Tag Archives: dietary supplements

Probiotic Dietary Supplement Safety & Efficacy Is in Question

Probiotic dietary supplements have become quite popular in recent years, touted for such conditions as general health (prevention), immune health (prevention), leaky gut, diabetes mellitus, and dysbiosis from antibiotic overuse, among others.

Probiotics are generally safe for a heathy person (Generally Recognized as Safe [GRAS] per the FDA classification).  However, some live  probiotic strains may negatively play on a weakened immune system in at-risk persons,  allowing unwanted organisms to enter the body and cause pneumonia, endocarditis, or sepsis.  Probiotic supplements are not for everyone!

Activia yogurt, Yakuit yogurt, Dannon Probiotic yogurt, kefir, kimchi, sauerkraut, tempeh, miso, and kombucha are examples of food sourced-probiotics. Culturelle and Align are popular probiotic dietary supplements. Florastor is a prescription medication.  Examples of probiotic strains include, but are not limited to, bacteria (e.g. Lactobacillus, Lactococcus, Leuconostoc, Pediococcus, Bifidobacterium, Bacillus) and yeast (e.g., Saccharomyces).

It’s important to choose the right probiotic product for your health needs with the help of your pharmacist, who can thoroughly evaluate the product  before recommending it to you.  Product criteria:

  • strain identification by genome sequencing
  • transmissible antibiotic resistant gene profile
  • toxicology in vitro and in vivo studies
  • clinical studies on efficacy (how well does the product work)
  • target population (healthy  vs sick)
  • product formulation and labeling (product purity, contaminants)

If probiotic manufacturers claim to treat/prevent disease, their probiotics should be studied and marketed as drugs, rather than as  supplements, upholding FDA regulation.  Probiotics are not drugs, not magic bullets, nor are they universally safe and effective.

The appropriate probiotic strain and formulation should be recommended by your healthcare professional based on your individual health needs.

For more information or to schedule an integrative health and wellness consultation with Dr. Cathy Rosenbaum,  holistic clinical pharmacist, Certified Health Coach, Certified Dementia Practitioner, and Tai Chi Easy Practice Leader in Blue Ash OH,  please visit www.rxintegrativesolutions.com.

–Dr. Cathy Rosenbaum

 

 

 

Kothari.  Probiotic supplements might not be universally-effective and safe: A review.  Biomed Pharmacother 2019;111:537-547.

Energy Drinks – Are Those Shots Really Safe?

Beverages like Red Bull, Rockstar, Monster Energy, 5-Hour Energy, Mountain Dew Kickstart, and Full Throttle are touted to increase energy, improve mental alertness, and enhance physical endurance. Some of these products are marketed as beverages while others are marketed as dietary supplements.

According to the Center for Disease Control and Prevention, between 2007 and 2011, the number of energy drink-associated emergency room visits doubled. In 2011, one in 10 of them resulted in a hospitalization. Some college students will unsafely consume energy drinks along with alcohol or other products/drugs (e.g., marijuana, OTC or prescription medications).

Ever looked at the nutrition label on the back of one of these products? They contain more than just caffeine and sugar, namely B vitamins, amino acids (taurine and carnitine), and other dietary supplements -> green tea extract, guarana, yohimbine, green coffee bean extract, bitter orange, glucuronolactone, ginkgo biloba, and ginseng. A single 16-oz bottle may contain up to 62 grams of added sugar, more than the maximum amount recommended in one day (15 teaspoonfuls – 250 calories).

In smaller quantities, caffeine may boost energy and alertness. In larger quantities, caffeine can negatively affect the cardiovascular system. Taurine may boost metabolism. In theory, extra carnitine may impact fat burn. The body is typically not deficient in endogenous carnitine, so it’s a waste of your money. Guarana contains caffeine. Green tea extract contains caffeine and the antioxidant EGCG. Green coffee bean extract contains caffeine. Yohimbine and bitter orange are central nervous system stimulants.

Ginseng does not impact energy and may lower blood sugar in diabetics – diabetics should be careful with its use. Ginkgo biloba has not been clinical proven to improve energy. Water soluble B vitamins protect nerves but may not improve energy. Thankfully, they will be eliminated by the kidney if taken in excess.

