Development process of a clinical guideline to manage type 2 diabetes in adults by Ayurvedic practitioners.

Background: Type 2 diabetes mellitus (T2DM), a common chronic health condition, has major health and socioeconomic consequences. In the Indian subcontinent, it is a health condition for which individuals commonly consult Ayurvedic (traditional medical system) practitioners and use their medicines. However, to date, a good quality T2DM clinical guideline for Ayurvedic practitioners, grounded on the best available scientific evidence, is not available. Therefore, the study aimed to systematically develop a clinical guideline for Ayurvedic practitioners to manage T2DM in adults. Methods: The development work was guided by the UK's National Institute for Health and Care Excellence (NICE) manual for developing guidelines, the Grading of Recommendations, Assessment, Development and Evaluation (GRADE) approach, and the Appraisal of Guidelines for Research and Evaluation (AGREE) II instrument. First, a comprehensive systematic review was conducted which evaluated Ayurvedic medicines' effectiveness and safety in managing T2DM. In addition, the GRADE approach was used for assessing the certainty of the findings. Next, using the GRADE approach, the Evidence-to-Decision framework was developed, and we focused on glycemic control and adverse events. Subsequently, based on the Evidence-to-Decision framework, a Guideline Development Group of 17 international members made recommendations on Ayurvedic medicines' effectiveness and safety in T2DM. These recommendations formed the basis of the clinical guideline, and additional generic content and recommendations were adapted from the T2DM Clinical Knowledge Summaries of the Clarity Informatics (UK). The feedback given by the Guideline Development Group on the draft version was used to amend and finalize the clinical guideline. Results: A clinical guideline for managing T2DM in adults by Ayurvedic practitioners was developed, which focuses on how practitioners can provide appropriate care, education, and support for people with T2DM (and their carers and family). The clinical guideline provides information on T2DM, such as its definition, risk factors, prevalence, prognosis, and complications; how it should be diagnosed and managed through lifestyle changes like diet and physical activity and Ayurvedic medicines; how the acute and chronic complications of T2DM should be detected and managed (including referral to specialists); and advice on topics like driving, work, and fasting including during religious/socio-cultural festivals. Conclusion: We systematically developed a clinical guideline for Ayurvedic practitioners to manage T2DM in adults.

Content and quality of clinical practice guidelines for the management of type 2 diabetes in India: A systematic review.

INTRODUCTION: Over the last few decades, India has witnessed an increase in the number of people with type 2 diabetes mellitus (T2DM). Consequently, several clinical practice guidelines (CPGs) have been developed to assist western and traditional Indian medicine practitioners in managing this disease. This systematic review aimed to evaluate and synthesize the content and quality of these CPGs. METHODS: Several databases and sources were searched from inception to May 2022, to identify CPGs for managing adults with T2DM in India. The screening of titles and abstracts and full texts, data extraction and quality assessment were conducted by two independent reviewers. Any disagreements were resolved through discussion or by involving a third reviewer. A data extraction tool from a previous study was adapted to extract the content of the included CPGs, and the Appraisal of Guidelines for Research and Evaluation II tool was used to assess the quality of the included CPGs. A narrative synthesis was conducted. RESULTS: Of 3350 records identified, 11 were retrieved for full-text screening and five CPGs were included in this systematic review-three focused on traditional Indian medicine (Ayurveda) and two focused on western medicine. These two western medicine CPGs contained comprehensive recommendations for managing T2DM but only one of these, the Research Society for the Study of Diabetes in India/Endocrine Society of India (RSSDI/ESI) CPG, was of high quality. CONCLUSIONS: Only one CPG can be recommended for managing T2DM by western medicine practitioners in India. Future CPGs, especially for traditional Indian medicine practitioners, should be developed and updated using the standard CPG manuals and quality appraisal tools. REGISTRATION: PROSPERO (CRD42021279499).

A clinical guideline-based management of type 2 diabetes by ayurvedic practitioners in Nepal: A feasibility cluster randomized controlled trial protocol.

