A New Therapy for Vitiligo Using Fire Needles: A Systematic Review of Evidence from 3618 Subjects

Table 1

Characteristics of the included trials.

The First author, year of publication

Sample size

Sample age (mean [SD] year)

Disease duration (mean [SD])

TCM syndrome

Were baseline data comparable?

Intervention

Outcomes

Duration of treatment

Follow-up (months)

E

C

E

C

E

C

E

C

Bo Z. F, 2017 [10]

23

23

32.54 [11.61]

32.75 [10.26]

5.28 [2.35] years

5.53 [2.42] years

Qi-stagnancy and blood stasis

Yes

(A) (1) Fire needles (once/7 days); (2) plus (B)

(B) “Shu Gan Huo Xue” decoction of TCM (0.5 dose/once, twice/1 day)

TER, ADs

12 weeks

NR

Chen G. F, 2017 [11]

27

26

29.5 [1.3]

31.5 [1.5]

NR

NR

NR

Yes

(A) (1) Fire needles (once/14 days); (2) plus (B)

(B) (1) “Bailing pian ” of Chinese patent drug (0.33 g4/once, 3 times/1 day); (2) NB-UVB (twice/7 days, Shanghai SIGMA Co., SS-03B)

TER, DPER, ADs

6 months

NR

Kuang W. B, 2013 [12]

96

90

8.7

9.2

NR

NR

NR

Yes

(2) Plus (B)

(B) 308-nm excimer laser (twice/7 days, Shenzhen GSD Co.)

TER

12 weeks

NR

Luo G. P, 2016 [13]

72

75

23.38 [7.56]

27.85 [12.64] months

NR

NR

NR

Yes

(A) (1) Fire needles (once/14 days);

(B) Halometasone cream (twice/1 day, Hongkong Bright Future Co., HC20100039)

TER, DPER (E), DAER (E), DDER (E), DCER (E), ADs

6 months

NR

Ren L. S, 2016 [14]

50

50

26.5

29.5

3.0 years

2.5 years

NR

Yes

(A) (1) Fire needles (once/7 days); (2) plus (B)

(B) 308-nm excimer laser (twice/7 days, Italy DEKA Co., MEL308-nm)

TER, number of treatments, ADs, FUP

12 weeks

3

Xie H. L, 2017 [15]

38

34

25.46 [15.52]

26.85 [8.47]

29.43 [14.26] months

28.69 [15.42] months

NR

Yes

(A) (1) Fire needles (once/7 days); (2) plus (B)

(B) 0.1% tacrolimus ointment (twice/1 day, Astellas (China) Co.)

TER, DPER (E), DAER (E), DDER (E), ADs

12 weeks

NR

Xu D. P, 2016 [16]

29

29

31.3

33.6

NR

NR

Liver-kidney yin deficiency; blockage of the vessel

Yes

(A) (1) Fire needles (once/7 ～ 10 days); (2) plus (B)

(B) “Huo Xue Bu Shen Xiao Bai” decoction of TCM (0.5 dose/once, twice/1 day)

TER, ADs

6 months

NR

Yu C. D, 2017 [17]

30

28

31.5

30.6

3.0 years

2.5 years

NR

NR

(A) (1) Fire needles (once/7 days); (2) plus (B)

(B) 308-nm excimer laser (twice/7 days, USHIO (Japan) Co., TheraBeam UV308)

TER, ADs

12 weeks

NR

Zhao Y, 2015 [18]

39

39

32.1

34.6

NR

NR

Qi-stagnancy and blood stasis

Yes

(A) (1) Fire needles (once/7 days); (2) plus (B)

(B) “Qu Bai Yi HAO” decoction of Chinese drug preparation (200 ml/once or twice/1 day)

TER, ADs

16 weeks

NR

Zhou R. X, 2012 [19]

100

100

35.6

34.5

5.5 years

5.1 years

NR

Yes

(A) (1) Fire needles (separate from (B), once/2 days); (2) plus (B)

(B) NB-UVB (once/2 days, German Waldmann Co., UV100 L)

TER, ADs

120 days

NR

Zhu Y. Y, 2016 [20]

43

40

22

24

2.7 years

3.4 years

NR

Yes

(A) (1) Fire needles (once/7 days); (2) plus (B)

(B) 308-nm excimer laser (twice/7 days, 308-nm XeCl from America)

