A Detoxification Intervention for Gulf War Illness: A Pilot Randomized Controlled Trial.

Approximately 30% of the 700,000 US veterans of the 1990-1991 Persian Gulf War developed multiple persistent symptoms called Gulf War illness. While the etiology is uncertain, several toxic exposures including pesticides and chemical warfare agents have shown associations. There is no effective medical treatment. An intervention to enhance detoxification developed by Hubbard has improved quality of life and/or reduced body burdens in other cohorts. We evaluated its feasibility and efficacy in ill Gulf War (GW) veterans in a randomized, waitlist-controlled, pilot study at a community-based rehabilitation facility in the United States. Eligible participants (n = 32) were randomly assigned to the intervention (n = 22) or a four-week waitlist control (n = 10). The daily 4-6 week intervention consisted of exercise, sauna-induced sweating, crystalline nicotinic acid and other supplements. Primary outcomes included recruitment, retention and safety; and efficacy was measured via Veteran's Short Form-36 (SF-36) quality of life, McGill pain, multidimensional fatigue inventory questionnaires and neuropsychological batteries. Scoring of outcomes was blinded. All 32 completed the trial and 21 completed 3-month follow-up. Mean SF-36 physical component summary score after the intervention was 6.9 (95% CI; -0.3, 14.2) points higher compared to waitlist control and 11 of 16 quality of life, pain and fatigue measures improved, with no serious adverse events. Most improvements were retained after 3 months. The Hubbard regimen was feasible, safe and might offer relief for symptoms of GW illness.

Predictors of exercise compliance in individuals with Gulf War veterans illnesses: Department of Veterans Affairs Cooperative Study 470.

Although the health benefits of exercise for individuals with Persian Gulf War veterans illnesses (GWVI) are documented, many of these individuals do not exercise regularly enough to obtain benefits. The purpose of this study was to investigate factors predicting exercise compliance among individuals with GWVI in a multicenter, randomized, clinical trial. Participants were 1,092 veterans who reported at least two of the following cardinal symptoms of GWVI: (1) fatigue, (2) musculoskeletal pain, and (3) cognitive problems. Participants received exercise alone or exercise and cognitive-behavioral therapy. The overall level of compliance was relatively low during the exercise treatment phase (46.2%) and decreased by one-half during the follow-up period (23.0%). Predictors of compliance during treatment included less pain and greater age, motivation, and body mass index. Predictors of compliance during the follow-up period included less pain and greater age. The results highlight factors that affect adoption and maintenance of physical activity in a population with GWVI.

Health status of Persian Gulf War veterans: self-reported symptoms, environmental exposures and the effect of stress.

BACKGROUND: Most US troops returned home from the Persian Gulf War (PGW) by Spring 1991 and many began reporting increased health symptoms and medical problems soon after. This investigation examines the relationships between several Gulf-service environmental exposures and health symptom reporting, and the role of traumatic psychological stress on the exposure-health symptom relationships. METHODS: Stratified, random samples of two cohorts of PGW veterans, from the New England area (n = 220) and from the New Orleans area (n = 71), were selected from larger cohorts being followed longitudinally since arrival home from the Gulf. A group of PGW-era veterans deployed to Germany (n = 50) served as a comparison group. The study protocol included questionnaires, a neuropsychological test battery, an environmental interview, and psychological diagnostic interviews. This report focuses on self-reported health symptoms and exposures of participants who completed a 52-item health symptom checklist and a checklist of environmental exposures. RESULTS: The prevalence of reported symptoms was greater in both Persian Gulf-deployed cohorts compared to the Germany cohort. Analyses of the body-system symptom scores (BSS), weighted to account for sampling design, and adjusted by age, sex, and education, indicated that Persian Gulf-deployed veterans were more likely to report neurological, pulmonary, gastrointestinal, cardiac, dermatological, musculoskeletal, psychological and neuropsychological system symptoms than Germany veterans. Using a priori hypotheses about the toxicant effects of exposure to specific toxicants, the relationships between self-reported exposures and body-system symptom groupings were examined through multiple regression analyses, controlling for war-zone exposure and post-traumatic stress disorder (PTSD). Self-reported exposures to pesticides, debris from Scuds, chemical and biological warfare (CBW) agents, and smoke from tent heaters each were significantly related to increased reporting of specific predicted BSS groupings. CONCLUSIONS: Veterans deployed to the Persian Gulf have higher self-reported prevalence of health symptoms compared to PGW veterans who were deployed only as far as Germany. Several Gulf-service environmental exposures are associated with increased health symptom reporting involving predicted body-systems, after adjusting for war-zone stressor exposures and PTSD.

Rehabilitative care of war-related health concerns.

The objective of this study was to pilot the effectiveness of a 3-week rehabilitative intervention that used medical review, graded exercise, education on Gulf War exposures, active coping, and nutrition to improve disability and related distress for Gulf War veterans with persistent symptoms. One hundred and nine veterans were assessed at program entry and exit and at 1 and 3 months after program completion. Outcomes were physical symptoms, quality of life, physical health concern, and psychosocial distress--contrasted across time and demographic groups. After treatment, veterans showed modest and global improvements; women were more likely than men to show improvement. The finding that Gulf War veterans who completed specialized rehabilitative management experienced modest, short-term improvements is encouraging, given that veterans of the conflict remain concerned about their future health. Controlled studies are needed.

Post-war syndromes: illustrating the impact of the social psyche on notions of risk, responsibility, reason, and remedy.

The 20th century offered many examples of post-war syndromes such as Da Costa's syndrome, irritable heart, shell shock, effort syndrome, medical evacuation syndrome, post-traumatic stress disorder, and Gulf War syndrome. These post-war syndromes occur under conditions of substantial medical and scientific uncertainty, conditions that potentially magnify the impact of social context on clinical care for these syndromes. This article reviews the social circumstances surrounding four post-war syndromes. The case is made that social context has significantly impacted professional and lay perceptions of causal mediators, relevant risk factors, defining symptoms, and appropriate therapies for these syndromes. Furthermore, it is argued that social context influences what parties are held responsible for post-war syndromes, and what clinical disciplines are ultimately deemed appropriate to provide legitimate post-war illness care.

Research on informed consent: investigator-developed versus focus group-developed consent documents, a VA cooperative study.

In the Department of Veterans Affairs Cooperative Study (VACSP) #470, A Randomized, Multicenter, Controlled Trial of Multi-Modal Therapy in Veterans with Gulf War Illnesses, a substudy was designed with the primary objective of comparing the utility of an informed consent document developed by a focus group of Gulf War veterans (focus group-developed) to an informed consent document developed by the standard process involving the study investigators (investigator-developed). In December 1998 a focus group of five Gulf War veterans convened at the coordinating center and developed a consent document during three sessions. The focus group used the investigator-developed consent document as a "starting point" and then modified it by consensus agreement. They also reviewed and modified the substudy's assessment questionnaire. Utility will be evaluated in 1092 veterans participating in the parent study, VACSP #470, by directly comparing selected patient-centered outcomes between those receiving the focus group-developed consent document versus those receiving the investigator-developed document. The primary outcomes to be evaluated over a 1-year follow-up period include measures of the informed consent process, such as patient recall, expectations about risks and benefits of participation, and understanding about the voluntariness of consent. Secondary outcomes will assess the impact of the substudy on the parent study with respect to recruitment and adherence. VACSP #470 was initiated in May 1999 in 20 sites that were randomly allocated to use either the focus group-developed or investigator-developed consent document. Sites are unaware of the type of consent document assigned. This article focuses on the rationale and design of the informed consent substudy and also discusses potential ethical issues.