Interventions for basal cell carcinoma: abridged Cochrane systematic review and GRADE assessments.

BACKGROUND: Basal cell carcinoma (BCC) is the most common cancer affecting white-skinned individuals, and the worldwide incidence is increasing. Although rarely fatal, BCC is associated with significant morbidity and costs. OBJECTIVES: To assess the effects of interventions for primary BCC in immunocompetent adults. METHODS: We updated our searches of the following databases to November 2019: Cochrane Skin Group Specialised Register, CENTRAL, MEDLINE, Embase, CINAHL and LILACS. Certainty of evidence was assessed using the Grading of Recommendations Assessment, Development and Evaluation method. We used standard methodological procedures expected by Cochrane. RESULTS: We included 52 randomized controlled trials with 6990 participants (median age 65 years; range 20-95). Mean study duration was 13 months (range 6 weeks-10 years). Ninety-two per cent (n = 48/52) of studies exclusively included histologically low-risk BCC (nodular and superficial subtypes). The certainty of evidence was predominantly low or moderate for the outcomes of interest. Overall, surgical interventions have the lowest recurrence rates, and there may be slightly fewer recurrences with Mohs micrographic surgery over surgical excision for primary, facial BCC (high-risk histological subtype or located in the 'H-zone' or both) (low-certainty evidence). Nonsurgical treatments, when used for low-risk BCC, are less effective than surgical treatments, but recurrence rates are acceptable and cosmetic outcomes are probably superior. CONCLUSIONS: Surgical interventions have lower recurrence rates and remain the gold standard for high-risk BCC. Of the nonsurgical treatments, topical imiquimod has the best evidence to support its efficacy for low-risk BCC. Priorities for future research include agreement on core outcome measures and studies with longer follow-up.

The needs and experiences of patients with skin cancer: a qualitative systematic review with metasynthesis.

Skin cancer incidence is increasing worldwide. This is an update of a previous review published in 2010 that identified only two studies and found that the needs and experiences of individuals with skin cancer were under-researched. Our objective was to undertake a qualitative systematic review of the needs and experiences of people with a diagnosis of skin cancer. To update the previous review, the following databases were searched from 2010 to 30 November 2015: CINAHL PsycINFO, Medline and Embase. The methodological quality of the studies was assessed using the Joanna Briggs Institute Qualitative Assessment Review Instrument. The qualitative research findings were synthesized using a pragmatic meta-aggregative approach. A total of 14 studies (16 papers) were included. Only three studies included patients with keratinocyte carcinoma. Overall, 15 categories were identified and these resulted in four overarching synthesized findings (SFs) from diagnosis (SF1), throughout treatment (SF2) and follow-up (SF3), and then a fourth SF (SF4) that addressed patients' satisfaction with their care and their relationship with healthcare professionals. Despite the fact that patients with keratinocyte carcinoma and melanoma can have a very different prognosis, they also share similar needs and concerns especially around the time of diagnosis and follow-up/surveillance for new lesions. Healthcare professionals working with patients with skin cancer need to understand their psychosocial concerns and their information needs in order to design services appropriately. Future studies need to consider patients with keratinocyte carcinoma in addition to patients with melanoma.

Regional variations of basal cell carcinoma incidence in the U.K. using The Health Improvement Network database (2004-10).

BACKGROUND: Basal cell carcinoma (BCC) is one of the most common types of nonmelanoma skin cancer affecting the white population; however, little is known about how the incidence varies across the U.K. OBJECTIVES: To determine the variation in BCC throughout the U.K. METHODS: Data from 2004 to 2010 were obtained from The Health Improvement Network database. European and world age-standardized incidence rates (EASRs and WASRs, respectively) were obtained for country-level estimates and levels of socioeconomic deprivation, while strategic health-authority-level estimates were directly age and sex standardized to the U.K. standard population. Incidence-rate ratios were estimated using multivariable Poisson regression models. RESULTS: The overall EASR and WASR of BCC in the U.K. were 98.6 per 100,000 person-years and 66.9 per 100,000 person-years, respectively. Regional-level incidence rates indicated a significant geographical variation in the distribution of BCC, which was more pronounced in the southern parts of the country. The South East Coast had the highest BCC rate followed by South Central, Wales and the South West. Incidence rates were substantially higher in the least deprived groups and we observed a trend of decreasing incidence with increasing levels of deprivation (P < 0.001). Finally, in terms of age groups, the largest annual increase was observed among those aged 30-49 years. CONCLUSIONS: Basal cell carcinoma is an increasing health problem in the U.K.; the southern regions of the U.K. and those in the least deprived groups had a higher incidence of BCC. Our findings indicate an increased incidence of BCC for younger age groups below 49 years.

