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1.  Ultraviolet Phototherapy Management of Moderate-to-Severe Plaque Psoriasis 
Executive Summary
Objective
The purpose of this evidence based analysis was to determine the effectiveness and safety of ultraviolet phototherapy for moderate-to-severe plaque psoriasis.
Research Questions
The specific research questions for the evidence review were as follows:
What is the safety of ultraviolet phototherapy for moderate-to-severe plaque psoriasis?
What is the effectiveness of ultraviolet phototherapy for moderate-to-severe plaque psoriasis?
Clinical Need: Target Population and Condition
Psoriasis is a common chronic, systemic inflammatory disease affecting the skin, nails and occasionally the joints and has a lifelong waning and waxing course. It has a worldwide occurrence with a prevalence of at least 2% of the general population, making it one of the most common systemic inflammatory diseases. The immune-mediated disease has several clinical presentations with the most common (85% - 90%) being plaque psoriasis.
Characteristic features of psoriasis include scaling, redness, and elevation of the skin. Patients with psoriasis may also present with a range of disabling symptoms such as pruritus (itching), pain, bleeding, or burning associated with plaque lesions and up to 30% are classified as having moderate-to-severe disease. Further, some psoriasis patients can be complex medical cases in which diabetes, inflammatory bowel disease, and hypertension are more likely to be present than in control populations and 10% also suffer from arthritis (psoriatic arthritis). The etiology of psoriasis is unknown but is thought to result from complex interactions between the environment and predisposing genes.
Management of psoriasis is related to the extent of the skin involvement, although its presence on the hands, feet, face or genitalia can present challenges. Moderate-to-severe psoriasis is managed by phototherapy and a range of systemic agents including traditional immunosuppressants such as methotrexate and cyclospsorin. Treatment with modern immunosuppressant agents known as biologicals, which more specifically target the immune defects of the disease, is usually reserved for patients with contraindications and those failing or unresponsive to treatments with traditional immunosuppressants or phototherapy.
Treatment plans are based on a long-term approach to managing the disease, patient’s expectations, individual responses and risk of complications. The treatment goals are several fold but primarily to:
1) improve physical signs and secondary psychological effects,
2) reduce inflammation and control skin shedding,
3) control physical signs as long as possible, and to
4) avoid factors that can aggravate the condition.
Approaches are generally individualized because of the variable presentation, quality of life implications, co-existent medical conditions, and triggering factors (e.g. stress, infections and medications). Individual responses and commitments to therapy also present possible limitations.
Phototherapy
Ultraviolet phototherapy units have been licensed since February 1993 as a class 2 device in Canada. Units are available as hand held devices, hand and foot devices, full-body panel, and booth styles for institutional and home use. Units are also available with a range of ultraviolet A, broad and narrow band ultraviolet B (BB-UVB and NB-UVB) lamps. After establishing appropriate ultraviolet doses, three-times weekly treatment schedules for 20 to 25 treatments are generally needed to control symptoms.
Evidence-Based Analysis Methods
The literature search strategy employed keywords and subject headings to capture the concepts of 1) phototherapy and 2) psoriasis. The search involved runs in the following databases: Ovid MEDLINE (1996 to March Week 3 2009), OVID MEDLINE In-Process and Other Non-Indexed Citations, EMBASE (1980 to 2009 Week 13), the Wiley Cochrane Library, and the Centre for Reviews and Dissemination/International Agency for Health Technology Assessment. Parallel search strategies were developed for the remaining databases. Search results were limited to human and English-language published between January 1999 and March 31, 2009. Search alerts were generated and reviewed for relevant literature up until May 31, 2009.
English language reports and human studies
Ultraviolet phototherapy interventions for plaque-type psoriasis
Reports involving efficacy and/or safety outcome studies
Original reports with defined study methodology
Standardized measurements on outcome events such as technical success, safety, effectiveness, durability, quality of life or patient satisfaction
Non-systematic reviews, letters, comments and editorials
Randomized trials involving side-to-side or half body comparisons
Randomized trials not involving ultraviolet phototherapy intervention for plaque-type psoriasis
Trials involving dosing studies, pilot feasibility studies or lacking control groups
Summary of Findings
A 2000 health technology evidence report on the overall management of psoriasis by The National Institute Health Research (NIHR) Health Technology Assessment Program of the UK was identified in the MAS evidence-based review. The report included 109 RCT studies published between 1966 and June 1999 involving four major treatment approaches – 51 on phototherapy, 32 on oral retinoids, 18 on cyclosporin and five on fumarates.. The absence of RCTs on methotrexate was noted as original studies with this agent had been performed prior to 1966.
Of the 51 RCT studies involving phototherapy, 22 involved UVA, 21 involved UVB, five involved both UVA and UVB and three involved natural light as a source of UV. The RCT studies included comparisons of treatment schedules, ultraviolet source, addition of adjuvant therapies, and comparisons between phototherapy and topical treatment schedules. Because of heterogeneity, no synthesis or meta-analysis could be performed. Overall, the reviewers concluded that the efficacy of only five therapies could be supported from the RCT-based evidence review: photochemotherapy or phototherapy, cyclosporin, systemic retinoids, combination topical vitamin D3 analogues (calcipotriol) and corticosteroids in combination with phototherapy and fumarates. Although there was no RCT evidence supporting methotrexate, it’s efficacy for psoriasis is well known and it continues to be a treatment mainstay.
The conclusion of the NIHR evidence review was that both photochemotherapy and phototherapy were effective treatments for clearing psoriasis, although their comparative effectiveness was unknown. Despite the conclusions on efficacy, a number of issues were identified in the evidence review and several areas for future research were discussed to address these limitations. Trials focusing on comparative effectiveness, either between ultraviolet sources or between classes of treatment such as methotrexate versus phototherapy, were recommended to refine treatment algorithms. The need for better assessment of cost-effectiveness of therapies to consider systemic drug costs and costs of surveillance, as well as drug efficacy, were also noted. Overall, the authors concluded that phototherapy and photochemotherapy had important roles in psoriasis management and were standard therapeutic options for psoriasis offered in dermatology practices.
The MAS evidence-based review focusing on the RCT trial evidence for ultraviolet phototherapy management of moderate-to-severe plaque psoriasis was performed as an update to the NIHR 2000 systemic review on treatments for severe psoriasis. In this review, an additional 26 RCT reports examining phototherapy or photochemotherapy for psoriasis were identified. Among the studies were two RCTs comparing ultraviolet wavelength sources, five RCTs comparing different forms of phototherapy, four RCTs combining phototherapy with prior spa saline bathing, nine RCTs combining phototherapy with topical agents, two RCTs combining phototherapy with the systemic immunosuppressive agents methotrexate or alefacept, one RCT comparing phototherapy with an additional light source (the excimer laser), and one comparing a combination therapy with phototherapy and psychological intervention involving simultaneous audiotape sessions on mindfulness and stress reduction. Two trials also examined the effect of treatment setting on effectiveness of phototherapy, one on inpatient versus outpatient therapy and one on outpatient clinic versus home-based phototherapy.
Conclusions
The conclusions of the MAS evidence-based review are outlined in Table ES1. In summary, phototherapy provides good control of clinical symptoms in the short term for patients with moderate-to-severe plaque-type psoriasis that have failed or are unresponsive to management with topical agents. However, many of the evidence gaps identified in the NIHR 2000 evidence review on psoriasis management persisted. In particular, the lack of evidence on the comparative effectiveness and/or cost-effectiveness between the major treatment options for moderate-to-severe psoriasis remained. The evidence on effectiveness and safety of longer term strategies for disease management has also not been addressed. Evidence for the safety, effectiveness, or cost-effectiveness of phototherapy delivered in various settings is emerging but is limited. In addition, because all available treatments for psoriasis – a disease with a high prevalence, chronicity, and cost – are palliative rather than curative, strategies for disease control and improvements in self-efficacy employed in other chronic disease management strategies should be investigated.
