Abstract
BackgroundMigraine is one of the most prevalent chronic pain manifestations of childhood. Despite the multitude of available treatments, parents are often concerned about chronic therapies and pediatricians have insufficient confidence in prescribing prophylactic drugs. Therefore, there is now growing interest for natural supplements used to control recurrent migraine headaches. Such approach may increase acceptance and adherence to long-term prophylaxis therapy in children.MethodsThis is an observational multicenter study performed in children (n = 91) with migraine, with (MO) or without aura (MA), or tension-type headache (TTH). A fixed-dose Andrographis paniculata, CoQ10, riboflavin, and magnesium, was administered for 16 weeks. Patients were evaluated at baseline (T0), at week 8 (T1) and at the end of treatment at week 16 (T2). A follow-up period occurred at week 20 (T3) and week 32 (T4).ResultsThe herbal supplement significantly reduced the frequency of headaches in TTH patients during treatment period (T0: 11.97 + 1.92 vs T2: 5.13 + 1.93; p < 0.001) and the efficacy was maintained after 16 weeks of treatment withdrawal (T4: 4.46 + 1.75; p < 0.001 vs T0). The frequency of migraine attacks was also reduced in the MO group during treatment (T0: 9.70 + 0.96 vs T2: 4.03 + 0.75; p < 0.01) and after withdrawal (T4: 2.96 + 0.65; p < 0.01 vs T0). Conversely, MA patients showed reduction in migraine’s frequency during treatment (T0: 8.74 + 1.91 vs T2: 3.78 + 2.02; p < 0.01) but not at the end of the study (T4: 5.57 + 3.31; p > 0.05 vs T0).TTH patients did not report significant improvement of pain intensity. A significant effect was observed in the MO group during treatment (T0: 3.06 + 0.11 vs T2: 2.14 + 0.19; p < 0.001) and after treatment withdrawal (T4: 2.20 + 0.21; p < 0.001 vs T0). Likewise, MA group showed a significant treatment effect (T0: 2.57 + 0.20 vs T2: 0.86 + 0.45; p < 0.001) and the efficacy persisted at the end of the study (T4: 1.00 + 0.58; p < 0.001 vs T0).ConclusionThis fixed-dose Tanacetum parthenium preparation improved headache frequency and pain intensity in children affected by TTH. Despite the main limits, this study supports the use of nutraceutical in pediatric headache/migraine.
Highlights
Migraine is one of the most prevalent chronic pain manifestations of childhood
Inclusion criteria were migraine with aura (MA), without aura (MO) or tension-type headache (TTH), as defined according to the International Classification of Headache Disorders, 3rd
A small group of patients (8.8%) interrupted the study protocol due to treatment inefficacy while the 7.7% of patients was lost at follow-up
Summary
Migraine is one of the most prevalent chronic pain manifestations of childhood. There is growing interest for natural supplements used to control recurrent migraine headaches. Such approach may increase acceptance and adherence to long-term prophylaxis therapy in children. Migraine is one of the most prevalent neurological symptom and chronic pain manifestation of childhood, affecting up to 10% of children between the ages of 5 and 15 years and up to 28% of adolescents aged from 15 to 19 years [1]. Due to the potential limitations of conventional treatment of obtaining a satisfactory response to pain in many cases of primary headache, various alternative treatments are sought by patients; in particular, parents ask healthcare professionals to provide migraine relief for their children. Even clinicians prefer to avoid prescription of prophylactic therapies in children due to the poor evidence of efficacy and significant potential adverse effects in this population [9] and the well-known “placebo effect” observed in children [10]
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