Coenzyme Q10 is sold as a dietary supplement.

Questions and Answers About (Ubi Q) Coenzyme Q ₁₀

1. What is coenzyme Q₁₀?

Coenzyme Q ₁₀ is a compound that is made naturally in the body. The Q and the 10 in coenzyme Q₁₀ refer to the groups of chemicals that make up the coenzyme. Coenzyme Q₁₀ is also known by these other names:

• CoQ₁₀.
• Q₁₀.
• Vitamin Q₁₀.
• Ubiquinone.
• Ubidecarenone.

A coenzyme helps an enzyme do its job. An enzyme is a protein that speeds up the rate at which natural chemical reactions take place in cells of the body. The body's cells use coenzyme Q₁₀ to make energy needed for the cells to grow and stay healthy. The body also uses coenzyme Q₁₀ as an antioxidant. An antioxidant is a substance that protects cells from chemicals called free radicals. Free radicals can damage DNA (deoxyribonucleic acid). Genes, which are pieces of DNA, tell the cells how to work in the body and when to grow and divide. Damage to DNA has been linked to some kinds of cancer. By protecting cells against free radicals, antioxidants help protect the body against cancer.

Coenzyme Q₁₀ is found in most body tissues. The highest amounts are found in the heart, liver, kidneys, and pancreas. The lowest amounts are found in the lungs. The amount of coenzyme Q₁₀ in tissues decreases as people get older.

2. What is the history of the discovery and use of coenzyme Q₁₀ as a complementary or alternative treatment for cancer?

Coenzyme Q₁₀ was first identified in 1957. Its chemical structure was determined in 1958. Interest in coenzyme Q₁₀ as a possible treatment for cancer began in 1961, when it was found that some cancer patients had a lower than normal amount of it in their blood. Low blood levels of coenzyme Q₁₀ have been found in patients with myeloma, lymphoma, and cancers of the breast, lung, prostate, pancreas, colon, kidney, and head and neck.

Studies suggest that coenzyme Q₁₀ may help the immune system work better. Partly because of this, coenzyme Q₁₀ is used as adjuvant therapy for cancer. Adjuvant therapy is treatment given following the primary treatment to increase the chances of a cure.

3. What is the theory behind the claim that coenzyme Q₁₀ is useful in treating cancer?

Coenzyme Q₁₀ may be useful in treating cancer because it boosts the immune system. Also, studies suggest that CoQ₁₀ analogs (drugs that are similar to CoQ₁₀) may prevent the growth of cancer cells directly. As an antioxidant, coenzyme Q₁₀ may help prevent cancer from developing.

Refer to the PDQ health professional summary on Coenzyme Q10 for more information on the theory behind the study of coenzyme Q₁₀ in the treatment of cancer.

4. How is coenzyme Q₁₀ administered?

Coenzyme Q₁₀ is usually taken by mouth as a pill (tablet or capsule). It may also be given by injection into a vein (IV). In animal studies, coenzyme Q₁₀ is given by injection.

5. Have any preclinical (laboratory or animal) studies been conducted using coenzyme Q₁₀?

A number of preclinical studies have been done with coenzyme Q₁₀. Research in a laboratory or using animals is done to find out if a drug, procedure, or treatment is likely to be useful in humans. These preclinical studies are done before any testing in humans is begun. Most laboratory studies of coenzyme Q₁₀ have looked at its chemical structure and how it works in the body. The following has been reported from preclinical studies of coenzyme Q₁₀ and cancer:

• Animal studies found that coenzyme Q₁₀ boosts the immune system and helps the body fight certain infections and types of cancer.
• Coenzyme Q₁₀ helped to protect the hearts of study animals that were given the anticancer drug doxorubicin, an anthracycline that can cause damage to the heart muscle.
• Laboratory and animal studies have shown that analogs of coenzyme Q₁₀ may stop cancer cells from growing.
5. Have any clinical trials (research studies with people) of coenzyme Q₁₀ been conducted?

There have been no well-designed clinical trials involving large numbers of patients to study the use of coenzyme Q₁₀ in cancer treatment. There have been some clinical trials with small numbers of people, but the way the studies were done and the amount of information reported made it unclear if benefits were caused by the coenzyme Q₁₀ or by something else. Most of the trials were not randomized or controlled. Randomized controlled trials give the highest level of evidence:

• In randomized trials, volunteers are assigned randomly (by chance) to one of 2 or more groups that compare different factors related to the treatment.
• In controlled trials, one group (called the control group) does not receive the new treatment being studied. The control group is then compared to the groups that receive the new treatment, to see if the new treatment makes a difference.

Some research studies are published in scientific journals. Most scientific journals have experts who review research reports before they are published, to make sure that the evidence and conclusions are sound. This is called peer review. Studies published in peer-reviewed scientific journals are considered better evidence. No randomized clinical trials of coenzyme Q₁₀ as a treatment for cancer have been published in a peer-reviewed scientific journal.

