Treatment of constipation-predominant irritable bowel syndrome with calcium polycarbophil:A randomized,double-blind,placebo-controlled,multicenter study

Objective To evaluate the efficacy and safety of calcium polycarbophil in treatment of constipation-predominant irritable bowel syndrome(C-IBS).Methods A multi-center,randomized. double blind,placebo-controlled clinical study was performed with 449 C-IBS patients.After one-week run-in period,eligible subjects were randomized and allocated to either treatment group (n=225) or control group (n=224).The patients were received either 2 tablets of calcium polycarbophil or placebo together with 200 ml water 3 times a day for consecutive 4 weeks.The symptoms of all subjects inclu- ding daily abdominal pain or discomfort,bloating,defecation frequencies with consistency per bowel movement,which was judged by Bristol Stool Form Scale,feeling of incomplete bowel movement and straining during a bowel movement were recorded daily.The general feeling of IBS and the severity of constipation were also recorded weekly,and the adverse event were investigated.Results The general feeling and the severity of constipation were significantly relieved in the treatment group at the second week in comparison with the control group(P0.05).There was no significant differences between the two groups in improvement of the symptoms of abdominal pain or discomfort,bloating,the consistency per bowel movement,feeling of incomplete bowel movement and straining during a bowel movement after 2 weeks of treatment.At the third week,the frequency of bowel movement was significantly increased in the treatment group than those in the control group.The prevalence of adverse events was 2.28% in the treatment group and 4.63% in the control group (P=0.1998).Conclusion The results indicate that calcium polycarbophil is effective and safe to treat C-IBS.