Acupuncture for Myasthenia Gravis

Overseen By Amanda A Herrmann, PhD

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: HealthPartners Institute

Disqualifiers: Neurological, Psychiatric, Cardiac, 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: 48

24 Participants Needed

Trial Summary

What is the purpose of this trial?

This trial is testing whether acupuncture can help people with Myasthenia Gravis (MG). Twenty patients will receive acupuncture regularly over a few months. The study aims to see if acupuncture can improve their quality of life and daily activities. Acupuncture has been studied for its effectiveness in treating Myasthenia Gravis (MG) in various contexts.

Do I have to stop taking my current medications for the trial?

The trial information does not specify whether you need to stop taking your current medications. It's best to discuss this with the study team to get a clear answer.

What data supports the effectiveness of acupuncture as a treatment for myasthenia gravis?

Research suggests that acupuncture, including electroacupuncture, may help improve symptoms of myasthenia gravis, as seen in a case where auricular acupuncture helped resolve a relapse when used alongside medication. Additionally, studies are being conducted to evaluate its overall effectiveness and safety for this condition. ^{1 2 3 4 5}

Is acupuncture generally safe for humans?

Research shows that acupuncture is generally safe when performed by trained professionals, with minor side effects like bleeding, pain, or temporary worsening of symptoms being the most common. Serious adverse events are rare, but can include organ injuries or infections, so it's important to choose a qualified practitioner. ^{6 7 8 9 10}

How is acupuncture different from other treatments for myasthenia gravis?

Acupuncture is unique because it involves inserting thin needles into specific points on the body to potentially help manage symptoms of myasthenia gravis, unlike conventional treatments that typically use medications like anticholinergic drugs, corticosteroids, and immunosuppressants. It may offer a complementary approach by possibly improving short-term symptoms and reducing relapses, as suggested by some studies. ^{1 2 3 4 5}

Research Team

Amanda A Herrmann, PhD

Principal Investigator

HealthPartners Neuroscience Research

Gaurav K Guliani, MD

Principal Investigator

HealthPartners Neurology

Eligibility Criteria

This trial is for adults aged 18-80 with Myasthenia Gravis. Participants must be able to consent and speak English. Excluded are those with bleeding disorders, heart arrhythmias, stimulator devices, recent other trials participation, pregnancy or planning to become pregnant during the study, substance abuse issues, outside acupuncture treatment while enrolled, or serious neurological conditions.

Inclusion Criteria

Ability to provide and provision of signed and dated informed consent form

I have been diagnosed with myasthenia gravis.

I am between 18 and 80 years old.

Exclusion Criteria

I am not pregnant, breastfeeding, nor planning to become pregnant during the study.

I do not speak English.

I am willing to participate in all study related activities.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment (Immediate Start)

Participants receive acupuncture treatment two times per week for 12 weeks

12 weeks

24 visits (in-person)

Control (Delayed Start)

Participants act as a control group for the first 12 weeks

12 weeks

Treatment (Delayed Start)

Delayed start group receives acupuncture treatment two times per week for 12 weeks

12 weeks

24 visits (in-person)

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

Treatment Details

Interventions

• Acupuncture

Trial Overview The AcuMG trial tests if acupuncture can improve life quality in people with Myasthenia Gravis. It involves 20 participants receiving treatments twice weekly for 12 weeks. They're split into two groups: one starts immediately and the other after a delay of 12 weeks (serving as a control group initially).

Participant Groups

Group I: Immediate Start Experimental Treatment 1 Intervention

Patients will receive acupuncture treatment two times per week for 12 weeks.

Group II: Delayed start Active Control 1 Intervention

Patients will act as control group for the first 12 weeks then will receive acupuncture treatment two times per week for 12 weeks.

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?

HealthPartners Institute

Lead Sponsor

Trials

196

Recruited

3,721,000+

Findings from Research

This systematic review aims to evaluate the effectiveness and safety of acupuncture as an adjuvant therapy for myasthenia gravis (MG) by analyzing randomized controlled trials (RCTs) from multiple databases, ensuring a comprehensive assessment.

The review will provide high-quality evidence regarding acupuncture's role in treating MG, with a focus on minimizing bias and ensuring rigorous trial quality assessment through established methods.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Acupuncture for patients with myasthenia gravis: A systematic review protocol. Shi, S., Ji, X., Wang, Y., 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 78 acupuncturists and 31,822 consultations, the incidence of adverse events was found to be 684 per 10,000 consultations, indicating that while acupuncture does have risks, they are relatively low when performed by trained professionals.

The most common minor adverse events included bleeding and needling pain, with 70% of symptom aggravations resolving afterward, and only 14 significant adverse events reported, suggesting that acupuncture is generally safe in skilled hands.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Survey of adverse events following acupuncture (SAFA): a prospective study of 32,000 consultations. White, A., Hayhoe, S., Hart, A., et al.[2022]

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 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]

References

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

Acupuncture for patients with myasthenia gravis: A systematic review protocol. [2022]

2. China pubmed.ncbi.nlm.nih.gov

[Electroacupuncture warming therapy combined with western medicine for treatment of myasthenia gravis and effect on IL-4 level in the patients]. [2013]

3. China pubmed.ncbi.nlm.nih.gov

The effectiveness and safety of acupuncture for the treatment of myasthenia gravis: a systematic review and meta-analysis of randomized controlled trials. [2020]

4. England pubmed.ncbi.nlm.nih.gov

Auricular acupuncture to resolve the exacerbations in ocular myasthenia--a case report. [2019]

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

Acupuncture for ocular myasthenia gravis: A protocol for systematic review and meta-analysis. [2022]

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

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

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

Survey of adverse events following acupuncture (SAFA): a prospective study of 32,000 consultations. [2022]

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

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

9. England pubmed.ncbi.nlm.nih.gov

A prospective survey of adverse events and treatment reactions following 34,000 consultations with professional acupuncturists. [2019]

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

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