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Evaluation of an Oral Supplement

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  THERAPEUTIC HOTLINE Evaluation of an oral supplementcontaining   Phyllanthus emblica   fruitextracts,vitamin E,and carotenoids in vitiligo treatment Roberta Colucci ,  Federica Dragoni ,  Rossana Conti , Lisa Pisaneschi ,  Linda Lazzeri  &  Silvia Moretti Section of Dermatology, Department of Surgery and Translational Medicine,University of Florence, Florence, Italy   ABSTRACT:  Phyllanthus emblica , vitamin E, and caroteinods are compounds showing antioxidative,anti-inflammatory,andrepigmentingeffects,whoseroleinvitiligotreatmenthasnotbeenevaluatedsofar. Sixty-five subjects (group A) were treated with one tablet of an oral supplement containing  P. emblica  (100 mg), vitamin E (10 mg), and carotenoids (4.7 mg) three times/day for 6 months andcompared with a control group (group B, 65 patients), which instead was not treated with antioxidants.Bothgroupsweresimultaneouslytreatedwithacomparabletopicaltherapyand/orphototherapy.Aftera 6 months follow-up, a significantly higher number of patients in group A had a mild repigmentationon the head/neck regions ( p  = 0.019) and on the trunk (trend,  p  = 0.051). The number of patients whopresented no repigmentation in head/neck, trunk, upper, and lower limbs was significantly higher ingroup B (respectively,  p  = 0.009,  p  = 0.001,  p  = 0.001,  p  = 0.025). Moreover, group B patients showedhigher signs of inflammation ( p  = 0.002), a more rapid growth of the lesions ( p  = 0.039), a higherpercentage of worsening disease ( p  = 0.003), and more erythema ( p  = 0.059), whereas group A patientsshowed a higher percentage of steady disease ( p  = 0.065). Our results suggest that the supplement withantioxidantsinpatientswithvitiligomightrepresentavaluableinstrumenttoincreasetheeffectivenessof other vitiligo treatments. [Correction added after online publication 06-Oct-2014: the dosages of vitamin E and carotenoids have been updated.] KEYWORDS:  antioxidants, vitiligo Introduction  Vitiligo is a disease characterized by the appear-ance of depigmented macules, whose pathogen-esis is not completely understood yet (1). Varioustheories have been proposed (1) and among themthere is the autocytotoxic-metabolic theory, sug-gestingtheroleofanoxidativestressasthebasisof melanocyte disappearance (2). Several studieshave shown an impairment in redox system of skinand blood of vitiligo patients, thus resulting inreactive oxygen species (ROS) accumulation (2), whose levels could be also increased by the con-stant inflammatory milieu due to autoimmuneprocesses (3,4).The abovementioned theory suggests the possi-bility that antioxidants could be useful to reducethe oxidative stress and the consequent damage of   Address correspondence and reprint requests to: RobertaColucci, MD, Section of Dermatology, Department of Surgery and Translational Medicine, University of Florence, OspedalePiero Palagi, viale Michelangelo 41, 50125 Firenze, Italy, oremail: roberta.colucci21@gmail.com. 1 Dermatologic Therapy,Vol. ãã, 2014, ãã–ããPrinted in the United States · All rights reserved © 2014 Wiley Periodicals, Inc. DERMATOLOGIC THERAPY  ISSN 1396-0296   melanocyte, thus contributing to a possiblerepigmentation of the depigmented macules, assome studies demonstrated (5,6). Phyllanthus emblica  ( Emblica officinalis  ,Indian-gooseberry) is a tree whose fruit extractsshow antioxidative, anti-inflammatory, and repig-menting effects (7). Also, vitamin E and carote-noids have been reported to share with  P. emblica some similar beneficial properties (8,9). However,their possible role in vitiligo treatment has notbeen evaluated so far.The aim of our study was to assess the efficacy and tolerability of an oral supplement containing the abovementioned natural compounds in agroup of patients affected by nonsegmental vitiligoand subdued to conventional concomitant topicaltherapy or phototherapy. Materials and methods One hundred thirty patients affected by nonsegmental vitiligo who referred consecutively to our Florence University specialized vitiligo out-patient service, were examined from October 2012to July 2013.The study design has been approved by theEthical Board of the “Centro Studi del GruppoItaliano Studi Epidemiologici in Dermatologia(GISED)” and an informed consent was obtainedfrom each patient.Exclusion criteria were age  < 18 years, segmentalvitiligo, vitiligo duration  < 1 year, use of systemicimmunosuppressant