Use of nutritional supplements based on melatonin, tryptophan and vitamin B6 (Melamil Tripto®) in children with primary chronic headache, with or without sleep disorders: a pilot study.
Study Goal
The researchers aimed to determine whether adding tryptophan and vitamin B6 to melatonin would enhance the reduction of night awakenings in children with chronic headache.
Results Summary
The combination of melatonin, tryptophan, and vitamin B6 (MET-group) showed a statistically significant reduction in night awakenings compared to melatonin alone (ME-group), though headache event reduction was similar between groups.
Population
Children with chronic headache, some with sleep disorders.
Effective Dosage
Not specified
Duration
2 months
Interactions
None mentioned
| Intervention | Direction | Endpoint | Population | Dosage | Impact | Claim # |
|---|---|---|---|---|---|---|
exogenous melatonin | increase | sleep-wake cycles and sleep quality | children | - | has been shown to be useful and safe in improving | #1 |
melatonin nutritional supplement | decrease | number of headache events | children with chronic headache | 91.7% | responders were 91.7% | #2 |
melatonin, tryptophan, and vitamin B6 nutritional supplements | decrease | number of headache events | children with chronic headache | 66.7% | responders were 66.7% | #3 |
melatonin nutritional supplement | decrease | number of night awakenings | children with chronic headache | 3.6±3.2, 3.2±3.5, and 2.7±3.4 | mean number at baseline, after 30 days, and after 60 days were 3.6±3.2, 3.2±3.5, and 2.7±3.4 | #4 |
melatonin, tryptophan, and vitamin B6 nutritional supplements | decrease | number of night awakenings | children with chronic headache | 7.4±8.1, 4.0±4.4, and 3.3±2.9 | mean number of night awakenings was 7.4±8.1, 4.0±4.4, and 3.3±2.9 | #5 |
either nutritional supplement | decrease | monthly number of headache episodes and night awakenings | children with chronic headache | - | can help in decreasing | #6 |
tryptophan and vitamin B6 addition | decrease | night awakenings | children with chronic headache | - | appears to have stronger influence on reduction than melatonin only | #7 |
BACKGROUND: Headache is one of the main complaints in pediatric neurology. Exogenous melatonin has been shown to be useful and safe in improving sleep-wake cycles and sleep quality in children. Tryptophan as well plays a key role in sleep regulation. So far, no studies tried to analyze the effects of a combination of both melatonin and tryptophan in treating chronic headache in children affected also by night-time awakenings. METHODS: Thirty-four children with a diagnosis of chronic headache (with or without sleep disorders) have been enrolled. The study was articulated in two steps: 1) each child was observed for one month without any intervention; 2) children have been then randomized into two groups: the "ME-group", which received the nutritional supplement melatonin for two months and the "MET-group", which received the nutritional supplements melatonin, tryptophan, and vitamin B6 for two months. RESULTS: In terms of changes in number of headache events, responders in the ME-group were 91.7% and those in the MET-group were 66.7% (P=0.113). In terms of changes in number of night awakenings, in the ME group, mean number at baseline, after 30 days, and after 60 days were 3.6±3.2, 3.2±3.5, and 2.7±3.4 (P=0.495). In the MET group, mean number of night awakenings was 7.4±8.1, 4.0±4.4, and 3.3±2.9 (P=0.041). CONCLUSIONS: Using either nutritional supplement for two months can help in decreasing the monthly number of headache episodes and night awakenings. The addition of tryptophan and vitamin B6 appears to have stronger influence on night awakenings reduction than melatonin only.