INTRODUCTION: Type 2 diabetes mellitus (T2DM) is a common chronic condition with significant health and socioeconomic consequences. In Nepal, T2DM is a common disease for which people consult ayurvedic (traditional medical system) practitioners and use ayurvedic medicines. Strong concerns remain about the suboptimal T2DM management of many patients by ayurvedic practitioners, and therefore, based on the best available scientific evidence, we have developed a clinical guideline for managing T2DM by ayurvedic practitioners. The research question to be addressed by a definitive cluster randomized controlled trial (RCT) is whether the introduction of a clinical guideline can improve the management of T2DM by ayurvedic practitioners in Nepal as compared to usual ayurvedic management (i.e., without any clinical guideline). In preparation for this future work, this current study aims to determine the feasibility of undertaking the definitive cluster RCT. METHODS: This is a 2-arm, feasibility cluster RCT with a blinded outcome assessment and a qualitative evaluation. The study is conducted in 12 public and private ayurveda centers in and outside the Kathmandu Valley in Nepal (1:1 intervention:control). Eligible participants should be new T2DM adult patients (i.e., treatment naïve) - the glycated hemoglobin level should be 6.5% or above but less than 9%. At least 120 participants (60/group) will be recruited and followed up for 6 months. Important parameters, needed to design the definitive trial, will be estimated, such as the standard deviation of the outcome measure (i.e., glycated hemoglobin level at 6-month follow-up), intraclass correlation coefficient, cluster size, recruitment, the time needed to recruit participants, follow-up, and adherence to the recommended ayurvedic medicine. Semi-structured qualitative interviews will be conducted with around 20 to 30 participants and all the participating ayurvedic practitioners to explore their experiences and perspectives of taking part in the study and of the intervention and a sample of eligible people declining to participate in the study to explore the reasons behind nonparticipation. DISCUSSION: We are now conducting a feasibility cluster RCT in Nepal to determine the feasibility of undertaking the definitive cluster trial. The first participant was recruited on 17 July 2022. If the feasibility is promising (such as recruitment, follow-up, and adherence to the recommended ayurvedic medicine), then the parameters estimated will be used to design the definitive cluster trial. Decisions over whether to modify the protocol will mainly be informed by the qualitative data.

Effectiveness and Safety of Ayurvedic Medicines in Type 2 Diabetes Mellitus Management: A Systematic Review and Meta-Analysis.

Introduction: Many Ayurvedic medicines have the potential for managing type 2 diabetes mellitus (T2DM), with previous systematic reviews demonstrating effectiveness and safety for specific Ayurvedic medicines. However, many of the reviews need updating and none provide a comprehensive summary of all the Ayurvedic medicines evaluated for managing T2DM. Objective: The objective of this systematic review was to evaluate and synthesize evidence on the effectiveness and safety of Ayurvedic medicines for managing T2DM. Inclusion criteria: Published and unpublished RCTs assessing the effectiveness and safety of Ayurvedic medicines for managing T2DM in adults. Methods: The JBI systematic review methodology was followed. A comprehensive search of sources (including 18 electronic databases) from inception to 16 January 2021 was made. No language restrictions were applied. Data synthesis was conducted using narrative synthesis and random effects meta-analyses, where appropriate. Pooled results are reported as mean differences (MD) with 95% confidence intervals (CI). Results: Out of 32,519 records identified from the searches, 219 articles were included in the systematic review representing 199 RCTs (21,191 participants) of 98 Ayurvedic medicines. Overall, in the studies reviewed the methodology was not adequately reported, resulting in poorer methodological quality scoring. Glycated hemoglobin (HbA1c) was reduced using Aegle marmelos (L.) Corrêa (MD -1.6%; 95% CI -3 to -0.3), Boswellia serrata Roxb. (-0.5; -0.7 to -0.4), Gynostemma pentaphyllum (Thunb.) Makino (-1; -1.5 to -0.6), Momordica charantia L. (-0.3; -0.4 to -0.1), Nigella sativa L. (-0.4; -0.6 to -0.1), Plantago ovata Forssk. (-0.9; -1.4 to -0.3), Tinospora cordifolia (Willd.) Hook.f. and Thomson (-0.5; -0.6 to -0.5), Trigonella foenum-graecum L. (-0.6; -0.9 to -0.4), and Urtica dioica L. (-1.3; -2.4 to -0.2) compared to control. Similarly, fasting blood glucose (FBG) was reduced by 4-56 mg/dl for a range of Ayurvedic medicines. Very few studies assessed health-related quality of life (HRQoL). Adverse events were not reported in many studies, and if reported, these were mostly none to mild and predominately related to the gastrointestinal tract. Conclusion: The current evidence suggests the benefit of a range of Ayurvedic medicines in improving glycemic control in T2DM patients. Given the limitations of the available evidence and to strengthen the evidence base, high-quality RCTs should be conducted and reported.

Effectiveness and safety of Ayurvedic medicines in type 2 diabetes mellitus management: a systematic review protocol.