Glucuronolactone, a component of connective tissue, is metabolized into glucuronic acid and is touted to ‘detoxify’ (what?) in the body, a nebulous claim that is unproven in humans. It has no impact on energy.

Possible side effects from energy drinks include, but are not limited to, rapid heartbeat, heart palpitations, heart attack, and headaches. Caffeine and other stimulants may also be associated with anxiety, sleep problems, digestive problems, and dehydration.

If you feel you need to consume energy drinks, a good health rule is to consume them in moderation and remember that there may be negative outcomes. Talk it over with your primary care physician. Be healthy, eat whole foods, get ample restorative sleep, and stay safe.

REFERENCES:

Higgins. Energy beverages: content and safety. May Clin Proc 2010:85:1033-1941.
Sankararaman. Impact of energy drinks on health and well-being. Current Nutrition Reports 2018;7:121-130.
Uliah. Energy drinks and myocardial infarction. Cureus 2018;10;e2658

___________________________________________

Cathy Rosenbaum PharmD RPh MBA CHC 10/12/18©

 

 

Finding Gluten-Free Nutrition, Dietary Supplements, and Medications

Non-celiac gluten intolerance and celiac disease are becoming more common. Celiac disease is a chronic autoimmune disorder caused by a genetic intolerance to gluten. Non-celiac gluten intolerance is diagnosed in people who do not have celiac disease, but have intestinal or extra-intestinal symptoms related to ingestion of gluten-containing grains.

Both conditions are treated by avoiding gluten containing foods. Finding ‘gluten free’ nutrition is becoming easier to do, but eliminating gluten from one’s diet can be a complex and time-consuming process.

Gluten is the protein component of wheat (e.g., including spelt, kamut, semolina, and triticale), barley (e.g., including malt), and rye. When a person with celiac disease or non-celiac intolerance ingests gluten, specifically the antigenic gluten constituent called gliadin, it can cause intestinal inflammation, diarrhea, abdominal pain, bloating, weight loss, fatigue, and iron deficiency anemia. Food malabsorption and nutritional deficiencies result.

Over time, these conditions can cause liver disease, defective gallbladder emptying, and osteoporosis. Celiac disease may be a reversible cause of osteoporosis. Adherence to a gluten-free diet is one way to help suffers minimize overall symptoms and to maintain maximal bone mineral density.

For perspective, oats are considered a type of gluten grain, but do not have the antigen that other gluten grains above do. Thus, oats do not induce an immune reaction in the small intestine of people with celiac disease. However, many commercial oat products are contaminated with wheat, barley, or rye and it’s important to carefully read their labels. Look for products that are certified to contain less than 20 ppm of gluten (FDA’s ‘gluten free’ definition).

Consumption of as little as 10 mg-50 mg gluten daily can lead to a clinical relapse in people with these conditions. Celiac disease may increase the risk of developing some types of cancer (e.g., T cell lymphoma and intestinal adenocarcinoma) if gluten restrictions are not maintained or gluten intake is only partly restricted.

It is important to find out where gluten resides in foods. This means not only reading food labels on products you purchase for home but also on foods you consume from fast food establishments and restaurant dining. Soups, sausages, and ice cream may contain hidden amounts of gluten as fillers. Talk with your grocer and restaurant owners before you consume questionable food items.

Watch out for the gluten content in herbs, other dietary supplements, and medications.

Gluten-Free Foods
Consuming foods certified to be ‘gluten free’ will help keep the daily gluten total to under 50 mg and not cause symptoms for most people with celiac disease. Gluten-free grains include rice, millet, corn, quinoa, sorghum, and buckwheat. For more information, visit http://glutenfreecooking.about.com/od/gettingstarted/a/hiddengluten.htm
or http://www.glutenfreeliving.com/nutrition/ingredients.

Gluten-Free Herbs and Other Dietary Supplements
It would be impossible to find information about the gluten content in over 60,000 products on the worldwide market. One can contact dietary supplement manufacturers directly for more information on gluten content before taking any of these products, including vitamins.

