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International Journal of Molecular... Mar 2016In the United States (US), the risk of hepatotoxicity linked to the widespread use of certain herbal products has gained increased attention among regulatory scientists.... (Review)
Review
In the United States (US), the risk of hepatotoxicity linked to the widespread use of certain herbal products has gained increased attention among regulatory scientists. Based on current US law, all dietary supplements sold domestically, including botanical supplements, are regulated by the Food and Drug Administration (FDA) as a special category of foods. Under this designation, regulatory scientists do not routinely evaluate the efficacy of these products prior to their marketing, despite the content variability and phytochemical complexity that often characterizes them. Nonetheless, there has been notable progress in the development of advanced scientific methods to qualitatively and quantitatively measure ingredients and screen for contaminants and adulterants in botanical products when hepatotoxicity is recognized.
Topics: Chemical and Drug Induced Liver Injury; Clinical Trials as Topic; Dietary Supplements; Humans; Legislation, Food; Marketing; Plant Preparations; United States; United States Food and Drug Administration
PubMed: 26950122
DOI: 10.3390/ijms17030331 -
Clinical Gastroenterology and... Apr 2019This narrative review provides an overview of the current regulation of probiotics, with a focus on those used for the dietary management of medical conditions (Medical... (Review)
Review
BACKGROUND & AIMS
This narrative review provides an overview of the current regulation of probiotics, with a focus on those used for the dietary management of medical conditions (Medical Foods).
FINDINGS
The probiotic market has grown rapidly, both for foods and supplements intended to enhance wellness in healthy individuals, and for preparations for the dietary management of disease. Regulation of probiotics varies between regions. Unless they make specific disease-related health claims, probiotics are regulated as food supplements and regulation is focused on the legitimacy of any claims, rather than efficacy, safety and quality. Many properties of probiotics are strain-specific, and safety and efficacy findings associated to specific formulations should not be generalized to other probiotic products. Manufacturing processes, conditions and ingredients are important determinants of product characteristics and changes to manufacturing are likely to give rise to a product not identical to the "original" in efficacy and safety if proper measures and controls are not taken. Current trademark law and the lack of stringent regulation of probiotic manufacturing mean that the trademark owner can commercialize any formulation under the same brand, even if significantly different from the original. These regulatory deficits may have serious consequences for patients where probiotics are used as part of clinical guideline-recommended management of serious conditions such as inflammatory bowel diseases, and may make doctors liable for prescribing a formulation not previously tested for safety and efficacy.
CONCLUSIONS
Current regulation of probiotics is inadequate to protect consumers and doctors, especially when probiotics are aimed at the dietary management of serious conditions.
Topics: Diet Therapy; Dietary Supplements; Drug and Narcotic Control; Health Policy; Humans; Probiotics
PubMed: 29378309
DOI: 10.1016/j.cgh.2018.01.018 -
Nutrients Mar 2024The complex role of the gut microbiome in the pathogenesis of gastrointestinal (GI) disorders is an emerging area of research, and there is considerable interest in... (Review)
Review
The complex role of the gut microbiome in the pathogenesis of gastrointestinal (GI) disorders is an emerging area of research, and there is considerable interest in understanding how diet can alter the composition and function of the microbiome. Prebiotics and probiotics have been shown to beneficially modulate the gut microbiome, which underlies their potential for benefit in GI conditions. Formulating specific recommendations for the public regarding these dietary supplements has been difficult due to the significant heterogeneity between strains, doses, and duration of treatment investigated across studies, as well as safety concerns with administering live organisms. This review aims to summarize the existing evidence for the use of prebiotics and probiotics in various GI disorders, paying special attention to strain-specific effects that emerged and any adverse effects noted.
Topics: Humans; Prebiotics; Irritable Bowel Syndrome; Probiotics; Dietary Supplements; Gastrointestinal Diseases
PubMed: 38542689
DOI: 10.3390/nu16060778 -
Nutrients May 2020The term "nutraceuticals" is derived from "nutrition" and "pharmaceuticals" and is used fornutrition products that are also used as medicine [1] [...].
The term "nutraceuticals" is derived from "nutrition" and "pharmaceuticals" and is used fornutrition products that are also used as medicine [1] [...].
Topics: Dietary Supplements; Food Contamination; Food Quality; Functional Food; Humans; Noncommunicable Diseases
PubMed: 32485839
DOI: 10.3390/nu12061593 -
International Journal of Environmental... Apr 2022Given the widespread use of dietary supplements (DS) and herbal products (HP), healthcare professionals (HCPs) will increasingly encounter patients who use these...
