The Effectiveness of bFGF in the Treatment of Tympanic Membrane Perforations: A Systematic Review and Meta-Analysis.

OBJECTIVE

To investigate the effectiveness of basic fibroblast growth factor (bFGF) versus placebo or no intervention in the treatment of tympanic membrane (TM) perforations from randomized controlled trials (RCTs), prospective and retrospective studies.

DATA SOURCES

PubMed, EMBASE, and Cochrane databases were screened from their inceptions to June 2019.

STUDY SELECTION

Inclusion criteria: 1) English language; 2) observational (retrospective or prospective) or treatment (RCT) studies; 3) reported the outcomes on the application of bFGF in adult or pediatric population.

EXCLUSION CRITERIA

1. studies without a control group; 2) animal studies, in vitro studies, review studies, and case reports.

DATA EXTRACTION

Number of patients, cause of TM perforation, perforation size, treatment, mean age, follow-up time, sex, closure rate, healing time, mean air-bone gap improvement.

DATA SYNTHESIS

A total of 14 studies were included, including seven RCTs and seven non-RCTs with a total of 1,072 participants. The odds ratio for closure rate of bFGF treatment was 7.33 (95% confidence interval [CI], 4.65 to 11.53; p < 0.01; I = 44%) and the standardized mean difference (SMD) for healing time was -5.89 (95% CI: -7.85 to -3.93, p < 0.01, I = 98%), suggesting bFGF application has a significant effect on closure of TM perforations. However, no significant change in hearing (SMD: 0.08, 95% CI: -0.11 to 0.27, p = 0.39, I = 0%) was seen as a result of bFGF treatment.

CONCLUSIONS

Our meta-analysis has revealed that the application of bFGF can significantly enhance the closure rate as well as shorten the healing time for TM perforations. In terms of hearing, there is as yet no evidence that bFGF has a significant effect. Given its ease, availability, and safety, bFGF can be used effectively for TM repair.