The following has been reported from studies of coenzyme Q₁₀ in people:

Randomized trial of coenzyme Q₁₀ and doxorubicin

A randomized trial of 20 patients looked at whether coenzyme Q₁₀ would protect the heart from the damage caused by the anthracycline drug doxorubicin. The results of this trial and others have shown that coenzyme Q₁₀ decreases the harmful effects of doxorubicin on the heart.

Studies of coenzyme Q₁₀ as an adjuvant therapy for breast cancer

Small studies have been done on the use of coenzyme Q₁₀ after standard treatment in patients with breast cancer:

• In a study of coenzyme Q₁₀ in 32 breast cancer patients, it was reported that some signs and symptoms of cancer went away in 6 patients. Details were given for only 3 of the 6 patients. The researchers also reported that all the patients in the study used less pain medicine, had improved quality of life, and did not lose weight during treatment.

• In a follow-up study, two patients who had breast cancer remaining after surgery were treated with high doses of coenzyme Q₁₀ for 3 to 4 months. It was reported that after treatment with high-dose coenzyme Q₁₀, the cancer was completely gone in both patients.

• In a third study led by the same researchers, 3 breast cancer patients were given high-dose coenzyme Q₁₀ and followed for 3 to 5 years. The study reported that one patient had complete remission of cancer that had spread to the liver, another had remission of cancer that had spread to the chest wall, and the third had no breast cancer found after surgery.

It is not clear, however, if the benefits reported in these studies were caused by coenzyme Q₁₀ therapy or something else. The studies had the following weaknesses:

• The studies were not randomized or controlled.
• The patients used other supplements in addition to coenzyme Q₁₀.
• The patients received standard treatments before or during the coenzyme Q₁₀ therapy.
• Details were not reported for all patients in the studies.

Anecdotal reports of coenzyme Q₁₀

Anecdotal reports are incomplete descriptions of the medical and treatment history of one or more patients. There have been anecdotal reports that coenzyme Q₁₀ has helped some cancer patients live longer, including patients with cancers of the pancreas, lung, colon, rectum, and prostate. The patients described in these reports, however, also received treatments other than coenzyme Q₁₀, including chemotherapy, radiation therapy, and surgery.

7. Have any side effects or risks been reported from coenzyme Q₁₀?

No serious side effects have been reported from the use of coenzyme Q₁₀. The most common side effects include the following:

• Insomnia (being unable to fall sleep or stay asleep).
• Higher than normal levels of liver enzymes.
• Rashes.
• Nausea.
• Pain in the upper part of the abdomen.
• Dizziness.
• Feeling sensitive to light.
• Feeling irritable.
• Headache.
• Heartburn.
• Feeling very tired.

It is important to check with health care providers to find out if coenzyme Q₁₀ can be safely used along with other drugs. Certain drugs, such as those that are used to lower cholesterol, blood pressure, or blood sugar levels, may decrease the effects of coenzyme Q₁₀. Coenzyme Q₁₀ may change way the body uses warfarin (a drug that prevents the blood from clotting) and insulin.

As noted in Question 1, the body uses coenzyme Q₁₀ as an antioxidant. Antioxidants protect cells from free radicals. Some conventional cancer therapies, such as anticancer drugs and radiation treatment, kill cancer cells in part by causing free radicals to form. Researchers are studying whether using coenzyme Q₁₀ along with conventional therapies has any effect, good or bad, on the way these conventional therapies work in the body.

8. Is coenzyme Q₁₀ approved by the US Food and Drug Administration (FDA) for use as a cancer treatment in the United States?

Coenzyme Q₁₀ is sold as a dietary supplement and is not approved by the FDA for use as a cancer treatment. In the United States, dietary supplements are regulated as foods, not drugs. This means that approval by the FDA is not required before coenzyme Q₁₀ is sold, unless specific health claims are made about the supplement. Also, the way companies make coenzyme Q₁₀ is not regulated. Different batches and brands of coenzyme Q₁₀ supplements may be different from each other.

NUCARNIT:-L-carnitine, acetyl-L-carnitine, and propionyl-L-carnitine are available over-the-counter as dietary supplements

Carnitine (NUCARNIT)

