Gulf War Illness: Evaluation of an Innovative Detoxification Program
| Status: | Completed |
|---|---|
| Conditions: | Psychiatric |
| Therapuetic Areas: | Psychiatry / Psychology |
| Healthy: | No |
| Age Range: | Any |
| Updated: | 12/30/2018 |
| Start Date: | April 2010 |
| End Date: | December 2015 |
Pilot Study of Application of the Hubbard Detoxification Program to Veterans With Gulf War Illness
Gulf War illness is found in about one fourth of veterans of the 1990-1991 Gulf War and is
characterized by persistent memory and concentration problems, headaches, fatigue and muscle
and joint pain. It is not known what causes the illness, but exposure to chemicals is
suspected. The Hubbard detoxification program consists of exercise and sauna therapy together
with administration of several dietary supplements, particularly crystalline niacin used at
increasing concentrations over a period of about four weeks. The investigators hypothesize
that this program will reduce symptoms, as tested by administration of cognitive and quality
of life tests and serum clinical chemistry tests.
characterized by persistent memory and concentration problems, headaches, fatigue and muscle
and joint pain. It is not known what causes the illness, but exposure to chemicals is
suspected. The Hubbard detoxification program consists of exercise and sauna therapy together
with administration of several dietary supplements, particularly crystalline niacin used at
increasing concentrations over a period of about four weeks. The investigators hypothesize
that this program will reduce symptoms, as tested by administration of cognitive and quality
of life tests and serum clinical chemistry tests.
This will be a pilot randomized controlled trial of feasibility, safety and changes in
fatigue and pain symptoms, measured quality of life, mental health status, and
neuro-cognitive functioning of a group of GWVs after a 4 to 6 week sauna detoxification
regimen as compared to control. For control subjects we will also have a group of GWVs
receiving usual care who are randomly assigned to a waitlist and who will start the
intervention after a four to six week delay. The waitlist group will also take part in the
baseline tests a second time just prior to their treatment 4 to 6 weeks later and a 7-day
post-treatment battery of tests the same as described for the treatment group. Finally, there
will be a 3-month follow-up with both the groups. The Severna Park Health and Wellness Center
(SPHWC) is a commercial center that offers the Hubbard detoxification program. The
investigators will contract with SPHWC to provide the program to the subjects of this study
and to provide office space for the Study Coordinator, so that all components of this project
except the initial Physician evaluation and blood sample acquisition can be done at the
Center, not just the detoxification.
Study Variables: The investigators will examine feasibility of the research design, and
safety of the regimen and estimate changes in:
- Quality of life as measured by the Veterans Short Form (SF36-V). The SF36-V also
includes physical (PCS) and mental (MCS) component summary scores.
- Case status for GWI will be assessed utilizing the Kansas criteria.
- Symptoms of fatigue and pain in GWI will be measured wit, the Multidimensional Fatigue
Inventory, and the short-form McGill Pain-2 Questionnaire.
- Cognitive function will be measured with a battery of neurocognitive tests. These will
include visual motor, memory and executive functioning as measured by the Trailmaking
test, Grooved Pegboard, Wechsler Memory Abbreviated test, and the Stroop color word
test. To account for potential confounding in neurocognitive testing, mental health
status will be evaluated using the Symptom Checklist 90 revised and the State Trait
Anxiety Inventory.
- Physical health status will be assessed via standard medical examination and laboratory
analyses of serum metabolic panel, lipid profile and hormones.
Sampling Method: This will be a convenience sample and will consist of Gulf War Veterans who
meet the Kansas case definition for Gulf War illness and reside in the Washington/Baltimore
area or can travel to and reside in the area for several weeks. The individuals who show
interest in this study, who meet eligibility criteria and subsequently agree to participate
will be selected to enroll in the study.
Randomization: Volunteers will be randomly assigned to a group when they enroll. One group
will be the immediate experimental intervention group and one group will be the wait-list
control group. Random assignment will be achieved by use of sequentially numbered, opaque,
sealed envelopes. Both will undergo the detoxification protocol, but the control group will
be tested twice prior to treatment.
fatigue and pain symptoms, measured quality of life, mental health status, and
neuro-cognitive functioning of a group of GWVs after a 4 to 6 week sauna detoxification
regimen as compared to control. For control subjects we will also have a group of GWVs
receiving usual care who are randomly assigned to a waitlist and who will start the
intervention after a four to six week delay. The waitlist group will also take part in the
baseline tests a second time just prior to their treatment 4 to 6 weeks later and a 7-day
post-treatment battery of tests the same as described for the treatment group. Finally, there
will be a 3-month follow-up with both the groups. The Severna Park Health and Wellness Center
(SPHWC) is a commercial center that offers the Hubbard detoxification program. The
investigators will contract with SPHWC to provide the program to the subjects of this study
and to provide office space for the Study Coordinator, so that all components of this project
except the initial Physician evaluation and blood sample acquisition can be done at the
Center, not just the detoxification.
Study Variables: The investigators will examine feasibility of the research design, and
safety of the regimen and estimate changes in:
- Quality of life as measured by the Veterans Short Form (SF36-V). The SF36-V also
includes physical (PCS) and mental (MCS) component summary scores.
- Case status for GWI will be assessed utilizing the Kansas criteria.
- Symptoms of fatigue and pain in GWI will be measured wit, the Multidimensional Fatigue
Inventory, and the short-form McGill Pain-2 Questionnaire.
- Cognitive function will be measured with a battery of neurocognitive tests. These will
include visual motor, memory and executive functioning as measured by the Trailmaking
test, Grooved Pegboard, Wechsler Memory Abbreviated test, and the Stroop color word
test. To account for potential confounding in neurocognitive testing, mental health
status will be evaluated using the Symptom Checklist 90 revised and the State Trait
Anxiety Inventory.
- Physical health status will be assessed via standard medical examination and laboratory
analyses of serum metabolic panel, lipid profile and hormones.
Sampling Method: This will be a convenience sample and will consist of Gulf War Veterans who
meet the Kansas case definition for Gulf War illness and reside in the Washington/Baltimore
area or can travel to and reside in the area for several weeks. The individuals who show
interest in this study, who meet eligibility criteria and subsequently agree to participate
will be selected to enroll in the study.
Randomization: Volunteers will be randomly assigned to a group when they enroll. One group
will be the immediate experimental intervention group and one group will be the wait-list
control group. Random assignment will be achieved by use of sequentially numbered, opaque,
sealed envelopes. Both will undergo the detoxification protocol, but the control group will
be tested twice prior to treatment.
Inclusion Criteria:
- Any veteran of the 1990-1991 Gulf War who meets the Kansas Gulf War Illness case
definition.
Exclusion Criteria:
- Veterans who meet the inclusion criteria but have been diagnosed by a physician with
(1) chronic conditions (eg., cancer, heart disease, diabetes, liver disease, multiple
sclerosis, etc.) that are not associated with Gulf War service but can produce diverse
symptoms similar to Gulf War Illness; (2) conditions that might interfere with
respondents' ability to report symptoms (eg., psychiatric conditions or history of
hospitalization for depression, alcohol or drug dependence; (3) pregnancy or
unwillingness to use contraception.
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