E-mail: greenwfl@pbrc.edu Summary Since passage of the Dietary Supplement Health and Education Act of 1994, the sale of herbal dietary supplements containing caffeine and ephedrine for weight loss has become widespread in the United States. This review of the literature in Medline relative to the use of caffeine and ephedrine in the treatment of obesity concludes that caffeine and ephedrine are effective in causing weight loss.

Lastly, we included only studies that tested a product in an Description Conjugated linoleic acid (CLA) is a group of linoleic acid derivates produced by bacteria in the gut of ruminant animals.7 The major dietary sources of CLA are dairy products and beef.7 Most of the research on CLA and weight loss has been done in animals. Adverse cardiovascular and central nervous system events associated with dietary supplements containing ephedra alkaloids N Engl J Med. (2000) Cited by (50) Adulteration of herbal sexual enhancers and slimmers: The wish for better sexual well-being and perfect body can be risky 2017, Food and Chemical Toxicology Ephedrine, as well as caffeine, that have been reported to exert similar slimming effect to diethylpropion and even superior than that of dexfenfluramine has been also detected as adulterants in herbal products for weight loss (Greenway, 2001). Actually, Ephedra has been revealed to be active in endorsing weight reduction, particularly when combined with caffeine, nevertheless it has a serious risk to induce adverse effect (Lenz and Hamilton, 2004). Nevertheless, due to the reports on serious toxic effects of ephedrine such as nephrolithiasis and even death due to its sympathomimetic activity, FDA has been considering its use since mid-1990s and finally banned its sale in the USA since 2004 (Powell et al., 1998; Seamon and Clauson, 2005). Arrow Up and Right View all citing articles on Scopus Recommended articles (6) View full text Copyright © 2004 American Pharmacists Association.

Body weight was observed before and after 10 days of treatment with three YGD capsules or three placebo capsules before each meal for 10 days in 44 healthy overweight patients attending a primary health care centre. Active treatment with YGD capsules resulted in weight maintenance of the group (73 kg at the beginning and 72.5 kg at the end of 12 months). Conclusions The herbal preparation, YGD capsules, significantly delayed gastric emptying, reduced the time to perceived gastric fullness and induced significant weight loss over 45 days in overweight patients treated in a primary health care context.

Search for more papers by this author From the Cleveland Clinic Foundation, Cleveland, OH 44118. Search for more papers by this author From the Cleveland Clinic Foundation, Cleveland, OH 44118.

Published: 18 April 2001 JA Nasser 1 , SB Heymsfield 1 , V Wang 1 , G Chen 1 & … JL Solomon 1 International Journal of Obesity volume 25 , pages 316–324 (2001 )Cite this article 7806 Accesses 167 Citations 31 Altmetric Metrics details Abstract OBJECTIVE: To examine in overweight humans the short-term safety and efficacy for weight loss of an herbal supplement containing Ma Huang, Guarana and other ingredients. DESIGN: An 8 week randomized, double-blind placebo controlled study of a herbal dietary supplement (72 mg/day ephedrine alkaloids and 240 mg/day caffeine). SUBJECTS: Overweight men and women (body mass index, ≥29 and ≤35 kg/m2 ). MEASUREMENTS: The primary outcome variable was body weight change.

Background Nowadays the use of herbal weight loss products as alternative obesity treatment has increased, which leads to the growing market of herbal remedies worldwide (1 , 2 ). According to the consumer’s belief, these products are “natural herbal components” and are regarded as harmless and effective methods of obesity treatment (3 , 4 ). Since these adulterated herbal products are manufactured illegally, their safety, efficacy, and quality control are not verified (5 , 6 ). The presence of synthetic substances and the analogues of prescription drugs in adulterated herbal weight loss formulations, can cause multiple health risks, that pose major concerns for all health agencies around the world (3 , 7 , 8 ). Thus, the World Health Organization (9 ), Food and Drug Administration (FDA), European Medicines Agency (10 ) have issued several guidelines for safe and appropriate use of herbal medicines (11 , 12 ). De Carvalho et al. (5 ) showed that the most probable adulterant classes of pharmaceuticals used in weight loss formulations are anorexic (sibutramine, rimonabant), anxiolytic (benzodiazepines), antidepressant (fluoxetine.), diuretic (furosemide) and laxative (phenolphthalein). In addition the presence of other pharmaceutical classes, such as ephedrine, bumetanide (13 ), phenytoin, caffeine and thyroid hormones in weight loss formulations has been recently reported in the Netherlands (14 ), UK (Royal College of Physicians 1998), USA (15 ), and Iran (16 ). Unfortunately, consumers who took adulterated herbal weight loss supplements complained of many side effects and clinical problems such as, cardiovascular disease (15 ), liver (17 , 18 ) and renal failure (5 ), mental/mood changes e.g. excitement, restlessness, confusion, depression and occasionally even thoughts of suicide (16 , 19 , 20 ). Herbal medicines are sold at herbal shops and also advertised by satellite channels in the Persian language or on internet with direct delivery (2 ). One problem is that, a herbalist (a person who involves in production, distribution and application of herbal remedies) usually does not have the appropriate knowledge or the required ethics (3 , 5 ). Marketing and sale of these supplements on the internet and satellite channels are not strictly controlled and are not always required to pass safety and control tests before advertisement and sell in the market. 2. On the other hand, the recommended dose for herbal weight loss pills are 2-3 tablets per day, which is higher than the therapeutic dose of sibutramine (Table 1 ). The next adulterant is the laxative phenolphthalein that was withdrawn as a medicine several years ago because of its carcinogenic effects (14 , 27 ). Hence, high phenolphthalein intake increases the risk of cancer (Table 1 ); that is also associated with sibutramine in several herbal weight loss formulations (5 , 14 , 27 ). Bumetanide as a diuretic, like laxatives, is not very effective as a weight-loss drug but has similar health risks (4 , 28 ). Although not prescribed as a medicine in Iran, athletes in Arizona use diuretics to decrease weight and as masking agents of doping (13 ). Phenytoin is found only in trace amounts in some of these illegal supplements.

