Efficacy and Safety of Vibrating Capsule for Functional Constipation: A Randomized, Double-Blind, Placebo-Controlled, Multicenter Trial

Background: Functional constipation (FC) is an intractable disease that carries large financial burden as well as emotional and physical stress. We aimed to assess the efficacy and safety of the newly developed smartphone-controlled vibrating capsule (VC) in patients with FC. Methods: This was a multicenter, blinded, placebo-controlled randomized trial in six top general hospitals in China focusing on patients aged 18 to 80 with FC. Patients were randomly assigned in a 1:1 ratio to receive VCs or placebo treatment for six weeks (two capsules per week) after two-week baseline period. The primary outcome was the responder rate, defined as the proportion of patients with an increase of at least one complete spontaneous bowel movement (CSBM) per week during treatment compared to baseline in the full analysis set. This trial is registered with ClinicalTrials.gov, number NCT04671264, and is completed. Findings: From December 2018 to February 2020, 107 patients were randomly assigned to receive VCs (n=53) or placebo treatment (n=54). The responder rate in the VC group was significantly higher than that in the placebo group (64·2% vs. 35·8%; difference, 27·7% [95% CI, 10·4% to 45·1%]; P = 0·005). More patients in the VC group reported weekly CSBMs ≥ 1 for at least four weeks during treatment ( P =0·022) and follow-up period ( P =0·041). The mean PAC-SYM and PAC-QoL total scores differed significantly from the baseline in both groups (all P < 0·0001). The most common adverse event associated with VC was abdominal discomfort (3·8%). Interpretation: VCs can greatly promote defecation, as well as ameliorating symptoms and improving the quality of life in patients with FC with sustained efficacy. Funding Statement: The funding source of our work is "One hundred leading scientists for 21st century" of Health Department of Shanghai Municipal Government (to ZL, No.2017BR005). Declaration of Interests: We declare no competing interests. Ethics Approval Statement: The study was approved by the institutional review board at all participating centers. No subsequent amendments of the protocol were made in the process of study implementation. The trial was performed in accordance with the principles of the Declaration of Helsinki and reported in accordance with CONSORT guidelines. An independent Data and safety monitoring committee (DSMC) appointed by the ethics committee and the Shanghai and National Medical Products Administration provided trial regular oversight. Trial Registration: This trial is registered with ClinicalTrials.gov, number NCT04671264, and is completed.