Efficacy Evaluation Of Tonglichangrong Capsules For The Treatment Of Chronic Functional Constipation

Objective:To evaluate the efficacy and safety of Tonglichangrong capsules for chronic functional constipationMethods:A randomized, double-blinded, placebo-controlled clinical trial design was adopted in the trial. Patients who with chronic functional constipation were divided into experiment group and control group by computer-generated random number list, which had a ratio of 3:1. Treatment group were given Tongli changrong capsules 2g Bid for a week, control group were given placebo 2g Bid for a week.Results:Among 110 included cases,109 were screened for full analysis set (FAS),105 were screened per-protocol set (PPS),102 were screened for security data set(SS).The primary outcome was the score of main symptoms of real hot constipation. The secondary outcomes were the score of minor symptoms of excessive heat syndrome, defecate frequency in 7 days, duration of start efficacy. Safety evaluation included adverse events and related laboratory tests. The results were as follows:(1) Primary outcome1) Improvement of main symptoms score. In FAS, the score were 14.35±3.31 and 6.44±6.62 in baseline and 7 days after treatment in experiment group, and in control group, the score were 13.56±3.76 and 12.26±3.94.In PPS, the score were 14.23±3.36 and 6.33±6.48 respectively in baseline and 7 days after treatment in experiment group, and the corresponding score in control group were 13.56±3.76 and 12.26±3.94. The differences were statistically significant between the two groups (ρ<0.05), FAS and PPS had the same results.(2) Secondary outcomes (FAS)1 improvement of minor symptoms score. The score were 3.83±1.24 and 2.12±1.83 in baseline and 7 days after treatment in experiment group, and in control group, the score were 3.96±0.98 and 3.89±0.97 respectively. There were statistic significance between the two groups (p<0.05).2) Defecate frequency in 7 days. No. of defecation in 7 days were 2.25±1.20 and 4.24±2.51 in baseline and 7 days after treatment in experiment group, and the corresponding number were 2.22±1.09 and 2.74±0.94 in control group. The differences were statistically significant between the two groups (p<0.05).3)Duration of start efficacy. It was 25.12±24.84 hours in experiment group and 25.39±18.23 hours in control group. There were no statistically significant differences between the two groups (p>0.05).(3) Effective rate (FAS)The total efficacy rate were 63.41% and 25.93% in treatment group and control group respectively. The differences were statistically significant between the two groups (p<0.05).(4) Assessment of safety3 cases of adverse events occurred in treatment group and 1 case of adverse event occurred in control group. There were no statistically significant differences between the two groups (p>0.05).Conclusion:Tonglichangrong capsules could improve symptoms of dry stool, difficult to pass, abdominal distension and increase defecate frequency in 7 days. It was an effective and safe agent in the treatment of chronic functional constipation.