Acupuncture for Gulf War Syndrome

(CARE Trial)

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

200 Participants Needed

Trial Summary

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 data supports the effectiveness of acupuncture as a treatment for Gulf War Syndrome?

Research shows that acupuncture can reduce the need for pain medications and improve symptoms, ability to function, and quality of life in military patients. Additionally, acupuncture has anti-inflammatory effects and has been used effectively for pain management in military settings, which may be beneficial for symptoms of Gulf War Syndrome. ^{1 2 3 4 5}

Is acupuncture generally safe for humans?

Acupuncture is generally considered safe when performed by well-trained practitioners, but it can have some risks. Serious adverse events (like organ injuries or infections) are rare, while minor issues (like dizziness or local reactions) are more common. It's important to ensure that the acupuncturist is properly trained to minimize these risks. ^{6 7 8 9 10}

How does acupuncture differ from other treatments for Gulf War Syndrome?

Acupuncture is unique for Gulf War Syndrome as it offers a non-drug, non-invasive approach that can address multiple symptoms like pain, fatigue, and cognitive issues, unlike standard treatments which often rely on medications. This trial is the first to explore acupuncture specifically for this condition, highlighting its potential as an alternative therapy. ^{1 5 11 12 13}

What is the purpose of this trial?

This unblinded Phase II clinical trial will test the effects of individualized acupuncture treatments offered in extant acupuncture practices in the community; practitioners will have had at least 5 years of experience plus additional training provided by the study. Veterans with diagnosed symptoms of Gulf War Illness will be randomized to either six months of biweekly acupuncture treatments (group 1, n=100) or 2 months of waitlist followed by weekly acupuncture treatments (group 2, n=100). 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

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

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)

Treatment Details

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.

Participant Groups

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+

Findings from Research

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]

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]

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]

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]

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]

References

1. United States pubmed.ncbi.nlm.nih.gov

The effectiveness of acupuncture in the treatment of Gulf War Illness. [2015]

2. United States pubmed.ncbi.nlm.nih.gov

Reduction in Pain Medication Prescriptions and Self-Reported Outcomes Associated with Acupuncture in a Military Patient Population. [2022]

3. United States pubmed.ncbi.nlm.nih.gov

Battlefield acupuncture: Opening the door for acupuncture in Department of Defense/Veteran's Administration health care. [2017]

4. United States pubmed.ncbi.nlm.nih.gov

Anti-inflammatory actions of acupuncture. [2022]

5. United States pubmed.ncbi.nlm.nih.gov

Frequency-Specific Microcurrent as Adjunctive Therapy for Three Wounded Warriors. [2020]

6. England pubmed.ncbi.nlm.nih.gov

Safety of Acupuncture: Overview of Systematic Reviews. [2022]

7. England pubmed.ncbi.nlm.nih.gov

Safety of acupuncture by Korean Medicine Doctors: a prospective, practice-based survey of 37,490 consultations. [2022]

8. England pubmed.ncbi.nlm.nih.gov

Adverse events associated with acupuncture: three multicentre randomized controlled trials of 1968 cases in China. [2021]

9. United States pubmed.ncbi.nlm.nih.gov

The Reporting Quality of Acupuncture-Related Infections in Korean Literature: A Systematic Review of Case Studies. [2022]

10. England pubmed.ncbi.nlm.nih.gov

Acupuncture-related adverse events: systematic review and meta-analyses of prospective clinical studies. [2021]

11. England pubmed.ncbi.nlm.nih.gov

Acupuncture for chronic asthma. [2022]

12. England pubmed.ncbi.nlm.nih.gov

Acupuncture for chronic asthma. [2018]

13. China pubmed.ncbi.nlm.nih.gov

[Acupuncture in Oman]. [2014]