Gluten-Free Medications
Over-the-counter and prescription medications may contain gluten in the list of inactive ingredients. For example, sweeteners used in medications may be hidden sources of gluten. Some manufacturers cannot guarantee their medications are gluten-free because the suppliers of raw materials can not do so, making it even more difficult for consumers to figure out what is safe to take and what is not.

A great resource for determining the overall ingredient content in medications, including whether or not gluten is present, can be found online at www.glutenfreedrugs.com .

Another online medication reference comes from the National Institutes of Health at www.dailymed.nlm.nih.gov. Go to the site, type in the generic name of the medication you want to review, then scroll down to the name of the manufacturer of that particular product, then click on ‘description.’ Scroll down to the inactive ingredients and look for gluten.

A third way to find more information about your medication’s gluten content is to call the medication manufacturer directly. Be sure to have the medication’s lot number available when you call.

Finally, click on https://www.ncbi.nlm.nih.gov/pubmed/?term=Gluten+content+of+the+top+200+medications+of+2009%3A+a+follow+up+to+the+influence+of+gluten+on+a+patient%E2%80%99s+medication+choices for “Gluten content of the top 200 medications: follow up to the influence of gluten on a patient’s medication choices” by AR King in Hosp Pharm 2013:48:736-43.

By Cathy Rosenbaum PharmD MBA RPh CHC

Grapefruit Interactions with Medication

Certain prescription and/or OTC medications and dietary supplements may negatively interact with grapefruit juice, grapefruit, Seville oranges, pomelos, and tangelos due to chemicals in the fruits.

Fruit chemicals are thought to block enzymes in the body that metabolize medication in the small intestine, thereby causing the medication to hang around longer than expected. Interestingly, these fruits may also interfere with transporters in the body, causing medication to be less well absorbed into the bloodstream, and may reduce medication or supplement effects. Sound confusing? It’s complicated.

Product classes involved in unwanted interactions include, but are not limited to:

-Antihistamines (e.g., Allegra)
-Antianxiety
-Antihypertensives
-Cholesterol-lowering ‘statins’
-Corticosteroids for Crohn’s disease and ulcerative colitis
Dietary supplements

Only some of the medications and supplements in each of the categories can be affected by the fruit/juices. Every person may react differently based on the amount of fruit they consume, the medication or supplement type/dose taken, and the individual’s natural ‘enzyme levels.’

Don’t worry, but do get educated about how and when to properly take your medications and supplements to be safe. Enjoy healthy nutrition. Talk with your pharmacist about what’s best for you!

Beyond Use Dates on Prescription/OTC Medications & Dietary Supplements

Expiration dates on OTC & prescription medications and dietary supplements typically fall between 12 – 60 months after product production. Pharmaceutical manufacturers are required by law to establish these dates but do not have to study product stability and potency beyond those dates.

A recent study published in JAMA Internal Medicine using eight medications containing 15 active ingredients demonstrated product potency for decades beyond the original expiration dates. Another study in the military concluded the same results for 100 medications after 15 years.

The U. S. government has a Shelf Life Extension Program to extend dates on federal stockpiles for the military. But this is the exception to the rule in a special population to save the government money in repurchasing.

The bottom line for consumers is this – > follow the product manufacturer’s established expiration date stamped on the OTC bottle or prescription vial. Follow these same guidelines for your dietary supplements as well.

Keep all of these products in a cool, dry, dark place in your home.

Vitamins, Are They Safe?

A recent review of multiple studies indicates that mega-dosing of fat soluble vitamins (A, E, D) and some water soluble vitamins (C, folic acid) may not help prevent disease and can potentially cause harm. Please talk with your doctor or pharmacist about the right combination and dosage of multiple vitamins and other dietary supplements for your health needs. Everyone is unique and different!

– Hamishehkar, Ranjdoost, et al. Vitamins, Are They Safe? Adv Pharm Bull 2016:6(4):467-477.

Polypharmacy Is Not Jolly!

Polypharmacy Is Not Jolly! By Cathy Rosenbaum PharmD MBA RPh CHC

Hallelujah. The healing paradigm is finally shifting in the U.S. The time is ripe for doctors to rethink how they prescribe medications. Less is more. As a fellow health care professional, I believe medical students should be taught to utilize drugs sparingly, as only one of many, customizable tools in their future healing quivers.

