Efficacy and safety of Botulinum toxin A for improving esthetics in facial complex: A systematic review

Gangigatti, Ritu; Bennani, Vincent; Aarts, John; Choi, Joanne; Brunton, Paul

doi:10.1590/0103-6440202104127

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Article • Braz. Dent. J. 32 (4) • Jul-Aug 2021 • https://doi.org/10.1590/0103-6440202104127 copy

Efficacy and safety of Botulinum toxin A for improving esthetics in facial complex: A systematic review

Authorship SCIMAGO INSTITUTIONS RANKINGS

Abstract

Aim: To evaluate efficacy and safety of Botulinum toxinA for improving esthetics in the facial complex and correlating them to the dosage and side effects through a systematic review. Methods: A literature search was performed using PubMed, Medline, Web of Sciences, and Scopus databases. Quality of studies was appraised through the GRADE system. This review follows the ‘Preferred reporting items for systematic review and meta-analysis protocols’ (PRISMA-P) 2015 statement. Efficacy was analyzed through improvement rate and effect sizes. Graphical comparison of efficacy and ocular adverse effects (adverse effects around the eye) at various anatomical locations was made by calculating the average improvement rate and adverse events. Results: Twenty-five studies were included in this systematic review after application of the inclusion criteria. Moderate to severe cases in glabellar, lateral canthal, and forehead regions showed higher improvement rates between 20U to 50U, with an effect lasting up to 120 days. Gender and age seemed to have a direct effect on efficacy. Headaches were the most common adverse effect, followed by injection site bruising; all adverse effects resolved within 3-4 days. Conclusions: Treatment with Botulinum toxinA to enhance esthetics of facial complex is efficient and safe at all recommended dosages. Presence of complexing proteins influenced the efficacy of BoNT-A. undesirable muscular adverse effects around the eyes were more predominant when treating the glabellar region. There was no correlation found between the BoNT-A dosage and side effects, however, an increase in dosage did not always lead to an increase in efficacy.

Key Words:
Botulinum toxinA; esthetics; facial; efficacy; adverse effects

Authors	Type of study	Degree of consistency	Effect size	Score	Grade
Ascher et al., 2004¹⁴	4	1	N.A	5	High
Brandt et al., 2009¹⁵	4	1	N.A	5	High
Carruthers et al., 2014¹⁶	4	1	N.A	5	High
Carruthers et al., 2013¹⁷	4	1	N.A	5	High
Carruthers et al., 2002¹⁸	4	1	N.A	5	High
Carruthers et al., 2003¹⁹	4	1	N.A	5	High
Carruthers et al., 2017²⁰	4	1	N.A	5	High
Fagien et al., 2007²¹	4	1	2	7	High
Harii and Kawashima, 2008²²	4	1	N.A	5	High
Kane et al., 2009²³	4	1	N.A	5	High
Kerscher et al., 2015²⁴	4	1	N.A	5	High
Lowe et al., 2002²⁵	4	1	N.A	5	High
Lowe et al., 2005²⁶	4	1	N.A	5	High
Rzany et al., 2006²⁷	4	1	N.A	5	High
Solish et al., 2016²⁸	4	1	N.A	5	High
Wu et al., 2009²⁹	4	1	N.A	5	High
Keen et al., 1994³⁰	4	1	N.A	5	High
Beer et al., 2005³¹	2	1	N.A	3	Moderate
Feng et al., 2015³²	4	1	N.A	5	High
Hsu and Frankel, 2017³³	2	1	0	3	Moderate
Lowe et al., 1996³⁴	4	1	1	6	High
Polo, 2008³⁵	2	1	1	4	High
Suber et al., 2014³⁶	2	1	N.A	3	Moderate
Sucupira and Abramovitz et al., 2012³⁷	2	1	0	3	Moderate
Mazzuco and Hexsel, 2010³⁸	2	1	N.A	3	Moderate

