CONSORT adoption and quality of reporting of randomized controlled trials: a systematic analysis in two dermatology journals

Background  CONSORT (Consolidated Standards for Reporting Trials) guidelines were constructed to ensure optimal reporting quality of randomized controlled trials (RCTs).
Objectives  To determine the effect of the adoption of CONSORT on the reporting quality of RCTs, we performed a systematic evaluation of RCTs published in two dermatology journals pre- and post-CONSORT adoption.
Methods  The journals selected for the study were the Journal of the American Academy of Dermatology and the British Journal of Dermatology . We selected RCTs published in 1997 and 2006 using both Medline and hand searching. The following critical CONSORT criteria were recorded: sample size, type of disease studied, type of control, single-centre or multicentre study, type of funding, blinding, methods and type of randomization, definition of a primary endpoint, justification for sample size selection and power calculation, population for analysis, and adequacy of group comparison. A multivariable analysis was conducted to determine factors associated with optimal reporting quality.
Results  In total, 98 studies were included. Improvement in reporting quality was evident for the specification of the randomization method (20% in 1997 vs. 45% in 2006, P  <   0·01) and for the justification of sample size (22% in 1997 vs. 43% in 2006, P  = 0·027). The percentage of studies with optimal reporting quality increased from 11% in 1997 to 28% in 2006 ( P  =   0·03). Factors significantly associated with a good methodological quality were pharmaceutical industry funding and publication in 2006 vs. 1997.
Conclusions  There is a need to improve the reporting quality of RCTs published in dermatology journals.     

N-acetyltransferase 2 acetylation polymorphism: prevalence of slow acetylators does not differ between atopic dermatitis patients and healthy subjects

The genetic polymorphism of human N-acetyltransferase 2 (NAT2) divides the human population into groups with rapid, intermediate and slow acetylator status. Slow acetylator status has been considered a predisposing factor for allergic diseases, lupus erythematosus, toxic epidermal necrolysis or Stevens-Johnson syndrome. The aim of this study was to investigate whether Caucasian patients suffering from atopic dermatitis differed from healthy individuals with regard to the genotype and phenotype of NAT2. Twenty unrelated healthy Caucasian volunteers (9 females and 11 males, aged from 22 to 59 years) and twenty unrelated Caucasian patients suffering from atopic dermatitis (9 females and 11 males, aged between 20 and 54 years) participated in this study. For each one, the NAT2 genotype was determined by polymerase chain reaction with DNA extracted from peripheral blood, using specific primers for the wild-type allele (wt) and the 3 most frequent mutated alleles of NAT2 (C481-->T, G590-->A and G857-->A). The NAT2 phenotype was evaluated with dapsone as a test substrate using high-pressure liquid chromatography. Statistical analysis was performed using the chi(2) test. Phenotype and genotype were distributed as follows: (1) of the healthy subjects, 60% were rapid acetylators (RA) and 40% were slow acetylators (SA); 10% of the RA and 15% of the SA were homozygous, 50% of the RA and 25% of the SA were heterozygous; (2) of the patients, 55% were RA, 40% were SA and 5% were intermediate acetylators (IA); 10% of the RA and 10% of the SA were homozygous, 45% of the RA and 35% of the SA were heterozygous. No significant statistical difference was found between the two groups for genotypes (p = 0.75) or phenotypes (p = 0.60). The phenotyping and genotyping results of healthy subjects were comparable to those found in previous studies. The absence of a significant statistical difference between healthy subjects and atopic dermatitis patients is in contrast to the results of previous studies. Some authors considered that allergic patients are mostly SAs. This could be explained by the fact that we only considered patients suffering from atopic dermatitis whereas, in other studies, patients suffered from different (one or several associated) allergic diseases. NAT2 polymorphism does not differ between patients suffering from atopic dermatitis and healthy subjects. The importance attributed to the SA status, which was previously considered a predisposing factor for allergic diseases such as atopic dermatitis, should be reviewed.     

Psychopharmacological treatment of dermatological patients – when simply talking does not help

In dermatology, primary emotional disorders with cutaneous manifestations, secondary emotional disorders caused by dermatoses and multifactorial diseases are possible indications for the use of psychopharmaceuticals. Neuroleptics (anti‐psychotics) are usually used in psychiatric illnesses, while antidepressants are foremost in treating depression as well as obsessive‐compulsive, anxiety and panic disorders. Minor tranquilizers may be used sympto‐matically. To define the indications for mid‐ and long‐term treatment with psychopharmaceuticals, the unequivocal diagnosis of the main and secondary psychiatric symptoms as well as the primary target symptoms must be designated. At the start of therapy planning, any possible desired and undesired side effects must be taken into account, such as stimulation, sedation, anticholinergic side effects or weight gain. The main antidepressants are the well‐tolerated selective serotonin reuptake inhibitors (SSRI) such as sertraline, fluoxetine or citalopram. A clear long‐term plan and how to monitor it must be discussed with patient carefully because of the need for individual dose titration and the late onset of action of many of these medications. Good results can be achieved in dermatologic patients requiring psychopharmaceuticals if the indications are carefully assessed and the therapy logically structured.     