Office of Dietary Supplements • National Institutes of Health

Table of Contents Carnitine: What is it? What are recommended intakes for carnitine? What foods provide carnitine? Absorption and metabolism of carnitine When can a carnitine deficiency occur? What are some current issues and controversies about carnitine? Are there health risks from too much carnitine? Carnitine and medication interactions Supplemental sources of carnitine Carnitine intakes and healthful diets References Reviewers Carnitine: What is it? Carnitine, derived from an amino acid, is found in nearly all cells of the body. Its name is derived from the Latin carnus or flesh, as the compound was isolated from meat. Carnitine is the generic term for a number of compounds that include L-carnitine, acetyl-L-carnitine, and propionyl-L-carnitine [1-2]. Carnitine plays a critical role in energy production. It transports long-chain fatty acids into the mitochondria so they can be oxidized ("burned") to produce energy. It also transports the toxic compounds generated out of this cellular organelle to prevent their accumulation. Given these key functions, carnitine is concentrated in tissues like skeletal and cardiac muscle that utilize fatty acids as a dietary fuel [1-2]. The body makes sufficient carnitine to meet the needs of most people. For genetic or medical reasons, some individuals (such as preterm infants), cannot make enough, so for them carnitine is a conditionally essential nutrient [1]. What are recommended intakes for carnitine? Healthy children and adults do not need to consume carnitine from food or supplements, as the liver and kidneys produce sufficient amounts from the amino acids lysine and methionine to meet daily needs [1-3]. The Food and Nutrition Board (FNB) of the National Academy of Sciences reviewed studies on the functions of carnitine in 1989 and concluded it was not an essential nutrient [3]. The FNB has not established Dietary Reference Intakes (DRIs)—including a recommended dietary allowance (RDA)—for carnitine [4]. What foods provide carnitine? Animal products like meat, fish, poultry, and milk are the best sources. In general, the redder the meat, the higher its carnitine content. Dairy products contain carnitine primarily in the whey fraction [1,3,5]. The carnitine content of several foods is listed in Table 1. Table 1: Selected food sources of carnitine [1] Food Milligrams (mg) Beef steak, cooked, 4 ounces 56-162 Ground beef, cooked, 4 ounces 87-99 Milk, whole, 1 cup 8 Codfish, cooked, 4 ounces 4-7 Chicken breast, cooked, 4 ounces 3-5 Ice cream, ½ cup 3 Cheese, cheddar, 2 ounces 2 Whole-wheat bread, 2 slices 0.2 Asparagus, cooked, ½ cup 0.1 Carnitine occurs in two forms, known as D and L, that are mirror images (isomers) of each other. Only L-carnitine is active in the body and is the form found in food [1,6]. Absorption and metabolism of carnitine Adults eating mixed diets that include red meat and other animal products obtain about 60-180 milligrams of carnitine per day [6]. Vegans get considerably less (about 10-12 milligrams) since they avoid animal-derived foods. Most (54-86%) dietary carnitine is absorbed in the small intestine and enters the bloodstream [1,6]. The kidneys efficiently conserve carnitine, so even carnitine-poor diets have little impact on the body's total carnitine content [1,5]. Rather than being metabolized, excess carnitine is excreted in the urine as needed via the kidneys to maintain stable blood concentrations. When can a carnitine deficiency occur? Two types of carnitine deficiency states exist. Primary carnitine deficiency is a genetic disorder of the cellular carnitine-transporter system that usually manifests itself by five years of age with symptoms of cardiomyopathy, skeletal-muscle weakness, and hypoglycemia. Secondary carnitine deficiencies may occur due to certain disorders (such as chronic renal failure) or under particular conditions (e.g., use of certain antibiotics) that reduce carnitine absorption or increase its excretion [1,5]. There is scientific agreement on carnitine's value as a prescription product for treating such deficiencies [2]. What are some current issues and controversies about carnitine? Carnitine has been studied extensively because it is important to energy production and is a well-tolerated and generally safe therapeutic agent [7]. Researchers prefer to use acetyl-L-carnitine in research studies because it is better absorbed from the small intestine than L-carnitine and more efficiently crosses the blood-brain barrier (i.e., gets into brain tissue) [8]. Athletic performance Some athletes take carnitine to improve performance. However, twenty years of research finds no consistent evidence that carnitine supplements can improve exercise or physical performance in healthy subjects—at doses ranging from 2-6 grams/day administered for 1 to 28 days [9-11]. (The total body content of carnitine is about 20 grams in a man weighing 155 pounds, almost all of it in the skeletal muscle [11].) For example, carnitine supplements do not appear to increase the body's use of oxygen or improve metabolic status when exercising, nor do they necessarily increase the amount of carnitine in muscle [10]. Aging A decline in mitochondrial function is thought to contribute to the aging process. Carnitine may be involved because its concentration in tissues declines with age and thereby reduces the integrity of the mitochondrial membrane [12]. Research in aged rats found supplementation with high doses of acetyl-L-carnitine and alpha-lipoic acid (an antioxidant) to reduce mitochondrial decay [13-15]. The animals also moved about more and improved their performance on memory-requiring tasks. At present there are no equivalent studies of this kind in humans. However, a meta-analysis of double-blind, placebo-controlled studies suggests that supplements of acetyl-L-carnitine may improve mental function and reduce deterioration in older adults with mild cognitive impairment and Alzheimer's disease [16]. In these studies, subjects took 1.5-3.0 grams/day of acetyl-L-carnitine for 3-12 months. Cardiovascular and peripheral-arterial disease Several studies have examined supplemental carnitine in the management of cardiac ischemia (restriction of blood flow to the heart) and peripheral arterial disease (of which the most important symptom is poor circulation in the legs, known as intermittent claudication) [17-18]. Because levels of carnitine are low in the failing heart muscle, supplemental amounts might be beneficial to the organ by counteracting the toxic effects of free fatty acids and improving carbohydrate metabolism [17]. In short-term studies, carnitine has demonstrated anti-ischemic properties when given orally and by injection. A double-blind, placebo-controlled, multicenter clinical trial in Italy with patients who had suffered a first heart attack found that supplemental carnitine (given intravenously for five days, then 6 grams/day orally for one year) reduced heart failure and overall mortality [19]. The results were not conclusive but promising enough to justify a larger study whose results have not yet been reported [17,20]. Claudication results from an inadequate supply of oxygen-rich blood to the legs and leads to an accumulation of acetylcarnitine in muscle due to its incomplete utilization. Patients with peripheral arterial disease who develop claudication have significant impairments in exercise performance and find it difficult to walk even short distances at a slow speed [18]. Two published randomized, controlled trials raise the possibility that carnitine may improve the performance of skeletal muscles in the leg. In one European