Dexatrim is an over-the-counter (OTC) dietary supplement meant to assist with weight loss. Dexatrim claims it "gives you the power to lose weight, curb binges, and keep you in control of your diet."Dexatrim Dietary Supplement. (2010). Retrieved from http://www.dexatrim.com/ Current Dexatrim products available are in capsule form and include Dexatrim Max Complex 7, Dexatrim Max Daytime Appetite Control, Dexatrim Natural Green Tea, and Dexatrim Natural Extra Energy. The major active ingredients found in current Dexatrim products include

caffeine Caffeine is a central nervous system (CNS) stimulant of the methylxanthine class. It is mainly used recreationally as a cognitive enhancer, increasing alertness and attentional performance. Caffeine acts by blocking binding of adenosine to ...

green tea extract Green tea is a type of tea that is made from ''Camellia sinensis'' leaves and buds that have not undergone the same withering and oxidation process which is used to make oolong teas and black teas. Green tea originated in China, and since then ...

, Asian (Panax)

ginseng Ginseng () is the root of plants in the genus '' Panax'', such as Korean ginseng ('' P. ginseng''), South China ginseng ('' P. notoginseng''), and American ginseng ('' P. quinquefolius''), typically characterized by the presence of ginsenosides ...

root extract, and

dehydroepiandrosterone Dehydroepiandrosterone (DHEA), also known as androstenolone, is an endogenous steroid hormone precursor. It is one of the most abundant circulating steroids in humans. DHEA is produced in the adrenal glands, the gonads, and the brain. It fun ...

(DHEA).

Active Ingredients: Weight Loss Efficacy & Potential Side Effects

Caffeine

The

content in the daily recommended dose of Dexatrim products ranges from 50–400 mg per day. There are a number of studies showing that caffeine has a short-term stimulatory effect on basal metabolic rate. However, in 1992, in a double-blind placebo controlled study, caffeine (at a dose of 200 mg daily) was found to be no more effective in promoting weight loss as compared to a placebo. Potential side effects of caffeine may include insomnia, anxiety, gastrointestinal discomfort, diarrhea, headaches and abnormal heart beat.

Green tea extract

Green tea extract Green tea is a type of tea that is made from ''Camellia sinensis'' leaves and buds that have not undergone the same withering and oxidation process which is used to make oolong teas and black teas. Green tea originated in China, and since then ...

is currently used for a variety of conditions including improving mental alertness and aiding in weight loss.National Centre for Complementary and Integrative Health, National Institutes of Health. (2010, July). Herbs at a Glance: Green Tea. Retrieved from http://nccih.nih.gov/health/greentea/ There is currently insufficient data to determine the efficacy of green tea extract in aiding weight loss. In addition to the potential side effects from the caffeine content in green tea extract, there is some risk of liver problems associated with green tea extract consumption. Liver problems have not been observed with the use of green tea in beverages.

Asian (panax) ginseng root extract

Asian (panax)

is used for a wide variety of conditions—without US

Food & Drug Administration The United States Food and Drug Administration (FDA or US FDA) is a federal agency of the Department of Health and Human Services. The FDA is responsible for protecting and promoting public health through the control and supervision of food s ...

(FDA) approval—including aiding in thinking and memory,

diabetes Diabetes, also known as diabetes mellitus, is a group of metabolic disorders characterized by a high blood sugar level ( hyperglycemia) over a prolonged period of time. Symptoms often include frequent urination, increased thirst and increased ...

, erectile dysfunction, premature ejaculation, and aiding in weight loss.MedlinePlus: US National Library of Medicine. (2011). Drugs & Supplements: Ginseng, Panax. Retrieved from https://www.nlm.nih.gov/medlineplus/druginfo/natural/1000.html Across a wide scope of studies, scientific data does not support the health claims associated with using ginseng. Short-term use of ginseng (under 3 months) is unlikely to produce side effects and appears safe for most people. Side effects, often associated with longer term use, can include headaches, insomnia, and gastrointestinal problems. There are many conditions in which ginseng use has special precautions and warnings. These include pregnancy, diabetes, auto-immune diseases, and bleeding disorders.

Dehydroepiandrosterone (DHEA)

Dehydroepiandrosterone Dehydroepiandrosterone (DHEA), also known as androstenolone, is an endogenous steroid hormone precursor. It is one of the most abundant circulating steroids in humans. DHEA is produced in the adrenal glands, the gonads, and the brain. It fun ...

(DHEA) is a steroid hormone produced by the

adrenal gland The adrenal glands (also known as suprarenal glands) are endocrine glands that produce a variety of hormones including adrenaline and the steroids aldosterone and cortisol. They are found above the kidneys. Each gland has an outer cortex whic ...

s (and by the

testes A testicle or testis (plural testes) is the male reproductive gland or gonad in all bilaterians, including humans. It is homologous to the female ovary. The functions of the testes are to produce both sperm and androgens, primarily testoste ...

in men), which can be converted in the body to male and female sex hormones, including

estrogen Estrogen or oestrogen is a category of sex hormone responsible for the development and regulation of the female reproductive system and secondary sex characteristics. There are three major endogenous estrogens that have estrogenic hormonal ac ...

and

testosterone Testosterone is the primary sex hormone and anabolic steroid in males. In humans, testosterone plays a key role in the development of male reproductive tissues such as testes and prostate, as well as promoting secondary sexual characteristi ...

