Safety and efficacy of vibrating capsule in the treatment of functional constipation: a single center randomized controlled study / 中华消化杂志

ABSTRACT

Objective:Based on the previous animal experiments, to preliminarily explore the safety and efficacy of self-developed new smartphone-controlled vibrating capsule (VC) in the treatment of patients with functional constipation (FC).Methods:At the Outpatient Department of Gastroenterology, Changhai Hospital, Naval Medical University, 24 patients with FC were prospectively enrolled. The trial process included basic period for ≥two weeks, treatment period for six weeks, and follow-up visits ≥six (once every two weeks). During treatment period, the patients were assigned into sham capsule group, VC at low frequency mode group and VC at high frequency mode group and the patients swallowed 12 corresponding capsules. The safety of VC treatment was evaluated based on the observation the occurrence of adverse events (AE) in patients of three groups, which included abdominal pain, abdominal distention, capsule retention and abnormal laboratory indicators. The efficacy of VC treatment was assessed by comparison of the patients of three groups in mean complete spontaneous bowel movements (CSBM) per week, mean spontaneous bowel movements (SBM) per week, capsule discharge time, patient assessment of constipation quatity of life questionnaire (PAC-QOL), patient assessment of constipation symptom questionnaire (PAC-SYM). Chi-square test, least significant difference- t test, Kruskal-Wallis test, Wilcoxon rank sum test and Fisher exact test were used for statistical analysis. Results:Two patients were lost in follow up. In the end, seven, eight and seven patients were enrolled in sham capsule group, VC at low frequency mode group and VC at high frequency mode group. AE occurred in three patients. At the sixth week of treatment, the difference between average CSBM in one week and baseline of sham capsule group, VC at low frequency mode group and VC at high frequency mode group was 0.0 (0.0, 2.0), 2.0 (1.0, 2.8) and 1.0 (0.0, 5.0), respectively; and the difference between average SBM in one week and baseline of sham capsule group, VC at low frequency mode group and VC at high frequency mode group was -1.0 (2.0, 2.0), 1.0 (-0.8, 2.0) and 1.0 (0.0, 4.0), respectively. During the six weeks of treatment period, the difference between mean CSBM per week and baseline of three, seven and five patients of sham capsule group, VC at low frequency mode group and VC at high frequency mode group was more than one, and the difference between SBM per week and baseline of two, five and five patients was more than one. At the sixth week of treatment, capsule discharge time of VC at low frequency mode group and VC at high frequency mode group was shorter than that of sham capsule group ((65.7±9.3) and (59.1±3.4) h vs. (96.7±10.0) h), and during the whole treatment period capsule discharge time of VC at low frequency mode group and VC at high frequency mode group was shorter than that of sham capsule group ((63.6±8.6) and (59.8±6.6) h vs. (100.5±13.1) h), and the differences were statistically significant ( t=3.119, 3.584, 2.832 and 3.036, all P<0.05). The PAC-SYM score of patients of sham capsule group, VC at low frequency mode group and VC at high frequency mode group during the period of treatment was 14.3±2.0, 9.9±2.3 and 7.0±2.0, respectively, there were no statistically significant differences among the three groups ( P>0.05). The PAC-QOL score of patients of sham capsule group, VC at low frequency mode group and VC at high frequency mode group during the period of treatment was 31.3±4.4, 24.0±3.8 and 13.9±4.1, respectively, and the PAC-QOL score of VC at high frequency mode group was lower than that of sham capsule group, and the difference was statistically significant ( t=2.808, P=0.012), however, there was no statistically significant difference in the PAC-QOL score between VC at low frequency mode group and sham capsule group, and between VC at high frequency mode group and VC at low frequency mode group (both P>0.05). Conclusions:VC can be safely used in patients with FC, which can promote defecation and relieve the symptoms of constipation. However, there is no significant difference in the therapeutic effect of capsules with different vibration frequencies.