INTRODUCTION
 
The researchers at CARI were asked by Wal-mart to investigate the side effects of the artificial Sweetener Nutrasweet (Aspartame). Our null
hypothesis is that there will be no significant relationship between headaches and the intake of Nutrasweet (Aspartame).

REVIEW OF LITERATURE
 
The purpose of this section is to report on research that has been conducted with regards to aspartame ingestion and headaches. The relationship between possible toxic effects of aspartame's component amino acids, aspartic acid and phenylalanine, and its major decomposition products, methanol and diketopiperazine, on brain neurochemicals is also discussed.
 
Aspartame, the methyl ester of the dipeptite formed from combining phelylalanine and aspartic acid, was approved by the US Food and Drug
Administration (FD) in July 1981. FDA monitors complaints from consumers and health professionals through the Adverse Reaction Monitoring System, a passive surveillance program. FDA has received thousands of reports of seizures that have been linked to ingestion of aspartame by consumers.1
 
To examine whether ingestion of aspartame is associated with headaches, Van Den Eden, et al, conducted a double-blind crossover study using volunteers with self-identified headaches after using aspartame.2 Of the 32 subjects randomized to receive aspartame and placebo in a two-treatment, four-period crossover design, 18 completed the full protocol, seven completed part of the protocol before withdrawing due to adverse effects, three withdrew for other reasons, two were lost to follow-up, one was withdrawn due to noncompliance, and one withdraw and gave no reason.
 
According to the study, subjects reported significantly more headaches during aspartame treatment compared with the placebo. The report concluded that aspartame appears to cause headaches in a subset of individuals with self-identified headaches after aspartame use. The researchers recommend a double-blind, single-subject test using aspartame and placebo for individuals where there is concern that aspartame may be a trigger to headaches.
 
Tollefson, et al investigated reports of seizures and headaches Associated with aspartame reported to the FDA's ARMS (Adverse Reaction Monitoring System).1 One case involved a 22-year-old woman with no previous or headache history who consumed a beverage sweetened with aspartame daily for I month. She experienced two nocturnal grand mal seizures, 5 hours apart, followed by headaches. The medical diagnosis was seizure of unknown etiology. Clinical laboratory tests and a complete blood cell count were all within normal range. She reported the seizure one year after its occurrence after reading a magazine article that related aspartame products to seizures and headaches. When contacted 26 months after the incident, she stated that she had remained free of seizures and had not resumed the use of aspartame.
 
The second case involved a 36-year-old man with a known seizure disorder controlled by anticonvulsant medication. He who reported what he described as a "breakthrough" seizure. His last seizure had occurred 2 years before this episode. He had been consuming 1400 mg aspartame daily (20 mg/kg) for approximately 2 weeks when he experienced two grand mal seizures with accompanying headaches in 1 day.
 
The third case report concerned a 42-year-old woman who used aspartame in caffeinated diet sodas as a diet aid. Her maximum daily consumption level was almost 5 L diet soda (approximately 2,700 mg aspartame). Approximately 3 months after first consuming aspartame, she experienced 3 migraine headaches with nausea and vomiting
 
She was unresponsive to nonprescription medications and experienced extreme changes in mood that included irritability, increased sensitivity, and anxiety. One year later, she began experiencing petit mal seizures associated with the headaches and subsequently had a nocturnal grand mal seizure.
 
After the grand mal seizure, the patient was placed on 600 mg carbamazepine USP (Tegretol) daily and ceased using aspartame. She stated that she has not had problems with seizures, headaches, or mood changes since she stopped using aspartame.
 
This report does indicate, however, that a large proportion of reported reactions (49%) in the ARMS database were classified as seizures and headaches that had no relationship to the consumption of aspartame. To a large extent, the high percentage of the reported reactions placed in this category was the result of the nature of a passive surveillance system, and that medical documentation for the reaction was often unavailable. More often, according to the report, the medical records were incomplete and inconclusive and had to be disregarded because so little information was provided. Also, when the medical records mentioned that the seizure patient had a disease that could potentially be the underlying cause of the seizure, the report was classified in this category.
 
Lipton, et al 3 found that in many neurologic disorders, injury to neurons may be caused at least in part by overstimulation of receptors for excitatory amino acids, including aspartate. These neurologic conditions range from acute insults such as headaches to strokes. They found that even at lower concentrations superoxide ions can participate in reactions to form products that may be toxic to neurons to cause mechanical trauma to the nervous system.
 
A recent report in the Journal of the American Medical Association reviewed a 115-week study to evaluate whether aspartame or its decomposition product, diketopoperazine induced brain neoplasms in mice and rats. Based on the results of this study, the board concluded that aspartame, at least when administered in the huge quantities employed in the study, may contribute to the development of brain tumors and recommended withdrawing approval of aspartame until additional studies could be conducted. 4
 
This chapter presented the selected aspects of the persistent concern that the use of aspartame may result in adverse abnormalities such as headaches and seizures. Since aspartame's approval, numerous reports have implicated aspartame in the occurrence of these problems. In addition, the FDA has received thousand complaints in a passive surveillance system to monitor adverse side effects. 5 The studies examined in this research report conclude that aspartame appears to cause headaches in a subset of individuals with self-identified headaches after aspartame use.
 
REFERENCES
 
1. Tollefson DVM, Barnard J: An analysis of FDA passive surveillance reports of seizures associated with consumption of aspartame. J Am Dietetic Assoc. 1994;92:5 598-601.
 
2. Van Den Eden SK, Koepsell TD, Longstreth WT Jr, Van Belle G, Daling JR, and McKnight B: Aspartame ingestion and headaches: A randomized crossover trial. Neurology. 1994;44 1787-1793
 
3. Lipton SA, Rosenberg PA. Excitatory amino acids as a final common pathway for neurologic disorders. The New England Journal of Medicine. 1994;330:9 613-624.
 
4. Council of Scientific Affairs. Aspartame: review of safety issues. Journal American Medical Association. 1995;254:3 400-402.
 

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