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Mr Pickels
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This was a last minute term paper I wrote for my stupid english class. It was a recommendation report. Feel free to plagarize it.
Ephedra Based Supplements: Effective Fat Loss Agents or Dangerous Killers?
Introduction
Obesity in the United States is a problem of epic proportions. The burden obesity puts on the health care system costs taxpayers $78.5 billion annually and employers another $12 billion (Dixon, 2003). Many citizens will resort to over-the-counter (OTC) supplements or prescription weight loss pills to shed the fat. The most popular OTC fat loss pills are ones containing ephedra.
Ephedra has received negative media coverage recently due to the deaths of professional athletes Korey Stringer and Steve Belcher. Both men died in training camps and had bottles of supplements containing the naturally occurring substance ephedra in their lockers. These circumstances have caused the U.S. Congress to review the pros and cons of ephedra use. If Congress concludes that ephedra poses an unnecessary risk to the population, then the sale and use of ephedra will become illegal. The supplements are currently available to anyone who wishes to purchase them. Ephedra is naturally occurring and can be derived from the Ma Haung plant (Dulloo, 2002). The main use for the substance is as a fat loss agent alone or when combined with aspirin and caffeine.
The two most popular FDA approved drugs for fat loss are Xenical and Meridia (Read, 2002). Both, like ephedra, have side effects. Xenical works by preventing fat in the gastrointestinal tract from being absorbed by the body (Leung, 2002) and is relatively safe. Meridia functions in a different manner. Meridia reduces caloric intake by suppressing hunger in the user (Leung, 2002).
This report will discuss whether the two currently FDA approved fat loss drugs are a better alternative to ephedra, thus justifying Congress’ review. Since the outcome of Congress’ decision could effect the health of millions of people, all aspects of effectiveness, cost, and safety will be discussed (Dulloo, 2002).
Effectiveness
The current prescription fat loss medications are quite effective. Subjects taking Xenical during a one year study lost just less than twenty pounds (Leung, 2002). This is caused by the 46.4% to 91.4% effectiveness of the gastrointestinal (GI) lipases inhibitors (Leung, 2002). This prevents the GI tract from metabolizing fat in the diet into a form useable by the body. By preventing dietary fat from being absorbed, Xenical reduces daily caloric intake. When a caloric deficit of 500 kcal per day is induced, users can lose approximately one pound of fat per week (Leung, 2002).
Meridia takes a different approach to fat loss than Xenical. Meridia reduces the reuptake of the monoamines serotonin, noradrenaline, and dopamine (Leung, 2002). By blocking the reuptake of the monamines, they continue to circulate in the bloodstream, allowing the user to feel satisfied longer (Leung, 2002). Meridia users lost up to 12.54 pounds in the six month study (Leung, 2002). This is comparable to the twenty pounds lost by the Xenical patients in the year long study.
Ephedra based supplements (EBS) work along yet another pathway. EBS initiates the release of epinephrine (Epi) and norepinephrine (NEpi), both of which are naturally occurring substances in the body. When Epi and NEpi circulate in the blood they change the blood chemistry so that there is less free floating insulin and more available glucagon. These hormones are responsible for the storage and metabolism of fats and sugars. When insulin is in the blood in high concentrations, body cells have an affinity to absorb nutrients sugars and store them for later use. Glucagon promotes the release of fats and causes the body to use the available fat as an energy source (Haller, 2000). Thus, a spike in Epi and NEpi levels will shift the body’s metabolism from running on sugar for fuel to that of a fat burning machine.
The most infamous aspect of EBS is their reputation as killers by causing athletes’ hearts to explode, but what the media overlooks is their effectiveness. If they were not as effective as the current drugs, then their use would not be justified. However, this does not seem to be the case.
In a six month study patients using EBS lost an average of 11.66 pounds (Boozer, 2002). Again, this is equal to the prescription medications currently approved by the FDA. However, the major difference is that EBS patients lost up to 22.66 pounds for the same six month period (Boozer, 2002). This is a claim that the prescriptions cannot make.
In a recent news report, Blatman stated that during the Performance Enhancement Products conference, Dr. Paul Coates, Director of the Office of Dietary Supplements (ODS) at the National Institute of Health (NIH) called for a study on the safety and efficacy of EBS so that they would “not enter the ephedra controversy unarmed.” The NIH funded a six month study to answer questions about EBS. Both Columbia and Harvard University participated. The results of the study supported previous research that EBS use significantly promotes a loss of body weight, body fat, and LDL cholesterol (Dulloo, 2002).