drugs, smoke addiction,pregnancy, breastfeeding, new depigmentedpatches in the past 12 months, and vitiligo exten-sion higher than 20% of total body area.Concomitant vitiligo treatments, namely corticosteroids, vitamin D analogs, calcineurininhibitors, and narrow band UVB-light (NB-UVB)phototherapy/excimerlampwerealsoinvestigated.Medical assessment was performed using amodifiedVitiligo EuropeanTask Force form (10,11)independently by two dermatologists, whichevaluatedsomeclinicalaspectsofvitiligo(Table 1).Digital pictures under natural andWood’s light foreach patient were taken.Patients were subsequently divided into twogroups: group A, including subjects treated withoral antioxidants ( n  = 65) and group B, which werenot treated with antioxidants ( n  = 65). Group A patientstookonetabletofanoralsupplementcon-taining   P. emblica  (100 mg), vitamin E (4.7 mg),and carotenoids (10 mg) three times a day for 6months and were asked to stop the treatment incase of side effects. Both groups were treated at thesame time with a comparable topical therapy and/or phototherapy. After a 6-month follow-up, we evaluated thepercentage of repigmentation, vitiligo course(steady or worsening, if an appearance or anenlargement of macules was reported during the 6months of follow-up or not), emotional triggering/precipitating factors, presence and severity of ery-thema, tolerability, and possible side effects of theoral supplement.The percentage of repigmentation after treat-ment was classified for each body side as none Table 1.  General characteristics of patients at the baseline a Group A (65 patients) Group B (65 patients)Sex M: 25 F: 40 M: 29 F: 36 Years (mean and SD) Age 38.01  ±  19.69 (range 18–64) 36.2  ±  19.37 (range 18–61) Age at onset 29.16  ±  17.43 27.10  ±  19.27 Vitiligo duration 8.80  ±  9.36 6.61  ±  8.19Concomitant therapy Corticosteroids 61 (93.8%) 60 (92.30%)Calcineurin inhibitors 34 (52.3%) 32 (49.23%) Vitamin D analogs 26 (40%) 25 (38.46%)Phototherapy 28 (43.1%) 26 (40%)Percentage of body area involvedSigns of inflammation 13 (26.4%) 15 (23.1%)Total medium extension 6.1% (range 0.04–20.0%) 8.6% (range 0.03–18%)Medium extension: head and neck 0.73% 0.55%Medium extension: trunk 2.16% 1.80%Medium extension: upper limb 1.48% 1.87%Medium extension: lower limb 2.17% 2.01%Medium extension: hands 0.74% 0.60%Medium extension: feet 0.82% 0.48% a Only the features evaluated after repigmentation are reported. Colucci et al.  2   (0%), mild (1–25%), moderate (26–50%), good (51–75%), and excellent (76–100%) and was assessedindependently by two dermatologists blinded totreatment, through a clinical examination bothunder natural andWood’s light.The SPSS 15 program (SPSS, Inc., Chicago, IL,USA) was used for data recording and statisticalanalysis. Characteristics of the study population were described using mean, standard deviations,frequencies and percentages. Chi-square tests andFisher tests for categorical data and the Student’s t  -testforquantitativedatawereperformed.Results were considered significant for  p  values  ≤ 0.05;trend for 0.05  <  p  values  ≤ 0.07. Results One hundred thirty patients affected by vitiligo were enrolled and among them 10 patients did notcomplete the study because of personal matters.Patients’characteristicsaresummarizedinTable 1.Group A patients had a significant mildrepigmentation in the head and neck region ( p  =0.019)andonthetrunk(trend, p =0.051;Figs 1and2), a higher not significant repigmentation for eachbody site (with different degrees; Figs 1–2), andhigher steady disease ( p  = 0.065; Fig. 1).On the contrary, the number of patients withoutrepigmentationinheadandneck,trunk,upperandlowerlimbswashigheringroupB(respectively, p =0.009,  p  = 0.001,  p  = 0.001,  p  = 0.025) (Figs 1–2). Inthis group, we also found significant more signs of inflammation ( p  = 0.002), rapid growth of thelesions ( p  = 0.039), higher percentage of worsening disease ( p  = 0.003; Fig. 1) and erythema ( p  = 0.059;Fig. 1).The oral supplement was well tolerated by every patient and no side effect was recorded. Discussion In the present study, we demonstrate for the firsttime that a pool of oral supplements containing extracts of   P. emblica  fruit, vitamin E, andcarotenoids can be useful in vitiligo treatment.Indeed, only the positive role of oral supple-ments containing alpha-lipoic acid, vitamin C,vitamin E, polyunsaturated fatty acids, and Polypodium leucotomos   plant in vitiligo treatment was so far reported (5,6).The significant higher activity of the disease,signs of inflammation of the lesions, rapid growthof lesions in group B patients, together with anhigher frequency of steady disease in group A  FIG. 1.  