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Medical Studies

EMPowerplus Q96

Depending on how this line of research develops, clinicians and researchers may need to rethink the traditional bias against nutritional supplementation as a potential treatment for major psychiatric disorders.

Do Vitamins or Mineral (Apart From Lithium) Have Mood-Stabilizing Effects?, Journal of Clinical Psychiatry, December 2001, Dr. Charles W. Popper, M.D., Department of Psychiatry, Harvard Medical School, McLean Hospital

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There is more published and ongoing research on this formula for mental health than on any other complex formula anywhere in the world.

Systematic review of safety and tolerability of a complex micronutrient formula used in mental health, BMC Psychiatry, Simpson JS, Crawford SG, Goldstein ET, Field C, Burgess E, Kaplan BJ, 2011 April 18

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It appears that nutritional supplementation may exert a stabilizing effect on mood, temper, and anxiety in a manner that is relatively independent of diagnostic category.

Improved Mood and Behavior During Treatment with a Mineral-Vitamin Supplement: An Open-Label Case Series of Children, Journal of Child and Adolescent Psychopharmacology, Kaplan BJ, Fisher JE, Crawford SG, Field CJ, Kolb B, Spring 2004

EMPowerplus Q96 from Q Sciences been examined in a variety of human conditions. The formulation holds the distinction of being the most researched micronutrient formula of its kind in the world.

26 published studies, including a double-blind placebo-controlled trial, have demonstrated both safety and effectiveness. In all, 44 researchers and 15 universities from 4 countries have participated in the research studies. All research was conducted and funded independently. These studies were completed under multiple labels, all of which are the EMPowerplus Q96 formulation.

The Journal of Alternative and Complementary MedicineJulia J. Rucklidge, PhD, Rachel Harrison, BA, and Jeanette Johnstone, MA The Journal of Alternative and Complementary Medicine. December 2011, 17(12) 2011, pp. 1125-1131  Read Full Study

Abstract
Objectives: Little research has investigated how micronutrients (minerals and vitamins) affect cognitive functioning, despite preliminary studies showing they may improve psychiatric functioning.

Intervention: This pilot study investigated the impact of a 36-ingredient micronutrient formula consisting mainly of vitamins and minerals on neurocognitive functioning in 14 adults with attention-deficit/hyperactivity disorder (ADHD) and severe mood dysregulation.

Design: The formula was consumed in an open-label trial over an 8-week period.

Outcome measures: The participants completed tests of memory (Wide Range Assessment of Memory and Learning) and executive functioning (Delis-Kaplan Executive Functioning System and Conners Continuous Performance Test) at baseline and at the end of the trial. A gender- and age-matched control group of 14 non-ADHD adults not taking the formula were assessed on the same tests 8 weeks apart in order to investigate the impact of practice on the results.

Results: There were no group differences in ethnicity, socio-economic status and estimated IQ. Significant improvement was observed in the ADHD group, but not the control group, across a range of verbal abilities including verbal learning, verbal cognitive flexibility and fluency, and verbal inhibition. These neurocognitive improvements were large and consistent with improved psychiatric functioning. No changes were noted above a practice effect in visual–spatial memory and there were no improvements noted in reaction time, working memory, or rapid naming for either groups.

CONCLUSIONS: Although the pilot and open-label design of the study limits the generalizability of the results, it supports a growing body of literature recognizing the importance of nutrients for mental health and cognition. The results also provide evidence supporting the need for randomized clinical trials of micronutrients as well as other experimental studies in order to better assess whether improved neurocognitive functioning may contribute to improved psychiatric symptoms.

New Zealand Journal of Pshycolgy

Julia J. Rucklidge and Neville M. Blampied.  New Zealand Journal of Psychology. Volume 40, No. 4, 2011, Pages 51-57, ISSN: 1179-7924 Read Full Study

Abstract

The September, 2010, 7.1 magnitude earthquake in Christchurch, New Zealand, provided an opportunity to study the after-effects of a major earthquake where death and injury were absent. It created a natural experiment into the protective effects on well-being of taking EMPowerplus (EMP+), a micronutrient supplement, in a group of 33 adults diagnosed with ADHD who had been assessed prior to the earthquake. Fortuitously, 16 were currently taking the supplement as part of on-going research at the time of the quake, while 17 were not (they had completed their trial of EMP+ or were waiting to begin consumption). The Depression Anxiety and Stress Scale (DASS-42) which had been administered at varying times before the earthquake on recruitment into the micronutrient study was re-administered by telephone 7-10 and again 14-18 days post-earthquake to volunteer, earthquake-exposed participants. A modified Brinley plot analysis of the individual DASS-42 scores showed that the 16 participants on the nutritional supplement were more resilient to the effects of the earthquake than the 17 individuals not taking the supplement. This effect was particularly marked for Depression scores.