Envision a country where you as the patient could be asked by your doctor to select from a menu of non-invasive, evidence-based holistic healing regimens when needed. That’s right, you would choose! Aromatherapy, guided imagery, spiritual retreats, Yoga, Tai Chi, personality testing, and acupuncture would be covered by insurance or included as part of your total office visit fee. Doctors would collaborate with evidence-based non-traditional medicine practitioners for your good.

Seniors over age 65 years represent 12% of the U.S. population and consume 32% of prescription medications. Many take five or more prescription medications, intentionally combining them with other over-the-counter medications and multi-ingredient dietary supplements. Boomers, we need to collectively push back against that machine.

Everything changes. Our body’s physiologic clock resets as we mature in the life journey. We become more sensitive to the effects of medications. Talk with your doctor about this list of possible options the next time you go to the office.

• Sleep Restoration – drink a cup of chamomile tea, lavender tea, or decaffeinated green tea before bedtime; try a few minutes of slow, deep breathing as you retire to inhale life-giving oxygen and calm you down from the day’s challenges
• Stress/Anxiety – repeat affirming statements about your life blessings (we all have them); read up on the benefits of acupressure
• Weight Loss – eat apples and drink water for snacks; walk around the dining room table and up/down home stairs for ½ hour a day (yes, and let your neighbors see you through the window)
• Arthritis Pain/Inflammation – talk with your doctor about the appropriateness of glucosamine HCL or turmeric dietary supplements instead of a years worth of NSAIDs like Naprosyn and Motrin that can damage the kidney, heart, and stomach
• Viral Colds – eat chicken noodle soap; try zinc lozenges, as directed on the package label, at the first sign of symptoms
• General Health – exude a positive attitude; teach your family to grow, cook, and eat from the Mediterranean diet (e.g., olive oil, colorful fruits and vegetables, moderate wine consumption, nuts); prefer whole (not processed) foods for your nutrition regimen, locally grown in your own organic garden or community supported agriculture farm

New Year’s Resolutions

Consumers:

• Let your feet do the shopping. Choose a primary care physician that thinks out of the box and is open to integrative health principles & practices (see the Academy for Integrative Health and Medicine @ www.aihm.org )
• Don’t expect to get a prescription medication every time you leave the doctor’s office
• Incorporate medicinal herbal spices and teas into your nutritional regimen for health and taste
• Take charge of holistic you in your body mind and spirit
• Get educated on the exciting integrative health and healing paradigm (visit www.NIHseniorhealth.gov, www.babyboomers.com, www.lifereimagined.com)

Physicians:

• Be aware of all medications and dietary supplements your patients are taking; supplements act like drugs and have interactions and side effects that you must acknowledge and manage
• Treat your patient as an equal partner in the decision-making process and consider his/her point of view before prescribing any medication
• Try prescription drug reduction strategies (one medication as opposed to several, lowest dose possible)
• Try drug holidays (e.g., FLEX study with Fosamax for osteoporosis)
• Try evidence-based, alternate drug regimens (e.g., every other day Zocor for high cholesterol)
• Promote healthy nutrition to your patients at every office visit; discuss connection to eating whole foods and a healthy immune system

Pharmacists:

• Explain to your patients the importance of shopping at one pharmacy for all prescription medications
• Get educated on nutrition and dietary supplements,
• Recommend medicinal herbal teas instead of OTC medications whenever appropriate
• Talk consumers out of taking antibiotics for viral infections

Summary
Integrative health and medicine is here to stay. Take a lifelong learning class in your local community. Teach your grandchildren about it as your contribution to the family legacy. Be a part of the health evolution revolution. Happy New Year!

Dr. Rosenbaum has authored and just published, Don’t Sweep It Under the Drug! Integrating Evidence-Based Body Mind & Spiritual Practices into Your Health & Wellness Tool Kit, available on www.Amazon.com. Her book is the Xulon Press Fall 2015 Second Place Winner of the Christian Authors Award, Category: Health.

The Sunshine Vitamin for Bone Health

By Cathy Rosenbaum PharmD MBA RPh
www.rxintegrativesolutions.com
July 12, 2014

Vitamin D’s Purpose

Vitamin D is found naturally in our body. It maintains normal blood concentrations of calcium and phosphorus, and helps our bones stay strong. Interestingly, the body manufactures vitamin D from cholesterol, through a process triggered in the skin by UVB rays from sunlight. Vitamin D is called ‘the sunshine vitamin.’ 

