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

Abstract

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.

Keywords:

• Vibrating capsules
• functional constipation
• responder rate
• meta-analysis
• systematic review

Transparency

Declaration of funding

This paper was not funded.

Declaration of financial/other relationships

The authors have no relevant affiliations or financial involvement with any organization or entity with a financial interest in or financial conflict with the subject matter or materials discussed in the manuscript. This includes employment, consultancies, honoraria, stock ownership or options, expert testimony, grants or patents received or pending, or royalties.

Peer reviewers on this manuscript have no relevant financial or other relationships to disclose.

Author contributions

M.T.A. and B.A. conceived the idea. A.S. and M.T.A. designed the research workflow. A.S., B.A. and M.T.A. searched the databases. A.E., A.M., M.E., and A.K. screened the retrieved records, extracted relevant data, A.E., A.M., and M.E. assessed the quality of evidence, and A.S. resolved the conflicts. A.S. and M.T.A. performed the analysis. A.K., M.E., A.S., M.A., and M.T.A. wrote the final manuscript. M.T.A. and B.A. supervised the project. All authors have read and agreed to the final version of the manuscript.

Acknowledgements

None.