Clinically Significant Symptom Reduction in Children with Attention-Deficit/Hyperactivity Disorder Treated with Micronutrients: An Open-Label Reversal Design Study

被引:33
作者
Gordon, Heather A. [1 ]
Rucklidge, Julia J. [1 ]
Blampied, Neville M. [1 ]
Johnstone, Jeanette M. [2 ,3 ]
机构
[1] Univ Canterbury, Dept Psychol, Christchurch 8140, New Zealand
[2] Oregon Hlth & Sci Univ, Dept Neurol, Portland, OR 97201 USA
[3] Oregon Hlth & Sci Univ, Dept Psychiat, Portland, OR 97201 USA
关键词
DEFICIT HYPERACTIVITY DISORDER; DEPRESSION RATING-SCALE; GLOBAL ASSESSMENT SCALE; MENTAL-HEALTH; DOUBLE-BLIND; ADHD; MOOD; MINERALS; VITAMINS; PLACEBO;
D O I
10.1089/cap.2015.0105
中图分类号
R72 [儿科学];
学科分类号
100202 ;
摘要
Objective: The purpose of this study was to investigate the clinical effect and safety of a broad spectrum, 36 ingredient micronutrient (vitamins and minerals) in treating children with attention-deficit/hyperactivity disorder (ADHD). Methods: This open-label, on-off-on-off (reversal design) study followed 14 participants (8-12 years of age) with ADHD, diagnosed using standardized instruments, for 6 months with no dropouts. Following baseline assessment, including hematology and biochemistry screening, participants began an 8 week treatment phase with micronutrients titrated up to maximum dose (15 capsules/day). Treatment was withdrawn for 4 weeks, reinstated for a further 8 weeks, and then withdrawn for 4 weeks. Primary outcomes included the Conners' Parent Rating Scale, the Clinical Global Impressions Scale (CGI), and the Strengths and Difficulties Questionnaire - Parent version (SDQ). Secondary outcomes were mood and global functioning. Results: Modified Brinley plots revealed a reduction in ADHD symptoms, improved mood, and improved overall functioning during intervention phases, and deterioration in ADHD symptoms, mood, and overall functioning during the withdrawal phases. Reliable change analyses, Cohen's d and percent superiority effect sizes, 95% confidence intervals and t tests confirmed clinically and statistically significant change between the intervention and withdrawal phases, with large effect sizes observed pre- to post-exposure of micronutrients (d=1.2-2.2) on ADHD symptoms during intervention phases. Seventy-one percent of participants showed at least a 30% decrease in ADHD symptoms by the end of the second treatment phase, and 79% were identified as much improved or very much improved at the end of the second phase (5 months) based on the clinician-rated CGI when considering functioning generally. The SDQ showed that these benefits occurred across other areas of functioning including emotional symptoms, conduct problems, and prosocial behaviours. The children's self-reports confirmed the improvements. Excellent adherence to treatment occurred throughout, side effects were mild and transitory, and no safety issues were identified through blood analyses. Conclusions: This study demonstrates the clinical benefit, feasibility, and safety of broad-spectrum micronutrients in the treatment of childhood ADHD. Replications utilizing double-blind placebo-controlled studies are warranted. Trial is registered with the Australia and New Zealand Clinical Trial Registry: ACTRN12612000645853
引用
收藏
页码:783 / 798
页数:16
相关论文
共 82 条
[1]   What are the cognitive effects of stimulant medications? Emphasis on adults with attention-deficit/hyperactivity disorder (ADHD) [J].
Advokat, Claire .
NEUROSCIENCE AND BIOBEHAVIORAL REVIEWS, 2010, 34 (08) :1256-1266
[2]  
American Psychiatric Association, 2013, DIAGN STAT MAN MENT, DOI DOI 10.1176/APPI.BOOKS.9780890425596
[3]   Stimulants and the developing brain [J].
Andersen, SL .
TRENDS IN PHARMACOLOGICAL SCIENCES, 2005, 26 (05) :237-243
[4]  
[Anonymous], CNS DRUGS
[5]  
[Anonymous], 2013, SIGNIFICANCE TESTING
[6]  
[Anonymous], 1976, ECDEU ASSESSMENT MAN
[7]  
[Anonymous], J ATTEN DISORD
[8]  
[Anonymous], 2011, Understanding The New Statistics: Effect Sizes, Confidence Intervals, and Meta-Analysis, DOI DOI 10.4324/9780203807002
[9]  
[Anonymous], 2000, DIAGN STAT MAN MENT, DOI DOI 10.1176/APPI.BOOKS.9780890425787
[10]  
[Anonymous], BR J PSYCHIAT