Psychiatry-Research

Julia Rucklidge, Jeanette Johnstone, Rachel Harrison, and Anna Boggis.  Psychiatry Research. Volume 189, Issue 2, Pages 281-287, 30 Read Full Study

Abstract

The role of good nutrition for resilience in the face of stress is a topic of interest, but difficult to study. A 7.1 earthquake took place in the midst of research on a micronutrient treatment for Attention-Deficit/Hyperactivity Disorder (ADHD), providing a unique opportunity to examine whether individuals with ADHD taking micronutrients demonstrated more emotional resilience post-earthquake than individuals with ADHD not taking micronutrients. Thirty-three adults with ADHD were assessed twice following the earthquake using a measure of depression, anxiety and stress also completed at some point pre-earthquake (baseline). Seventeen were not taking micronutrients at the time of the earthquake (control group), 16 were (micronutrient group). While there were no between-group differences one week post-quake (Time 1), at two weeks post-quake (Time 2), the micronutrient group reported significantly less anxiety and stress than the controls (effect size 0.69). These between group differences could not be explained by other variables, such as pre-earthquake measures of emotions, demographics, psychiatric status, and personal loss or damage following the earthquake. The results suggest that micronutrients may increase resilience to ongoing stress and anxiety associated with a highly stressful event in individuals with ADHD and are consistent with controlled studies showing benefit of micronutrients for mental health.

Human-Psychopharm

Julia J Rucklidge1, Rebecca Andridge, Brigette Gorman, Neville Blampied, Heather Gordon, and Anna Boggis.  Human Psychopharmacol Clin Exp. 2012; 27: 440–454. Read Full Study

Abstract

Objective: To compare two micronutrient (vitamins and minerals) formulas (Berocca™ and CNE™) and assess their impact on emotions
and stress related to the 6.3 earthquake on February 22nd 2011 in Christchurch, New Zealand.

Methods: 91 adults experiencing heightened anxiety or stress 2–3 months following the earthquake were randomized to Berocca™, CNE™ low dose (CNE4), or CNE™ high dose (CNE8), for 28 days and monitored weekly via on-line questionnaires and followed 1 month post-trial. A nonrandomized control group (n = 25) completed questionnaires at baseline and 4 weeks.

Results: All treatment groups experienced significant declines in psychological symptoms (p<.001). CNE™ groups experienced greater reduction in intrusive thoughts as compared with Berocca™ (p = .05), with no group differences on other measures of psychological symptoms. However, CNE8 group reported greater improvement in mood, anxiety, and energy (p<.05) with twice as many reporting being “much” to “very much” improved and five times more likely to continue taking CNE™post-trial than Berocca™group. Treated participants had better outcomes on most measures over 4 weeks as compared to controls.

Conclusions: This study supports micronutrients as an inexpensive and practical treatment for acute stress following a natural disaster with a slight advantage to higher doses ACTRN 12611000460909. Copyright © 2012 John Wiley & Sons, Ltd.

Human-Psychopharm

Julia J Rucklidge, Neville Blampied, Bridgette Gorman, Heather A. Gordan, and Ellen Sole. Human Psychopharmacol Clin Exp. May 2014, Volume 39, Issue 3, 230-243. Read Full Study

Abstract

OBJECTIVE: We investigated whether micronutrients given acutely following the Christchurch earthquakes continued to confer benefit 1 year following the treatment.

METHODS: Sixty-four adults from the original 91 participants experiencing heightened anxiety or stress 2-3 months following the 22nd February 2011 earthquake and who had been randomized to receive three different doses of micronutrients completed on-line questionnaires assessing mood, anxiety, stress, and symptoms associated with post-traumatic stress disorder 1 year after completing the initial study. Twenty-one out of 29 nonrandomized controls who did not receive the treatment also completed the questionnaires.

RESULTS: Both the treated and control groups experienced significant improvement in psychological functioning compared with end-of-trial. However, treated participants had better long-term outcomes on most measures compared with controls (ES=0.69-1.31). Those who stayed on micronutrients through to follow-up or stopped all treatment reported better psychological functioning than those who switched to other treatments including medications. About 10% of the sample continued to have post-traumatic stress disorder symptoms.

CONCLUSIONS: Disaster survivors improve psychologically over time regardless of receiving intervention; however, those taking micronutrients during the acute phase following a disaster show better outcomes, identifying micronutrients as a viable treatment for acute stress following a natural disaster with maintenance of benefits 1 year later.

CNS Spectums

Julia J. Rucklidge, PhD and Rachel Harrison, BA.  CNS Spectrums. 2010 May;15(5):289-95.  Read Full Study

Abstract
Bipolar disorder with co-occurring attention-deficit/hyperactivity disorder (ADHD) is a challenge to treat. Ten previous reports have shown potential benefit of a micronutrient treatment (consisting mainly of vitamins and minerals) for various psychiatric symptoms, including mood and ADHD. This case study aimed to investigate the longer term impact of the micronutrients on both psychiatric and neurocognitive functioning in an off-on-off-on (ABAB) design with 1 year follow-up. A 21-year-old female with bipolar II disorder, ADHD, social anxiety, and panic disorder entered an open-label trial using a nutritional treatment following a documented 8 year history of on-going psychiatric symptoms not well managed by medications. After 8 weeks on the formula she showed significant improvements in mood, anxiety, and hyperactivity/impulsivity. Blood test results remained normal after 8 weeks on the formula. She did not report any adverse side effects associated with the treatment. She then chose to come off the formula; after 8 weeks her depression scores returned to baseline, and anxiety and ADHD symptoms worsened. The formula was reintroduced, showing gradual improvement in all psychiatric symptoms. This case represents a naturalistic ABAB design showing on-off control of symptoms. After 1 year, the patient is now in remission from all mental illness. Neurocognitive changes mirrored behavioral changes, showing improved processing speed, consistency in response speed, and verbal memory. A placebo response and expectancy effects cannot be ruled out although previous poor response to treatment and the duration of the current positive response decrease the likelihood that other factors better explain change. These consistently positive outcomes alongside an absence of side effects indicate that further research, particularly larger and more controlled trials, is warranted using this multinutrient approach.