A systematic review of worldwide incidence of nonmelanoma skin cancer.

BACKGROUND: Nonmelanoma skin cancer (NMSC) is the most common cancer affecting white-skinned individuals and the incidence is increasing worldwide. OBJECTIVES: This systematic review brings together 75 studies conducted over the past half century to look at geographical variations and trends worldwide in NMSC, and specifically incidence data are compared with recent U.K. cancer registry data. METHODS: Following the development of a comprehensive search strategy, an assessment tool was adapted to look at the methodological quality of the eligible studies. RESULTS: Most of the studies focused on white populations in Europe, the U.S.A. and Australia; however, limited data were available for other skin types in regions such as Africa. Worldwide the incidence for NMSC varies widely with the highest rates in Australia [>1000/100, 000 person-years for basal cell carcinoma (BCC)] and the lowest rates in parts of Africa (< 1/100, 000 person-years for BCC). The average incidence rates in England were 76·21/100, 000 person-years and 22·65/100, 000 person-years for BCC and squamous cell carcinoma (SCC), respectively, with highest rates in the South-West of England (121·29/100, 000 person-years for BCC and 33·02/100, 000 person-years for SCC) and lowest rates by far in London (0·24/100, 000 person-years for BCC and 14·98/100, 000 person-years for SCC). The incidence rates in the U.K. appear to be increasing at a greater rate when compared with the rest of Europe. CONCLUSIONS: NMSC is an increasing problem for health care services worldwide. This review highlights a requirement for prevention studies in this area and the issues surrounding incomplete NMSC registration. Registration standards of NMSC should be improved to the level of other invasive disease.

Lifestyle factors of smoking, BMI and alcohol on the risk of Non-Melanoma Skin Cancer in adults: a systematic review.

BACKGROUND: Non-melanoma skin cancer is the most common cancer in humans and the most important risk factors are thought to be age, skin type, and exposure to ultraviolet radiation. Lifestyle factors may also play a part. To date no systematic review has been performed to collate evidence of the effects of smoking, alcohol or body mass index. OBJECTIVES: We performed a systematic review and meta-analysis to assess the effects of smoking, alcohol and body mass index on the risk of non-melanoma skin cancer and its subtypes. INCLUSION CRITERIA: Adults (18+ years old) of either sex from any ethnicitySmoking, alcohol, or body mass index (including other anthropometric measurements, such as weight, waist to hip ratio, and the percentage body fat)Non-melanoma skin cancer, cutaneous squamous cell carcinoma, or basal cell carcinomaComparative observational epidemiological studies SEARCH STRATEGY: We performed a comprehensive search of MEDLINE, EMBASE, CINAHL, Cochrane Library and CAB Abstracts from inception to October 2010. We also scanned reference lists to identify further eligible studies. METHODOLOGICAL QUALITY: Data from eligible studies were extracted and quality assessed using the Newcastle Ottawa Scale independently by two reviewers. DATA COLLECTION: The titles, abstracts and full text identified from the search were assessed independently by two reviewers against pre-specified inclusion/exclusion criteria. Disagreements were resolved through discussion with a third reviewer. DATA SYNTHESIS: For studies with similar exposures, a meta-analysis was performed using a random effects model and results were expressed as pooled odds ratio with 95% confidence intervals. Heterogeneity was assessed using I. Publication bias was assessed using funnel plots. Data were analysed using Review Manager. RESULTS: Thirty studies were included of which 22 used a case control design and the remaining used a cohort design. The overall quality of the studies was variable with a Newcastle Ottawa Scale median score of 6 out of 9 stars. No evidence of asymmetry was detected in the funnel plots. Smoking was not significantly related to increased risks of non-melanoma skin cancer (Odds Ratio 0.62, 95% CI 0.21 to 1.79, I=34%, 2 studies) or basal cell carcinoma (Odds Ratio 0.95, 95% CI 0.82 to 1.09; I=59%, 14 studies). However, smoking was significantly associated with a 52% increase in the risk of cutaneous squamous cell carcinoma (95% CI 1.15 to 2.01; I=64%; 6 studies). Subgroup analysis found no significant difference in results based on the definition of smoking (current, former, or ever smoker) for basal cell carcinoma, cutaneous squamous cell carcinoma or non-melanoma skin cancer. Alcohol was not significantly related to increased risks of non-melanoma skin cancer (1 study), basal cell carcinoma (Odds Ratio 1.03, 95% CI 0.94 to 1.13, I=0%, 9 studies) or cutaneous squamous cell carcinoma (1 study). Similar results were found irrespective of the type of alcohol assessed (beer, wine, or spirits) for basal cell carcinoma and cutaneous squamous cell carcinoma. A pooled analysis of five studies found a non-significant decrease in the risk of basal cell carcinoma associated with a higher body mass index (Odds Ratio 0.94, 95% CI 0.84 to 1.04, I=40%). In a subgroup analysis based on sex, the potential reduction in risk of basal cell carcinoma appeared to be confined to males (Males: Odds Ratio 0.90, 95% CI 0.78 to 1.04, I=45%, 4 studies; Females: Odds Ratio 1.01, 95% CI 0.85 to 1.19, I=14%, 3 studies). CONCLUSION: It is unclear at present if smoking modifies the risk of basal cell carcinoma; however, smoking clearly increases the risk of cutaneous squamous cell carcinoma. Limited evidence has been published about the risk of non-melanoma skin cancer with alcohol and body mass index; however there is some suggestion a high body mass index may be slightly protective of basal cell carcinoma, particularly in males.This study highlights the importance for clinicians to actively survey high risk patients, including current smokers.The majority of studies included in this systematic review assessed the associations between basal cell carcinoma and smoking, alcohol or body mass index. However, more evidence is needed before conclusive recommendations can be formed regarding the relationship between cutaneous squamous cell carcinoma and alcohol or body mass index.

