The Effectiveness of Individualized Acupuncture Protocols in the Treatment of Gulf War Illness: A Pragmatic Randomized Clinical Trial

Lisa Conboy, Travis Gerke, Kai-Yin Hsu, Meredith St John, Marc Goldstein, Rosa Schnyer, Lisa Conboy, Travis Gerke, Kai-Yin Hsu, Meredith St John, Marc Goldstein, Rosa Schnyer

Abstract

Background: Gulf War Illness is a Complex Medical Illness characterized by multiple symptoms, including fatigue, sleep and mood disturbances, cognitive dysfunction, and musculoskeletal pain affecting veterans of the first Gulf War. No standard of care treatment exists.

Methods: This pragmatic Randomized 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) and the secondary outcome is the McGill Pain scale.

Results: Of the 104 subjects who underwent randomization, 85 completed the protocol (82%). A clinically and statistically significant average improvement of 9.4 points (p = 0.03) in the SF-36P was observed for group 1 at month 6 compared to group 2, adjusting for baseline pain. The secondary outcome of McGill pain index produced similar results; at 6 months, group 1 was estimated to experience a reduction of approximately 3.6 points (p = 0.04) compared to group 2.

Conclusions: Individualized acupuncture treatment of sufficient dose appears to offer significant relief of physical disability and pain for veterans with Gulf War Illness. This work was supported by the Office of the Assistant Secretary of Defense for Health Affairs through the Gulf War Illness Research Program under Award No. W81XWH-09-2-0064. Opinions, interpretations, conclusions and recommendations are those of the author and are not necessarily endorsed by the Department of Defense.

Trial registration: ClinicalTrials.gov NCT01305811.

Conflict of interest statement

Competing Interests: The authors have declared that no competing interests exist.

Figures

Fig 1. PLOS CONSORT Flow Diagram: Diagram…
Fig 1. PLOS CONSORT Flow Diagram: Diagram of Screening, Randomization, and Follow-up.
Fig 2. Summary of model-based simulations xxxiii…
Fig 2. Summary of model-based simulationsxxxiii of changes in mean SF-36P at 4 measurement timepoints.
Scores moving in the positive direction indicate improvement. Scores moving in the positive direction indicate improvement.
Fig 3. Summary of model-based simulations xxxiii…
Fig 3. Summary of model-based simulationsxxxiii of changes in mean McGill Pain Scale at 4 measurement timepoints.
Scores moving in the negative direction indicate improvement. Scores moving in the negative direction indicate improvement.

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