Efficacy of a Quebracho, Conker Tree, and M. balsamea Willd Blended Extract in a Randomized Study in Patients with Irritable Bowel Syndrome with Constipation

Abstract

Aim: To assess efficacy and safety of a blended Quebracho, Conker Tree and Mentha balsamea Willd extract in patients diagnosed with irritable bowel syndrome with constipation (IBS-C). Materials and Methods: This was a 2-week double-blind, randomized, placebo-controlled study of patients previously diagnosed with IBS-C (N=16). Subjects were randomized at baseline and assessed using a scoring system for symptoms of constipation, bloating, and a total constipation plus bloating score before receiving the blended herbal extract or placebo. At baseline and 2 weeks, vital signs, concomitant medications, diary entries of symptoms, and adverse events were recorded as well as assessment of constipation, bloating, and a total constipation plus bloating score. Treatment group, time of symptom scores, and the interaction between group and time were analyzed. Paired t-tests were used to assess temporal effects within each treatment group. Results: There were no baseline differences in the constipation, bloating, and total constipation plus bloating scores for the herbal extract and placebo groups. The repeated measures analysis of variance tests showed a significant time/group interaction for the herbal extract effect on improving all three scores. There were significant improvements in the average constipation (p=0.0034), bloating (p<0.001) and constipation plus bloating scores (p<0.001) for the herbal extracts group compared to no improvement for the placebo arm. There were no reports of AEs over the 2-week period. Conclusion: The results from this pilot study suggest a blended extract of Quebracho, Conker Tree and M. balsamea Willd can safely manage symptoms in IBS-C subjects.