The Traditional Chinese Medicine and Relevant Treatment for the Efficacy and Safety of Atopic Dermatitis: A Systematic Review and Meta-Analysis of Randomized Controlled Trials
Table 1
General characteristics of included randomized controlled trials.
Author
Sample size
Age
Sex
Study design
Disease category
Diagnostic and evaluating criteria
Treating method
Treating duration
Dropout
Major outcome parameter
Side effect
Treatment group
Control group
Treatment group
Control group
Sheehan and Atherton 1992
47
1.5–18.1 years
Male: 27 Female: 20
Placebo-controlled, double-blind, crossover trial
Nonexudative atopic eczema
Simple scoring system
Traditional Chinese herbal formula (PSE101) versus placebo
5 months (assessed at 4 weekly intervals)
10
(1) Median clinical score for erythema and surface damage. (2) Clinical scores change for treatment group and control group. (3) The percentage changes of median and 95% CI median of clinical scores.
Eosinophilia and elevated serum IgE levels.
Fung et al. 1999
40
7–50 years
Male: 19 Female: 18
Double-blind, placebo-controlled, crossover study
Recalcitrant atopic dermatitis
The severity and extent of four clinical parameters (erythema, surface damage, lichenification, and scaling)
Traditional Chinese herbal formula (Zemaphyte) versus placebo
20 weeks (assessed at 4 weekly intervals)
3
(1) The median clinical scores variation for erythema, surface damage, lichenification, and scaling. (2) The comparison of median clinical scores at fourth week between the treatment group and control group. (3) The personal tendency of patients for Zemaphyte and placebo. (4) Complete blood picture and renal and liver function tests.
Auricular acupuncture versus combination of cyproheptadine and calamine lotion
5 weeks
0
Therapeutic effects between two groups (curing, markedly effective, effective, ineffective).
No report.
Bai et al. 2007
120
15–60 years (mean age: 27.45 years)
Male: 42 Female: 78
Randomized controlled trial
Acute eczema
Clinical criteria of acute eczema comes from Clinical Dermatology
Traditional Chinese medicine method (Shuangfujin) versus normal saline group; boric acid group; Pikangwang group
4 days
0
(1) Clinical score variation of skin damage. (2) Clinical score variation of pruritus. (3) The total clinical effectiveness and basic recovery comparison. (4) Adverse effects. (5) Syndrome improvement. (6) Laboratory index.
Regional erythema eruption and burning sensation.
Hon et al. 2007
42
43
5–21 years
Male: 23 Female: 19
Male: 23 Female: 20
Randomized, double-blind, placebo-controlled study
Atopic dermatitis
SCORAD; CDLQI; allergic rhinitis score
Traditional Chinese herbal medicine concoction versus placebo
12 weeks
0
(1) Improvement from baseline in mean SCORAD. (2) Improvement from baseline in mean CDLQI scores. (3) Blood counts, eosinophil counts, total IgE levels, and liver and renal function.
Upper respiratory tract; infection; diarrhoea; abdominal pain; episodes of asthma.
Chen et al. 2008
38
37
18–54 years
Male: 3 Female: 35
Male: 5 Female: 32
Randomized controlled trial
Facial corticosteroid addictive dermatitis
Clinical criteria for facial corticosteroid addictive dermatitis and TCM syndrome differentiation criteria (Xuexufengzao)
Modified Wuhua decoction combined with levocetirizine versus levocetirizine
30 days
12
(1) Clinical scores. (2) The variation of symptom score before and after treatment. (3) The variation of skin erythema and TEWL before and after treatment. (4) Adverse effect.
Gastrointestinal upsets; mild drowsiness.
Senapati et al. 2008
25
25
Treatment group mean age: 16.09 years; control group mean age: 17.46 years
Male: 11 Female: 14
Male: 7 Female: 18
Randomized placebo-controlled trial
Atopic dermatitis
Hanifin and Rajka criteria: diagnostic features of atopic dermatitis; IISA
Evening primrose oil versus placebo
5 months
12
(1) The scores of study cases at baseline and at five monthly evaluations. (2) Effect of evening primrose oil versus placebo on total scores of patients of atopic dermatitis. (3) Adverse effect.
Not found.
Shi et al. 2008
25
22
Treatment group: 14–32 years; control group: 15–31 years
Male: 14 Female: 11
Male: 12 Female: 10
Randomized controlled trial
Atopic dermatitis
The UK working party’s diagnostic criteria for atopic dermatitis derivation
Jiaweidangguiyin combined with loratadine versus loratadine
4 months
0
(1) The clinical effectiveness comparison between experimental group and control group. (2) The cytokine levels comparison before and after treating. (3) Safety and adverse effect.