Journal of Attention Disorders

Julia Rucklidge, Mairin Taylor, and Kathryn Whitehead.  Journal of Attention Disorders. 2011 Jan;15(1):79-91 Read Full Study

Abstract
OBJECTIVE: To investigate the impact of a 36-ingredient micronutrient formula consisting mainly of minerals and vitamins in the treatment of adults with both Attention-deficit/hyperactivity Disorder (ADHD) and severe mood dysregulation (SMD).

METHOD: 14 medication-free adults (9 men, 5 women; 18-55 years) with ADHD and SMD completed an 8-week open-label trial.

RESULTS: A minority reported transitory mild side effects. Significant improvements were noted across informants (self, observer, clinician) on measures of inattention and hyperactivity/impulsivity, mood, quality of life, anxiety, and stress all with medium to very large effect sizes (all ps < .01); however, the mean of inattention remained in a clinical range whereas the means on measures of mood and hyperactivity/impulsivity were normalized. Follow-up data showed maintenance of changes or further improvement for those who stayed on the micronutrients.

CONCLUSIONS: Although this study, as an open trial, does not in itself prove efficacy, it provides preliminary evidence supporting the need for a randomized clinical trial of micronutrients as treatment for the more complex presentations of ADHD.

Progress in Neuro-Psychopharmacology and Biological Psychiatry

Julia J. Rucklidge, Jeanette Johnstone, Brigette Gorman, Anna Boggis, and Christopher M. Frampton.  Progress in Neuro-Psychopharmacology and Biological Psychiatry. Volume 50, 3 April 2014, Pages 163-171.  Read Full Study

Abstract
Background: To date there has been no research investigating moderators of response to micronutrient treatment of mental illness, specifically baseline nutrient levels.

Method: We conducted analyses of data from a randomized placebo-controlled trial (RCT) of 80 adults (≥16 years) with Attention-Deficit/Hyperactivity Disorder (ADHD), whereby participants were treated acutely (8 weeks) with micronutrients or placebo followed by an open-label (OL) phase of 8 weeks whereby all participants received micronutrients. To ensure that all participants had been exposed to the micronutrients for 8 weeks, only those 64 who had adhered to the treatment protocol and completed 8 weeks on nutrients were included in the data analysis: 34 from the group that had been randomized to the micronutrient arm, and 30 from the group that had been randomized to the placebo group and hence had only received nutrients in the OL phase. Six outcomes were examined: change in ADHD symptoms (self/clinician), ADHD responder, Clinical Global Impression-Improvement (CGI-I), change in mood, and change in Global Assessment of Functioning (GAF). Demographic, developmental and psychiatric history, current clinical characteristics, and baseline nutrient levels were all considered as putative predictors.

Results: There were significant changes in all outcome variables after 8 weeks exposure to the micronutrients. Among the nutrients recorded at baseline, substantial deficiencies (27%) were only observed for vitamin D. However, other than an association showing that higher iron at baseline was correlated with higher baseline depression scores, baseline nutrient levels were not correlated with baseline psychiatric variables/current clinical characteristics. Regression analyses revealed that higher baseline ferritin and lower baseline copper and vitamin D levels were associated with a better response to treatment for some but not all outcomes. None of the other nutrient levels was found to be associated with outcome, including zinc, vitamin B12, iron, and folate. There were no childhood risk factors, demographic variables or clinical correlates that contraindicated micronutrient treatment; more severe symptoms at baseline and greater number of developmental risk factors predicted greater treatment response.

Conclusions: Further research looking at nutrients more broadly is required to confirm these initial observations about ferritin, vitamin D and copper; however, the results suggest that serum nutrient levels have limited value for identifying who will respond to treatment.

British Journal of Psychiatry

Julia J. Rucklidge, Chris M. Frampton, Brigette Gorman, and Anna Boggis.  British Journal of Psychiatry. 2014; 204:306-15.  Read Full Study

Abstract
Background: The role of nutrition in the treatment of attention-deficit hyperactivity disorder (ADHD) is gaining international attention; however, treatments have generally focused only on diet restriction or supplementing with one nutrient at a time.

Aims: To investigate the efficacy and safety of a broad-based micronutrient formula consisting mainly of vitamins and minerals, without omega fatty acids, in the treatment of ADHD in adults.

