SF‐36 healty survey on psoriasis quality‐of‐life: A study of 414 Taiwanese patients

Psoriasis is a chronic debilitating disease that impairs patients' physical and social functioning. The assessment of health‐related quality of life (HRQoL) provides a comprehensive insight into the actual disease burden that are not captured by the traditional clinical parameters. The objective of this study is to identify factors that may impact patients' HRQoL. We conducted a cross‐sectional study, recruiting a total of 414 psoriasis vulgaris patients between January 2008 and December 2011. Our study found no significant correlation between disease severity or duration of psoriasis with HRQoL. Female patients have poorer HRQoL. Psoriatic arthritis, nail involvement, burning and itching sensation have a detrimental effect on HRQoL. This study highlighted that specific disease‐associated symptoms such as itching and burning sensation, nail involvement and/or concomitant arthritis were important factors that may impact patients' HRQoL devoid of clinical severity. Physicians should carefully consider these factors when treating psoriasis patients.     

Reporting of outcomes in randomized controlled trials on nail psoriasis: a systematic review

One of the important complications of the skin disease, psoriasis, is the appearance of changes in the nails. These range from the formation of small pits across the surface of the nail to painful separation of the nail plate from the underlying nail bed and disfiguring enlargement and thickening of the nail itself. Given this wide range of changes in appearance it is important that, in assessing the results of treatment, researchers can use simple, but accurate, criteria for measuring changes in psoriatic nails under treatment; these are known as core outcome sets. This study, organised by investigators from the departments of dermatology in the Universities of Amsterdam and Nijmegen in the Netherlands, surveyed 65 clinical trials focussing on nail psoriasis, all of which used assessment measures for nail changes in psoriasis, the commonest of which is called the nail psoriasis severity index. However, they found that several different methods were used in the various studies. A detailed analysis of these studies has identified a number of variations in the methods used which make the results of different treatments difficult to compare. This is particularly because there was no standard way of expressing the final scores of the severity of nail disease found in these studies and also that the different aspects of severity were rated differently. Some of these assessment scoring systems have not been validated (substantiated) either. The authors call for a rethink of the use of nail assessments in psoriasis and highlight the need to develop new methods which are sufficiently robust to stand up to close scrutiny. These should allow investigators to assess the different changes seen in the diseased nails in a standardised way, so that results of different studies can be compared. They suggest that a consensus group should be established to carry out this work.     

Efficacy and safety of tofacitinib for moderate‐to‐severe plaque psoriasis: a systematic review and meta‐analysis of randomized controlled trials

The effects of tofacitinib in treating moderate‐to‐severe plaque psoriasis were unclear. We aimed to assess the effects of tofacitinib in treating moderate‐to‐severe plaque psoriasis. We searched PubMed, Cochrane Central Register of Controlled Trials and EMBASE for relevant randomized controlled trials (RCTs) and conducted a systematic review and meta‐analysis. Four RCTs with 2724 participants were included. Compared to placebo, tofacitinib significantly improved psoriasis {≥75% reduction in the Psoriasis Area and Severity Index score: 5 mg BID: risk difference (RD) 0.32 [95% confidence interval (CI) 0.28–0.35], 10 mg BID: RD 0.51 (95% CI 0.43–0.58); ≥90% reduction in the Psoriasis Area and Severity Index score: 5 mg BID: RD 0.19 (95% CI 0.17–0.22), 10 mg BID: RD 0.36 (95% CI 0.31–0.42); Physician's Global Assessment 0/1: 5 mg BID: RD 0.31 (95% CI 0.27–0.35), 10 mg BID: RD 0.48 (95% CI 0.44–0.53)} and participants’ life quality [Dermatology Life Quality Index 0/1: 5 mg BID: RD 0.24 (95% CI 0.20–0.2), 10 mg BID: RD 0.36 (95% CI 0.33–0.40)]. Tofacitinib was associated with an increase in minor adverse events [upper respiratory tract infection: 5 mg BID: RD 0.02 (95% CI 0.00–0.03), 10 mg BID: RD 0.02 (95% CI 0.00–0.04); hypercholesterolaemia: 5 mg BID: RD 0.02 (95% CI 0.01–0.04), 10 mg BID: RD 0.02 (95% CI 0.01–0.04)]. In conclusion, tofacitinib may be a treatment option for moderate‐to‐severe plaque psoriasis that is unresponsive to other therapies and patients who are intolerable to other therapies or prefer oral medications.     

