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Table 2 Summary of Study Results

From: A systematic review of natural health product treatment for vitiligo

Study ID Year & Country Study Design JADAD score (0–5) N (n = total;
a = active;
c = control)
Dropouts Inclusion/Exclusion Criteria Intervention Main Outcome Measure Results
Akyol 2002 [32]
Turkey
controlled 0 n = 30
a = 15
c = 15
not reported Inclusion
patients with active, extensive & generalized vitiligo
14–60 years old
skin type II, III, IV
Active
PUVA + vit E (900 IU/day)
Control
PUVA 3x/wk, 315–400 nm emission spect increased by 20% up to erythema
Duration: 6 months
front and back total body photographs
pigmentation rated as:
- bad (0–25%)
- moderate (25–74%)
- good (75% or more)
PUVA + Vit E allowed good improvement in 60% of patients, with no significant oxidation.
Active
bad 3 (20%)
moderate 3 (20%)
good 9 (60%)
Control
bad 5 (33%)
moderate 4 (27%)
good 6 (40%)
Bedi 1989 [26]
India
placebo, controlled 0 n = 32
c = "self controlled" placebo for 1 month every 3 months
2 participants lost to follow up Inclusion
- male and female
- 6–42 years old
- methoxsalen tablets 10–20 mg QD + methoxsalen ointment/lotion-0.75% + P. kurroa rhizomes – 200 mg dried herb BID + exposure to sunlight
Duration: 36–1.8 months; 12.13 months average treatment length
response rated as:
- 4 = complete cure
- 3 = fast & continuous reduction in patches
- 2 = slow, continues reduction in patches
- 1 = v. slow progress
- 0 = 0 progress
93% responded to treatment, 27% achieved complete cure.
4 = 8/30
3 = 17/30
2 = 2/30
1 = 3/30
 
Cheng 1987 [23]
China
randomized, controlled 1 n = 329
A: 16 = needle
B: 9 = medication
C: 5 = phototherapy
D: 128 = needle + medication
E: 61 = needle + medication + suntan
F: 110 = needle + medication + phototherapy
not reported not reported - needle = 1 g/2 ml bottle, injected 2–4 mL QD
- medication = 235 used "Vitiligo medication"; 48 used 8-MOP; 25 used "vitiligo cream"; rest prescribed egg yolk before suntan or phototherapy
- suntan = mid-May to end of Sept whole body naked suntan, 1–3 hr per day, 8–10 am, or 4–6 pm
- phototherapy = long wave phototherapy, every 2–3 days 5–25 cm2 or 1–10% of body surface
response rated as:
- excellent = color of lesion turns to normal
- very good = color of lesion turns normal for over 60% of body surface
- good = lesion gets smaller and appearance of black granules
- bad = lesion identical to that before the treatment
Treatment with suntan effective after 60 days.
Group A:
2 = excellent
5 = very good
9 = good
Group B
1 = excellent
2 = very good
6 = good
Group C
4 = good
1 = bad
Group F
16 = excellent
35 = very good
58 = good
1 = bad
109 = overall good result
Group D
8 = excellent
37 = very good
79 = good
4 = bad
124 = overall good result
Group E
12 = excellent
26 = very good
23 = good
61 = overall good result
Cormane 1985 [20]
Netherlands
controlled by run in over 4 months 0 n = 19 not reported Inclusion
- male and female
- generalized vitiligo
- above 18 years old
Exclusion
- past spontaneous improvement
- CI to phenylalanine
l-phe 50 mg/kg after a low protein breakfast + UVA 2x/wk
Duration: 6–8 months
Controlled by run in with l-phe 50 mg/kg 2x/wk for 4 months
repigmentation was classified as dense, sparse or none Repigmentation achieved in 94.7% of patients.
dense repigmentation in 26.3% (5 pts)
sparse 68.4% (13 pts)
none 5.2 (1 pt)
 
Jin 1983 [25]
China
randomized, controlled 1 n = 232
A: n = 100
B: n = 51
C: n = 52
D: n = 28
not reported not reported A: Chinese Herb/Medicine 1
Ingredients: multi herb formula
B: Corticoids
15 mg per day, oral (if effective decrease 5 mg every 2–4 weeks)
C: Chinese Herb/Medicine 2 + Corticoids
Ingredients different from Chinese Herb/Medicine 1* Group A,B,C also applies 30% Psoralen topically
D: Control
apply 30% Psoralen topically
Duration: 2 months
response rated as:
- Excellent = all lesions disappear, normal skin color reappears
- Very good = reduction in lesion, >60% of damaged skin surface regains normal skin color
- Good = reduction in lesion, 10–60% of damaged skin surface regains normal skin color
- Bad = lesion shows no change in appearance or size, <10% of damaged skin surface regains normal skin color
Chinese medicine 2 & corticoids provided the best treatment.
Group A
13% = excellent
17% = very good
34% = good
36% = bad
Group C
31% = excellent
14% = very good
28% = good
27% = bad
Group B
18% = excellent
13% = very good
29% = good
40% = bad
Group D
0% = excellent
6% = very good
27% = good
67% = bad
Khemis 2004 [30]
France
randomized, double blind 2 n = 30
self controlled by contralateral side
13 dropped out Inclusion
participants with 2 vitiliginous lesions each with at least 10 cm in diameter
Exclusion
unstable vitiligo
Active
Vitix + UVB
Control
Placebo + UVB
primary:
- reduction of lesion surface area by 50%
- photographs under normal and Woods Lamp
The difference between control and active was not significant
4 participants did not repigment
4 participants received a reduction
6 achieved a reduction of more than 50% of lesion with Vitix and UVB but not with control
3 achieved had a reduction of more than 50% of lesion with control but not with Vitix and UVB.
 