Per the Institute of Medicine, “despite the many claims of benefit surrounding vitamin D, the evidence does not support a basis for a causal relationship between vitamin D and many of the health outcomes purported to be affected by vitamin D intake.” Some of these claims yet to be proven in well designed human clinical studies include antioxidant, anti-inflammatory, and anti-cancer indications.

Reasons for Low 25-(OH)-Vitamin D Blood Levels

We require a certain level of 25-(OH)-vitamin D in the blood for health. That level can be measured by a simple blood test you can request from your doctor. If you have not yet had your blood tested or it has been awhile since your last blood level drawn, you may wish to ask your doctor to order a 25-(OH)-vitamin D level. The test will determine if you might benefit from supplementation or nutritional changes in your diet to increase vitamin D if your blood level is low (visit http://ods.od.nih.gov/factsheets/VitaminD-HealthProfessional for more information).

Since we’re talking about bone health, it is important to monitor for osteopenia or osteoporosis by way of a DEXA scan. Talk with your doctor about ordering a DEXA scan to measure bone density if you have not had one for several years (visit the National Bone Health Alliance @ www.nbha.org for more information).

25-(OH)-vitamin D blood levels may be low due to reduced exposure to sunlight (e.g., less than 20 minutes of exposure a few times a week), reduced gastrointestinal absorption or nutritional intake, Crohn’s Disease, reduced kidney conversion to the active vitamin form, or from medication interactions such as statins for cholesterol lowering (visit http://www.livestrong.com/article/282052-vitamin-d-deficiency-caused-by-prescription-medication ).

Don’t just start taking vitamin D because you think you need it. You might already be getting enough from sunlight exposure as well as your diet. The Institute of Medicine recommends 600 IU – 800 IU vitamin D3 daily from food or supplements unless otherwise directed by your doctor.

Sources of Vitamin D

Vitamin D can be found in sardines, wild salmon, herring, mushrooms exposed to UV light, fortified milk, yogurt, and breakfast cereals, egg yolks, beef liver, canned tuna, cod liver oil, and cheese.

Vitamin D2, or ergocalciferol, is the form found in prescription strength capsules.
Vitamin D3, or cholecalciferol, is the form found in most over-the-counter vitamin D products.

Vitamin D3 is also available in a variety of dietary supplements. Since there are so many different supplement doses on the market, you may wonder why some people are taking larger doses. Talk to your doctor about your individual needs. Mega doses of vitamin D can cause hypervitaminosis long term if blood levels are found to be excessive.

Side Effects

Fat soluble vitamins like vitamin D can accumulate in the body over time. Symptoms of vitamin D toxicity include headache, diarrhea, nausea, increased blood pressure, anorexia, weight loss, increased thirst, weakness, nervousness, and with long term extreme doses, abnormal heart rhythms. Many of these might not be attributed to vitamin overuse, but confused with other medical conditions. For more information on long term vitamin D safety, visit www.healthlettermayoclinic.com (Sept 2009).

Importance of Exercise for Bone Health

Finally, because bone density decreases after the age of 30 years, bone stressing exercise is important at any age and helps to preserve bone strength. The areas of risk for bone density loss include the wrists, hips, and spine. Talk with your doctor about an exercise program that is right for your individual needs.

“The light of the eyes rejoices the heart, and good news refreshes the bones.” Proverbs 15:30

The Alpha and Omega of Omega 3 Fatty Acids

Growth in the dietary supplement category over the past few years has skyrocketed with over 60,000 products available to consumers worldwide. A dietary supplement is a product that contains an ingredient intended to add further nutritional value to (i.e., to supplement) the diet, and may be one or more of the following:
• a vitamin
• a mineral
• an herb or other botanical
• an amino acid
• a concentrate, tincture, or extract

In the U.S.A., the major regulatory driver within this product category has been the Dietary Supplement Health Education Act (DSHEA) of 1994. Under this Act, supplements are presumed to be safe and do not need FDA approval before they are marketed. Supplements are regulated by the FDA as food under the Center for Safe Food and Nutrition (CSFAN), and bear a nutrition label. However, supplements are used by many like medications to treat medical conditions, and as such may have side effects and interactions that need to be managed. With regard to prevention, supplements are not a replacement for good nutrition or a healthy lifestyle including restorative sleep, exercise, emotional, social, and spiritual wisdom (Proverbs 3:1-8).

