Ravichandran Gayathri1, Thangavelu Aruna1, Sivaraman Malar1, Bennur Shilpa2, Karukkupalayam Ramasamy Dhanasekar3. 1. Department of Pharmacology, Kilpauk Medical College, Chennai, Tamil Nadu, India. 2. Department of Medical & Scientific Affairs, Tablets India Limited, Jhaver Centre, 72 Marshalls Road, Egmore, Chennai, 600008, India. 3. Department of Medical & Scientific Affairs, Tablets India Limited, Jhaver Centre, 72 Marshalls Road, Egmore, Chennai, 600008, India. ds@tabletsindia.com.
Abstract
BACKGROUND: The symptoms of irritable bowel syndrome (IBS) lead to considerable impairment of health-related quality of life and high health care costs. Available therapies are not efficient in treating the symptoms of IBS. Studies have shown the beneficial effects of Saccharomyces cerevisiae CNCM I-3856. Therefore, this study was done to evaluate the efficacy and safety of S. cerevisiae CNCM I-3856 in the treatment of IBS. METHODS: This was a prospective, randomized, placebo-controlled study. One hundred newly diagnosed subjects with IBS were subgrouped into IBS-D, IBS-C, and IBS-M and then randomized to the S. cerevisiae CNCM I-3856 and placebo groups. Saccharomyces cerevisiae/placebo was administered in addition to standard treatment for a period of 8 weeks. Subjects were assessed for improvement of abdominal pain and change in stool consistency using a 7-point Likert scale and Bristol stool scale respectively. RESULTS: The mean reduction of abdominal pain score in the S. cerevisiae CNCM I-3856 group was statistically significant when compared with the placebo group (p < 0.001). Similar improvement was also seen in the subgroups. Improvement in stool consistency in IBS-D subgroup at the end of treatment period was found to be statistically significant in S. cerevisiae group when compared to that of placebo (p < 0.001). A similar improvement was seen in the IBS-C and IBS-M subgroups. No serious adverse events were recorded in both groups. CONCLUSION: The use of Saccharomyces cerevisiae CNCM I-3856 in IBS at a dose of 2 billion CFU twice daily for 8 weeks has shown to have an improvement in abdominal pain and stool consistency due to its analgesic and anti-inflammatory activity in subjects with IBS.
RCT Entities:
BACKGROUND: The symptoms of irritable bowel syndrome (IBS) lead to considerable impairment of health-related quality of life and high health care costs. Available therapies are not efficient in treating the symptoms of IBS. Studies have shown the beneficial effects of Saccharomyces cerevisiae CNCM I-3856. Therefore, this study was done to evaluate the efficacy and safety of S. cerevisiae CNCM I-3856 in the treatment of IBS. METHODS: This was a prospective, randomized, placebo-controlled study. One hundred newly diagnosed subjects with IBS were subgrouped into IBS-D, IBS-C, and IBS-M and then randomized to the S. cerevisiae CNCM I-3856 and placebo groups. Saccharomyces cerevisiae/placebo was administered in addition to standard treatment for a period of 8 weeks. Subjects were assessed for improvement of abdominal pain and change in stool consistency using a 7-point Likert scale and Bristol stool scale respectively. RESULTS: The mean reduction of abdominal pain score in the S. cerevisiae CNCM I-3856 group was statistically significant when compared with the placebo group (p < 0.001). Similar improvement was also seen in the subgroups. Improvement in stool consistency in IBS-D subgroup at the end of treatment period was found to be statistically significant in S. cerevisiae group when compared to that of placebo (p < 0.001). A similar improvement was seen in the IBS-C and IBS-M subgroups. No serious adverse events were recorded in both groups. CONCLUSION: The use of Saccharomyces cerevisiae CNCM I-3856 in IBS at a dose of 2 billion CFU twice daily for 8 weeks has shown to have an improvement in abdominal pain and stool consistency due to its analgesic and anti-inflammatory activity in subjects with IBS.
Entities:
Keywords:
Bristol stool scale; Functional GI disorders; Likert scale; Probiotics; Rome III criteria
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