Liu 2003 [24]
China
randomized, controlled 1 n = 74
a = 41
c = 33
not reported not reported Active
- Xiaobai mixture orally (30 g walnut, 10 g red flower, 30 g black sesame, 30 g black beans, 10 g zhi bei fu ping, 10 g lu lu tong, 5 plums)1 mL is equivalent to 0.1 g raw medication, 160 mL once a day
Control
- 10 mg 8-MOP TID
Duration: 3 months
repigmentation rated as:
- Excellent = normal skin color reappears
- Very good = >50% of damaged skin surface regains normal skin color
- Good = 10–50% of damaged skin surface regains normal skin color
- Bad = <10% of damaged skin surface regains normal skin color
95% of active and 79% of control group showed good results.
Active
- 12 = excellent results
- 16 = very good results
- 11 = good results
- 2 = bad results
- Overall 95.12% showed good results
Control
- 3 = excellent results
- 14 = very good results
- 9 = good results
- 7 = bad results
 
Middelkamp-Hup 2007 [28]
Netherlands
placebo controlled, randomized, double blind 5 n = 50
a = 25
c = 24
1 lost to follow up at last session Inclusion
- 18 years and older
- vitiligo vulgaris
Exclusion
- history of skin cancer
- photosensitive
- pregnancy or lactation
- segmental vitiligo
- phototherapy 3 months prior
- use of topical treatments
- starting vitamins during the study
Active
Polypodium leucotomos 250 mg TID + NB-UVB 2x/wk (210–360 j/cm2 at start & gradually increased)
Control
placebo TID + NB-UVB
Duration: 25–26 weeks
severity of vitiligo rated as:
- very severe
- severe
- more severe
- less severe
- not so severe
secondary measures:
- digital photography of all vitiligo lesions
- patient self assessment scale 0–10
- monitored at w0, w6, w12, w26
- for quality of life used skin index-29
Clear trend toward increase in repigmentation in head and neck area with NB-UVB and oral P. leucotomos treatment.
Percent Repigmentation :
Head & Neck
active = 44%
control = 27%
Extremities
active = 30%
control = 26%
Trunk
active = 36%
control = 30%
Hands and Feet
active = 24%
control = 19%
Parsad 2003 [2]
India
randomized, placebo controlled, double blind 2 n = 52
a = 26
c = 26
1 active
2 control
"withdrew for reasons unrelated to the study"
Inclusion
gradually progressive slow spreading vitiligo
Exclusion
more than 3 lesions or surface area of depigmentation greater than 10 cm2 over last 1 month
Active
40 mg Ginkgo biloba with 9.6 mg ginkgoflavone glycosides, TID
Control
sugar capsule TID
Duration: 6 months
- photographs at 6-weekly intervals
- repigmentation judged as minimal (25%), moderate (50%), marked (75%), complete (100%)- degree of repigmentation was determined by comparison of paper tracings, written descriptions, and actual measurement of vitiliginous areas
Gingko biloba was significantly more effective.
Active
-20 pts stopped progression of disease (out of 25)
- 10 pts showed marked to complete repigmentation (75–100%) (out of 25)
Control
- 8 pts arrested progression of disease (out of 22)
- 2 pts showed marked to complete repigmentation (75–100%) (out of 22)
 
Rojas-Urdaneta 2007 [22]
Venezuela
randomized, double blind 3 n = 100
divided into 5 groups
all completed the study Inclusion
- stable vulgar vitiligo
- no treatment for 5 months before study
- 18 to 50 years old
- male or female
- no other pathology
- provided consent for study and treatment
Exclusion
- concomitant disease
- treatment of vitiligo 5 months prior to study
- not complying with instructions
A: antioxidant and mitochondrial stimulating cream & oral antioxidants & phenylalanine
B: placebo cream and oral antioxidants and phenylalanine
C: oral administration of antioxidants and phenylalanine
D: placebo cream
E: antioxidant and mitochondrial stimulating cream
cream = VitilVenz
phenylalanine = 500 mg q12 hrs for 5 months
oral antioxidants = Vit A 20,000 IU
Vit C 1000 mg
Vit E 400 IU
Zinc 15 mg
Selenium 50 μg
Magnesium 2 mg
CoQ10 75 mcg
pygnogenol 1 mg
main outcome measures:
- clinical area of newly formed pigment every 30 days
- point system for classifying size
- histological presence of melanocytes at beginning and end
The use of antioxidant and mitochondrial cream, and oral antioxidants and phenylalanine provided best results.
group A
- best results, 10.4 points (p < 0.001)
group E
- second best results 9.77 points (p < 0.001)
group B, C
- 4 points (p < 0.05)
group D
- comparison placebo group
 