TER, ADs

12 weeks

NR

Yang D. K, 2014 [21]

30

29

35.5

32.5

7.3 years

7.2 years

NR

Yes

(A) (1) Fire needles (once/5–7 days); (2) plus (B)

(B) “Fu Fang Zi Gui Pian” of Chinese patent drug (1.6 g/once, 3 times/1 day)

TER, DPER, ADs

2 months

NR

Mai L. X, 2017 [22]

31

23

34.81 [8.85]

34.04 [11.17]

33.42 [38.84] months

34.30 [52.52] months

NR

Yes

(A) (1) Fire needles (once/14 days); (2) plus (B)

(B) (1) NB-UVB (twice/7 days, TL20 W/01 lamp tube, wave length 311-313-nm, wave peak 311-nm); (2) Vitamin B complex tablets (2#/once, 3 times/1 day)

TER, ADs

16 weeks

NR

Dun G, 2016 [23]

50

50

33.5

48.6 months

NR

Yes

(A) (1) Fire needles (once/7 days); (2) plus (B)

(B) 308-nm excimer laser (twice/7 days, Italy DEKA Co., MEL308-nm)

TER, DPER, ADs

6 months

6

Jiang M. J, 2016 [24]

30

30

29.5

30.2

2.6 years

2.5 years

NR

Yes

(A) (1) Fire needles (once/7 days); (2) plus (B)

(B) 308-nm excimer laser (twice/7 days, Wuhan MIRACLE LASER Co., MEL308-nm)

TER, ADs

12 weeks

NR

Jing L. H, 2015 [25]

31

29

28.7

29.2

2.3 years

2.7 years

NR

Yes

(A) (1) Fire needles (once/7 days); (2) “Bai Dian Yin” decoction of Chinese herbal granules (twice/1 day)

(B) (1) NB-UVB (twice/7 days, Shanghai SIGMA Co., SS-05B-40); (2) “Bai Dian Yin” decoction of Chinese herbal granules (twice/1 day)

TER

12 weeks

NR

Li X. S, 2017 [26]

60

60

25.6 [11.21]

25.3 [10.63]

2.6 [1.7] years

2.8 [1.2] years

NR

Yes

(A) (1) Fire needles (determined for every patient); (2) “Zi Tong Xiao Bai” of Chinese patent drug (adult: 6#/once, 3 times/1 day; children: 3#/once, 3 times/1 day)

(B) (1) NB-UVB (twice/7 days); (2) “Zi Tong Xiao Bai” of Chinese patent drug (adult: 6#/once, 3 times/once/1 day; children: 3#/once, 3 times/1 day)

TER, DPER, ET, ADs

3 months

NR

Wang W. L, 2017 [27]

39

39

32.50 [8.30]

33.79 [9.12]

28.16 [16.05] months

27.28 [20.21] months

NR

Yes

(A) (1) Fire needles (once/7 days); (2) plus (B)

(B) (1) NB-UVB (once/3 days, German Waldmann 311); (2) 0.1% tacrolimus ointment (twice/1 day, Astellas (China) Co.)

TER, ADs

4 months

NR

Yang D, 2017 [28]

31

31

32.5 [16.5]

30.52 [15.55]

NR

NR

NR

Yes

(A) (1) Fire needles (once/14 days); (2) plus (B)

(B) 0.1% tacrolimus ointment (twice/1 day)

TER, ADs, FUP

12 weeks

2

Liu J. J, 2015 [29]

31

29

32.26 [8.450]

32.72 [8,071]

36.13 [23.082] months

33.90 [18.074] months

NR

Yes

(A) (1) Fire needles (once/7 days); (2) “Ru Yi Hei Bai” of Chinese medicinal powder (6 g/once, 3 times/1 day)

(B) (1) “Bai Bo” of Chinese medicinal pill (5 g/once or twice/1 day); (2) “Ka Li Zi Ran Ding” of Chinese herbal tincture (3-4/1 day); (3) UVA once or twice/1 day, Xinjiang WEIATANG)

TER, DPER (ungrouped), TSLA, DPSLA, ADs

2 months

NR

Wang X, 2016 [30]

36

36

33.66 [8.31]

33.73 [8.57]

