Does Aspartame Trigger Migraine? No, Says FDA


There is an ongoing controversy as to whether aspartame is responsible for causing headaches in people who ingest it. The FDA calls aspartame the most researched food additive ever approved.

While there have been multiple reports of users experiencing sudden and severe onset of migraine headaches after using of aspartame, studies done by various institutions would seem to indicate the link is not causal. The FDA says they have received the results of over 100 clinical trials and doxological studies, and upon review they have concluded that aspartame is safe for ingestion by the human population.

Following concerns in the late 1970s about saccharin, an artificial sweetener marketed as Sweet ‘n Low, the industry sought an alternative product. Saccharin remains on the anticipated carcinogens list, as it has been proven to cause cancer in animals; despite this it remains a highly popular sweetener.

Aspartame, marketed under such brand names as Equal and NutraSweet, was approved by the FDA in 1981, and is present in many diet drinks, foods and gum as well as being marketed heavily as a tabletop sweetener.

Aspartame is frequently used by dieters wishing to reduce sugar consumption. As a very low calorie product it has found favor with calorie counters world-wide.

In the past decade, many reports have been made by aspartame users concerning adverse effects, particularly in the case of migraine headaches. Patients claiming they suffered serious headaches after consuming aspartame took part in an in-depth study under the auspices of the Duke University Medical Center.

Dr Susan Schiffman carried out the study; with Monsanto/NutraSweet making a contribution to the costs. NutraSweet, you will recall, is a brand name under which aspartame is marketed. Researchers evaluated 40 sufferers of aspartame related headaches.

Some subjects of the study were dosed with a 30mg/kg bw on days three and five of the double blind study. Others received a placebo. Of the volunteers who participated in the study, 35% who consumed aspartame developed headaches, but 45% in the placebo group developed headaches.

There has been frequent criticism of the study due to its short term and below optimum conditions. Researchers counter by claiming that all the CDC guidelines had been complied with, so the results were valid.

These results of the study, which were published in the New England Journal of Medicine, claimed that no correlation whatsoever existed between consumption of aspartame and migraine headaches (1).

Allegations of aspartame promoting migraines are numerous on the world wide web. Researchers have carried out over 200 studies in order to evaluate the safety of aspartame, looking at everything from lymphoma to epilepsy,. It is completely harmless, in the opinion of the FDA.

The European Food Safety Administration published a review stating that aspartame had indeed caused lymphoma in laboratory rats, but since no other studies had shown similar results, concluded their study was faulty and declined to raise any concerns about aspartame (3).

After evaluation of nearly half a million men and women aged between 50 and 69 over a five year period, the US National Cancer Institute concluded there was no evidence to link aspartame consumption with lymphoma, leukemia or brain tumors (4).

The Scientific Committee on Food did an exhaustive review of more than 500 papers on the subject of aspartame and came to the conclusion that concerns about aspartame causing any adverse reaction were unfounded (5).

Proponents of the use of aspartame have raised concerns that the ‘myth of aspartame headaches’ can cause people to overlook severe medical problems and that blaming aspartame for migraines can endanger those with more serious health issues. Sufferers of frequent headaches or migraine should always consult their medical practitioner, irrespective of what they perceive the cause to be.

Those with migraines who stop taking aspartame sweetened beverages and foods and experience a cessation of symptoms are said by the medical community to be experiencing a form of ingrained reaction – they believe strongly that the aspartame is the cause of their symptoms, so the absence of aspartame causes the pain to cease.

This is also expected to work the other way – that if they believe drinking an aspartame sweetened beverage will give them a headache, they will proceed to develop one – a theory upheld by the results of the placebo group in the Duke trial.

This has not been proven beyond doubt; to date there has been no medical evidence to corroborate suggestions that the consumption of aspartame will trigger a migraine. At the time of writing, the Duke Study is considered to be the most authoritative on the subject.

(1) New England Journal of Medicine Volume 317:1181-1185 November 5, 1987

(2) CFSAN/Office of Food Additive Safety April 20, 2007

(3) EFSA findings (Website available on request)

(4) Council on Scientific Affairs (1985) Aspartame. Review of safety issues.

(5) Scientific Committee findings Website available on request

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