OBJECTIVE: The objective of this review is to evaluate and synthesize evidence on the effectiveness and safety of Ayurvedic medicines for managing type 2 diabetes mellitus. INTRODUCTION: Several randomized controlled trials have been conducted to assess the effectiveness and safety of Ayurvedic medicines for managing type 2 diabetes. Systematic reviews have been conducted on this topic but need to be updated. The findings from this review will be used to develop a clinical guideline for managing type 2 diabetes by Ayurvedic practitioners in India. INCLUSION CRITERIA: Randomized controlled trials assessing the effectiveness and safety of Ayurvedic medicines for managing type 2 diabetes in adults will be included in this systematic review. METHODS: The authors will search for a wide range of sources to find both published and unpublished studies, including, but not limited to, MEDLINE (Ovid), Embase (Ovid), CINAHL (EBSCOhost), PsycINFO (Ovid), Web of Science, Cochrane Central Register of Controlled Trials (CENTRAL), and Allied and Complementary Medicine Database (Ovid). No language restrictions will be applied. The JBI systematic review methodology will be followed when conducting the review. Data synthesis will be conducted using narrative synthesis and meta-analyses, where appropriate. SYSTEMATIC REVIEW REGISTRATION NUMBER: PROSPERO CRD42018118285.

Incidence, prevalence, risk factors and health consequences of polypharmacy in adults in South Asia: a systematic review protocol.

OBJECTIVE: The objective of the systematic review is to summarize the incidence, prevalence, risk factors and health consequences of polypharmacy in adults in South Asia. INTRODUCTION: Several studies have been conducted in South Asia on the incidence, prevalence, risk factors and health consequences of polypharmacy in adults. Until now, no systematic review has been conducted on this topic. INCLUSION CRITERIA: Related epidemiological studies conducted on adults (aged 18 years and over) and residing in any country within South Asia (i.e. Afghanistan, Bangladesh, Bhutan, India, Maldives, Nepal, Pakistan and Sri Lanka) will be eligible for inclusion. METHODS: MEDLINE, Embase, CINAHL, PsycINFO, BNI, Web of Science, Scopus and AMED databases will be searched to identify published studies. The search for unpublished studies will be undertaken in EThOS, OpenGrey and ProQuest Dissertations and Theses. Databases will be searched from their inception dates and no language restrictions will be applied. The JBI systematic review methodology will be followed to conduct the review. Data synthesis will be conducted using narrative synthesis and meta-analyses, where appropriate.

Probiotics for treating eczema.

