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Observational Study
. 2019 Mar 12;45(1):36.
doi: 10.1186/s13052-019-0624-z.

An observational study of fixed-dose Tanacetum parthenium nutraceutical preparation for prophylaxis of pediatric headache

Filomena Moscano  1 , Michela Guiducci  2 , Lucia Maltoni  1 , Pasquale Striano  3 , Maria Giuseppina Ledda  4 , Francesco Zoroddu  5 , Umberto Raucci  6 , Maria Pia Villa  2 , Pasquale Parisi  7
Affiliations
Observational Study

An observational study of fixed-dose Tanacetum parthenium nutraceutical preparation for prophylaxis of pediatric headache

Filomena Moscano et al. Ital J Pediatr. .

Abstract

Background: Migraine 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.

Methods: This 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).

Results: The 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).

Conclusion: This 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.

Keywords: Nutraceuticals; Observational study; Pediatric migraine; Prophylaxis; Tanacetum parthenium.

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Conflict of interest statement

Ethics approval and consent to participate

Not applicable.

Consent for publication

All the Authors gave the consent for publication.

Competing interests

The authors declare that they have no competing interests. No financial or non-financial benefits have been received or will be received from any party related directly or indirectly to the subject of this article. No honorarium, grant, or other form of payment was given to anyone to produce the manuscript.

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Figures

Fig. 1
Fig. 1
Results for frequency of attacks (a) and Intensity of pain (b) at baseline and at the post-baseline time points by subgroup of diagnosis (values are means). Migraine with (MO) or without aura (MA), tension-type headache (TTH). Bars are standard deviations. *p < 0.05
See this image and copyright information in PMC

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