Comparison of efficacy of folic acid and silymarin in the management of antiepileptic drug induced liver injury: a randomized clinical trial.

BACKGROUND: Liver injury associated with antiepileptic drugs accounts for a large proportion of drug-induced liver injuries (DILI) in children. Although withdrawal of the causative agent is the only proved treatment for DILI, in some clinical situations it is not possible. Recent studies have reported promising results of using hepatoprotective drugs with antioxidant actions for the management of DILI. This study aimed to evaluate the efficacy of folic acid versus silymarin treatment in relation to decreasing liver enzymes in patients with DILI due to antiepileptic therapy. METHODS: This randomized, open-label, clinical trial evaluated 55 children with epilepsy who were on antiepileptic treatment and experienced DILI. The children were randomized to receive either silymarin (5 mg/kg per day) or folic acid (1 mg per day) for one month and were followed up for three months. RESULTS: Liver enzymes significantly decreased in both groups. The decrease trend in alanine aminotransferase (ALT) and aspartate aminotransferase (AST) were stronger in the folic acid group compared to silymarin group (P=0.04 and P=0.007, respectively). At the end of the study patients in the folic acid group had significantly lower ALT (P=0.04), AST (P=0.02), and gamma-glutamyl transferase (GGT) (P<0.001) levels and also higher percentage of normal ALT (30.7% vs 3.4%, P=0.009) and AST (42.3% vs 0%, P<0.001), and GGT (23.1% vs 0%, P=0.008) values compared to the patients in the silymarin group. No rebound elevations in ALT, AST and GGT levels or adverse reactions were noted in neither of the study groups. CONCLUSION: Although both treatments were safe and effective in decreasing liver enzymes, folic acid seems to be superior to silymarin in the management of DILI.

Evaluation of Feeding Disorders Including Gastro-Esophageal Reflux and Oropharyngeal Dysfunction in Children With Cerebral Palsy.

Objective: This cross sectional study aims to survey developing feeding disorders and nutritional deficiencies disorders in children with neurodevelopmental disorders such as cerebral palsy. Materials and methods: A total of 50 children (28 boys and 22 girls) with cerebral palsy and symptoms suggesting gastrointestinal problems such as choking, recurrent pneumonia and poor weight gain, who referred to the Pediatric department of Vali-asr Hospital, Imam Khomeini hospital complex between 1 October 2012 and 30 October 2013, were checked. Motor function classification system was used to classify patient's functional gross motor severity. All patients were examined and underwent deglutition videofluroscopy (modified barium swallow) and upper GI endoscopy with esophageal biopsies. Outcome of this study was the prevalence of oropharyngeal incoordination and GERD. Its relationship with some variables like motor and cognitive developmental delay were analyzed and p value < 0.05 was considered significant. Medical therapy and/or oral physiotherapy and nutritional rehabilitation were started. They were examined after 6 months of treatment. Decrease in choking and episodes of respiratory infections that needed hospitalization and weight gain after 6 months treatment were considered as secondary outcomes (response to treatment). Results: Prevalence of GERD was 66% and oropharyngeal dysphagia was estimated 82%. According to results of video-fluroscopy and endoscopic biopsies, 52% of patients were affected by both GERD and oropharyngeal dysfunction. The gross motor function disability was the only variable that significantly related to the prevalence of feeding disorders (p = 0.015). Despite nutritional rehabilitation only 46% of children have weight gain. Conclusion: Feeding disorders such as GERD and oropharyngeal dysfunction are more prevalent in children with cerebral palsy especially in children with severe gross motor disabilities. Since, clinical manifestations of these disorders can be similar accurate diagnostic methods should be selected for all children with cerebral palsy and gastrointestinal symptoms. Treatment should start early to reduce the complications and improve outcomes.

Comparison of Fecal Calprotectin in Exclusively Breastfed and Formula or Mixed Fed Infants in the First Six Months of Life.

