DEPARTMENT OF DEFENSE - CONGRESSIONALLY DIRECTED MEDICAL RESEARCH PROGRAMS

Gulf War Illness: Evaluation of an Innovative Detoxification Program

Principal Investigator: CARPENTER, DAVID O
Institution Receiving Award: NEW YORK, STATE UNIVERSITY OF, ALBANY
Program: GWIRP
Proposal Number: GW093066
Award Number: W81XWH-10-1-1004
Funding Mechanism: Innovative Treatment Evaluation Award
Partnering Awards:
Award Amount: $633,677.00


PUBLIC ABSTRACT

Close to 700,000 U.S. military personnel served in the 1990-1991 Gulf War. Within about 2 years, approximately one in four developed persistent health effects now referred to as Gulf War illness; few have since improved or recovered. A 2008 report from the Research Advisory Committee on Gulf War Veterans' Illnesses noted that "evidence strongly and consistently indicates" that exposure to pesticides and pyridostigmine bromide (PB) pills are causally associated with Gulf War illness, adding that low-level exposure to nerve agents, close proximity to oil well fires, receipt of multiple vaccines, and effects of combinations of Gulf War exposures could not be ruled out as causes of Gulf War illness.

Modern medicine has few tools to address symptoms associated with low-level exposures to toxic chemicals. A regimen developed by Hubbard utilizes elements including exercise, low heat sauna, and vitamin and mineral supplements to supplementation to repair and rebuild the body and to encourage the release of stored toxins through sweat and increased metabolism. The program is delivered on a 7-day per week schedule; on average, completion is attained within 33 days.

In the decades following its development, this therapy has been implemented to address exposure-related symptoms in a variety of populations, including street drug users and addicts; Michigan residents exposed to fire retardant accidentally sold as cattle feed; electrical workers; firefighters, residents, and workers affected by the Chernobyl disaster; and police exposed to chemicals during raids on illicit drug labs. Nearly 1,000 World Trade Center rescue workers have completed the program, with improvements in quality of life and job fitness. Published reports and clinical experience in thousands of cases have established the safety of the program.

Case histories of Gulf War veterans who have completed this program were presented at a 1999 Gulf War research conference organized by the Centers for Disease Control and Prevention, and the final report from the conference recommended that a treatment trial be conducted to further examine its benefits. To date, no such trial has been undertaken. The proposed research would respond to this recommendation. Its objective is to investigate the ability of this therapy to reduce symptoms and improve functional status in Persian Gulf War veterans with chronic health problems.

Improvements in fatigue and pain symptoms, quality of life, mental health, and thinking and reasoning abilities in a group of Gulf War veterans who have completed the regimen will be compared to those observed in a control group of Gulf War veterans receiving usual care who are randomly assigned to a waitlist. The control group will then undergo the program after a 4- to 6-week delay. In all, 50 veterans will participate.

A demonstration via the proposed pilot trial that persistent Gulf War symptoms can be significantly reduced and that affected veterans can regain a more normal quality of life would support future large-scale clinical trials. The data collected have the potential to enable the Department of Veterans Affairs, Department of Defense, and private practitioners to establish facilities around the country where this rehabilitative therapy can be provided in a cost-effective manner.