Acupuncture plus moxibustion for herpes zoster: A systematic review and meta‐analysis of randomized controlled trials

Herpes zoster is an acute inflammatory condition which can have a significant impact on quality of life. Antiviral therapies are effective, but do not meet patients' expectations of symptomatic relief. Acupuncture and moxibustion have been used for herpes zoster; this systematic review evaluated their efficacy and safety. Nine English and Chinese databases were searched from their inceptions to March 2016. Randomized controlled trials evaluating the combination of acupuncture plus moxibustion in adult herpes zoster were included. Outcomes included pain intensity and duration, quality of life and adverse events. Meta‐analysis was performed using RevMan software (version 5.3). Nine studies (945 participants) were included. Studies were of low to moderate methodological quality based on risk of bias assessment. Pain intensity (visual analogue scale) was lower among those who received acupuncture plus moxibustion compared with pharmacotherapy (one study; MD ?8.25 mm, 95% CI ?12.36 to ?4.14). The clinical significance of this result is yet to be established. Some benefits were seen for other pain and cutaneous outcomes, and global improvement in symptoms. Mild adverse events were reported in the intervention groups. Acupuncture plus moxibustion may improve pain and cutaneous outcomes, although current evidence is limited by the number of studies and methodological shortcomings.     

Gabapentin for uremic pruritus: a systematic review of randomized controlled trials

Uremic pruritus is one of the most prevalent and bothersome dermatologic symptoms in patients with end-stage renal disease. Some studies suggest a possible neuropathic cause of uremic pruritus. Gabapentin, an anticonvulsant, may control pruritus with neuropathic origin. The objectives of this study were to assess the efficacy of gabapentin in reducing pruritus scores of patients with uremic pruritus and evaluate its safety among dialysis patients. Meta-analysis of randomized controlled trials, using gabapentin as treatment for uremic pruritus among hemodialysis patients was included and analyzed using Review Manager Version 5.1.4 software. Seven out of 17 screened articles were included, with a total of 315 participants. Meta-analysis of the incidence of improved pruritus scores after treatment from four studies (n = 171) showed that treatment with gabapentin decreased the severity of uremic pruritus as compared to the placebo (risk ratio = 0.18; 95% confidence interval: 0.09, 0.33; I² = 4%: P =< 0.00001). Six studies (n = 290) presented with incidence of adverse drug events such as dizziness, drowsiness, and somnolence. In the pooled analysis, treatment with gabapentin was associated with a higher incidence of adverse drug events compared to the comparator drugs, but the results were not significant (risk ratio = 1.3, 95% confidence interval: 0.81, 2.11; P = 0.28, I² = 37%). The results of this systematic review suggest that gabapentin is efficacious and safe in improving uremic pruritus among dialysis patients.     

A systematic review of randomized controlled trials of treatments for inherited forms of epidermolysis bullosa