RCT Evidence for Ultraviolet Phototherapy Treatment of Moderate-To-Severe Plaque Psoriasis
Phototherapy is an effective treatment for moderate-to-severe plaque psoriasis
Narrow band PT is more effective than broad band PT for moderate-to-severe plaque psoriasis
Oral-PUVA has a greater clinical response, requires less treatments and has a greater cumulative UV irradiation dose than UVB to achieve treatment effects for moderate-to-severe plaque psoriasis
Spa salt water baths prior to phototherapy did increase short term clinical response of moderate-to-severe plaque psoriasis but did not decrease cumulative UV irradiation dose
Addition of topical agents (vitamin D3 calcipotriol) to NB-UVB did not increase mean clinical response or decrease treatments or cumulative UV irradiation dose
Methotrexate prior to NB-UVB in high need psoriasis patients did significantly increase clinical response, decrease number of treatment sessions and decrease cumulative UV irradiation dose
Phototherapy following alefacept did increase early clinical response in moderate-to-severe plaque psoriasis
Effectiveness and safety of home NB-UVB phototherapy was not inferior to NB-UVB phototherapy provided in a clinic to patients with psoriasis referred for phototherapy. Treatment burden was lower and patient satisfaction was higher with home therapy and patients in both groups preferred future phototherapy treatments at home
Ontario Health System Considerations
A 2006 survey of ultraviolet phototherapy services in Canada identified 26 phototherapy clinics in Ontario for a population of over 12 million. At that time, there were 177 dermatologists and 50 geographic regions in which 28% (14/50) provided phototherapy services. The majority of the phototherapy services were reported to be located in densely populated areas; relatively few patients living in rural communities had access to these services. The inconvenience of multiple weekly visits for optimal phototherapy treatment effects poses additional burdens to those with travel difficulties related to health, job, or family-related responsibilities.
Physician OHIP billing for phototherapy services totaled 117,216 billings in 2007, representing approximately 1,800 patients in the province treated in private clinics. The number of patients treated in hospitals is difficult to estimate as physician costs are not billed directly to OHIP in this setting. Instead, phototherapy units and services provided in hospitals are funded by hospitals’ global budgets. Some hospitals in the province, however, have divested their phototherapy services, so the number of phototherapy clinics and their total capacity is currently unknown.
Technological advances have enabled changes in phototherapy treatment regimens from lengthy hospital inpatient stays to outpatient clinic visits and, more recently, to an at-home basis. When combined with a telemedicine follow-up, home phototherapy may provide an alternative strategy for improved access to service and follow-up care, particularly for those with geographic or mobility barriers. Safety and effectiveness have, however, so far been evaluated for only one phototherapy home-based delivery model. Alternate care models and settings could potentially increase service options and access, but the broader consequences of the varying cost structures and incentives that either increase or decrease phototherapy services are unknown.
Economic Analyses
The focus of the current economic analysis was to characterize the costs associated with the provision of NB-UVB phototherapy for plaque-type, moderate-to-severe psoriasis in different clinical settings, including home therapy. A literature review was conducted and no cost-effectiveness (cost-utility) economic analyses were published in this area.
Hospital, Clinic, and Home Costs of Phototherapy
Costs for NB-UVB phototherapy were based on consultations with equipment manufacturers and dermatologists. Device costs applicable to the provision of NB-UVB phototherapy in hospitals, private clinics and at a patient’s home were estimated. These costs included capital costs of purchasing NB-UVB devices (amortized over 15-20 years), maintenance costs of replacing equipment bulbs, physician costs of phototherapy treatment in private clinics ($7.85 per phototherapy treatment), and medication and laboratory costs associated with treatment of moderate-to-severe psoriasis.
NB-UVB phototherapy services provided in a hospital setting were paid for by hospitals directly. Phototherapy services in private clinic and home settings were paid for by the clinic and patient, respectively, except for physician services covered by OHIP. Indirect funding was provided to hospitals as part of global budgeting and resource allocation. Home therapy services for NB-UVB phototherapy were not covered by the MOHLTC. Coverage for home-based phototherapy however, was in some cases provided by third party insurers.
Device costs for NB-UVB phototherapy were estimated for two types of phototherapy units: a “booth unit” consisting of 48 bulbs used in hospitals and clinics, and a “panel unit” consisting of 10 bulbs for home use. The device costs of the booth and panel units were estimated at approximately $18,600 and $2,900, respectively; simple amortization over 15 and 20 years implied yearly costs of approximately $2,500 and $150, respectively. Replacement cost for individual bulbs was about $120 resulting in total annual cost of maintenance of about $8,640 and $120 for booth and panel units, respectively.
Estimated Total Costs for Ontario
Average annual cost per patient for NB-UVB phototherapy provided in the hospital, private clinic or at home was estimated to be $292, $810 and $365 respectively. For comparison purposes, treatment of moderate-to-severe psoriasis with methotrexate and cyclosporin amounted to $712 and $3,407 annually per patient respectively; yearly costs for biological drugs were estimated to be $18,700 for alefacept and $20,300 for etanercept-based treatments.
Total annual costs of NB-UVB phototherapy were estimated by applying average costs to an estimated proportion of the population (age 18 or older) eligible for phototherapy treatment. The prevalence of psoriasis was estimated to be approximately 2% of the population, of which about 85% was of plaque-type psoriasis and approximately 20% to 30% was considered moderate-to-severe in disease severity. An estimate of 25% for moderate-to-severe psoriasis cases was used in the current economic analysis resulting in a range of 29,400 to 44,200 cases. Approximately 21% of these patients were estimated to be using NB-UVB phototherapy for treatment resulting in a number of cases in the range between 6,200 and 9,300 cases. The average (7,700) number of cases was used to calculate associated costs for Ontario by treatment setting.
Total annual costs were as follows: $2.3 million in a hospital setting, $6.3 million in a private clinic setting, and $2.8 million for home phototherapy. Costs for phototherapy services provided in private clinics were greater ($810 per patient annually; total of $6.3 million annually) and differed from the same services provided in the hospital setting only in terms of additional physician costs associated with phototherapy OHIP fees.
Keywords
Psoriasis, ultraviolet radiation, phototherapy, photochemotherapy, NB-UVB, BB-UVB PUVA
PMCID: PMC3377497  PMID: 23074532
2.  Ginkgo biloba for the treatment of vitilgo vulgaris: an open label pilot clinical trial 
Background
Vitiligo is a common hypopigmentation disorder with significant psychological impact if occurring before adulthood. A pilot clinical trial to determine the feasibility of an RCT was conducted and is reported here.
Methods
12 participants 12 to 35 years old were recruited to a prospective open-label pilot trial and treated with 60 mg of standardized G. biloba two times per day for 12 weeks. The criteria for feasibility included successful recruitment, 75% or greater retention, effectiveness and lack of serious adverse reactions. Effectiveness was assessed using the Vitiligo Area Scoring Index (VASI) and the Vitiligo European Task Force (VETF), which are validated outcome measures evaluating the area and intensity of depigmentation of vitiligo lesions. Other outcomes included photographs and adverse reactions. Safety was assessed by serum coagulation factors (platelets, PTT, INR) at baseline and week 12.
Results
After 2 months of recruitment, the eligible upper age limit was raised from 18 to 35 years of age in order to facilitate recruitment of the required sample size. Eleven participants completed the trial with 85% or greater adherence to the protocol. The total VASI score improved by 0.5 (P = 0.021) from 5.0 to 4.5, range of scale 0 (no depigmentation) to 100 (completely depigmented). The progression of vitiligo stopped in all participants; the total VASI indicated an average repigmentation of vitiligo lesions of 15%. VETF total vitiligo lesion area decreased 0.4% (P = 0.102) from 5.9 to 5.6 from baseline to week 12. VETF staging score improved by 0.7 (P = 0.101) from 6.6 to 5.8, and the VETF spreading score improved by 3.9 (P < 0.001)) from 2.7 to -1.2. There were no statistically significant changes in platelet count, PTT, or INR.
