Acupuncture for Gulf War Syndrome

(CARE Trial)

Not yet recruiting at 2 trial locations

Overseen By Lisa Conboy

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: University of Utah

Must not be taking: Antipsychotics

Disqualifiers: Severe psychiatric illness, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Approved in 4 Jurisdictions This treatment is already approved in other countries

Compensation: Varies

Number of Visits: 3

Duration: 24 weeks for Group 1, 16 weeks for Group 2

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests whether acupuncture can improve symptoms for veterans with Gulf War Syndrome. Participants will receive acupuncture treatments at varying frequencies to assess the impact on their physical health and well-being. The study aims to determine if regular acupuncture can ease symptoms such as fatigue, mood issues, and joint or muscle pain. Veterans who have experienced these symptoms for more than six months and served in the Gulf region from August 1990 onwards may be eligible to join. As an unphased trial, this study offers veterans a unique opportunity to explore alternative treatments that may enhance their quality of life.

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications. It's best to discuss this with the trial coordinators or your doctor.

What prior data suggests that acupuncture is safe for treating Gulf War Syndrome?

Research has shown that acupuncture is generally safe and well-tolerated for managing Gulf War Syndrome. In studies, acupuncture did not cause serious side effects, and participants responded well to the treatment. Although no specific published trials exist on acupuncture for Gulf War Illness, previous research on its safety is reassuring. Participants in these studies did not report significant negative effects, suggesting that acupuncture can be a safe option for those considering joining this clinical trial. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about acupuncture for Gulf War Syndrome because it offers a non-drug alternative to traditional treatments, like medications for pain and fatigue. Unlike these medications, which can come with side effects, acupuncture is a natural method that involves inserting thin needles into specific points on the body to potentially relieve symptoms. Additionally, acupuncture is thought to address the body's energy flow, or "qi," which may provide holistic benefits not typically achieved with standard pharmacological treatments. This approach could offer a new avenue for symptom management without the common drawbacks of conventional drugs.

What evidence suggests that acupuncture might be an effective treatment for Gulf War Syndrome?

Research suggests that acupuncture might help manage symptoms of Gulf War Syndrome. In this trial, participants will either receive bi-weekly acupuncture treatments or be placed on a wait list for 2 months, followed by weekly acupuncture for 4 months. One study found that personalized acupuncture treatments were well received and helped reduce physical problems and pain for those with Gulf War Illness. Another study showed that combining acupuncture with other therapies, like mindfulness meditation, might further reduce symptoms. Although no published trials specifically focus on acupuncture for Gulf War Illness, these findings indicate that acupuncture could be a promising option for symptom relief. ^{1 2 4 6 7}

Are You a Good Fit for This Trial?

This trial is for veterans with Gulf War Illness, a condition affecting those who served in the Persian Gulf War. It includes chronic symptoms like fatigue and pain. Participants should have these symptoms but not other conditions like Klinefelter or Triple X Syndrome.

Inclusion Criteria

I have had severe symptoms in at least 2 of the CDC's symptom clusters for over 6 months.

I served in the Gulf region from August 1990 to now.

Exclusion Criteria

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)

Currently enrolled in another clinical trial

Unable to complete the protocol based on the evaluation of the Medical Monitor.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Waitlist

Participants in group 2 are monitored on a waitlist for 2 months before starting treatment

8 weeks

Regular check-ins (virtual)

Treatment

Group 1 receives bi-weekly acupuncture for 6 months; Group 2 receives weekly acupuncture for 4 months after a 2-month waitlist

24 weeks for Group 1, 16 weeks for Group 2

Bi-weekly visits (in-person) for Group 1, weekly visits (in-person) for Group 2

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

2 visits (in-person)

What Are the Treatments Tested in This Trial?

Interventions

• Acupuncture

Trial Overview The study tests acupuncture's effectiveness on Gulf War Illness symptoms. Two groups of participants will receive treatments from experienced acupuncturists: one gets biweekly sessions for six months, the other starts with a two-month wait then weekly sessions.

How Is the Trial Designed?

Group I: Bi-weekly acupuncture treatment Experimental Treatment 1 Intervention

Bi-weekly acupuncture treatment

Group II: Wait list Active Control 1 Intervention

Wait list for 2 months followed by weekly acupuncture for 4 months

Acupuncture is already approved in United States, European Union, China for the following indications:

Approved in United States as Acupuncture for:

• Pain management
• Hot flashes
• Fatigue
• Sleep disturbances
• Anxiety
• Depression
• Neuropathy

Approved in European Union as Acupuncture for:

• Pain management
• Hot flashes
• Fatigue
• Sleep disturbances
• Anxiety
• Depression

Approved in China as Acupuncture for:

• Pain management
• Hot flashes
• Fatigue
• Sleep disturbances
• Anxiety
• Depression
• Neuropathy

Who Is Running the Clinical Trial?

University of Utah

Lead Sponsor

Trials

1,169

Recruited

1,623,000+

United States Department of Defense

Collaborator

Trials

940

Recruited

339,000+

University of California, Berkeley

Collaborator

Trials

193

Recruited

716,000+

Beth Israel Deaconess Medical Center

Collaborator

Trials

872

Recruited

12,930,000+

Published Research Related to This Trial

Acupuncture can lead to adverse events (AEs), including organ or tissue injuries, infections, local reactions, and other complications, with serious AEs being rare but potentially life-threatening, as highlighted by a review of 17 systematic reviews.

