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P507 Tanacetum parthenium, griffonia simplicifolia and magnesium as symptomatic and prophylactic treatment for headache in paediatric patients
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  1. Pietro Ferrara1,
  2. Federica Di Ruscio2,
  3. Anna Rita Bellomo3,
  4. Andrea Ianni4,
  5. Tommasangelo Petitti4,
  6. Massimo Pettoello-Mantovani5
  1. 1Institute of Pediatrics, Università Cattolica del Sacro Cuore, Rome, Italy
  2. 2Campus Bio-Medico University, Rome, Italy
  3. 3Giovan Battista Grassi Hospital, Rome, Italy
  4. 4Public Health and Statistics, Campus Bio-Medico University, Rome, Italy
  5. 5Department of Pediatrics, Scientific Institute Casa Sollievo della Sofferenza, University of Foggia, Foggia, Italy

Abstract

Objective The aim of the this study is to evaluate the use and the self-perceived efficacy and tolerability of three nutraceutical components - Tanacetum parteninum, Griffonia simpliciofila and Magnesium - in children and adolescents with primary headaches without other comorbidities.

Design This is a longitudinal cohort study.

Setting The study was conducted as a prospective study. After the first examination and the prescription of exams, patients were subjected to one month baseline period without treatment to verify the number and the intensity of attacks.

Patients We enrolled a total of 42 children, 25 female (59,52%) and 17 male (40,48%). The average age of children at the time of recruitment is 10,59 ± 3,18 years. The inclusion criteria employed have been: (a) aged between 3–17 years; (b) diagnosis of primary headache and/or migraine (including migraine with or without aura; chronic headache; persistent headache); (c) headache/migraine present for at least three months; (d) at least three migraine attacks per month in the last three months. The exclusion criteria have been: (a) patients with chronic pain of different nature; (b) secondary headache.

Interventions We administered AURASTOP® at the dose of 1 teaspoon 2 times per day for 2–3 months and when an attack occurs, in children above 4 years of age, at a dose of 1 pouch.

Main outcome measures It has been used two validated questionnaire: Migraine Disability Assessment (MIDAS) and The six-item Headache Impact Test (HIT-6). MIDAS is a brief questionnaire and measures headache-related disability. HIT-6 was designed to provide a global measure of adverse headache impact. Treatment with AURASTOP® has been conducted for 3 months, with two sachets-day. Compliance of patients was monitored weekly by means of a weekly exchange of emails or phone calls to parents.

Results A reduction in MIDAS scores was observed comparing pre-treatment (46.48 ± 8.35) and post-treatment (9.78 ± 18.16) data. After the treatment 1/42 patients (2.38%) had worsened, 9/42 patients (21.43%) had not improved, 10/42 (23.91%) had gone up 1 class, 12/10 patients (28.57%) had gone up 2 classes, 10/42 (23.91%) had gone up 3 classes of MIDAS score. Therefore, the improvement of disability related to the headache is statically significant (Fisher’s exact test). The reduction of HIT-6 score post-treatment (46.48 ± 8.35) compared with pre-treatment (62.55 ± 5.50) was statistically significant (P < 0.05).

Conclusions AURASTOP® can be used as a prophylactic treatment and as symptomatic treatment in paediatric patients with headache.

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