Acupuncture for Sepsis

Overseen By Jun Mao, MD, MSCE

Age: 18+

Sex: Any

Trial Phase: Phase 2

Sponsor: Memorial Sloan Kettering Cancer Center

Disqualifiers: ICU admission, Implanted device, others

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

Prior Safety Data This treatment has passed at least one previous human trial

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

Compensation: Varies

Number of Visits: Unknown

Duration: Up to 2 years

78 Participants Needed

Trial Summary

What is the purpose of this trial?

Researchers think acupuncture may improve outcomes for participants with sepsis, based on laboratory studies and previous studies in people with sepsis. The purpose of this study to see whether real acupuncture can improve outcomes for participants with sepsis when compared to sham acupuncture. Sham acupuncture is performed the same way as real acupuncture but will use different needles and target different sites or places on the body than real acupuncture.

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 team or your doctor.

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

Research suggests that acupuncture may help improve immune function and survival rates in sepsis, as seen in studies with rats and some patient observations. However, while acupuncture has been used for various conditions, more high-quality evidence is needed to confirm its effectiveness specifically for sepsis. ^{1 2 3 4 5}

Is acupuncture generally safe for humans?

Acupuncture is generally considered safe when performed by trained professionals, but it can have minor side effects like bleeding, pain, or symptom aggravation. Serious adverse events are rare, but there have been reports of organ injuries and infections. It's important to ensure that the practitioner is well-trained to minimize risks. ^{6 7 8 9 10}

How is acupuncture different from other treatments for sepsis?

Acupuncture is unique for sepsis treatment because it involves stimulating specific points on the body, such as Zusanli (ST36), to potentially enhance survival and improve immune function, unlike standard treatments that typically involve antibiotics and supportive care. It is a non-drug therapy that has been used in traditional Chinese medicine for thousands of years and may offer a complementary approach to managing sepsis. ^{1 2 3 4 5}

Research Team

Gary Deng, MD, PhD

Principal Investigator

Memorial Sloan Kettering Cancer Center

Eligibility Criteria

This study is for individuals at high risk of developing sepsis, possibly due to conditions like pre-eclampsia. Participants must meet certain health criteria to join, but specific inclusion and exclusion details are not provided.

Inclusion Criteria

Having MSK sepsis order-set placed within the previous 24 hours

I am 18 years old or older.

Exclusion Criteria

The patient is on a clinical trial and its Principal Investigator does not give approval to enrollment to this study

Admitted to ICU before being approached for consenting

I cannot give consent for myself and have no one to do it on my behalf.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive either real acupuncture or sham acupuncture to assess its impact on sepsis outcomes

Up to 2 years

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

Treatment Details

Interventions

• Acupuncture
• Sham Acupuncture

Trial Overview The trial is testing whether real acupuncture can improve outcomes in patients at high risk for sepsis compared to sham acupuncture, which mimics the procedure without targeting the same points or using the same needles.

Participant Groups

Group I: Acupuncture Experimental Treatment 1 Intervention

Group II: Sham Acupuncture Placebo Group 1 Intervention

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?

Memorial Sloan Kettering Cancer Center

Lead Sponsor

Trials

1,998

Recruited

602,000+

Findings from Research

A systematic review of 54 studies suggests that acupuncture at the ST36 point may help reduce organ injuries caused by sepsis, potentially benefiting the heart, lungs, kidneys, liver, gastrointestinal tract, and immune system.

The proposed mechanisms for acupuncture's effects include reducing oxidative stress and inflammation, improving blood flow, and maintaining immune balance, although the overall quality of the studies indicates that more rigorous research is needed to confirm these findings.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Acupuncture at Zusanli (ST36) for Experimental Sepsis: A Systematic Review. Lai, F., Ren, Y., Lai, C., et al.[2022]

Acupuncture significantly improved immune function in sepsis patients, as evidenced by increased levels of T cell subgroups and immunoglobulins after 6 days of treatment, similar to the effects of thymosin alpha1.

Both acupuncture and thymosin alpha1 treatment led to shorter ICU stays, lower hospital readmission rates, and reduced 28-day mortality compared to standard care, indicating their potential as effective adjunct therapies for sepsis.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

[Effect of Acupuncture on Prognosis and Immune Function of Sepsis Patients]. Xiao, QS., Ma, MY., Zhang, XS., et al.[2018]

Acupuncture was found to enhance survival rates and improve neutrophil migration in a rat model of sepsis, suggesting its potential as a treatment for this serious condition.

The study standardized a model using cecal ligation and puncture (CLP) to induce sepsis, allowing for a focused investigation into acupuncture's effects on the infectious process.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Effect of various acupuncture treatment protocols upon sepsis in Wistar rats. Scognamillo-Szabó, MV., Bechara, GH., Ferreira, SH., et al.[2006]

In a study of 50 sepsis patients, those receiving electroacupuncture alongside standard treatment showed significant improvements in intestinal permeability and function, as indicated by lower lactulose to mannitol ratios and serum D-lactic acid levels after 3 days.

The combination of electroacupuncture and conventional treatment led to a faster time to target feeding and a higher overall effective rate (80.8% vs. 54.2%) compared to standard treatment alone, suggesting that electroacupuncture may enhance recovery in sepsis patients.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

[Impacts of electroacupuncture on intestinal permeability in sepsis patients]. Wu, JN., Zhu, MF., Lei, S., et al.[2022]

This systematic review aims to evaluate the efficacy and safety of acupuncture as a complementary therapy for sepsis by analyzing randomized controlled trials (RCTs) from various databases, focusing on outcomes like 28-day mortality and physiological health scores.

The review will also assess inflammatory markers and immune responses, such as TNF-α, IL-6, and T cell counts, to understand the potential mechanisms through which acupuncture may influence sepsis outcomes.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Efficacy and safety of acupuncture as a complementary therapy for sepsis: A protocol of systematic review and meta-analysis. Xian, J., Wang, L., Zhang, C., 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 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 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]

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]

References

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

Acupuncture at Zusanli (ST36) for Experimental Sepsis: A Systematic Review. [2022]

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

[Effect of Acupuncture on Prognosis and Immune Function of Sepsis Patients]. [2018]

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

Effect of various acupuncture treatment protocols upon sepsis in Wistar rats. [2006]

4. China pubmed.ncbi.nlm.nih.gov

[Impacts of electroacupuncture on intestinal permeability in sepsis patients]. [2022]

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

Efficacy and safety of acupuncture as a complementary therapy for sepsis: A protocol of systematic review and meta-analysis. [2022]

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

Safety of Acupuncture: Overview of Systematic Reviews. [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

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

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

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

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

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