Clinical trial NCT01305811: Acupuncture in the Treatment of Gulf War Illness
Official title: Acupuncture in the Treatment of Gulf War Illness
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
PHASE2
Conditions: Persian Gulf Syndrome
Keywords: Complex Medical Illness
Gulf War Illness
Veteran
Lead sponsor: New England School of Acupuncture
Sponsor class: OTHER
Collaborators: name: United States Department of Defense
First posted: 2011-03-01
Enrollment: 104
Sex: ALL
Minimum age (years): 39
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: This unblinded Phase II clinical trial tested the effects of individualized acupuncture treatments offered in extant acupuncture practices in the community; practitioners had at least 5 years of experience plus additional training provided by the study. Veterans with diagnosed symptoms of Gulf War Illness were randomized to either six months of biweekly acupuncture treatments (group 1, n=52) or 2 months of waitlist followed by weekly acupuncture treatments (group 2, n=52). Measurements were taken at baseline, 2, 4 and 6 months. The primary outcome is the SF-36 physical component scale score (SF-36P).

Detailed description: Gulf War Illness (GWI) is a complex, poorly understood illness characterized by many symptoms, including fatigue after exertion, sleep and mood problems, difficulty concentrating, difficulty thinking and finding words, and musculoskeletal pain. Individuals often present with many symptoms, some of them severe and disabling, and with additional medical diagnoses, including chronic fatigue syndrome, fibromyalgia, irritable bowel syndrome, digestive complaints, and mood-related psychiatric disorders, such as depression, posttraumatic stress disorder, and other anxiety disorders. More than 100,000 veterans of the first Gulf War (Operation Desert Shield/Storm, 1990-1991) out of 700,000 US service personnel deployed to the Persian Gulf have presented with medical complaints through programs established to address the problem, which came to be called chronic multisymptom illness (CMI). Groups of veterans in the United Kingdom, Canada, and Australia have been identified with similar problems. The veterans have received treatment directed at their symptoms, but at 5- and 10-year follow-ups, many reported their symptoms remained, some of them severe and disabling. Clearly, an effective treatment for these conditions would be of great benefit to those who were injured during their military service.

The cause of CMI is unknown, and the symptoms can not be explained by physical and laboratory examinations. Several factors have been considered, including exposure to vaccines, chemicals likely to be encountered in combat (chemical weapons, smoke, pesticides) and stress related to military service, deployment, and combat. After investigation by the Centers for Disease Control (CDC), researchers suspect that the symptoms reflect a range of injuries to the nervous system. It may be that the factors that led to these injuries were not specific to the Persian Gulf region, and that veterans of the current war in Iraq and Afghanistan, as well as active duty personnel, are exposed to similar stressors and will benefit from an investigation of CMI and its treatment.

The goal of this study is to help identify whether acupuncture is an effective treatment for Gulf War Syndrome. Acupuncture is likely to be helpful in treating GWI because it has already been used successfully to reduce many of its key symptoms - fatigue, irritability, anxiety, insomnia, and pain. Acupuncture treatment is designed to treat each individual's symptoms making it very well suited for treating the varied symptoms of GWI. Veterans will receive care that is directed specifically at their most distressing symptom. Although the specific etiology of CMI is unknown, acupuncture's analgesic and anti-inflammatory effects are likely to be helpful. Acupuncture seems to work, in part, on peripheral nerves near the site of injury, in the brain, central nervous system, and on the endocrine system, in ways that promote the body's own efforts to reduce pain and heal even chronic injuries. Numerous studies have shown acupuncture is well tolerated by patients, safe, and cost-effective compared to routine care. Acupuncture will be provided by licensed acupuncturists with at least 5 years of clinical experience, who have received 20-hours of training related to symptoms of GWI.

Subjects were recruited via local advertisements and direct mailing to veterans on the Defense Manpower Data Center (http://www.virec.research.va.gov/Non-VADataSources/DMDC.htm). Through questionnaires, physician assessment, and medical histories, the investigators measured the severity of symptoms before beginning treatment, and after 2, 4 and 6 months of treatment. One group of patients received acupuncture evaluation and treatment twice per week for 6 months. A second group, for comparison purposes, will be monitored on a wait list for 2 months, and will then be offered weekly acupuncture for 4 months. Based on previous acupuncture research on fatigue, stress, and pain, the investigators expect this length of treatment will be enough for patients to receive significant benefit. The investigators also planed to collect samples of blood from our volunteers that will help identify possible disease mechanisms for the illness and track the effects of treatment.

Eligibility criteria: Inclusion

1. deployed to the "Gulf Theater of operations, as defined by 38 CFR 3.317, includes Iraq, Kuwait, Saudi Arabia, Bahrain, Qatar, the United Arab Emirates, Oman, the Gulf of Aden, the Gulf of Oman, the Persian Gulf, the Arabian Sea, the Red Sea, and the airspace above all of these locations" between August 1990 and the present date,
2. they have at least 2 of the following symptoms from the 3 CDC clusters of symptom that have lasted for more than 6 months. Each symptom cluster must be characterized as "mild-moderate" or "severe" with at least one symptom in each cluster required to be severe. The clusters are:

A-Fatigability

* fatigue 24 hours or more after exertion B-Mood and Cognition
* feeling depressed or
* feeling irritable or
* difficulty thinking or concentrating or
* feeling worried, tense, anxious or
* problems finding words or
* problems getting to sleep C-Musculoskeletal
* joint pain or muscle pain

Exclusion:

* Currently enrolled in another clinical trial
* Have another disease that likely could account for the symptoms, as determined by our Medical Monitor
* Severe psychiatric illness (in the last 2 years psychiatric hospitalization, suicidal attempt, alcohol or substance abuse, use of antipsychotic medication) as measured by the Primary Care Evaluation of Mental Disorder (Prime MD).
* Unable to complete the protocol on based on the evaluation of the Medical Monitor

Primary outcomes:
measure: SF-36P
timeFrame: 6 months
Secondary outcomes:
Other outcomes:
measure: SF-36P
timeFrame: 2 months
Locations:
city: Newton
country: United States
facility: New England School of Acupuncture
state: Massachusetts
Study officials:
affiliation: New England School of Acupuncture
name: Lisa A Conboy, ScD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Conboy L, Gerke T, Hsu KY, St John M, Goldstein M, Schnyer R. The Effectiveness of Individualized Acupuncture Protocols in the Treatment of Gulf War Illness: A Pragmatic Randomized Clinical Trial. PLoS One. 2016 Mar 31;11(3):e0149161. doi: 10.1371/journal.pone.0149161. eCollection 2016.