It is clear that in clinical trial after clinical trial, EBS are proven effective at promoting weight loss. Due to the fact that EBS are proven at least equal and often more effective than the leading prescriptions, cost would be another important factor to consider when deciding to use EBS or a prescription.
Cost
A one month supply of Meridia costs about $216 from an online discount pharmacy. Xenical costs approximately $166 from www.prescriptiondrugs.com. As Leung’s reported stated “the cost effectiveness of Xenical is yet to be determined.” No statements were made about the cost effectiveness of Meridia in the report. A one month supply of an EBS cost approximately $51.00 from www.sruonline.com and similar websites. This is for popular products such as Hydroxycut and Stacker 2. Cheaper generic versions with the same ratio of ingredients are available for half as much on the same websites. Greenway found that EBS are more cost-effective for weight reduction as well as more effective than the prescription medications (1999).
Since EBS cost up to 76% less than the most popular prescription and are more effective, they are clearly the sensible choice.
Safety
Xenical and Meridia both have side effects. Xenical has a tendency to cause a condition known as staetorrhea. This will cause the patient to have loose stools caused by excessive amounts fat in fecal material (Leung, 2002). They also were deficient in fat soluble vitamins A, D, and K. Supplementation was necessary in the study (Leung, 2002). There were also notable problems with drug interaction and minor hypertension.
Meridia was much worse in terms of side effects. Dry mouth, insomnia, constipation, headache, withdrawal, and increases in blood pressure and heart rate (Leung, 2002). Notably, the increase in blood pressure and heart rate were in people who did not previously have or were genetically predisposed to the said symptoms (Leung, 2002). These symptoms are the exact reasons that EBS are under the microscope.
The most important issue in the ephedra debate is the overall safety of the EBS. If EBS are equally as safe as or safer than the competing prescription drugs, than allowing the continued production of EBS would be the obvious choice to ease the financial burden on patients, taxpayers, and employers that obesity is causing.
The FDA has a system for monitoring complaints of supplements and prescriptions. Anyone can call the Adverse Event Monitoring System (AEMS) to report side effects (Blatman, 2003). After the FDA issued a warning about EBS, they attempted to ban the sale of EBS but Congress prevented the ban on the grounds of insufficient data (Blatman, 2003).
In the fall of 2000, it was discovered that out of 141 AEMS cases, 10 events lead to death and 13 caused permanent damage (Haller, 2000). In most instances, however, excessive amounts of ephedra were consumed. This supported the FDA’s claim that EBS can be dangerous, but evidence of abuse was clear.
Harvard Medical School in Boston studied 167 overweight, but healthy subjects, to determine the safety of EBS (Boozer, 2002). There were no significant changes in blood pressure, heart rate, or irregular heart beat for healthy adults. Also, they found that EBS have no effect on liver, kidney, or thyroid function. The findings lead Boozer to state that “when used by healthy overweight men and women in combination with healthy diet and exercise habits, [EBS] may be beneficial for weight reduction without significantly increased risk of adverse events.” These individuals had no preexisting heart conditions just as the Meridia group did.
Since the FDA approved drugs could cause significant elevations in blood pressure and heart rate (without genetic predisposition or preexisting heart conditions) and ephedra did not, it is clear that when used properly, EBS pose no threat to healthy individuals who follow the label restrictions that come with EBS. The bottles that EBS are sold in contain labels that state not to take them if the user has any of the mentioned conditions.
Conclusion
The current research available on EBS states that EBS are more effective, cheaper, and safer than their prescription counterparts. This would lead one to conclude that EBS will not cause a heart condition, however they may exaggerate or aggravate a preexisting heart condition. Xenical and Meridia both have undesierable side effects including staetorrhea (Xenical) and elevated blood pressure and heart rate (Meridia).
The advantages of EBS clearly outweigh those of Xenical and Meridia. They are safe for general use as long the directions and precautions provided are followed.
Recommendations
Since EBS can be dangerous for particular groups of people, more research needs to be done to find an alternative fat loss agent for them to use. Since supplements are not FDA controlled there is no way that consumers can be sure that what is on the label is what they are receiving. The FDA can assume responsibilities of purity to make sure that the levels of ingredients are accurate. This would make a complete ban of EBS unnecessary.
