Electro-acupuncture at Zusanli, Qihai, and Guanyuan Acupoints Regulate Immune Function in Patients With Sepsis (EAIm-sepsis)

Guangdong Provincial Hospital of Traditional Chinese Medicine

Status: Completed

Conditions: Immune Dysfunction; Sepsis

Treatments: Device: electro-acupuncture

Study type: Interventional

Funder types: Other

Identifiers

NCT05367986

EAIm-sepsis

Details and patient eligibility

About

The purpose of this study was to investigate the biochemical and clinical effects of electro-acupuncture in patients with sepsis.

Full description

Patients were randomly divided into an electro-acupuncture (EA) group and a Western medicine group(WM group) using restricted block randomization (1:1 ratio).

Patients in the Western medicine group received conventional treatment with Western medicine. According to the International Guidelines for Management of Sepsis and Septic Shock: 2016, conventional treatment includes antibiotics and other anti-infection measures, fluid management, mechanical ventilation, and nutritional support, but did not include the use of immunosuppressants or immune enhancers including hormones, gamma globulin, and thymosin. Patients in the electro-acupuncture group were treated with Western medicine and electro-acupuncture. Electro-acupuncture was given at the Zusanli (ST36), Guanyuan (CV4), and Qihai (CV6) acupoints, twice a day for 30 minutes, and for 5 days in total.

The indicators of immune dysfunction including the percentage of T lymphocyte subsets, percentage of natural killer (NK) cells, and serum soluble programed cell death protein (sPD-1) level, and clinical effect including APACHE-II and SOFA score, whole blood analysis, levels of tumor necrosis factor-α (TNF-α) and C-reactive protein (CRP), were determined before treatment and after treatment for 5 days.

Enrollment: 78 patients

Sex: All

Ages: 18 to 85 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Diagnosis of sepsis;
• Signed the informed consent form.

Exclusion criteria

• Pregnancy or psychiatric disorder;
• Immune deficiency or using immunosuppressants or immune enhancers;
• History of malignancy;
• HIV positive;
• Unwilling to participate in the study or cooperate with the treatment. Patients who cannot tolerate electroacupuncture treatment or loss of follow-up for complicating with other diseases during the study would be dropped off.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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78 participants in 2 patient groups

Western medicine group(WM group)

No Intervention group

Description:

Patients in the Western medicine group received conventional treatment with Western medicine. According to International Guidelines for Management of Sepsis and Septic Shock: 2016, conventional treatment includes antibiotics and other anti-infection measures, fluid management, mechanical ventilation, and nutritional support, but does not include the use of immunosuppressants or immune enhancers including hormones, gamma globulin, and thymosin.

electro-acupuncture (EA) group

Experimental group

Description:

Patients in the electro-acupuncture group were treated with Western medicine and electro-acupuncture. Electro-acupuncture was given at the Zusanli (ST36), Guanyuan (CV4), and Qihai (CV6) acupoints, twice a day for 30 minutes, and for 5 days in total.

Treatment:

Device: electro-acupuncture