multicenter clinical trial, subjects with moderate to severe claudication who were supplemented with L-carnitine (in the form of propionyl-L-carnitine at 2 grams/day for 12 months) significantly improved their maximal walking distance and perceived quality of life as compared to subjects receiving the placebo [21]. A similar multicenter trial in the United States and Russia found the same daily dose and form of carnitine administered for 6 months in patients with disabling claudication to significantly improve walking distance and speed, reduce bodily pain, enhance physical function, and improve perceived health state as compared to controls [22]. Cancer Fatigue resulting from chemotherapy, radiation treatment, and poor nutritional status is common in cancer patients [23]. They may also be deficient in carnitine [23]. In one study, treatment with carnitine supplements (4 grams/day for one week) ameliorated fatigue in most chemotherapy-treated subjects and restored normal blood levels of carnitine [24]. In another trial, terminal cancer patients supplemented with carnitine (doses ranged from 250 milligrams to 3 grams/day) experienced less fatigue and improved mood and quality of sleep [23]. In both studies, most subjects were carnitine deficient before taking the supplements. Type 2 diabetes Insulin resistance, which plays an important role in the development of type 2 diabetes, may be associated with a defect in fatty-acid oxidation in muscle [25]. This raises the question as to whether mitochondrial dysfunction might be a factor in the development of the disease. Increased storage of fat in lean tissues has become a marker for insulin resistance [25]. Early research suggests that supplementation with L-carnitine intravenously may improve insulin sensitivity in diabetics by decreasing fat levels in muscle and may lower glucose levels in the blood by more promptly increasing its oxidation in cells [25-27]. A recent analysis of two multicenter clinical trials of subjects with either type 1 or type 2 diabetes found that treatment with acetyl-L-carnitine (3 grams/day orally) for one year provided significant relief of nerve pain and improved vibration perception in those with diabetic neuropathy. The treatment was most effective in subjects with type 2 diabetes of short duration [28]. HIV and AIDS The human immunodeficiency virus (HIV) causes a decline in the number of lymphocytes (one type of white blood cell), resulting in acquired immunodeficiency syndrome (AIDS). HIV-infected individuals often accumulate fat in some areas of the body and lose fat in others and develop high levels of blood fats (hyperlipidemia) and insulin resistance, which together constitute the lipodystrophy syndrome. This syndrome may represent mitochondrial toxicity brought about by the HIV infection and the antiretroviral drugs used to treat it, and can induce a carnitine deficiency that limits mitochondrial fat metabolism [29]. The molecular mechanisms by which this occurs are poorly understood. Preliminary research provides conflicting findings [30] but suggests that supplementation with carnitine both intravenously and orally (at doses of 2-6 grams/day for weeks or months) in HIV-infected individuals may slow the death of lymphocytes (which in turn may slow HIV progression) [31-32], reduce neuropathy [33-35], and favorably affect blood lipid levels [36-38]. End-stage renal disease and hemodialysis Carnitine homeostasis (balance within the body) among individuals with renal diseases can be substantially impaired by several factors, particularly reduced synthesis and increased elimination of the compound by the kidneys as well as reduced intake from food due to poor appetite and consumption of fewer animal products [39]. Many patients with end-stage renal disease, particularly those on hemodialysis, become carnitine insufficient. Carnitine blood levels and muscle stores are low, which may contribute to anemia, muscle weakness, fatigue, altered levels of blood fats, and heart disorders. Numerous studies suggest that high doses of supplemental carnitine (often injected) in patients on maintenance hemodialysis can correct some or all of these symptoms, though most involve small numbers of patients and are not double-blinded trials. A recent meta-analysis of these studies concludes that carnitine supplements may aid anemia management but not blood-lipid profiles, and that their effects on exercise capacity or heart stability are inconclusive [40]. Male infertility The carnitine content of seminal fluid is directly related to sperm count and motility [41-42], suggesting that the compound might be of value in treating male infertility. Several studies indicate that carnitine supplementation (2-3 grams/day for 3-4 months) may improve sperm quality [43-45], and one randomized, double-blind crossover trial found that 2 grams/day of carnitine taken for 2 months by 100 infertile men increased the concentration and both total and forward motility of their sperm [46]. The reported benefits may relate to increased mitochondrial fatty-acid oxidation (providing more energy for sperm) and reduced cell death in the testes [47]. However, a recent randomized controlled trial with 21 infertile men found that 3 grams/day of carnitine taken for 24 weeks produced no significant increases in sperm motility or total motile sperm counts as compared to placebo [48]. Larger and more carefully designed studies are needed to evaluate carnitine's potential value as an infertility therapy. Are there health risks from too much carnitine? At doses of approximately 3 grams/day, carnitine supplements may cause nausea, vomiting, abdominal cramps, diarrhea, and a "fishy" body odor [1-2]. More rare side effects include muscle weakness in uremic patients and seizures in those with seizure disorders. Carnitine and medication interactions Carnitine interacts with pivalate-conjugated antibiotics such as pivampicillin that are used in the long-term prevention of urinary-tract infections [49]. Chronic administration of these antibiotics increases the excretion of pivaloyl-carnitine, which can lead to carnitine depletion. However, while tissue carnitine levels may become low enough to limit fatty acid oxidation, no cases of illness due to deficiency have been described [1,6]. Blood concentrations of carnitine may be reduced in children treated for convulsions with phenobarbital, valproic acid, phenytoin, or carbamazepine, but no clinical consequences have been shown [50-51]. Supplemental sources of carnitine L-carnitine, acetyl-L-carnitine, and propionyl-L-carnitine are available over-the-counter as dietary supplements. Carnitine is often promoted as an aid for weight loss, to improve exercise performance, and to enhance a sense of well-being [2]. It is also a drug approved by the Food and Drug Administration to treat primary and certain secondary carnitine-deficiency syndromes. Carnitine intakes and healthful diets Most people obtain sufficient carnitine because of the body's natural production of the substance as well as from their diets. The Dietary Guidelines for Americans describes a healthy diet as one that: emphasizes a variety of fruits, vegetables, whole grains, and fat-free or low-fat milk and milk products; includes lean meats, poultry, fish, beans, eggs, and nuts; is low in saturated fats, trans fats, cholesterol, salt (sodium), and added sugars; and stays within your daily calorie needs. For more information about building a healthful diet, refer to the Dietary Guidelines for Americans (http://www.healthierus.gov/dietaryguidelines/index.html) and the U.S. Department of Agriculture's food guidance system (MyPyramid; http://www.mypyramid.gov).

