Banned Stimulants Remain in Supplements, Despite FDA Efforts to Remove Them

MedicalResearch.com Interview with:

Pieter Cohen, M.D. Associate Professor of Medicine Cambridge Health Alliance Assistant Professor of Medicine Harvard Medical School

Dr. Cohen

Pieter Cohen, M.D
Associate Professor of Medicine
Department of Medicine
Cambridge Health Alliance
Somerville MA 02143

MedicalResearch.com: What is the background for this study? What are the main findings?

Response: Since ephedra was banned from supplements in 2004, a variety of experimental stimulants have been introduced into sports and weight loss supplements as ephedra replacements.  The FDA has made some efforts to remove these emerging stimulants from supplements, but whether FDA action to remove these stimulants has it’s intended effect is not known.

We studied the effect of FDA action to remove four experimental stimulants from supplements.

We found that the FDA public notices did not work.  The stimulants remained in supplements even years after the FDA moved to remove them.

MedicalResearch.com: What should readers take away from your report?

Response: Given the regulatory paradigm under which supplements are sold, consumers cannot trust that they will be effective or safe.  Clinicians should understand that supplements might contain hidden ingredients that have potent drug-like effects and consider the effects of supplements when patients experience unexplained symptoms.

MedicalResearch.com: What recommendations do you have for future research as a result of this work? 

Response: One of the most concerning findings was that one stimulant appeared in the supplements analyzed only after the FDA warned that it was not permitted to be sold in supplements. Future studies should investigate whether FDA announcements regarding new experimental stimulants might have the unintended consequence of firms learning about the stimulant and then adding it to their supplements.

Disclosures: Dr Cohen was subject of a civil suit brought by Hi-Tech Pharmaceuticals, a supplement company, regarding β-methylphenylethylamine;  The jury found in Dr Cohen’s favor. Dr Cohen has collaborated in research with NSF International and received research support from Consumers Union. No other disclosures were reported.

Citation:

Cohen PA, Wen A, Gerona R. Prohibited Stimulants in Dietary Supplements After Enforcement Action by the US Food and Drug Administration. JAMA Intern Med. Published online October 22, 2018. doi:10.1001/jamainternmed.2018.4846

Oct 23, 2018 @ 2:33 pm

 

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Cardiac Stimulant Found in Some OTC Supplements

MedicalResearch.com Interview with:

Pieter Cohen, M.D. Associate Professor of Medicine Cambridge Health Alliance Assistant Professor of Medicine Harvard Medical School

Dr. Cohen

Pieter Cohen, M.D.
Associate Professor of Medicine
Cambridge Health Alliance
Assistant Professor of Medicine
Harvard Medical School

MedicalResearch.com: What is the background for this study?

Response: Dietary supplements lead to an estimated 23,000 emergency department visits each year in the United States (US), and weight loss and sports supplements contribute to a disproportionately large number of these emergency department visits. It is not known which ingredients in weight loss and sports supplements pose the greatest risk to consumers, but there are stimulants found in botanical remedies that might pose risks.

In the current study, we investigated the presence and quantity of higenamine a stimulant found in botanicals and available in sports and weight loss supplements sold in the US.

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Cystic Fibrosis: Antioxidant-Enriched MVI May Decrease Respiratory Illnesses

MedicalResearch.com Interview with:

Scott D Sagel MD PhD Professor of Pediatrics University of Colorado School of Medicine Aurora, Colorado

Dr. Sagel

Scott D Sagel MD PhD
Professor of Pediatrics
University of Colorado School of Medicine
Aurora, Colorado

MedicalResearch.com: What is the background for this study?

Response: Inflammation is an important feature of cystic fibrosis (CF) lung disease and contributes to lung damage and lung function decline in CF. We need safe and effective anti-inflammatory treatments in CF. Anti-oxidant therapy has been an area of promise, but with mixed results in CF.

This clinical trial, conducted at 15 CF centers affiliated with the cystic fibrosis Foundation Therapeutics Development Network, enrolled 73 patients who were 10 years and older (average age 22 years), with pancreatic insufficiency, which causes malabsorption of antioxidants. Subjects were randomized to either a multivitamin containing multiple antioxidants including carotenoids such as beta(β)-carotene, tocopherols (vitamin E), coenzyme Q10 (CoQ10), and selenium or to a control multivitamin without antioxidant enrichment. The antioxidants used in the study were delivered in a capsule specifically designed for individuals with difficulties absorbing fats and proteins, including those with cystic fibrosis.