Method: This double-blind randomised controlled trial assigned 80 adults with ADHD in a 1:1 ratio to either micronutrients (n = 42) or placebo (n = 38) for 8 weeks (trial registered with the Australian New Zealand Clinical Trials Registry: ACTRN12609000308291).

Results: Intent-to-treat analyses showed significant between-group differences favouring active treatment on self- and observer- but not clinician-ADHD rating scales. However, clinicians rated those receiving micronutrients as more improved than those on placebo both globally and on ADHD symptoms. Post hoc analyses showed that for those with moderate/severe depression at baseline, there was a greater change in mood favouring active treatment over placebo. There were no group differences in adverse events.

Conclusions: This study provides preliminary evidence of efficacy for micronutrients in the treatment of ADHD symptoms in adults, with a reassuring safety profile.

Journal of Clinical Psychiatry

Miles Simmons, M.D.  Journal of Clinical Psychiatry. 2003 Mar;64(3):338.  Read Full Study

Abstract
In a letter to the editor of the Journal of Clinical Psychiatry, Dr. Miles Simmons, a psychiatrist in private practice in Brunswick, Maine, reported his clinical experience with EMPowerplus. Impressed by the striking response of one of his patients to EMPowerplus, Dr. Simmons carefully monitored treatment-resistant patients from his private practice who were willing to try this nutritional approach.

RESULTS: Of 19 patients that met the DSM-IV criteria for bipolar disorder (14 bipolar I and 5 bipolar II), Dr. Simmons observed that “12 of the 19 patients showed marked clinical improvement, 3 showed moderate improvement, and 1 showed mild improvement” (84% positive response rate). Of 16 medicated patients (who were taking 2.7 psychiatric medications on average) 13 were able to completely discontinue their psychiatric medications (over an average of 5.2 weeks) had remained stable on EMPowerplus alone for an average of 13 months.

Journal of Child and Adolescent Psychopharmacology

Bonnie J. Kaplan, Ph.D., Susan G. Crawford, M.Sc.,
Beryl Gardner, M.D., and Geraldine Farrelly, M.D. 
Journal of Child and Adolescent Psychopharmacology. 2002 Fall;12(3):205-19.  Read Full Study

Abstract
A group of scientists at the University of Calgary and the Alberta Children’s Hospital reported the effects of EMPowerplus on 2 medication-free boys with explosive rage and mood disorders (atypical obsessive-compulsive disorder and pervasive developmental delay), using an ABAB (off-on-off-on) study design.

Results: In both cases, symptoms increased when the micronutrient supplement was withdrawn and improved when the supplement was introduced. When taking the supplement, the boys had fewer emotional outbursts, fewer anxious and obsessional thoughts, more positive mood, and better temper control. Improvements were noted on the Conners Parent Rating Scale (CPRS) mood and temper symptoms, Children’s Version Yale-Brown Obsessive-Compulsive Scale (CY-BOCS) obsessive-compulsive symptoms, and Child Behavior Checklist (CBCL) symptoms of aggressive, delinquent, and anxious/depressed behavior, as well as social and attention problems. Neither boy experienced any adverse effects from taking an adult dose of the nutritional supplement. At the time of publication, both boys had been stable on the nutritional supplement for over 2 years.

Journal of Clinical Psychiatry

Charles W. Popper, M.D.  Journal of Clinical Psychiatry. 2001 Dec;62(12):933-5.  Read Full Study

Abstract
Dr. Charles Popper, psychopharmacologist and psychiatrist at Harvard University’s McLean Hospital, published a commentary on the Kaplan et al. (2001) paper, in which he reported the results of his clinical experience with EMPowerplus.

Results: Of 22 patients (10 adults, 9 adolescents, 3 pre-adolescents) who clinically met criteria for bipolar disorder, 19 (86%) showed a positive response to the micronutrient treatment. Of 15 patients taking medications, 11 (73%) were able to gradually withdraw from their medications, and were stable taking the micronutrient treatment alone.

Journal of Clinical Psychiatry

Bonnie J. Kaplan, Ph.D; J/ Steven A. Simpson, Ph.D., M.D.; Richard C. Ferre, M.D.; Chris P. Gorman, M.D.; David M. McMullen, M.D.; and Susan G. Crawford, M.Sc.  Journal of Clinical Psychiatry. 2001 Dec;62(12):936-44.  Read Full Study

Abstract
A group of scientists at the University of Calgary and the Alberta Children’s Hospital conducted a study to determine the therapeutic benefit of EMPowerplus™ on 14 unselected adult bipolar patients who had taken psychotropic medications for an average of 6.7 years. Patients were assessed by their own psychiatrists with the Hamilton Rating Scale for Depression (HAM-D), the Brief Psychiatric Rating Scale (BPRS), and the Young Mania Rating Scale (YMRS).

RESULTS: For the 11 patients who completed the minimum 6-month open trial, average symptom reduction was 55% on the HAM-D, 60% on the BPRS, and 66% on the YMRS. The effect size for the intervention was large (>.8) for each measure. The number of psychotropic medications decreased significantly from an average of 2.7 to 1.0. In some cases, the micronutrient treatment replaced psychotropic medications and the patients remained stable. The only reported side effect (i.e., nausea) was infrequent, minor, and transitory.

