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What you must know about dietary supplements and its legal regulations

  • Bio Innovation


Dietary supplements are products intended to supplement the diet, and are not drugs for disease treatments. They are vitamins, minerals, herbals, botanical, amino acids, enzymes, metabolites and many other products. Some supplements play an important role in health, for example calcium and vitamin D are important for keeping bones strong, and folic acid is important for pregnant women to prevent certain birth defect in their babies. Dietary supplements are available in the market in the form of tablets, capsules, soft gels, gel caps, powders, drinks and energy bars. These dietary supplements do not have to be approved by the U.S. Food and Drug Administration (FDA) before marketing as required for prescription drugs or over-the counter drugs, but manufacturers must register their manufacturing facilities with the FDA and are responsible to having evidence that their dietary supplement products are safe and label claims are not misleading. With a few well define exceptions dietary supplements such as per-workout for athletics and weight loss products may only be marketed to support structure or function of the body, without claiming to treat a disease or condition, and must include a label that highlight “These statements have not been evaluated by FDA and this product is not intended to diagnose, treat, cure, or prevent any diseases”
Review Article
What you must know about Dietary Supplements and its Legal Regulations
Osama O Ibrahim*
Consultant Biotechnology, Bio Innovation, Gurnee, Illinois, USA
*Corresponding Author: Osama O Ibrahim, Consultant Biotechnology, Bio Innovation, Gurnee, Illinois, USA.
Citation: Osama O Ibrahim. “What you must know about Dietary Supplements and its Legal Regulations”
EC Nutrition 13.8 (2018): 551-
Received: June 22, 2018; Published: July 27, 2018
Dietary supplements are not drugs to treat diseases but are products intended to supplement diets. They are vitamins, minerals,
amino acids, proteins, enzymes, metabolites, herbal/botanical plants and many others. Some supplements plays an important role
in health such as calcium and vitamin D to keep bones strong [1], and folic acid for pregnant women to prevent certain birth defect
in new born children [2]. Dietary supplements are marketed in the form of tablets, capsules, soft gels, gel caps, powders, drinks and
energy bars. There is no need for dietary supplements to be approved by the U.S. Food and Drug Administration (FDA) before mar-
keting as in the case of prescription and over counter drugs, but dietary supplements manufacturers are responsible to register their
manufacturing facilities with FDA and to demonstrate that their manufactured products are safe and label claims are not misleading.
Keywords: Dietary Supplements; Dietary Supplements Ingredient; Herbal Supplements; Botanical Supplements; DSHES; FDA; TCA; GMP
Dietary Supplements Health and Education Act (DSHEA) were passed by United State Congress in the year 1994 to provide a
regulatory framework for the safety of dietary supplements.
and are taken by mouth in different forms (pills, capsules, tablets or liquid). Dietary supplements are nutrient compounds includes vita-
These ingredients of dietary supplants are sold individually or in combination. In United States there are over 50,000 marketed dietary
supplements consumed daily by over 50% of American population. Multivitamins and menials are the most commonly consumed dietary
supplements especially for people failed to consume a balanced diet. The total market size of dietary supplements in North America alone
was estimated in the year 2016 for about $37 billion [8] and is rising due to the awareness towards calorie reduction, weight loss, and the
Dietary Supplements Health and Education Act (DSHEA) [9] were passed in the year 1994 by United States Congress to provide a
       
(other than tobacco) intended to supplement the diet and must be labeled as dietary supplements. DSHEA granted the United States Food
and Drug Administration (FDA) the authority to establish dietary supplement regulations, for manufacturing, health claims, labeling and
to encourage research on these supplements. Plus, DSHEA gave to Federal Trade Commission (FTC) a division of FDA the authority to
regulate dietary supplements advertising.
What you must know about Dietary Supplements and its Legal Regulations
Citation: Osama O Ibrahim. “What you must know about Dietary Supplements and its Legal Regulations”
EC Nutrition 13.8 (2018): 551-
It is against United States Federal regulations for dietary supplements manufacturers to claim that their products prevent or treat any
effect. The FDA enforces these regulations, and prohibits the sale of dietary supplements or ingredients that are harmful, or not manufac-
tured according to Good Manufacturing Practices (GMPs) standard.