Given the widespread use of dietary supplements (DS) and herbal products (HP), healthcare professionals (HCPs) will increasingly encounter patients who use these preparations with conventional drugs and who need their services to reduce the consequences of adverse therapeutic outcomes. The aim of our survey was to assess the knowledge and behaviors of HCPs regarding the risk of potential drug−dietary supplement (DDSIs) and drug−herbal product (DHPIs) interactions. This cross-sectional survey collected data via on paper-based questionnaire among general practitioners (GPs) (n = 105), specialty doctors (n = 87) and nurses (n = 154). The HCPs were mostly familiar with the interaction of doxycycline with magnesium (83%) and were least familiar with interaction of warfarin with glucosamine (14%). The results on DDSIs and DHPIs knowledge showed that GPs scored significantly higher than nurses (p < 0.001 and p = 0.003, respectively), while specialty doctors scored significantly higher than nurses only on DDSIs knowledge (p < 0.001). Only 28% of respondents reported that they often or always ask patients on drug therapy about the use of DS or HP, and 25% of respondents record such data in the medical documentation of patients. Our results showed that HCPs have sufficient knowledge about most major DDSIs and DHPIs, but insufficient knowledge about most moderate interactions. However, their overall knowledge and behavior regarding the risk of these interactions indicate the need for further continuing education and training.
Topics: Cross-Sectional Studies; Dietary Supplements; Health Knowledge, Attitudes, Practice; Health Personnel; Humans; Surveys and Questionnaires
PubMed: 35409970
DOI: 10.3390/ijerph19074290 -
BMC Complementary Medicine and Therapies Apr 2021The use of herbal and dietary supplement (HDS) in health and disease management has gained global attention. HDS are generally accepted by the public and are associated...
BACKGROUND
The use of herbal and dietary supplement (HDS) in health and disease management has gained global attention. HDS are generally accepted by the public and are associated with positive health behaviours. However, several reports have been documented with regards to their potential adverse effects and interaction with conventional medicines. Limited data is currently available on the use of HDS among elderly population in Malaysia. This present study aims to investigate the prevalence of and pattern of HDS use among a sample of community-dwelling elderly in a suburban town in Malaysia.
METHODS
A cross-sectional survey was conducted between March and May 2019 among the elderly aged ≥60 years old. The participants with the following criteria were included in the study: aged ≥60 years, residing in Puncak Alam and able to understand Malay or English language. Data were collected using a pre-validated questionnaire. All statistical analysis was conducted using IBM SPSS ver. 23.
RESULTS
Overall, 336 out of 400 elderly responded to the survey, achieving a response rate of 84%. This study observed that almost 50% of the respondents were using at least one type of HDS in the past one month of the survey. Among HDS non-users, most of them preferred to use modern medicines (62.6%, 114/182). Among the HDS users, 75.3% (116/154) were using at least one type of modern medicine (prescription or over-the-counter medicine). Multivariate analysis showed that having good to excellent perceived health (adjusted OR = 2.666, 95% CI = 1.592-4.464), having felt sick at least once in the past one month (adjusted OR = 2.500, 95% CI = 1.426-4.383), and lower body mass index (adjusted OR = 0.937, 95% CI = 0.887-0.990) were associated with HDS use. It was noted that only a small percentage of HDS users (16.2%, 25/154) had informed healthcare providers on their HDS use.
CONCLUSION
The use of HDS is common among the elderly sampled. Hence, healthcare providers should be more vigilant in seeking information of HDS use for disease management in their elderly patients. Campaigns that provide accurate information regarding the appropriate use of HDS among the elderly are pertinent to prevent misinformation of the products.
Topics: Aged; Cross-Sectional Studies; Dietary Supplements; Female; Humans; Independent Living; Malaysia; Male; Middle Aged; Suburban Population
PubMed: 33794868
DOI: 10.1186/s12906-021-03287-1 -
International Journal of Environmental... May 2022Probiotic microorganisms that are potentially beneficial to the health of the host are commercially available in a great variety of products. Not all microorganism... (Review)
Review
Probiotic microorganisms that are potentially beneficial to the health of the host are commercially available in a great variety of products. Not all microorganism strains present in products have proven beneficial to the health properties. These products include not only foodstuffs but also dietary supplements, food for special medical purposes, medicinal products, as well as cosmetics and medical devices. These products contain from one to a dozen bacterial strains of the same or different species and sometimes also fungal strains. Since the pro-health effects of probiotics depend on a specific strain, the number of its cells in a dose, and the lack of pathogenic microorganisms, it is extremely important to control the quality of probiotics. Depending on the classification of a given product, its form, and its content of microorganisms, the correct determination of the number of microorganisms and their identification is crucial. This article describes the culture-dependent and culture-independent methods for testing the contents of probiotic microorganisms, in addition to biochemical and genetic methods of identification. The microbiological purity requirements for various product categories are also presented. Due to numerous reports on the low quality of probiotic products available on the market, it is important to standardise research methods for this group of products and to increase the frequency of inspections of these products.