According to a survey by Bailey, et al. (JAMA Intern Med 2013;173:355), polls showed people used supplements to improve their health, to improve bone density, to lower total cholesterol levels, boost immunity, or manage joint pain from osteoarthritis. Respondents reported they took multiple vitamins, calcium, and fish oil most often, without the recommendation of a health care professional. That practice may be unsafe!

Anti-Inflammatory Fish Oil Supplements
The USDA’s 2013 Dietary Guidelines for Americans recommend that adults keep daily fat intake to a maximum of 20%-35% of total calories. Most of this fat should come from mono- and polyunsaturated fats (i.e., fish, nuts, vegetable oils).

Omega 6 and omega 3 are two essential (polyunsaturated) fatty acids (EFAs) that we must obtain from our diet. At this time, clinical studies supporting any omega 3 health benefits are inconclusive, with the exception of prescription strength Lovaza (omega 3) which is FDA approved for lowering very high triglyceride levels.

The typical American diet is rich in omega 6 essential fatty acids and lacking in omega 3 essential fatty acids. However, many foods contain both. There are three main omega 3 constituents in nature, namely eicosapentaenoic acid (EPA), docosahexaenoic acid (DHA), and alpha linolenic acid (ALA). ALA is a precursor to EPA and DHA. Our body does not metabolize ALA into EPA and DHA very well.

Foods rich in omega 6 essential fatty acids in order of decreasing content include sunflower oil, corn oil, wheat germ oil, safflower margarine, sesame oil, walnuts, avocado oil, almond oil, peanuts, peanut butter, and palm oil.

Foods rich in various types of omega 3 essential fatty acids in order of decreasing content include salmon oil, sardine oil, cod liver oil, canola oil, herring, shrimp, krill oil, flaxseed oil, and walnuts (ALA).

When purchasing fish oil-based products, make sure you check with the manufacturer to ensure they have been tested for mercury, polychlorinated biphenyls (PCBs), and other unwanted contaminants. This kind of information rarely appears on the label.

Check to see how much EPA and DHA are in that 1,000 mg dose of fish oil to assess product value before purchase. You should look for EPA and DHA as your active ingredients! If the amount of EPA plus DHA combined is 30% or less of the total dose (i.e. 300 mg in a 1,000 mg capsule) you are not getting the quality you desire for your money. Most of the rest of that dose is typically composed of omega 6 fatty acids or omega 3’s we cannot metabolize (i.e. ALA).

There are no established dietary reference intake (DRI) standards for DHA or EPA daily consumption. The Institute of Medicine suggests an intake of 160 milligrams of DHA and EPA combined each day. The American Heart Association recommends eating fatty fish at least two times each week, which is equal to about 1,250 mg DHA and EPA each day.

The European Food Safety Agency recommends 250 mg/day EPA and DHA combined for adults or 1-2 servings/week of oily fish. The World Health Organization recommends 1-2 servings of oily fish/week providing 200 mg – 500 mg/serving of EPA and DHA for the general population to prevent ischemic stroke and coronary heart disease.

Pregnant women require 200 mg of DHA daily to support fetal development. The Environmental Protection Agency advises women of childbearing age, nursing moms, and young children to consume only 2 servings per week of sardines or salmon and avoid tuna due to the methyl mercury content.

There are three grades of fish oil on the market, namely cod liver oil, health food grade fish oil, and pharmaceutical grade fish oil. Look for pharmaceutical grade omega 3 fatty acids as the highest quality of these three.

In general, please know that the dose of omega 3 that’s right for you may not be appropriate for others and could differ for diabetics and people with heart disease due to potential side effects. Talk with your physician and pharmacist about what’s best for your health needs before you purchase any dietary supplements.

By Cathy Rosenbaum PharmD MBA RPh, Rx Integrative Solutions