Systematic review of safety and tolerability of a complex micronutrient formula used in mental health.

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 RESULTS: Data were assembled from all the known published and unpublished studies for the complex formula with the largest amount of published research in mental health.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.

Bright light therapy improves cancer-related fatigue in cancer survivors: a randomized controlled trial.

PURPOSE: Cancer-related fatigue (CRF) is a common and distressing symptom that can persist after cancer treatment has concluded. Bright light therapy has shown preliminary efficacy in reducing CRF, but its impact on other psychosocial factors is unclear. The purpose was to examine the impact of a 1-month light therapy intervention on fatigue, mood, and quality of life in cancer survivors with fatigue. METHODS: This 4-week blinded randomized controlled trial recruited cancer survivors who met diagnostic criteria for CRF. Participants were randomly assigned to receive a light therapy device that produced either bright white light (BWL; intervention) or dim red light (DRL; active control). Participants were instructed to use the device daily for 30 min upon waking for 28 days. The primary outcome, fatigue, was assessed weekly. Secondary outcomes assessed pre- and post-intervention included mood, depressive symptoms, and quality of life. RESULTS: A total of 81 participants were randomly assigned to receive BWL (n = 42) or DRL (n = 39). Analyses revealed a group-by-time interaction for fatigue (p = .034), wherein the BWL condition reported a 17% greater reduction in fatigue than those in the DRL condition (between group d = .30). There were also significant improvements over time for both groups on measures of mood, depressive symptoms, and quality of life (p's < .01). CONCLUSIONS: BWL was associated with greater improvements in fatigue and both groups displayed improvements on secondary psychosocial outcomes. IMPLICATIONS FOR CANCER SURVIVORS: These findings, along with previous reports of light therapy for CRF, support the use of this intervention to improve fatigue in cancer survivors.

Vitamins, minerals, and mood.

In this article, the authors explore the breadth and depth of published research linking dietary vitamins and minerals (micronutrients) to mood. Since the 1920s, there have been many studies on individual vitamins (especially B vitamins and Vitamins C, D, and E), minerals (calcium, chromium, iron, magnesium, zinc, and selenium), and vitamin-like compounds (choline). Recent investigations with multi-ingredient formulas are especially promising. However, without a reasonable conceptual framework for understanding mechanisms by which micronutrients might influence mood, the published literature is too readily dismissed. Consequently, 4 explanatory models are presented, suggesting that mood symptoms may be expressions of inborn errors of metabolism, manifestations of deficient methylation reactions, alterations of gene expression by nutrient deficiency, and/or long-latency deficiency diseases. These models provide possible explanations for why micronutrient supplementation could ameliorate some mental symptoms.

The LITE study: Rationale and protocol for a randomized controlled trial of light therapy for cancer-related fatigue in cancer survivors.

UNLABELLED: Fatigue is a common and distressing symptom that can last for months or years in up to one-third of cancer survivors. Despite its prevalence, the nature and mechanisms of cancer-related fatigue are poorly understood and the available treatments may not provide sufficient relief. Fatigue has been identified as a significant contributor to decreased quality of life, making it an important target for intervention. One approach that may be a safe and inexpensive treatment is bright light therapy. METHODS: This study is a 4-week blinded randomized controlled trial. Subjects will be men and women who meet criteria for cancer-related fatigue and have completed cancer treatment. Subjects will be randomly assigned to receive a Litebook treatment device that produces either bright white light (treatment) or dim red light (active control). The devices will be used daily for 30min upon waking for a period of four weeks. The primary outcome, fatigue, will be measured with the Multidimensional Fatigue Symptom Inventory-SF. Secondary outcomes include mood disturbance, sleep quality, quality of life, diurnal cortisol, and inflammatory biomarkers. Fatigue assessments will be completed weekly and secondary outcomes will be assessed at pre- and post-intervention. CONCLUSIONS: The current research will examine the effect of light exposure on cancer-related fatigue and its potential psychological, behavioral, and biological mechanisms. If successful, this research would support the use of light therapy for the management of persistent fatigue in cancer survivors, expanding existing treatment options. It may also improve upon the current understanding of the mechanisms that underlie cancer-related fatigue.

Germane facts about germanium sesquioxide: I. Chemistry and anticancer properties.

This paper reviews the history, chemistry, safety, toxicity, and anticancer effects of the organogermanium compound bis (2-carboxyethylgermanium) sesquioxide (CEGS). A companion review follows, discussing the inaccuracies in the scientific record that have prematurely terminated research on clinical uses of CEGS. CEGS is a unique organogermanium compound first made by Mironov and coworkers in Russia and, shortly thereafter, popularized by Asai and his colleagues in Japan. Low concentrations of germanium occur in nearly all soils, plants and animal life; natural occurrence of the CEGS form is postulated but not yet demonstrated. The literature demonstrating its anticancer effect is particularly strong: CEGS induces interferon-gamma (IFN-gamma), enhances natural killer cell activity, and inhibits tumor and metastatic growth--effects often detectable after a single oral dose. In addition, oral consumption of CEGS is readily assimilated and rapidly cleared from the body without evidence of toxicity. Given these findings, the absence of human clinical trials of CEGS is unexpected. Possible explanations of why the convincing findings from animal research have not been used to support clinical trials are discussed. Clinical trials on CEGS are recommended.

Impact of a residential psychosocial program for cancer patients: a focus group investigation.

