| Research purpose: To explore the effect of laxatives on the improvement of symptoms of functional constipation(syndrome of deficiency of fluid and dryness of intestine)in children using placebo as a historical control,and to observe the safety of its clinical application.Research Methods: In the first part,through the systematic retrieval of CNKI,VIP,Wan Fang,CMB,Medline,Cochrane Library and other domestic and foreign databases,the literature of randomized controlled trials of placebo-controlled children’s functional constipation(FC)was collected,the basic data and the efficacy and safety information of placebo were extracted,and a single-group meta-analysis was performed using R software to assess the placebo effect and explore its influencing factors,providing a control for the second part of the clinical study.The second part uses a placebo historical control,one-arm clinical study design approach.Thirty-six children with FC were planned to be included,all of whom were given laxatives.The course of treatment is 2 weeks,follow-up once a week,follow-up after 4 weeks of discontinuation.The observation indicators were weekly spontaneous defecation(SBM)response rate,number of bowel movements,fecal traits,painful bowel movements,number of fecal incontinence(FI),efficacy of TCM symptoms,number of remedial drug use,constipation recurrence rate and adverse events/reactions,which were observed and recorded weekly.The SBM response rate at the course of 2 weeks of treatment was the main evaluation index.By the confidence interval method,the interval estimation of the experimental group was compared with the placebo effect,and if the lower limit of the SBM response rate of 95%CI in the experimental group was higher than the upper limit of the placebo effect of 95% CI,the laxative side was considered to be more effective than the placebo.Research Outcomes: Part one: 13 articles including 671 placebo children were included.Single-group meta-analysis of placebo showed SBM response rates [Proportion =22.2%,95%CI(6%,38.4%)];weekly SBM frequency [MRAW=2.69,95% CI(1.36,4.02)];treatment success rates [Proportion=27.1%,95%CI(0.51%,56.8%)];weekly defecations[MRAW=2.13,95% CI(1.16,3.10)];Weekly FI frequency [MRAW=4.08,95%CI(1.24,6.93];4Weekly FI incidence [Proportion=14.6%,95%CI(8.7%,23.5%)];Weekly remedial drug use[Proportion=40.8%,95%CI(19.8%,63.7%)];Adverse event incidence [Proportion=21.4%,95% CI(8.6%,44.1%)];Adverse event incidence [Proportion=21.4%,95% CI(8.6%)]Incidence of adverse reactions [Proportion=1.3%,95% CI(0.3%,5.2%)].Meta-regression analysis showed that the duration and year of treatment may be factors influencing the FC placebo effect.Part two: This study enrolled 36 children,of whom 35 were admitted to FAS and SS and30 were enrolled in PPS.At 2 weeks of treatment,the SBM response rate and its 95% CI were85.7%(69.7%,95.2%),and the lower limit was higher than the upper limit of the historical placebo effect of 95% CI,suggesting that the laxative prescription was more effective than placebo.Analysis of other indicators,treatment for 2 weeks,the number of SBM was 4.74(4.17,5.32)times per week,the number of bowel movements was 4.83(4.29,5.37)times per week,and the number of FI times was 0.03(-0.03,0.87)times/week,fecal trait score disappeared by 20%,defecation pain disappeared by 62.9%,the use rate of remedial drugs was 5.7%(0.7%,19.2%),and the difference between the number of defecations,fecal traits and the number of use of remedial drugs was statistically significant(P<0.05).Research Conclusions: Functional constipation in children has a placebo effect in terms of spontaneous defecation(SBM),treatment success rate,stool traits,frequency of defecation,fecal incontinence,painful bowel movements,remedial drug use,hard stools and adverse events/reactions,and the size of the effector values is related to age,year,duration,number of centers and diagnostic criteria,respectively.Compared with the historical placebo pooled effect value,the fi frequency,frequency of defecation and remedial drug use rate were better than placebo;the effective rate of TCM symptoms was 71.4%(53.7%,85.4%);the individual symptoms of TCM had a certain improvement,and their before-and-after comparisons showed that only the differences in defecation time,stool traits and difficulty defecation were statistically significant(P<0.05).Follow-up 4 weeks after discontinuation showed a recurrence rate of 6.9%(0.8%,22.8%)of laxatives.The safety results showed that the incidence of adverse events and its 95% CI in the trial was 8.6%(1.8%,23.1%);no adverse reactions occurred.Compared with historical placebo pooled effect values,the safety of this party is better than that of placebo.Research Conclusions: Functional constipation in children has a placebo effect in terms of SBM,treatment success rate,stool traits,frequency of bowel movements,fecal incontinence,painful bowel movements,remedial drug use,hard stools,and adverse events/reactions.This study preliminarily explored the effectiveness,safety and value of laxative addition and subtraction for children with functional constipation(intestinal dryness)on SBM response rate,constipation symptoms,TCM symptoms and remedial drug use rate. |
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