Meta-Analysis of Adverse Reactions of Botulinum Toxin A in Facial Rejuvenation Treatment.

BACKGROUND

Facial rejuvenation is a popular non-surgical treatment, and its treatment safety is of key significance to patients. The purpose of this meta-analysis is to compare the effects of botulinum toxin A and placebo on the occurrence of adverse reactions in facial rejuvenation treatment.

OBJECTIVE

According to PRISMA guidelines, a comprehensive search was conducted in Chinese and English databases, and 20 randomized controlled trials (RCTs) were included. The main result is to evaluate the level of adverse events (AEs), and the secondary result is to evaluate the level of AEs in crow's feet (CFL), glabellar lines (GL), and forehead lines (FHL).

METHODS

The randomized, double-blind, placebo-controlled clinical trial of botulinum toxin A for facial rejuvenation published up to August 2023 was searched by computer, and the completed data were retrieved manually. Two researchers screened out the included studies and evaluated the quality of the literature, and analyzed the included studies with Revman 5.3 software.

RESULTS

The 20 RCTs literatures included 7275 cases in the experimental group and 2552 cases in the control group. The AEs level in the experimental group was significantly higher than that in the placebo group (RR=1.22; 95%CI 1.13-1.32; p < 0.00001), and the level of heterogeneity is low (P = 0.11, I2 = 29%). The AE level of patients in CFL test group was significantly higher than that in control group (RR = 1.13; 95%CI 1.02-1.04; P = 0.01), and the level of heterogeneity is low (P = 0.14, I2 = 38%). The level of AE in GL experimental group was significantly higher than that in control group (RR = 1.42; 95%CI 1.21-1.67; p < 0.0001), and the level of heterogeneity is low (P  = 0.60, I2 = 0%). The AE level of patients in FHL experimental group was significantly higher than that in control group (RR = 1.53; 95%CI 1.12-2.10; p < 0.008), and the level of heterogeneity is low (P = 0.99, I2 = 0%).

CONCLUSION

This meta-analysis confirmed the safety of BTX-A in the treatment of facial rejuvenation (CFL, GL, FHL). Although the incidence of adverse reactions was low, there was still a significant difference compared with the placebo control group.

LEVEL OF EVIDENCE II

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