Authors Year	Number of subjects	Subjects Mean age (years)	Dosage	Efficacy - outcome Improvement rate (%)
				Day 7 - 8		Day 30		Day 112-120		AE (%)	Rank
				a	b	a	b	a	b	AE (%)	Rank
^G Ascher et al., 2004¹⁴	n=119	48.6	25U			72.4	51.7			14.7	High
		50.9	50U			93.1	75.9			8.8
		48.8	75U			75.9	75.9			0
		48.3	Placebo			13.3	6.7			5.8
^G Brandt et al., 2009¹⁵	n=158	43.1	50U			89.3	75.7	24.2	20.2	47.0	High
^G Brandt et al., 2009¹⁵	n=158	42.7	Placebo			3.9	9.8	4.1	6.1	40.0	High
^L Carruthers et al., 2014¹⁶	n= 445	46.7	24U	≈76	≈52	≈89	≈78	≈58	≈43	39.1	High
^L Carruthers et al., 2014¹⁶	n= 445	46.2	Placebo	≈9	≈9	≈12	≈13	≈15	≈28	33.0	High
^G Carruthers et al., 2013¹⁷	n=276	46.6	20U*			87.5	71.2			7.1	High
^G Carruthers et al., 2013¹⁷	n=276	46.4	Placebo			9.8	10.9			2.2	High
^G Carruthers et al., 2002¹⁸	n=264	44.7	20U	82.3	69.1	83.7	79.4	26.2	67.6	28.1	High
^G Carruthers et al., 2002¹⁸	n=264	44.3	Placebo	4.9	29.4	1.6	23.5	0	35.0	33.3	High
^G Carruthers et al., 2003¹⁹	n=273	47.7	20U	≈65.0	≈78.0	76.7	69.9	24.4	52.7	26.9	High
^G Carruthers et al., 2003¹⁹	n=273	46.4	Placebo	≈7.0	≈22	≈5.0	≈18	2.9	≈35	37.2	High
^G Carruthers et al., 2017²⁰	n=268	49.0	20U*			100	100	88.2	82.4	24.3	High
		50.0	40U*			100	100	97.4	89.7	26.4
		47.0	60U*			100	100	85.4	87.8	32.2
		50.0	20U			97.6	95.2	80.5	70.7	29.8
		50.0	Placebo - 52			0	2.9	0	2.9	13.0
^G Feng et al., 2015²¹	n=488	44.2	10U-183	71.5		73.7		30.6		28.3	High
		42.8	20U-183	85.7		87.4		60.6		26.7
		44.3	Placebo			2.4				5.7
^G Harii & Kawashima, 2008²²	n=135	45.7	10U	81.8	84.1	86.4	84.1	23.8	35.7	67.4	High
			20U	88.6	81.8	88.6	93.2	31.8	45.5	75.0
			Placebo	0	0	0	2.1	0	0	59.2
^G Kane et al., 2009²³	n=816	49.2	50U			96.0	96.0			31.0	High
			60U			90.0	89.0
			70U			81.0	85.0
			80U			61.0	76.0
		48.7	Placebo			0-9	9-0			28.0
^G,F,L Kerscher et al., 2015²⁴	n=156	47.4	20U*(G)	98.1		95.1		41.7		61.9	High
			10-20U*(F)	93.3		91.3		41.7
			12U*(L)	92.3		93.2		30.1
		47.5	Placebo (G)	5.9		6.3		2.2		54.9
			Placebo (F)	9.8		4.2		6.5
			Placebo (L)	17.6		14.6		15.2
^L Lowe et al., 2002²⁵	n= 60	46.9	6U			≥89.0				11-25	High
		49.5	12U			≥95.0
		46.3	18U			≥95.0
		N.S	Placebo	N.S
^L Lowe et al., 2005²⁶	n=162	47.0	3U	36.4	40.0	45.5	42.4	27.3	19.4	17.0	High
			6U	51.5	37.5	51.5	48.4	33.3	40.6	17.0
			12U	64.5	55.2	87.1	73.3	41.9	40.0	15.0
			18U	60.6	45.2	84.8	51.6	39.4	25.8	16.0
			Placebo	12.5	16.7	15.6	14.8	9.4	6.3	18.0
^F Rzany et al., 2006²⁷	n=110 for 3 injection patterns	46.6	10U			86.1				4.1	High
	n=110 for 3 injection patterns	46.6	Placebo			18.9				5.4
	n=111 for 5 injection patterns	46.4	10U			86.3				13.8
	n=111 for 5 injection patterns	46.4	Placebo			7.90				10.5
^F Solish et al., 2016²⁸	n=175	46.8	30U			84.7	89.8			33.9	High
			40U			92.9	91.2			35.1
			Placebo - 59			13.6	15.3			25.4
^G Wu et al., 2009²⁹	n=227	41.7	20U	91.7	91.1	94.1	95.2	52.9	52.9	32.3	High
^G Wu et al., 2009²⁹	n=227	44.1	Placebo	3.5	1.7	3.5	0	1.7	0	19.3	High
^F,L Keen et al., 1994³⁰	n=11	42.8	16U (F) 5U (L)			100	90.9			27.2	High
^F,L Keen et al., 1994³⁰	n=11	42.8	Placebo-			N.S	N.S			27.2	High
^g Mazzuco and Hexsel, 2010³⁸	n=16	N.S	5-15U			75.1				6.2	Moderate

