Azimi Maryam, Niayesh Hanieh, Raeiszadeh Mahboobeh, Khodabandeh-Shahraki Sedigheh
Gastroenterology and Hepatology Research Center, Kerman University of Medical Sciences, Kerman 7716913555, Iran; Department of Traditional Medicine, School of Persian Medicine, Kerman University of Medical Sciences, Kerman 7716913555, Iran.
Student Research Committee, Afzalipour Faculty of Medicine, Kerman University of Medical Sciences, Kerman 7716913555, Iran.
J Integr Med. 2022 May;20(3):230-236. doi: 10.1016/j.joim.2022.03.001. Epub 2022 Mar 10.
Constipation is a common chronic bowel disorder with an incidence of more than 50% in the elderly population. Complementary and alternative medicine is a cost-effective and satisfactory treatment for constipation used widely by the elderly.
This study evaluates the efficacy of an herbal formula made from Foeniculum vulgare Mill. and Rosa damascena for the treatment of constipation in an elderly population and consequent changes to their quality of life.
DESIGN, SETTING, PARTICIPANTS AND INTERVENTION: This double-blind randomized active controlled clinical trial, with parallel group allocation ratio of 1:1, was conducted in a referral clinic in Afzalipour Hospital, affiliated to Kerman University of Medical Sciences in Kerman, Southeastern Iran. Individuals over 60 years of age, diagnosed with functional constipation (based on the Rome IV criteria), were included in this study. Participants received a sachet of 10 g F. vulgare and R. damascena (herbal formula group) or polyethylene glycol 4000 (PEG 4000 group) with a glass of warm water two times a day for 4 weeks and were followed up for 4 additional weeks.
Constipation severity, stool consistency, and the quality of life were used as the primary outcomes. Drug side effects were used as a secondary outcome. The outcomes were assessed using the Constipation Assessment Scale, the Bristol Stool Form Scale, and the Patient Assessment of Constipation Quality of Life questionnaire.
A total of 25 participants in each group completed the four-week treatment cycle and the eight-week follow-up. At the end of the four-week treatment cycle, all clinical outcomes had significant improvements in both groups (P < 0.05). The analysis of constipation severity (P < 0.001), stool consistency (P < 0.001), and the quality of life (P < 0.001) showed significant improvements with fewer side effects (mild diarrhea) and a longer duration of symptom relief in the herbal formula group compared to the PEG 4000 group.
Although both interventions significantly improved the treatment outcomes, constipation severity, stool consistency and the quality of life were improved more effectively by the herbal formula than by PEG 4000; however, the mechanism of action is not yet understood.
This trial was registered in the Iranian Registry of Clinical Trials (IRCTID: IRCT20200108046056N1).
便秘是一种常见的慢性肠道疾病，在老年人群中的发病率超过50%。补充和替代医学是一种经济有效且令人满意的便秘治疗方法，被老年人广泛使用。
本研究评估由小茴香和大马士革蔷薇制成的草药配方治疗老年便秘患者的疗效以及对其生活质量的影响。
设计、地点、参与者和干预措施：本双盲随机活性对照临床试验采用1:1平行组分配比例，在伊朗东南部克尔曼市克尔曼医科大学附属阿夫扎利普尔医院的一家转诊诊所进行。纳入年龄超过60岁、诊断为功能性便秘（基于罗马IV标准）的个体。参与者每天两次，每次用一杯温水冲服一袋10克的小茴香和大马士革蔷薇（草药配方组）或聚乙二醇4000（PEG 4000组），持续4周，并额外随访4周。
便秘严重程度、粪便稠度和生活质量作为主要观察指标。药物副作用作为次要观察指标。使用便秘评估量表、布里斯托粪便形态量表和便秘患者生活质量问卷对观察指标进行评估。
每组共有25名参与者完成了为期四周的治疗周期和为期八周的随访。在四周治疗周期结束时，两组的所有临床观察指标均有显著改善（P < 0.05）。与PEG 4000组相比，草药配方组在便秘严重程度（P < 0.001）、粪便稠度（P < 0.001）和生活质量（P < 0.001）方面有显著改善，副作用更少（轻度腹泻），症状缓解持续时间更长。
虽然两种干预措施均显著改善了治疗效果，但草药配方在改善便秘严重程度、粪便稠度和生活质量方面比PEG 4000更有效；然而，其作用机制尚不清楚。
本试验在伊朗临床试验注册中心注册（IRCTID: IRCT20200108046056N1）。