Interventions to reduce Staphylococcus aureus in the management of atopic eczema: an updated Cochrane review.

BACKGROUND: An association between the bacterium Staphylococcus aureus and atopic eczema has been recognized for many years. Although few would dispute the benefit of systemic antibiotics in people with overtly clinically infected eczema, the clinical role of S. aureus in causing inflammatory flares in clinically uninfected eczema is less clear. OBJECTIVES/METHODS: To see if atopic eczema can be improved by antistaphylococcal agents, we performed a systematic review of randomized controlled trials (RCTs) using Cochrane Skin Group's Specialised Register, the Cochrane Central Register of Controlled Trials, MEDLINE (from 2000), EMBASE (from 1980), the metaRegister of Current Controlled Trials (to March 2009), plus manual searching of references and conference proceedings. RCTs that compared interventions to reduce S. aureus in people with atopic eczema with no treatment, vehicle, or another active compound were included. Publication status and language were not barriers to inclusion. RESULTS: Twenty-six studies involving 1229 participants were included. The studies were generally short term and of poor quality. There was no significant difference in global outcome for clinically infected eczema when oral antibiotics were compared with placebo [one study, relative risk (RR) 0.40, 95% confidence interval (CI) 0.13-1.24] or when topical steroid antibiotic combinations were compared with steroid alone (two studies, RR 0.52, 95% CI 0.23-1.16). One study of children with infected eczema that added bleach to bathwater showed a significant improvement in eczema severity when compared with bathwater alone, although the difference could have been explained by regression to the mean. Although antistaphylococcal interventions reduced S. aureus numbers in people with clinically uninfected eczema, none of the studies showed any clinical benefit. CONCLUSIONS: We failed to find any evidence that commonly used antistaphylococcal interventions are clinically helpful in people with eczema that is not clinically infected. Their continued use should be questioned in such situations, until better and longer-term studies show clear evidence of clinical benefit.

Probiotics for the treatment of eczema: a systematic review.

