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

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests whether acupuncture, a traditional Chinese therapy using thin needles, can help people with Myasthenia Gravis (MG), a condition that causes muscle weakness. Participants with MG will be randomly assigned to two groups: one will begin acupuncture immediately, while the other will wait 12 weeks before starting treatment. The researchers aim to determine if acupuncture can enhance quality of life and daily activities for those with MG. English-speaking individuals with MG may be suitable candidates for this trial. As an unphased trial, this study provides a unique opportunity to explore alternative therapies for improving life with MG.

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 prior data suggests that acupuncture is safe for individuals with Myasthenia Gravis?

Research has shown that acupuncture is safe and practical for people with myasthenia gravis (MG). One study found that adults with MG considered acupuncture a safe treatment. Additionally, a meta-analysis, which combines results from many studies, found that acupuncture can improve treatment outcomes for MG without causing major side effects. This evidence suggests that acupuncture is a well-tolerated treatment option for those with MG. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Unlike the standard treatments for myasthenia gravis, which typically include medications like anticholinesterase agents and immunosuppressants, acupuncture offers a non-drug approach. Researchers are excited because acupuncture taps into the body's natural energy pathways, potentially reducing symptoms without the side effects commonly associated with pharmaceuticals. Additionally, acupuncture provides a complementary therapy option that could enhance the effectiveness of existing treatments, offering patients more holistic management of their condition.

What evidence suggests that acupuncture is effective for Myasthenia Gravis?

This trial will compare the effects of immediate versus delayed acupuncture treatment for Myasthenia Gravis (MG). Research has shown that acupuncture can benefit people with MG. One study that combined results from various research found that acupuncture enhances treatment effectiveness. People receiving acupuncture often experience more improvement than those using other treatments. Another review found that acupuncture strongly positively affects MG symptoms. Overall, acupuncture might improve the quality of life for people with MG. ^{1 2 3 4 6}

Who Is on the Research Team?

Amanda A Herrmann, PhD

Principal Investigator

HealthPartners Neuroscience Research

Gaurav K Guliani, MD

Principal Investigator

HealthPartners Neurology

Are You a Good Fit for This Trial?

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.

Exclusion Criteria

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

I am willing to participate in all study related activities.

Any other medical conditions that could affect their ability to participate in acupuncture treatments for the study duration (as determined by study investigators)

Timeline for a Trial Participant

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

What Are the Treatments Tested in This Trial?

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).

How Is the Trial Designed?

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+

Published Research Related to This Trial

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]

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC10760751/

Effects of acupuncture treatment for myasthenia gravis This meta-analysis demonstrated that acupuncture as an auxiliary may play a positive role in treating MG. It can improve the effective rate of treatment.

2. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC12397582/

Acupuncture Treatment for Individuals With Myasthenia ... Most studies reported a higher clinical effective rate in the acupuncture group, as measured by a >25% reduction in TCM relative clinical score, ...

3. apm.amegroups.org apm.amegroups.org/article/view/32183/html

a systematic review and meta-analysis of randomized ... Conclusions: This meta-analysis suggests that acupuncture as an integrative therapy has a significant positive effect in treating MG.

4. journals.lww.com journals.lww.com/md-journal/fulltext/2024/05030/acupuncture_and_moxibustion_treatment_for.29.aspx

Acupuncture and moxibustion treatment for myasthenia... Acupuncture and moxibustion has a good effect on MG, which is better than conventional Western medicine in improving the total clinical effective rate and ...

5. frontiersin.org frontiersin.org/journals/microbiology/articles/10.3389/fmicb.2022.1082565/full

Traditional Chinese medicine improves myasthenia gravis ... MBZYQD can improve the immune function of the host by regulating the diversity, structure and function of the intestinal microbiota to treat myasthenia gravis.

6. journals.lww.com journals.lww.com/md-journal/fulltext/2021/04160/external_treatment_of_traditional_chinese_medicine.50.aspx

External treatment of traditional Chinese medicine for... A mass of studies revealed that the external treatment of traditional Chinese medicine (TCM) for MG is a safe and economical approach.