Journal of Child and Adolescent Psychopharmacology

Elisabeth A. Frazier, B.S., Mary A. Fristad, Ph.D., ABPP, and L. Eugene Arnold, M.D., M.Ed.  Journal of Child and Adolescent Psychopharmacology. 2009 Aug;19(4):453-60.  Read Full Study

Abstract
Early-onset bipolar disorder has significant morbidity and mortality. Development of safe, effective treatments to which patients will adhere is critical. Pharmacologic interventions for childhood bipolar spectrum disorders are limited and are associated with significant risk for adverse events (Kowatch et al 2005). Diet and nutrition research suggests vitamins, minerals, and other nutrients are important underpinnings of general physical and mental health; further, they may even be useful in treating mood dysregulation by providing a more favorable risk-benefit ratio than contemporary psychotropic agents (Kaplan, Crawford, Field, & Simpson 2007). This article reviews the literature on multinutrient supplementation and mental health, and examines a case study of a 12-year-old boy with bipolar disorder and comorbid diagnoses treated for 6 years with conventional medication and finally a multinutrient supplement.

The multinutrient supplement in this case study is EMPowerplus (EMP+), a 36-ingredient supplement containing sixteen minerals, fourteen vitamins, three amino acids and three antioxidants. It was used to treat a 12-year-old boy initially diagnosed with bipolar disorder-not otherwise specified (BP-NOS) at age 6, whose diagnosis evolved by age 10 to bipolar I (BP-I), mixed, with psychotic features. He also met criteria for generalized anxiety disorder by age 8 and obsessive-compulsive disorder by age 10. After six years of conventional treatment (ages 6-12), he received fourteen months of EMP+. Symptom manifestation over seven years is described in conjunction with treatment history. EMP+ resulted in superior outcome to conventional treatment.

Clinical Medicine Insights: Psychiatry

Dermot Gately and Bonnie J. Kaplan.  Clinical Medicine Insights: Psychiatry. 2009 Apr;4:3-16. (2009).  Read Full Study

Abstract
Background: Bipolar disorder is a lifelong problem with imperfect available treatments. Recent research has shown potential benefit of nutritional treatment for mood symptoms. The goal of the current study was to determine whether adults with bipolar disorder reported treatment benefit from consuming a micronutrient formula.

Methods: Self-report data were available from 682 adults who reported a diagnosis of bipolar disorder; 81% were taking psychiatric medications. Those reporting additional diagnoses were excluded, as well as those who provided data <60 times during 180 days of using the micronutrients, leaving 358 for analysis.

Results: Mean symptom severity was 41% lower than baseline after 3 months (effect size = 0.78), and 45% lower after 6 months (effect size = 0.76) (both paired t-tests significant, p<0.001). In terms of responder status, 53% experienced >=50% improvement at 6 months. Half the sample were taking medications approved for bipolar disorder (lithium, anticonvulsants, atypical antipsychotics), and half were either medication-free or taking other medications: the magnitude of treatment benefit did not differ between these two groups. Regression analyses indicated that decreased symptom severity over the 6 months was associated with increasing micronutrient dosage and with reducing medication. Symptom improvements were significant and sustained at 6 months, suggesting that benefits were not attributable to placebo/expectancy effects.

Conclusions: Further research on this micronutrient formula is warranted.

Journal of Child and Adolescent Psychopharmacology

Elisabeth A. Frazier, PhD, Barbara Gracious, PhD, L. Eugene Arnold, MD, MEd, Mark Failla, PhD, Chureeporn Chitchumroonchokchai, PhD, Diane Habash, PhD, RD, LD, and Mary A. Fristad, PhD, ABPP. Journal of Child and Adolescent Psychopharmacology. 2003 23(8):558-567. Read Full Study

Abstract
Objective: The purpose of this study was to report the safety, tolerability, and serum micronutrient concentrations and their correlations with mood changes from an 8 week pilot feasibility study of a 36 ingredient multinutrient supplement, EMPowerplus (EMP+), for pediatric bipolar spectrum disorders (BPSD).

Methods: Ten children ages 6–12 received EMP + escalating from one to four capsules t.i.d., with four children increased to the maximum suggested dose, five capsules t.i.d. Outcome measures were micronutrient concentrations in serum and red blood cells, vital signs, body mass index (BMI), dietary intake (Food Frequency Questionnaire and 24 hour dietary recall interview), and mood and global functioning ratings.

Results: Seven children (70%) completed the study. Three (30%) terminated early for tolerability and compliance issues. Adverse effects were mild and transient, and chiefly consisted of initial insomnia or gastrointestinal (GI) upset. No differences occurred in BMI ( p = 0.310) or waist–hip ratio (WHR; p = 0.674) pre- to postsupplementation. Four of the tested serum vitamin concentrations increased from pre- to postsupplementation: vitamin A-retinol, vitamin B6, vitamin E-a-tocopherol; and folate (all p < 0.05). The increase in serum 25-OH vitamin D approached significance ( p = 0.063). No differences were found in dietary intake pre- to postsupplementation, suggesting that blood nutrient level increases were caused by EMP+.