Dietary Supplement

A dietary supplement is intended to supply nutrients, (vitamins, minerals, fatty acids or amino acids) that are missing or not consumed in sufficient quantity in a person's diet. This category may also include herbal supplements which claim to treat or prevent certain diseases or conditions.

In the United States, a dietary supplement is defined under the Dietary Supplement Health and Education Act of 1994^[1] (DSHEA) as a product that is intended to supplement the diet and bears or contains one or more of the following dietary ingredients:

• a vitamin
• a mineral
• an herb or other botanical (excluding tobacco)
• an amino acid
• a dietary substance for use by man to supplement the diet by increasing the total dietary intake, or
• a concentrate, metabolite, constituent, extract, or combination of any of the above

Furthermore, it must be:

• intended for ingestion in pill, capsule, tablet, powder or liquid form
• not represented for use as a conventional food or as the sole item of a meal or diet
• labeled as a "dietary supplement"

Pursuant to the DSHEA, the Food and Drug Administration regulates dietary supplements as foods, and not as drugs. The FDA does not approve dietary supplements based on their safety and efficacy; the FDA can take action only after a dietary supplement has been proven harmful. However, certain foods (such as infant formula and medical foods) are deemed special nutritionals because they are consumed by highly vulnerable populations and are thus regulated more strictly than the majority of dietary supplements. The FDA claims that their rationale for a lack of regulation is a "freedom to choose" by the consumer, but there are economic benefits as well. The FDA chooses not to regulate dietary supplements because clinical trials are lengthy and costly. They tend to believe that the supplement is beneficial until problems arise.^[2]

The claims that a dietary supplement makes are essential to its classification. If a dietary supplement claims to cure, mitigate, or treat a disease, it would be considered to be an unauthorized new drug and in violation of the applicable regulations and statutes. As the FDA states it in a response to this question in a FAQ:

Is it legal to market a dietary supplement product as a treatment or cure for a specific disease or condition?
No, a product sold as a dietary supplement and promoted on its label or in labeling* as a treatment, prevention or cure for a specific disease or condition would be considered an unapproved--and thus illegal--drug. To maintain the product's status as a dietary supplement, the label and labeling must be consistent with the provisions in the Dietary Supplement Health and Education Act (DSHEA) of 1994.
*Labeling refers to the label as well as accompanying material that is used by a manufacturer to promote and market a specific product.

Dietary supplements are permitted to make structure/function claims. These are broad claims that the product can support the structure or function of the body (e.g., "glucosamine helps support healthy joints"). The FDA must be notified of these claims within 30 days of their first use, and there is a requirement that these claims be substantiated.