BACKGROUND: Eczema is a common chronic skin condition. Probiotics have been proposed as an effective treatment for eczema; their use is increasing, as numerous clinical trials are under way. This is an update of a Cochrane Review first published in 2008, which suggested that probiotics may not be an effective treatment for eczema but identified areas in which evidence was lacking. OBJECTIVES: To assess the effects of probiotics for treating patients of all ages with eczema. SEARCH METHODS: We updated our searches of the following databases to January 2017: the Cochrane Skin Group Specialised Register, the Cochrane Central Register of Controlled Trials (CENTRAL), in the Cochrane Library, the Global Resource of Eczema Trials (GREAT) database, MEDLINE, Embase, PsycINFO, the Allied and Complementary Medicine Database (AMED), and Latin American Caribbean Health Sciences Literature (LILACS). We searched five trials registers and checked the reference lists of included studies and relevant reviews for further references to relevant randomised controlled trials (RCTs). We also handsearched a number of conference proceedings. We updated the searches of the main databases in January 2018 and of trials registries in March 2018, but we have not yet incorporated these results into the review. SELECTION CRITERIA: Randomised controlled trials of probiotics (live orally ingested micro-organisms) compared with no treatment, placebo, or other active intervention with no probiotics for the treatment of eczema diagnosed by a doctor. DATA COLLECTION AND ANALYSIS: We used standard methodological procedures as expected by Cochrane. We recorded adverse events from the included studies and from a separate adverse events search conducted for the first review. We formally assessed reporting bias by preparing funnel plots, and we performed trial sequential analysis for the first primary outcome - eczema symptoms at the end of active treatment.We used GRADE to assess the quality of the evidence for each outcome (in italic font). MAIN RESULTS: We included 39 randomised controlled trials involving 2599 randomised participants. We included participants of either gender, aged from the first year of life through to 55 years (only six studies assessed adults), who had mild to severe eczema. Trials were undertaken in primary and secondary healthcare settings, mainly in Europe or Asia. Duration of treatment ranged from four weeks to six months, and duration of follow-up after end of treatment ranged from zero to 36 months. We selected no standard dose: researchers used a variety of doses and concentrations of probiotics. The probiotics used were bacteria of the Lactobacillus and Bifidobacteria species, which were taken alone or combined with other probiotics, and were given with or without prebiotics. Comparators were no treatment, placebo, and other treatments with no probiotics.For all results described in this abstract, the comparator was no probiotics. Active treatment ranged from six weeks to three months for all of the following results, apart from the investigator-rated eczema severity outcome, for which the upper limit of active treatment was 16 weeks. With regard to score, the higher the score, the more severe were the symptoms. All key results reported in this abstract were measured at the end of active treatment, except for adverse events, which were measured during the active treatment period.Probiotics probably make little or no difference in participant- or parent-rated symptoms of eczema (13 trials; 754 participants): symptom severity on a scale from 0 to 20 was 0.44 points lower after probiotic treatment (95% confidence interval (CI) -1.22 to 0.33; moderate-quality evidence). Trial sequential analysis shows that target sample sizes of 258 and 456, which are necessary to demonstrate a minimum mean difference of -2 and -1.5, respectively, with 90% power, have been exceeded, suggesting that further trials with similar probiotic strains for this outcome at the end of active treatment may be futile.We found no evidence suggesting that probiotics make a difference in QoL for patients with eczema (six studies; 552 participants; standardised mean difference (SMD) 0.03, 95% CI -0.36 to 0.42; low-quality evidence) when measured by the participant or the parent using validated disease-specific QoL instruments.Probiotics may slightly reduce investigator-rated eczema severity scores (24 trials; 1596 participants). On a scale of 0 to 103 for total Severity Scoring of Atopic Dermatitis (SCORAD), a score combining investigator-rated eczema severity score and participant scoring for eczema symptoms of itch and sleep loss was 3.91 points lower after probiotic treatment than after no probiotic treatment (95% CI -5.86 to -1.96; low-quality evidence). The minimum clinically important difference for SCORAD has been estimated to be 8.7 points.We noted significant to extreme levels of unexplainable heterogeneity between the results of individual studies. We judged most studies to be at unclear risk of bias; six studies had high attrition bias, and nine were at low risk of bias overall.We found no evidence to show that probiotics make a difference in the risk of adverse events during active treatment (risk ratio (RR) 1.54, 95% CI 0.90 to 2.63; seven trials; 402 participants; low-quality evidence). Studies in our review that reported adverse effects described gastrointestinal symptoms. AUTHORS' CONCLUSIONS: Evidence suggests that, compared with no probiotic, currently available probiotic strains probably make little or no difference in improving patient-rated eczema symptoms. Probiotics may make little or no difference in QoL for people with eczema nor in investigator-rated eczema severity score (combined with participant scoring for eczema symptoms of itch and sleep loss); for the latter, the observed effect was small and of uncertain clinical significance. Therefore, use of probiotics for the treatment of eczema is currently not evidence-based. This update found no evidence of increased adverse effects with probiotic use during studies, but a separate adverse events search from the first review revealed that probiotic treatment carries a small risk of adverse events.Results show significant, unexplainable heterogeneity between individual trial results. Only a small number of studies measured some outcomes.Future studies should better measure QoL scores and adverse events, and should report on new probiotics. Researchers should also consider studying subgroups of patients (e.g. patients with atopy or food allergies, adults) and standardising doses/concentrations of probiotics given.

Diet during pregnancy and infancy and risk of allergic or autoimmune disease: A systematic review and meta-analysis.