Background.  Many interventions have been described for inherited epidermolysis bullosa (EB), but it is unclear which are beneficial.
Aims.  A systematic review of randomized controlled trials (RCTs) was performed to inform practice and highlight research gaps.
Methods.  The Cochrane Central Register of Controlled Trials, MEDLINE, EMBASE and the Cochrane Skin Group specialist library, from inception until 1 April 2007, were searched. Primary outcomes were healing of lesions or prevention of new lesions. Trials were assessed for quality of reporting and data were extracted.
Results.  Five randomized double-blind placebo-controlled crossover studies were identified ( n  = 102). Two studies assessed oral tetracyclines in EB simplex (EBS). In one study ( n  = 12), 4/6 patients improved and 2/6 deteriorated on a dose of 1500 mg of tetracycline daily; only two patients completed the study. In the second study ( n  = 21), 6/18 and 7/18 improved on oxytetracycline 1 g and placebo, respectively. Two RCTs assessed topical interventions for EBS: aluminium chloride hexahydrate solution 20% ( n  = 23) and bufexamac cream 5% ( n  = 8). Neither showed a benefit over placebo. One RCT of 36 patients with recessive dystrophic EB compared phenytoin with placebo and failed to show any difference in mean lesion counts (difference = 0, 95% CI −11 to 4).
Conclusions.  There is no reliable trial evidence for interventions in inherited EB. In future, it may be that gene treatment becomes the best treatment approach for these diseases.     

Impact of biologic therapies on risk of major adverse cardiovascular events in patients with psoriasis: systematic review and meta‐analysis of randomized controlled trials

Concerns have been raised regarding an increased risk of major adverse cardiovascular events (MACEs) (myocardial infarction, cerebrovascular accident or cardiovascular death) in patients treated with anti‐interleukin (IL)‐12/23 agents for moderate‐to‐severe psoriasis. We aimed to examine the risk of MACEs in adult patients with plaque psoriasis that are exposed to biologic therapies via a meta‐analysis of randomized controlled trials (RCTs). Data were obtained from systematic searches in the Cochrane Library, MEDLINE and Embase, U.S. Food and Drug Administration, European Medicines Agency, individual pharmaceutical companies online search platforms and five trials registers (up to 31 March 2016). We selected RCTs reporting adverse events in adults with plaque psoriasis receiving at least one licensed dose of biologic therapy, conventional systematic therapy or placebo. We calculated Peto odds ratios (ORs) with 95% confidence intervals (CIs) and calculated I² statistics to assess heterogeneity. Overall, 38 RCTs involving 18 024 patients were included. No MACEs were observed in 29 studies, while nine RCTs reported 10 patients experiencing MACEs. There was no statistically significant difference in risk of MACEs associated with the use of biologic therapies overall (OR 1·45, 95% CI 0·34–6·24); tumour necrosis factor‐α inhibitors (adalimumab, etanercept and infliximab) (OR 0·67, 95% CI 0·10–4·63); anti‐IL‐17A agents (secukinumab and ixekizumab) (OR 1·00, 95% CI 0·09–11·09) or ustekinumab (OR 4·48, 95% CI 0·24–84·77). No heterogeneity was observed in these comparisons. In conclusion, the limited existing evidence suggests that licensed biologic therapies are not associated with MACEs during the short randomized controlled periods in clinical trials.     

Outcome measures for vulval skin conditions: a systematic review of randomized controlled trials

Symptoms and signs of vulval skin disorders are common. These conditions can have a considerable impact on quality of life, restricting physical activities and causing difficulty in everyday activities and may also affect social, psychosexual and psychological well‐being. There are no standardized measures routinely used to assess the impact of vulval disease on daily life. To report outcome measures used in clinically based randomized controlled trials (RCTs) investigating therapeutic interventions in vulval disease. The Medline, EMBASE and CENTRAL databases were searched to identify RCTs of vulval skin conditions written in English. Studies with laboratory tests or survival rates as the primary outcome, or those investigating menopausal symptoms or infections were excluded. Twenty‐eight published RCTs were included. The vulval conditions represented were vulvodynia (n = 14), lichen sclerosus (n = 9), vulval intraepithelial neoplasia (n = 2), vulval pruritus (n = 2) and lichen planus (n = 1). The 28 RCTs measured 25 different outcomes, using 49 different scales. The method of outcome assessment was lacking on nine occasions. Only 21% (six of 28) of included trials had a clearly stated primary outcome. Patient‐reported outcomes were more commonly reported than clinician‐related outcome measures. The most commonly reported patient‐rated outcome measure was a reduction in pain (measured 15 times) and an overall improvement in symptoms using a patient global assessment (measured 11 times). The most commonly reported clinician‐rated outcome was an overall assessment of the appearance of affected sites (measured 13 times). There were no agreed standard scales used for the global assessments. Only nine of the recorded outcome measure tools were designed to assess vulval disease or sexual functioning, the remainder were general measures. There is heterogeneity in the outcome measures used when reporting therapeutic interventions in vulval disease. This field of dermatology would benefit from development of a vulval‐specific outcome measure and the establishment of a core outcome measure set.     

