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1.
J Diet Suppl ; 18(3): 293-315, 2021.
Article in English | MEDLINE | ID: mdl-32319852

ABSTRACT

Military personnel use dietary supplements (DS) for performance enhancement, bodybuilding, weight loss, and to maintain health. Adverse events, including cardiovascular (CV) effects, have been reported in military personnel taking supplements. Previous research determined that ingestion of multi-ingredient dietary supplements (MIDS), can lead to signals of safety concerns. Therefore, to assess the safety of MIDS, the Department of Defense via a contractor explored the development of a model-based risk assessment tool. We present a strategy and preliminary novel multi-criteria decision analysis (MCDA)-based tool for assessing the risk of adverse CV effects from MIDS. The tool integrates toxicology and other relevant data available on MIDS; likelihood of exposure, and biologic plausibility that could contribute to specific aspects of risk.Inputs for the model are values of four measures assigned based on the available evidence supplemented with the opinion of experts in toxicology, modeling, risk assessment etc. Measures were weighted based on the experts' assessment of measures' relative importance. Finally, all data for the four measures were integrated to provide a risk potential of 0 (low risk) to 100 (high risk) that defines the relative risk of a MIDS to cause adverse reactions.We conclude that the best available evidence must be supplemented with the opinion of experts in medicine, toxicology and pharmacology. Model-based approaches are useful to inform risk assessment in the absence of data. This MCDA model provides a foundation for refinement and validation of accuracy of the model predictions as new evidence becomes available.


Subject(s)
Decision Support Techniques , Dietary Supplements , Risk Assessment , Dietary Supplements/adverse effects , Humans , Military Personnel
2.
Phytother Res ; 35(6): 3013-3031, 2021 Jun.
Article in English | MEDLINE | ID: mdl-33373071

ABSTRACT

In times of health crisis, including the current COVID-19 pandemic, the potential benefit of botanical drugs and supplements emerges as a focus of attention, although controversial efficacy claims are rightly a concern. Phytotherapy has an established role in everyday self-care and health care, but, since botanical preparations contain many chemical constituents rather than single compounds, challenges arise in demonstrating efficacy and safety. However, there is ample traditional, empirical, and clinical evidence that botanicals can offer some protection and alleviation of disease symptoms as well as promoting general well-being. Newly emerging viral infections, specifically COVID-19, represent a unique challenge in their novelty and absence of established antiviral treatment or immunization. We discuss here the roles and limitations of phytotherapy in helping to prevent and address viral infections, especially regarding their effects on immune response. Botanicals with a documented immunomodulatory, immunostimulatory, and antiinflammatory effects include adaptogens, Boswellia spp., Curcuma longa, Echinacea spp., Glycyrrhiza spp., medicinal fungi, Pelargonium sidoides, salicylate-yielding herbs, and Sambucus spp. We further provide a clinical perspective on applications and safety of these herbs in prevention, onset, progression, and convalescence from respiratory viral infections.


Subject(s)
COVID-19 Drug Treatment , Plant Preparations/pharmacology , Plants, Medicinal/chemistry , Dietary Supplements , Humans , Immunity/drug effects , Phytotherapy/methods , SARS-CoV-2/drug effects
3.
Nutr Rev ; 74(11): 708-721, 2016 11.
Article in English | MEDLINE | ID: mdl-27753625

ABSTRACT

CONTEXT: Dietary supplements are widely used by military personnel and civilians for promotion of health. OBJECTIVE: The objective of this evidence-based review was to examine whether supplementation with l-arginine, in combination with caffeine and/or creatine, is safe and whether it enhances athletic performance or improves recovery from exhaustion for military personnel. DATA SOURCES: Information from clinical trials and adverse event reports were collected from 17 databases and 5 adverse event report portals. STUDY SELECTION: Studies and reports were included if they evaluated the safety and the putative outcomes of enhanced performance or improved recovery from exhaustion associated with the intake of arginine alone or in combination with caffeine and/or creatine in healthy adults aged 19 to 50 years. DATA EXTRACTION: Information related to population, intervention, comparator, and outcomes was abstracted. Of the 2687 articles screened, 62 articles meeting the inclusion criteria were analyzed. Strength of evidence was assessed in terms of risk of bias, consistency, directness, and precision. RESULTS: Most studies had few participants and suggested risk of bias that could negatively affect the results. l-Arginine supplementation provided little enhancement of athletic performance or improvements in recovery. Short-term supplementation with arginine may result in adverse gastrointestinal and cardiovascular effects. No information about the effects of arginine on the performance of military personnel was available. CONCLUSIONS: The available information does not support the use of l-arginine, either alone or in combination with caffeine, creatine, or both, to enhance athletic performance or improve recovery from exhaustion. Given the information gaps, an evidence-based review to assess the safety or effectiveness of multi-ingredient dietary supplements was not feasible, and therefore the development of a computational model-based approach to predict the safety of multi-ingredient dietary supplements is recommended.


