Phase 2 N=104 Randomized Double-blind Treatment

Acupuncture in the Treatment of Gulf War Illness

Persian Gulf Syndrome

Bottom Line

View on ClinicalTrials.gov: NCT01305811 ↗

Enrolled (actual)

104

Serious AEs

1.0%

Results posted

May 2015

Primary outcome: Primary: SF-36P — 73.7; 64.3 units on a scale — p=0.03

Study Design & Population

Study type: Interventional
Phase: Phase 2
Interventions: Acupuncture (Device)
Age: Adult, Older Adult · 39+ yrs
Sex: All
Sponsor: New England School of Acupuncture
Primary completion: Jan 2013

Outcome Measures

Outcome	Result	p-value
PRIMARY SF-36P	0.32; 4.53	=0.22

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).

Eligibility Criteria

Inclusion

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,
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

View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT01305811). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.