Safety and efficacy of sucrosomial iron in inflammatory bowel disease patients with iron deficiency anemia.

Iron deficiency anemia (IDA) is one of the most common complications of inflammatory bowel disease (IBD). We planned a prospective study to address tolerability and efficacy of sucrosomial iron, a new oral formulation of ferric pyrophosphate, in IBD patients. Thirty patients with a confirmed diagnosis of Crohn's Disease (CD) or ulcerative colitis (UC) and mild IDA were enrolled. Patients with severe IBD were excluded. All patients underwent 12 weeks of oral treatment with 30 mg/day of sucrosomial iron. Treatment compliance and adverse events were investigated every 4 weeks. Iron status, hematological parameters and IBD activity scores were determined at baseline and at the end of treatment, as well as serum hepcidin and non-transferrin bound iron (NTBI) levels. Twenty-four (80%) patients took more than 90% of the prescribed regimen. Forty-four adverse events (AEs) were recorded, but none of them is considered certainly or probably related to the study treatment. Interestingly, only eleven gastrointestinal events were recorded in 9 (30%) patients. At the end of treatment, all iron parameters improved significantly and Hb increased in 86% of patients (from 11.67 to 12.37 g/dl, p = 0.001). Serum hepcidin showed a significant increase in 79% of patients and became positively correlated with C-reactive protein (CRP) at the end of the study, while NTBI remained below the detection threshold after iron supplementation. The IBD activity scores improved in both CD and UC. This pilot interventional study supports the therapeutic use of sucrosomial iron in IBD and paves the way for future studies in larger or more difficult IBD populations.

How children and parents evaluate the Headache Centre's intervention.

BACKGROUND: While adult headache patients' satisfaction with treatments has been widely investigated, less attention has been paid to children and adolescent headache patients' opinions and their parents' views. OBJECTIVE: The aim of our follow-up survey was to analyze the outcomes of the Headache Centre's intervention and the evolution of headache according to patients until the age of 16 and their parents. METHODS: We studied all outpatients suffering from episodic primary headache according to International Classification of Headache Disorders 2nd edition criteria, seen for the first time in 2005-2006 at the Headache Centre of the University Hospital of Modena (Italy), and at least one of their parents. The duration of the follow-up ranged from 1 to 3 years. For the purpose of the study, a specific questionnaire was created and administered by a telephone interview. RESULTS: We enrolled 84 patients (38 females, 45%; 46 males, 55%; mean age +/- SD: 12.9 +/- 2.9 years) with primary headache: migraine without aura 66%, episodic tension-type headache 23%, migraine with aura 11%. At the follow-up, 70% of the patients reported that headache had improved; frequency had decreased significantly more than severity (P = .000, Fisher's exact test), both in those who had followed a prophylactic treatment and in those who had not. A high percentage of the children and parents could precisely indicate trigger factors for headache: especially excessive worrying and studying. The patients reporting an improvement attributed it to pharmacological prophylactic treatment, but also to other factors: first of all, better school results and more happiness than before. Seventy-seven percent of the parents thought that the Headache Centre's intervention had helped them to better understand and manage their children's headache. CONCLUSIONS: Children's and adolescents' headache has in most cases a favorable prognosis; the Headache Centre's intervention is considered effective by most parents. We must increase and focus therapeutic efforts addressed to the few patients with worsening headaches in spite of treatment, since these children's/adolescents' headache also is at risk to progress in the adult age.