Subject(s)
Arginine/administration & dosage , Arginine/adverse effects , Athletic Performance , Dietary Supplements , Military Personnel , Caffeine/administration & dosage , Cardiovascular Diseases/chemically induced , Creatine/administration & dosage , Dietary Supplements/adverse effects , Gastrointestinal Diseases/chemically induced , Humans
4.
Explore (NY) ; 11(3): 217-21, 2015.
Article in English | MEDLINE | ID: mdl-25847764

ABSTRACT

State legislation that authorizes any healthcare profession is known as the Practice Act. In order for a profession to establish a recognizable national presence and be integrated into mainstream medicine, all the state Practice Acts must evidence consistency. The extent to which state Practice Acts fail to exhibit consistency can inhibit the ability of the profession to grow and become successful. We looked at the histories of other health professions, along with the 45 acupuncture Practice Acts in the USA, in order to understand the time worn paths that lead to integration in the mainstream and how the acupuncture profession might benefit.


Subject(s)
Acupuncture Therapy , Acupuncture/legislation & jurisprudence , State Government , Humans , United States
5.
Postgrad Med ; 127(1): 107-16, 2015 Jan.
Article in English | MEDLINE | ID: mdl-25584933

ABSTRACT

There is a popular belief that multivitamin and mineral (MVM) supplements can help prevent cancer and other chronic diseases. Studies evaluating the effects of MVM supplements on cancer risk have largely been observational, with considerable methodologic limitations, and with conflicting results. We review evidence from the few available randomized, controlled trials that assessed the effects of supplements containing individual vitamins, a combination of a few select vitamins, or complete MVM supplements, with a focus on the recent Physicians' Health Study II (PHS II). PHS II is a landmark trial that followed generally healthy middle-aged and older men (mean age 64 years) who were randomized to daily MVM supplementation for a mean duration of 11 years. Men taking MVMs experienced a statistically significant 8% reduction in incidence of total cancer (hazard ratio [HR]: 0.92; 95% confidence interval [CI]: 0.86-0.998; p = 0.04). Men with a history of cancer derived an even greater benefit: cancer incidence was 27% lower with MVM supplementation versus placebo in this subgroup (HR: 0.73; 95% CI: 0.56-0.96; p = 0.02). Positive results of PHS II contrast with randomized studies of individual vitamins or small combinations of vitamins, which have largely shown a neutral effect, and in some cases, an adverse effect, on cancer risk. The results of PHS II may have a considerable public health impact, potentially translating to prevention of approximately 68 000 cancers per year if all men were to use similar supplements, and to an even greater benefit with regard to secondary prevention of cancer.


Subject(s)
Neoplasms/prevention & control , Primary Health Care , Vitamins/therapeutic use , Dietary Supplements , Female , Humans , Male , Primary Health Care/methods , Risk Assessment
6.
Nutr Rev ; 72(3): 217-25, 2014 Mar.
Article in English | MEDLINE | ID: mdl-24697258

ABSTRACT

This Department of Defense-sponsored evidence-based review evaluates the safety and putative outcomes of enhancement of athletic performance or improved recovery from exhaustion in studies involving beta-alanine alone or in combination with other ingredients. Beta-alanine intervention studies and review articles were collected from 13 databases, and safety information was collected from adverse event reporting portals. Due to the lack of systematic studies involving military populations, all the available literature was assessed with a subgroup analysis of studies on athletes to determine if beta-alanine would be suitable for the military. Available literature provided only limited evidence concerning the benefits of beta-alanine use, and a majority of the studies were not designed to address safety. Overall, the strength of evidence in terms of the potential for risk of bias in the quality of the available literature, consistency, directness, and precision did not support the use of beta-alanine by military personnel. The strength of evidence for a causal relation between beta-alanine and paresthesia was moderate.