Similar to food manufacturers there is no need for government approval to manufacture or sell dietary supplements, and there is no
required clinical trials to be sold as pharmaceutical drugs. Dietary supplements manufacturers have the responsibility not the govern-
In summary dietary supplements regulations are different than the regulations of conventional foods and pharmaceutical drugs. The
FDA role for dietary supplements begins after the product enters the market place and have the authority to remove any dietary supple-
ment from the market if demonstrated to be unsafe.
Dietary supplements
Multivitamins and minerals
include herbs, hormones or drugs [10].
Vitamins are supplements that people used to boost their energy level, and some minerals plays role as enzymes cofactors in metabolic
pathways for energy.
a. -
tial vitamins of Thiamin (B12), niacin (B3  6), Pantothenic acid, Folic acid, Cyanocobalamin
(B12), and Biotin. Vitamin C, (L-ascorbic acid), is present in some foods, and available as a dietary supplement. Unlike most
animals, human is unable to synthesize [13] vitamin C so it is an essential in our diet for the biosynthesis of collagen, L-
b. -
sumed 
helping eyes adjust to light. Vitamin A also, plays role in bone growth, tooth development, reproduction, cell division, gene
rous [16] by increasing the small intestine absorption rate of these minerals, to maintain healthy bones. Vitamin D also play
sential fatty acids from destruction [17] Vitamin K plays an essential role in normal blood clotting, promoting bone health,
and helping proteins biosynthesis for blood, bones, and kidneys [18].
Minerals does not provide energy or calories for the body, but are needed in small amounts to keep healthy body, and for other func-
tions such as enzymes activity. Human body does not synthesize minerals, and must be obtained from foods, or from dietary supplements.
These minerals are Ca, Mg, Cr, Zn, Se, K, Fe, Mn, I, P, and Cu. Calcium (Ca) function is to keep bones and teeth strong and, supporting skeletal
structure. Calcium also, play roles in cell signaling, blood clotting, muscle contraction and nerve function [19]. Iron (Fe) is an essential
element for red blood cells production (hemoglobin) and muscle cells structure (myoglobin) [20].
What you must know about Dietary Supplements and its Legal Regulations
Citation: Osama O Ibrahim. “What you must know about Dietary Supplements and its Legal Regulations”
EC Nutrition 13.8 (2018): 551-
D per day during the pregnancy and breast feeding, to maintain proper levels of calcium and phosphorus [21] in their body, and should
calcium during pregnancy only by doctor advice.
Global market of vitamins and minerals is over $9 billion per year [23] and are available in the market in packages contain at least 10
vitamins and 10 minerals with the recommended 100% daily value (DV) and below the tolerable dose as determined by FDA.
   
lower blood cholesterol, alleviate irritable bowel syndrome, reduce the risk of colon cancer, and increase feelings of satiety [24]. However,
and other medical problems [25]. To avoid such implications, the American Dietetic Association (ADA) recommends that the average adult
Fatty Acids
Essential fatty acids, are polyunsaturated short carbons chain that our body cannot synthesize and must ingested for good health. The
two known polyunsaturated fatty acids that essential for human are alpha-linolenic acid (ALA) and linoleic acid. The body convert alpha
        
signaling and necessary for the production of hormones and neurotransmitters. Selecting of right fatty acids in dietary supplement could
help in improving a range of health conditions such as cardiovascular, diabetes and neurological function.
Conjugate fatty acids (CFA) is an isomer of linoleic acid (LA) and are naturally present in meat and dairy products. Average daily intake
of conjugated fatty acids for most people is less than one gram per day mainly from meat and dairy products [32]. Conjugated fatty acids
 
the evaluations of physiological bioactivity of conjugated fatty acids on lifestyle-related diseases in humans and animals are necessary.