Not found.
Xu et al. 2008
22
20
Treatment group: 52.09 ± 16.94 years; control group: 43 ± 16.53 years
Male: 10 Female: 12
Male: 10 Female: 10
Randomized controlled trial
Chronic eczema
Clinical criteria of chronic eczema comes from Clinical Dermatology and TCM syndrome differentiation criteria (Xuexufengzao); SSRI and Eczema Area and Severity Index score
Herbal Saxifrage cream versus hydrocortisone
4 weeks
0
(1) Symptom score before treatment and SSRI after treatment in two groups. (2) Clinical efficacy in two groups.
No report.
Gao et al. 2009
30
30
Treatment group: 35.6 ± 13.8 years; control group: 37.5 ± 12.9 years
Male: 13 Female: 17
Male: 11 Female: 19
Randomized controlled trial
Chronic urticaria
Chronic urticaria comes from the TCM disease diagnostic and effective criteria
Penetrative needling of Shendao versus levocetirizine hydrochloride
12 weeks
0
(1) Comparison between acupuncture and medication groups in the symptom scores. (2) Comparison between acupuncture and medication groups in serum IgE level.
No report.
Kobayashi et al. 2010
37
40
20–40 years
—
A 6-month, Multicenter, double-blind, randomized, placebo-controlled study
Atopic dermatitis
The scoring system by the Atopic Dermatitis Severity Evaluation Committee of Japanese Dermatological Association
Traditional herbal medicine (Hochu-ekki-to) versus placebo
24 weeks
14
(1) Clinical efficacy of Hochu-ekki-to(time course change of skin severity score during examination; time course change of equivalent dosage of topical agent during examination). (2) Adverse effects and abnormal laboratory findings.
No report.
Pfab et al. 2010
30
18–50 years
Male: 16 Female: 14
A blinded, randomized, placebo-controlled, crossover trial
Atopic dermatitis
Visual analogue scale and the Eppendorf Itch Questionnaire
Acupuncture versus placebo
10 minutes
0
(1) Wheal and flare size. (2) Skin perfusion measured at the stimulus site. (3) The validated Eppendorf Itch Questionnaire.
No report.
Cheng et al. 2011
47
24
Treatment group mean age: 12.2 years; control group mean age: 13.6 years
Male: 25 Female: 22
Male: 12 Female: 12
A randomized, double-blind, placebo-controlled trial
Refractory atopic dermatitis
Hanifin and Rajka criteria: diagnostic features of atopic dermatitis
Chinese herbal product (Xiao-Feng-San) versus placebo
8 weeks
10
(1) Improvement in scores (clinical lesion; erythema; surface damage; pruritus; sleep) between baseline and week 8. (2) Score improvement (clinical lesion; erythema; surface damage; pruritus; sleep) from baseline to weeks 4, 8, and 12. (3) Immunologic markers variation before and after treatment. (4) Laboratory index.
Transient elevation of aspartate aminotransferase; gastrointestinal upsets.
Hon et al. 2012
42
43
5–21 years
—
Randomized, double-blind, placebo-controlled study
Atopic dermatitis
Hanifin and Rajka criteria: diagnostic features of atopic dermatitis; SCORAD; allergic rhinitis scores; the Children’s Dermatology Life Quality Index
Traditional Chinese herbal medicine versus placebo
12 weeks
0
(1) Percentage improvement of SCORAD from baseline. (2) The total allergic rhinitis scores between two groups. (3) Adverse effects.
Not found.
Pfab et al. 2011
5
5
Mean age: 25.2 ± 4.5
Male: 8; female: 2
Unicenter, single-blinded, prospective, randomized clinical pilot trial
Atopic eczema
Visual analogue scale; SCORAD
Acupuncture versus blank group
33 days
0
(1) SCORAD comparison between two groups. (2) Itch intensity (VAS) between two groups. (3) Basophil activation test comparison between two groups.
No report.
Xiu and Wang 2011
100
100
Treatment group: 14 months to 60 years; control group: 2 to 65 years
Male: 60 Female: 40
Male: 55 Female: 45
Randomized controlled trial
Chronic urticaria
—
Acupoint injection with autoblood versus medicine group
30 days
0
(1) Clinical effectiveness comparison between two groups. (2) The mean onset time between two groups. (3) The cured numbers for different kinds of chronic urticaria.