22.59 [9.80] months

22.65 [9.31] months

NR

Yes

(A) (1) Fire needles (once/7 days); (2) “Tong Luo Qu Bai” dedoction of TCM (0.5 dose/once or twice/1 day)

(B) (1) “Bai Dian Feng ” of Chinese medicinal pill (12 g/once or twice/1 day); (2) “Ka Li Zi Ran Ding” of Chinese herbal tincture (3-4 times/1 day); (3) UVA (once or twice/1 day, Xinjiang WEIATANG)

TER, TSLA, HAMD, ADs

6 months

NR

Yang M, 2017 [31]

18

19

37.11 [11.97]

38.47 [9.92]

8.92 [10.10] years

8.41 [7.62] years

NR

Yes

(A) (1) Fire needles (1^st–4^th weeks: once/3 days; 5^th–8^th week: once/5 days; 9^th–12^th weeks: once/7 days); (2) plus (B)

(B) 0.1% tacrolimus ointment (twice/1 day, Astellas (China) Co., J20100015)

TER, TSLA, S-CLSM, FUP, ADs

12 weeks

1

Zhang J. Y, 2016 [32]

35

35

32.53 [10.920]

32.37 [9.103]

2.06 [1.42] years

2.05 [1.21] years

NR

Yes

(A) (1) Fire needles (once/7 days); (2) moxa-moxibustion (15 min/once, once/1 day, location: local skin lesion, Xiabai acupoint, Dianfeng acupoint, Zusanli acupoint)

(B) Halometasone cream (once/1 day; intermittent treatment: stopping for 1 week after using for 1 week, German Waldmann Co.)

TER, TRCA, TSLA, TPP, FUP, LA, ADs, CA

3 months

3

Du Y. S, 2019 [33]

40

38

45.49 [3.08]

45.56 [3.12]

1.82 [0.57] years

1.86 [0.54] years

NR

Yes

(A) (1) Fire needles (once/7 days); (2) cotton moxibustion (once/7 days); (3) plus (B)

(B) NB-UVB (three times/7 days, German Waldmann Co.)

TER, ADs

16 weeks

NR

He G, 2018 [34]

28

28

26 [0.3]

27 [0.2]

2.8 [0.6] years

2.6 [0.3] years

NR

Yes

(A) (1) Fire needles (once/7 days); (2) moxa-moxibustion (30 min/once, once/1 day, location: local skin lesion)

(B) Tacrolimus ointment (>10 years old patients: 0.1%; ≤10 years patients: 0.03%; twice/1 day, Astellas (China) Co.)

TER, ADs

12 weeks

NR

Lin M, 2019 [35]

48

47

34.36 [5.44]

33.94 [5.23]

5.45 [2.43] years

5.64 [2.38] years

NR

Yes

(A) (1) Fire needles (once/7 days); (2) plus (B)

(B) (1) “Bu Shen Huo Xue” decoction of TCM (0.5 dose/once, twice/1 day); (2) tacrolimus ointment (twice/1 day)

TER, TSLA, CL, ADs

12 weeks

NR

Liu Z. H, 2019 [36]

60

60

31.32 [6.11]

31.33 [6.45]

10.21 [7.13] years

10.29 [7.1] years

Liver-kidney yin deficiency; Qi-stagnancy and blood stasis; Liver depression and Qi-stagnancy

Yes

(A) (1) Fire needles (once/7 days); (2) plus (B)

(B) “Ka Li Zi Ran Ding” of Chinese herbal tincture, then sunbathing for 30 min (3-4 times/1 day)

TER, TSLA, ET, ADs

NR

NR

Tian L. Y, 2018 [37]

40

40

38.4 [6.9]

38.7 [6.3]

5.1 [1.4] years

5.5 [1.2] years

NR

Yes

(A) (1) Fire needles (once/14 days); (2) plus (B)

(B) NB-UVB (twice/7 days, Shanghai SIGMA Co., SS-01)

TER, CL, TPP, ADs

2 months

NR

Wang W. L, 2018 [38]

50

50

36.03 [7.05]

35.37 [6.59]

NR

NR

NR

Yes

(A) (1) Fire needles (once/7 days); (2) plus (B)

(B) (1) NB-UVB (three times/7 days, German Waldmann Co.); (2) “Bai Dian Feng” decoction of Chinese herbal granules (three times/1 day)

TER, CL

12 weeks

NR

Xu C. Q, 2018 [39]

40

40

20.83 [13.47]

20.19 [12.28]

28.67 [12.34] months

29.43 [14.26] months

NR

Yes

(A) (1) Fire needles (once/7 days); (2) plus (B)

(B) 308-nm excimer laser (Shenzhen GSD Co.)