Protein and amino acids
Protein is amino acids linked together in a chain by peptide linkages and is one of the three macronutrients for energy (carbohydrates,
     
growth, increase body weight gain, increase lean muscle mass, and increase strength and power.
Amino acids are primary source of nitrogen for the body and are essential source for muscle growth, immune systems, enzymes, and
that cannot be synthesize in the body and must obtained from foods or from dietary supplements. These essential amino acids are phenyl
alanine, threonine, methionine, tryptophan, lysine, leucine, isoleucine, and valine. The rest of known 20 amino acids are non-essential
What you must know about Dietary Supplements and its Legal Regulations
Citation: Osama O Ibrahim. “What you must know about Dietary Supplements and its Legal Regulations”
EC Nutrition 13.8 (2018): 551-
amino acids.
age label especially for essential amino acids and for branched chain amino acids (BCAAs). Branched chain amino acids are leucine, iso-
leucine and valine. The daily requirement intake of leucine is 40 milligram per kilogram body weight, and for both isoleucine and valine
daily requirements intake is 10 - 30 milligram per kilogram body weight for each. Protein supplements claims including branched chain
amino acids (BCAAs) is for stimulating the synthesis of muscle proteins.
Marketed protein supplements contain about 20 - 30 grams of protein per serving and It is important to highlight that high dose of
daily protein intake could have side effects such as: nausea, thirst, bloating, cramps, fatigue, headache, reducing appetite and increasing
bowl movements [34].
L- Glutamine supplement
L-Glutamine is one of the 20 building block amino acids in proteins and is the major amino acid in body muscles protein, making about
61% of skeletal tissue [35]. L-Glutamine is not essential amino acid, but it can be essential in the time of intense athletic training or in the
case of gastrointestinal disease. Bodybuilders should take about 10 to 15 grams of L-glutamine per day [36]. To minimize breakdown of
in the body.
Creatine supplement
Creatine is a nitrogenous organic chemical compound synthesized by the body muscle motions and is marketed as a supplement for
athletics. Creatine supply body cells with energy in the form of Adenine Tri Phosphate (ATP). The recommended maintenance dose of
creatine for athletes is in the range of 5 to 10 grams per day [37]. Creatine is marketed in the form of monohydrate, ethyl, hydrochlo-
ride, magnesium chelate, malate, nitrate and gluconate. Creatine supplement claims for athletics are to improve muscle growth, improve
creatine as dietary supplement [38] and should consult with a physician before taking creatine supplement with medications.
Herbal supplements
    
                
tablets, capsules, powders; tea bags; and in other forms. Total sale of herbal supplements is $7.5 billion per year in United States alone
Chamomile and Peppermint, are used for digestion and considered safe [40] with mild action. Herbal supplement Kava reported to have
 
manufacturers must follow Good Manufacturing Practices (GMP) to ensure that they are consistently manufactured and meet quality
Food and Drug Administration (FDA) considers some herbal supplements are worthless or unsafe. Some concerns about the safety
of herbal supplants because they are unregulated, may contain additives or contaminants, may cause allergic reaction, may interact with
What you must know about Dietary Supplements and its Legal Regulations
Citation: Osama O Ibrahim. “What you must know about Dietary Supplements and its Legal Regulations”
EC Nutrition 13.8 (2018): 551-
Ginseng: Refers to the roots of Asian plant Panax ginseng. The active chemical compound in this plant that is being studied for poten-
tial use in medicine is ginsenoside (C42H72O14
Ginseng as dietary supplements should be standardized to contain about 4 - 5% of the active chemical compound ginsenoside [42].
Ginkgo: The plant Ginkgo biloba is the best-selling herbal supplements in United States. There are about 40 chemical compounds in
Ginkgo might help people with Alzheimer. The recommended daily intake of Ginkgo supplements is in the range of 120 to 240 milligrams
drugs and consulting a physician is recommended.
Hydroxyl citric acid:6H8O8Garicinia cambogia.
    
1,200 milligrams per day.
