An observational study of fixed-dose Tanacetum parthenium nutraceutical preparation for prophylaxis of pediatric headache.
| Intervention | Direction | Endpoint | Population | Dosage | Impact | Claim # |
|---|---|---|---|---|---|---|
A fixed-dose Andrographis paniculata, CoQ10, riboflavin, and magnesium | decrease | frequency of headaches | TTH patients | T0: 11.97 + 1.92 vs T2: 5.13 + 1.93 | significantly reduced | #1 |
A fixed-dose Andrographis paniculata, CoQ10, riboflavin, and magnesium | decrease | frequency of headaches | TTH patients | T4: 4.46 + 1.75 vs T0 | efficacy was maintained | #2 |
A fixed-dose Andrographis paniculata, CoQ10, riboflavin, and magnesium | decrease | frequency of migraine attacks | MO group | T0: 9.70 + 0.96 vs T2: 4.03 + 0.75 | reduced | #3 |
A fixed-dose Andrographis paniculata, CoQ10, riboflavin, and magnesium | decrease | frequency of migraine attacks | MO group | T4: 2.96 + 0.65 vs T0 | reduced | #4 |
A fixed-dose Andrographis paniculata, CoQ10, riboflavin, and magnesium | decrease | migraine's frequency | MA patients | T0: 8.74 + 1.91 vs T2: 3.78 + 2.02 | showed reduction | #5 |
A fixed-dose Andrographis paniculata, CoQ10, riboflavin, and magnesium | no change | migraine's frequency | MA patients | T4: 5.57 + 3.31 vs T0 | not at the end of the study | #6 |
A fixed-dose Andrographis paniculata, CoQ10, riboflavin, and magnesium | no change | pain intensity | TTH patients | - | did not report significant improvement | #7 |
A fixed-dose Andrographis paniculata, CoQ10, riboflavin, and magnesium | decrease | pain intensity | MO group | T0: 3.06 + 0.11 vs T2: 2.14 + 0.19 | significant effect was observed | #8 |
A fixed-dose Andrographis paniculata, CoQ10, riboflavin, and magnesium | decrease | pain intensity | MO group | T4: 2.20 + 0.21 vs T0 | significant effect was observed | #9 |
A fixed-dose Andrographis paniculata, CoQ10, riboflavin, and magnesium | decrease | pain intensity | MA group | T0: 2.57 + 0.20 vs T2: 0.86 + 0.45 | showed a significant treatment effect | #10 |
A fixed-dose Andrographis paniculata, CoQ10, riboflavin, and magnesium | decrease | pain intensity | MA group | T4: 1.00 + 0.58 vs T0 | efficacy persisted | #11 |
This fixed-dose Tanacetum parthenium preparation | decrease | headache frequency | children affected by TTH | - | improved | #12 |
This fixed-dose Tanacetum parthenium preparation | decrease | pain intensity | children affected by TTH | - | improved | #13 |
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.