Effect of acupuncture at Baliao (BL31, BL32, BL33, BL34) on complete spontaneous bowel movements in functional constipation patients: study protocol for a randomized sham-controlled trial
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Background Functional constipation lacks satisfactory and curative therapy. Acupuncture is a promising treatment while high-quality evidence is insufficient. Method This is a multicenter, single-blind, superiority, parallel, randomized controlled trial. Participants diagnosed with functional constipation are allocated to treatment (Baliao acupuncture group) and control (sham-acupuncture group) groups at a 1:1 ratio. The randomization sequence is computer-generated. The primary outcome is the change from baseline in complete spontaneous bowel movements per week with a superiority margin of 1.5 to compare the Baliao acupuncture group and sham-acupuncture group. Resting-state functional magnetic resonance imaging and heart rate variability are used to investigate the therapeutic mechanisms. Statistical analysis is performed using an intention-to-treat analysis. Discussion This study will partially illustrate that acupuncture at the Balian acupoints can modulate autonomic nervous activity and specific brain region activity to relieve functional constipation. Trial registration This trial is registered in ClinicalTrials.gov (Identifier number: NCT07010367, register date: 2025-06-07). Ethical approval was obtained from The Ethics Committee of Guang’anmen Hospital, China Academy of Chinese Medical Sciences (approval number: 2025-020-QS).