Enzymes sources as dietary supplements are from animals such as pepsin, trypsin and chymotrypsin, from plants such as bromelain,
papain, and diastase, and from microbial such as amylases, proteases, and lipases. Most enzymes supplements commercially used as
bined with herbals (botanicals) or other dietary supplements.
Coenzyme Q10
Coenzyme Q10 (CoQ10
present in mammalian cells (mitochondria), participates in metabolic pathways which generates energy in the form of ATP. It is also act
10 found in vital organs that require high energy,
     10 from food
sources is about 3 - 6 milligrams per day. CoQ10 has become a popular natural supplement produced from yeast with claims to boost en-
vitamins A, C, and E.
Primary metabolites, are intermediate small chemicals substances found inside cells from metabolic pathways, it can be recognize and
cells, control metabolism, and have useful biological functions in cells. Secondary metabolites are organic compounds that secreted as
What you must know about Dietary Supplements and its Legal Regulations
Citation: Osama O Ibrahim. “What you must know about Dietary Supplements and its Legal Regulations”
EC Nutrition 13.8 (2018): 551-
the body in maintaining better balance.
Examples for primary metabolites are:
a. Pyruvate: Pyruvate is a natural substance in the body generated from carbohydrates metabolic pathway [48]. Calcium
pyruvate (C6H6Ca06i) is the pyruvate supplement that is used for weight-loss and its recommended intake is about 5 grams
per day.
b. Glucosamine sulfate: (C6H5N09S) is naturally present in the body for building tendons, ligaments, and cartilage, plus, it is
the 
intake about 1000 to 2000 milligrams per day [50].
Dietary Supplements Regulations in united states
Before the year 1990, Food and Drug Administration (FDA) regulated dietary supplements that only contains essential nutrients to pro-
tect public from mislabeling and unsafe products. In the year 1990 Nutrition Labeling and Education Act included herbs as dietary supple-
ments, and in the year 1994, Congress passed the Dietary Supplements Health and Education Acts (DSHEA) a legislation provided regula-
tory framework for assuring the safety of dietary supplements.
and herbs and granted the U.S. Food and Drug Administration (FDA) the authority to regulate dietary supplements processing, health
        
In summary DSHEA recommendations are [51]:
a. No need for dietary supplements manufacturers to receive FDA approval before marketing their products.
b. 
of 
c. Dietary supplements manufacturers and distributers are responsible to meet DSHEA, and FDA all safety and labeling re-
quirements before marketing their products.
d. The role of FDA authority on dietary supplements begins after the product enters the marketplace.
e. Dietary supplement manufacturers and distributers are responsible to inform FDA with any serious adverse events that are
reported to them by consumers or health care professionals on their marketed products
f. 
g. Labeling claims for dietary supplements are allowed as long it does not diagnose, prevent, treat or cure diseases.
h. FDA is responsible for dietary supplements labeling claims, including packaging, inserts, and other promotional materials
distributed at the point of sale.
i. Federal Trade Commission (FTC) is responsible for dietary supplements advertising, including prints, broadcast ads, cata-
logs, and any similar direct marketing materials.
j. All dietary supplements claims must meet both FDA and FTC requirements.
What you must know about Dietary Supplements and its Legal Regulations
Citation: Osama O Ibrahim. “What you must know about Dietary Supplements and its Legal Regulations”
EC Nutrition 13.8 (2018): 551-
Calcium and osteoporosis.
Sodium and hypertension.
Folic acid and neural tube pregnancies.
Fibers and cancer.
Fruits and vegetables and cancer.
Dietary fat and cancer.
Soy protein and coronary heart disease.
Omega-3-fatty acids and heart disease
Saturated fats and cholesterol and coronary artery disease
Sugar alcohols and dental caries
Vitamins B (folic acid, B6, and B12) and heart disease.
Domestic and foreign manufacturers of dietary supplements are responsible to apply Good Manufacture Practice (GMP) for their
production process, packaging, labeling and distribution. Dietary supplements manufacturers are also responsible to ensure that their
herbicides, fertilizer, and harmful microorganism., developing shelf life and storage conditions for each product, and having reliable docu-
GMP requirements for dietary supplements are [53]:
Design plants that easy facilitate maintenance and cleaning.
