Eosinophilia-Myalgia Syndrome Clinical Trial
Official title:
L-5-Hydroxy-Tryptophan-Related Eosinophilia-Myalgia Syndrome (EMS): Clinical Patient Evaluation
In 1989 more than 1500 people who took the dietary supplement L-tryptophan for insomnia and
depression developed eosinophilia myalgia syndrome (EMS)-a potentially fatal disease
characterized by an excess of a type of white blood cell called eosinophils. Disease
symptoms include fever, muscle aches and inflammation, and skin rashes. As many as 40 of the
patients who became ill died. It is suspected that impurities in the supplements caused the
disease. More recently, similar impurities have been detected in batches of a similar
dietary supplement called L-5-hydroxytryptophan.
This study is designed to learn more about EMS that develops in patients taking
L-5-hydroxytryptophan. The study is open to patients newly diagnosed with eosinophilia
myalgia who have taken L-5-HTP. Patients in the study will have a physical examination and
urine and blood tests. They may also have X rays, an electrocardiogram, magnetic resonance
imaging (MRI), and a skin test for tuberculosis. They will have a psychiatric interview,
take a memory test, and fill out questionnaires relating to sadness and depression.
Patients may also undergo special tests to study conduction of nerve impulses and muscle
function.
Samples of patients' supplements will be taken for chemical analysis.
| Status | Completed |
| Enrollment | 20 |
| Est. completion date | August 2000 |
| Est. primary completion date | |
| Accepts healthy volunteers | No |
| Gender | Both |
| Age group | N/A and older |
| Eligibility |
Patients must be at least 18 years of age. Patients newly diagnosed with eosinophilia and myalgia, and who ingested L-5-HTP. Subjects will be defined as having 5-L-HTP related EMS according to the diagnostic criteria originally established by the CDC for diagnosis of L-tyrptophan-related EMS. |
N/A
| Country | Name | City | State |
|---|---|---|---|
| United States | National Institute of Mental Health (NIMH) | Bethesda | Maryland |
| Lead Sponsor | Collaborator |
|---|---|
| National Institute of Mental Health (NIMH) |
United States,
Eidson M, Philen RM, Sewell CM, Voorhees R, Kilbourne EM. L-tryptophan and eosinophilia-myalgia syndrome in New Mexico. Lancet. 1990 Mar 17;335(8690):645-8. — View Citation
Kamb ML, Murphy JJ, Jones JL, Caston JC, Nederlof K, Horney LF, Swygert LA, Falk H, Kilbourne EM. Eosinophilia-myalgia syndrome in L-tryptophan-exposed patients. JAMA. 1992 Jan 1;267(1):77-82. — View Citation
Silver RM, Heyes MP, Maize JC, Quearry B, Vionnet-Fuasset M, Sternberg EM. Scleroderma, fasciitis, and eosinophilia associated with the ingestion of tryptophan. N Engl J Med. 1990 Mar 29;322(13):874-81. — View Citation