The FDA could also allow EBS to be available only after physician approval. By making users consult with their primary health care provider (PHCP) over the phone, their files can be reviewed to insure no complications will arise. Then the PHCP can phone in “permission” much the same way as a prescription. By avoiding an office visit the cost would remain low. This would give the FDA the authority it needs to control the purity (safety) of the substance and keep it out of the hands that it may harm.
The current information is available and should be properly presented to and discussed by the U.S. Congress. If that is done than EBS will continue to be available. This will ease the physical and financial strain that obesity is causing in the U.S. today.
Works Cited
Blatman, Judy. “Press Room.” Council for Responsible Nutrition. 2001. 25 July 2003
<**broken link removed**>.
Boozer CN, Daly PA, Homel P, Solomon JL, Blanchard D, Nasser JA, Strauss R, Meredith T. 2002. Herbal ephedra/caffeine for weight loss: a 6-month randomized safety and efficacy trial. International Journal of Obesity Related Metabolic Disorders. 26(5):593-604.
Dixon, Kim. “U.S. Employers Report the Cost of Obesity.” News. 2003. 4 August 2003. <http://www.medformation.com/mf/news.nsf/ReutersNews/U.S._ employers_point_to_cost_of_obesity_>.
Dulloo, AG. Herbal simulation of ephedrine and caffeine in treatment of obesity. International Journal of Obesity Related Metabolic Disorders. 26(5):590-592.
Leung, Wilson. Weight Management and Current Options in Pharmacotherapy: Orlistat and Subutramine. Clinical Therapeutics. 25(1): 58-80.
Greenway FL, Raum WJ, DeLany JP. 2000. The effect of an herbal dietary supplement containing ephedrine and caffeine on oxygen consumption in humans. Journal of Alternative Complementary Medicine. 6(6):553-5.
Haller CA, Benowitz NL. 2000. Adverse cardiovascular and central nervous system events associated with dietary supplements containing ephedra alkaloids. New England Journal of Medicine. 343(25):1833-8.
Prescriptiondrugs.com. “Weight Loss.” Weight Loss. 2003. 25 July 2003.
<**broken link removed**>.
Read, A. “Weight Loss Drugs FAQ.” All Phentermine Weight Loss Center. 2002. 25 July 2003
<**broken link removed**>.
Supplements-R-US. “Thermogenic Fat Loss Supplements.” Supplements-R-US. 2003. 25 July 2003
<**broken link removed**>.
Ephedra Based Supplements: Effective Fat Loss Agents or Dangerous Killers?
Introduction
Obesity in the United States is a problem of epic proportions. The burden obesity puts on the health care system costs taxpayers $78.5 billion annually and employers another $12 billion (Dixon, 2003). Many citizens will resort to over-the-counter (OTC) supplements or prescription weight loss pills to shed the fat. The most popular OTC fat loss pills are ones containing ephedra.
Ephedra has received negative media coverage recently due to the deaths of professional athletes Korey Stringer and Steve Belcher. Both men died in training camps and had bottles of supplements containing the naturally occurring substance ephedra in their lockers. These circumstances have caused the U.S. Congress to review the pros and cons of ephedra use. If Congress concludes that ephedra poses an unnecessary risk to the population, then the sale and use of ephedra will become illegal. The supplements are currently available to anyone who wishes to purchase them. Ephedra is naturally occurring and can be derived from the Ma Haung plant (Dulloo, 2002). The main use for the substance is as a fat loss agent alone or when combined with aspirin and caffeine.
The two most popular FDA approved drugs for fat loss are Xenical and Meridia (Read, 2002). Both, like ephedra, have side effects. Xenical works by preventing fat in the gastrointestinal tract from being absorbed by the body (Leung, 2002) and is relatively safe. Meridia functions in a different manner. Meridia reduces caloric intake by suppressing hunger in the user (Leung, 2002).
This report will discuss whether the two currently FDA approved fat loss drugs are a better alternative to ephedra, thus justifying Congress’ review. Since the outcome of Congress’ decision could effect the health of millions of people, all aspects of effectiveness, cost, and safety will be discussed (Dulloo, 2002).
Effectiveness
The current prescription fat loss medications are quite effective. Subjects taking Xenical during a one year study lost just less than twenty pounds (Leung, 2002). This is caused by the 46.4% to 91.4% effectiveness of the gastrointestinal (GI) lipases inhibitors (Leung, 2002). This prevents the GI tract from metabolizing fat in the diet into a form useable by the body. By preventing dietary fat from being absorbed, Xenical reduces daily caloric intake. When a caloric deficit of 500 kcal per day is induced, users can lose approximately one pound of fat per week (Leung, 2002).
