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Research

15 universities, 34 publication and 49 independent researchers all say Truehope's EMPowerplus Advanced™ is a safe, effective, all-natural formula for common mood disorders. Click here to get your bottle today!

Click the links below to view research regarding the following conditions:

Children

Efficacy and cost of micronutrient treatment of childhood psychosis.
BMJ Case Rep. 2012 Nov 9;2012, pii: bcr2012007213. doi: 10.1136/bcr-2012-007213
Full Text Summary

"...Analyses demonstrated a 37% decrease in depression scores and a 45% decrease in mania scores from the start of treatment through final visit."

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.

Feasibility of a Nutritional Supplement as Treatment for Pediatric Bipolar Spectrum Disorders.
The Journal of Alternative and Complementary Medicine, July 2012, 18(7): 678-685. doi:10.1089/acm.2011.0270
Full Text Summary

"Exploratory analyses of mood symptoms throughout this pilot trial suggest decreases in depression and mania symptoms over the course of EMPowerplus Advanced supplementation."

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.

Database analysis of children and adolescents with bipolar disorder consuming a micronutrient formula.
BMC Psychiatry, 2010 Sep 28;10:74
Full Text Summary

"...severity of bipolar symptoms was 46% lower than baseline..."

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.

Multinutrient supplement as treatment: literature review and case report of a 12-year-old boy with bipolar disorder.
Journal of Child and Adolescent Psychopharmacology, 2009 Aug;19(4):453-60
Full Text Summary

"EMP+ [EMPowerplus] resulted in superior outcome to conventional treatment. This report adds to accumulating preliminary evidence that further basic science and clinical studies of multinutrient supplements are warranted."

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. This report adds to accumulating preliminary evidence that further basic science and clinical studies of multinutrient supplements are warranted.

Improved mood and behavior during treatment with a mineral-vitamin supplement: an open-label case series of children.
Journal of Child and Adolescent Psychopharmacology, 2004 Spring;14(1):115-22
Full Text Summary

"The fact that symptom improvements were sustained or even increased at 6 months strongly suggests that the benefit cannot be attributed to a placebo effect."

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).

Treatment of mood lability and explosive rage with minerals and vitamins: two case studies in children.
Journal of Child and Adolescent Psychopharmacology, 2002 Fall;12(3):205-19
Full Text Summary

"When taking the supplement, the boys had fewer emotional outbursts, fewer anxious and obsessional thoughts, more positive mood, and better temper control."

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.

Mood Dysregulation

Can Micronutrients Improve Neurocognitive Functioning in Adults with ADHD and Severe Mood Dysregulation? A Pilot Study
The Journal of Alternative and Complementary Medicine, December 2011, 17(12) 2011, pp. 1125-1131
Full Text Summary

"...Scores showed that [all] the 16 participants on the nutritional supplement were more resilient to the effects of the earthquake than the 17 individuals not taking the supplement..."

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.

Effect of micronutrients on behavior and mood in adults with ADHD: evidence from an 8-week open label trial with natural extension.
Journal of Attention Disorders, 2011 Jan;15(1):79-91
Full Text Summary

"...Measures of mood and hyperactivity/impulsivity were normalized."

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.

Improved mood and behavior during treatment with a mineral-vitamin supplement: an open-label case series of children.
Journal of Child and Adolescent Psychopharmacology, 2004 Spring;14(1):115-22
Full Text Summary

"The fact that symptom improvements were sustained or even increased at 6 months strongly suggests that the benefit cannot be attributed to a placebo effect."

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).

Do vitamins or minerals (apart from lithium) have mood-stabilizing effects?
Journal of Clinical Psychiatry, 2001 Dec;62(12):933-5
Full Text Summary

"Of 15 patients taking medications, 11 (73%) were able to gradually withdraw from their medications, and were stable taking the micronutrient treatment alone."

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.

Effective mood stabilization with a chelated mineral supplement: an open-label trial in bipolar disorder.
Journal of Clinical Psychiatry, 2001 Dec;62(12):936-44
Full Text Summary

"...The micronutrient treatment replaced psychotropic medications and the patients remained stable."

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.

Nutrients

Systematic review of safety and tolerability of a complex micronutrient formula used in mental health.
BMC Psychiatry, 2011 Apr 18;11:62
Full Text Summary

"...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."

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.

OBJECTIVES
The aim of this project was to compile all known safety and tolerability data collected on one complex nutrient formula.

DATA SOURCES AND 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.

Withdrawal

Use of Micronutrients Attenuates Cannabis and Nicotine Abuse as Evidenced From a Reversal Design: A Case Study
Journal of Psychoactive Drugs, Volume 45, Issue 2, 2013 - DOI:10.1080/02791072.2013.785840
Full Text Summary

"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."

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.

OCD

Successful treatment of OCD with a micronutrient formula following partial response to Cognitive Behavioral Therapy (CBT): a case study
Journal of Anxiety Disorders, 2009 Aug;23(6):836-40
Full Text Summary

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."

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.