.MedlinePlus: US National Library of Medicine. (2011). Drugs & Supplements: DHEA. Retrieved from https://www.nlm.nih.gov/medlineplus/druginfo/natural/331.html DHEA is used to treat a variety of conditions (without FDA approval) including aging, Alzheimer’s,

schizophrenia Schizophrenia is a mental disorder characterized by continuous or relapsing episodes of psychosis. Major symptoms include hallucinations (typically hearing voices), delusions, and disorganized thinking. Other symptoms include social wit ...

, erectile dysfunction, systemic lupus erythematosus, and for aiding in weight loss. There is insufficient data to support DHEA’s efficacy for weight loss. The DHEA content in the daily recommended dose of Dexatrim Max ranges from 100–200 mg per day. Side effects at this dose can include acne, hair loss, facial hair growth and deeper voice in women, stomach upset, and high blood pressure, particularly if the supplement is used for a longer period of time. There are many conditions in which DHEA use has special precautions and warnings. These include pregnancy and breast-feeding, hormone-sensitive conditions and cancers, liver problems, diabetes, and cholesterol problems. DHEA use is banned by the

National Collegiate Athletic Association The National Collegiate Athletic Association (NCAA) is a nonprofit organization that regulates student athletics among about 1,100 schools in the United States, Canada, and Puerto Rico. It also organizes the athletic programs of colleges ...

(NCAA).

History of Dexatrim

Dexatrim has been on the market for more than 30 years.Cons of Dexatrim. (2011, September 12). Retrieved from www.ehow.com/facts_5405275_cons-dexatrim.html The brand was originally owned by Thompson Medical, which was acquired by

Chattem Chattem, Inc. is an American, Chattanooga, Tennessee-based, producer and marketer of over-the-counter healthcare products, toiletries, dietary supplements, topical analgesics, and medicated skin care products. Originally named the Chattanooga Me ...

in 1998. It is now part of

Sanofi Sanofi S.A. is a French multinational pharmaceutical and healthcare company headquartered in Paris, France. Originally, the corporation was established in 1973 and merged with Synthélabo in 1999 to form Sanofi-Synthélabo. In 2004, Sanofi-Syn ...

. Dexatrim formula has changed considerably over the years. In prior formulations, Dexatrim contained the decongestant

phenylpropanolamine Phenylpropanolamine (PPA) is a sympathomimetic agent which is used as a decongestant and appetite suppressant. It was commonly used in prescription and over-the-counter cough and cold preparations. In veterinary medicine, it is used to contr ...

(PPA) and the amphetamine-like compound

ephedra Ephedra may refer to: * Ephedra (medicine), a medicinal preparation from the plant ''Ephedra sinica'' * ''Ephedra'' (plant), genus of gymnosperm shrubs See also * Ephedrine Ephedrine is a central nervous system (CNS) stimulant that is of ...

. A 2000 study by

Yale University School of Medicine The Yale School of Medicine is the graduate medical school at Yale University, a private research university in New Haven, Connecticut. It was founded in 1810 as the Medical Institution of Yale College and formally opened in 1813. The primary te ...

showed an increased risk of hemorrhagic stroke with taking PPA. A case of

myocardial Cardiac muscle (also called heart muscle, myocardium, cardiomyocytes and cardiac myocytes) is one of three types of vertebrate muscle tissues, with the other two being skeletal muscle and smooth muscle. It is an involuntary, striated muscle that ...

injury was also reported using Dexatrim (with PPA) at doses recommended for weight control. In 2000, following the request of the FDA to discontinue marketing drug products containing PPA, Dexatrim dropped PPA from its formula. In 2004, FDA banned a second Dexatrim ingredient, ephedra. Although ephedra showed some effectiveness for short-term weight loss, it was linked to raising blood pressure and increasing the risk of heart problems and stroke. In March 2014, Chattem sold Dexatrim to NVE Pharmaceuticals.{{Cite news, url=https://www.prweb.com/releases/2014/3/prweb11643454.htm, title=NVE Pharmaceuticals Announces the Acquisition of Dexatrim to the Stacker2 Family, date=March 11, 2014, work=PRWeb, access-date=September 26, 2018

Controversy over use and possible adverse effects

Currently, no over-the-counter weight-loss supplements have met criteria for recommended use by physicians.Saper, R.B, Eisenberg, D.M., & Phillips, R.S. (2004). Common Dietary Supplements for Weight Loss. Am Fam Physician, 70(9), 1731–1738. Dexatrim claims to provide a powerful benefit for weight loss despite the lack of scientific data to support their claims. Dexatrim further provides a disclaimer that no claims of efficacy and safety made by Dexatrim have been approved by the FDA. Although available OTC, the active ingredients in Dexatrim products carry risk of side effects, adverse reactions and adverse drug interactions, particularly if used at high-recommended or higher-than-recommended doses and/or for prolonged periods. The Dexatrim product itself carries a warning about the possible side effects of Dexatrim in patients with a history of high blood pressure, and also recommends the advice of a qualified physician before taking Dexatrim. In addition, the use of Dexatrim or other OTC weight-loss supplements presents a possible factor in establishing disruptive eating patterns,Thompson, J., Manore, M., & Sheeshka, J. (2010). Nutrition: A Functional Approach (2nd Cdn ed.). Toronto, ON: Pearson Canada. increases the risk that individuals will use these OTC supplements in lieu of seeking proper medical and nutritional consultation, and presents increased psychological risks associated with unsuccessful weight-loss attempts.

References

Dietary supplements Chattem