Conclusions
The criteria for feasibility were met after increasing the maximum age limit of the successful recruitment criterion; participant retention, safety and effectiveness criteria were also met. Ingestion of 60 mg of Ginkgo biloba BID was associated with a significant improvement in total VASI vitiligo measures and VETF spread, and a trend towards improvement on VETF measures of vitiligo lesion area and staging. Larger, randomized double-blind clinical studies are warranted and appear feasible.
Trial Registration
Clinical trials.gov registration number NCT00907062
doi:10.1186/1472-6882-11-21
PMCID: PMC3065445  PMID: 21406109
3.  Vitiligo in adults and children 
Clinical Evidence  2008;2008:1717.
Introduction
Vitiligo is an acquired skin disorder characterised by white (depigmented) patches in the skin, due to the loss of functioning melanocytes. The extent and distribution of vitiligo often changes during the course of a person's lifetime and its progression is unpredictable.
Methods and outcomes
We conducted a systematic review and aimed to answer the following clinical questions: What are the effects of medical treatments, and of ultraviolet light treatments, for vitiligo in children and in adults? We searched: Medline, Embase, The Cochrane Library and other important databases up to March 2007 (BMJ Clinical Evidence reviews are updated periodically, please check our website for the most up-to-date version of this review). We included harms alerts from relevant organisations such as the US Food and Drug Administration (FDA) and the UK Medicines and Healthcare products Regulatory Agency (MHRA).
Results
We found 25 systematic reviews, RCTs, or observational studies that met our inclusion criteria. We performed a GRADE evaluation of the quality of evidence for interventions.
Conclusions
In this systematic review we present information relating to the effectiveness and safety of the following interventions: corticosteroids, oral levamisole, topical immunomodulators, topical Vitamin D analogues, ultraviolet A plus psoralen (PUVA), and ultraviolet B (narrowband, and broadband).
Key Points
Vitiligo is an acquired skin disorder characterised by white (depigmented) patches in the skin, caused by the loss of functioning melanocytes. Vitiligo patches can appear anywhere on the skin, but common sites are usually around the orifices, the genitals, or sun-exposed areas such as the face and hands.The extent and distribution of vitiligo often changes during the course of a person's lifetime, and its progression is unpredictable.
Limited courses of potent topical corticosteroids are a safe and effective therapy for localised vitiligo and are often the first-choice treatment for this. The consensus is that adverse effects of oral corticosteroids outweigh the benefits in vitiligo. There is currently insufficient evidence available to assess their effectiveness.
Narrowband UVB is considered a safe and effective therapy for moderate to severe generalised vitiligo and is often the first-choice treatment for this.
Tacrolimus requires further evaluation, but is well tolerated in children and adults without the long-term adverse effects of topical corticosteroids. There is currently insufficient evidence available to assess other immunomodulators in vitiligo.
Vitiligo patches in certain body areas, such as the acral sites, palms and soles, lips, mucosa, and nipples, and segmental forms in any area are relatively resistant to all conventional treatment modalities. In these cases, counselling and cosmetic camouflage become a priority, and often no treatments are advocated.
There is insufficient evidence to assess topical vitamin D analogues, levamisole, and broadband UVB in vitiligo.
Consensus is that for the treatment of vitiligo in adults, oral PUVA is effective, whereas topical PUVA is unlikely to be effective. However, topical PUVA has fewer adverse effects than oral PUVA. PUVA is likely to be harmful in children.
PMCID: PMC2907927  PMID: 19450313
4.  Vitiligo in adults and children 
Clinical Evidence  2011;2011:1717.
Introduction
Vitiligo is an acquired skin disorder characterised by white (depigmented) patches in the skin, due to the loss of functioning melanocytes. The extent and distribution of vitiligo often changes during the course of a person's lifetime and its progression is unpredictable.
Methods and outcomes
We conducted a systematic review and aimed to answer the following clinical questions: What are the effects of medical treatments, and of ultraviolet light treatments, for vitiligo in adults and in children? We searched: Medline, Embase, The Cochrane Library, and other important databases up to March 2010 (Clinical Evidence reviews are updated periodically, please check our website for the most up-to-date version of this review). We included harms alerts from relevant organisations such as the US Food and Drug Administration (FDA) and the UK Medicines and Healthcare products Regulatory Agency (MHRA).
Results
We found 25 systematic reviews, RCTs, or observational studies that met our inclusion criteria. We performed a GRADE evaluation of the quality of evidence for interventions.
Conclusions
In this systematic review we present information relating to the effectiveness and safety of the following interventions: corticosteroids (oral and topical), oral levamisole, topical immunomodulators, topical vitamin D analogues, ultraviolet A plus psoralen (PUVA [oral or topical]), and ultraviolet B (narrowband).
Key Points
Vitiligo is an acquired skin disorder characterised by white (depigmented) patches in the skin, caused by the loss of functioning melanocytes. Vitiligo patches can appear anywhere on the skin, but common sites are usually around the orifices, the genitals, or sun-exposed areas such as the face and hands.The extent and distribution of vitiligo often changes during the course of a person's lifetime, and its progression is unpredictable.
Limited courses of potent topical corticosteroids in adults and children are a safe and effective therapy for localised vitiligo and are often the first-choice treatment for this disorder. The consensus is that adverse effects of oral corticosteroids in adults and children outweigh the benefits in vitiligo. There is currently insufficient RCT evidence available to assess their effectiveness.
Narrowband ultraviolet B in adults and children is considered a safe and effective therapy for moderate to severe generalised vitiligo and is often the first-choice treatment for this disorder.
Tacrolimus requires further evaluation, but is well tolerated in children and adults without the long-term adverse effects of topical corticosteroids. There is currently insufficient RCT evidence available to assess other immunomodulators in vitiligo.
There is insufficient RCT evidence to fully assess levamisole or topical vitamin D analogues in vitiligo in children or in adults.
Consensus is that for the treatment of vitiligo in adults, oral psoralen plus ultraviolet A (PUVA) is effective, whereas topical PUVA is unlikely to be effective. However, topical PUVA has fewer adverse effects than oral PUVA. PUVA is likely to be harmful in children.
Vitiligo patches in certain body areas, such as the acral sites, palms and soles, lips, mucosa, and nipples, and segmental forms in any area are relatively resistant to all conventional treatment modalities. In these cases, counselling and cosmetic camouflage become a priority, and often no treatments are advocated.
PMCID: PMC3217714  PMID: 21439099
5.  VITILIGO TREATMENT WITH VITAMINS, MINERALS AND POLYPHENOL SUPPLEMENTATION 
Indian Journal of Dermatology  2009;54(4):357-360.
Background:
Mammalian pigmentation results from the synthesis and accumulation of photo protective epidermal melanin. Melanin was formed from the amino acid precursor L-tyrosine within specialized cells, the melanocytes. Oxidative stress has been suggested to be the initial pathogenetic event in melanocyte degeneration with H2O2 accumulation in the epidermis of patients with active disease. Auto immunity has been also suggested as another hypothesis in the pathogenesis of depigmentation disorders. Topical corticosteroids and phototherapy as common treatment modalities have been prescribed in patients with vitiligo. However, they are often not effective and safe (epidermal atrophy). Therefore, research for alternative therapies continues.
Aims:
To evaluate the beneficial effects of a supplementation with antioxidant vitamins (A, C, E) and minerals (zinc, selenium) for vitiligo treatment.
Methods:
Forty experimental autoimmune vitiligo mice C57BL6, aged from 5 to 12 months showing visible signs of induced vitiligo, were sequentially randomized into five parallel groups (8 mice per group). Each group mice was allocated an identical pre coded cage. the first group (SZV) received the ED + 1,4 g zinc (Zn) + 0.04 g selenium (Se) + vitamins (A 118 UI, C 8,5 mg, E 5,4 UI) /kg diet, the second group (PSZV) received the ED + 1,4 g zinc (Zn) + 0.04 g selenium (Se) + vitamins (A 118 UI, C 8.5 mg, E 5,4 UI)/kg diet + Polyphenol orally, the group 3 (PSZ) received the ED + green tea decoction prepared from 100 g/l (polyphenol orally) + 1,4 g Zn + 0.04 g Se, the 4 (P) received the ED + green tea decoction prepared green tea decoction prepared from 100 g/l, the control group 5(C) received the ED + distilled water. Cure was defined as repigmentation of treated sites. Photographic and optical techniques were used both at the baseline and on weekly basis.