Meridia takes a different approach to fat loss than Xenical. Meridia reduces the reuptake of the monoamines serotonin, noradrenaline, and dopamine (Leung, 2002). By blocking the reuptake of the monamines, they continue to circulate in the bloodstream, allowing the user to feel satisfied longer (Leung, 2002). Meridia users lost up to 12.54 pounds in the six month study (Leung, 2002). This is comparable to the twenty pounds lost by the Xenical patients in the year long study.
Ephedra based supplements (EBS) work along yet another pathway. EBS initiates the release of epinephrine (Epi) and norepinephrine (NEpi), both of which are naturally occurring substances in the body. When Epi and NEpi circulate in the blood they change the blood chemistry so that there is less free floating insulin and more available glucagon. These hormones are responsible for the storage and metabolism of fats and sugars. When insulin is in the blood in high concentrations, body cells have an affinity to absorb nutrients sugars and store them for later use. Glucagon promotes the release of fats and causes the body to use the available fat as an energy source (Haller, 2000). Thus, a spike in Epi and NEpi levels will shift the body’s metabolism from running on sugar for fuel to that of a fat burning machine.
The most infamous aspect of EBS is their reputation as killers by causing athletes’ hearts to explode, but what the media overlooks is their effectiveness. If they were not as effective as the current drugs, then their use would not be justified. However, this does not seem to be the case.
In a six month study patients using EBS lost an average of 11.66 pounds (Boozer, 2002). Again, this is equal to the prescription medications currently approved by the FDA. However, the major difference is that EBS patients lost up to 22.66 pounds for the same six month period (Boozer, 2002). This is a claim that the prescriptions cannot make.
In a recent news report, Blatman stated that during the Performance Enhancement Products conference, Dr. Paul Coates, Director of the Office of Dietary Supplements (ODS) at the National Institute of Health (NIH) called for a study on the safety and efficacy of EBS so that they would “not enter the ephedra controversy unarmed.” The NIH funded a six month study to answer questions about EBS. Both Columbia and Harvard University participated. The results of the study supported previous research that EBS use significantly promotes a loss of body weight, body fat, and LDL cholesterol (Dulloo, 2002).
It is clear that in clinical trial after clinical trial, EBS are proven effective at promoting weight loss. Due to the fact that EBS are proven at least equal and often more effective than the leading prescriptions, cost would be another important factor to consider when deciding to use EBS or a prescription.
Cost
A one month supply of Meridia costs about $216 from an online discount pharmacy. Xenical costs approximately $166 from www.prescriptiondrugs.com. As Leung’s reported stated “the cost effectiveness of Xenical is yet to be determined.” No statements were made about the cost effectiveness of Meridia in the report. A one month supply of an EBS cost approximately $51.00 from www.sruonline.com and similar websites. This is for popular products such as Hydroxycut and Stacker 2. Cheaper generic versions with the same ratio of ingredients are available for half as much on the same websites. Greenway found that EBS are more cost-effective for weight reduction as well as more effective than the prescription medications (1999).
Since EBS cost up to 76% less than the most popular prescription and are more effective, they are clearly the sensible choice.
Safety
Xenical and Meridia both have side effects. Xenical has a tendency to cause a condition known as staetorrhea. This will cause the patient to have loose stools caused by excessive amounts fat in fecal material (Leung, 2002). They also were deficient in fat soluble vitamins A, D, and K. Supplementation was necessary in the study (Leung, 2002). There were also notable problems with drug interaction and minor hypertension.
Meridia was much worse in terms of side effects. Dry mouth, insomnia, constipation, headache, withdrawal, and increases in blood pressure and heart rate (Leung, 2002). Notably, the increase in blood pressure and heart rate were in people who did not previously have or were genetically predisposed to the said symptoms (Leung, 2002). These symptoms are the exact reasons that EBS are under the microscope.
The most important issue in the ephedra debate is the overall safety of the EBS. If EBS are equally as safe as or safer than the competing prescription drugs, than allowing the continued production of EBS would be the obvious choice to ease the financial burden on patients, taxpayers, and employers that obesity is causing.
The FDA has a system for monitoring complaints of supplements and prescriptions. Anyone can call the Adverse Event Monitoring System (AEMS) to report side effects (Blatman, 2003). After the FDA issued a warning about EBS, they attempted to ban the sale of EBS but Congress prevented the ban on the grounds of insufficient data (Blatman, 2003).
