Systematic review of safety and tolerability of a complex micronutrient formula used in mental health
Tóm tắt
Theoretically, consumption of complex, multinutrient formulations of vitamins and minerals should be safe, as most preparations contain primarily the nutrients that have been in the human diet for millennia, and at safe levels as defined by the Dietary Reference Intakes. However, the safety profile of commercial formulae may differ from foods because of the amounts and combinations of nutrients they contain. As these complex formulae are being studied and used clinically with increasing frequency, there is a need for direct evaluation of safety and tolerability. All known safety and tolerability data collected on one complex nutrient formula was compiled and evaluated. Data were assembled from all the known published and unpublished studies for the complex formula with the largest amount of published research in mental health. Biological safety data from 144 children and adults were available from six sources: there were no occurrences of clinically meaningful negative outcomes/effects or abnormal blood tests that could be attributed to toxicity. Adverse event (AE) information from 157 children and adults was available from six studies employing the current version of this formula, and only minor, transitory reports of headache and nausea emerged. Only one of the studies permitted a direct comparison between micronutrient treatment and medication: none of the 88 pediatric and adult participants had any clinically meaningful abnormal laboratory values, but tolerability data in the group treated with micronutrients revealed significantly fewer AEs and less weight gain. This compilation of safety and tolerability data is reassuring with respect to the broad spectrum approach that employs complex nutrient formulae as a primary treatment.
Tài liệu tham khảo
Barringer T, Kirk J, Santaniello A, Foley K, Michielutte R: Effect of a multivitamin and mineral supplement on infection and quality of life: A randomized, double-blind, placebo-controlled trial. Ann Intern Med. 2003, 138: 365-371.
Correa A, Botto L, Liu Y, Mulinare J, Erickson JD: Do multivitamin supplements attenuate the risk for diabetes-associated birth defects?. Pediatrics. 2003, 111 (5 Part 2): 1146-1151.
Ito TY, Trant AS, Polan ML: A double-blind placebo-controlled study of ArginMax, a nutritional supplement for enhancement of female sexual function. J Sex Marital Ther. 2001, 27 (5): 541-549. 10.1080/713846828.
Sato Y, Honda Y, Iwamoto J, Kanoko T, Satoh K: Effect of folate and mecobalamin on hip fractures in patients with stroke: A randomized controlled trial. JAMA. 2005, 293 (9): 1082-1088. 10.1001/jama.293.9.1082.
Mitchell BL, Ulrich CM, McTiernan A: Supplementation with vitamins or minerals and immune function: can the elderly benefit?. Nutr Res. 2003, 23: 1117-1139. 10.1016/S0271-5317(02)00545-6.
Gariballa S, Forster S, Walters S, Powers H: A randomized, double-blind, placebo-controlled trial of nutritional supplementation during acute illness. Am J Med. 2006, 119 (8): 693-699. 10.1016/j.amjmed.2005.12.006.
Remington R, Chan A, Paskavitz J, Shea TB: Efficacy of a vitamin/nutriceutical formulation for moderate-stage to later-stage Alzheimer's disease: a placebo-controlled pilot study. Am J Alzheimers Dis Other Demen. 2009, 24 (1): 27-33. 10.1177/1533317508325094.
Chan A, Paskavitz J, Remington R, Rasmussen S, Shea T: Efficacy of a vitamin/nutriceutical formulation for early-stage Alzheimer's Disease: A 1-year, open-label pilot study with a 16-month caregiver extension. Am J Alzheimers Dis Other Demen. 2009, 23 (6): 571-585. 10.1177/1533317508325093.
Schoenthaler S, Amos S, Doraz W, Kelly MA, Muedeking G, Wakefield J: The effect of randomized vitamin-mineral supplementation on violent and non-violent antisocial behavior among incarcerated juveniles. J Nutr Environ Med. 1997, 7 (4): 343-352. 10.1080/13590849762475.
Schoenthaler SJ, Bier ID: The effect of vitamin-mineral supplementation on juvenile delinquency among American schoolchildren: A randomized, double-blind placebo-controlled trial. J Altern Complement Medicine. 2000, 6: 7-17. 10.1089/acm.2000.6.7.
Gesch CB, Hammon SM, Hampson SE, Eves A, Crowder MJ: Influence of supplementary vitamins, minerals and essential fatty acids on the antisocial behaviour of young adult prisoners. Br J Psychiatry. 2002, 181: 22-28. 10.1192/bjp.181.1.22.
