VA Launches Large Studies Of Treatments For Gulf Veterans
October 22, 1998
Washington, D.C. -- The Department of Veterans Affairs (VA) is leading a $20 million effort with the Department of Defense (DoD) to conduct large-scale randomized, controlled trials of treatments for the symptoms of undiagnosed illnesses of Gulf War veterans.
Since the Gulf War, thousands of Gulf War veterans have suffered from a variety of symptomatic complaints including fatigue, muscle and joint pain, and problems with memory and thinking. Because neither the cause nor a single underlying disease process has been identified, doctors have treated veterans for their individual symptoms.
"Despite the lack of a comprehensive case definition for the symptom complex often called Gulf War veterans' illnesses, VA has identified subgroups of patients for whom potential treatments are now appropriate," said Dr. John R. Feussner, VA Chief Research and Development Officer and chairperson of the Research Working Group of the Persian Gulf Veterans Coordinating Board.
VA's Cooperative Studies Evaluation Committee, an advisory panel of independent scientific experts, approved both trials. An international panel of experts, including scientists from the National Institutes of Health, universities, DoD, and VA, was consulted in the design of the protocols.
Exercise/Behavioral Therapy (EBT) Trial The EBT trial, focusing on exercise and behavioral therapy, will enroll more than 1,000 veterans who experience at least two of the three otherwise unexplained symptoms of fatigue, muscle and joint pain, and memory and thinking problems.
The trial will be conducted at multiple VA medical centers to test whether two different therapeutic interventions, alone or in combination, improve physical function. Researchers will randomly assign study volunteers to different groups receiving aerobic exercise training, cognitive behavioral therapy, both together, or usual and customary medical care as a control group.
Aerobic exercise has been shown to be effective in managing symptoms of some chronic illnesses. Cognitive behavioral therapy (CBT) has also been shown to be effective in small clinical studies. CBT is a highly structured treatment strategy that teaches patients various techniques for diminishing the severity of their symptoms.
The investigators in the present trial hypothesize that the same techniques, used individually or in combination, may help veterans suffering from such symptoms as fatigue. The EBT trial is not aimed at curing Gulf War veterans' illnesses, but will evaluate non-pharmacologic strategies for reducing the severity of the veterans' symptoms so that they can achieve a higher level of function in life. The present trial, through the treatment of large numbers of veterans and the use of multiple study sites, is designed to demonstrate definitively whether exercise alone or in combination with CBT improves health.
VA clinical researcher Dr. Sam Donta, an infectious disease specialist at the Boston VA Medical Center and a professor of medicine at Boston University, is leading the trial. His co-investigators include Dr. Daniel Clauw, Associate Professor of Rheumatology at Georgetown University, and Dr. Charles Engel, Director of the Gulf War Veterans Treatment Center at the Walter Reed Army Medical Center in Washington, D.C.
Antibiotic Treatment (ABT) Trial The second trial focuses on Mycoplasma fermentans, a hypothesized infectious cause of the variety of symptoms being experienced by Gulf War veterans. Although there is no established, definitive link between infection with this organism and Gulf War veterans' illnesses, undetermined numbers of ill veterans are taking the antibiotic doxycycline for up to 12 months in hopes of improving their health.
Anecdotal reports that this treatment may be useful are not sufficient to establish doxycycline as an effective treatment for Gulf War veterans' illnesses. A randomized, controlled clinical study, such as the ABT trial, is necessary to determine the effectiveness of antibiotics for these illnesses.
In this trial, hundreds of qualified ill veterans at several VA sites will be randomly assigned to either a placebo control group or a treatment group, whose members will receive doxycycline orally for 12 months; a qualified volunteer will be required to have evidence of infection with Mycoplasma demonstrated by detection of the organism's DNA using the modern molecular technique known as polymerase chain reaction (PCR). The study will assess improvement of physical functioning and elimination of Mycoplasma.
Dr. Donta is also leading the antibiotic study. His co-investigators are Dr. Joel Baseman, professor and chairman of the Microbiology Department at the University of Texas Medical Center in San Antonio, a leading international expert in mycoplasma infections, and Dr. Engel of the Gulf War Veterans Treatment Center at the Walter Reed Army Medical Center.
The EBT and ABT trials are research studies and not part of standard clinical care for Gulf War veterans. Recruitment for these studies will begin after Jan. 1, 1999, and information about participation will be disseminated at that time. Veterans who are in need of medical care now or who wish to take advantage of the special examination program available to all Gulf veterans under the Gulf War Health Registry may receive information from their local VA medical center or the VA's Gulf War Helpline at 1-800-PGW-VETS (1-800-749-8387).