Other claims that required approval from FDA include health claims and qualified health claims. Health claims are permitted to be made if they meet the requirements for the claims found in the applicable regulations. Qualified health claims can be made through a petition process, including scientific information, if FDA has not approved a prior petition.

European Union

The Food Supplements Directive^[3] requires that supplements be demonstrated to be safe, both in quantity and quality. Some vitamins are essential in small quantities but dangerous in large quantities. Some herbal remedies, notably St Johns Wort, may interact with drugs or render them less effective. Such an issue has been raised in the case of oral contraceptives. Consequently, only those supplements that have been proven to be safe may be sold without prescription. In practice, the number of reported incidents with food supplements is nevertheless low.

In Europe, it is also an established notion that food supplements should not be labeled with drug claims but can bear - to a degree that differs from one member state to the other - health claims.

Legal challenge

The dietary supplements industry in Europe strongly opposed the Directive. A large number of consumers throughout Europe, including over one million in the UK, and many doctors and scientists, have signed petitions against what are viewed by the petitioners as unjustified restrictions of consumer choice ^[4]. The European Court of Justice ruled^[5] on 12 July 2005 that the Directive is valid, although the court's own Advocate General advised that the declaration was invalid under EU law ^[4]. The court made clear, however, that it must be possible for manufacturers to add vitamins and minerals to the list of ingredients of a food supplement, that refusal must be on scientific grounds, and that there should be a right to appeal.

Russian legislation, Ministry of Health's order number 117 dated as of 15 April, 1997, under the title "Concerning the procedure for the examination and health certification of Biologically Active Dietary Supplements", provides the usage of the following terminology:

As a rule, BADSs are foodstuffs with clinically proven effectiveness. BADSs are recommended not only for prophylactics, but can be included into a complex therapy for the prevention of pharmaceutical therapy's side effects and for the achievement of complete remission.

The development of BADSs and their applications has been very fast moving. They were originally considered as dietary supplements for people who had heightened requirements for some normal dietary components (for example, sportsmen). Later, they were employed as preventive medicines against chronic diseases.

Criticisms of vitamin supplementation

Regular supplementation with vitamin E, beta carotene and vitamin A may increase mortality by four, seven and sixteen percent respectively.^[6] The same study found that vitamin C and selenium had no effect, positive or negative on longevity.

Q. How do I know if I need a dietary supplement?

A. Because many products are marketed as dietary supplements, it is important to remember that supplements include vitamins and minerals, as well as herbs, botanicals and other substances.

Some supplements may help ensure that you get adequate amounts of essential nutrients or help promote optimal health and performance if you do not consume a variety of foods, as recommended in the MyPyramid and Dietary Guidelines for Americans.

However, dietary supplements are not intended to treat, diagnose, mitigate, prevent, or cure disease. In some cases, dietary supplements may have unwanted effects, especially if taken before surgery or with other dietary supplements or medicines, or if you have certain health conditions.

Do not self diagnose any health condition. Work with your health care provider to determine how best to achieve optimal health and always check with your health care provider before taking a supplement, especially when combining or substituting them with other foods or medicine.

You can use the checklist at the following link to talk to your health care provider about your nutritional status and whether taking a dietary supplement(s) is right for you:

http://dietary-supplements.info.nih.gov/pubs/partnersbrochure.asp#firsttool

Q. How can I get more information about a particular dietary supplement such as whether it is safe and effective?

A. Scientific evidence supporting the benefits of some dietary supplements (e.g., vitamins and minerals) is well established for certain health conditions, but others need further study. This is partly due to the way dietary supplements are regulated by the U.S. Food and Drug Administration (FDA).

Research studies in people to prove that a dietary supplement is safe are not required before the supplement is marketed, unlike for drugs. It is the responsibility of dietary supplement manufacturers/distributors to ensure that their products are safe and that their label claims are accurate and truthful. If the FDA finds a supplement to be unsafe once it is on the market, only then can it take action against the manufacturer and/or distributor, such as by issuing a warning or requiring the product to be removed from the marketplace.

The manufacturer does not have to prove that the supplement is effective, unlike for drugs. The manufacturer can say that the product addresses a nutrient deficiency, supports health, or reduces the risk of developing a health problem, if that is true. If the manufacturer does make a claim, it must be followed by the statement "This statement has not been evaluated by the Food and Drug Administration. This product is not intended to diagnose, treat, cure, or prevent any disease."

Dietary supplements are not intended to treat, diagnose, mitigate, prevent, or cure disease. In some cases, dietary supplements may have unwanted effects, especially if taken before surgery or with other dietary supplements or medicines, or if you have certain health conditions. Whatever your choice, supplements should not replace prescribed medications or the variety of foods important to a healthful diet.

Do not self diagnose any health condition. Work with your health care provider to determine how best to achieve optimal health and always check with your health care provider before taking a supplement, especially when combining or substituting them with other foods or medicine.