BACKGROUND: Probiotics have been proposed as a treatment for eczema, but the results of intervention trials have been mixed. OBJECTIVE: To evaluate the efficacy of probiotics for treating eczema by performing a systematic review of randomized-controlled trials (RCTs). DESIGN: We searched the Cochrane Skin Group Specialised Register, Cochrane Central Register of Controlled Trials, MEDLINE, EMBASE, PsycINFO, AMED, LILACS, ISI Web of Science, the reference lists of articles, ongoing clinical trial registers and conference proceedings. RCTs of live orally ingested microorganisms for the treatment of eczema were eligible for inclusion. RESULTS: Twelve trials (781 participants) were identified. Meta-analysis of data from five of these trials showed that there was no significant reduction in eczema symptoms with probiotic treatment compared with placebo (mean difference -0.90 points on a 20-point visual analogue scale; 95% confidence interval -2.84, 1.04). Meta-analysis of data from seven trials showed no significant difference in investigator rated eczema severity between probiotic and placebo treatments. Subgroup analysis by eczema severity or presence of atopy did not identify a specific population in which probiotic treatment was effective. There was significant heterogeneity between studies; however, the results of three studies that used the same probiotic strain were concordant. The adverse events search identified case reports of sepsis and bowel ischaemia caused by probiotics. CONCLUSIONS: Currently, probiotics cannot be recommended for treating eczema. The heterogeneity between studies may be attributable to probiotic strain-specific effects, which means that novel probiotic strains may still have a role in eczema management.

Dietary exclusions for improving established atopic eczema in adults and children: systematic review.

Atopic eczema is the most common inflammatory skin disease of childhood in developed countries. We performed a systematic review of randomized controlled trials to assess the effects of dietary exclusions for the treatment of established atopic eczema. Nine trials (421 participants) were included, most of which were poorly reported. Six were studies of egg and milk exclusion (n = 288), one was a study of few foods (n = 85) and two were studies of an elemental diet (n = 48). There appears to be no benefit of an egg- and milk-free diet in unselected participants with atopic eczema. There is also no evidence of benefit in the use of an elemental or few-foods diet in unselected cases of atopic eczema. There may be some benefit in using an egg-free diet in infants with suspected egg allergy who have positive specific IgE to eggs - one study found 51% of the children had a significant improvement in body surface area with the exclusion diet as compared with normal diet (95% CI 1.07-2.11) and change in surface area and severity score was significantly improved in the exclusion diet as compared with the normal diet at the end of 6 weeks (MD 5.50, 95% CI 0.19-10.81) and end of treatment (MD 6.10, 95% CI 0.06-12.14). Despite their frequent use, we find little good quality evidence to support the use of exclusion diets in atopic eczema.

Dietary exclusions for established atopic eczema.

BACKGROUND: Atopic eczema (AE) is a non-infective chronic inflammatory skin disease characterised by an itchy red rash. OBJECTIVES: To assess the effects of dietary exclusions for the treatment of established atopic eczema. SEARCH STRATEGY: We searched The Cochrane Skin Group Specialised Register (to March 2006), The Cochrane Central Register of Controlled Trials (CENTRAL) in The Cochrane Library (Issue 1, 2006), MEDLINE (2003 to March 2006), EMBASE (2003 to March 2006), LILACS (to March 2006), PsycINFO (1806 to March 2006), AMED (1985 to March 2006), ISI Web of Science (March 2006), www.controlled-trials.com, www.clinicaltrials.gov and www.nottingham.ac.uk/ongoingskintrials (March 2006). Pharmaceutical companies were contacted where appropriate for reviews or unpublished trials. SELECTION CRITERIA: People who have atopic eczema as diagnosed by a doctor. DATA COLLECTION AND ANALYSIS: Two independent authors carried out study selection and assessment of methodological quality. MAIN RESULTS: We found 9 RCTs involving a total of 421 participants of which 6 were studies of egg and milk exclusion (N=288), 1 was a study of few foods (N=85) and 2 were studies of an elemental diet (N=48). There appears to be no benefit of an egg and milk free diet in unselected participants with atopic eczema. There is also no evidence of benefit in the use of an elemental or few-foods diet in unselected cases of atopic eczema. There may be some benefit in using an egg-free diet in infants with suspected egg allergy who have positive specific IgE to eggs - one study found 51% of the children had a significant improvement in body surface area with the exclusion diet compared to normal diet (RR 1.51, 95% CI 1.07 to 2.11) and change in surface area and severity score was significantly improved in the exclusion diet compared to the normal diet at the end of 6 weeks (MD 5.50,95% CI 0.19 to 10.81) and end of treatment (MD 6.10, 95% CI 0.06 to12.14). Methodological difficulties have made it difficult to interpret these studies. Poor concealment of randomisation allocation, lack of blinding and high dropout rates without an intention-to-treat analysis indicates that these studies should be interpreted with great caution. AUTHORS' CONCLUSIONS: There may be some benefit in using an egg-free diet in infants with suspected egg allergy who have positive specific IgE to eggs. Little evidence supports the use of various exclusion diets in unselected people with atopic eczema, but that may be because they were not allergic to those substances in the first place. Lack of any benefit may also be because the studies were too small and poorly reported. Future studies should be appropriately powered focusing on participants with a proven food allergy. In addition a distinction should be made between young children whose food allergies improve with time and older children/adults.

