The Efficacy of Combination Therapy Involving Excision Followed by Intralesional 5-Fluorouracil and Betamethasone, and Radiotherapy in the Treatment of Keloids: A Randomized Controlled Trial

Figures & data

Table 1 Patient Characteristics

Characteristic	Group A (n = 18)	Group B (n = 20)	Group C (n = 17)	P
Sex (male/female)	5/13	5/15	8/9	ND*
Age (years)	27.50 (23.75, 34.00)	30.00 (22.25, 44.25)	31.00 (23.50, 54.50)	ND**
Existence (years)	4.00 (3.00, 7.00)	5.00 (3.25, 7.75)	8.00 (4.50, 15.00)	ND**
BMI (kg/m^2)	21.21±3.10	22.04±2.16	22.96±3.39	ND***
Previous therapy (none/exist)	6/12	7/13	11/5	ND*
Family history (none/exist)	3/15	2/18	1/16	ND*
Etiology:  Acne, folliculitis	5	6	4	ND*
surgery, injury	6	7	4
Spontaneous	7	7	9
Localization:  Head and face	2	0	2	ND*
trunk	13	18	15
Limbs	3	2	0

Note: *Chi square or Fisher’s test. **Kruskal–Wallis test. ***One-way ANOVA.

Abbreviation: ND, no difference.

Table 2 Results: Comparison of VSS (Mean±std)

Groups	n	Before Treatment	After Treatment	Paired t-Test Value
Group A	18	10.17±2.31	4.56±2.06*	t=13.843 P<0.001
Group B	20	9.70±1.59	6.10±1.17	t=10.987 P<0.001
Group C	17	9.24±1.92	4.24±1.48**	t=8.086 P<0.001
One-way ANOVA value		F=0.997	F=7.349
		P=0.376	P=0.002

Note: Compared with group B, *P <0.05, **P <0.01.

Figure 1 Comparison of VSS (A), OSAS (B) and PSAS (C). (A) comparison of VSS among the three groups before and after treatment, (B) comparison of OSAS among the three groups before and after treatment, (C) comparison of PSAS among the three groups before and after treatment. After 4 months, the improvement of VSS, OSAS and PSAS in group A and C were significantly increased compared with group B. There was no statistical difference in group A and C. *P<0.05, **P<0.01.

Table 3 Results: Comparison of OSAS (Mean±std)

Groups	n	Before Treatment	After Treatment	Paired t-Test Value
Group A	18	34.06±7.67	18.50±6.12**	t=11.905 P<0.001
Group B	20	32.40±4.49	23.35±3.95	t=11.977 P<0.001
Group C	17	31.82±5.79	18.53±6.15*	t=7.351 P<0.001
One-way ANOVA value		F=0.646	F=5.034
		P=0.528	P=0.010

Note: Compared with group B, *P <0.05, **P <0.01.

Table 4 Results: Comparison of PSAS [Median (Interquartile Range)]

Groups	n	Before Treatment	After Treatment	Wilcoxon Rank Sum Test Value
Group A	18	43.50 (32.50, 48.50)	21.00 (15.75, 25.25)*	Z=–3.726 P<0.001
Group B	20	42.00 (37.25, 43.75)	29.00 (23.75, 33.00)	Z=–3.529 P<0.001
Group C	17	44.00 (38.00, 48.50)	16.00 (14.50, 20.00)**	Z=–3.576 P<0.001
Kruskal–Wallis test value		χ²=1.743	χ²=17.095
		P=0.418	P<0.001

Note: Compared with group B, *P <0.05, **P <0.01.

Table 5 Results: Comparison of Recurrence and Adverse Side Effects

Groups	n	Recurrence	Adverse Side Effects
			Scab	Telangiectasia	Hyperpigmentation	Hypopigmentation
Group A	18	2	3	2	2	1
Group B	20	4	3	1	1	0
Group C	17	1	1	4	5	0
Fisher’s test value		P=0.535	P=0.423

Figure 2 Adverse side effects resulting from treatments. The most common side effect in group A, B and C was scab, scab and hyperpigmentation, respectively.

Table 6 Results: Comparison of Pain [Median (Interquartile Range)]

Groups	n	Before Treatment	After Treatment	Wilcoxon Rank Sum Test Value
Group A	18	4.00 (1.75, 5.00)	1.00 (1.00, 2.00)	Z=–3.053 P=0.002
Group B	20	3.00 (2.25, 4.00)	1.00 (1.00, 3.00)	Z=–2.556 P=0.011
Group C	17	5.00 (3.00, 5.50)	1.00 (1.00, 3.00)	Z=–2.656 P=0.008
Kruskal–Wallis test value		χ²=3.444	χ²=0.784
		P=0.179	P=0.676

Table 7 Results: Comparison of Pruritus [Median (Interquartile Range)]

Groups	n	Before Treatment	After Treatment	Wilcoxon Rank Sum Test Value
Group A	18	6.00 (3.75, 7.00)	2.00 (1.00, 3.25)	Z=–3.309 P<0.001
Group B	20	4.00 (3.00, 7.00)	2.00 (1.25, 3.00)	Z=–3.219 P<0.001
Group C	17	5.00 (3.50, 7.00)	2.00 (1.00, 4.00)	Z=–3.195 P<0.001
Kruskal–Wallis test value		χ²=2.562	χ²=0.477
		P=0.278	P=0.788

Figure 3 Example of keloid in epigastric region treated with excision followed by intralesional 5-FU and betamethasone. (A) Before treatment, (B) at 6 months of follow-up.

Figure 4 Example of keloid in pubic region treated with excision followed by intralesional 5-FU and betamethasone. (A) Before treatment, (B) at 6 months of follow-up.

Figure 5 Example of keloid treated with intralesional 5-FU and betamethasone. (A) Before treatment, (B) at 6 months of follow-up.

Figure 6 Example of keloid treated with excision followed by radiotherapy. (A) Before treatment, (B) at 6 months of follow-up.