BACKGROUND: There is uncertainty about the influence of diet during pregnancy and infancy on a child's immune development. We assessed whether variations in maternal or infant diet can influence risk of allergic or autoimmune disease. METHODS AND FINDINGS: Two authors selected studies, extracted data, and assessed risk of bias. Grading of Recommendations Assessment, Development and Evaluation (GRADE) was used to assess certainty of findings. We searched Medical Literature Analysis and Retrieval System Online (MEDLINE), Excerpta Medica dataBASE (EMBASE), Web of Science, Central Register of Controlled Trials (CENTRAL), and Literatura Latino Americana em Ciências da Saúde (LILACS) between January 1946 and July 2013 for observational studies and until December 2017 for intervention studies that evaluated the relationship between diet during pregnancy, lactation, or the first year of life and future risk of allergic or autoimmune disease. We identified 260 original studies (964,143 participants) of milk feeding, including 1 intervention trial of breastfeeding promotion, and 173 original studies (542,672 participants) of other maternal or infant dietary exposures, including 80 trials of maternal (n = 26), infant (n = 32), or combined (n = 22) interventions. Risk of bias was high in 125 (48%) milk feeding studies and 44 (25%) studies of other dietary exposures. Evidence from 19 intervention trials suggests that oral supplementation with nonpathogenic micro-organisms (probiotics) during late pregnancy and lactation may reduce risk of eczema (Risk Ratio [RR] 0.78; 95% CI 0.68-0.90; I2 = 61%; Absolute Risk Reduction 44 cases per 1,000; 95% CI 20-64), and 6 trials suggest that fish oil supplementation during pregnancy and lactation may reduce risk of allergic sensitisation to egg (RR 0.69, 95% CI 0.53-0.90; I2 = 15%; Absolute Risk Reduction 31 cases per 1,000; 95% CI 10-47). GRADE certainty of these findings was moderate. We found weaker support for the hypotheses that breastfeeding promotion reduces risk of eczema during infancy (1 intervention trial), that longer exclusive breastfeeding is associated with reduced type 1 diabetes mellitus (28 observational studies), and that probiotics reduce risk of allergic sensitisation to cow's milk (9 intervention trials), where GRADE certainty of findings was low. We did not find that other dietary exposures-including prebiotic supplements, maternal allergenic food avoidance, and vitamin, mineral, fruit, and vegetable intake-influence risk of allergic or autoimmune disease. For many dietary exposures, data were inconclusive or inconsistent, such that we were unable to exclude the possibility of important beneficial or harmful effects. In this comprehensive systematic review, we were not able to include more recent observational studies or verify data via direct contact with authors, and we did not evaluate measures of food diversity during infancy. CONCLUSIONS: Our findings support a relationship between maternal diet and risk of immune-mediated diseases in the child. Maternal probiotic and fish oil supplementation may reduce risk of eczema and allergic sensitisation to food, respectively.

Smoking in movies and smoking initiation in adolescents: systematic review and meta-analysis.

BACKGROUND AND AIMS: Preventing young people from initiating smoking is a vital public health objective. There is strong evidence that exposure to smoking imagery in movies is associated with an increased risk of smoking uptake. However, the estimate of the magnitude of effect is not clear, as previous reviews have synthesized estimates of cross-sectional and longitudinal associations. Therefore, we have performed a systematic review to quantify cross-sectional and longitudinal associations between exposure to smoking in movies and initiating smoking in adolescents. METHODS: Four electronic databases (MEDLINE, EMBASE, PsycINFO and International Bibliography of the Social Sciences, IBSS) and grey literature were searched from inception to May 2015 for comparative epidemiological studies (cross-sectional and cohort studies) that reported the relation between exposure to smoking in movies and smoking initiation in adolescence (10-19 years). Reference lists of studies and previous reviews were also screened. Two authors screened papers and extracted data independently. RESULTS: Seventeen studies met our inclusion criteria. Random-effects meta-analysis of nine cross-sectional studies demonstrated higher exposure (typically highest versus lowest quantile) to smoking in movies was associated significantly with a doubling in risk of ever trying smoking [relative risk (RR) = 1.93, 95% confidence interval (CI) = 1.66-2.25]. In eight longitudinal studies (all deemed high quality), higher exposure to smoking in movies was associated significantly with a 46% increased risk of initiating smoking (RR = 1.46; 95% CI = 1.23-1.73). These pooled estimates were significantly different from each other (P = 0.02). Moderate levels of heterogeneity were seen in the meta-analyses. CONCLUSIONS: The cross-sectional association between young people reporting having seen smoking imagery in films and smoking status is greater than the prospective association. Both associations are substantial, but it is not clear whether or not they are causal.

Interventions for vitiligo.

