Irritable bowel syndrome (IBS) is a functional gastrointestinal disorder characterized by recurrent abdominal pain and altered bowel habits. Under the Rome IV criteria, IBS can be classified into constipation-predominant (IBS-C), diarrhea-predominant (IBS-D), mixed (IBS-M), and unclassified (IBS-U) subtypes. IBS-D represents one of the most clinically disruptive phenotypes due to the combined burden of abdominal pain and frequent loose stools1. These symptoms are the major drivers of impaired quality of life and healthcare utilization. Despite available pharmacologic treatments, recurrence rates remain high and adverse effects often limit patient satisfaction, creating an unmet need for safe and effective alternative therapies.
Transcutaneous Electrical Acustimulation (TEA) is an emerging therapy which delivers appropriate electrical stimulation to acupoints that are in the vicinity of peripheral nerves through surface electrodes, has been demonstrated to improve bowel symptoms and visceral hypersensitivity by modulating autonomic function and brain-gut interaction2. Previous trials of TEA in IBS have shown improvement in bowel symptoms, pain, and quality of life, with good safety and tolerability2,3. However, multicenter evidence for IBS-D is lacking.
This trial aims to evaluate whether TEA can improve overall symptoms in patients with IBS-D. Specifically, the primary objective is to assess the effect of TEA on the composite responder rate, defined by concurrent improvement in both abdominal pain and loose stool days. Secondary objectives include evaluating broader symptom severity, stool characteristics, as well as on quality of life, psychological symptoms, and the durability of clinical benefits during follow-up.
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Parallel
Portable stimulator
DeviceA pair of surface electrocardiogram electrodes was applied on skin. A watch-size digital stimulators was used to deliver electrical stimulation.
Composite responder
Abdominal pain or discomfort responder if the weekly average of the daily worst APS or ADS (past 24 hours) decreases by ≥30% from baseline. For participants with both abdominal pain and abdominal discomfort, responder status will be determined based on the symptom with the higher baseline score. stool consistency responder if the number of days per week with at least one stool of Bristol Stool Form Scale type 6 or 7 is reduced by ≥50% from baseline. Only participants who simultaneously meet both criteria will be considered primary endpoint responders.
Composite responder rates assessed at weeks 2 and 8
Abdominal pain or discomfort responder if the weekly average of the daily worst APS or ADS (past 24 hours) decreases by ≥30% from baseline. For participants with both abdominal pain and abdominal discomfort, responder status will be determined based on the symptom with the higher baseline score. stool consistency responder if the number of days per week with at least one stool of Bristol Stool Form Scale type 6 or 7 is reduced by ≥50% from baseline. Only participants who simultaneously meet both criteria will be considered primary endpoint responders.
IBS-SSS
This questionnaire consists of five components: severity and frequency of abdominal pain, severity of abdominal distension, dissatisfaction with bowel habits, and interference with daily life, each scored from 0 to 100, yielding a total score between 0 and 500. According to the total score, IBS severity is categorized as mild (75-175), moderate (175-300), or severe (\>300).
IBS-QoL
The IBS-QoL includes 34 items covering eight domains: dysphoria, interference with activity, body image, health worry, food avoidance, social reaction, sexual activity, and relationships. Each item is rated on a 5-point scale, and the total score will be converted to a 0-100 scale, where higher values indicate better quality of life, using the formula: (actual raw score - lowest possible score) / possible score range × 100.
The Hospital Anxiety and Depression Scale (HADS)
It consists of 14 items, divided into two subscales: HADS-A (anxiety) and HADS-D (depression), with 7 items each. Each item is scored from 0 to 3, yielding subscale scores ranging from 0 to 21. Higher scores indicate greater symptom severity.
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