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Think Vitamin Supplements Improve Your Heart Health? Think Again!

MedicalResearch.com Interview with:
“Pills Vitamins Macro April 22, 2012 4” by Steven Depolo is licensed under CC BY 2.0David J.A. Jenkins, MD, PhD, DSc
Professor and Canada Research Chair in Nutrition and Metabolism
Department of Nutritional Sciences
University of Toronto 

MedicalResearch.com: What is the background for this study?

Response: The study was requested by the editor of JACC (Dr. Valentin Fuster) due to the widespread use of vitamin and mineral supplementation by the public and the requirement to know if there were any benefits or harms for cardiovascular disease.

Our study was a follow-up to the US Preventive Services Task Force 2013 recommendations.

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Could Some Iron Supplements Raise Your Risk of Colon Cancer?

MedicalResearch.com Interview with:

Nathalie Scheers PhD Asst. Professor Chalmers University of Technology Dept of Biology and Biological Engineering Food and Nutrition Science Göteborg, Sweden 

Dr. Scheers

Nathalie Scheers PhD
Asst. Professor
Chalmers University of Technology
Dept of Biology and Biological Engineering
Food and Nutrition Science
Göteborg, Sweden 

MedicalResearch.com: What is the background for this study? What are the main findings?

Response: Many different forms of iron supplements are used to treat iron deficiency symptoms or as phosphate binders in patients with renal disease. two of these iron supplements, the chelates ferric citrate and ferric EDTA have been observed to drive colon cancer in mice. In the newly published study in Oncotarget, we are reporting our work on how these iron compounds differ compared to the simple salt ferrous sulphate, which is another common iron supplement.

The main finding of this study was that ferric citrate and ferric EDTA promoted the cancer biomarker amphiregulin which in turn activated the MAP kinase ERK in gut epithelial cancer cells. There were no such effects in ferrous sulphate-treated cells.  Continue reading

Review Finds Antioxidant Supplements of Little to No Benefit in Exercise Recovery

MedicalResearch.com Interview with:
“Pills Vitamins Macro April 22, 2012 4” by Steven Depolo is licensed under CC BY 2.0
Dr Mayur Ranchordas, SFHEA
Senior Lecturer in Sport Nutrition and Exercise Metabolism
Sport Nutrition Consultant
Chair of the Sport and Exercise Research Ethics Group
Sheffield Hallam University
Academy of Sport and Physical Activity
Faculty of Health and Wellbeing
Sheffield

MedicalResearch.com: What is the background for this study? 

Response: People engaging in intense exercise often take antioxidant supplements, such as vitamin C and/or E or antioxidant-enriched foods, before and after exercise in the anticipation that these will help reduce muscle soreness. In a new review published in the Cochrane Library we looked at the evidence from 50 studies. These all compared high-dose antioxidant supplementation with a placebo and their participants all engaged in strenuous exercise that was sufficient to cause muscle soreness. Of the 1089 participants included in the review, nearly nine out of ten of these were male and most participants were recreationally active or moderately trained.

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Prebiotin™ Fiber Supplement Tested in NIH/NIDDK Pilot Study In End-Stage Kidney Disease Patients

MedicalResearch.com Interview with:

Ron Walborn Jr. Prebiotin CEO

Ron Walborn Jr.

Ron Walborn Jr.
Prebiotin CEO 

MedicalResearch.com: What is the background for this study? What are the main findings?

Response: The product Prebiotin™ Prebiotic Fiber was brought to market in 2007 by Dr. Frank Jackson, a gastroenterologist out of Harrisburg, PA. He found through 40 years of experience with his patients that a variety of digestive issues benefitted from daily supplementation with a soluble prebiotic fiber, specifically, oligofructose-enriched inulin (OEI) derived from chicory root.