Zaalberg A, Nijman H, Bulten E, Stroosma L, van der Staak C: Effects of nutritional supplements on aggression, rule-breaking, and psychopathology among young adult prisoners. Aggressive Behav. 2010, 36: 117-126. 10.1002/ab.20335.
Gariballa S, Forster S: Effects of dietary supplements on depressive symptoms in older patients: a randomised double-blind placebo-controlled trial. Clin Nutr. 2007, 26 (5): 545-551. 10.1016/j.clnu.2007.06.007.
Schlebusch L, Bosch BA, Polglase G, Kleinschmidt I, Pillay BJ, Cassimjee MH: A double-blind, placebo-controlled, double-centre study of the effects of an oral multivitamin-mineral combination on stress. S Afr Med J. 2000, 90 (12): 1216-1223.
Carroll D, Ring C, Suter M, Willemsen G: The effects of an oral multivitamin combination with calcium, magnesium, and zinc on psychological well-being in healthy young male volunteers: a double-blind placebo-controlled trial. Psychopharmacology (Berl). 2000, 150 (2): 220-225. 10.1007/s002130000406.
Benton D: The impact of diet on anti-social, violent and criminal behaviour. Neurosci Biobehav Rev. 2007, 31 (5): 752-774. 10.1016/j.neubiorev.2007.02.002.
Mehl-Madrona L, Leung B, Kennedy C, Paul S, Kaplan BJ: Micronutrients versus standard medication management in autism: A naturalistic case-control study. J Child Adolesc Psychopharm. 2010, 20 (2): 95-103. 10.1089/cap.2009.0011.
Rucklidge JJ, Gately D, Kaplan BJ: Database analysis of children and adolescents with bipolar disorder consuming a micronutrient formula. BMC Psychiatry. 2010, 10: 74-10.1186/1471-244X-10-74.
Gately D, Kaplan BJ: Database analysis of adults with bipolar disorder consuming a micronutrient formula. Clinical Medicine: Psychiatry. 2009, 4: 3-16.
Kaplan BJ, Fisher JE, Crawford SG, Field CJ, Kolb B: Improved mood and behavior during treatment with a mineral-vitamin supplement: an open-label case series of children. J Child Adolesc Psychopharmacol. 2004, 14 (1): 115-122. 10.1089/104454604773840553.
Kaplan BJ, Crawford SG, Gardner B, Farrelly G: Treatment of mood lability and explosive rage with minerals and vitamins: two case studies in children. J Child Adolesc Psychopharmacol. 2002, 12 (3): 205-219. 10.1089/104454602760386897.
Kaplan BJ, Simpson JS, Ferre RC, Gorman CP, McMullen DM, Crawford SG: Effective mood stabilization with a chelated mineral supplement: an open-label trial in bipolar disorder. J Clin Psychiatry. 2001, 62 (12): 936-944. 10.4088/JCP.v62n1204.
Popper CW: Do vitamins or minerals (apart from lithium) have mood-stabilizing effects?. J Clin Psychiatry. 2001, 62 (12): 933-935. 10.4088/JCP.v62n1203.
Simmons M: Nutritional approach to bipolar disorder. J Clin Psychiatry. 2003, 64 (3): 338-10.4088/JCP.v64n0317d. author reply 338-9
Frazier EA, Fristad MA, Arnold LE: Multinutrient supplement as treatment: literature review and case report of a 12-year-old boy with bipolar disorder. J Child Adolesc Psychopharmacol. 2009, 19 (4): 453-460. 10.1089/cap.2008.0157.
Rucklidge J, Taylor M, Whitehead K: Effect of micronutrients on behavior and mood in adults with ADHD: Evidence from an 8-week open label trial with natural extension. J Atten Disord. 2010
Rucklidge JJ, Harrison R: Successful Treatment of Bipolar Disorder II and ADHD with a Micronutrient Formula: A Case Study. CNS Spectr. 2010, 15 (5): 289-295.
Rucklidge JJ: Successful treatment of OCD with a micronutrient formula following partial response to Cognitive Behavioral Therapy (CBT): a case study. J Anxiety Disord. 2009, 23 (6): 836-840. 10.1016/j.janxdis.2009.02.012.
Marks J: The safety of the vitamins: an overview. Int J Vitam Nutr Res Suppl. 1989, 30: 12-20.
Sarris J, Kavanagh DJ, Byrne G: Adjuvant use of nutritional and herbal medicines with antidepressants, mood stabilizers and benzodiazepines. J Psychiatr Res. 2010, 44 (1): 32-41. 10.1016/j.jpsychires.2009.06.003.
The pre-publication history for this paper can be accessed here:http://www.biomedcentral.com/1471-244X/11/62/prepub