changes based on both MMSE and ADAS-cog scores were statistically significant between the placebo and the MLC601 group (p < 0.001). Only 5 patients (14.7%) reported minor AEs in the MLC601 group, the most commonly reported of which were gastrointestinal, none of them leading to patient withdrawal. CONCLUSION: MLC601 has shown promising efficacy and acceptable AEs in MCI patients.

The Effectiveness of Attribution Retraining on Health Enhancement of Epileptic Children.

OBJECTIVE: Epilepsy is a chronic neurological disease. Evidence has indicated that epilepsy has an impact on mental and physical health of children. The present study aimed to determine the effectiveness of attribution retraining on health enhancement of epileptic children. MATERIALS & METHODS: This was an experimental study with a pre-test and a post-test design with a control group. Thirty students with epilepsy (11 female and 19 male students) were selected in convenience from Iranian Epilepsy Association. They were assigned to experimental and control groups and their mothers completed Child Health Questionnaire (CHQ-PF.28) before and after the intervention. The experimental group attended to eleven sessions (each session 45 minutes; twice a week). Subjects were trained by attribution retraining program, but control group was not. Multivariate analysis of covariance (MANCOVA) was used for analyzing the data. RESULTS: Health (both psychosocial and physical) of experimental group enhanced significantly after the intervention sessions compared to control group. CONCLUSION: Attribution retraining is an effective intervention to enhance the psychosocial and physical health of epileptic children.

Comparing Zonisamide With Sodium Valproate in the Management of Migraine Headaches: Double-Blind Randomized Clinical Trial of Efficacy and Safety.

BACKGROUND: Migraine is one of the most debilitating medical conditions and has a high socioeconomic burden. As conventional therapeutic methods do not entirely alleviate the symptoms, new alternatives are being considered. OBJECTIVES: This study evaluates the efficacy and safety of zonisamide compared with sodium valproate in the management of migraine headaches. PATIENTS AND METHODS: In the current double-blind, parallel, randomized, controlled trial, 96 patients with a migraine diagnosis based on the international headache society (HIS) criteria were selected. They were divided randomly into two groups; the case group was given zonisamide, and sodium valproate was given to a control group. In addition to the side effects of the drugs, the severity, duration, and frequency of migraine attacks were evaluated at baseline and at three months. RESULTS: The 96 selected patients were divided randomly into two treatment groups (zonisamide n = 48, sodium valproate n = 48). Seven patients were excluded from analysis because of early dropout, leaving 89 (n = 45; n = 44) patients for analysis. While using zonisamide, six (13%) patients complained of fatigue, and two (4%) patients encountered noticeable appetite and weight loss. In the control group, five (11%) patients reported dizziness, and four (9%) patients faced obvious appetite and weight gain. Both drugs were considerably efficient in reducing further attacks. There was no statistically significant correlation between frequency or severity of migraine attacks and the drug used for treatment in three months of follow-up. CONCLUSIONS: Both medications are effective in reducing migraine attacks. It will be important to consider the drugs' adverse effects and availability and patients' medical and socioeconomic condition to select the appropriate treatment.

Effects of Coriandrum sativum Syrup on Migraine: A Randomized, Triple-Blind, Placebo-Controlled Trial.

