Effectiveness of chlorhexidine versus povidone-iodine for preventing surgical site wound infection: A meta-analysis.

A systematic evaluation was conducted to assess the efficacy of two disinfectants, chlorhexidine and povidone-iodine, as primary components in preventing surgical site infection (SSI). A comprehensive computerised search was performed in the PubMed, EMBASE, Web of Science, Cochrane Library, CNKI and Wanfang databases for randomised controlled trials (RCTs) on chlorhexidine and povidone-iodine disinfection for the prevention of SSI from inception until July 2023. Two independent researchers completed literature screening, data extraction and quality assessment of the included studies. The meta-analysis was conducted using RevMan 5.4 software. Ultimately, 20 RCTs were included, which included 13 133 patients, with 6460 patients in the chlorhexidine group and 6673 patients in the povidone-iodine group. The meta-analysis results revealed that the incidence rate of surgical site wound infections [odds ratio (OR): 0.67, 95% confidence interval (CI): 0.58-0.78, p < 0.001)], superficial SSI rate (OR: 0.59, 95% CI: 0.46-0.75, p < 0.001) and deep SSI rate (OR: 0.49, 95% CI: 0.31-0.79, p = 0.003) were all lower in patients subjected to chlorhexidine disinfection compared to those patients receiving povidone-iodine disinfection. Existing evidence suggests that chlorhexidine is more effective than povidone-iodine at preventing SSI. However, owing to the potential quality limitations of the included studies, further validation through high-quality large-scale RCTs is warranted.

Protocol adherence rates in superiority and noninferiority randomized clinical trials published in high impact medical journals.

BACKGROUND/AIMS: Noninferiority clinical trials are susceptible to false confirmation of noninferiority when the intention-to-treat principle is applied in the setting of incomplete trial protocol adherence. The risk increases as protocol adherence rates decrease. The objective of this study was to compare protocol adherence and hypothesis confirmation between superiority and noninferiority randomized clinical trials published in three high impact medical journals. We hypothesized that noninferiority trials have lower protocol adherence and greater hypothesis confirmation. METHODS: We conducted an observational study using published clinical trial data. We searched PubMed for active control, two-arm parallel group randomized clinical trials published in JAMA: The Journal of the American Medical Association, The New England Journal of Medicine, and The Lancet between 2007 and 2017. The primary exposure was trial type, superiority versus noninferiority, as determined by the hypothesis testing framework of the primary trial outcome. The primary outcome was trial protocol adherence rate, defined as the number of randomized subjects receiving the allocated intervention as described by the trial protocol and followed to primary outcome ascertainment (numerator), over the total number of subjects randomized (denominator). Hypothesis confirmation was defined as affirmation of noninferiority or the alternative hypothesis for noninferiority and superiority trials, respectively. RESULTS: Among 120 superiority and 120 noninferiority trials, median and interquartile protocol adherence rates were 91.5 [81.4-96.7] and 89.8 [83.6-95.2], respectively; P = 0.47. Hypothesis confirmation was observed in 107/120 (89.2%) of noninferiority and 64/120 (53.3%) of superiority trials, risk difference (95% confidence interval): 35.8 (25.3-46.3), P < 0.001. CONCLUSION: Protocol adherence rates are similar between superiority and noninferiority trials published in three high impact medical journals. Despite this, we observed greater hypothesis confirmation among noninferiority trials. We speculate that publication bias, lenient noninferiority margins and other sources of bias may contribute to this finding. Further study is needed to identify the reasons for this observed difference.

Antimalarial drug toxicities in patients with cutaneous lupus and dermatomyositis: A retrospective cohort study.

BACKGROUND: Although existing evidence demonstrates the efficacy of antimalarials for rheumatic skin disease, the safety of these medications, and particularly quinacrine, remains debated. OBJECTIVE: We investigated the toxicity risk associated with antimalarials in patients with cutaneous lupus erythematosus and dermatomyositis. METHODS: A total of 532 patients (mean age, 52.29 years; sample composition by sex, 85.15% female vs 14.85% male) were selected from 2 databases on cutaneous lupus erythematosus (69.92%) and dermatomyositis (30.08%). Details regarding treatment and toxicities were extracted and 5 treatment courses were defined (ie, hydroxychloroquine [HCQ], chloroquine [CQ], quinacrine [Q], HCQ-Q combination therapy [HCQ-Q], and CQ-Q combination therapy [CQ-Q]). The hazard ratio for each major toxicity was estimated by using the Cox proportional hazard model to compare the different treatments with HCQ. RESULTS: The most common toxicities included cutaneous eruption, gastrointestinal upset, mucocutaneous dyspigmentation, neurologic toxicity, and retinopathy. The hazards of cutaneous eruption, gastrointestinal upset, and neurologic toxicities were lower with HCQ-Q than with HCQ; however, this may represent selection bias. Although there was increased retinopathy risk with CQ and CQ-Q versus with HCQ, retinopathy was not seen with Q. LIMITATIONS: Retrospective analysis. CONCLUSIONS: With the exception of retinopathy, which was not seen with Q, the risks for other toxicities associated with Q monotherapy or combination treatment were not significantly different from those with HCQ.