In addition to talking with your health care provider about dietary supplements, you can search on-line for information about a particular dietary supplement. It is important to ensure that you obtain information from reliable sources such as:

• Fact sheets on dietary supplements from the National Institutes of Health: http://dietary-supplements.info.nih.gov/Health_Information/ Information_About_Individual_Dietary_Supplements.aspx
• Nutrient Recommendations: Dietary Reference Intakes (DRI) and Recommended Dietary Allowances (RDA): http://dietary-supplements.info.nih.gov/Health_Information/Dietary_Reference_Intakes.aspx
• IBIDS database of dietary supplement literature: http://dietary-supplements.info.nih.gov/Health_Information/IBIDS.aspx
• Dietary supplement warnings and safety information from the U.S. Food and Drug Administration: http://www.cfsan.fda.gov/~dms/ds-warn.html
• Consumer information from the Federal Trade Commission: http://www.ftc.gov/bcp/menu-health.htm

For tips on evaluating sources of healthcare information on the internet, please see the following document: How to Evaluate Health Information on the Internet: Questions and Answers.

Q. Where can I find information about the use of dietary supplements for a particular health condition or disease?

A. Scientific evidence supporting the benefits of some dietary supplements (e.g., vitamins and minerals) is well established for certain health conditions, but others need further study. Whatever your choice, supplements should not replace prescribed medications or the variety of foods important to a healthful diet.

Dietary supplements are not intended to treat, diagnose, mitigate, prevent, or cure disease. In some cases, dietary supplements may have unwanted effects, especially if taken before surgery or with other dietary supplements or medicines, or if you have certain health conditions.

Do not self diagnose any health condition. Work with your health care provider to determine how best to achieve optimal health and always check with your health care provider before taking a supplement, especially when combining or substituting them with other foods or medicine.

In addition to talking with your health care provider about dietary supplements for a particular health condition or disease, you can search on-line for information. It is important to ensure that you obtain information from reliable sources such as:

• Health Information from the National Library of Medicine’s MedlinePlus Database: http://www.nlm.nih.gov/medlineplus/
• Fact sheets on dietary supplements from the National Institutes of Health: http://dietary-supplements.info.nih.gov/Health_Information/ Information_About_Individual_Dietary_Supplements.aspx
• IBIDS database of dietary supplement literature: http://dietary-supplements.info.nih.gov/Health_Information/IBIDS.aspx

Dr Marwah

Hydergine

GENERIC NAME: ERGOLOID MESYLATES - ORAL (ER-go-loyd MESS-ill-ates)

BRAND NAME(S): Gerimal, Hydergine

USES: This medication is used to increase blood flow to the brain and treat changes in mood, memory or behavior.

HOW TO USE: Take this medication exactly as prescribed. Do not increase your dose or take it for longer than prescribed without consulting your doctor. It may take several weeks before you see any improvement from the medication. Do not stop taking this medication without your doctor's approval.

SIDE EFFECTS: Notify your doctor if you develop: skin rash, blurred vision, dizziness, fainting, flushing, headache, loss of appetite, nausea or vomiting, stomach cramps, stuffy or runny nose. If you notice other effects not listed above, contact your doctor or pharmacist.

PRECAUTIONS: Tell your doctor your medical history, especially of: blood pressure problems, heart problems, behavioral problems, liver disease, allergies. This medication should be used only when clearly needed during pregnancy. Discuss the risks and benefits with your doctor. It is not known if this medication is excreted into breast milk. Consult your doctor before breast-feeding.

DRUG INTERACTIONS: Tell your doctor of all prescription and nonprescription drugs you may use, especially of: nitrates (e.g., isosorbide, nitroglycerin), dopamine, macrolide antibiotics (e.g., erythromycin), efavirenz, saquinavir, triptan drugs (e.g., naratriptan, sumatriptan). Do not start or stop any medicine without doctor or pharmacist approval.

NOTES: Do not share this medication with others.

MISSED DOSE: If you miss a dose, take as soon as remembered; do not take if it is almost time for the next dose, instead, skip the missed dose and resume your usual dosing schedule. Do not "double-up" the dose to catch up. Check with your doctor if 2 or more doses have been missed.

STORAGE: Store at room temperature away from sunlight and moisture. Keep oral solution from freezing.

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Dr Marwah

Blood In Urine At A Glance

Blood In Urine At A Glance
* Blood in urine can sometimes be visible only with a microscopic examination.
* Evaluating blood in urine requires consideration of the entire urinary tract.
* Tests used for the diagnosis of blood in urine include the intravenous pyelogram, cystoscopy, and urine cytology.
* Management of blood in urine depends upon the underlying cause.

Dr Marwah

Procurement of medicines from local chemists

Procurement of medicines from local chemists

 
 •       Several items are being procured and issued by the government hospitals and simultaneously patients are also asked to buy those very items themselves.

 •       It must be an accepted fact that resources will never be sufficient to provide each and every item to all the patients. Therefore, it needs to be cleared as to which items the hospital must supply and which items the patients must buy.