BACKGROUND: Migraine is one of the most common and debilitating neurological problems. Although numerous preventive drugs are used to treat migraine, their complications are unavoidable. Application of herbal medicine, especially well-known medicinal plants, to treatment of chronic diseases, like migraine, could be effective. Coriandrum sativum L. (C. sativum) fruit is one of the most commonly prescribed herbs in Persian medicine, which has been used to treat headache. OBJECTIVES: This study was designed to evaluate the effects of C. sativum syrup on duration, severity and frequency of migraine. PATIENTS AND METHODS: A total of 68 migraineurs, who had the eligibility criteria, according to international headache society diagnostic criteria, were randomly assigned to intervention group (n = 34) or control group (n = 34). In addition to 500 mg of sodium valproate per day, in intervention group, they received 15 mL of Coriander fruit syrup and 15 mL of placebo syrup, in control group, three times a day, during a month. The subjects were followed for clinical efficacy at weeks 1, 2, 3 and 4. The number of migraine attacks per week, as well as the duration and severity of attacks, were evaluated. RESULTS: Of 68 patients randomized, 66 were included in analysis. The generalized estimating equations analysis showed that the Coriander fruit syrup decreased duration, severity and frequency of migraine, in the intervention group (P < 0.001). To be more precise, the mean migraine duration, severity and frequency, in the intervention group, were 5.7 hours, 3.65 units and about 50% less than control group, respectively. CONCLUSIONS: Results of this study showed that C. sativum fruit is efficient in reduction of the duration and frequency of migraine attacks and in diminishing pain degree.

Central nervous system tuberculosis: an imaging-focused review of a reemerging disease.

Central nervous system (CNS) tuberculosis is a potentially life threatening condition which is curable if the correct diagnosis is made in the early stages. Its clinical and radiologic manifestations may mimic other infectious and noninfectious neurological conditions. Hence, familiarity with the imaging presentations of various forms of CNS tuberculosis is essential in timely diagnosis, and thereby reducing the morbidity and mortality of this disease. In this review, we describe the imaging characteristics of the different forms of CNS tuberculosis, including meningitis, tuberculoma, miliary tuberculosis, abscess, cerebritis, and encephalopathy.

Efficacy of Attribution Retraining on Mental Health of Epileptic Children.

BACKGROUND: Epilepsy affects children's quality of life and leads to social and mental problems. Promoting the mental health of children, especially epileptic ones, and preventing problems affecting them constitute major concerns for every country. Mental health promotion requires intervention programs. OBJECTIVES: We sought to assess the efficacy of attribution retraining on the mental health of epileptic children. PATIENTS AND METHODS: The present study is a semi-experimental investigation with a pretest and posttest design and includes a control group. Thirty children, comprising 17 boys and 13 girls, were selected randomly from the Iranian epilepsy association in Tehran and assigned to experimental and control groups. They answered to the general health questionnaire (Goldberg and Hiller, 1979). The experimental group participated in 11 training sessions (twice a week; 45 minutes for each session) and received attribution retraining. The data were analyzed using the multiple analysis of covariance. RESULTS: The findings showed that the experimental group, in comparison with the control group, experienced a reduction in physical symptoms, anxiety and insomnia, social dysfunction, and depression and an increase in mental health significantly (P < 0.01) after the training sessions. There were no significant differences, however, between the two groups at 6 weeks' follow-up. CONCLUSIONS: Attribution retraining improved mental health in the epileptic children in our study. It, therefore, seems to be an appropriate intervention for promoting the mental health of children.

Effectiveness and Safety of MLC601 in the Treatment of Mild to Moderate Alzheimer's Disease: A Multicenter, Randomized Controlled Trial.

BACKGROUND: MLC601 is a possible modulator of amyloid precursor protein processing, and in a clinical trial study MLC601 showed some effectiveness in cognitive function in Alzheimer's disease (AD) patients. We aimed to evaluate the effectiveness and safety of MLC601 in the treatment of mild to moderate AD as compared to 3 approved cholinesterase inhibitors (ChEIs) including donepezil, rivastigmine and galantamine. METHODS: In a multicenter, nonblinded, randomized controlled trial, 264 volunteers with AD were randomly divided into 4 groups of 66; groups 1, 2, 3 and 4 received donepezil, rivastigmine, MLC601 and galantamine, respectively. Subjects underwent a clinical diagnostic interview and a cognitive/functional battery including the Mini-Mental State Examination (MMSE) and Alzheimer's Disease Assessment Scale - Cognitive subscale (ADAS-Cog). Patients were visited every 4 months, and the score of cognition was recorded by the neurologists. RESULTS: There were no significant differences in age, sex, marital status and baseline score of cognition among the 4 groups. In total, 39 patients (14.7%) left the study. Trend of cognition changes based on the modifications over the time for MMSE and ADAS-cog scores did not differ significantly among groups (p = 0.92 for MMSE and p = 0.87 for ADAS-Cog). CONCLUSION: MLC601 showed a promising safety profile and also efficacy compared to 3 FDA-approved ChEIs.