BACKGROUND: Vitiligo is a chronic skin disorder characterised by patchy loss of skin colour. Some people experience itching before the appearance of a new patch. It affects people of any age or ethnicity, more than half of whom develop it before the age of 20 years. There are two main types: generalised vitiligo, the common symmetrical form, and segmental, affecting only one side of the body. Around 1% of the world's population has vitiligo, a disease causing white patches on the skin. Several treatments are available. Some can restore pigment but none can cure the disease. OBJECTIVES: To assess the effects of all therapeutic interventions used in the management of vitiligo. SEARCH METHODS: We updated our searches of the following databases to October 2013: the Cochrane Skin Group Specialised Register, CENTRAL in The Cochrane Library (2013, Issue 10), MEDLINE, Embase, AMED, PsycINFO, CINAHL and LILACS. We also searched five trials databases, and checked the reference lists of included studies for further references to relevant randomised controlled trials (RCTs). SELECTION CRITERIA: Randomised controlled trials (RCTs) assessing the effects of treatments for vitiligo. DATA COLLECTION AND ANALYSIS: At least two review authors independently assessed study eligibility and methodological quality, and extracted data. MAIN RESULTS: This update of the 2010 review includes 96 studies, 57 from the previous update and 39 new studies, totalling 4512 participants. Most of the studies, covering a wide range of interventions, had fewer than 50 participants. All of the studies assessed repigmentation, however only five reported on all of our three primary outcomes which were quality of life, > 75% repigmentation and adverse effects. Of our secondary outcomes, six studies measured cessation of spread but none assessed long-term permanence of repigmentation resulting from treatment at two years follow-up.Most of the studies assessed combination therapies which generally reported better results. New interventions include seven new surgical interventions.We analysed the data from 25 studies which assessed our primary outcomes. We used the effect measures risk ratio (RR), and odds ratio (OR) with their 95% confidence intervals (CI) and where N is the number of participants in the study.We were only able to analyse one of nine studies assessing quality of life and this showed no statistically significant improvement between the comparators.Nine analyses from eight studies reported >75% repigmentation. In the following studies the repigmentation was better in the combination therapy group: calcipotriol plus PUVA (psoralen with UVA light) versus PUVA (paired OR 4.25, 95% CI 1.43 to 12.64, one study, N = 27); hydrocortisone-17-butyrate plus excimer laser versus excimer laser alone (RR 2.57, 95% CI 1.20 to 5.50, one study, N = 84); oral minipulse of prednisolone (OMP) plus NB-UVB (narrowband UVB) versus OMP alone (RR 7.41, 95% CI 1.03 to 53.26, one study, N = 47); azathioprine with PUVA versus PUVA alone (RR 17.77, 95% CI 1.08 to 291.82, one study, N = 58) and 8-Methoxypsoralen (8-MOP ) plus sunlight versus psoralen (RR 2.50, 95% CI 1.06 to 5.91, one study, N = 168). In these three studies ginkgo biloba was better than placebo (RR 4.40, 95% CI 1.08 to 17.95, one study, N = 47); clobetasol propionate was better than PUVAsol (PUVA with sunlight) (RR 4.70, 95% CI 1.14 to 19.39, one study, N = 45); split skin grafts with PUVAsol was better than minipunch grafts with PUVAsol (RR 1.89, 95% CI 1.25 to 2.85, one study, N = 64).We performed one meta-analysis of three studies, in which we found a non-significant 60% increase in the proportion of participants achieving >75% repigmentation in favour of NB-UVB compared to PUVA (RR 1.60, 95% CI 0.74 to 3.45; I² = 0%).Studies assessing topical preparations, in particular topical corticosteroids, reported most adverse effects. However, in combination studies it was difficult to ascertain which treatment caused these effects. We performed two analyses from a pooled analysis of three studies on adverse effects. Where NB-UVB was compared to PUVA, the NB-UVB group reported less observations of nausea in three studies (RR 0.13, 95% CI 0.02 to 0.69; I² = 0% three studies, N = 156) and erythema in two studies (RR 0.73, 95% CI 0.55 to 0.98; I² = 0%, two studies, N = 106), but not itching in two studies (RR 0.57, 95% CI 0.20 to 1.60; I² = 0%, two studies, N = 106).Very few studies only assessed children or included segmental vitiligo. We found one study of psychological interventions but we could not include the outcomes in our statistical analyses. We found no studies evaluating micropigmentation, depigmentation, or cosmetic camouflage. AUTHORS' CONCLUSIONS: This review has found some evidence from individual studies to support existing therapies for vitiligo, but the usefulness of the findings is limited by the different designs and outcome measurements and lack of quality of life measures. There is a need for follow-up studies to assess permanence of repigmentation as well as high- quality randomised trials using standardised measures and which also address quality of life.

Lasers or light sources for treating port-wine stains.

