Tavakoli Ali, Shirzad Meysam, Taghavi Alireza, Fattahi Mohammadreza, Ahmadian-Attari Mohammadmahdi, Mohammad Taghizadeh Leila, Rostami Chaijan Mahsa, Sedigh Rahimabadi Masih, Akrami Rahimeh, Pasalar Mehdi
Research Center for Traditional Medicine and History of Medicine, Shiraz University of Medical Sciences, Shiraz, Iran.
Department of Traditional Medicine, Faculty of Medicine, Shiraz University of Medical Sciences, Shiraz, Iran.
Galen Med J. 2019 Jul 7;8:e1307. doi: 10.31661/gmj.v8i0.1307. eCollection 2019.
Ulcerative colitis is the most common form of inflammatory bowel disease worldwide, which presents with superficial ulcers in the rectum and colon. The aim of this study was to assess the effectiveness of rose oil soft capsules over placebo on the clinical outcomes in moderate to severe ulcerative colitis.
This study was a pilot randomized, double-blind clinical trial, and the 40 patients were assigned into rose oil and placebo groups (n=20 per group). All patients were instructed to use their prescribed two soft capsules three times daily for two months. The clinical symptoms, quality of life the patients, and calprotectin level were evaluated via partial Mayo clinic score, irritable bowel disease questionnaire (IBDQ-9), and calprotectin kit as primary outcome measures.
The mean age of the participants was 41±10 years. Most of them (53.6%) were male, and the remaining (46.4%) were female. The demographic and baseline data showed no differences between the two groups. Partial Mayo clinic scores decreased in both groups after the treatment, but the difference between the rose oil and placebo groups was not statistically significant (P=0.99). IBDQ-9 score also increased in both interventions before and after the treatment (P=0.012), though the differences between these two groups were not statistically significant (P=0.61). There were no significant differences between the two study groups either in terms of calprotectin level (P=0.219).
This study showed that rose oil might improve ulcerative colitis clinical outcomes, but for a better evaluation, it is imperative to conduct experiments with a large sample size and longer follow-up observation.
溃疡性结肠炎是全球最常见的炎症性肠病形式，表现为直肠和结肠的浅表溃疡。本研究的目的是评估玫瑰油软胶囊相对于安慰剂对中度至重度溃疡性结肠炎临床结局的有效性。
本研究是一项试点随机双盲临床试验，40例患者被分为玫瑰油组和安慰剂组（每组n = 20）。所有患者均被指示每天服用规定的两粒软胶囊，每日三次，持续两个月。通过部分梅奥诊所评分、肠易激综合征问卷（IBDQ - 9）和钙卫蛋白试剂盒评估临床症状、患者生活质量和钙卫蛋白水平，作为主要结局指标。
参与者的平均年龄为41±10岁。其中大多数（53.6%）为男性，其余（46.4%）为女性。两组的人口统计学和基线数据无差异。治疗后两组的部分梅奥诊所评分均下降，但玫瑰油组和安慰剂组之间的差异无统计学意义（P = 0.99）。治疗前后两种干预措施的IBDQ - 9评分也均升高（P = 0.012），尽管两组之间的差异无统计学意义（P = 0.61）。两组在钙卫蛋白水平方面也无显著差异（P = 0.219）。
本研究表明玫瑰油可能改善溃疡性结肠炎的临床结局，但为了进行更好的评估，必须进行大样本量和更长随访观察的实验。