Results:
By the end of the study, mices showed visible repigmentation. Using the investigator's global assessment, therapeutic success in terms of a clear repigmentation documented in 70% of treated mice.
Conclusion:
Our findings suggest that an antioxidant supplementation is significantly beneficial in contributing superior clinical efficacy to cure vitiligo.
doi:10.4103/0019-5154.57613
PMCID: PMC2807713  PMID: 20101338
Polyphenol; vitiligo; vitamins
6.  Survey and online discussion groups to develop a patient-rated outcome measure on acceptability of treatment response in vitiligo 
BMC Dermatology  2014;14:10.
Background
Vitiligo is a chronic depigmenting skin disorder which affects around 0.5-1% of the world’s population. The outcome measures used most commonly in trials to judge treatment success focus on repigmentation. Patient-reported outcome measures of treatment success are rarely used, although recommendations have been made for their inclusion in vitiligo trials. This study aimed to evaluate the face validity of a new patient-reported outcome measure of treatment response, for use in future trials and clinical practice.
Method
An online survey to gather initial views on what constitutes treatment success for people with vitiligo or their parents/carers, followed by online discussion groups with patients to reach consensus on what constitutes treatment success for individuals with vitiligo, and how this can be assessed in the context of trials. Participants were recruited from an existing database of vitiligo patients and through posts on the social network sites Facebook and Twitter.
Results
A total of 202 survey responses were received, of which 37 were excluded and 165 analysed. Three main themes emerged as important in assessing treatment response: a) the match between vitiligo and normal skin (how well it blends in); b) how noticeable the vitiligo is and c) a reduction in the size of the white patches. The majority of respondents said they would consider 80% or more repigmentation to be a worthwhile treatment response after 9 months of treatment. Three online discussion groups involving 12 participants led to consensus that treatment success is best measured by asking patients how noticeable their vitiligo is after treatment. This was judged to be best answered using a 5-point Likert scale, on which a score of 4 or 5 represents treatment success.
Conclusions
This study represents the first step in developing a patient reported measure of treatment success in vitiligo trials. Further work is now needed to assess its construct validity and responsiveness to change.
doi:10.1186/1471-5945-14-10
PMCID: PMC4075774  PMID: 24929563
Vitiligo; Outcome measure; Patient-reported outcome; Randomised controlled trial
7.  Feasibility, double-blind, randomised, placebo-controlled, multi-centre trial of hand-held NB-UVB phototherapy for the treatment of vitiligo at home (HI-Light trial: Home Intervention of Light therapy) 
Trials  2014;15:51.
Background
Hand-held NB-UVB units are lightweight devices that may overcome the need to treat vitiligo in hospital-based phototherapy cabinets, allowing early treatment at home that may enhance the likelihood of successful repigmentation. The pilot Hi-Light trial examined the feasibility of conducting a large multi-centre randomised controlled trial (RCT) on the use of such devices by exploring recruitment, adherence, acceptability, and patient education.
Methods
This was a feasibility, double-blind, multi-centre, parallel group randomised placebo-controlled trial of hand-held NB-UVB phototherapy for the treatment of vitiligo at home. The overall duration of the trial was seven months; three months recruitment and four months treatment. Participants were randomly allocated to active or placebo groups (2:1 ratio). The primary outcome measure was the proportion of eligible participants who were willing to be randomised. The secondary outcomes included proportion of participants expressing interest in the trial and fulfilling eligibility criteria, withdrawal rates and missing data, proportion of participants adhering to and satisfied with the treatment, and incidence of NB-UVB short-term adverse events.
Results
Eighty-three percent (45/54) of vitiligo patients who expressed interest in the trial were willing to be randomised. Due to time and financial constraints, only 29/45 potential participants were booked to attend a baseline hospital visit. All 29 (100%) potential participants were confirmed as being eligible and were subsequently randomised. Willingness to participate in the study for General Practice (family physicians) surgeries and hospitals were 40% and 79%, respectively; 86% (25/29) of patients adhered to the treatment and 65% (7/11) of patients in the active group had some degree of repigmentation. Only one patient in the active group reported erythema grade 3 (3%). Both devices (Dermfix 1000 NB-UVB and Waldmann NB-UVB 109) were acceptable to participants.
Conclusions
Hand-held NB-UVB devices need evaluation in a large, pragmatic RCT. This pilot trial has explored many of the uncertainties that need to be overcome before embarking on a full scale trial, including the development of a comprehensive training package and treatment protocol. The study has shown strong willingness of participants to be randomised, very good treatment adherence and repigmentation rates, and provided evidence of feasibility for a definitive trial.
Trial registration
NCT01478945
doi:10.1186/1745-6215-15-51
PMCID: PMC3923442  PMID: 24507484
Hand-held phototherapy; Home phototherapy; Patient education; Randomised trial; Vitiligo
8.  Narrow Band-Ultraviolet B Versus Clobetasol Propionate Foam in the Treatment of Vitiligo: A Retrospective Study 
Dermatology and Therapy  2013;3(1):95-105.
Introduction
Several therapeutic options are available for the treatment of vitiligo; among these phototherapy and topical steroids are the most widely documented. A topical formulation of 0.05% clobetasol propionate foam (CPF) has been introduced in the market, but no data are available about the efficacy and tolerability of this new formulation in the treatment of vitiligo. The aim of this study was to investigate the efficacy and tolerability of CPF in the treatment of vitiligo, in comparison with narrowband-ultraviolet B (NB-UVB) phototherapy.
Methods
The medical records of the first 60 vitiligo patients treated with NB-UVB phototherapy or with CPF were selected. Response to the treatment was determined for each anatomic site (neck, upper and lower limbs, trunk, hands/wrists, feet/ankles). Based on the area of repigmentation, treatment outcome was calculated according to a scale ranging from 0 (absent) to 4 (excellent). The incidence of adverse effects was also noted as a secondary endpoint. Significance level was set at P = 0.05.
Results
For each anatomic site, statistical analyses demonstrated that the efficacy of CPF was significantly higher compared to NB-UVB. Side effects occurred in 4 patients (13.33%) in the CPF group compared to none in the NB-UVB group.
Discussion
Clobetasol propionate has been used in vitiligo in different vehicles, but never in foam. The data showed that CPF is effective and seems to be superior to NB-UVB phototherapy, with furthermore a good safety profile.
Conclusion
This new foam formulation of clobetasol propionate may expand the options currently available for vitiligo therapy; however, further investigations are needed to confirm our preliminary observations.
doi:10.1007/s13555-013-0028-8
PMCID: PMC3680636  PMID: 23888259
Clobetasol propionate foam; Narrowband-ultraviolet B phototherapy; VersaFoam; Vitiligo
9.  Narrow Band-Ultraviolet B Versus Clobetasol Propionate Foam in the Treatment of Vitiligo: A Retrospective Study 
Dermatology and Therapy  2013;3(1):95-105.
Introduction
Several therapeutic options are available for the treatment of vitiligo; among these phototherapy and topical steroids are the most widely documented. A topical formulation of 0.05% clobetasol propionate foam (CPF) has been introduced in the market, but no data are available about the efficacy and tolerability of this new formulation in the treatment of vitiligo. The aim of this study was to investigate the efficacy and tolerability of CPF in the treatment of vitiligo, in comparison with narrowband-ultraviolet B (NB-UVB) phototherapy.
Methods
The medical records of the first 60 vitiligo patients treated with NB-UVB phototherapy or with CPF were selected. Response to the treatment was determined for each anatomic site (neck, upper and lower limbs, trunk, hands/wrists, feet/ankles). Based on the area of repigmentation, treatment outcome was calculated according to a scale ranging from 0 (absent) to 4 (excellent). The incidence of adverse effects was also noted as a secondary endpoint. Significance level was set at P = 0.05.
