PMID- 27495260 OWN - NLM STAT- MEDLINE DCOM- 20171004 LR - 20220311 IS - 1432-5241 (Electronic) IS - 0364-216X (Linking) VI - 40 IP - 5 DP - 2016 Oct TI - Adverse Events of Botulinum Toxin Type A in Facial Rejuvenation: A Systematic Review and Meta-Analysis. PG - 769-77 LID - 10.1007/s00266-016-0682-1 [doi] AB - BACKGROUND: Botulinum toxin A (BTX-A) is a medical product that is used widely in cosmetics, and concern over the safety profile has increased among injectors and patients. OBJECTIVE: The purpose was to enhance the statistical effect size using a meta-analysis to detect the incidence rate of adverse events (AEs) in the treatment of facial wrinkles. METHODS: A systematic search was performed for randomized, double-blind, placebo-controlled trials published through July 2015. RESULTS: We searched 16 trials, including 42,405 individual participants, and found that in all enrolled facial rejuvenation studies, patients in the BTX-A group had significantly more AEs than those patients in the placebo group (RR = 1.24; 95 % CI 1.07-1.43; p = 0.003). For crow's feet lines injection analysis, the BTX-A group did not exhibit any significant increase in AEs compared with the control group (RR = 1.19; 95 % CI 0.96-1.48; p = 0.12), except in injection site hematoma (RR = 2.14; 95 % CI 1.13-4.07; p = 0.02) in the treatment group. For frown wrinkle injection analysis, AEs were significantly observed in the BTX-A group (RR = 1.47; 95 % CI 1.23-1.77; p < 0.0001), particularly headaches (RR = 1.53; 95 % CI 1.15-2.03; p = 0.003), eyelid ptosis (RR = 5.56; 95 % CI 1.68-18.38; p = 0.005), and heavy eyelids (RR = 6.94; 95 % CI 1.27-37.93; p = 0.03). CONCLUSION: This meta-analysis confirmed the safety profile of BTX-A for glabellar and crow's feet lines, and BTX-A usage for the removal of upper facial wrinkles, which have some significant mild-to-moderate adverse profiles, including headache, eye disorder, eyelid ptosis, and heavy eyelids. Facial injectors should abide by the technical standards of neurotoxic drugs and be familiar with the local pharmacological effects to lessen the severe side effects. LEVEL OF EVIDENCE I: This journal requires that authors assign a level of evidence to each article. For a full description of these Evidence-Based Medicine ratings, please refer to the Table of Contents or the A5 online Instructions to Authors www.springer.com/00266 . FAU - Jia, Zhenhua AU - Jia Z AD - Department 16, Plastic Surgery Hospital, Chinese Academy of Medical Sciences and Peking Union Medical College, No. 33 Badachu Road, Shijingshan District, Beijing, 100144, People's Republic of China. FAU - Lu, Haibin AU - Lu H AD - Department 16, Plastic Surgery Hospital, Chinese Academy of Medical Sciences and Peking Union Medical College, No. 33 Badachu Road, Shijingshan District, Beijing, 100144, People's Republic of China. FAU - Yang, Xiaonan AU - Yang X AD - Department 16, Plastic Surgery Hospital, Chinese Academy of Medical Sciences and Peking Union Medical College, No. 33 Badachu Road, Shijingshan District, Beijing, 100144, People's Republic of China. FAU - Jin, Xiaolei AU - Jin X AD - Department 16, Plastic Surgery Hospital, Chinese Academy of Medical Sciences and Peking Union Medical College, No. 33 Badachu Road, Shijingshan District, Beijing, 100144, People's Republic of China. FAU - Wu, Rongwei AU - Wu R AD - Department 16, Plastic Surgery Hospital, Chinese Academy of Medical Sciences and Peking Union Medical College, No. 33 Badachu Road, Shijingshan District, Beijing, 100144, People's Republic of China. FAU - Zhao, Jingyi AU - Zhao J AD - Department 16, Plastic Surgery Hospital, Chinese Academy of Medical Sciences and Peking Union Medical College, No. 33 Badachu Road, Shijingshan District, Beijing, 100144, People's Republic of China. FAU - Chen, Lulu AU - Chen L AD - Department 16, Plastic Surgery Hospital, Chinese Academy of Medical Sciences and Peking Union Medical College, No. 33 Badachu Road, Shijingshan District, Beijing, 100144, People's Republic of China. FAU - Qi, Zuoliang AU - Qi Z AD - Department 16, Plastic Surgery Hospital, Chinese Academy of Medical Sciences and Peking Union Medical College, No. 33 Badachu Road, Shijingshan District, Beijing, 100144, People's Republic of China. baolong204@126.com. LA - eng PT - Journal Article PT - Meta-Analysis PT - Review PT - Systematic Review DEP - 20160805 PL - United States TA - Aesthetic Plast Surg JT - Aesthetic plastic surgery JID - 7701756 RN - 0 (Neuromuscular Agents) RN - EC 3.4.24.69 (Botulinum Toxins, Type A) SB - IM MH - Botulinum Toxins, Type A/administration & dosage/*adverse effects MH - Dose-Response Relationship, Drug MH - Face MH - Female MH - Follow-Up Studies MH - Humans MH - Male MH - Neuromuscular Agents/*adverse effects/therapeutic use MH - Patient Safety MH - Randomized Controlled Trials as Topic MH - Rejuvenation/*physiology MH - Risk Assessment MH - Skin Aging/*drug effects MH - Treatment Outcome OTO - NOTNLM OT - Adverse events OT - Botulinum toxin type A OT - Crow's feet OT - Glabellar lines OT - Meta-analysis EDAT- 2016/08/09 06:00 MHDA- 2017/10/05 06:00 CRDT- 2016/08/07 06:00 PHST- 2016/01/09 00:00 [received] PHST- 2016/06/30 00:00 [accepted] PHST- 2016/08/07 06:00 [entrez] PHST- 2016/08/09 06:00 [pubmed] PHST- 2017/10/05 06:00 [medline] AID - 10.1007/s00266-016-0682-1 [pii] AID - 10.1007/s00266-016-0682-1 [doi] PST - ppublish SO - Aesthetic Plast Surg. 2016 Oct;40(5):769-77. doi: 10.1007/s00266-016-0682-1. Epub 2016 Aug 5.