In the late summer of 2012, Prebiotin caught the attention of Dr. Dominic Raj at the Internal Medicine Department of George Washington University. Dr. Raj’s laboratory showed that patients with kidney disease may have a higher level of release of endotoxins like p-Cresol sulfate and indole from the bacteria in the gut, which can move into the bloodstream and promote inflammation.

This early work was the basis of a successful grant application. Researchers were interested in investigating the therapeutic potential of altering the composition and/or function of the gut microbiome in this patient population, based on the understanding that by building up the levels of healthy bacteria in the gut, undesirable bacteria is eventually crowded out, thereby reducing the release of harmful endotoxins into the system.

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Neither Vitamin E or Selenium Found To Prevent Dementia

MedicalResearch.com Interview with:

Richard J. Kryscio, Ph.D. Statistics and Chair, Biostatistics and Sanders-Brown Center on Aging Sanders-Brown Center on Aging University of Kentucky

Dr. Richard Kryscio

Richard J. Kryscio, Ph.D.
Statistics and Chair, Biostatistics and Sanders-Brown Center on Aging
Sanders-Brown Center on Aging
University of Kentucky 

MedicalResearch.com: What is the background for this study?

Response: At the time the trial was initiated (2002), there was ample evidence that oxidative stress is an important mechanism in brain aging. Research showed that protein oxidation is linked to the brain’s response to the abnormal proteins seen in Alzheimer disease (amyloid beta plaques in particular) leading to inflammation, DNA repair problems, reduced energy production, and other cellular changes that are identified mechanisms in the Alzheimer brain.

Both vitamin E and selenium are antioxidants. Antioxidants, either through food or supplements, are believed to reduce oxidative stress throughout the body. In the brain, they may reduce the formation of amyloid beta plaques, reduce brain inflammation, and improve other brain processes. Studies in humans support these hypotheses. The Rotterdam study in the Netherlands, as an example, showed that initial blood levels of vitamin E could predict dementia risk. Those people with higher vitamin E levels were 25% less likely to develop dementia. Also, selenium deficiency results in cognitive difficulties and several population-based studies have shown an association between selenium level and cognitive decline (lower selenium levels are linked to thinking changes in the elderly).
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Use of Health Supplements Varies By Age Group

MedicalResearch.com Interview with:

Elizabeth D. Kantor, PhD MPH Department of Epidemiology and Biostatistics Memorial Sloan Kettering Cancer Center NY, NY

Dr. Elizabeth D. Kantor

Elizabeth D. Kantor, PhD MPH
Department of Epidemiology and Biostatistics
Memorial Sloan Kettering Cancer Center
NY, NY

MedicalResearch.com: What is the background for this study?

Response: Prior studies show that use of supplements increased between the 1980s and mid-2000s, and despite much research conducted on the health effects of supplements, we know little about recent trends in use.

Given this gap, we decided to create an up-to-date, comprehensive resource on the prevalence and trends of supplement use among US adults using nationally representative data from the National Health and Nutrition Examination Survey (NHANES). Data were collected over seven continuous cycles (from 1999-2000 to 2011-2012).

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Complex Dietary Supplement Abolishes Brain Cell Loss in Mice

MedicalResearch.com Interview with:

Jennifer Lemon, PhD Research Associate Medical Radiation Sciences McMaster University

Dr. Jennifer Lemon

Jennifer Lemon, PhD
Research Associate
Medical Radiation Sciences
McMaster University

MedicalResearch.com: What is the background for this study?

Dr. Lemon: Research with the supplement began in 2000, as part of my doctoral degree; we developed the supplement to try to offset the severe cognitive deterioration and accelerated aging in a mouse model we were working with in the lab. Based on aging research, five mechanisms appeared to be key contributors to the process of aging; those include oxidative stress, inflammation, mitochondrial deterioration, membrane dysfunction and impaired glucose metabolism. The criteria we used for including components in the supplement were as follows: each one of the 30 components had scientific evidence to show they acted on one or more of the above mechanisms were able to be taken orally, and were available to humans over-the-counter. Even then the hope was that if the formulation was successful, this would make it more available to the general public.

