Zhu Jia-Hui, Qian Yang-Yang, Pan Jun, He Chen, Lan Yu, Chen Wei-Na, Wang Bang-Mao, Zhao Wei, Li Jing-Nan, Li Xiao-Qing, Lv Bin, Fan Yi-Hong, Zuo Xiu-Li, Li Zhen, Zou Duo-Wu, Li Zhao-Shen, Liao Zhuan
Department of Gastroenterology, Digestive Endoscopy Center, Changhai Hospital, 168 Changhai Road, Shanghai 200433, China.
National Clinical Research Center for Digestive Diseases, Shanghai, China.
EClinicalMedicine. 2022 Apr 25;47:101407. doi: 10.1016/j.eclinm.2022.101407. eCollection 2022 May.
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.
From December 2018 to February 2020, we did a multicenter, blinded, placebo-controlled randomised 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 a 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.
107 patients aged from 18 to 74 were randomly assigned to receive VC ( = 53) or placebo treatment ( = 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, 10·4-45·1]; = 0·005). More patients in the VC group reported weekly CSBMs ≥ 1 for at least four weeks during treatment (difference, 22·7% [95% CI, 8-46]; = 0·022) and follow-up period (difference, 17.3% [95% CI, 0-35]; = 0·048). The mean Patient Assessment of Constipation-Symptoms score and Patient Assessment of Constipation-Quality of Life score differed significantly from the baseline in both groups (all < 0·0001). The most common adverse event associated with VC was abdominal discomfort (3·7%).
VCs can promote defecation, as well as ameliorating symptoms and improving the quality of life in patients with FC with sustained efficacy. VC appears to be a potential alternative physical treatment for FC with the exact mechanism and parameters warranting further investigation.
The study was supported by "One hundred leading scientists for 21st century" of Health Department of Shanghai Municipal Government (to ZL, No.2017BR005).
功能性便秘（FC）是一种难治性疾病，会带来巨大的经济负担以及情感和身体压力。我们旨在评估新开发的智能手机控制振动胶囊（VC）对FC患者的疗效和安全性。
2018年12月至2020年2月，我们在中国六家顶级综合医院进行了一项多中心、双盲、安慰剂对照的随机试验，重点关注年龄在18至80岁的FC患者。在为期两周的基线期后，患者按1:1的比例随机分配，接受VC或安慰剂治疗六周（每周两粒胶囊）。主要结局是缓解率，定义为在全分析集中，与基线相比，治疗期间每周至少增加一次完全自主排便（CSBM）的患者比例。该试验已在ClinicalTrials.gov注册，编号为NCT04671264，且已完成。
107例年龄在18至74岁的患者被随机分配接受VC治疗（n = 53）或安慰剂治疗（n = 54）。VC组的缓解率显著高于安慰剂组（64.2%对35.8%；差异为27.7%[95%CI，10.4 - 45.1]；P = 0.005）。VC组更多患者在治疗期间（差异为22.7%[95%CI，8 - 46]；P = 0.022）和随访期（差异为17.3%[95%CI，0 - 35]；P = 0.048）报告每周CSBM≥1至少四周。两组患者的便秘症状患者评估评分和便秘生活质量患者评估评分的均值与基线相比均有显著差异（均P < 0.0001）。与VC相关的最常见不良事件是腹部不适（3.7%）。
VC可促进排便，改善FC患者的症状和生活质量，且疗效持续。VC似乎是FC的一种潜在替代物理治疗方法，其确切机制和参数值得进一步研究。
本研究由上海市卫生健康委员会“21世纪百千万人才工程”资助（资助ZL，编号2017BR005）。