Conclusions: In this open prospective study, short-term use of EMP + in children with BPSD appeared safe and well tolerated, with a side effect profile preferable to first-line psychotropic drugs for pediatric bipolar spectrum disorders. A double-blind, randomized clinical trial is feasible, appears safe, and is warranted by open-label clinical outcomes and plausible mechanisms of action, combined with documentation of increased serum concentrations of specific micronutrients.

The Journal of Alternative and Complementary Medicine

Elisabeth A. Frazier, MA, Mary A. Fristad, PhD, ABPP, and L. Eugene Arnold, MD, MEd. The Journal of Alternative and Complementary Medicine. July 2012, 18(7): 678-685. Read Full Study

Abstract
Objectives: Current psychotropic medications for childhood bipolar spectrum disorders (BPSD) are associated with significant adverse events. As nutrients play an important role in physical and mental health, they may be useful in treating mood disorders with few side-effects. This open-label study explored the feasibility of testing therapeutic effects of a multinutrient supplement, EMPowerplus! (EMP + ), for pediatric BPSD.

Design: EMP + was started at one capsule t.i.d. and escalated to a goal of four capsules t.i.d., which eight children attained. Four (4) of these increased to the maximum dose, five capsules t.i.d. Mood symptoms were assessed seven times over 8 weeks.

Subjects: Ten (10) children, age 6–12 with BPSD, were enrolled in 6.5 months. Seven (7) participants completed the full trial. Three (3) dropped out due to palatability and/or adherence issues.

Results: Mean medication adherence was 91%. With one-tailed nonparametric Fisher’s randomization tests, intent-to-treat analyses demonstrated a 37% decrease in depression scores ( p<0.06) and a 45% decrease in mania scores ( p<0.01) from the start of treatment through final visit, suggesting improvement and possible treatment response. Study completers demonstrated significant decreasing trends in both depression and mania scores from baseline to final visit ( p<0.05). Side-effects were minor and transient, mostly temporary gastric discomfort.

Conclusions: Future randomized, placebo-controlled trials of EMP + are warranted and feasible.

BMC Psychiatry

Julia J Rucklidge1, Dermot Gately, and Bonnie J Kaplan. BMC Psychiatry. 2010 Sep 28;10:74. Read Full Study

Abstract
Background: Eleven previous reports have shown potential benefit of a 36-ingredient micronutrient formula (known as EMPowerplus™) for the treatment of psychiatric symptoms. The current study asked whether children (7-18 years) with pediatric bipolar disorder (PBD) benefited from this same micronutrient formula; the impact of Attention-Deficit/Hyperactivity Disorder (ADHD) on their response was also evaluated.

Methods: Data were available from an existing database for 120 children whose parents reported a diagnosis of PBD; 79% were taking psychiatric medications that are used to treat mood disorders; 24% were also reported as ADHD. Using Last Observation Carried Forward (LOCF), data were analyzed from 3 to 6 months of micronutrient use.

Results: At LOCF, mean symptom severity of bipolar symptoms was 46% lower than baseline (effect size (ES) = 0.78) (p < 0.001). In terms of responder status, 46% experienced >50% improvement at LOCF, with 38% still taking psychiatric medication (52% drop from baseline) but at much lower levels (74% reduction in number of medications being used from baseline). The results were similar for those with both ADHD and PBD: a 43% decline in PBD symptoms (ES = 0.72) and 40% in ADHD symptoms (ES = 0.62). An alternative sample of children with just ADHD symptoms (n = 41) showed a 47% reduction in symptoms from baseline to LOCF (ES = 1.04). The duration of reductions in symptom severity suggests that benefits were not attributable to placebo/expectancy effects. Similar findings were found for younger and older children and for both sexes.

Conclusions: The data are limited by the open label nature of the study, the lack of a control group, and the inherent self-selection bias. While these data cannot establish efficacy, the results are consistent with a growing body of research suggesting that micronutrients appear to have therapeutic benefit for children with PBD with or without ADHD in the absence of significant side effects and may allow for a reduction in psychiatric medications while improving symptoms. The consistent reporting of positive changes across multiple sites and countries are substantial enough to warrant a call for randomized clinical trials using micronutrients.

Journal of Child and Adolescent Psychopharmacology

Lewis Mehl-Madrona, M.D., Ph.D., M.Phil., Brenda Leung, N.D., M.Sc., Ph.D. (cand.), Carla Kennedy, M.A., Sarah Paul, and Bonnie J. Kaplan, Ph.D.  Journal of Child and Adolescent Psychopharmacology. 2010 Apr;20(2):95-103 Read Full Study