Siddiqui 1994 trial 1 [21]
Netherlands
randomized, controlled, open label 0 n = 149
A: no tx = 11
B: l-phe +UVA = 132
C: l-phe alone = 6
out of 132 l-phe + UVA, 60 dropped out because they were unable to attend every 3 months for evaluations) Inclusion
- disseminated vitiligo over 10–40% of body
- age 18–61 yrs
Exclusion
- only distal vitiligo
- only acrofacial vitiligo
- contraindications (same as Carmane 1985)
- patients in the open trial were not enrolled in the blind trial
A: l-phe 50–100 mg/kg + UVA 2x/wk; 30–45 min after l-phe ingestion daily
B: l-phe 100 mg alone
C: no tx
Duration: 1.5 yrs
length & width measures + color photographs every 3 months
Repigmentation Classification:
- partial 25–40%
- incomplete 40–60%
- good 60–80%
L-phenylalanine + UVB provided better results than L-phenylalanine alone.
Group A
positive 94
stable 20
deterioration 18
n = 132
Group C
positive 0
stable 7
deterioration 4
n = 11
Group B
positive 0
stable 5
deterioration 1
n = 6
Siddiqui 1994 trial 2 [21]
Netherlands
placebo controlled, randomized, double blind 3 n = 32 5 in placebo
3 active (2 stopped for personal reasons)
Inclusion
18–56 years old
vitiligo for 1–33 years
l-phe 100 mg/kg/day or placebo
UVA 2–3x/wk or no irradiation
Duration: 6 months
length and width measured + color photographs every 3 months
Repigmentation Classification:
- partial 25–40%
- incomplete 40–60%
- good 60–80%
L-phenylalanine + UVB provided best results.
l-phe + UVA
positive 6
stable 1
deterioration 1
% repigmentation 30–60
n = 8
dropouts 0
l-phe
positive 1
stable 3
deterioration 1
% repig 25
n = 5
dropouts 3
placebo + UVA
positive 0
stable 4
deterioration 2
% repig 0
n = 6
dropouts 2
placebo
positive 0
stable 3
deterioration 2
% repig 0
n = 5
dropouts 3
Tjioe 2002 [31]
Sweden
randomized, open label, controlled 2 n = 27
a = 14
c = 13
1 active and 1 control did not repigment more than 5% after 4 months and were advised to stop Inclusion
- male & female over 18 yrs
- stable vitiligo vulgaris (1 year with no changes)
- fitzpatrick's skin II – IV
Exclusion
- other vitiligo treatment
- history of skin cancer
- on photosensitizing medications
- Psychiatric/epileptic disorders
- renal failure or allergies to substances in trial
Active
- UVB 3x/wk
- oral cobalamin 1000 ug sustained release BID
- folic acid 5 mg BID
Control
- UVB (311 nm) 3x/wk, started at 0.10 J/cm2 increased by 0–30% on individual basis
Duration: 12 months
primary:
visually scored as percentage of repigmentation of depigmented lesions primary criterion were areas showing most active repigmentation
secondary:
before and after photographs with % repigmentation visually estimated
No significant difference between the two groups.
25 out of 27 total showed prominent repigmentation in some areas, 1 in each group did not respond more than 5%
 
Valkova 2004 [27]
Bulgaria
controlled
(group assignment by alternation)
0 n = 33
a = 16
c = 17
not reported Inclusion
-vitiligo
- male & female and 8 kids
- age 6–59 (mean 24.3 years)
- photo-type II-IV
- 2–21 years of disease
Active
- local KUVA
- 5% khellin in water/oil applied to lesion area
- 1 hr later – UVA – 2–2.5 j/cm2
Control
- systemic PUVA
- oral psoralen (0.4 mg/kg)
- 2 hrs later-UVA – 1–1.5 j/cm2
- 3x/wk
Duration: 4.1 months
- % of repigmentation measured by planimetry (actual measurement)- % repigmentation according to rule of three Both KUVA and PUVA treatment lead to similar results, but KUVA is local, therefore with potentially with less adverse events.
active n
90–100% 3(18.8%)
60–80% 4(25.0%)
20–50% 7(56.2%)
no effect 2
Signs of repigmentation appeared between 10–16 procedures
control n
90–100% 2 (11.8%)
60–80% 7 (41.2%)
20–50% 7 (41.2%)
no effect 1
anonymous 2006 [29]
Japan
randomized,
double blind
0 n = 19
a = 10
c = 9
not reported Inclusion
generalized vitiligo
Exclusion
acral or segmental vitiligo
Active
PUVA + Polypodium leucotomos
Control
PUVA + placebo
Duration: 12 wks
repigmentation scored as:
- none or minimal (<25% repigmentation)
- mild (25–50%)
- moderate to excellent (>50%)
Percentage of patients with skin repig. greater than 50% was significantly higher in PUVA + Polypodium
active
none = 2
mild = 3
moderate = 5
Control
none = 5
mild = 4
moderate = 0