No report.
Choi et al. 2012
12
12
Treatment group: 18.6 ± 8.4 years; control group: 14.2 ± 6.0 years old
Hanifin and Rajka criteria: diagnostic features of atopic dermatitis and dampness-heat pattern type of AD; SCORAD and EASI score
TJ-15 combined with TJ-17 versus TJ-15
4 weeks
5
(1) Change of SCORAD score. (2) Change of EASI score. (3) Clinical safety evaluated by laboratory index.
No report.
Lee et al. 2012
8
7
19–79 years; treatment group median age: 34 years; control group median age: 36 years
Male: 4 Female: 4
Male: 6 Female: 1
Single-center, randomized controlled trial
Atopic dermatitis
VAS scores, EASI scores, and IGA
Acupressure versus using any prescription or over-the-counter medications or lotions (except acupressure technique)
4 weeks
0
(1) Change in VAS between control and experimental groups. (2) Change in IGA score between control and experimental groups. (3) Change in EASI score between control and experimental groups.
No report.
Pfab et al. 2012
20
Mean age: 23.3 ± 1.7 years
Male: 6 Female: 14
A patient- and examiner-blinded, randomized, placebo-controlled, crossover trial
(1) Mean itch intensity. (2) Wheal and flare size. (3) Qualitative assessment of itch intensity (EIQ). (4) Mean attention scores. (5) Evaluation of blinding.
No report.
Wu et al. 2012
50
35
18–70 years
Male: 28 Female: 22
Male: 15 Female: 20
Randomized controlled trial
Atopic dermatitis
Clinical criteria of chronic urticaria comes from Clinical Dermatology
Yiqi Huoxue Qufeng decoction versus Fuyang granule
8 weeks
0
(1) The clinical effects comparison between two groups. (2) The DAO comparison between two groups. (3) The positive rate of IgE comparison between two groups.
No report.
Quan et al. 2014
30
30
Treatment group: 24.3 years; control group: 23.45 years
Male: 13 Female: 16
Male: 14 Female: 16
Randomized controlled trial
Atopic dermatitis
The western medicine diagnostic criteria and traditional Chinese medicine diagnosis standard; SCORAD scores
Flying needle combined with herbal medicine versus herbal medicine combined with regular skin-care
3 months
1
(1) The comparison of SCORAD scores. (2) Total effective rate. (3) Side effect.
No report.
Liu et al. 2015
250
5–25 years
Male: 107 Female: 143
Randomized controlled trial
Atopic dermatitis
The criteria of Hanifin and Rajka; SCORAD; QoL scores; self-assessment scores
PTQXT versus combination TCM therapy versus control group (mometasone furoate)
12 weeks
0
(1) Efficacy outcomes (SCORAD, QoL scores, self-assessment scores). (2) Adverse effects. (3) Test of blinding.
Slight diarrhoea.
Mehrbani et al. 2015
24
18
Treatment group: 28.62 ± 2.30 years; control group: 24.33 ± 1.50 years
Male: 4 Female: 20
Male: 2 Female: 16
A randomized, double-blind, placebo-controlled clinical trial
Moderate-to-severe atopic dermatitis
The criteria of Hanifin and Rajka
Dodder seed extract versus placebo
15 days
10
(1) Efficacy. (2) Safety profile.
Anorexia; mild gastrointestinal problems.
Yen and Hsieh 2016
16
17
Treatment group: years; control group: years
Male: 10 Female: 5
Male: 10 Female: 6
A preliminary, randomized, controlled, open-label study
Atopic dermatitis/ eczema
The criteria of Hanifin and Rajka; EASI scores and TIS scores
TYO (Tzu-Yun ointment) versus TS cream (topical steroid)
8 weeks
0
(1) Effect of TYO and TS cream on EASI and TIS scores in patients with eczema/atopic dermatitis. (2) Comparison between effects of TYO and TS cream on EASI and TIS scores in patients with eczema/atopic dermatitis.
No report.
Note. SCORAD: SCORing Atopic Dermatitis; CDLQI: Children’s Dermatology Life Quality Index; IISA: Intensity Item Score Aggregate; TCM: traditional Chinese medicine; SSRI: Symptom Score Reducing Index; EASI: Eczema Area and Severity Index; VAS: visual analogue scale; IGA: Investigator’s Global Assessment; EIQ: Eppendorf Itch Questionnaire; QoL: Quality of Life; PTQXT: Pei Tu Qing Xin Tang; TIS: Three-Item Severity.