Abstract
Autism spectrum disorder (ASD) is often accompanied by self-injurious behavior (SIB), aggression, and tantrums, symptoms that have reportedly improved with micronutrient (vitamins and minerals) treatment. The current study took advantage of naturally occurring differences in parental preferences for treatment approaches. The micronutrient group asked for treatment without pharmaceuticals (n¼44, aged 2–28 years at entry [M¼8.395.58]). Their records were matched with those of 44 similar children whose families requested conventional treatment (medication group). Both groups improved on both the Childhood Autism Rating Scale and the Childhood Psychiatric Rating Scale (all p values <0.0001). Both groups also exhibited significant decreases in total Aberrant Behavior Checklist scores, but the micronutrient group’s improvement was significantly greater ( p<0.0001). SIB Intensity was lower in the micronutrient group at the end of the study ( p¼0.005), and improvement on the Clinical Global Impressions scale was greater for the micronutrient group ( p¼0.0029). It is difficult to determine whether the observed changes were exerted through improvement in mood disorder or through an independent effect on autistic disorder. There were some advantages to treatment with micronutrients—lower activity level, less social withdrawal, less anger, better spontaneity with the examiner, less irritability, lower intensity SIB, markedly fewer adverse events, and less weight gain. Advantages of medication management were insurance coverage, fewer pills, and less frequent dosing.

Journal of Anxiety Disorders

Julia J. Rucklidge.  Journal of Anxiety Disorders. 2009 Aug;23(6):836-40.  Read Full Study

Abstract
Obsessive Compulsive Disorder (OCD) affects 0.5–2% of young people many of whom are resistant to conventional treatments. This case study describes an 18-year-old male with OCD who first underwent cognitive behavioral therapy (CBT) for a 1-year period with a modest response (his OCD had shifted from severe to moderate). Within a year, his anxiety had deteriorated back to the severe range and he now had major depression. He then entered an ABAB design trial using a nutritional formula consisting mainly of minerals and vitamins (together, known as micronutrients). After 8 weeks on the formula, his mood was stabilized, his anxiety reduced, and his obsessions were in remission. The treatment was then discontinued for 8 weeks, during which time his obsessions and anxiety worsened and his mood dropped. Reintroduction of the formula again improved the symptoms. This case illustrates the importance of considering the effect micronutrients have on mental illness.

Journal of Child and Adolescent Psychopharmacology

Bonnie J. Kaplan, Ph.D., Jennifer E. Fisher, M.D., Susan G. Crawford, M.Sc., Catherine J. Field, Ph.D., R.D., and Bryan Kolb, Ph.D. Journal of Child and Adolescent Psychopharmacology. 2004 Spring;14(1):115-22.  Read Full Study

Abstract
A group of scientists from three Alberta universities and the Alberta Children’s Hospital published the results of 11 unselected children with mood and behavior problems. The diagnoses of the children included attention deficit hyperactivity disorder (ADHD), bipolar disorder, oppositional defiant disorder (ODD), obsessive-compulsive disorder (OCD), Asperger syndrome, generalized anxiety disorder (GAD), Prader-Willi Syndrome depression, anxiety, and rage. The children were assessed for a minimum of 8 weeks on an adult dose of EMPowerplus, which was well-tolerated. Outcomes were measured with the Young Mania Rating Scale (YMRS), the Youth Outcome Questionnaire (YOQ), and the Child Behavior Checklist (CBCL).

Results: For all 9 children who completed the trial, the micronutrient treatment was clinically beneficial, and all effect sizes were large (>.8). Improvement was significant on the YOQ (measuring children’s mood, physical symptoms, self-harm behavior, interpersonal relationship problems, social problems, and attention problems), the YMRS (measuring symptoms such as irritability and disruptive aggressive behaviors), and 7 of the 8 CBCL scales (withdrawn behavior, anxious/depressed mood, social problems, thought problems, attention problems, delinquent behavior, and aggressive behavior).

BMJ Case Reports

Megan Rodway, Annette Vance, Amany Watters, Helen Lee, Elske Bos, and Bonnie J. Kaplan, Ph.D.  BMJ Case Reports. 2012 Nov 9;2012. pii: bcr2012007213. doi: 10.1136/bcr-2012-007213.  Read Full Study

Abstract
Psychosis is difficult to treat effectively with conventional pharmaceuticals, many of which have adverse long-term health consequences. In contrast, there are promising reports from several research groups of micronutrient treatment (vitamins, minerals, amino acids and essential fatty acids) of mood, anxiety and psychosis symptoms using a complex formula that appears to be safe and tolerable. We review previous studies using this formula to treat mental symptoms, and present an 11-year-old boy with a 3-year history of mental illness whose parents chose to transition him from medication to micronutrients. Symptom severity was monitored in three clusters: anxiety, obsessive compulsive disorder and psychosis. Complete remission of psychosis occurred, and severity of anxiety and obsessional symptoms decreased significantly (p<0.001); the improvements are sustained at 4-year follow-up. A cost comparison revealed that micronutrient treatment was <1% of his inpatient mental healthcare. Additional research on broad-spectrum micronutrient treatment is warranted.