Author/s Year	Assessment used	Number of subjects	Mean age (years)	Dosage	Baseline		Week 1		Week 4		Week 12		Effect size	AE (%)	Rank
Author/s Year	Assessment used	Number of subjects	Mean age (years)	Dosage	a	b	a	b	a	b	a	b	Effect size	AE (%)	Rank
^C Beer et al., 2005³¹	Change from baseline	n=20	N.S	5U			-0.8 ± 1.2		-1.3 ± 1.2		-0.8 ± 0.9		1.1	N.R	Moderate
^C Beer et al., 2005³¹	Change from baseline	n=20	N.S	Placebo			-0.2 ± 1.2		-0.2 ± 1.1		-0.1 ± 0.8		0.1	N.R	Moderate
^G Fagien et al., 2007³²	i) Maximum contraction ii) Rest	n=70	44.0	20U	2.8 ± 0.9	1.7 ± 0.8			0.7 ± 0.8	0.5 ± 0.8	1.2 ± 0.6	0.4 ± 0.5	i) 5.5 ii) 2.7	1.5	High
^G Fagien et al., 2007³²	i) Maximum contraction ii) Rest	n=70	44.0	Placebo	2.8 ± 0.4	1.7 ± 0.9			2.8 ± 0.6	1.7 ± 0.9			i) 0 ii) 0	1.5	High
^C Hsu and Frankel, 2017³³	i) Vertical position of pogonion ii) Horizontal position of pogonion	n=11	46.3	12-15U	1.4 ± 0.2	0.1 ± 0.1			1.4 ± 0.18	0.1 ± 0.1			i) 0.2 ii) 0.4	N.R	Moderate
^G Lowe et al., 1996³⁴	i) Glabellar line length ii) Depth at maximum frown	n=30	N.S	10U	54.2 ± 10	7.5 ± 2.1			30.8 ± 23.6	2.03 ± 2.3	37.9 ± 11.9	3.0 ± 1.7	i) 2.3 ii) 2.7	20	High
^G Lowe et al., 1996³⁴	i) Glabellar line length ii) Depth at maximum frown	n=30	N.S	Placebo	62.7 ± 15.1	8.1 ± 3.02			63.7 ± 15.9	8.6 ± 3.0	64.9 ± 16.6	8.1 ± 3.2	i)0.1 ii)0.0	20	High
^g Polo, 2008³⁵	Gingival display	n=30	24.4	2.5U	5.2 ± 1.4		0.1 ± 1.1						3.6	10	Moderate
^g Suber et al., 2014³⁶	Gingival display	n=14	34.0	4-6U	4.8 ± 0.9		0.7 ± 1.3						3.5	N.R	Moderate
^g Sucupira and Abramovitz, 2012³⁷	Gingival display	n=52	N.S	1.95U	3.6		0.6						0.7	N.R	Moderate

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[1] Correspondence: Dr. Vincent Bennani Department of Oral Rehabilitation, University of Otago 310 Great King St, North Dunedin, Dunedin 9016 e-mail: ncent.bennani@otago.ac.nz