Repigmentation obtained on each body side and summary of statistically significant parameters: a significantly highernumberofpatientsingroupAhadamildrepigmentationintheheadandneckregionsandonthetrunk.Thenumberofpatients who presented no repigmentation in head and neck,trunk,upper and lower limbs was significantly higher in group B.A higher(not significant) prevalence of repigmentation for each body site was found in group A, with different degrees, and a higherpercentageofsteadydiseasewerealsoreportedingroupApatients.GroupBpatientsshowedmoresignsofinflammation,rapidgrowth of the lesions,lower percentage of worsening disease and more erythema compared with Group A.  Antioxidants and vitiligo treatment  3  patients, might be explained by the markedanti-inflammatory, immunomodulatory, and anti-oxidative properties of   P. emblica  (7,12,13), whichcouldhavereducedtheoxidativestressresponsiblefor the recruitment of inflammatory cells and forthedestructionofmelanocytes(14).Indeed, invivo and  in vitro  studies demonstrated that this extractcan limit ROS production (12,13,15,16), stimulatethe endogenous enzymatic antioxidant defenses(12,13,15,16), and protect normal human dermalfibroblasts against UVB damages (13).Our finding also reported a significant less fre-quent phototherapy-induced erythema in patientsof group A. This event might be explained by theuse of carotenoids (8), which could have enhancedthe skin resistance to the erythematous action of UVB (8,17,18). Indeed, some studies demonstratedthat beta-carotenoids can prevent UVB-inducederythema(8),mostlywhenassociatedwithvitaminE (17) since the latter is able to reverse theUV-inducedlipidperoxidationandthusinflamma-tion (9). In addition, since ROS accumulation acti-vates immune system (4), we suppose that themarked antioxidative properties of   P. emblica might have contributed as well to limit the inflam-matory processes leading to the development of erythema.Finally, we suppose that the higher percentageof repigmentation in sun-exposed body regions ingroup A patients could be due to the action of carotenoids (18,19) that could have stimulated theprocessofrepigmentation(18,19)actinginsynergy  with the exposure to sunlight and with vitamin E(19). It has been demonstrated indeed that vitaminE can stimulate the growth of cultured humanmelanocytes when associated with vitamin C andbeta-carotenoids (19).In conclusion, we suggest that the componentsof this supplement can counteract the oxidativestressandtheinflammatoryprocessesoccurringinpatients with vitiligo, and possibly can interfere with the pathogenetic mechanisms of the disease.Our results are encouraging and promising,even if a multi-center, randomized, double-blindclinical trial is needed to confirm the beneficialeffects of the evaluated compounds in vitiligotreatment. Nevertheless, our findings suggest thatthe supplement with antioxidants in patients withvitiligo might represent a safe and valuable toolto increase the effectiveness of other vitiligotreatments.  Acknowledgements  We acknowledge Dr. Luigi Naldi (Centro Studi delGruppo Italiano Studi Epidemiologici inDermatologia) (GISED) for the critical revision of the manuscript. References 1. Alikhan A, Felsten LM, Daly M, Petronic-Rosic V. Vitiligo: acomprehensive overview. Part I. Introduction, epidemiol-ogy, quality of life, diagnosis, differential diagnosis, associa-tions, histopathology, etiology, and work-up. J Am AcadDermatol 2011:  65 : 473–491.2. Shallreuter KU, Bahadoran P, Picardo M, et al. Vitiligopathogenesis: autoimmune disease, genetic defect, exces-sive reactive oxygen species, calcium imbalance, or whatelse? Exp Dermatol 2008:  17 : 139–140, discussion 141–160.3. Taieb A. Vitiligo as an inflammatory skin disorder: a thera-peutic perspective. Pigment Cell Melanoma Res 2012:  25 :9–13.4. Colucci R, Böhm M, Moretti S. Commentary from the Edi-torial Board to Vitiligo: interplay between oxidative stress FIG. 2.  Pretreatment and posttreatment photographs of three group A patients.An improvement of vitiligo macules with signsof follicular repigmentation was visible after a 6 months follow-up on the hands (patients 1 and 2) and on the right hip (patient3) of patients treated with the oral supplement. Colucci et al. 4

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Sep 10, 2019
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