University of Lethbridge
Celeste Halliwell and Bryan Kolb.  Canadian Centre for Behavioural Neuroscience, The University of Lethbridge. Soc Neuro Abs. 29:459-411.  Read Synopsis and Findings  |  Read 203 Page Full Study

Abstract
Early cortical injury has been attributed to the consequential effects of various factors, such as alcohol, drug addiction, smoking, and inadequate nutrient intakes during periods of pregnancy and lactation, or delivery of infants by forceps, and premature deliveries. These are only a few examples of circumstances, or “injury”, that may result in disorders ranging from mild learning difficulties to aggressive behavior. Injury to the cortex during the early years of development has been known to result in poor behavioral outcome into adulthood. Presently, the most common form of treatment includes a pharmacological agent, which may be accompanied with behavioral modification therapies supported by families. As an alternative form of therapy towards the treatment of early cortical injury, choline and a vitamin and mineral supplement (EM Power+) were used to determine the possibilities of nutrition intervention in an animal model. The injuries were incurred by aspiration lesion at days three, (Exp. l) and four, (Exp.2) and lesions were localized to the midline medial frontal cortex in some rats, while a different group of rats received lesions in the posterior parietal cortex. The pre and postnatal choline treated animals showed favorable results for the medial frontal lesions, and the postnatal vitamin supplement treated animals showed favorable results for treatment in both medial frontal and posterior parietal lesions. All animals were tested in adulthood indicating that nutrition intervention is very beneficial for alleviating some of the functional deficits commonly seen from early cortical injury.

METHOD: From a total of 103 animals thirty-eight two to four day old rats received frontal lesions, or the removal of the frontal lobes of their brain. Twenty three of this group were supplemented with EMPowerplus. Twenty-four two to four day old rats received posterior parietal lesions or removal of the parietal region of the brain. Fourteen of this group were supplemented with EMPowerplus. Both the control and supplemented rats underwent testing for performance in behavioral and skill challenges.

RESULTS: Behavioral Findings:

  • The supplement completely reversed the cognitive spatial deficit and partially reversed the motor deficits in the medial frontal lesion animals, and reduced the cognitive deficits in the posterior parietal lesion animals.
  • Control rats on the other hand experienced continued severe cognitive spatial deficits from the frontal lesions and posterior parietal lesion controls showed no recovery.
  • In the Morris Tank Test “The Rats with frontal lesions were impaired at the task, and this impairment was reversed with the supplement treatment, suggesting a complete recovery of function.”
  • The investigators have never seen any other treatment that facilitated recovery from posterior parietal lesions.

Journal of Psychoactive Drugs

Rachel Harrison, M.Sc.; Julia J. Rucklidge, Ph.D. and Neville Blampied, M.Sc.  Journal of Psychoactive Drugs. 45 (2), 168–178, 2013.  Read Full Study

Abstract
Prior research shows that micronutrients, particularly amino acids, can assist individuals with substance dependence to quit various drugs of abuse, including cannabis, alcohol, and cocaine. As part of a wider investigation of the impact of micronutrients (mostly vitamins and minerals) on psychiatric symptoms, such as Attention-Deficit/Hyperactivity Disorder (ADHD), depression, and anxiety, we observed that many participants reduced or eliminated use of alcohol, cigarettes, and cannabis. One case using a single-case reversal (off-on-off-on-off) design is presented and shows not only on-off control of psychiatric symptoms as micronutrients are consumed or withdrawn, but also simultaneous on-off use of cannabis and cigarettes, despite not directly targeting this substance use as part of the treatment protocol.

This case adds to a growing body of research supporting the use of micronutrients in the treatment of psychiatric symptoms and suggests it may extend to substance dependence. Micronutrients, by assisting with mood regulation and reductions in anxiety, may assist with successful cessation of drug use. Alternatively, they may directly impact on the brain reward circuitry believed to be involved in the expression of addictions, thereby providing the appropriate precursors and cofactors necessary for adequate neurotransmitter synthesis. This case should continue to stimulate researchers to consider the role of nutrients, in particular vitamins and minerals, in drug treatment programs and encourage more rigorous trials.

Advances in Mind-Body Medicine

Julia J. Rucklidge.  Advances in Mind-Body Medicine. Summer 2013;27(3).  Read Full Study

Abstract
Micronutrients are increasingly used to treat psychiatric disorders including attention-deficit/hyperactivity disorder (ADHD), mood disorders, stress, and anxiety. However, a number of factors influence optimal response and absorption of nutrients, including the health of the gut, particularly the presence of yeast infections, such as Candida. As part of a wider investigation into the impact of micronutrients on psychiatric symptoms, many participants who experienced a yeast infection during their treatment showed a diminished response to the micronutrients. One case was followed systematically over a period of 3 years with documentation of deterioration in psychiatric symptoms (ADHD and mood) when infected with Candida and then symptom improvement following successful treatment of the infection with olive leaf extract (OLE) and probiotics. This case outlines that micronutrient treatment might be severely compromised by infections such as Candida and may highlight the importance of gut health when treating psychiatric disorders with nutrients. Given the role that inflammation can play in absorption of nutrients, it was hypothesized that the infection was impairing absorption of the micronutrients.

BMC Psychiatry

J Steven A Simpson, Susan G Crawford, Estelle T Goldstein, Catherine Field, Ellen Burgess, and Bonnie J Kaplan.  BMC Psychiatry. 2001 Apr 18, 11:62.  Read Full Study

Abstract
Background: 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.

Methods: All known safety and tolerability data collected on one complex nutrient formula was compiled and evaluated.

Results: 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.

Conclusions: 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.