Electroacupuncture at Zusanli (ST36) for sepsis-induced acute respiratory distress syndrome: protocol for an exploratory randomized controlled trial to evaluate feasibility and signal detection
Year: 2026
Type: article
Abstract: Background Sepsis-induced Acute Respiratory Distress Syndrome (ARDS) represents a catastrophic breakdown of systemic homeostasis, where uncontrolled pulmonary inflammation is inextricably linked to gastrointestinal (GI) dysfunction via the “gut-lung axis.” Current management lacks interventions capable of simultaneously modulating systemic inflammation and restoring GI function. Electroacupuncture (EA) at Zusanli (ST36) has emerged as a novel neuromodulatory strategy based on recent neuroanatomical discoveries. This exploratory trial aims to assess the safety and preliminary efficacy of adjunctive EA in mitigating inflammation and improving GI function in patients with sepsis-induced ARDS. Methods This is a prospective, randomized, controlled trial to be conducted at The Affiliated Traditional Chinese Medicine Hospital,Guangzhou Medical University. One hundred participants diagnosed with sepsis-induced ARDS (2024 Global Definition) will be recruited and randomly assigned (1:1) to either the EA group or the Control group. Both groups will receive standard conventional therapy. The EA group will receive additional bilateral EA stimulation at ST36 (dense-disperse wave, 20/100 Hz) for 30 min daily over 7 consecutive days. The primary outcome is the relative change in serum interleukin-6 (IL-6) levels from baseline (Day 0) to the end of treatment (Day 8). Additional inflammatory biomarkers, including white blood cell count, neutrophil percentage, procalcitonin (PCT), C-reactive protein (CRP), and serum amyloid A (SAA), will be evaluated as secondary exploratory outcomes. Secondary outcomes include objective GI functional parameters (Gastric Residual Volume, bowel sounds, defecation frequency, and Bristol Stool Scale score) and safety profiles. As an exploratory trial, the sample size is designed to estimate the effect size and its precision to inform the design of a future definitive trial. Results The trial is currently in the patient recruitment phase. We anticipate that this study will evaluate predefined feasibility parameters, including recruitment, consent, treatment completion, and outcome data completeness, alongside preliminary biological signals regarding the modulation of the gut-lung axis. Discussion This pilot trial is grounded in the neuroanatomical basis of the “gut-lung axis.” We hypothesize that EA at ST36 will activate the vagal-adrenal anti-inflammatory reflex, thereby disrupting the pathogenic cycle in critical illness. By simultaneously targeting both the immune and gastrointestinal systems, this study seeks to explore the specific biological signal and preliminary efficacy of EA, providing estimates of treatment effect to inform the design of a future definitive trial. The findings will not only provide estimates of the predefined feasibility parameters and preliminary efficacy signals but also lay the essential groundwork for designing larger, multicenter investigations into acupuncture's role in critical care. Clinical Trial Registration https://itmctr.ccebtcm.org.cn/mgt/project/view/2101619906628943872 , identifier ITMCTR2026001814.
Source: Frontiers in Medicine
Language: English
Subfield: Complementary and alternative medicine
Field: Medicine
Domain: Health Sciences
Open Access status: gold
Estimated APC paid: $3,801
OpenAlex ID: W7225787124