TER, FUP, ADs

12 weeks

3 months

Yin Y. Q, 2018 [40]

32

31

25.16 [3.58]

25.30 [3.61]

2.92 [1.08] years

3.01 [1.05] years

NR

Yes

(A) (1) Fire needles (once/14 days); (2) plus (B)

(B) Halometasone cream (twice/1 day, Hongkong Bright Future Co., HC20150050)

TER, DPER

6 months

NR

Zhao X, 2018 [41]

49

49

31.5 [3.1]

30.8 [2.9]

5.2 [1.3] years

5.5 [1.4] years

NR

Yes

(A) (1) Fire needles (once/10 days); (2) plus (B)

(B) “Bu Shen Huo Xue” decoction of TCM (0.5 dose/once, twice/1 day)

TER, ADs

3 months

NR

Dang C, 2019 [42]

20

20

24.49 [6.62]

29.82 [13.35] months

NR

Yes

(A) (1) Fire needles (once/7 days); (2) plus (B)

(B) (1) Mometasone furoate (once/1 day; Shanghai schering-plough pharmaceutical Co., LTD); (2) NB-UVB (once/2 days); (3) compound betamethasone (1 ml/1 month, Schering-Plough Labo N.V. Belgium)

TER, TSLA, ADs

12 weeks

NR

He G, 2019 [43]

35

35

27 [8.2]

25 [9.3]

2.2 [1.5] years

2.5 [1.8] years

NR

Yes

(A) (1) Fire needles (once/7 days); (2) moxa-moxibustion (30 min/once, once/1 day, location: local skin lesion)

(B) 0.1% tacrolimus ointment (J20100015, Astellas (China) Co.)

TER, ADs

12 weeks

NR

Liu X, 2018 [44]

45

40

34.6 [5.2]

34.6 [5.2]

NR

NR

NR

NR

(A) (1) Fire needles (once/7 days); (2) plus (B)

(B) NB-UVB (once/1 day)

TER, the satisfaction of patients

3 months

NR

Chen S. Y, 2018 [45]

20

20

15.14 [1.2]

15.2 [1.3]

2.8 [1.1] years

2.7 [1.1] years

NR

Yes

(A) (1) Fire needles (once/7 days); (2) 308-nm excimer laser (once/7 days, Chongqing DMGD co., XECL-308C)

(B) 308-nm excimer laser (twice/7 days, Chongqing DMGD Co., XECL-308C)

TER, ET

3 months

NR

Chen X, 2018 [46]

35

36

37.686 [13.45]

32.611 [11.79]

52.09 [54.82] months

31.61 [45.60] months

Liver-kidney yin deficiency; Qi-stagnancy and blood stasis

Yes

(A) (1) Fire needles (once/7 days); (2) plus (B)

(B) (1) Chinese materia medica preparation; (2) 0.1% tacrolimus ointment (twice/1 day)

TER, different syndrome effectiveness rate, VNS analysis, ADs

12 weeks

NR

Cheng K, 2018 [47]

20

20

38.65 [13.36]

39.75 [12.15]

26.83 [8.11] months

26.23 [9.01] months

NR

Yes

(A) (1) Fire needles (once/3 days); (2) plus (B)

(B) 308-nm excimer laser (twice/7 days, Shenzhen GSD Co.)

TER, DPER, DDER, DCER, ADs

72 days

NR

Fu F, 2019 [48]

30

30

31.9 [10.6]

32.5 [9.75]

24.7 [12.73] months

27.65 [14.21] months

Blockage of the vessel

Yes

(A) (1) Fire needles (once/7 days); (2) plus (B)

(B) “Jia Wei Tao Hong Si Wu” decoction of TCM (0.5 dose/once, twice/1 day)

TER, ADs

12 weeks

NR

Gu T, 2018 [49]

52

52

36.8

38.2

1 months–7 years

6 months–8 years

NR

Yes

(A) (1) Fire needles (once/7 days); (2) plus (B)

(B) 308-nm excimer laser (PhotoMedex, American, AL10000, twice/7 days)

