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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.
Bravaccio, C, Terrone, G, Rizzo, R, Gulisano, M, Tosi, M, Curatolo, P, Emberti Gialloreti, L
Minerva pediatrica. 2020;(1):30-36
Abstract
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.
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B vitamins and cognition in subjects with small vessel disease: A Substudy of VITATOPS, a randomized, placebo-controlled trial.
Ting, SKS, Earnest, A, Li, H, Hameed, S, Chang, HM, Chen, CLH, Tan, EK
Journal of the neurological sciences. 2017;:124-126
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The China Stroke Secondary Prevention Trial (CSSPT) protocol: a double-blinded, randomized, controlled trial of combined folic acid and B vitamins for secondary prevention of stroke.
Liu, X, Shi, M, Xia, F, Han, J, Liu, Z, Wang, B, Yang, F, Li, L, Wu, S, Wang, L, et al
International journal of stroke : official journal of the International Stroke Society. 2015;(2):264-8
Abstract
RATIONALE Epidemiological studies suggest that elevated homocysteine is linked to stroke and heart disease. However, the results of lowering homocysteine levels in reducing the risk of stroke recurrence are controversial. AIMS The study aims to evaluate whether homocysteine-lowering therapy with folic acid and vitamins B6 and B12 reduces recurrent stroke events and other combined incidence of recurrent vascular events and vascular death in ischemic stroke patients of low folate regions. DESIGN This is a multicenter, randomized, double-blinded, placebo-controlled trial. Patients (n = 8000, α = 0.05, β = 0.10) within one-month of ischemic stroke (large-artery atherosclerosis or small-vessel occlusion) or hypertensive intracerebral haemorrhage with plasma homocysteine level ≥ 15 μmol/l will be enrolled. Eligible patients will be randomized by a web-based, random allocation system to receive multivitamins (folic acid 0.8 mg, vitamin B6 10 mg, and vitamin B12 500 μg) or matching placebo daily with a median follow-up of three-years. STUDY OUTCOMES Patients will be evaluated at six monthly intervals. The primary outcome event is the composite event 'stroke, myocardial infarction, or death from any vascular cause', whichever occurs first. Secondary outcome measures include nonvascular death, transient ischemic attack, depression, dementia, unstable angina, revascularization procedures of the coronary, and cerebral and peripheral circulations. DISCUSSION This is the first multicenter randomized trial of secondary prevention for ischemic stroke in a Chinese population with a higher homocysteine level but without folate food fortification.
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Homocysteine-lowering therapy and risk for venous thromboembolism: a randomized trial.
Ray, JG, Kearon, C, Yi, Q, Sheridan, P, Lonn, E, ,
Annals of internal medicine. 2007;(11):761-7
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Abstract
BACKGROUND Elevated total homocysteine levels are associated with a higher risk for venous thromboembolism. Whether decreasing homocysteine levels with vitamin therapy reduces the risk for venous thromboembolism is not known. OBJECTIVE To determine whether decreasing homocysteine levels alters the risk for symptomatic venous thromboembolism. DESIGN Secondary analysis of data from the randomized, placebo-controlled Heart Outcomes Prevention Evaluation 2 (HOPE-2) trial. SETTING 145 clinical centers in 13 countries. PARTICIPANTS 5522 persons 55 years of age or older with known cardiovascular disease or diabetes mellitus and at least 1 other risk factor for vascular disease. INTERVENTION A daily supplement of 2.5 mg of folic acid, 50 mg of vitamin B(6), and 1 mg of vitamin B(12) or matching placebo for 5 years. MEASUREMENT Prospectively diagnosed and confirmed symptomatic deep venous thrombosis or pulmonary embolism. RESULTS The geometric mean homocysteine level decreased by 2.2 micromol/L in the vitamin therapy group and increased by 0.80 micromol/L in the placebo group. Venous thromboembolism occurred in 88 participants during a mean follow-up of 5 years. The incidence rate of venous thromboembolism was the same in the vitamin therapy group and the placebo group (0.35 per 100 person-years; hazard ratio, 1.01 [95% CI, 0.66 to 1.53]). Vitamin therapy did not reduce the risk for deep venous thrombosis (hazard ratio, 1.04 [CI, 0.63 to 1.72]), pulmonary embolism (hazard ratio, 1.14 [CI, 0.57 to 2.28]), or unprovoked venous thromboembolism (hazard ratio, 1.21 [CI, 0.66 to 2.23]). LIMITATIONS The proportion of patients with a previous episode of venous thromboembolism at enrollment was not known, and venous thromboembolism events were not centrally adjudicated. CONCLUSION Decreasing homocysteine levels with folic acid and vitamins B6 and B12 did not reduce the risk for symptomatic venous thromboembolism.