Develop Hazard Analysis Control Points (HACCP) for each dietary supplant production process.
Having proper standard manufacture operations.
Having quality control procedures.
Store dietary supplement ingredients under proper conditions.
light, and sanitation to protect and assure products quality and activity.
Maintain records keeping for one year past the shelf life date or for two years after the distribution of last batch of dietary
Must have a proper handling of consumer complains.
Dietary supplements manufacturers are also responsible to have a valid good sanitation practice for product and non-product contact
surfaces. 
Labels and advertise regulations [54]
Labels on dietary supplement packages should listed accurate quantity of contents, complete list of ingredients, ingredients safety in-
formation, the part of plant used in the case of herb supplements, and list of nutrition information including serving size, and percentage
What you must know about Dietary Supplements and its Legal Regulations
Citation: Osama O Ibrahim. “What you must know about Dietary Supplements and its Legal Regulations”
EC Nutrition 13.8 (2018): 551-
of daily value (DV). Labels information should show, the name and place of the business, and a disclaimer stated that “this product is not
intended to diagnose, treat, cure, or prevent any diseases”.
Advertising including prints, broadcast ads, catalogs, and any other marketing materials are under the responsibility of Federal Trade
Dietary supplements are available in different forms such as pills, capsules, powders, tablets or liquids and can be purchase without
a physician prescription. More than 50% of American population are taking daily or occasion one or more dietary supplements to make
sure that they are getting enough essential nutrients and to maintain or improve their health. Majority of Americans consumers do not
need to take these dietary supplements because, they are getting all of required nutrients from eating a variety of healthy foods.
In United States there are over 50,000 marketed dietary supplement and some of these dietary supplements have side effects, when
they are taken with prescription or over counter drugs. Plus, dietary supplements could have side effects for people with health condi-
tions, and consultations with health care providers or physicians are always recommended.
in dietary supplement supports bone health, and the intake of vitamin D with calcium in dietary supplement helps the body to absorb
in good health. Iron in dietary supplement is needed for women during pregnancy, and breastfed infants, to prevent anemic due to blood
loss. The daily intake of 400 micrograms folic acid in dietary supplement is important for all women of childbearing age to prevent birth
defect. Research evidence suggested that vitamin B12 keeps nerves and blood cells healthy [55] and the main source of vitamin B12 is from
the daily intake of meat and dairy products. In the case of vegetarians they should consider taking vitamin B12 as dietary supplement to
make sure of getting vitamin B12
a week or two before the surgery as recommended by health professions and physicians.
Despite the important of plants in medicine, FDA considers some herbal remedies are worthless or harmful because herbal supplants
are unregulated, sometime mislabeled, may contain additives or contaminants, may cause allergic reaction, may interact with prescrip-
Hypericum perforatum a native plant of Europe and Asia is marketed under trade
name St. -
     
or purity.
Before 1994 Food and Drug Administration (FDA) only protected the public from mislabeled and unsafe dietary supplements of es-
sential -
 
marketed dietary supplements are different in regulations from prescription and over-the-counter drugs that must be approval by FDA
What you must know about Dietary Supplements and its Legal Regulations
Citation: Osama O Ibrahim. “What you must know about Dietary Supplements and its Legal Regulations”
EC Nutrition 13.8 (2018): 551-
   
their products, but they must follow certain Good Manufacturing Practices (GMP) to ensure the identity, purity, strength, and composi-
tion of their marketed dietary supplements. Manufacturers are also responsible for the safety of their products, the truthful of their label
FDA responsibilities are after dietary supplements inter marketplace, to monitor the safety and to make sure that the information on
labels and packages insert are accurate and claims made for these products are truthful and not misleading. The responsibility of Federal
not misleading.
It is important to highlight that FDA has the authority to take an action if marketed dietary supplement poses a direct health threat to
consumers. Their enforcements are only after dietary supplement was marketed and adverse health effects have already occurred.