TER, ADs

12 weeks

NR

He X. L, 2018 [50]

29

28

40.17 [12.73]

39.57 [13.20]

45.59 [42.88] months

26.89 [27.12] months

NR

Yes

(A) (1) Fire needles (once/7–10 days); (2) “Jia Wei Tao Hong Si Wu” decoction of TCM (200 ml/once, twice/1 day)

(B) (1)308-nm excimer laser (twice/7 days) (2) “Jia Wei Tao Hong Si Wu” decoction of TCM (200 ml/once, twice/1 day)

TER, TSLA, DDER, QLQI score, ADs

90 days

NR

Li B, 2018 [51]

29

28

18.2 [2.3]

17.6 [2.1]

NR

NR

NR

Yes

(A) (1) Fire needles (once/7 days); (2) moxa-moxibustion (15 min/once, once/1 day, location: local skin lesion, Xiabai acupoint, Dianfeng acupoint, Zusanli acupoint)

(B) Halometasone cream (once/1 day; intermittent treatment: stopping for 1 week after using for 1 week.)

TER, TSLA, ADs

3 months

NR

Liu Y, 2019 [52]

31

31

34.2 [3.9]

33.9 [3.6]

2.5 [0.7]

2.4 [0.6]

Qi-stagnancy and blood stasis

Yes

(A) (1) Fire needles (once/7 days); (2) “Jia Wei Ru Yi Hei Bai” decoction of TCM (0.5 dose/once, twice/1 day)

(B) 0.03% tacrolimus ointment (twice/1 day, Astellas (China) Co.)

TER, TPP, CL, FUP, ADs

3 months

3 months

Reng S. S, 2018 [53]

24

24

34.69 [3.59]

3.29 [1.10]

Liver-kidney yin deficiency

Yes

(A) (1) Fire needles (7–10 days/1 month); (2) plus (B)

(B) (1) “Qu Yu Bu Shen” decoction of TCM (200–300 ml/once, twice/1 day); (2) tacrolimus ointment (twice/1 day)

TER, TRCR, ADs

6 months

NR

Xia F, 2019 [54]

24

23

37.0 [14.2]

37.3 [14.8]

4.6 [4.1]

4.3 [4.0]

NR

Yes

(A) (1) Fire needles (1^st month: once/3 days; 2^nd month: once/5 days; 3^rd month: once/7 days); (2) plus (B)

(B) 0.1% tacrolimus ointment (twice/1 day, Astellas (China) Co.)

TER, TSLA, FUP, TPP

3 months

6 months

Zhang F. R, 2018 [55]

34

33

32.65 [14.00]

31.42 [13.81]

32.50 [39.55]

36.03 [34.06]

NR

Cold and blood stasis resistance

(A) (1) Fire needles (once/7 days); (2) “Wen Jing” decoction of TCM (200 ml/once, twice/1 day) (3) plus (B)

(B) 0.1% tacrolimus ointment (twice/1 day, Astellas (China) Co.)

TER, TPP, Dermoscopy dynamic monitoring, TSLA, FUP, ADs

12 weeks

3 months

Zhao X. M, 2019 [56]

45

45

33.5 [3.8]

33.8 [3.5]

2.2 [0.7]

2.3 [0.8]

NR

Yes

(A) (1) Fire needles (once/7 days); (2) “Xiao Ban” tincture of TCM (3-4 times/1 day); (3) plus (B)

(B) Halometasone cream (once/1 day; intermittent treatment: stopping for 1 week after using for 2 weeks, Hongkong Bright Future Co., HC20100039)

TER, TPP, TSLA, CL, ADs

6 months

NR

SD, standard deviation; TCM, traditional Chinese medicine; E, experimental group; C, control group; ADs, adverse events; FUP, follow-up period; NR, not reported; TER, total effectiveness rate; DPER, different position effectiveness rate; DAER, different acreage effectiveness rate; DDER, different duration effectiveness rate; DCER, different classification effectiveness rate; ET, effectual time; TSLA, total skin lesion area; DPSLA, different position skin lesion area; s-CLSM, skin-confocal laser scanning microscope; TRCA, total restored color area; TPP, total pigment point; LA, loss analysis; CA, compliance analysis; CL, cytokine level, VSS, Vitiligo symptom score; VNS, validation of the Vitiligo Noticeability Scale; QL.