Anti-irritable Bowel Syndrome Syrup Improves Constipation-Predominant Irritable Bowel Syndrome: A Randomized, Placebo-Co
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hinese Journal of Integrative Medicine
Available online at link.springer.com/journal/11655 Journal homepage: www.cjim.cn/zxyjhen/zxyjhen/ch/index.aspx E-mail: [email protected]
Original Article
Anti-irritable Bowel Syndrome Syrup Improves Constipation-Predominant Irritable Bowel Syndrome: A Randomized, Placebo-Controlled Trial Hamide Khorram Pazhouh1, Seyyd Musa al-Reza Hosseini2, Ali Taghipour3, Shokouhsadat Hamedi4, and Mohammadreza Noras5 Objective:: To evaluate the efficacy and safety of administration of the formulated Persian ABSTRACT Objective herbal syrup on improving the symptoms of patients with constipation-predominant irritable bowel syndrome Methods:: This study was conducted in 70 patients with IBS-C, who were recruited from 3 medical (IBS-C). Methods centers in Mashhad, Iran, from November 2017 to August 2018. Seventy patients were randomly assigned to 2 groups including treatment and placebo groups by block randomization, 35 cases in each group. Patients in the treatment group received 15 mL of anti-IBS syrup, thrice daily for 6 weeks and followed up for 4 weeks. Placebo syrup was also prepared through similar instruction, BP syrup without plant extract was used. Primary outcome induding IBS Symptom Severity Scale (IBS-SSS) questionnaire and secondary outcomes in terms of Hospital Anxiety and Depression (HADS) questionnaires, the Bristol Stool Form Scale (BSFS) were completed and evaluated at weeks 6 and 10, respectively. Safety indices were collected at the end of the treatment and Common Terminology Criteria for Adverse Events v4.0 (CTCAE) was used to evaluate the adverse events. Results:: The response to treatment was 84.4% (27/32) in the treatment group and 46.4% (13/28) in the placebo Results group, respectively (P = 0.002). Compared with pre-treatment, a significant decrease was found on the IBS-SSS and BSFS scores after 6-week intervention in both groups (P 0.05). Side effects reported in the treatment group included 2 cases of headache during the first week of the onset of the treatment, 1 case of drowsiness, 1 case of increase in menstrual bleeding, which did not result in discontinuation of the treatment. In Conclusions:: Anti-IBS syrup significantly the placebo group, 1 case of exacerbation of the disease was reported. Conclusions reduced the severity of IBS symptoms compared to placebo. However, there was a need for further investigation regarding the anxiety and depression scores. (Registration No. IRCT2017061034446N1). KEYWORDS irritable bowel syndrome, herbal medicine, Persian medicine, complementary medicine, functional digestive disorders, randomized controlled trial
Irritable bowel syndrome (IBS) is a functional disorder of the gastrointestinal (GI) tract. It is characterized by chronic abdominal pain and altered bowel habits. (1) The prevalence of IBS has been estimated to be 10% to 20% in different regions worldwide. These rates have been reported to be lower in Asian countries compared to Western countries.(2) There are no exact data on the prevalence of IBS in Iran, b
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