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Current treatment of West syndrome in Japan.
Tsuji, T, Okumura, A, Ozawa, H, Ito, M, Watanabe, K
Journal of child neurology. 2007;(5):560-4
Abstract
About 10 years have passed since a previous survey on the treatment of West syndrome in Japan. To elucidate current practice, a questionnaire was sent to 113 institutes. It included (1) the drugs used for the treatment, (2) their dosage, and (3) the dosage and the schedule of adrenocorticotropic hormone therapy. Response rate was 51.3%. Adrenocorticotropic hormone, valproic acid, vitamin B(6), and zonisamide were frequently used. Vitamin B(6) was used most frequently as the first-choice drug followed by valproic acid, zonisamide, and adrenocorticotropic hormone. The most frequently used dose of synthetic adrenocorticotropic hormone-Z was 0.0125 mg/kg/d. Adrenocorticotropic hormone was administered every day for 2 weeks and then tapered off in more than 80% of the institutes. Although therapeutic strategy and drug usage have not changed largely during these 10 years, 2 alterations were observed: an increased use of zonisamide and a shortened duration of adrenocorticotropic hormone therapy.
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Rationale, design and baseline characteristics of a large, simple, randomized trial of combined folic acid and vitamins B6 and B12 in high-risk patients: the Heart Outcomes Prevention Evaluation (HOPE)-2 trial.
Lonn, E, Held, C, Arnold, JM, Probstfield, J, McQueen, M, Micks, M, Pogue, J, Sheridan, P, Bosch, J, Genest, J, et al
The Canadian journal of cardiology. 2006;(1):47-53
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Abstract
BACKGROUND Epidemiological studies suggest that mild to moderate elevation in plasma homocysteine concentration is associated with increased risk of atherothrombotic cardiovascular (CV) disease. Simple, inexpensive and nontoxic therapy with folic acid and vitamins B6 and B12 reduces plasma homocysteine levels by approximately 25% to 30% and may reduce CV events. Therefore, a large, randomized clinical trial--the Heart Outcomes Prevention Evaluation (HOPE)-2 study--is being conducted to evaluate this therapy in patients at high risk for CV events. OBJECTIVES To evaluate whether long-term therapy with folic acid and vitamins B6 and B12 reduces the risk of major CV events in a high-risk population. The primary study outcome is the composite of death from CV causes, myocardial infarction and stroke. METHODS A total of 5522 patients aged 55 years or older with pre-existing CV disease or with diabetes and additional risk factor(s) at 145 centres in 13 countries were randomly assigned to daily therapy with combined folic acid 2.5 mg, vitamin B6 50 mg and vitamin B12 1 mg, or to placebo. Follow-up will average five years, to be completed by the end of 2005. RESULTS The patients' baseline characteristics confirmed their high-risk status. Baseline homocysteine levels varied between countries and regions. HOPE-2 is one of the largest trials of folate and vitamins B6 and B12 and is expected to significantly contribute to the evaluation of the role of homocysteine lowering in CV prevention.
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Decrease of carotid intima-media thickness in patients at risk to cerebral ischemia after supplementation with folic acid, Vitamins B6 and B12.
