Treatment of diarrhea-predominant irritable bowel syndrome with N-acetyl-D-glucosamine: A randomized, double-blind, placebo-controlled multi-center study Coorperative group / 中华消化杂志

ABSTRACT

Objective To evaluate the efficacy and safety of N-acetyl-D-glucosamine in treatment of diarrhea-predominant irritable bowel syndrome (D-IBS). Methods A multi-center, randomized, double-blind, placebo-controlled clinical study was performed in 430 patientswith D-IBS. After 2-week baseline period, eligible subjects were randomly either received 100 mg of N-acetyl-D-glucosamine (treated group,n=323) or placebo (control group,n= 107) 3 times a day for consecutive 4 weeks, followed by 2-week withdrawal follow-up. The major parameters were assessed by visual analogue scale (VAS) score and Common Symptom Sensation score. The minor parameters included abdominal pain or discomfort, severity of diarrhea, bloating, urgency, defecation frequencies with consistency per bowel movement which was judged by bristol stool scale and utilization of Smect. The evidence of adverse events was reeoded. Results The major parameters were singnifieantly improved in the treated group with effective rate of 65.16 % at the fourth week of treatment in comparison with control group (effective rate of 34. 29% ,P<0.01). Except the utilization of Smect (P= 1.00), the other minor parameters were significantly improved in treated group compared with control group (P< 0.01) after 1 week treatment. The occurrence of adverse events was 0.96% in the treated group and 0. 95% in the control group (P = 1. 00). Conclusions The results indicate that N-acetyl-D-glucosamine is effective and safe in the treatment of D-IBS by improving ecological environment and preventing activation of mast cells.