Adelaide Medical School, University of Adelaide, Adelaide, Australia.
Freemasons Foundation Centre for Men's Health, University of Adelaide, Adelaide, Australia.
Australas J Dermatol. 2021 Feb;62(1):e35-e40. doi: 10.1111/ajd.13434. Epub 2020 Sep 23.
A randomised controlled trial was undertaken to compare the efficacy of topical Calendula officinalis (Calendula) versus standard of care (Sorbolene: 10% glycerine in cetomacragol cream) in reducing the prevalence of radiation-induced dermatitis in women undergoing breast cancer radiotherapy.
A total of 271 women were screened and 82 were randomised. The primary outcome was prevalence of acute radiation-induced dermatitis (RTOG grade 2+) assessed at multiple skin sites. A chi-squared test was conducted for the primary outcome with a worst-case scenario imputation.
The recruitment target (n = 178) was not achieved. A total of n = 81 participants were analysed (n = 40 Calendula; n = 41 Sorbolene). There was no detectable difference in prevalence of radiation-induced dermatitis grade 2+ between the Calendula (53%) and Sorbolene (62%) groups (primary analysis OR = 0.87, 95% CI: [0.36, 2.09], P = 0.92; covariate adjusted complete case analysis OR 0.40, 95% CI: [0.13, 1.20], P = 0.10).
This randomised controlled trial showed no difference between Calendula and standard of care (Sorbolene) for the prevention of radiation-induced dermatitis. However, the study was underpowered (limited recruitment) for the primary comparison.
进行了一项随机对照试验，比较金盏花（Calendula）与标准护理（Sorbolene： Cetomacrogol 乳膏中的 10%甘油）在降低接受乳腺癌放疗的女性放射性皮炎发生率方面的疗效。
共筛选了 271 名女性，其中 82 名被随机分组。主要结局是在多个皮肤部位评估急性放射性皮炎（RTOG 分级 2+）的发生率。采用卡方检验进行主要结局的分析，同时进行最差情况情景的插补。
未达到招募目标（n=178）。共有 n=81 名参与者被纳入分析（n=40 名金盏花组；n=41 名 Sorbolene 组）。金盏花组（53%）和 Sorbolene 组（62%）放射性皮炎 2+发生率之间没有明显差异（主要分析 OR=0.87，95%CI：[0.36, 2.09]，P=0.92；协变量调整的完全病例分析 OR 0.40，95%CI：[0.13, 1.20]，P=0.10）。
这项随机对照试验表明，金盏花与标准护理（Sorbolene）在预防放射性皮炎方面没有差异。然而，主要比较的研究效力不足（招募受限）。