The overall methodological quality of the reviews on acupuncture AEs was mediocre, indicating a need for improved research standards and emphasizing the importance of patient safety and acupuncturist training in practice.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Safety of Acupuncture: Overview of Systematic Reviews. Chan, MWC., Wu, XY., Wu, JCY., et al.[2022]

In a survey of 37,490 acupuncture treatments conducted by 222 Korean Medicine Doctors, adverse events (AEs) were reported at a frequency of 1,205 per 10,000 treatments, with common AEs including bleeding, needle site pain, and bruising.

Most reported AEs were mild and transient, with only two life-threatening cases that resolved without lasting effects, suggesting that acupuncture performed by qualified practitioners is generally safe.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Safety of acupuncture by Korean Medicine Doctors: a prospective, practice-based survey of 37,490 consultations. Won, J., Lee, JH., Bang, H., et al.[2022]

Acupuncture has a relatively low risk of adverse events (AEs), with at least one AE occurring in about 9.31% of patients undergoing treatment, and serious adverse events (SAEs) being very rare at approximately 1.01 per 10,000 patients.

The most common minor AEs are mild reactions such as bleeding or pain at the needle site, which are often considered intended effects of acupuncture, highlighting the need for standardized assessment tools to differentiate between adverse reactions and therapeutic responses.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Acupuncture-related adverse events: systematic review and meta-analyses of prospective clinical studies. Bäumler, P., Zhang, W., Stübinger, T., et al.[2021]

A review of 23 observational studies on acupuncture-related adverse events revealed that many did not provide sufficient information to determine the cause of complications, highlighting a gap in reporting quality.

The study emphasizes the need for better involvement of acupuncture experts in reporting adverse events to improve the understanding and safety of acupuncture practices, particularly regarding infections.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The Reporting Quality of Acupuncture-Related Infections in Korean Literature: A Systematic Review of Case Studies. Kim, TH., Kang, JW., Park, WS.[2022]

In a study involving 1968 patients across three multicenter randomized controlled trials, only 3.76% experienced adverse events from acupuncture, indicating a low risk associated with this therapy.

The most common adverse events were minor, such as subcutaneous haematoma and needle site pain, and all but one patient recovered within two weeks, suggesting acupuncture is generally safe when performed by skilled practitioners.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Adverse events associated with acupuncture: three multicentre randomized controlled trials of 1968 cases in China. Zhao, L., Zhang, FW., Li, Y., et al.[2021]

Battlefield acupuncture is being utilized in military medical facilities to provide nonpharmacologic pain management for warriors suffering from conditions like polytrauma, PTSD, and muscle pain, highlighting its potential effectiveness in treating pain without opioids.

The implementation of battlefield acupuncture involves training funded by the DoD and VA, emphasizing a collaborative approach to pain management and the integration of this technique into medical education for future healthcare providers.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Battlefield acupuncture: Opening the door for acupuncture in Department of Defense/Veteran's Administration health care. Walker, PH., Pock, A., Ling, CG., et al.[2017]

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC4816551/

The Effectiveness of Individualized Acupuncture Protocols ... Acupuncture is well tolerated, safe and effective in the management of Gulf War Syndrome. The inclusion of acupuncture in the routine management ...

2. sciencedirect.com sciencedirect.com/science/article/abs/pii/S155171441200033X

The effectiveness of acupuncture in the treatment of Gulf ... No published trials of acupuncture for the treatment of GWI exist. This trial is designed to both answer questions of the effectiveness of acupuncture for our ...

3. nursing.utah.edu nursing.utah.edu/libraries/pdf.js/web/viewer.html?file=https%3A%2F%2Fnursing.utah.edu%2Fsites%2Fg%2Ffiles%2Fzrelqx146%2Ffiles%2Fmedia%2Fdocuments%2F2025%2Fconboy_gwi_protocol.pdf

The effectiveness of acupuncture in the treatment of Gulf War ... The effectiveness of acupuncture in the treatment of Gulf War IllnessLisa Conboya,⁎, Meredith St Johna, Rosa SchnyerbaNew England School of Acupuncture, ...

4. journals.sagepub.com journals.sagepub.com/doi/abs/10.1177/27536130231171854

Gulf War Illness: A Randomized Controlled Trial ... Findings suggest a possible beneficial effect of combining 2 CIH therapies, mindfulness meditation and auricular acupuncture, in reducing overall symptom ...

5. researchgate.net researchgate.net/publication/299538999_The_Effectiveness_of_Individualized_Acupuncture_Protocols_in_the_Treatment_of_Gulf_War_Illness_A_Pragmatic_Randomized_Clinical_Trial

The Effectiveness of Individualized Acupuncture Protocols ... Conclusions: Individualized acupuncture treatment of sufficient dose appears to offer significant relief of physical disability and pain for ...

6. clinicaltrials.gov clinicaltrials.gov/study/NCT01305811

Acupuncture in the Treatment of Gulf War Illness 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 ...

7. apps.dtic.mil apps.dtic.mil/sti/tr/pdf/ADA538720.pdf

Effectiveness of Acupuncture in the Treatment of Gulf War Illness Our objectives are to find: a successful treatment of GW I, by gathering data to better understand: 1) the efficacy of acupuncture in treating GWI, 2) the.