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Many Patients Do Not Tell Their Primary Care Physician About Alternative Medicine Use

MedicalResearch.com Interview with:

Judy Jou, MA PhD Candidate PhD Candidate in Health Services Research, Policy, & Administration Division of Health Policy and Management University of Minnesota, Twin Cities Minneapolis, MN

Judy Jou

Judy Jou, MA PhD Candidate
PhD Candidate in Health Services Research, Policy, & Administration
Division of Health Policy and Management
University of Minnesota, Twin Cities
Minneapolis, MN 

MedicalResearch.com: What is the background for this study? What are the main findings?

Response:  Use of complementary and alternative medicine (CAM) is rising among U.S. adults, but CAM is often poorly integrated into patients’ treatment and self-care routines. We analyzed nearly 7,500 responses from the 2012 National Health Interview Survey (NHIS) and found that over two-fifths of U.S. adults who used CAM during the past year did not disclose their complementary and alternative medicine use to their primary health care providers, with rates of disclosure varying by the type of CAM used. We also examined reasons for non-disclosure and found that, in contrast to prior studies, lack of provider-initiated conversation about  complementary and alternative medicine was the most commonly cited reason, rather than patients’ concerns about negative reactions from their providers regarding their complementary and alternative medicine use.

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Study Finds No Evidence of Benefit from Chromium Supplements

Prof. Peter Lay PhD Professor of Inorganic Chemistry School of Chemistry | Faculty of Science Director, Vibrational Spectroscopy Core Facility Research Portfolio The University of Sydney

Prof. Peter Lay

MedicalResearch.com Interview with:
Prof. Peter Lay PhD

Professor of Inorganic Chemistry
School of Chemistry | Faculty of Science
Director, Vibrational Spectroscopy Core Facility
Research Portfolio
The University of Sydney

Medical Research: What is the background for this study? What are the main findings?
Response: My group has been studying the molecular mechanisms of chromium(VI)-induced cancers and the biochemistry of vanadium over the last three decades. Vanadium drugs have been in clinical trials for their anti-diabetic effects that occur via species with very similar chemistry to chromium(VI).  The more we understood the biochemistry of each, the more we questioned whether the efficacies of anti-diabetic chromium(III) supplements were associated with the generation of carcinogenic chromium(VI) and chromium(V). To test this, we conducted experiments to either provide evidence for our hypothesis or disprove it.  This work commenced some 15 years ago with studies on the changes in the nature of chromium(III) supplements exposed to simulated gastrointestinal juices, as well as in human and animal blood serum over times that mimicked the residence time of the supplements in the human body.

We discovered that all supplements were changed to a range of different Cr(III) species in both the GI tract and the blood.1,2  Common species were observed, but the rates at which they formed were dependent on the nature of the chromium(III) supplement.  Both the supplements themselves and the chromium(III) species that formed in blood serum were partially oxidised to Cr(VI) at concentrations of the oxidant, hydrogen peroxide (a type of bleach), found in the blood of people with type II diabetes.1,2 One of the clinical features of patients with type II diabetes is increased levels of oxidants, such as hydrogen peroxide, in their blood and cells. These oxidants are associated with many of the side-effects of type II diabetes that are associated with reduced life expectancy.

These transformed chromium(III) species bound to blood proteins were more easily oxidised to chromium(VI) than the administered Cr(III) supplements.  The faster a particular chromium(III) supplement reacted with blood proteins to form these easily oxidised chromium(III)-protein species, the more active was the Cr(III) supplement in its anti-diabetic activity in animal and human studies reported by other groups.1-5  According to many health and regulatory bodies, chromium(III) has minimal or no efficacy in glucose metabolism and no other beneficial effects, such as weight loss or muscle building, in well conducted human and animal trials with non-diabetic subjects. This is consistent with our proposed mechanism of action. It is only under oxidising physiological conditions associated with type II diabetes that chromium(III) can be partially transformed to sufficient concentrations of carcinogenic chromium(VI) to enable significant biological activity.  In a large clinical trial where diabetic patients were treated with high doses of chromium(III) picolinate (one of the least efficacious supplements in animal studies), there was no efficacy in patients with controlled type II diabetes. Only those patients with uncontrolled type II diabetes exhibited improved glucose metabolism.  These patients, who have the highest concentrations of oxidants with the ability to transform chromium(III) to chromium(VI) in blood, are therefore at the greatest risk of developing Cr-induced cancers. Even where efficacy was observed, glucose metabolism was only reduced to the levels in patients with controlled type II diabetes; i.e., no patients exhibited a return to normal glucose metabolism.4,5

