Vitamin E gel reduces time of healing of digital ulcers in systemic sclerosis.
BACKGROUND
In systemic sclerosis (SSc), digital ulcers (DU) are painful, difficult to heal and frequently infected, thus greatly affecting quality of life and increasing SSc-related disability. Vitamin E has been previously used in cutaneous lesions for its antioxidant and anti-inflammatory effects.


OBJECTIVE
To study the healing effect of D-alpha-tocopheryl acetate (acetic ester of alpha-tocopherol) (VE) gel on DU of SSc patients.


METHODS
27 SSc patients with a total of 86 DU were enrolled in an open pilot study. The patients were randomly assigned to two groups: 15 patients were treated until DU healing with the local standard ulcer care protocol with the application of vitamin E gel (experimental group), while 12 patients were treated with standard ulcer care protocol only (control group). In both groups, DU were treated twice a week and pain was scored by a NRS (numeric rating scale). In both groups the cost of medications was analysed.


RESULTS
VE induced a faster healing of DU in respect to controls (13.22+/-2.72 weeks, versus 20.94+/-3.65; p<0.0001) with a lower number of medications (26.18+/-5.63 vs. 41.88+/-7.31; p<0.0001). Resolution of pain was faster in experimental (17.82+/-4,59 medications) than in controls (26.26+/-19.16 medications) (p=0.0022). In the experimental group, the cost of medications was significantly lower (6,919.15 euros/patient) than in the control group (11,056.32 euros/patient).


CONCLUSIONS
The application of VE reduces time of healing and has a faster resolution of pain, with a significant reduction of costs. Topical VE may improve the management of DU in SSc.
Department of Biomedicine, Scleroderma Ulcer Care Unit, Division of Rheumatology, AOUC, University of Florence, Italy.
G
G
Fiori
F
F
Galluccio
F
F
Braschi
L
L
Amanzi
I
I
Miniati
M L
ML
Conforti
A
A
Del Rosso
S
S
Generini
A
A
Candelieri
A
A
Magonio
R
R
Goretti
L
L
Rasero
M
M
Matucci-Cerinic
D000287:Administration, Topical; D000975:Antioxidants / Q000008:administration & dosage / Q000627:therapeutic use*; D005260:Female; D005385:Fingers; D005782:Gels; D006801:Humans; D008297:Male; D008875:Middle Aged; D010146:Pain / Q000188:drug therapy / Q000209:etiology / Q000503:physiopathology; D010865:Pilot Projects; D012595:Scleroderma, Systemic / Q000150:complications / Q000188:drug therapy* / Q000503:physiopathology; D012720:Severity of Illness Index; D012867:Skin / Q000187:drug effects / Q000473:pathology; D012883:Skin Ulcer / Q000188:drug therapy* / Q000209:etiology / Q000503:physiopathology; D014810:Vitamin E / Q000008:administration & dosage / Q000627:therapeutic use*
D000975:Antioxidants; D005782:Gels; D014810:Vitamin E