Several independent organizations offer quality testing for marketed dietary supplements and allow to pass International standard
analytical tests to display their seals of approval on marketed dietary supplements. These seals of approval provide assurance that mar-
keted dietary supplements are properly manufactured, contains ingredients listed on the label, and does not contain harmful levels of
contaminants. However, these seals of approval still does not guarantee that marketed dietary supplements are safe or effective.
Finally consumers of dietary supplements are responsible for their own safety by selecting supplements with reliable ingredients and
chase supplements from retail stores not from the internet, consult the physician on the safety of a supplement before purchasing, stop
There are thousands of dietary supplements in the market and many are non-effective or even some might cause harm than good, as
in the case of some herbal supplements. Since there are little known about the safety of dietary supplements, consumers should consult
with their personal physician and purchase dietary supplements with reliable and safety ingredients.
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Volume 13 Issue 8 August 2018
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Background Surgical resection remains the primary treatment for gastrointestinal (GI) malignancy including early-stage cancer. Omega-3 polyunsaturated fatty acids (n-3 PUFAs) have been reported to have beneficial clinical and immune-modulating effects in the prognosis of GI cancer patients undergoing surgery. Methods We searched PubMed, Embase, EBSCO-Medline, Cochrane Central Register of Controlled Trials (CENTRAL), CNKI and Wanfang to identify primary research reporting the effects of n-3 PUFAs compared with isocaloric nutrition on GI cancer patients who underwent surgery up to the end of June 30, 2016. Two authors independently reviewed and selected eligible randomized controlled trials (RCTs). ResultsA total of 9 RCTs (623 participants) were included. The n-3 PUFAs regime resulted in lower levels of C-reactive protein (CRP) (P < 0.05), interleukin-6 (IL-6) (P < 0.01), and higher levels of albumin (ALB), CD3+ T cells, CD4+ T cells and CD4+/CD8+ ratio (P < 0.05) compared with the isocaloric nutrition regime. However, there was no significant difference in the level of tumor necrosis factor-α (TNF-α) between the n-3 PUFAs regime and the isocaloric nutrition regime (P = 0.17). And the level of CD8 + T cells decreased compared with the isocaloric nutrition regime (P < 0.0001). Conclusions Our meta-analysis revealed that n-3 PUFAs are effective in improving the nutritional status and immune function of GI cancer patients undergoing surgery as they effectively enhance immunity and attenuate the inflammatory response.
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The prevalence of primary or idiopathic osteoarthritis (OA) of knee and hip joints has substantially increased in general population during the last decades. Analgesics and non-steroidal anti-inflammatory drugs are currently extensively used as non-surgical treatment options. However, they act as symptomatic treatments, not offering a cure of OA and they are accused for an increased risk of adverse events. Glucosamine (GL) and chondroitin (CH) are nutritional supplements that have recently gained widespread use as treatment options for OA. They potentially or theoretically act as chondroprotectors or/and as “diseasemodifying OA drugs” offering not only symptomatic relief but also alteration of the natural history of OA. However, although many studies have showed a significant treatment effect, accompanied with remarkable safety, there is still controversy regarding their relative effectiveness compared with placebo or other treatments. The scope of this review is to present and critically evaluate the current evidence-based information regarding the administration of GL and CH for the treatment of knee or hip OA. Our focus is to investigate the clinical efficacy and safety after the use of these supplements. An effect of GL and CH on both clinical and radiological findings has been shown. However, only a few high quality level I trials exist in the literature, especially for the assessment of radiological progression of OA. The effect sizes are generally small and probably not clinically relevant. Even the validity of these results is limited by the high risk of bias introduced in the studies. Both GL and CH seem to be safe with no serious adverse events reported. There is currently no convincing information for the efficacy of GL or CH as treatment options in OA.
