Electroacupuncture vs Prucalopride for Severe Chronic Constipation: A Multicenter, Randomized, Controlled, Noninferiority Trial

Abstract

INTRODUCTION: This multicenter, randomized, noninferiority trial compared electroacupuncture with prucalopride for the treatment of severe chronic constipation (SCC). METHODS: Participants with SCC (≤ 2 mean weekly complete spontaneous bowel movements [CSBMs]) were randomly assigned to receive either 28-session electroacupuncture over 8 weeks with follow-up without treatment over 24 weeks or prucalopride (2 mg/d before breakfast) over 32 weeks. The primary outcome was the proportion of participants with ≥3 mean weekly CSBMs over weeks 3–8, based on the modified intention-to-treat population, with −10% as the noninferior margin. RESULTS: Five hundred sixty participants were randomized, 280 in each group. Electroacupuncture was noninferior to prucalopride for the primary outcome (36.2% vs 37.8%, with a difference of −1.6% [95% confidence interval, −8% to 4.7%], P < 0.001 for noninferiority); almost the same results were found in the per-protocol population. The proportions of overall CSBM responders through weeks 1–8 were similar in the electroacupuncture and prucalopride groups (24.91% vs 25.54%, with a difference of −0.63% [95% confidence interval, −7.86% to 6.60%, P = 0.864]). Except during the first 2-week treatment, no between-group differences were found in outcomes of excessive straining, stool consistency, and quality of life. Adverse events occurred in 49 (17.69%) participants in the electroacupuncture group and 123 (44.24%) in the prucalopride group. One non-treatment-related serious adverse event was recorded in the electroacupuncture group. DISCUSSION: Electroacupuncture was noninferior to prucalopride in relieving SCC with a good safety profile. The effects of 8-week electroacupuncture could sustain for 24 weeks after treatment. Electroacupuncture is a promising noninferior alternative for SCC (see Visual Abstract, http://links.lww.com/AJG/B776).

Self-administered acupressure for chronic severe functional constipation

“…[ 19 ] Acupuncture has been proven to be noninferior to prucalopride in relieving severe chronic constipation in a recent study. [ 20 ] However, acupuncture for constipation can be performed only in specialist clinics, making it inconvenient for the patient. Both acupuncture and acupressure are based on meridian theory in Chinese medicine and influence the flow of qi by stimulating acupoints.…”

Acupuncture methods for functional constipation: protocol for a systematic review and network meta-analysis

“…As an important part of nonpharmacologic therapies, acupuncture treatment has been frequently promoted for managing FC worldwide. Several randomized controlled trials (RCT) have confirmed that acupuncture could increase the frequency of bowel movements, soften stool formation, alleviate defecation straining, and improve the quality of life (12)(13)(14)(15). Clinically, a variety of acupuncture methods are available for FC treatment, including electroacupuncture (EA), auricular acupuncture (AA), warmneedling acupuncture (WNA), fire acupuncture (FA), and moxibustion.…”

“…Clinically, a variety of acupuncture methods are available for FC treatment, including electroacupuncture (EA), auricular acupuncture (AA), warmneedling acupuncture (WNA), fire acupuncture (FA), and moxibustion. Recently, Liu et al found that the effectiveness of EA was non-inferior to prucalopride in relieving severe chronic constipation (15). A comparison between AA and usual care demonstrated a significant patient preference for AA (16).…”

“…Hence, the primary outcomes will be the weekly stool frequency [including bowel movement (BM), spontaneous bowel movement (SBM), and complete SBM] at the end of treatment and follow-up. An SBM is described as a bowel movement that occurred without assistance from drugs or other techniques during the past 24 h (13,15). A complete SBM is described as an SBM with a feeling of complete evacuation (13,15).…”

Evaluating the efficacy and safety of electro-acupuncture in patients with antipsychotic-related constipation: protocol for a randomized controlled trial

“…It has been widely used for treating gastric disorders in clinical practice as a potentially effective therapy. Recent evidence indicated that acupuncture was noninferior to prucalopride for functional constipation with fewer adverse effects [ 13 ]. Considering the particularity of schizophrenic patients, whether acupuncture is efficient for treating antipsychotic-related constipation remains unknown.…”