Results
For each anatomic site, statistical analyses demonstrated that the efficacy of CPF was significantly higher compared to NB-UVB. Side effects occurred in 4 patients (13.33%) in the CPF group compared to none in the NB-UVB group.
Discussion
Clobetasol propionate has been used in vitiligo in different vehicles, but never in foam. The data showed that CPF is effective and seems to be superior to NB-UVB phototherapy, with furthermore a good safety profile.
Conclusion
This new foam formulation of clobetasol propionate may expand the options currently available for vitiligo therapy; however, further investigations are needed to confirm our preliminary observations.
doi:10.1007/s13555-013-0028-8
PMCID: PMC3680636  PMID: 23888259
Clobetasol propionate foam; Narrowband-ultraviolet B phototherapy; VersaFoam; Vitiligo
10.  A Pilot Study of 1% Pimecrolimus Cream for the Treatment of Childhood Segmental Vitiligo 
Annals of Dermatology  2013;25(2):168-172.
Background
There is as yet no effective and safe treatment for vitiligo. One percent pimecrolimus cream, a topical calcineurin inhibitor, has been tried for the treatment of vitiligo, with its therapeutic efficacy having mostly been reported in non-segmental vitiligo. However, questions about the therapeutic efficacy of 1% pimecrolimus cream have remained unanswered regarding segmental vitiligo.
Objective
The aim of this study was to study the therapeutic efficacy and safety of 1% pimecrolimus cream for segmental childhood vitiligo.
Methods
Nine childhood patients with segmental vitiligo were treated with 1% pimecrolimus cream twice daily for three months, after which good responders were scheduled to continue with the 1% pimecrolimus cream monotherapy. The efficacy and safety of this treatment were determined by the levels of repigmentation, initial response time and the presence of adverse events including burning, dryness, stinging and itching.
Results
Four of nine patients achieved mild to moderate responses after three months of treatment and thus continued with treatment. Among these four patients, three achieved an excellent response and one patient achieved a moderate response, with a mean treatment duration of 7.3 months. Transient local burning sensation was the most common adverse event. In comparison with the patients with poor response, those patients with good response showed a shorter disease duration (8.5±10.5 mo vs. 13.4±10.1 mo), more frequent facial involvement (4/4 patients vs. 3/5 patients) and earlier initial response after treatment (1.0±0.0 mo vs. 2.0±1.0 mo).
Conclusion
This study suggests that 1% pimecrolimus cream is an effective and well-tolerated treatment for segmental childhood vitiligo.
doi:10.5021/ad.2013.25.2.168
PMCID: PMC3662909  PMID: 23717007
Pimecrolimus; Vitiligo
11.  Short-term Effects of 308-nm Xenon-chloride Excimer Laser and Narrow-band Ultraviolet B in the Treatment of Vitiligo: A Comparative Study 
Journal of Korean Medical Science  2005;20(2):273-278.
We compared the clinical efficacy of a short-term intervention of 308-nm excimer laser with that of narrow-band UVB (NBUVB) phototherapy for vitiligo patients to see the early response. Twenty-three symmetrically patterned patches of vitiligo on 8 patients were selected. Vitiligo patches on one side of the body were treated 2 times per week for a maximum of 20 treatments with the excimer laser, and NBUVB phototherapy was used on patches on the other side. Improvement (repigmentation) was assessed on a visual scale via serial photographs taken every five treatments and scored as follows: 0, ≤1% improvement; 1, ≤25% improvement; 2, 26-50% improvement; 3, 51-75% improvement; and 4, ≥75% improvement. At five treatments, the excimer laser-treated patches had an average score of 0.26, compared with 0.04 for patches treated with NBUVB phototherapy. A slightly higher repigmentation (p>0.05) in the excimer treated area was thus observed. At 10, 15, or 20 treatments, the differences between the average scores were significant: 0.83, 1.17, and 1.39 for the excimer-treated patches, and 0.17, 0.30, and 0.74 for the NBUVB phototherapy-treated areas (p<0.05). In conclusion, the 308-nm excimer laser appears to be more effective than NBUVB phototherapy, as it produces more rapid and profound repigmentation.
doi:10.3346/jkms.2005.20.2.273
PMCID: PMC2808605  PMID: 15832000
Vitiligo; 308-nm Excimer Laser; Laser Therapy, Low-Level; Narrow Band UVB; Phototherapy; Ultraviolet Therapy
12.  A pilot study assessing the effect of prolonged administration of high daily doses of vitamin D on the clinical course of vitiligo and psoriasis 
Dermato-endocrinology  2013;5(1):222-234.
Autoimmunity has been associated with vitamin D deficiency and resistance, with gene polymorphisms related to vitamin D metabolism frequently described in affected patients. High doses of vitamin D3 may conceivably compensate for inherited resistance to its biological effects. This study aimed to assess the efficacy and safety of prolonged high-dose vitamin D3 treatment of patients with psoriasis and vitiligo. Nine patients with psoriasis and 16 patients with vitiligo received vitamin D3 35,000 IU once daily for six months in association with a low-calcium diet (avoiding dairy products and calcium-enriched foods like oat, rice or soya “milk”) and hydration (minimum 2.5 L daily). All psoriasis patients were scored according to “Psoriasis Area and Severity Index” (PASI) at baseline and after treatment. Evaluation of clinical response of vitiligo patients required a quartile grading scale. All patients presented low vitamin D status (serum 25(OH)D3 ≤ 30 ng/mL) at baseline. After treatment 25(OH)D3 levels significantly increased (from 14.9 ± 7.4 to 106.3 ± 31.9 ng/mL and from 18.4 ± 8.9 to 132.5 ± 37.0 ng/mL) and PTH levels significantly decreased (from 57.8 ± 16.7 to 28.9 ± 8.2 pg/mL and from 55.3 ± 25.0 to 25.4 ± 10.7 pg/mL) in patients with psoriasis and vitiligo respectively. PTH and 25(OH)D3 serum concentrations correlated inversely. The PASI score significantly improved in all nine patients with psoriasis. Fourteen of 16 patients with vitiligo had 25–75% repigmentation. Serum urea, creatinine and calcium (total and ionized) did not change and urinary calcium excretion increased within the normal range. High-dose vitamin D3 therapy may be effective and safe for vitiligo and psoriasis patients.
doi:10.4161/derm.24808
PMCID: PMC3897595  PMID: 24494059
vitiligo; psoriasis; vitamin D; 25(OH)D3; high dose; calcium; treatment; toxicity; autoimmunity
13.  Neonatal jaundice 
Clinical Evidence  2011;2011:0319.
Introduction
About 50% of term and 80% of preterm babies develop jaundice, which usually appears 2 to 4 days after birth, and resolves spontaneously after 1 to 2 weeks. Jaundice is caused by bilirubin deposition in the skin. Most jaundice in newborn infants is a result of increased red cell breakdown and decreased bilirubin excretion.
Methods and outcomes
We conducted a systematic review and aimed to answer the following clinical question: What are the effects of treatments for unconjugated hyperbilirubinaemia in term and preterm infants? We searched Medline, Embase, The Cochrane Library, and other important databases up to February 2010 (Clinical Evidence reviews are updated periodically, please check our website for the most up-to-date version of this review). We included harms alerts from relevant organisations such as the US Food and Drug Administration (FDA) and the UK Medicines and Healthcare products Regulatory Agency (MHRA).
Results
We found 42 systematic reviews, RCTs, or observational studies that met our inclusion criteria. We performed a GRADE evaluation of the quality of evidence for interventions.
Conclusions
In this systematic review we present information relating to the effectiveness and safety of the following interventions: albumin infusion, exchange transfusion, home phototherapy, immunoglobulin, hospital phototherapy, and tin-mesoporphyrin.