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Panax ginseng is one of the most universally used herbal medicines in Asian and Western countries. Most of the biological activities of ginseng are derived from its main constituents, ginsenosides. Interestingly, a number of studies have reported that ginsenosides and their metabolites/derivatives—including ginsenoside (G)-Rb1, compound K, G-Rb2, G-Rd, G-Re, G-Rg1, G-Rg3, G-Rg5, G-Rh1, G-Rh2, and G-Rp1—exert anti-inflammatory activities in inflammatory responses by suppressing the production of proinflammatory cytokines and regulating the activities of inflammatory signaling pathways, such as nuclear factor-κB and activator protein-1. This review discusses recent studies regarding molecular mechanisms by which ginsenosides play critical roles in inflammatory responses and diseases, and provides evidence showing their potential to prevent and treat inflammatory diseases.
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Background This systematic review evaluated St. John’s wort (SJW) for the treatment of Major Depressive Disorder (MDD). The objectives of this review are to (1) evaluate the efficacy and safety of SJW in adults with MDD compared to placebo and active comparator and (2) evaluate whether the effects vary by severity of MDD. Methods We searched PubMed, CINAHL, PsycINFO, CENTRAL, Embase, AMED, MANTIS, Web of Science, and ICTRP and existing reviews to November 2014. Two independent reviewers screened the citations, abstracted the data, and assessed the risk of bias. We included randomized controlled trials (RCTs) examining the effect of at least a 4-week administration of SJW on depression outcomes against placebo or active comparator in adults with MDD. Risk of bias was assessed using the Cochrane Risk of Bias tool and USPSTF criteria. Quality of evidence (QoE) was assessed using the GRADE approach. ResultsThirty-five studies examining 6993 patients met inclusion criteria; eight studies evaluated a hypericum extract that combined 0.3 % hypericin and 1–4 % hyperforin. The herb SJW was associated with more treatment responders than placebo (relative risk [RR] 1.53; 95 % confidence interval [CI] 1.19, 1.97; I2 79 %; 18 RCTs; N = 2922, moderate QoE; standardized mean differences [SMD] 0.49; CI 0.23, 0.74; 16 RCTs; I2 89 %, N = 2888, moderate QoE). Compared to antidepressants, SJW participants were less likely to experience adverse events (OR 0.67; CI 0.56, 0.81; 11 RCTs; moderate QoE) with no difference in treatment effectiveness (RR 1.01; CI 0.90, 1.14; 17 RCTs, I2 52 %, moderate QoE; SMD −0.03; CI −0.21, 0.15; 14 RCTs; I2 74 %; N = 2248, moderate QoE) in mild and moderate depression. ConclusionsSJW monotherapy for mild and moderate depression is superior to placebo in improving depression symptoms and not significantly different from antidepressant medication. However, evidence of heterogeneity and a lack of research on severe depression reduce the quality of the evidence. Adverse events reported in RCTs were comparable to placebo and fewer compared with antidepressants. However, assessments were limited due to poor reporting of adverse events and studies were not designed to assess rare events. Consequently, the findings should be interpreted with caution. Systematic review registrationPROSPERO CRD42015016406.
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Mass spectrometry- and nuclear magnetic resonance-based metabolomic studies comparing diseased versus healthy individuals have shown that microbial metabolites are often the compounds most markedly altered in the disease state. Recent studies suggest that several of these metabolites that derive from microbial transformation of dietary components have significant effects on physiological processes such as gut and immune homeostasis, energy metabolism, vascular function, and neurological behavior. Here, we review several of the most intriguing diet-dependent metabolites that may impact host physiology and may therefore be appropriate targets for therapeutic interventions, such as short-chain fatty acids, trimethylamine N-oxide, tryptophan and tyrosine derivatives, and oxidized fatty acids. Such interventions will require modulating either bacterial species or the bacterial biosynthetic enzymes required to produce these metabolites, so we briefly describe the current understanding of the bacterial and enzymatic pathways involved in their biosynthesis and summarize their molecular mechanisms of action. We then discuss in more detail the impact of these metabolites on health and disease, and review current strategies to modulate levels of these metabolites to promote human health. We also suggest future studies that are needed to realize the full therapeutic potential of targeting the gut microbiota.