In the fall of 2000, it was discovered that out of 141 AEMS cases, 10 events lead to death and 13 caused permanent damage (Haller, 2000). In most instances, however, excessive amounts of ephedra were consumed. This supported the FDA’s claim that EBS can be dangerous, but evidence of abuse was clear.
Harvard Medical School in Boston studied 167 overweight, but healthy subjects, to determine the safety of EBS (Boozer, 2002). There were no significant changes in blood pressure, heart rate, or irregular heart beat for healthy adults. Also, they found that EBS have no effect on liver, kidney, or thyroid function. The findings lead Boozer to state that “when used by healthy overweight men and women in combination with healthy diet and exercise habits, [EBS] may be beneficial for weight reduction without significantly increased risk of adverse events.” These individuals had no preexisting heart conditions just as the Meridia group did.
Since the FDA approved drugs could cause significant elevations in blood pressure and heart rate (without genetic predisposition or preexisting heart conditions) and ephedra did not, it is clear that when used properly, EBS pose no threat to healthy individuals who follow the label restrictions that come with EBS. The bottles that EBS are sold in contain labels that state not to take them if the user has any of the mentioned conditions.
Conclusion
The current research available on EBS states that EBS are more effective, cheaper, and safer than their prescription counterparts. This would lead one to conclude that EBS will not cause a heart condition, however they may exaggerate or aggravate a preexisting heart condition. Xenical and Meridia both have undesierable side effects including staetorrhea (Xenical) and elevated blood pressure and heart rate (Meridia).
The advantages of EBS clearly outweigh those of Xenical and Meridia. They are safe for general use as long the directions and precautions provided are followed.
Recommendations
Since EBS can be dangerous for particular groups of people, more research needs to be done to find an alternative fat loss agent for them to use. Since supplements are not FDA controlled there is no way that consumers can be sure that what is on the label is what they are receiving. The FDA can assume responsibilities of purity to make sure that the levels of ingredients are accurate. This would make a complete ban of EBS unnecessary.
The FDA could also allow EBS to be available only after physician approval. By making users consult with their primary health care provider (PHCP) over the phone, their files can be reviewed to insure no complications will arise. Then the PHCP can phone in “permission” much the same way as a prescription. By avoiding an office visit the cost would remain low. This would give the FDA the authority it needs to control the purity (safety) of the substance and keep it out of the hands that it may harm.
The current information is available and should be properly presented to and discussed by the U.S. Congress. If that is done than EBS will continue to be available. This will ease the physical and financial strain that obesity is causing in the U.S. today.
Works Cited
Blatman, Judy. “Press Room.” Council for Responsible Nutrition. 2001. 25 July 2003
<**broken link removed**>.
Boozer CN, Daly PA, Homel P, Solomon JL, Blanchard D, Nasser JA, Strauss R, Meredith T. 2002. Herbal ephedra/caffeine for weight loss: a 6-month randomized safety and efficacy trial. International Journal of Obesity Related Metabolic Disorders. 26(5):593-604.
Dixon, Kim. “U.S. Employers Report the Cost of Obesity.” News. 2003. 4 August 2003. <http://www.medformation.com/mf/news.nsf/ReutersNews/U.S._ employers_point_to_cost_of_obesity_>.
Dulloo, AG. Herbal simulation of ephedrine and caffeine in treatment of obesity. International Journal of Obesity Related Metabolic Disorders. 26(5):590-592.
Leung, Wilson. Weight Management and Current Options in Pharmacotherapy: Orlistat and Subutramine. Clinical Therapeutics. 25(1): 58-80.
Greenway FL, Raum WJ, DeLany JP. 2000. The effect of an herbal dietary supplement containing ephedrine and caffeine on oxygen consumption in humans. Journal of Alternative Complementary Medicine. 6(6):553-5.
Haller CA, Benowitz NL. 2000. Adverse cardiovascular and central nervous system events associated with dietary supplements containing ephedra alkaloids. New England Journal of Medicine. 343(25):1833-8.
Prescriptiondrugs.com. “Weight Loss.” Weight Loss. 2003. 25 July 2003.
<**broken link removed**>.
Read, A. “Weight Loss Drugs FAQ.” All Phentermine Weight Loss Center. 2002. 25 July 2003
<**broken link removed**>.
Supplements-R-US. “Thermogenic Fat Loss Supplements.” Supplements-R-US. 2003. 25 July 2003
<**broken link removed**>.