BACKGROUND: Port-wine stains are birthmarks caused by malformations of blood vessels in the skin. Port-wine stains manifest themselves in infancy as a flat, red mark and do not regress spontaneously but may, if untreated, become darker and thicker in adult life. The profusion of various lasers and light sources makes it difficult to decide which equipment is the best for treating port-wine stains. OBJECTIVES: To study participant satisfaction, clinical efficacy, and adverse effects of the treatment of port-wine stains by lasers and light sources. SEARCH METHODS: We searched the following databases up to April 2010: the Cochrane Skin Group Specialised Register, the Cochrane Central Register of Controlled Trials (Clinical Trials) in The Cochrane Library, MEDLINE (from 2005), EMBASE (from 2007), LILACS (Latin American and Caribbean Health Science Information database, from 1982), and reference lists of articles. We also searched online trials registries for ongoing trials and contacted trial authors where appropriate. SELECTION CRITERIA: Randomised clinical trials (RCTs) of lasers or light sources for the treatment of port-wine stains. DATA COLLECTION AND ANALYSIS: Our outcomes of interest were participant satisfaction, reduction in redness of the port-wine stain as determined by clinical evaluation, and short- and long-term adverse effects of the treatments. Three authors independently extracted data and assessed trial quality. MAIN RESULTS: We included 5 RCTs involving a total of 103 participants; all of the trials used a within-participant design. The interventions and outcomes were too varied to be combined statistically. All trials used the pulsed dye laser for comparisons.None of the studies focused on participant satisfaction, which was one of our primary outcomes, but participant preference was evaluated in three of five studies. Participants preferred the pulsed dye laser to intense pulsed light based on the clinical effect. They marginally preferred the Neodymium:YAG (yttrium-aluminium-garnet) (Nd:YAG) laser to the pulsed dye laser due to shorter lasting purpura, and pulsed dye laser in conjunction with cooling was preferred to treatment with pulsed dye laser alone.All trials examined short-term efficacy of less than six months after treatments with the pulsed dye laser, intense pulsed light, and Nd:YAG laser. The pulsed dye laser was evaluated in all five trials. Depending upon the setting of the pulsed dye laser, this resulted in more than 25% reduction in redness. This was after 1 to 3 treatments for up to 4 to 6 months postoperatively in 50% to 100% of the participants. There was only one study each of intense pulsed light and Nd:YAG laser.Two trials had no occurrence of long-term adverse effects, i.e. six months after treatment. Three trials reported pigmentary alterations in 3% to 24% of the participants, with the highest percentage occurring in Chinese participants with darker skin types. In one study one participant experienced scarring of the skin caused by a too-high dose of the laser used. Short-term side-effects included pain, crusting, and blistering in the first two weeks after treatment. AUTHORS' CONCLUSIONS: The pulsed dye laser leads to clinically relevant clearance of port-wine stains. A limited number of RCTs evaluated the efficacy from intense pulsed light and other laser types. High-quality RCTs are needed to assess individual efficacy from different lasers and light sources, as well as participant satisfaction.

Interventions for infantile haemangiomas (strawberry birthmarks) of the skin.

BACKGROUND: Infantile haemangiomas (also known as strawberry birthmarks) are soft, raised swellings of the skin which are usually uncomplicated and tend to regress spontaneously over time. Some haemangiomas occur in high-risk areas or can develop complications; therefore, intervention may be necessary. Various interventions have been proposed, but it is unclear whether any of these interventions are effective. OBJECTIVES: To assess the effects of interventions for infantile haemangiomas. SEARCH STRATEGY: We searched the following databases up to March 2011: the Cochrane Skin Group Specialised Register, the Cochrane Central Register of Controlled Trials (Clinical Trials) in The Cochrane Library, MEDLINE, EMBASE, PsycINFO, AMED (Allied and Complementary Medicine), LILACS (Latin American and Caribbean Health Science Information database), CINAHL, and reference lists of articles. We also searched online trials registries for ongoing trials and grey literature. SELECTION CRITERIA: We included children with haemangiomas. DATA COLLECTION AND ANALYSIS: Two authors independently screened titles, abstracts, and the full text of publications; extracted data; and assessed risk of bias. MAIN RESULTS: We included 4 studies with a total of 271 participants.One randomised controlled trial (RCT) compared pulsed dye laser (PDL) therapy versus the 'wait and see' approach. At one year PDL was significantly more likely to result in complete clearance. The risk ratio (RR) was 6.10 (95% CI [confidence interval] 1.89 to 19.64); however, there was no difference when clearance was defined as 'complete or minimal residual signs'. Redness was significantly less pronounced in the PDL group, but no differences were seen for height or surface area. Significant increases in atrophy and skin hypopigmentation were seen in the PDL group.One very old RCT assessed radiation versus mock-radiation; there was no significant difference in clearance at six years (RR 1.08, 95% CI 0.63 to 1.87) between the groups, irrespective of the size of the haemangioma and the skin colour.In one small RCT there was a significantly greater reduction in size of the haemangioma with oral prednisolone compared to intravenous methylprednisolone at three months (mean difference [MD] was 58 mm [95% CI 29.24 to 86.76]), and one year. Similar adverse events occurred in both groups.In another small RCT there was a significant reduction in the surface area of the haemangioma with bleomycin compared to the control (RR 21, 95% CI 1.34 to 328.86). AUTHORS' CONCLUSIONS: This review has found limited evidence from individual RCTs to support some of the existing interventions (corticosteroid and PDL) for infantile haemangiomas. There is a need for further high-quality RCTs to validate the findings from these studies, and RCTs to assess the effect of other treatments, in particular relating to propranolol.