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Background The extent and the progression of vascular calcification (VC) are independent predictors of cardiovascular risk in the haemodialysis population. Vitamin K is essential for the activation of matrix gla protein (MGP), a powerful inhibitor of tissue calcification. Functional vitamin K deficiency may contribute to the high VC burden in haemodialysis patients. In addition, haemodialysis patients are frequently treated with vitamin K antagonists, mainly to prevent stroke in atrial fibrillation, potentially compounding the cardiovascular risk in these already vulnerable patients. New oral anticoagulants (NOACs) are valuable alternatives to vitamin K antagonists in the general population, but their use in dialysis has been encumbered by substantial renal clearance. However, a recent pharmacokinetic study provided information on how to use rivaroxaban in haemodialysis patients.
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Herbal tea is essentially an herbal mixture made from leaves, seeds and/ or roots of various plants. As per popular misconception, they are not derived from the usual tea plants, but rather from what are called as ‘tisanes’. There are several kinds of tisanes (herbal teas) that have been used for their medicinal properties. Some of them being consumed for its energizing properties to help induce relaxation, to curb stomach or digestive problems and also strengthen the immune system. Some of the popular herbal teas are Black tea, Green tea, Chamomile tea, Ginger tea, Ginseng tea, Peppermint tea, Cinnamon tea etc. Some of these herbal teas possess extremely strong medicinal benefits such as, Astragalus tea, a Chinese native herb that is used for its anti-inflammatory and anti-bacterial properties; which in many cases helps people living with HIV and AIDS. Demonstrating very few demerits, researchers continue to examine and vouch for the health benefits of drinking herbal teas.
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Calcium is an essential nutrient that is necessary for many functions in human health. Calcium is the most abundant mineral in the body with 99% found in teeth and bone. Only 1% is found in serum. The serum calcium level is tightly monitored to remain within normal range by a complex metabolic process. Calcium metabolism involves other nutrients including protein, vitamin D, and phosphorus. Bone formation and maintenance is a lifelong process. Early attention to strong bones in childhood and adulthood will provide more stable bone mass during the aging years. Research has shown that adequate calcium intake can reduce the risk of fractures, osteoporosis, and diabetes in some populations. The dietary requirements of calcium and other collaborative nutrients vary slightly around the world. Lactose intolerance due to lactase deficiency is a common cause of low calcium intake. Strategies will be discussed for addressing this potential barrier to adequate intake. The purpose of this narrative review is a) to examine the role of calcium in human health, b) to compare nutrient requirements for calcium across lifecycle groups and global populations, c) to review relationships between calcium intake, chronic disease risk, and fractures, and d) to discuss strategies to address diet deficiencies and lactose intolerance.
Osteoarthritis (OA) is a joint disease that most commonly accompanied with pain and joint deformity which eventually leads to disability. Burden of OA will be accounted second in women and fourth in men in Iran. Most therapies of knee osteoarthritis are symptomatic treatment. This study was designed to assess the efficacy of Glucosamine and Chondroitin sulfate in complete dose and one - third dose as a low cost protocol on treating of knee OA. Study was performed as a randomized double blind clinical trial. Symptomatic knee OA cases at Kellgren - Lawrence based stages I, II and III were enrolled in study following exclusion of systemic disease as well as joint disease. Cases were divided into 3 groups: complete dose treatment (Group I), One - third dose treatment (Group II) and placebo user (Group III). Then cases were followed for 12 weeks via Visual Analog Scale (VAS) and Western Ontario and McMaster universities (WOMAC) questionnaires associated with subsequent statistically analyzes. Statistically significant differences in the rate decline of pain, stiffness, functionality and eventually total scores as well as VAS scores were observed between both treatment groups (Group I and II) and placebo users (Group III) without any Statistically significant differences between themselves (Group I and Group II). Due to effects of Glucosamine and Chondroitin sulfate at one-third dose level recommends for OA as a low cost protocol in association with weight loss and muscles physiotherapy as well as healthy use of joints.