Key Points
About 50% of term and 80% of preterm babies develop jaundice, which usually appears 2 to 4 days after birth, and resolves spontaneously after 1 to 2 weeks. Jaundice is caused by bilirubin deposition in the skin. Most jaundice in newborn infants is a result of increased red cell breakdown and decreased bilirubin excretion.Breastfeeding, haemolysis, and some metabolic and genetic disorders also increase the risk of jaundice.Unconjugated bilirubin can be neurotoxic, causing an acute or chronic encephalopathy that may result in cerebral palsy, hearing loss, and seizures.
Phototherapy provided by conventional or fibreoptic lights in hospital reduces neonatal jaundice compared with no treatment (as assessed by serum bilirubin levels). Low threshold compared with high threshold phototherapy reduces neurodevelopmental impairment and hearing loss and reduces serum bilirubin on day 5 in extremely low birth weight infants. However, it increases the duration of phototherapy, and there is no effect on mortality or the rate of exchange transfusion.Close phototherapy compared with distant light-source phototherapy reduces the duration of phototherapy in infants with hyperbilirubinaemia.
We don't know whether home phototherapy is more or less effective than hospital phototherapy as we found no studies comparing the two treatments.
There is consensus that exchange transfusion reduces serum bilirubin levels and prevents neurodevelopmental sequelae, although we found no studies to confirm this. Exchange transfusion has an estimated mortality of 3 to 4 per 1000 exchanged infants, and 5% to 10% permanent sequelae in survivors.
We don't know whether albumin infusion is beneficial.
Tin-mesoporphyrin is not currently licensed for routine clinical use in the UK or US, and further long-term studies are warranted to confirm its place in clinical practice.
However, tin-mesoporphyrin reduced the need for phototherapy (as assessed by serum bilirubin levels) when given either to preterm infants on the first day, or to jaundiced term or near-term infants within the first few days of life.
Intravenous immunoglobin reduces the need for exchange transfusion in high-risk infants with haemolytic hyperbilirubinaemia, as well as reduces serum bilirubin levels, the requirement for phototherapy, and the length of hospital stay. Benefits of immunoglobulin were observed when used either alone or in conjunction with phototherapy. No adverse effects were reported. However, we don't know whether immunoglobulin prevents neurodevelopmental sequelae.
PMCID: PMC3217664  PMID: 21920055
14.  Current and emerging therapy for the management of vitiligo 
Vitiligo is an acquired cutaneous disorder of pigmentation, with an incidence of 0.5% to 2% worldwide. There are three major hypotheses for the pathogenesis of vitiligo that are not exclusive of each other: biochemical/cytotoxic, neural and autoimmune. Recent data provide strong evidence supporting an autoimmune pathogenesis of vitiligo. As vitiligo can have a major effect on quality of life, treatment can be considered and should preferably begin early when the disease is active. Current treatment modalities are directed towards stopping progression of the disease and achieving repigmentation. Therapies include corticosteroids, topical immunomodulators, photo(chemo)therapy, surgery, combination therapies and depigmentation of normally pigmented skin. Topical class 3 corticosteroids can be used for localized vitiligo. The use of topical immunomodulators (TIMs) in vitiligo seems to be equally effective as topical steroids, especially when used in the face and neck region. In photo(chemo)therapy, narrowband ultraviolet-B therapy (NB-UVB) seems to be superior to psoralen ultraviolet-A therapy (PUVA) and broadband UVB. In surgical techniques, split-thickness grafting and epidermal blister grafting were shown to be effective methods, although the non-cultured epidermal suspension technique has many advantages and seems to be a promising development. Depigmentation therapy can be considered if vitiligo affects more than 60% to 80% of the body. Complementary therapies such as Polypodium leucotomos show promising results in combination with UVB therapy. No causative treatment for vitiligo is currently available. More randomized controlled trials on the treatment of vitiligo are necessary.
PMCID: PMC3047938  PMID: 21436965
vitiligo; non surgical treatment; surgical treatment
15.  Efficacy of Targeted Narrowband Ultraviolet B Therapy in Vitiligo 
Indian Journal of Dermatology  2014;59(5):485-489.
Background:
Phototherapy is one of the most effective treatment options in vitiligo. Targeted phototherapy devices are becoming more popular as they offer a lot of advantages over the conventional whole-body phototherapy units.
Aims and Objectives:
The present study was conducted to assess the efficacy and safety of a targeted narrowband ultraviolet B (NBUVB) device in vitiligo.
Materials and Methods:
A total of 40 patients of vitiligo were treated with a targeted NBUVB device twice-weekly for a maximum of 30 sessions or until 100% repigmentation, whichever was reached first. The extent of repigmentation achieved was assessed and adverse effects, if any, were also noted down.
Results:
There were 31 responders (77.5%) who achieved repigmentation ranging from 50% to 100%. The onset of repigmentation was seen as early as the 3rd dose in some cases and by the 10th dose in all responders. A total of 97 lesions were treated out of which 45 lesions (46.6%) achieved 90-100% repigmentation. Lesions showing 75% and 50% repigmentation were 14 and 15 in number respectively. 23 lesions failed to show any significant repigmentation at the end of 30 doses. Best response was seen on the face and neck with 20 of the 31 lesions achieving 90-100% repigmentation in this area. Duration of vitiligo was seen to have no statistically significant impact on the repigmentation achieved.
Conclusion:
Targeted NBUVB phototherapy seems to be an effective treatment option in localized vitiligo with a rapid onset of repigmentation seen as early as 2nd week of treatment.
doi:10.4103/0019-5154.139892
PMCID: PMC4171919  PMID: 25284856
Phototherapy; treatment; targeted narrowband ultraviolet B phototherapy; vitiligo
16.  Cost effectiveness of home ultraviolet B phototherapy for psoriasis: economic evaluation of a randomised controlled trial (PLUTO study) 
Objective To assess the costs and cost effectiveness of phototherapy with ultraviolet B light provided at home compared with outpatient ultraviolet B phototherapy for psoriasis.
Design Cost utility, cost effectiveness, and cost minimisation analyses performed alongside a pragmatic randomised clinical trial (the PLUTO study) at the end of phototherapy (mean 17.6 weeks) and at one year after the end of phototherapy (mean 68.4 weeks).
Setting Secondary care, provided by a dermatologist in the Netherlands.
Participants 196 adults with psoriasis who were clinically eligible for narrowband (TL-01) ultraviolet B phototherapy were recruited from the dermatology departments of 14 hospitals and were followed until the end of phototherapy. From the end of phototherapy onwards, follow-up was continued for an unselected, consecutive group of 105 patients for one year after end of phototherapy.
Interventions Ultraviolet B phototherapy provided at home (intervention) and conventional outpatient ultraviolet B phototherapy (control) in a setting reflecting routine practice in the Netherlands. Both treatments used narrowband ultraviolet B lamps (TL-01).
Main outcome measures Total costs to society, quality adjusted life years (QALYs) as calculated using utilities measured by the EQ-5D questionnaire, and the number of days with a relevant treatment effect (≥50% improvement of the baseline self administered psoriasis area and severity index (SAPASI)).
Results Home phototherapy is at least as effective and safe as outpatient phototherapy, therefore allowing cost minimisation analyses (simply comparing costs). The average total costs by the end of phototherapy were €800 for home treatment and €752 for outpatient treatment, showing an incremental cost per patient of €48 (95% CI €−77 to €174). The average total costs by one year after the end of phototherapy were €1272 and €1148 respectively (difference €124, 95% CI €−155 to €403). Cost utility analyses revealed that patients experienced equal health benefits—that is, a gain of 0.296 versus 0.291 QALY (home v outpatient) by the end of phototherapy (difference 0.0052, −0.0244 to 0.0348) and 1.153 versus 1.126 QALY by one year after the end of phototherapy (difference 0.0267, −0.024 to 0.078). Incremental costs per QALY gained were €9276 and €4646 respectively, both amounts well below the normally accepted standard of €20 000 per QALY. Cost effectiveness analyses indicated that the mean number of days with a relevant treatment effect was 42.4 versus 55.3 by the end of phototherapy (difference −12.9, −23.4 to −2.4). By one year after the end of phototherapy the number of days with a relevant treatment effect were 216.5 and 210.4 respectively (6.1, −41.1 to 53.2), yielding an incremental cost of €20 per additional day with a relevant treatment effect.
