Abstract：
OBJECTIVE: The purpose of this phase III randomized double-blinded controlled trial was to investigate the efficacy of a rose geranium in sesame oil (RG) nasal spray compared with an isotonic saline (IS) nasal spray for alleviating nasal vestibulitis symptoms among patients undergoing chemotherapy.
METHODS: Patients undergoing active chemotherapy who reported associated nasal symptoms were randomized 1:1 to receive RG or IS, administered twice daily for 2 weeks. Consenting participants completed nasal symptom questionnaires at baseline and then weekly while on treatment. The proportion of patients experiencing improvements in their nasal symptoms 2 weeks after initiating the nasal spray, using a six-point global impression of change score, was estimated within and between each randomized arm, and compared between arms, using Fisher\'s exact test. The estimated odds ratio was determined (95% confidence interval).
RESULTS: One hundred and six patients consented to this study; 43 participants in the RG arm and 41 in the IS arm were evaluable for the primary endpoint. Participants had a mean age of 57.8 years (SD 13.9). Demographic characteristics and baseline nasal symptoms were similar between arms. Of the evaluable participants who received RG, 67.4% reported improved nasal symptoms, compared with 36.6% of the participants who received IS (P = 0.009). Adverse events were sparse and did not differ between arms.
CONCLUSIONS: Rose geranium in sesame oil significantly improves nasal vestibulitis symptoms among patients undergoing chemotherapy.
BACKGROUND: NCT04620369.
METHODS: Patients undergoing active chemotherapy who reported associated nasal symptoms were randomized 1:1 to receive RG or IS, administered twice daily for 2 weeks. Consenting participants completed nasal symptom questionnaires at baseline and then weekly while on treatment. The proportion of patients experiencing improvements in their nasal symptoms 2 weeks after initiating the nasal spray, using a six-point global impression of change score, was estimated within and between each randomized arm, and compared between arms, using Fisher\'s exact test. The estimated odds ratio was determined (95% confidence interval).
RESULTS: One hundred and six patients consented to this study; 43 participants in the RG arm and 41 in the IS arm were evaluable for the primary endpoint. Participants had a mean age of 57.8 years (SD 13.9). Demographic characteristics and baseline nasal symptoms were similar between arms. Of the evaluable participants who received RG, 67.4% reported improved nasal symptoms, compared with 36.6% of the participants who received IS (P = 0.009). Adverse events were sparse and did not differ between arms.
CONCLUSIONS: Rose geranium in sesame oil significantly improves nasal vestibulitis symptoms among patients undergoing chemotherapy.
BACKGROUND: NCT04620369.
摘要：
目的：这项III期随机双盲对照试验的目的是研究在芝麻油（RG）鼻喷雾剂中使用玫瑰天竺葵与等渗盐水（IS）鼻喷雾剂对缓解化疗患者鼻前庭炎症状的疗效。
方法：接受主动化疗并报告相关鼻部症状的患者以1：1的比例随机分配接受RG或IS，每天两次，持续2周。同意的参与者在基线时完成鼻部症状问卷，然后在治疗期间每周完成一次。开始鼻腔喷雾2周后鼻部症状改善的患者比例，使用六点的全球变化分数，在每个随机分组内和之间进行估计，和武器之间的比较，使用费希尔的精确检验。确定估计的比值比(95%置信区间)。
结果：106名患者同意这项研究；RG组的43名参与者和IS组的41名参与者可评估主要终点。参与者的平均年龄为57.8岁（SD13.9）。两组之间的人口统计学特征和基线鼻部症状相似。在接受RG的可评估参与者中，67.4%报告鼻腔症状改善，与36.6％接受IS的参与者相比（P=0.009）。不良事件很少，两组之间没有差异。
结论：芝麻油中的玫瑰天竺葵可显著改善化疗患者的鼻前庭炎症状。
背景：NCT04620369。
方法：接受主动化疗并报告相关鼻部症状的患者以1：1的比例随机分配接受RG或IS，每天两次，持续2周。同意的参与者在基线时完成鼻部症状问卷，然后在治疗期间每周完成一次。开始鼻腔喷雾2周后鼻部症状改善的患者比例，使用六点的全球变化分数，在每个随机分组内和之间进行估计，和武器之间的比较，使用费希尔的精确检验。确定估计的比值比(95%置信区间)。
结果：106名患者同意这项研究；RG组的43名参与者和IS组的41名参与者可评估主要终点。参与者的平均年龄为57.8岁（SD13.9）。两组之间的人口统计学特征和基线鼻部症状相似。在接受RG的可评估参与者中，67.4%报告鼻腔症状改善，与36.6％接受IS的参与者相比（P=0.009）。不良事件很少，两组之间没有差异。
结论：芝麻油中的玫瑰天竺葵可显著改善化疗患者的鼻前庭炎症状。
背景：NCT04620369。
