The efficacy and safety of vibrating capsules for functional constipation: a systematic review and meta-analysis of randomized controlled trials.

OBJECTIVE

Chronic constipation is a challenging functional gastrointestinal disorder that remains a global burden. Pharmacologic therapy, including laxatives and dietary fibers, are suggested as lines of treatment. Recent trials introduced an orally ingested vibrating capsule (VC) as an eligible option for chronic constipation management.

METHODS

We conducted a literature search in English on electronic databases CENTRAL, PubMed, EMBASE, Scopus, and WOS until February 27th, 2023. RevMan was used to perform the meta-analysis. The results were reported as risk ratios (RRs), mean differences (MDs), and 95% confidence intervals (CIs). The study protocol was registered in PROSPERO with ID: (CRD42023409422).

RESULTS

Three RCTs with a total of 601 patients were included in our analysis. There was no difference between the VC and placebo in responder rate (RR: 1.37 with 95% CI [0.82, 2.28], p = .22), CSBM change from baseline (MD: 0.21 with 95% CI [-0.26, 0.69], p = .38), SBM change from baseline (MD: 0.14 with 95% CI [-0.22, 0.49], p = .46), and the incidence of any adverse event (RR: 1.45 with a 95% CI of [0.79, 2.63], p = .23). However, VC was associated with increased vibration sensation (RR: 17.23, 95% CI [3.29, 90.20], p = .0008).

CONCLUSIONS

VC was not effective to improve bowel movement in patients with functional constipation with no difference in response rate. However, evidence is still uncertain, with only three small RCTs that yielded heterogenous findings, mainly due to the different vibration protocols. Also, our findings suggest that VC is safe and well-tolerated, with no significant harmful effects observed. Therefore, more large-scale RCTs are needed to confirm the efficacy and safety of VC in patients with functional constipation, determining the most effective dose, frequency, and duration of treatment.