According to Rome IV criteria, irritable bowel syndrome (IBS) is the most common functional bowel disorder with recurrent abdominal pain associating with defecation or a change in bowel habit. Several studies reported the efficacy of herbal medicines in improving IBS symptoms. This pilot study evaluated the efficacy of the herbal medicine of Melissa officinalis (Badranjbooyeh), Pimpinella anisum (Anisun); and Rosa damascene (Gole Sorkh) on symptoms severity score of patients with irritable bowel syndrome, constipation predominant (IBS-C).
This double-blind randomized pilot controlled clinical trial, with parallel groups allocation ratio of 1:1, was conducted in a referral clinic of Afzalipour Hospital affiliated with Kerman University of Medical Sciences in Kerman, southeastern Iran. A total of 40 patients with IBS-C (diagnosed based on the Rome IV criteria) were included in this study. The patients with complications during the intervention, pregnancy or lactation, a history of allergy to herbal drugs, and severe organic or psychiatric disorders were excluded. The participants received one capsule containing 500 mg of herbal Aqueous extract or placebo (Corn starch) three times a day for 4 weeks. IBS Symptoms Severity Scale (IBS-SSS) were assessed via standard questionnaire.
A total 20 participants in each group completed the study, and their data were analyzed statistically. All clinical outcomes (abdominal pain severity, abdominal pain frequency, bloating/distention severity, bowel habit dissatisfaction, and interaction with quality of life) showed significant improvements in herbal medicine group compared to the placebo without serious side effects (independent t-test, P <0.05).
Although this pilot study showed the efficacy of this herbal medicine in improving IBS-SSS, more studies with larger sample size are needed to confirm the efficacy and safety of this herbal medicine in patients with IBS. Trial registration: This trial was registered in the Iranian Registry of Clinical Trials under Reg. No. IRCT20150927024228N4.