Subjects: A total of 167 subjects (body mass index (BMI) 31.8±4.1 kg/m2 ) randomized to placebo (n =84) or herbal treatment (n =83) at two outpatient weight control research units. Results: By last observation carried forward analysis, herbal vs placebo treatment decreased body weight (−5.3±5.0 vs −2.6±3.2 kg, P

It is a common belief that herbal remedies are safe because they are “natural,” with fewer side effects compared to conventional medicines [10], [11], [12]. However, despite the use of traditional medicines for centuries for the prevention and treatment of illnesses, the effectiveness and safety of many of these products are unclear [13]. There is also significant disparity between countries in laws, policies and regulations regarding the quality, safety and efficacy of CAM therapies [14]. Practitioners and consumers may also be unaware of the possible interactions of CAM with prescription drugs and other potential adverse reactions [14]. Inconsistencies in regulatory practice may contribute to problems regarding quality, safety and efficacy of these products, allowing ineffective or unsafe CAM products to be sold [14]. This was highlighted in a recent study of unapproved pharmaceutical ingredients found in dietary supplements in America. There have also been further case studies identifying undeclared pharmaceuticals such as sibutramine in weight loss supplements [21], [22]. In Belgium, in the early 1990s, at least 100 cases of interstitial fibrosis of the kidneys and renal failure occurred in women after they consumed Chinese herbs as part of a weight loss regimen [23]. Retrospectively, it was discovered that the Chinese herb Stephania tetrandra , which had been prescribed, had been unintentionally replaced with the Chinese herb Aristolochia fangchi . Species in the genus Aristolochia contain aristolochic acid, which is a nephrotoxin and a carcinogen [24]. It was believed that the effects of the Aristolochia were magnified by the presence of the other ingredients in the weight loss supplements, such as acetazolamide and fenfluramine.

In the early 1970s, the prevalence of dietary supplement use was 28% and 38% among adult men and women, respectively.1 More recent data from The National Health and Nutrition Examination Survey (NHANES) 2003-2006 have revealed a dramatic rise in usage, with approximately 50% of all Americans and 70% of adults ≥71 y reporting dietary supplement use.2 Direct causality to liver injury is difficult to establish with HDS, as they are comprised of a variety of different compounds that may change over time, are prone to contamination or adulteration, and can be used with other agents, including conventional medications. Table 1 Characteristics of weight loss supplements as described in case reports Weight loss supplement N Clinical features Predominant pattern of injury Underwent transplantation Hydroxycut Stevens et al. 2 Fatigue, jaundice Hepatocellular and cholestatic 0 Fong et al. 8 Nausea, vomiting, abdominal pain Hepatocellular 3 Jones 1 Nausea, vomiting, and jaundice Hepatocellular 0 Shim 1 Fatigue, jaundice Hepatocellular 0 Laczek 3 Malaise, jaundice Hepatocellular 0 Dara 2 Nausea, vomiting, fatigue, abdominal pain Hepatocellular 0 Kaswala 1 Nausea, vomiting, abdominal pain, jaundice Hepatocellular 0 OxyElite Pro Roytman et al. 8 Nausea, fatigue, abdominal pain, jaundice Hepatocellular 2 Foley et al. 7 Nausea, vomiting, jaundice, abdominal pain Hepatocellular 1 Ingredients in weight loss supplements with hepatotoxic potential Although products marketed under the Hydroxycut and OEP labels have been highlighted above, the lack of standard nomenclature in the dietary supplement industry as well as the ubiquity of products available to the public make it likely that many more products are marketed and/or used for weight loss.