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香桃木草药与抗痔疮药膏对Ⅰ、Ⅱ度内痔产后妇女痔疮症状及生活质量影响的比较:一项三盲随机对照临床试验

Comparison of the effect of Myrtus communis herbal and anti-hemorrhoid ointments on the hemorrhoid symptoms and quality of life in postpartum women with grade I and II internal hemorrhoid: A triple-blinded randomized controlled clinical trial.

作者信息

Malekuti Jamileh, Mirghafourvand Mojgan, Samadi Khadijeh, Abbasalizadeh Fatemeh, Khodaei Laleh

机构信息

Faculty of Nursing and Midwifery, Tabriz University of Medical Sciences, Tabriz, Iran.

Reproductive Health, Social Determinants of Health Research Center, Tabriz University of Medical Sciences, Tabriz, Iran.

出版信息

J Complement Integr Med. 2019 Aug 21;16(4):/j/jcim.2019.16.issue-4/jcim-2018-0147/jcim-2018-0147.xml. doi: 10.1515/jcim-2018-0147.

Abstract

Introduction Due to the effects of hemorrhoids on physical and mental health, this study aimed to compare the effect of Myrtus communis herbal and anti-hemorrhoid ointments on symptoms of hemorrhoid and quality of life (primary outcomes) and satisfaction of the treatment and side effects (secondary outcomes). Methods This triple-blind randomized controlled trial was performed on women with grade I and II hemorrhoid referring to health centers in Tehran, Iran, in 2017. Individuals were randomly assigned to two groups of 67 people through block randomization method. The intervention group received the Myrtus communis herbal ointment and the control group received anti-hemorrhoid ointment twice a day, every 12 ± 2 h, an applicator of the drug through the rectum for 4 weeks. The Colorectal Evaluation of a Clinical Therapeutics Scale (CORECTS) was used to assess the severity of symptoms of hemorrhoid. To assess the quality of life, the World Health Organization Quality of Life questionnaire (WHOQOL-BREF) was used to measure the general quality of life of participants. This questionnaire was completed once before the start of the study, then on the fourth and the eighth week after the start of the intervention. Repeated measure ANOVA, Chi-square, Mann-Whitney U and independent t-test were used for data analysis. Results The severity of all symptoms of hemorrhoid decreased in both two group and there was no statistically significant difference between the two groups (p>0.05). However, the mean of anal itching at 4 and 8 weeks after the intervention was significantly lower in the Myrtus communis ointment group (p<0.05). There was no significant difference between groups in terms of quality of life at 4 and 8 weeks after the intervention (p>0.05). There was a significant difference between the two groups in terms of satisfaction with the drug (p=0.019) and the participants in the Myrtus communis ointment group were more satisfied with their drug use. Conclusions Myrtus communis herbal ointment was able to reduce the symptoms of hemorrhoid in the affected women. Therefore, it is likely that the use of this drug will promote the health of mothers with hemorrhoid.

摘要

引言 由于痔疮对身心健康有影响,本研究旨在比较香桃木草药软膏和抗痔疮软膏对痔疮症状、生活质量(主要结局)以及治疗满意度和副作用(次要结局)的影响。

方法 2017年,在伊朗德黑兰的健康中心,对患有I级和II级痔疮的女性进行了这项三盲随机对照试验。通过区组随机化方法将个体随机分为两组,每组67人。干预组每天两次,每12±2小时通过直肠给药器使用香桃木草药软膏,对照组使用抗痔疮软膏,持续4周。使用临床治疗量表的结直肠评估(CORECTS)来评估痔疮症状的严重程度。为了评估生活质量,使用世界卫生组织生活质量问卷(WHOQOL-BREF)来测量参与者的总体生活质量。该问卷在研究开始前完成一次,然后在干预开始后的第四周和第八周完成。使用重复测量方差分析、卡方检验、曼-惠特尼U检验和独立t检验进行数据分析。

结果 两组痔疮的所有症状严重程度均降低,两组之间无统计学显著差异(p>0.05)。然而,干预后第4周和第8周,香桃木软膏组的肛门瘙痒平均值显著较低(p<0.05)。干预后第4周和第8周,两组在生活质量方面无显著差异(p>0.05)。两组在药物满意度方面存在显著差异(p=0.019),香桃木软膏组的参与者对药物使用更满意。

结论 香桃木草药软膏能够减轻受影响女性的痔疮症状。因此,使用这种药物可能会促进患有痔疮的母亲的健康。

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