Topical herbal medicines for atopic eczema: a systematic review of randomized controlled trials

Despite the availability of medicines with proven efficacy, many patients use complementary or alternative medicines (CAMs) to manage atopic eczema (AE). Due to the lack of objective information on topical CAMs, this systematic review evaluates the current evidence for the efficacy and safety of topical herbal preparations in AE. Using Cochrane systematic review methodology, PubMed, the Cochrane Library, the Cochrane Central Register of Controlled Trials (CENTRAL), CINAHL (via EBSCO), MEDLINE (via EBSCO), Proquest Health and Medical Complete, GREAT and CAM‐QUEST were searched from inception until June 2014. Bibliographies of retrieved studies were hand searched for further relevant trials. All controlled clinical trials of topical herbal medicines for AE in humans of any age were included regardless of the control intervention or randomization. Only English‐language publications were considered. Eight studies met the inclusion criteria. Seven investigated extracts of single plants and one an extract from multiple plants. Only two studies that showed a positive effect were considered to have a low risk of bias across all domains (those of liquorice gel and Hypericum perforatum). In these two, the test product was reported to be superior to placebo. Despite variations in diagnostic criteria and lack of validated tools for outcome assessments in one of these, the promising results may warrant continued research in better‐designed studies. No meta‐analysis was performed due to heterogeneity in all studies. There is currently insufficient evidence of efficacy for any topical herbal extract in AE. Many studies had methodological flaws and even those showing efficacy were single trials with small patient cohorts.     

Efficacy and safety of topical clascoterone cream for treatment of acne vulgaris: A systematic review and meta‐analysis of randomized placebo‐controlled trials

To systematically and meta‐analytically pool evidence from randomized placebo‐controlled trials that examined the efficacy and safety of topical clascoterone cream in patients with acne vulgaris. Four databases were screened from inception to 10 October 2020. Included studies were assessed for risk of bias. Efficacy outcomes included investigator's global assessment (IGA) treatment success and absolute change in inflammatory lesion counts (ILCs) and noninflammatory lesion counts (NILCs). Safety outcomes included the proportion of patients with any treatment‐emergent adverse event (TEAE) as well as incidence of any TEAE, serious adverse events (AEs), AEs related to study drug, AEs leading to study drug discontinuation, nasopharyngitis, headache, oropharyngeal pain, and vomiting. Dichotomous data were analyzed using the risk ratio (RR) and 95% confidence interval (95% CI) whereas continuous data were analyzed using the mean difference (MD) and 95% CI. Review Manager Software version 5.4.1 was used for statistical analysis. Five clinical trials, comprising 2457 patients (1357 and 1100 patients received clascoterone and placebo, respectively) were included. Studies revealed an overall low risk of bias. Clascoterone significantly increased IGA success rates (RR = 2.87, 95% CI [2.11, 3.89], P < .001) and decreased NILCs (MD = ?5.64, 95% CI [?8.41, ?2.87], P < .01) without substantially impacting the ILCs (MD = ?1.82, 95% CI [?5.06, 1.43], P = .27). No significant differences were noted between both groups for all safety outcomes, except for nasopharyngitis which was significantly lower in the clascoterone group (RR = 0.47, 95% CI [0.27, 0.83], P = .01). Topical clascorterone cream is safe and effective in the treatment of acne vulgaris.