Interventions for non-metastatic squamous cell carcinoma of the skin.

BACKGROUND: Squamous cell carcinoma (SCC) is the second most common skin cancer, and is becoming increasingly common around the world. Left untreated, it may spread to other parts of the body, and, although the risk is low, it may ultimately lead to death. Surgical excision is the first line of treatment for most skin SCCs, although other forms of treatment are also used depending upon the nature and site of the tumour and individual participant factors. A multi-professional approach is therefore required for the management of people with this condition. OBJECTIVES: To assess the effects of treatments for primary non-metastatic squamous cell carcinoma of the skin. SEARCH STRATEGY: In February 2010 we searched for relevant trials in The Cochrane Skin Group Specialised Register, The Cochrane Library (Issue 1, 2010), MEDLINE, EMBASE, PsycINFO, AMED, LILACS, and the ongoing trials registries. SELECTION CRITERIA: We only included randomised controlled trials (RCTs) of interventions for primary SCC of the skin. Inclusion criteria were: adults with one or more histologically proven primary SCCs of the skin which had not metastasised. The primary outcome measures were time to recurrence one to five years after treatment, and quality of life. Secondary outcomes included early treatment failure within six months, number of adverse events by the end of treatment, aesthetic appearance as assessed by the participant and clinician, discomfort to the participant during and after treatment, and death. DATA COLLECTION AND ANALYSIS: Two authors (LL, FB-H) independently carried out study selection and assessment of methodological quality and data extraction. MAIN RESULTS: One trial involving 65 people was included. This compared the time to recurrence in participants with aggressive skin SCC who were randomised to receive either adjuvant 13-cis-retinoic acid and interferon alpha after surgery with or without radiation treatment, or no adjuvant therapy after their initial treatment. There was no significant difference in time to recurrence of tumour between the two groups (hazard ratio 1.08, 95% confidence intervals 0.43 to 2.72).Most studies identified from the searches were excluded as they were either uncontrolled case series, did not include participants with invasive primary SCC, or included only participants with recurrent or metastatic disease. AUTHORS' CONCLUSIONS: Little evidence from RCTs comparing the efficacy of different interventions for primary cutaneous SCCs exists. There is a clear need for well-designed randomised studies in order to improve the evidence base for the management of this condition.

Interventions for vitiligo.

BACKGROUND: Around one per cent of the world's population has vitiligo, a disease which causes white patches on the skin. There are a variety of treatments available, most of which are unsatisfactory. OBJECTIVES: To assess all interventions used to manage vitiligo. SEARCH STRATEGY: In November 2009 we updated searches of the Cochrane Skin Group Specialised Register, the Cochrane Central Register of Controlled Trials in The Cochrane Library (Issue 4, 2009), MEDLINE, EMBASE, AMED, PsycINFO, LILACS and ongoing trials databases. SELECTION CRITERIA: Randomised controlled trials (RCTs). DATA COLLECTION AND ANALYSIS: At least 2 review authors independently assessed study eligibility and methodological quality, and carried out data extraction. Two of the 57 included studies could be combined for meta-analysis. MAIN RESULTS: In this update, 57 trials, including 19 from the original review, were assessed with 3139 participants. Most of the RCTs, which covered a wide range of interventions, had fewer than 50 participants. All of the studies assessed repigmentation, 6 measured cessation of spread, and 5 investigated the effect of treatment on quality of life.Most of the studies assessed combination therapies which generally reported better results. New interventions include monochromatic excimer light (MEL), Polypodium leucotomos, melanocyte transplantation, oral antioxidants, Chinese zengse pill, and pimecrolimus. We analysed the data from 28 studies that met our outcome criteria of improvement in quality of life and greater than 75% repigmentation.Fifteen analyses from studies comparing various interventions showed a statistically significant difference between the proportions of participants achieving more than 75% repigmentation. The majority of analyses showing statistically significant differences were from studies that assessed combination interventions which generally included some form of light treatment.Topical preparations, in particular corticosteroids, reported most adverse effects. However, in the combination studies it was difficult to ascertain which treatment caused these effects. None of the studies was able to demonstrate long-term benefits. Very few studies were conducted on children or included segmental vitiligo. We found one study of psychological interventions and none evaluating micropigmentation, depigmentation, or cosmetic camouflage. AUTHORS' CONCLUSIONS: This review has found some evidence from individual studies to support existing therapies for vitiligo, but the usefulness of the findings is limited by the different designs and outcome measurements and lack of quality of life measures. There is a need for follow-up studies to assess permanence of repigmentation as well as high quality randomised trials using standardised measures and which also address quality of life.