Coupled with all of this information our separate studies showed that chromium(VI) and chromium(V), but not chromium(III), are strong inhibitors of protein tyrosine phosphatase (PTP) enzymes.  The relevance of this is that drugs that inhibit PTPs activate circulating insulin in people with type II diabetes.  That is, it causes insulin to bind more strongly to cells involved in glucose metabolism (such as fat cells) to bring about the cascade of biochemical reactions that import glucose into cells and metabolise it.1-5

Thus we were able to link all of the animal, human and in vitro studies to show that physiological conditions under which chromium(III) had the highest probability of being transformed to chromium(VI) were also those in which chromium(III) supplements were most active.1-5 Moreover, we were able to provide a mechanism of activity that required chromium(VI) and chromium(V) to be generated for insulin enhancing activity.1-5  What remained was to establish whether we could observe Cr(VI) and Cr(V) in cells treated with chromium(III) supplements. This has now been established in our most recent study6 that have just been published. Contrary to the press releases of the dietary supplement industry, the published paper was carefully planned to mimic those conditions found in vivo.  The chromium(III) supplement chosen was that which had a chemical structure most closely resembling those generated in blood plasma. Thus we were able to complete the circle in linking our extensive studies on the biochemistry of chromium(III) species generated from chromium(III) supplements in the blood and show that such species were absorbed by the relevant cells and partially oxidised to chromium(VI) and chromium(V).

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Men’s Supplements Never Tested Despite Marketed as “Clinically Proven”

Dr. Nicholas G. Zaorsky MD Resident Physician, Radiation Oncology Fox Chase Cancer Center

Dr. Nicholas Zaorsky

MedicalResearch.com Interview with:
Dr. Nicholas G. Zaorsky MD
Resident Physician, Radiation Oncology
Fox Chase Cancer Center

Medical Research: What was the motivation for your studies?

Dr. Zaorsky: Men often walk down grocery store aisles and see bottles of pills labeled “men’s health” or “prostate health.” We call these pills “men’s health supplements.” Our goal is to determine what effect (if any) these pills have on the cancer that men are most commonly diagnosed with – that is, prostate cancer.

Medical Research: What is the significance of these findings in simple terms? What are the implications for human health? What would you hope a general audience might take away from these findings?

Dr. Zaorsky:  Men with prostate cancer commonly use these pills because of the high incidence of prostate cancer (about 1 in 6 men will be diagnosed with the disease), the stress associated with the diagnosis, the desire to benefit from all potential treatments, and the limited regulation on marketing and sale of the supplements.  Many men believe the supplements will help their cancer or (at worst) do nothing – so what’s the harm?  We found that men’s health supplements have no effect on curing prostate cancer treated with radiation therapy (a common treatment option). Men who took these pills also had no difference in their side effects during or after treatment.  Although we did not see a change in side effects, there have been thousands of cases in the US where supplements have harmed patients.

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Calcium Supplements Linked To Increased Risk of Kidney Stones

MedicalResearch.com Interview with:
Christopher Loftus M.D. candidate
Cleveland Clinic Lerner College of Medicine

Medical Research: What is the background for this study? What are the main findings?

Response: Most kidney stones are made, at least partially, of calcium composite. In a prospective study of nurses in the post-menopausal age, it was found that diets that contained high amounts of calcium were beneficial in preventing kidney stones in this population. In the gut, calcium can bind to oxalate which prevents it from being absorbed into the body and decreases the concentration of calcium in the urine. However there has been debate as to whether supplemental calcium (calcium pills) has the same beneficial effects as calcium in the diet. Supplemental calcium enters the gut in large quantities all at once so it may enter the blood stream in higher concentrations over smaller amounts of time. By the same token, vitamin D plays a role in the management and balance of calcium in the body and could potentially have an effect on stone formation as well.  It has also been debated whether vitamin D supplementation has major effect on patients who are known to be stone formers.  So we reviewed CT scans of patients and 24 hour urine collections (both male and female of adult age) who were known to have kidney stones and measured the growth of stones over a period of time.