Topics: Bacteria; Dietary Supplements; Probiotics
PubMed: 35565098
DOI: 10.3390/ijerph19095701 -
Jornal de Pediatria 2015Triggered by the growing knowledge on the link between the intestinal microbiome and human health, the interest in probiotics is ever increasing. The authors aimed to... (Review)
Review
OBJECTIVE
Triggered by the growing knowledge on the link between the intestinal microbiome and human health, the interest in probiotics is ever increasing. The authors aimed to review the recent literature on probiotics, from definitions to clinical benefits, with emphasis on children.
SOURCES
Relevant literature from searches of PubMed, CINAHL, and recent consensus statements were reviewed.
SUMMARY OF THE FINDINGS
While a balanced microbiome is related to health, an imbalanced microbiome or dysbiosis is related to many health problems both within the gastro-intestinal tract, such as diarrhea and inflammatory bowel disease, and outside the gastro-intestinal tract such as obesity and allergy. In this context, a strict regulation of probiotics with health claims is urgent, because the vast majority of these products are commercialized as food (supplements), claiming health benefits that are often not substantiated with clinically relevant evidence. The major indications of probiotics are in the area of the prevention and treatment of gastro-intestinal related disorders, but more data has become available on extra-intestinal indications. At least two published randomized controlled trials with the commercialized probiotic product in the claimed indication are a minimal condition before a claim can be sustained. Today, Lactobacillus rhamnosus GG and Saccharomyces boulardii are the best-studied strains. Although adverse effects have sporadically been reported, these probiotics can be considered as safe.
CONCLUSIONS
Although regulation is improving, more stringent definitions are still required. Evidence of clinical benefit is accumulating, although still missing in many areas. Misuse and use of products that have not been validated constitute potential drawbacks.
Topics: Bifidobacterium; Child; Dermatitis, Atopic; Diarrhea; Dietary Supplements; Gastrointestinal Diseases; Gastrointestinal Tract; Humans; Lacticaseibacillus rhamnosus; Probiotics; Saccharomyces
PubMed: 25458874
DOI: 10.1016/j.jped.2014.08.005 -
Journal of the American Academy of... Apr 2021The use of herbal supplements that promise to improve immune health has gained popularity among dermatology patients. However, there is little to no evidence that herbal... (Review)
Review
The use of herbal supplements that promise to improve immune health has gained popularity among dermatology patients. However, there is little to no evidence that herbal supplements improve dermatologic conditions. Several in vitro and in vivo studies have shown that Spirulina platensis, Aphanizomenon flos-aqua, Chlorella, Echinacea, and alfalfa activate immune cells via certain cytokines and chemokines. Case reports suggest the association of ingesting immunostimulatory herbs and the clinical onset or flares of diseases characterized by an exaggerated immune response such as lupus erythematosus, dermatomyositis, and autoimmune blistering disorders. Therefore, it is imperative to investigate the prevalence of herbal supplement use in this patient population. In addition, in vitro studies should examine the underlying mechanisms by which herbs stimulate immune pathways that are already overactive in autoimmune patients.
Topics: Adjuvants, Immunologic; Animals; Aphanizomenon; Autoimmune Diseases; Chlorella; Cytokines; Dietary Supplements; Disease Progression; Echinacea; Humans; Medicago sativa; Skin Diseases; Spirulina
PubMed: 32553683
DOI: 10.1016/j.jaad.2020.06.037 -
Australian Journal of General Practice Mar 2019Tinnitus is a common and multifactorial condition that requires careful medical assessment and management. Many people with tinnitus believe foods can exacerbate or... (Review)
Review
BACKGROUND
Tinnitus is a common and multifactorial condition that requires careful medical assessment and management. Many people with tinnitus believe foods can exacerbate or reduce their perception of the condition, but the research on the relationship between diet and tinnitus is limited.
OBJECTIVE
The aim of this article is to review the available literature on the efficacy of a healthy diet, use of dietary supplements, caffeine restriction and salt restriction against tinnitus.
DISCUSSION
There is very weak evidence that dietary quality affects tinnitus symptoms, and further high-quality analytical studies are needed. On the other hand, the research is clear that dietary supplements are ineffective in reducing the symptoms of people with tinnitus and should therefore not be recommended by clinicians. There is also no supporting empirical scientific evidence for the commonly advocated restriction of caffeine and dietary salt for tinnitus patients.
Topics: Caffeine; Central Nervous System Stimulants; Dietary Supplements; Feeding Behavior; Humans; Sodium Chloride, Dietary; Tinnitus
PubMed: 31256469
DOI: 10.31128/AJGP-07-18-4643