Electroacupuncture for Women with Chronic Severe Functional Constipation: Subgroup Analysis of a Randomized Controlled Trial.

ABSTRACT

BACKGROUND: Acupuncture has been found to be effective for treating chronic constipation. OBJECTIVE: The objective of this exploratory study was to evaluate the efficacy of electroacupuncture (EA) in the subgroup of women with chronic severe functional constipation. METHODS: This is a subgroup analysis of the multicenter, randomized, sham-acupuncture (SA) controlled trial. The efficacy of 822 (76%) female patients of the 1075 randomized patients with chronic severe functional constipation was evaluated. Patients were randomly assigned to receive 28 sessions of EA or SA over 8 weeks with 12 weeks' follow-up. This study focused on sustained complete spontaneous bowel movements (CSBMs) responders over the 8-week treatment. RESULTS: The primary outcome which was percentage of the sustained CSBMs responders for the subset of women with severe constipation was significantly higher in the EA group (24.3%) than in the SA group (8.1%) with difference of 13.1% (95%CI, 6.5% to 19.7%; P<0.001). As for the secondary outcomes, responders for ≥9 of 12 weeks of follow-up were higher in the EA group than in the SA group. Additionally, EA had significantly better improvement in mean weekly CSBMs, mean weekly spontaneous bowel movements (SBMs), and mean score changes of stool consistency and straining as well as quality of life of patients. The incidence of adverse events (AEs) related to acupuncture was rare and no statistical significance was found between two groups. CONCLUSION: EA improved the spontaneity and the completeness of the bowel movement of women with severe functional constipation during 8-week treatment and the effect sustained for 12 weeks after stopping treatment.