Interventions for preventing non-melanoma skin cancers in high-risk groups.

BACKGROUND: Some groups of people have a greater risk of developing common non-melanoma skin cancers (NMSC). OBJECTIVES: To evaluate interventions for preventing NMSC in people at high risk of developing NMSC. SEARCH STRATEGY: We searched the Cochrane Skin Group Specialised Register (March 2007), the Cochrane Central Register of Controlled Trials (The Cochrane Library Issue 1, 2007, MEDLINE (from 2003 to March 2007), EMBASE (from 2005 to March 2007), the metaRegister of Controlled Trials (February 2007). References from trials and reviews were also searched. Pharmaceutical companies were contacted for unpublished trials. SELECTION CRITERIA: Randomised controlled trials of adults and children at high risk of developing NMSC. DATA COLLECTION AND ANALYSIS: Two review authors independently selected studies and assessed their methodological quality. MAIN RESULTS: We identified 10 trials (7,229 participants) that assessed a variety of interventions. One trial found T4N5 liposome lotion significantly reduced the rate of appearance of new BCCs in people with xeroderma pigmentosum. One of three trials of renal transplant recipients showed a significantly reduced risk of new NMSCs when acitretin was compared to placebo (relative risk (RR) 0.22 95% confidence interval (CI) 0.06 to 0.90) and no significant difference in risk of adverse events in two trials (RR 1.80, 95% CI 0.70 to 4.61). In three trials conducted in people with a history of NMSC, the evidence was inconclusive for the development of BCCs for retinol or isoretinoin. However the risk of a new SCC in one trial (HR 1.79, 95% CI 1.16 to 2.76) and adverse events in another trial (RR 1.76 95% CI 1.57 to 1.97) were significantly increased in the isotretinoin group compared with placebo. In one trial selenium showed a reduced risk of other types of cancer compared with placebo (RR 0.65, 95% CI 0.50 to 0.85) but also a significantly elevated risk of a new NMSC (HR 1.17 95% CI 1.02 to 1.34). The evidence for one trial of beta-carotene was inconclusive; and there was a trend towards fewer new NMSC in a trial of a reduced fat diet (RR 0.16, 95% CI 0.02 to 1.31), p=0.09. AUTHORS' CONCLUSIONS: Some preventative treatments may benefit people at high risk of developing NMSC, but the ability to draw firm conclusions is limited by small numbers of trials, often with one trial per intervention or with inconsistent results between studies.

Naftidrofuryl for acute stroke.

BACKGROUND: Stroke is the third most common cause of death and the most common cause of disability in the western world. The development of drugs to limit the effects of brain damage caused by stroke continues but no routine effective treatment has yet been identified. Naftidrofuryl has been reported to be beneficial in the treatment of acute stroke in some studies, but it is unclear whether all of the evidence supports these findings. OBJECTIVES: To assess the effects of naftidrofuryl in the acute phase of stroke. SEARCH STRATEGY: We searched the Cochrane Stroke Group Trials Register (last searched November 2006); the Cochrane Central Register of Controlled Trials (CENTRAL), the Cochrane Database of Systematic Reviews, and the Database of Abstracts of Reviews of Effects (The Cochrane Library Issue 2, 2006); MEDLINE (1966 to July 2006); EMBASE (1980 to July 2006); Science Citation Index (1981 to July 2006); National Research Register (July 2006); LILACS Database (1982 to July 2006); metaRegister of Controlled Trials (mRCT) (July 2006); SUMsearch (July 2006). To identify further published, unpublished and ongoing studies we searched reference lists, handsearched conference proceedings and contacted pharmaceutical companies and authors of relevant articles. SELECTION CRITERIA: We included patients with acute ischaemic or haemorrhagic stroke clinically diagnosed by a medical practitioner with or without a computerised tomography (CT) scan. DATA COLLECTION AND ANALYSIS: Two authors independently selected trials for inclusion, assessed trial quality, and extracted data using data extraction forms or, if available, re-analysed individual patient data. MAIN RESULTS: Six trials involving 1274 participants were included. We found no significant benefits of naftidrofuryl compared with placebo in reducing the risks of mortality (pooled odds ratio (OR) 1.03, 95% confidence interval (CI) 0.78 to 1.36, six studies) or combined death or dependency/disability (pooled OR 0.94, 95% CI 0.70 to 1.16, three studies). Pooled results showed naftidrofuryl had no significant effect on systolic, diastolic or mean arterial blood pressure. No trials reported the effects of naftidrofuryl on the risk of early death or deterioration, quality of life, stroke recurrence, or discharge site. However, we found a trend towards an increase in risk of minor adverse events in patients taking naftidrofuryl (OR 1.99, 95% CI 0.96 to 4.11, P = 0.06). AUTHORS' CONCLUSIONS: There is not enough evidence to support the use of naftidrofuryl in the treatment of acute ischaemic or haemorrhagic stroke.