Our main findings were that supplementary calcium increased the rate of stone formation in these patients. We also found that vitamin D had a protective effect and patients taking only vitamin D had a slower rate of stone progression.

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Weight Loss and Dietary Supplements Linked To Thousands Of Emergency Room and Hospital Stays Annually

Andrew I. Geller, MD Medical Officer in the Division of Healthcare Quality Promotion at CDC.

Dr. Andrew Geller

MedicalResearch.com Interview with:
Andrew I. Geller, M.D
From the Division of Healthcare Quality Promotion
Centers for Disease Control and Prevention

Medical Research: What is the background for this study? What are the main findings?

Dr. Geller: In recent years some dietary supplement products have been recalled for having unapproved ingredients or contaminants, but there is very little national data about how frequently dietary supplements that are not included in such recalls cause health problems. This study looks at how often people went to emergency departments (EDs) for problems caused by dietary supplements.

  • Supplements include herbals, complementary nutritionals (such as amino acid supplements), and vitamins and minerals.
  • We studied records from 63 emergency departments from 2004-2013.
  • We calculate that every year, dietary supplements cause:
  • More than 23,000 ED visits, and
  • More than 2,000 hospitalizations.
  • More than a quarter (28%) of these ED visits were among young adults (20-34 years).
  • More than half (56%) of the ED visits made by young adults were for problems with products for weight loss or increased energy.
  • Cardiac symptoms (irregular/fast heartbeat or chest pain) were common among patients with weight loss or energy supplement problems.
  • More than 20% were young children who got into supplements meant for someone else.
  • ED visits were less common among older adults, but more than 1 in 3 (36%) of these ED visits by older adults were for swallowing problems, such as choking on a pill, most commonly vitamin/mineral supplements.

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Creatine Supplement Increased Muscle Mass But Not Strength or Function in RA Patients

Prof. Andrew B Lemmey School of Sport, Health and Exercise Sciences Bangor University Bangor, Gwynedd, Wales, UKMedicalResearch.com Interview with:
Prof. Andrew B Lemmey

School of Sport, Health and Exercise Sciences
Bangor University
Bangor, Gwynedd, Wales, UK

Medical Research: What is the background for this study?

Prof. Lemmey: Substantial loss of lean mass (LM; mostly skeletal muscle) is common in patients with rheumatoid arthritis (RA), as we and others have shown that even amongst patients with well-controlled disease approximately 67% are significantly muscle wasted. This loss of muscle, termed “rheumatoid cachexia”, is a major contributor to the decreased strength and impaired physical function which continues to characterise RA. Unfortunately, current drug treatments for RA, including use of biologics and the ‘treat-to-target (T2T)’ strategy, do not reverse this LM loss, nor fully restore physical function (Lemmey et al., “Tight control of disease activity fails to improve body composition or physical function in rheumatoid arthritis patients”. Submitted to Rheumatology (Oxford), currently under review). Whilst high-intensity exercise (specifically, progressive resistance training (PRT)) has been shown to be highly effective in restoring both  lean mass and function in  rheumatoid arthritis patients (Lemmey et al., Arthritis Care & Research 2009;61(12):1726-34), the lack of uptake and adherence to sufficiently intense training (Lemmey et al., Arthritis Care & Research 2012;64(1):71-5) means this form of therapy is not widely adopted. Anabolic nutritional supplementation offers a potential adjunct treatment intervention for increasing LM, and thereby improving physical function, that could be widely accepted. Indeed, our group (Marcora et al., Clinical Nutrition 2005;24(3):442-54) has previously demonstrated that 12 weeks of daily oral protein supplementation improved lean mass and some measures of strength and function in  rheumatoid arthritis patients.

Creatine (Cr) is a popular dietary supplement generally shown to have greater benefits on both lean mass and physical function than generic protein supplementation. One study (Willer et al., Rheumatology 2000;39(3):293-8) has investigated the efficacy of Cr supplementation in rheumatoid arthritis patients. In this short uncontrolled trial, twelve patients underwent 3 weeks of supplementation, and although strength increased, no changes in function were found, and body composition changes were not investigated.