 CGHS

 
 •        It's a welfare scheme run by the government for its employees.

 •        It's not an insurance scheme.

•        Relation between the government and the employees is of employer and employees.       

•        If the medicine is not available and he is asked to buy than the cost must be reimbursed.

•        CGHS came into existence only to end the cumbersome system of reimbursement in 1954. So the system of local purchase is followed in the dispensaries.

Guidelines for procuring medicines from local chemists

•             Medicines available should not be indented.

•             Prescriptions should be signed and stamped by the specialist if out of CGHS formulary drugs are prescribed. 

•            Prescriptions  should be signed and stamped by the specialist in case out of CGHS formulary drugs are prescribed.

•               Only valid prescriptions are to be indented, if time barred fresh opinion of specialist is essential.

•              The prescriptions of recognized hospitals are only to be entertained.

•              Prescriptions and local purchase indents must be legible.

•              Advertised and food products, cosmetics, ayurvedic drugs prescribed by allopathic physician, inadmissible items declared and imported drugs should not be indented.

•              H O D items of formulary must be prescribed or countersigned by consultants only.

•              Quantity indented must not be more than the quantity prescribed and the strength of each item must be indicated.

•              The index card of the beneficiary should be invariably being checked from the record.

•              Date and the quantity indented and supplied should be written legibly in the prescripti

•              A photocopy of prescription required in case of- cost more than Rs 1000/- per medicine

•               These photocopies of prescriptions should be paged, numbered, indexed and got properly bound month wise.           

• Medicines should be supplied in full by the local chemist.

•               Write clearly and legibly and in capital letters and mention the strength of medicine. To bring transparency in the system give code to each medicine. Code should also be different in case of same medicine but different strength. (Suggestion and example lorvas storvas 10 to 40)

•               Avoid overwriting and all cuttings should be verified by cmo i/c.

•               Quantity of indented/ supplied medicines to be written in words also.

•               Mention the name of "prescribing doctor" along with hospital in the relevant column.

•               Medicines not supplied to be indicated as not available.

•               Substitute medicines should not be received. Substitute means medicines of different company/ strength.

•               The pharmacist should also sign along with his name.

•               The indent should be entered in register with the following columns

•               No. And date of indent

•               No. Of items indented.

•               No. Of items received

•               No. Of pages sent

•               Remarks

•               Local chemist should indicate batch no/ company name/ mfg. Date/ exp. Date, mrp, local tax and the quantity in the prescribed columns while supplying to the dispensary. Mrp and local tax should be shown separately.

•               Local chemist should not supply the inadmissible items. Pharmacist receiving the medicines should also ensure it. 

•               While receiving the indent, pharmacist should check the batch no, expiry date, mrp and strength of the medicines.

•               Medicines should be kept separately day wise for one week. The medicines, left undistributed, should be kept separately. After 15 days unclaimed medicines should be taken on charge and to be distributed to the first beneficiary came for the indent. A separate register should be maintained for above purpose. 

•               The pharmacist should verify the name and address of the beneficiary from the token card. 

•        Listed items should be taken on charge and separate register should be maintained for the purpose. No separate chit is required. Beneficiary should not be asked to get registered for the purpose. The pharmacist should submit the list of beneficiaries to the entry clerk at the end of the day.

•        Weekly summery of listed drugs and if possible of out of formulary medicines should be made. This summery will be useful for taking the medicine under the formulary and for the provisioning at a later stage.

•          `to avoid the misuse and to bring transparency in the system, all the medicines should be leveled as CGHS supply not for sale and all the sealed items should be handed over to the beneficiary after breaking the seal in front of him as per the store procedures. Medicines should be leveled in such a way that name batch number expiry date etc should always be visible clearly.

•          Re circulated medicines should not be accepted and matter should be brought to the notice of cmo i/c.

•            The pharmacist should be polite and also explain the doses duration,   frequency of medicines to be taken. And any adverse reactions expected to the beneficiary in their language.

•            Local chemist should write the different rates uniformly on the indent forms i.e. He should write ones under ones, tens under tens, hundreds under hundreds etc.

•        Bills should be checked thoroughly .rates has been already checked while receiving the indents so more attention can be given to calculations horizontally as well as vertically.

•         Where the packing size is different than the usual 10 more attention is to be given in horizontal calculations.

•         Costly medicines are also to be checked. Here we can apply ABC analysis and HML analysis.

•         Find out the 10% items where 70 % of budget is consumed and pay more attention to those items rates and calculations.

•         Out of others (hml analysis) take the costly items and check thoroughly.

•         From the rest, the random items may be checked.

•         Items like loprin which has very less value, in single /double figures; putting single digit in front is very easy not to get noticed. Take steps to prevent that. Ask the chemist to put 0 under hundreds. Tens as the case may be.

•         Always recheck from the dispensary copy. 

•         Keep all the L P vouchers month wise and if possible get it bounded.

DR G R MARWAH