Persian Medicine, Faculty of Persian and Complementary Medicine, Mashhad University of Medical Sciences, Mashhad, 9177899191, Iran.
Department of Gastroenterology, Faculty of Medicine, Mashhad University of Medical Sciences, Mashhad, 91776699199, Iran.
Chin J Integr Med. 2020 Oct;26(10):729-735. doi: 10.1007/s11655-020-3267-4. Epub 2020 Jul 4.
To evaluate the efficacy and safety of administration of the formulated Persian herbal syrup on improving the symptoms of patients with constipation-predominant irritable bowel syndrome (IBS-C).
This study was conducted in 70 patients with IBS-C, who were recruited from 3 medical 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.
The response to treatment was 84.4% (27/32) in the treatment group and 46.4% (13/28) in the placebo 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<0.001). Moreover, IBS-SSS and BSFS scores in the treatment group were lower than the placebo group after the intervention (P=0.041). There was no significant difference in the anxiety and depression scores after treatment 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 the placebo group, 1 case of exacerbation of the disease was reported.
Anti-IBS syrup significantly 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).
评估配方的波斯草药糖浆对改善便秘型肠易激综合征（IBS-C）患者症状的疗效和安全性。
本研究纳入了 2017 年 11 月至 2018 年 8 月期间伊朗马什哈德 3 家医疗中心的 70 例 IBS-C 患者，将其随机分为治疗组和安慰剂组，每组 35 例。治疗组患者接受 15 毫升抗 IBS 糖浆，每日 3 次，持续 6 周，并随访 4 周。安慰剂糖浆也是通过类似的指示制备的，使用不含植物提取物的 BP 糖浆。主要结局包括 IBS 症状严重程度量表（IBS-SSS）问卷和次要结局，包括医院焦虑和抑郁量表（HADS）问卷、布里斯托粪便量表（BSFS），分别在第 6 周和第 10 周进行评估。在治疗结束时收集安全性指标，并使用通用不良事件术语标准 4.0（CTCAE）评估不良事件。
治疗组的治疗反应率为 84.4%（27/32），安慰剂组为 46.4%（13/28）（P=0.002）。与治疗前相比，两组在 6 周干预后 IBS-SSS 和 BSFS 评分均显著下降（P<0.001）。此外，干预后治疗组的 IBS-SSS 和 BSFS 评分低于安慰剂组（P=0.041）。两组治疗后焦虑和抑郁评分无显著差异（P>0.05）。治疗组报告的不良反应包括治疗开始后第 1 周出现 2 例头痛、1 例嗜睡、1 例月经过多，均未导致治疗中断。安慰剂组报告 1 例病情加重。
与安慰剂相比，抗 IBS 糖浆可显著降低 IBS 症状的严重程度。然而，需要进一步研究焦虑和抑郁评分。（注册号：IRCT2017061034446N1）。
