| Objective: To evaluate the clinical effect of TCM on functional constipation.Methods: Search domestic and foreign databases by computer,type the search formula and set the search time from January 1,2011 to December 31,2020,and include all search results.According to the preset literature screening conditions,the literature of RCTs related to the treatment of chronic functional constipation with traditional Chinese medicine was eliminated.Enter and rank reference conditions,statistical methods,diagnostic criteria,intervention methods,outcome assessment indicators,and other data,and evaluate the quality of literatures.Finally,analyze the outcomes and assess the effect of treatments by using Revman 5.4.Results: Assessment of the quality of the literature: 13 studies were included,with a total of 1254 patients with functional constipation,of which 684 were in the treatment group and 658 in the control group.The number of cases in each literature was between 60 and 160,and 5 of them used a random number table method;Thirteen papers did not describe allocation concealment and blinding;3 documents mentioned detachment,3 of which described the reasons for detachment,and all mentioned the number of detachment cases,but the loss rate was controlled within 6%,and the remaining 10 article did not mention the abandonment situation;According to whether to report the expected outcome indicators to judge whether the report is selective,2 of the 13 articles have selective reports on the results,and the remaining 11 articles have been reported.One of the 13 articles has incomplete reference data and the remaining 12 studies have complete reference data.Meta-analysis:(1)At the effective rate level based on the "Guiding Principles for Clinical Research of Chinese New Drugs" according to the criteria for evaluating the efficacy of constipation,the Goal result:I2 =0%;P=0.55;OR=4.94;95%CI[2.84.8.64];P<0.00001,Chinese medicine is more effective than Western medicine in treating functional constipation.According to the mean age for subgroup analysis,the combined effect size OR of the subcombination with a mean age of≤50 years and>50 years is 5.90 [2.64,13,17] and 4.12[1,89,9,02],respectively,among those with optimal efficacy of the group ≤50 years.(2)Regarding the total effective rate based on the "Consensus on the diagnosis and treatment of chronic constipation",the results of the meta-a nalysis:I2=1%;P=0.37;OR=2.69;95%CI[1.48,4.87];P=0.001,suggesting that traditional Chinese medicine is more effective than Western medicine in treating chronic functional constipation.(3) In terms of improvement in the Bristol classification scores,target results:I2=98%;P;0.00001,this group of studies has strong heterogeneity,excluding two low quality studies,I2=0%;Z=3.87(P<0.0001);SMD=0.54;95%CI[0.27;081];P<0.00001,indicating that TCM has higher clinical efficacy than Western medicine.(4)Regarding the reduction of the level of vasoactive intestinal peptide,the results of the meta-analysis:I2=94%;P<0.0001,suggesting that this group has high heterogeneity,but due to less included literature,It is impossible to exclude literature for sensitivity Sexual analysis,select the random effects model:SMD=-0.59;95%CI[-1.72,0.54];P=0.31,indicating that TCM does not have an obvious advantage in reducing vasoactive intestinal peptide in patients with functional constipation;(5)In terms of reduction of serum nitric oxide synthase levels,the results of the metaanalysis:I2=83%;P<0.02,suggesting that the heterogeneity between the groups is relatively high,but due to the fact that there are fewer papers included,it is impossible to exclude papers for sensitivity.Sexual analysis,select the random effect model:SMD=-1.26;95%CI[-1.68,-0.84];P<0.00001,suggesting that TCM has obvious advantages in reducing serum nitric oxide synthase levels in patients with functional constipation;(6)In terms of reduction of the mean score of defecation time,the results of the meta-analysis:I2=83%;P=0.02.Due to the fact that there are few documents included,it is impossible to exclude documents for sensitivity analysis.The random effects model is selected:SMD=-0.37;95%CI[-0.81.0.08];P=0.31,suggesting that Chinese medicine has no obvious advantage in reducing the defecation time score in patients with functional constipation;(7)In terms of reduc- ing the mean weekly bowel frequency score,the results of the meta-analysis:I2=97%;P<0.00001,due to the lack of included literature,it is impossible to exclude literature for sensitivity analysis,choose the random effects model:SMD=-0.12;95%CI[-1.18;0.94];P=0.82,suggesting that TCM group is reducing weekly average.There is no obvious advantage in defecation frequency scoring;(8)At the level of the recurrence rate,the meta-analysis showed:I2=0%;P=0.82;OR=0.21;95%CI[0.09;0.52];P=0.0007,indicating that traditional Chinese medicine is reduced.The recurrence rate of patients with functional constipation is better than Western medicine.Conclusion: TCM has a definite curative effect in the treatment of CF.It has shown a better curative effect than Western medicine in improving clinical efficacy,Bristol classification score,reducing serum nitric oxide synthase and other aspects,and can better prevent recurrence.However,the 13 articles included this time have uneven sample sizes,inconsistent observation index standards,inadequate design,more publication bias,and scattered outcome indicators,resulting in vasoactive intestinal peptide scores and clinical symptoms.The analysis of other aspects is very heterogeneous,and it is difficult to draw effective conclusions.So more high-quality clinical studies are needed to provide evidence for the treatment of FC with TCM. |
PDF Full Text Request