Efficacy of the herbal formula of Foeniculum vulgare and Rosa damascena on elderly patients with functional constipation: A double-blind randomized controlled trial |
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| Affiliation: | 1. Gastroenterology and Hepatology Research Center, Kerman University of Medical Sciences, Kerman 7716913555, Iran;2. Department of Traditional Medicine, School of Persian Medicine, Kerman University of Medical Sciences, Kerman 7716913555, Iran;3. Student Research Committee, Afzalipour Faculty of Medicine, Kerman University of Medical Sciences, Kerman 7716913555, Iran;4. Herbal and Traditional Medicines Research Center, Kerman University of Medical Sciences, Kerman 7716913555, Iran;5. Department of Community Health Nursing, Razi Faculty of Nursing and Midwifery, Kerman University of Medical Sciences, Kerman 7716913555, Iran;1. Department of Biomedical Engineering, Southwest State University, Kursk 305040, Russian Federation;2. Electrical Energy Department, Balqa Applied University, Amman 11937, Jordan;3. Civil Engineering Department, Zarqa University, Zarqa Governorate 13222, Jordan;4. Saint-Petersburg National Research University of Information Technologies, Mechanics and Optics, Saint-Petersburg 197101, Russian Federation;5. Pediatric Faculty, Kursk State Medical University, Kursk 305041, Russian Federation;1. Hakim Ajmal Khan Institute for Literary and Historical Research in Unani Medicine, Central Council for Research in Unani Medicine, Jamia Millia Islamia Campus, New Delhi 110025, India;2. Department of Ilaj bit Tadbeer, School of Unani Medical Education and Research, Jamia Hamdard, New Delhi 110062, India;1. College of Chinese Materia Medica, Shanghai University of Traditional Chinese Medicine, Shanghai 201203, China;2. Engineering Research Center of Modern Preparation Technology of TCM of Ministry of Education, Shanghai University of Traditional Chinese Medicine, Shanghai 201203, China;3. Department of Traditional Chinese Medicine, Beicai Community Health Service Center of Pudong New District, Shanghai 201204, China;1. Department of Radiology, Shuguang Hospital, Shanghai University of Traditional Chinese Medicine, Shanghai 201203, China;2. Department of Acupuncture & Moxibustion, Shuguang Hospital, Shanghai University of Traditional Chinese Medicine, Shanghai 201203, China;1. College of Basic Medical Sciences, Yunnan University of Chinese Medicine, Kunming 650500, Yunnan Province, China;2. Department of Endocrinology, Yunnan Provincial Hospital of Traditional Chinese Medicine, Kunming 650021, Yunnan Province, China;3. Key Laboratory of Syndrome Micro-Differentiation of Yunnan Province, Kunming 650500, Yunnan Province, China |
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| Abstract: | BackgroundConstipation 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.ObjectiveThis 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 interventionThis 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.Main outcome measuresConstipation 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.ResultsA 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.ConclusionAlthough 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.Trial registrationThis trial was registered in the Iranian Registry of Clinical Trials (IRCTID: IRCT20200108046056N1). |
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| Keywords: | Elderly Constipation Persian medicine Randomized controlled trial |
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