Conclusions Home ultraviolet B phototherapy for psoriasis is not more expensive than phototherapy in an outpatient setting and proved to be cost effective. As both treatments are at least equally effective and patients express a preference for home treatment, the authors conclude that home phototherapy should be the primary treatment option for patients who are eligible for phototherapy with ultraviolet B light.
Trial registration Current Controlled Trials ISRCTN83025173 and Clinicaltrials.gov NCT00150930
doi:10.1136/bmj.c1490
PMCID: PMC2857750  PMID: 20406865
17.  Future research into the treatment of vitiligo: where should our priorities lie? Results of the vitiligo priority setting partnership 
The British Journal of Dermatology  2011;164(3):530-536.
Background
Vitiligo is the most frequent depigmentation disorder of the skin and is cosmetically and psychologically devastating. A recently updated Cochrane systematic review ‘Interventions for vitiligo’ showed that the research evidence for treatment of vitiligo is poor, making it difficult to make firm recommendations for clinical practice.
Objectives
To stimulate and steer future research in the field of vitiligo treatment, by identifying the 10 most important research areas for patients and clinicians.
Methods
A vitiligo priority setting partnership was established including patients, healthcare professionals and researchers with an interest in vitiligo. Vitiligo treatment uncertainties were gathered from patients and clinicians, and then prioritized in a transparent process, using a methodology advocated by the James Lind Alliance.
Results
In total, 660 treatment uncertainties were submitted by 461 participants. These were reduced to a list of the 23 most popular topics through an online/paper voting process. The 23 were then prioritized at a face-to-face workshop in London. The final list of the top 10 treatment uncertainties included interventions such as systemic immunosuppressants, topical treatments, light therapy, melanocyte-stimulating hormone analogues, gene therapy, and the impact of psychological interventions on the quality of life of patients with vitiligo.
Conclusions
The top 10 research areas for the treatment of vitiligo provide guidance for researchers and funding bodies, to ensure that future research answers questions that are important both to clinicians and to patients.
doi:10.1111/j.1365-2133.2010.10160.x
PMCID: PMC3084501  PMID: 21128908
18.  Add-On Effect of Chinese Herbal Medicine Bath to Phototherapy for Psoriasis Vulgaris: A Systematic Review 
Psoriasis vulgaris is the most common form of psoriasis. Phototherapy has been proven effective for psoriasis, but side effects have become a concern. Chinese herbal medicine (CHM) bath combined with phototherapy has been used in clinical settings, but the additional benefit requires evaluation. This review aims to evaluate the additional benefit and safety of adding CHM bath to phototherapy for psoriasis vulgaris. Cochrane library, PubMed, Embase, CNKI, and CQVIP were searched from their inceptions to 6 August 2012. Randomized controlled trials (RCTs) comparing CHM bath plus phototherapy to phototherapy alone for psoriasis vulgaris were included. Data was analyzed using Review Manager 5.1.0. Thirteen RCTs were included in the review, and eight were included in the meta-analysis. Meta-analysis showed higher efficacy of CHM bath plus phototherapy when compared with phototherapy alone in terms of PASI 60 (RR 1.25; 95% CI: 1.18–1.32). Mild adverse events were reported in ten studies, but these could be alleviated by reducing UV dosage or applying emollient. In conclusion, CHM bath appears to be a beneficial and safe adjunctive therapy to phototherapy for psoriasis vulgaris. However, these results should be interpreted with caution due to the low methodological quality of the included studies.
doi:10.1155/2013/673078
PMCID: PMC3745880  PMID: 23983796
19.  The Prevalence of Natural Health Product Use in Patients with Acute Cardiovascular Disease 
PLoS ONE  2011;6(5):e19623.
Background
Natural health products (NHP) use may have implications with respect to adverse effects, drug interactions and adherence yet the prevalence of NHP use by patients with acute cardiovascular disease and the best method to ascertain this information is unknown.
Objective
To identify the best method to ascertain information on NHP, and the prevalence of use in a population with acute cardiovascular disease.
Methods
Structured interviews were conducted with a convenience sample of consecutive patients admitted with acute cardiovascular disease to the University of Alberta Hospital during January 2009. NHP use was explored using structured and open-ended questions based on Health Canada's definition of NHP. The medical record was reviewed, and documentation of NHP use by physicians, nurses, and pharmacists, compared against the gold-standard structured interview.
Results
88 patients were interviewed (mean age 62 years, standard deviation [SD 14]; 80% male; 41% admitted for acute coronary syndromes). Common co-morbidities included hypertension (59%), diabetes (26%) and renal impairment (19%). NHP use was common (78% of patients) and 75% of NHP users reported daily use. The category of NHP most commonly used was vitamins and minerals (73%) followed by herbal products (20%), traditional medicines including Chinese medicines (9%), homeopathic preparations (1%) and other products including amino acids, essential fatty acids and probiotics (35%). In a multivariable model, only older age was associated with increased NHP use (OR 1.5 per age decile [95%CI 1.03 to 2.2]). When compared to the interview, the highest rate of NHP documentation was the pharmacist history (41%). NHP were documented in 22% of patients by the physician and 19% by the nurse.
Conclusions
NHP use is common in patients admitted with acute cardiovascular disease. However, health professionals do not commonly identify NHP as part of the medication profile despite its potential importance. Structured interview appears to be the best method to accurately identify patient use of NHP.
doi:10.1371/journal.pone.0019623
PMCID: PMC3090400  PMID: 21573067
20.  Public awareness, patterns of use and attitudes toward natural health products in Kuwait: a cross-sectional survey 
Background
There has been a global rise in the use of natural health products (NHPs). Proper regulation of NHPs is pivotal to ensure good quality control standards, enhance consumers' safety and facilitate their integration into modern healthcare systems. There is scarcity of published data on the prevalence of NHPs usage among the general Kuwaiti population. Hence, this study was designed to determine awareness, patterns of use, general attitude and information requirements about NHPs among the public in Kuwait.
Methods
A descriptive cross-sectional survey was performed using a pretested self-administered questionnaire on a sample of 1300 Kuwaiti individuals, selected from six governorates in Kuwait using a multistage stratified clustered sampling. Descriptive and multivariate logistic regression analysis were used in data analysis.
Results
The response rate was 90.2%. NHPs were thought to be herbal remedies by most of participants (63.5%), followed by vitamins/minerals (40.5%), traditional medicines (21.1%), probiotics (14.9%), amino acids and essential fatty acids (7.2%), and homeopathic medicines (5.6%). NHPs usage was reported by 71.4% (95% CI: 68.8-74.0%) of respondents, and mostly associated with females (OR: 1.90; 95% CI: 1.44-2.51). Herbal remedies were the most commonly used (41.3%; 95% CI: 38.5-44.2%). The most common reasons for using NHPs were to promote and maintain health and to prevent illness and build immune system. Family members and/or friends and mass media were the main sources for providing information about NHPs. About 18% of consumers have experienced a side effect due to using a NHP. Attitudes toward NHPs were generally positive; with more than 75% of participants believing that the Ministry of Health in Kuwait should regulate the claims made by the manufacturers of NHPs and it is important to talk to a medical doctor or a pharmacist prior to using NHPs. Most of the respondents showed increased interest to acquire knowledge about different types of information related to NHPs.
Conclusions
The prevalence of use of NHPs among Kuwaiti population is high. The present findings have major public health policy implications for Kuwait. Therefore, there is an apparent need to establish effective health education programs and implement better and more regulated NHPs use policies in Kuwait.
doi:10.1186/1472-6882-14-105
PMCID: PMC3999934  PMID: 24646341
Natural health products; Herbal remedies; Patterns of use; Kuwait
21.  Clinical patterns of vitiligo and its associated co morbidities: A prospective controlled cross-sectional study in South India 
Aim:
The purpose of this study is to assess the clinical patterns and associations of vitiligo, audiometric functions, and ocular involvement and to correlate the morphology, clinical behaviour and comorbidities associated with vitiligo.