Focus groups of past program participants were conducted to explore the impact of a novel residential psychosocial intervention for cancer patients. All participants had attended the program between 6 months and 1 year prior to the study. The intention was to elicit a broad range of feedback regarding the program's effects on people living with cancer. Of particular interest was the assessment of lasting outcomes for participants, and possibilities for program improvement. This article reports the substantive understanding resulting from these focus groups, and discusses the beneficial impact, effective program characteristics, and controversial issues of residential psychosocial programming.

An open-label study of the effects of bupropion SR on fatigue, depression and quality of life of mixed-site cancer patients and their partners.

This preliminary study investigated whether bupropion sustained release (SR) improved symptomatic fatigue, depression and quality of life in cancer patients and caregiver quality of life. The sample consisted of a prospective open case series of 21 cancer patients, with fatigue and with or without depression at moderate to severe levels, referred for psychiatric assessment from a tertiary care cancer centre. Both patient symptom ratings and caregiver ratings were measured before and after 4 weeks of treatment with the maximally tolerated dose of bupropion in the range of 100-300 mg per day. At trial completion, significant improvement was found for symptoms of fatigue and depression. Subjects were divided into two groups: depressed and non-depressed (based on a cut-off score of 17 on the Hamilton Depression Rating Scale). Both groups reported improvement for fatigue and depressive symptoms. Depressed subjects and their caregivers did not experience any change in quality of life, while the non-depressed subjects and their caregivers reported improvements. Results from this small group of patients suggest that bupropion may have potential as an effective pharmaceutical agent for treating cancer-related fatigue. A randomized, placebo-controlled trial with this medication is indicated.

Effects of a brief intervention on social support and psychiatric morbidity in breast cancer patients.

(1) To cross-sectionally and longitudinally investigate relationships between the availability and adequacy of both close personal attachment and interactional support, and psychiatric morbidity in a sample of early stage breast cancer patients participating in a 6-week psychoeducational intervention. (2) To address the question of directionality in these longitudinal relationships. (3) To investigate the effects of the intervention on levels of social support. Eighty-nine women were enrolled in the study, and randomly assigned to either the treatment or control condition. They were evaluated with the Interview Schedule for Social Interaction (ISSI), the Beck Depression Inventory (BDI), the Global Severity Index (GSI) of the Symptom Checklist (SCL) -90-R, and the Structured Clinical Interview for DSM-III-R (SCID) at three time periods: baseline (pre-intervention), 1 year post-intervention and 2 years post-intervention. Relationships between social support and the psychiatric measures were evaluated both cross-sectionally and longitudinally. Cross-sectionally, there were strong associations at each time period between being diagnosed with a DSM-III-R Axis I disorder and having less adequate perceived social support from both close relationships and more distant social ties. Initial levels of psychiatric symptoms on the BDI and GSI were better predictors of later social support than initial social support variables were of later psychiatric symptoms. Participation in the group intervention did not result in changes in social support at 1 or 2 years post-intervention. Cross-sectionally, there was a strong relationship between social support and psychiatric morbidity in these patients with early-stage breast cancer. Longitudinally, it appeared that although social support influenced psychiatric symptomatology somewhat, the influence of psychiatric symptoms on social support was greater. This illustrates the importance of both working to bolster social support and dealing with psychiatric symptomatology in this population.

Tapestry: a retreat program of support for persons living with cancer.

PURPOSE: In an effort to mitigate the negative psychological sequelae of a cancer diagnosis and cancer treatment, efforts have been made to explore a variety of psychosocial issues and interventions. This article describes the provision and preliminary evaluation of a novel psychosocial service delivery, a residential "retreat" program called Tapestry, which is run under the aegis of the established cancer care community in Alberta, Canada. OVERVIEW: Retreat programs offer a novel way to provide psychosocial support for those persons who are living with cancer. The retreats are unique in the provision of a respite and the opportunity to address the isolation and other existential issues arising from a cancer diagnosis. The program described in this article has provided such a service six times per year since 1998. The intervention is described, and preliminary evaluation data are presented. CLINICAL IMPLICATIONS: Cancer care has begun to move beyond a solely biomedical paradigm toward a more holistic ethos in service delivery and research orientation. While the face value of and demand for such programming continues to grow, few residential psychosocial programs are offered under the auspices of conventional cancer care centers, and little work has been done to examine the nature and possible efficacy of retreat programs as a valid forum for psychosocial service delivery.

Bupropion sustained release treatment reduces fatigue in cancer patients.

OBJECTIVE: To demonstrate that bupropion sustained release (SR) can reduce the symptoms of fatigue experienced by cancer patients. METHOD: We studied an open-label case series of outpatients with fatigue referred for psychiatric assessment from a tertiary care cancer centre. Inclusion criteria were the presence of fatigue or depression with marked fatigue. Clinical status was assessed using the Global Clinical Improvement scale. RESULTS: Fifteen subjects with various cancer sites and psychiatric diagnoses were treated with bupropion SR (modal dose 150 mg) for up to 2 years. Most (13 of 15) saw improvement. Thirteen patients had minor, expectable side effects, and 10 patients were able to continue with bupropion for an extended time. All subjects who improved showed improvement within 2 to 4 weeks. CONCLUSIONS: This is the first report that shows bupropion SR can reduce fatigue in cancer patients. Controlled studies with more homogeneous samples would be necessary to establish the efficacy of this intervention. Further studies should address whether this effect of bupropion is separate from its action as an antidepressant.