We conducted this study to compare fecal calprotectin between exclusively breastfed and formula or mixed fed infants aged one month and six months. Sixty term infants were enrolled from the labor ward of Valiasr Hospital between Oct 2011 and July 2015 and their fecal calprotectin was checked by the ELISA method and Hycult biotech kits. The enrolled infants had a birth weight of 2500-4000 g and no perinatal insults or hospitalization. Stool sampling was done at 1±1 week and at 6n±1 months. The six-month infants had no recent disease, antibiotic use or vaccination. The mean fecal calprotectin was higher in exclusively breastfed infants at first and sixth months than formula and mixed fed infants (368.85±204.49 and 283.21±381.41 µg/g versus 152.59±139.13 and 113.62±92.75 µg/g respectively). (P=0.0001 and 0.018) Fecal calprotectin was higher in infants with GERD than healthy babies in the first and sixth months (P=0.0001 and 0.004). Based on the role of calprotectin in inflammation, its higher levels in exclusively breastfed infants is contrary to breast milk benefits and may be a sign of enhanced mucosal immune maturity in them.

Comparison of the Effects of pH-Dependent Peppermint Oil and Synbiotic Lactol (Bacillus coagulans + Fructooligosaccharides) on Childhood Functional Abdominal Pain: A Randomized Placebo-Controlled Study.

BACKGROUND: Still there is no consensus on the best treatment for abdominal pain-related functional Gastrointestinal Disorders (FGIDs). OBJECTIVES: The purpose of this study was to compare the effects of a synbiotic Lactol (Bacillus coagulans + fructooligosaccharide (FOS)), peppermint oil (Colpermin) and placebo (folic acid) on abdominal pain-related FGIDs except for abdominal migraine. PATIENTS AND METHODS: This placebo-controlled study was conducted on 120 children aged 4 - 13 years to compare the efficacy of pH-dependent peppermint oil (Colpermin) versus synbiotic Lactol (Bacillus coagulans + fructooligosaccharids (FOS)) in decreasing duration, severity and frequency of functional abdominal pain. The patients were randomly allocated into three equal groups (n = 40 in each group) and each group received Colpermin or Lactol or placebo. RESULTS: Eighty-eight out of 120 enrolled patients completed a one-month protocol and analyses were performed on 88 patients' data. Analyses showed that improvement in pain duration, frequency and severity in the Colpermin group was better than the placebo group (P = 0.0001, P = 0.0001 and P = 0.001, respectively). Moreover, pain duration and frequency were decreased in the Lactol group more than the placebo (P = 0.012 and P = 0.0001, respectively), but changes in pain severity were not significant (P = 0.373). Colpermin was superior to Lactol in decreasing pain duration and severity (P = 0.040 and P = 0.013, respectively). No known side effects or intolerance were seen with Colpermin or Lactol. CONCLUSIONS: The pH-dependent peppermint oil capsule and Lactol tablet (Bacillus coagulans+ FOS) as synbiotics seem to be superior to placebo in decreasing the severity, duration and frequency of pain in abdominal pain-related functional GI disorders.

Ursodeoxycholic Acid Can Improve Liver Transaminase Quantities in Children with Anticonvulsant Drugs Hepatotoxicity: a Pilot Study.

The present study has been directed to investigate Ursodeoxycholic Acid (UDCA) effect in children, to reduce the high Liver transaminases induced by Anticonvulsant drugs (drug induced hepatitis). This idea has been driven from Cytoprotective and antioxidant properties of UDCA to be used in drug induced inflammation in Liver. Twenty two epileptic patients aged between 4 mo - 3 yr whom were under anticonvulsant therapy with drugs such as valperoic acid, primidone, levetiracetam, Phenobarbital or any combination of them and had shown Liver transaminases rise , after rule out of Viral-Autoimmune, Metabolic and Anatomic causes, have been prescribed UDCA in dose of 10-15 mg/kg/day, at least for 6 months. Any patient who have shown confusing factors such as genetic disorders with liver involvement or spontaneous decline in enzymes or had not treatment compliance has been excluded from the study. Transaminases range changes as well as Probable side effects of the drug have been monitored. The results indicated that UDCA is effective and well tolerable in the children with drug induced hyper transaminasemia. No side effect has been seen and recorded in this study. Based on this study and its results, we recommend UDCA as a safe and effective choice in drug induced hepatotoxicities.