Subject(s)
Dietary Supplements , Military Personnel , beta-Alanine/administration & dosage , Athletic Performance/physiology , Evidence-Based Medicine , Humans , United States
7.
Evid Based Complement Alternat Med ; 5(4): 409-13, 2008 Dec.
Article in English | MEDLINE | ID: mdl-18955236
8.
Cancer Res ; 68(20): 8377-83, 2008 Oct 15.
Article in English | MEDLINE | ID: mdl-18922910

ABSTRACT

Black cohosh is an herbal extract that is often used as an alternative to estrogen-based replacement therapies to treat hot flushes that frequently accompany the transition to menopause. Although cancer-free women as well as breast cancer patients and survivors use black cohosh to relieve vasomotor symptoms, there is limited information on its potential to influence breast cancer development or progression. Therefore, in this study, the effects of black cohosh on mammary tumorigenesis were investigated in the MMTV-neu mouse model due to its similarities to HER2(+) breast cancer, including stochastic development of mammary tumors, which frequently progress to metastatic disease. Using an adjusted dose for the mice to correlate to the recommended dose in women (40 mg/d), no differences were detected in the incidence or onset of mammary tumors in black cohosh-treated versus control females. The lack of effect on mammary tumor development suggests that black cohosh would not influence breast cancer risk if given to women before tumor formation. In contrast, black cohosh significantly increased the incidence of lung metastases in tumor-bearing animals compared with mice fed the isoflavone-free control diet. Additional studies will be needed to correlate these findings to women taking different black cohosh products at various times during breast cancer development; however, these results suggest caution for women using black cohosh, especially for extended periods of time. As metastatic progression is linked to patient survival, these data stress the importance of investigating how women's therapies influence all stages of mammary tumorigenesis, particularly for assessing their safety.


Subject(s)
Cimicifuga/toxicity , Lung Neoplasms/chemically induced , Lung Neoplasms/secondary , Mammary Neoplasms, Experimental/pathology , Receptor, ErbB-2/physiology , Animals , Estradiol/blood , Female , Mammary Tumor Virus, Mouse , Mice , Mice, Transgenic , Receptor, ErbB-2/analysis , Time Factors
9.
Hematol Oncol Clin North Am ; 22(4): 581-617, vii, 2008 Aug.
Article in English | MEDLINE | ID: mdl-18638690

ABSTRACT

Conventional wisdom generally recommends complete avoidance of all dietary supplements, especially during chemotherapy and radiation. This interdiction persists, in spite of high rates of dietary supplement use by patients throughout all phases of cancer care, and can result in patients' perceptions of physicians as negative, thus leading to widespread nondisclosure of use. A review of the clinical literature shows that some evidence for harm does exist; however, data also exist that show benefit from using certain well-qualified supplements. Physicians should increase their knowledge base about dietary supplement use in cancer and consider all of the data when advising patients. Strategies that are patient-centered and reflect the complete array of available evidence lead to more nuanced messages about dietary supplement use in cancer. This should encourage greater disclosure of use by patients and ultimately increase safety and efficacy for patients choosing to use dietary supplements during cancer care.


Subject(s)
Complementary Therapies , Dietary Supplements , Neoplasms/therapy , Antioxidants/adverse effects , Antioxidants/therapeutic use , Cachexia/therapy , Dietary Supplements/adverse effects , Dietary Supplements/statistics & numerical data , Gastrointestinal Diseases/chemically induced , Gastrointestinal Diseases/therapy , Herb-Drug Interactions , Hot Flashes/therapy , Humans , Lymphedema/therapy , Neoplasms/diet therapy , Neoplasms/drug therapy , Neoplasms/prevention & control , Neoplasms/radiotherapy , Peripheral Nervous System Diseases/chemically induced , Peripheral Nervous System Diseases/therapy , Phytotherapy , Plant Preparations/adverse effects , Plant Preparations/therapeutic use , Radiation Injuries/therapy , Radiotherapy/adverse effects , Randomized Controlled Trials as Topic/statistics & numerical data , Risk , Stomatitis/therapy
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