Till, U, Röhl, P, Jentsch, A, Till, H, Müller, A, Bellstedt, K, Plonné, D, Fink, HS, Vollandt, R, Sliwka, U, et al
Atherosclerosis. 2005;(1):131-5
Abstract
OBJECTIVE Hyperhomocysteinemia is associated with atherosclerotic risk. Although vitamins can lower homocysteine (Hcy), information about effects on atherosclerosis is scarce. METHODS We used carotid intima-media thickness (IMT) as an accepted marker of atherosclerotic changes. Fifty patients (60 +/- 8 years) with IMT> or =1 mm were included. In a double blind, randomized trial they received daily 2.5 mg folic acid, 25 mg Vitamin B6, and 0.5mg Vitamin B12 or placebo for 1 year. RESULTS In the treatment group, Hcy decreased from 10.50 +/- 3.93 to 6.56 +/- 1.53 micromol/l (P < 0.0001), whereas it remained unchanged in the placebo group (10.76 +/- 2.36 versus 10.45+/-3.30 micromol/l). IMT decreased from 1.50 +/- 0.44 to 1.42 +/- 0.48 mm (P = 0.034) in the treatment group, whereas it increased from 1.47 +/- 0.57 to 1.54 +/- 0.71 mm in the placebo group. The mean individual changes of IMT between both groups differed significantly (-0.08 +/- 0.17 versus 0.07 +/- 0.25 mm, P = 0.019). Multiple regression analysis revealed that the observed effect on IMT depended only on medication. CONCLUSIONS Vitamin supplementation significantly reduces IMT in patients at risk. This effect is independent of Hcy concentration.
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Supplementation with vitamin C and/or vitamin B(6) in the prevention of Depo-Provera side effects in adolescents.
Harel, Z, Biro, F, Kollar, L, Riggs, S, Flanagan, P, Vaz, R
Journal of pediatric and adolescent gynecology. 2002;(3):153-8
Abstract
BACKGROUND/OBJECTIVES Depo-Provera-induced menstrual irregularity is believed to be secondary to relative estrogen deficiency. Weight gain associated with this contraceptive method is believed to be due to Depo-Provera's steroid-like appetite stimulation effect and to an altered tryptophan metabolism. We examined whether vitamin C, an important factor in uterine estrogen binding, and vitamin B(6), a glucocorticoid antagonist and an important coenzyme in the tryptophan-serotonin pathway, might alleviate menstrual irregularities and weight gain associated with Depo-Provera. METHODS Fifty-five adolescent girls (age 16 +/- 1 yr, gyn age 4 +/- 1 yr, body mass index 25.2 +/- 0.9) who decided to initiate Depo-Provera (150 mg intramuscularly every 3 months) were randomly assigned to one of four groups (group 1: vitamin B(6) 50 mg plus placebo pill/day; group 2: vitamin C 500 mg plus placebo pill/day; group 3: vitamin B(6) 50 mg plus vitamin C 500 mg/day; group 4 (control): 2 placebo pills/day) for 6 months. Participants were assessed by their care providers every 3 months. SETTING Two urban hospital-based adolescent clinics. RESULTS Number of days of bleeding during the first interval (first 3 months) as well as during the second interval (months 4-6) among groups 1, 2, and 3 did not differ statistically from days of bleeding in control group. There were no significant body mass index (BMI) changes among groups 1-3 (-0.15 +/- 0.18, 0.34 +/- 0.56, 0.01 +/- 0.31) compared with control (-0.38 +/- 0.38) during the first interval as well as during the second interval (0.68 +/- 0.37, -0.39 +/- 0.21, 0.45 +/- 0.32, compared with 0.28 +/- 0.43). When data from all 55 participants were collapsed, there was no significant change in BMI during the first 6 months of Depo-Provera use. About 48% at 3 months and 44% at 6 months were very or somewhat concerned about menstrual irregularity; 41% at 3 months and 18% at 6 months were very or somewhat concerned about weight changes. More than half (57%) at 3 months and 74% at 6 months reported less tampon/pad use, and 77% at 3 months and 78% at 6 months reported decreased menstrual cramps. Overall, 59% at 3 months and 70% at 6 months were very satisfied with Depo-Provera; 97% at 3 months and 96% at 6 months said that they would recommend Depo-Provera to a friend or a relative. CONCLUSIONS This study does not support a role for vitamin C in the prevention of Depo-Provera-induced menstrual irregularities or for vitamin B(6) in the prevention of weight changes associated with Depo-Provera. The unchanged BMI during the first 6 months of Depo-Provera use in the present study suggests that raising awareness and close follow-up may prevent weight gain among adolescent girls using this contraceptive method.