Using a double-blind, placebo controlled design, the current study aimed to investigate the effects of 12 weeks of oral Cr supplementation on body composition (by DXA; dual energy X-ray absorptiometry), strength (knee-extensor and handgrip) and objectively-assessed physical function (chair and walk tests) in patients with RA. Thirty-five patients (Cr=15, Pl=20) completed the study.  Continue reading

Nutritional Supplementation Enhanced Pressure Ulcer Healing

MedicalResearch.com Interview with:
Emanuele Cereda, MD, PhD
Servizio di Dietetica e Nutrizione Clinica, Fondazione IRCCS Policlinico
San Matteo, Pavia, Italy and
Federico D’Andrea MD
SCDO Dietetica e Nutrizione Clinica, Azienda Ospedaliera Universitaria “Maggiore della Carità”, Novara, Italy

MedicalResearch: What is the background for this study? What are the main findings?

Response: Pressure ulcers (PUs) represent an important indicator of patient safety and quality of care. They negatively affect patient quality of life and increase healthcare costs. PUs are closely linked to malnutrition as it contributes not only to their development but also to impaired healing. Pressure ulcers patients are frequently unable to meet energy requirements through spontaneous feeding and nutritional support becomes essential. International guidelines currently recommend nutritional assessment and nutritional support as most Pressure ulcers patients can take advantage from adequate supply of proteins and calories. Beside, recent studies have suggested that additional provision of larger amount of some nutrients putatively involved in wound healing – arginine, zinc and antioxidants – may be of additional benefit. The OEST study has specifically investigated the role of these nutrients and has demonstrated that supplementation of malnourished Pressure ulcers patients with an oral nutritional formula enriched with arginine, zinc and antioxidants improves Pressure ulcers healing, independently of the adequate supply of proteins and calories. Continue reading

More Women Of Reproductive Age Need Folic Acid To Prevent Birth Defects

Jennifer Williams MSN, MPH, FNP-BC National Center on Birth Defects and Developmental Disabilities CDC, Atlanta, Georgia MedicalResearch.com Interview with:
Jennifer Williams MSN, MPH, FNP-BC

National Center on Birth Defects and Developmental Disabilities
CDC, Atlanta, Georgia

Medical Research: What is the background for this study? What are the main findings?

Response: Neural tube defects are serious birth defects of the brain and spine that can cause significant disability and death. Studies have shown that taking 400 mcg of folic acid daily before and during pregnancy can reduce the prevalence of neural tube defects. Therefore, in 1992, the US Public Health Service (USPHS) recommended that all women of childbearing age in the United States who are capable of becoming pregnant consume 400mcg of folic acid per day to reduce the risk of neural tube defects. To help women meet this requirement, in 1998 the US Food and Drug Administration (FDA) mandated that folic acid be added to enriched grain products for the prevention of neural tube defects.

This study looks at how many neural tube defects have been prevented annually since folic acid fortification. Using data from birth defects tracking systems, researchers found that since folic acid fortification, the birth prevalence of neural tube defects has decreased by 35% in the United States, which translates to about 1,300 babies that are born each year without a neural tube defect who might otherwise have been affected.  This study also reports that the number of babies born with a neural tube defect annually differs by the mother’s race/ethnicity. Hispanic mothers continue to be at the highest risk for having a baby with a neural tube defect.

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St. John’s Wort May Cause Dangerous Drug Interactions

MedicalResearch.com Interview with:
Scott A. Davis, MA
Research Administrative Coordinator
Department of Dermatology
Wake Forest School of Medicine

MedicalResearch: What are the main findings of the study?

Answer: St. John’s wort (SJW), a common complementary and alternative medicine (CAM) treatment for depression, is frequently used together with drugs that may interact dangerously with it. In data from the 1993-2010 National Ambulatory Medical Care Survey, a nationally representative survey of physician visits from the National Center for Health Statistics, SJW was prescribed together with drugs such as selective serotonin reuptake inhibitors (SSRIs), benzodiazepines, warfarin, statins, digoxin, verapamil, and oral contraceptives. Using SJW together with other antidepressants may cause serotonin syndrome, a potentially fatal condition.
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