Settings and Design:
For this prospective and cross-sectional study 80 self-reporting patients in the age group 7-75 years with vitiligo attending the outpatient department of Manipal hospital during the period August 2008 to February 2010 were selected and the data was analysed.
Materials and Methods:
The patients were subjected to detailed history, clinical examination and investigations [complete blood count (CBC), absolute eosinophil count (AEC), erythrocyte sedimentation rate (ESR), thyroid stimulating hormone (TSH), vitamin B12 estimation, fasting blood sugar (FBS), and post prandial blood sugar (PPBS),antibody titre estimations that is antithyroid peroxidase (ATPA), antithyroglobulin (ATA), antinuclear antibodies (ANA),urine analysis], audiometric evaluation and ophthalmic examination.
Statistical Analysis Used:
The Fisher exact test has been used to find the significance of study parameters on categorical scale between two or more groups.
Results:
In the present series of 80 cases, 41 (51.25%) were males and 39 (48.75%) were females. The male to female ratio was 1.05:1. In our study 20% cases gave definite family history of vitiligo and patients in the age group of 20 - 30 years were the most commonly affected. Generalized vitiligo (31.3%) was the most common type followed by segmental (30%), focal (18.8%), acrofacial (8.8%), and mucosal vitiligo (11.3%). In the present study there was a high incidence of autoantibodies (22.5%), vitamin B12 deficiency (30%), hypothyroidism (11.3%), elevated absolute eosinophil count (16.3%), hypoacusis (10%) and retinal changes (8.8%). This suggests multisystem autoimmunity in vitiligo.
doi:10.4103/2229-5178.96705
PMCID: PMC3481882  PMID: 23130284
Deafness; retinal changes; thyroid disease; vitiligo; vitamin B12 deficiency
22.  Treatment of vitiligo with autologous cultured keratinocytes in 27 cases 
European Journal of Plastic Surgery  2013;36(10):651-656.
Background
Vitiligo is an acquired depigmentation of the skin characterized by white spots with well-defined margins, causing psychological stress in patients due to cosmetic concerns. We examined 27 patients who underwent vitiligo treatment using autologous cultured keratinocytes.
Methods
The study comprised 20 patients with segmental vitiligo and seven patients with generalized vitiligo, and they were followed up for at least 1 year postoperatively. In all 27 cases, topical steroid or ultraviolet therapy had been previously performed by dermatologists, but this treatment had been ineffective. The patients' vitiligo had stabilized. The patients were treated using keratinocytes obtained from primary culture using Green's techniques or from first passage. Dispase treatment was used to detach the stratified cultured epithelial sheets from their culture dishes. The detached sheets shrank to approximately one half to two thirds of their original size on the culture dish. After the recipient site was completely epithelialized, the skin was exposed to sunlight.
Results
For patients with segmental vitiligo, 12 had a good therapeutic outcome (90 % or more repigmentation) after the first surgery. This number increased to 14 when patients with multiple surgeries were included. There were six patients with fair outcomes (50–90 % repigmentation), and no patients with poor outcomes (50 % or less repigmentation). For patients with generalized vitiligo, no patients had a good outcome despite multiple surgeries. There were three patients with fair outcomes, and four patients with no change outcomes.
Conclusions
Cultured keratinocyte grafting was a more effective treatment for segmental vitiligo than for generalized vitiligo.
Level of Evidence: Level IV, therapeutic study.
doi:10.1007/s00238-013-0875-7
PMCID: PMC3771432  PMID: 24039346
Cultured keratinocytes; Vitiligo; Phototherapy; Pigmentation; Melanocyte
23.  Effect of Ginkgo Biloba on the Pharmacokinetics of Raltegravir in Healthy Volunteers 
Antimicrobial Agents and Chemotherapy  2012;56(10):5070-5075.
Medicinal herbs may cause clinically relevant drug interactions with antiretroviral agents. Ginkgo biloba extract is a popular herbal product among HIV-infected patients because of its positive effects on cognitive function. Raltegravir, an HIV integrase inhibitor, is increasingly being used as part of combined antiretroviral therapy. Clinical data on the potential inhibitory or inductive effect of ginkgo biloba on the pharmacokinetics of raltegravir were lacking, and concomitant use was not recommended. We studied the effect of ginkgo biloba extract on the pharmacokinetics of raltegravir in an open-label, randomized, two-period, crossover phase I trial in 18 healthy volunteers. Subjects were randomly assigned to a regimen of 120 mg of ginkgo biloba twice daily for 15 days plus a single dose of raltegravir (400 mg) on day 15, a washout period, and 400 mg of raltegravir on day 36 or the test and reference treatments in reverse order. Pharmacokinetic sampling of raltegravir was performed up to 12 h after intake on an empty stomach. All subjects (9 male) completed the trial, and no serious adverse events were reported. Geometric mean ratios (90% confidence intervals) of the area under the plasma concentration-time curve from dosing to infinity (AUC0-∞) and the maximum plasma concentration (Cmax) of raltegravir with ginkgo biloba versus raltegravir alone were 1.21 (0.93 to 1.58) and 1.44 (1.03 to 2.02). Ginkgo biloba did not reduce raltegravir exposure. The potential increase in the Cmax of raltegravir is probably of minor importance, given the large intersubject variability of raltegravir pharmacokinetics and its reported safety profile.
doi:10.1128/AAC.00672-12
PMCID: PMC3457394  PMID: 22802250
24.  Positive pleiotropic effects of HMG-CoA reductase inhibitor on vitiligo 
Background
HMG-CoA reductase inhibitors (statins) are commonly used in medicine to control blood lipid disorder. Large clinical trials have demonstrated that statins greatly reduces cardiovascular-related morbidity and mortality in patients with and without coronary artery disease. Also, the use of HMG-CoA reductase inhibitors has been reported to have immunosuppressive effects.
Case presentation
We describe an unusual case of regression of vitiligo in a patient treated with high dose simvastatin. The relation between simvastatin and regression of vitiligo in this case report may be related to the autoimmune pathophysiology of the disease.
Conclusion
This unexpected beneficial impact provides another scientific credence to the hypothesis that immune mechanisms play a role in the development of vitiligo and that the use of statins as immuno-modulator could be of use not only for treatment relative to organ transplant but in other pathologies such as vitiligo.
doi:10.1186/1476-511X-3-7
PMCID: PMC425594  PMID: 15134579
25.  Evaluation of the Efficacy of Topical Tetracycline in Enhancing the Effect of Narrow Band UVB against Vitiligo: A Double-Blind, Randomized, Placebo-Controlled Clinical Trial 
ISRN Dermatology  2014;2014:472546.
Background. Vitiligo is a pigmentary disorder characterized by depigmented macules due to absence of melanocytes. Increased levels of tumor necrosis factor alpha and interleukin-1 in the epidermis of lesions may play a role in keratinocyte apoptosis and less production of melanogenic cytokines. Tetracyclines reduce production of tumor necrosis factor alpha and interleukin-1. Objective. To evaluate the effect of topical tetracycline on vitiligo patients on phototherapy. Methods. Thirty cases of generalized stable vitiligo were chosen randomly and pigmentation of two assigned lesions on right and left sides (same size and location) was determined by vitiligo area severity index, and medication and placebo were randomly assigned to be applied twice daily on either right or left side, respectively. Images were taken of the lesions at the end of the 4th, 8th, and 12th weeks and pigmentations were compared to baseline using aforementioned index. The patients also took narrow band ultraviolet B two to three times a week. Results. Mean pigmentation, based on vitiligo area severity index, changed significantly from 90.1667 to 86.6667 (P = 0.026) and on placebo side from 89.6667 to 86.8333 (P = 0.026). There was no significant difference between medication and placebo sides in terms of pigmentation (P = 0.566). Conclusions. No significant difference in improving repigmentation between medication and placebo sides was seen.
doi:10.1155/2014/472546
PMCID: PMC3934486  PMID: 24665368

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