Acupuncture for irritable bowel syndrome comorbid with anxiety and depression: study protocol for a placebo run-in, randomized clinical trial.

Researchers are launching a study to test whether acupuncture can help people with irritable bowel syndrome (IBS) who also experience anxiety and depression. Many IBS patients struggle with both gut symptoms like pain and bloating, as well as emotional distress, making treatment challenging. While acupuncture has shown promise for general IBS symptoms, there's limited evidence about how well it works when psychological issues are present.

This study will involve 80 IBS patients who also have anxiety or depression. After a one-week placebo run-in period to filter out strong placebo responders, participants will be randomly assigned to receive either real acupuncture or sham (fake) acupuncture three times per week for four weeks. They'll then be monitored for eight additional weeks. Researchers will measure improvements in IBS symptoms, anxiety and depression levels, abdominal pain, and bowel habits satisfaction.

The main goal is to determine what percentage of patients experience significant improvement, defined as at least a 50-point drop on the IBS Symptom Severity Scale. By including only patients who don't respond strongly to placebo treatment and comparing real acupuncture to sham acupuncture, researchers hope to get a clearer picture of acupuncture's true effectiveness for this specific group of IBS patients.

This research matters because IBS with psychological comorbidities is particularly difficult to treat, and patients need evidence-based options. The study design aims to provide more personalized evidence for people dealing with both gut and mental health symptoms. If you're considering acupuncture for IBS with anxiety or depression, seek care from a licensed acupuncturist with experience treating gastrointestinal conditions.

This placebo run-in, randomized controlled trial investigates acupuncture efficacy for IBS patients with comorbid anxiety and depression. Following a 1-week sham acupuncture run-in to exclude strong placebo responders, 80 eligible patients will be randomized to true acupuncture (TA) or sham acupuncture (SA) groups. Participants receive interventions three times weekly for 4 weeks, with 8-week follow-up.

The primary endpoint is response rate at week 4, defined as ≥50-point reduction in IBS-SSS from baseline. Secondary outcomes include IBS-SSS scores at multiple timepoints, HADS scores, VAS for abdominal pain, bowel habit satisfaction, and treatment credibility assessment.

This study addresses a significant evidence gap, as previous acupuncture research has focused on general IBS populations without specifically examining outcomes in patients with psychological comorbidities. The placebo run-in design strengthens internal validity by controlling for placebo response, which is particularly relevant in functional gastrointestinal disorders. Results will inform clinical decision-making for this challenging patient subgroup requiring integrated mind-body approaches.