Interventions for basal cell carcinoma of the skin.

BACKGROUND: Basal cell carcinoma (BCC) is the commonest skin cancer. BCCs are slow-growing, locally invasive, epidermal skin tumours which mainly affect white skinned people. The first line treatment is usually surgical excision, but numerous alternatives are available. OBJECTIVES: To assess the effects of treatments for basal cell carcinoma. SEARCH STRATEGY: We searched the Cochrane Skin Group Specialised Register (January 2006), the Cochrane Central Register of Controlled Trials (The Cochrane LIbrary Issue 1, 2006), the Cochrane Database of Systematic Reviews (The Cochrane Library Issue 1, 2006), MEDLINE (2004 to January 2006), EMBASE (2005 to January 2006), the metaRegister of Controlled Trials (February 2006). Cited references of all trials identified and key review articles were searched. Pharmaceutical companies were contacted where appropriate for reviews or unpublished trials. SELECTION CRITERIA: Inclusion criteria were adults with one or more histologically proven, primary basal cell carcinoma. The primary outcome measure was recurrence at three to five years, measured clinically. The secondary outcome included early treatment failure within six months, measured histologically. Adverse treatment effects included aesthetic appearance and pain during and after treatment. DATA COLLECTION AND ANALYSIS: Two authors independantly carried out study selection and assessment of methodological quality. MAIN RESULTS: Twenty seven studies were identified. Only one RCT of surgery versus radiotherapy had primary outcome data at four years, showing significantly more persistent tumours and recurrences in the radiotherapy group as compared to the surgery group, (RR 0.09, 95%CI, 0.01 to 0.69). One study found no significant difference for recurrence at 30 months when Moh's micrographic surgery was compared to surgery for high risk facial BCCs, (RR 0.64, 95%CI 0.16,2.64). One study of methylaminolevulinate photodynamic therapy (MAL PDT) versus cryotherapy found no significant difference in recurrences in the MAL PDT group when compared to cryotherapy at one year (RR 0.50, 95% CI 0.22,1.12). Cryotherapy showed no significant difference in recurrences at one year when compared to surgery on one small study. When radiotherapy was compared to cryotherapy there were significantly fewer recurrences at one year in the radiotherapy group compared to the cryotherapy group.Short-term studies suggest a success rate of 87 to 88% for imiquimod in the treatment of superficial BCC using a once-daily regimen for 6 weeks and a 76% treatment response when treating nodular BCC for 12 weeks, when measured histologically. AUTHORS' CONCLUSIONS: Overall there has been very little good quality research on treatments for BCC. Most trials have only evaluated BCCs in low risk locations. Surgery and radiotherapy appear to be the most effective treatments with surgery showing the lowest failure rates. Although cosmetic outcomes appear good with PDT, long term follow up data are needed. Other treatments might have some use but few have been compared to surgery. An ongoing study comparing imiquimod to surgery should clarify whether imiquimod is a useful option.

Probiotics for maintenance of remission in Crohn's disease.