Types of nasal delivery drugs and medications in Iranian traditional medicine to treatment of headache.

CONTEXT: Headache is a common symptom throughout the world. The main purpose of patient-centered approaches is the utilization of useful and simple treatment. Nowadays, there is a rising propensity toward herbal remedies. Nasal route is one of the ancient and topical prescriptions used in headache. In Iranian traditional medicine, physicians such as Avicenna were prescribing herbal drugs through the nose to treat a variety of central nervous system diseases like headache. In this review paper, authors have attempted to introduce different types of nasal administrations which were used in Iranian traditional medicine for the treatment of headaches. EVIDENCE ACQUISITION: Initially, we studied two different types of Canon and separated all herbs used in the treatment of headache. Next, all plants were classified according to the method of prescription. Then, we pick out all the plants which were nasally utilized in the treatment of headache and divided them based on the method of administration. In order to find scientific names of herbs, we used two different botany references. Moreover, we conducted various researches in scientific databases with the aim of finding results concerning the analgesic and antinociceptive effects of herbs. Throughout the research, key terms were "analgesic" and "antinociceptive "with the scientific names of all herbs separately. The databases searched included PubMed, Scopus, Cochrane library and SID. RESULTS: 35 plants were prescribed for the treatment of headaches, which were all nasally used. These plants took either the form of powder, liquid or gas (steam). They were divided in to six categories according to the method of prescription. The Percentage of usage for each method was as follows: 62% Saoot (nasal drop), 25% Shamoom (smell), 17% Inkabab (vapor), 11% Nafookh (snuff), 11% Nashooq (inhaling) and 2% Bokhoor (smoke). CONCLUSIONS: Medications that are used via nasal delivery have greater effect than oral medications. Iranian physicians were fully aware of systemic effects of topical medications, including prescription drugs through the nose. The study of ancient medical texts helps us in identification of herbal medicine and the investigation of new way for the preparation of drugs.

Imaging-based diagnosis of wernicke encephalopathy: a case report.

INTRODUCTION: Wernicke encephalopathy (WE) is a medical emergency characterized by ataxia, confusion, nystagmus and ophthalmoplegia resulting from thiamin deficiency. Alcoholism is the common cause for this disease. CASE PRESENTATION: A 41 year old man was brought to our emergency department (ED) complaining of confusion. One week earlier he had started to experience severe nausea and vomiting followed by diplopia, dysarthria and also dysphagia. One day later he had experienced gait disturbance and progressive ataxia accompanied with confusion, apathy and disorientation. He had no history of alcoholism, drug abuse or previous surgery but had history of untreated Crohn disease. Just before arrival to our emergency department, he had been hospitalized in another center for about a week but all investigations had failed to provide a conclusive diagnosis. Upon admission to our ED, he was dysarthric and replied with inappropriate answers. On physical examination, bilateral horizontal nystagmus in lateral gaze, left abducens nerve palsy and upward gaze palsy were seen. Gag reflex was absent and plantar reflexes were upwards bilaterally. After reviewing all the previously performed management measures, MRI was performed and was consistent with the diagnosis of WE. Treatment with thiamine led to partial resolution of his upward gaze palsy and nystagmus on the first day. At the end of the third day of treatment, except for gate ataxia, all other symptoms completely resolved and he was fully conscious. After the fifth day his gait became normal and after one week he was discharged in good general condition. DISCUSSION: After reviewing the current literature, it seems that brain MRI can be helpful in the diagnosis of WE in patients with the classic clinical trial in the absence of clear risk factors.