The cutaneous microflora of adolescent, persistent and late-onset acne patients does not differ

The cutaneous microbiology and antibody status to Propionibacterium acnes of patients with persistent (males, n = 32; females, n = 33) and late-onset (females, n = 25) acne were compared with individuals with adolescent acne (males, n = 22; females, n = 18) and normal control volunteers (persistent acne: males, n = 26; females, n = 30; late-onset: females, n = 20). Males had significantly higher grades of acne compared with females (P < 0.05). The microflora consisted in the main of propionibacteria, staphylococci and Malassezia; other bacteria represented less than 0.01% of the total microflora. At all sites for all samples there were significantly more propionibacteria than staphylococci or Malassezia (P < 0.05). There were significantly higher (P < 0.05) numbers of microorganisms in follicular casts from patients compared with their control volunteers for female facial skin and male back skin. Twenty-six papules and 48 normal follicles were analysed. A bimodal distribution of microbial colonization was noted, with about 90% of normal follicles and about 10% of acne follicles having no detectable viable microorganisms. Anti-P. acnes IgG antibody titres were measured using a secondary fluorescein isothiocyanate antibody technique, and no significant differences in titre were found between any groups of patients (P > 0.05). Correlation analysis showed no association between the population densities of P. acnes and anti-P. acnes IgG titres. There were no differences in the microbiology of skin of adolescent acne patients, persistent acne patients or late-onset acne patients which could account for these various forms of acne.     

《临床皮肤科杂志》中随机对照试验文章评价

为了分析《临床皮肤科杂志》发表的临床随机对照试验(RCT)文章的现状,采用手工检索调查1981～2000年间《临床皮肤科杂志》发表的临床研究论文,并根据循证医学推荐的国际标准对所发表的RCT进行分析。结果表明在5314篇临床研究论文中,RCT文章有182篇(占文章总数3.42%),且多为中小样本的研究。本结果提示皮肤科领域中RCT的数量和质量远远不能满足临床实践的需要,应提倡严格科学设计的多中心、大样本前瞻性RCT研究。     

Efficacy of topical treatments for molluscum contagiosum in randomized controlled trials

Although molluscum contagiosum (MC) is a common infectious dermatosis that is self-resolving, treatment can diminish discomfort and decrease the risk of autoinoculation and infection to others, because it is transmitted through direct skin contact. This systematic review evaluates the efficacy of topical treatments for MC. A PubMed search following Preferred Reporting Items for Systematic Reviews and Meta-Analyses guidelines was performed to find randomized, controlled trials of MC treatment. The search yielded 129 publications, but only 15 studies published between 1994 and 2020 were found to fit the inclusion criteria. Treatment modalities included podophyllotoxin, imiquimod, sodium nitrite, myrtle leaf extract, phenol, Salatac Gel (salicylic acid with lactic acid), potassium hydroxide, cantharidin, SB206, and VP-102. Outcomes were extracted from the literature, and subsequent quality and risk of bias assessments were performed. All treatments were more efficacious than the control except cantharidin, potassium hydroxide, and imiquimod, which had varying degrees of efficacy throughout studies. Overall, studies were of sufficient quality and had low risk of bias, but they had small sample sizes and lacked adequate explanation of statistical analysis. Current first-line treatment entails mechanical methods such as cryotherapy and curettage, which may be frightening to children with MC, so the development and assessment of topical treatments allows for alternative efficacious techniques.     

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.     

The effect of solar-simulated radiation on the elicitation phase of contact hypersensitivity does not differ between controls and patients with polymorphic light eruption

It has been suggested that polymorphic light eruption (PLE) is characterized by a failure of ultraviolet radiation (UVR)-induced immunosuppression, resulting in a type-IV hypersensitivity response to photoinduced antigens. We measured the effect of solar-simulated radiation (SSR) on the elicitation phase of contact hypersensitivity to 2,4-dinitrochlorobenzene (DNCB), in ten PLE patients and 11 controls. Subjects were given a sensitizing dose of DNCB, and 3 wk later were exposed to 0.75 and 2 minimum erythema doses (MED) of SSR on the upper inner arm. Immediately and 24 h later these sites, and a non-irradiated control site, were challenged with DNCB. The resulting increase in skin thickness was measured with high-frequency ultrasound. Overall, 2 MED caused 17%-20% suppression of elicitation responses (compared with 93% suppression of sensitization reported previously), but the effect of SSR varied greatly between subjects, with some subjects showing potentiated responses, which may be of relevance to false-positive reactions in photopatch testing. In a repeated measures general linear model, SSR overall caused significant suppression of responses (p<0.001); there was less suppression in older subjects (p=0.009) but there was no significant difference between PLE patients and age-matched normal controls. These results contrast with our previous finding of a resistance to UVR-induced suppression of sensitization to DNCB in PLE. This difference may reflect the greater importance of Langerhans cells in the sensitization phase, and is consistent with the hypothesis that PLE arises from impaired suppression of Langerhans cell activation or migration.