BACKGROUND: Crohn's disease (CD) is characterised by episodes of disease activity and symptom-free remission. Probiotics are microorganisms that can potentially benefit health, and have been evaluated as an alternate means of preventing relapse in patients with CD. OBJECTIVES: To assess the effectiveness of probiotics for the maintenance of remission in CD. SEARCH STRATEGY: The following databases were searched: the Cochrane Database of Systematic Reviews (2005, Issue 3); the Cochrane Central Register of Controlled Trials (2005, Issue 3); the Cochrane IBD/FBD Group Trials Register (2005), MEDLINE (1966-2005); EMBASE (1980-2005); ISI Web of Knowledge (BIDS) 1981-2005; On-line clinical trials databases (2005); and review articles. Experts in the field were contacted for unpublished data. SELECTION CRITERIA: Randomised controlled trials of probiotic therapy. DATA COLLECTION AND ANALYSIS: Two independent reviewers performed data extraction and assessment of methodological quality. The primary outcome was the relative risk (RR) of relapse after maintenance treatment (and 95% confidence intervals [CI]). MAIN RESULTS: Seven small studies were identified and varied according to probiotics tested, methodological quality and medication regimen. No studies were pooled for statistical analysis. There was no statistically significant benefit of E. coli Nissle for reducing the risk of relapse compared to placebo (RR 0.43, 95% CI 0.15 to 1.20), or Lactobacillus GG after surgically-induced remission (RR 1.58, 95% CI 0.30 to 8.40) or medically-induced remission (RR 0.83, 95% CI 0.25 to 2.80). There was no statistically significant benefit of probiotics for reducing the risk of relapse compared to maintenance therapy employing aminosalicylates or azathioprine (RR 0.67, 95% CI 0.13 to 3.30), and in this study the probiotic Lactobacillus GG was associated with adverse events. In children, there was there was no statistically significant difference between Lactobacillus GG and placebo for reducing the risk of relapse (RR 1.85, 95% CI 0.77 to 4.40). A small study using the yeast Saccharomyces boulardii demonstrated a difference that was not statistically significant in favour of probiotic combined with a reduced level of maintenance therapy over standard maintenance treatment alone (RR 0.17, 95% CI 0.02 to 1.23). AUTHORS' CONCLUSIONS: There is no evidence to suggest that probiotics are beneficial for the maintenance of remission in CD. All of the included studies enrolled small numbers of patients and may have lacked statistical power to show differences should they exist. Larger trials are required to determine if probiotics are of benefit in Crohn's disease.

Chinese herbal medicine for atopic eczema.

BACKGROUND: Traditional Chinese herbal mixtures have been used to treat atopic eczema for many years. Their efficacy has attracted public attention and recently some clinical trials have been undertaken. OBJECTIVES: To assess the effects of Chinese herbal mixtures in the treatment of atopic eczema. SEARCH STRATEGY: We searched the Cochrane Central Register of Controlled Trials (CENTRAL) ( January 2004), the Cochrane Skin Group Specialised Register (January 2004), MEDLINE (1966 to January 2004), EMBASE (1980 to January 2004), CINHL (1980 to January 2004) and a number of complementary medicine databases. In addition, the cited references of all trials identified and key review articles were searched. Pharmaceutical companies involved in oral traditional Chinese herbs and experts in the field were contacted. SELECTION CRITERIA: Randomised controlled trials of Chinese herbal mixtures used in the treatment of atopic eczema. DATA COLLECTION AND ANALYSIS: Two reviewers independently applied eligibility criteria, assessed the quality of the trials and extracted data. Any discrepancies were discussed to achieve consensus. MAIN RESULTS: Four randomised controlled trials, with eight weeks for each phase, met the inclusion criteria. The trials randomised 159 participants aged from 1 to 60 years. The withdrawal rates ranged from 7.5% to 22.5% and no trial used intention to treat analysis. Three trials were randomised placebo controlled, two-phase cross-over designs assessing the same Chinese herbal mixture, Zemaphyte. In two of these three trials the reduction in erythema and surface damage was greater on Zemaphyte than on placebo, and participants slept better and expressed a preference for Zemaphyte. One trial also reported that participants itched less. The fourth trial was an open-label design comparing Zemaphyte in herbal form with Zemaphyte as a freeze dried preparation. There was a reduction in erythema and surface damage with both formulations, but no comparison between the two formulations was reported. Some adverse effects were reported in all four trials, but none were regarded as serious. AUTHORS' CONCLUSIONS: Chinese herbal mixtures may be effective in the treatment of atopic eczema. However, only four small poorly reported RCTs of the same product, Zemaphyte, were found and the results were heterogeneous. Further well-designed, larger scale trials are required, but Zemaphyte is no longer being manufactured.