| Objective:To systematically evaluate the efficacy and safety of traditional Chinese medicine in improving Parkinson's disease with constipation,and to provide scientific basis for the clinical selection of Chinese medicine for Parkinson's disease with constipation.Methods:Search domestic and foreign databases.The domestic databases mainly include:CNKI,VIP Science and Technology Journal(VIP),Wanfang Digital Journal Group(WF),China Biomedical Literature Database(CBM-disc);foreign databases:including:Pub Med,Cochrane Library,EMbase.The search time is from January1 st,2020 to the date of publication of major databases at home and abroad.Two researchers screened the literature according to the inclusion and exclusion criteria set by this institute and extracted the basic information and relevant data of the literature.The quality of clinical research literature that met the inclusion criteria was evaluated.The Revman5.3 software was used to treat Chinese medicine for Parkinson's disease with constipation.Patients' clinical effectiveness,constipation symptoms and efficacy assessment questionnaire,constipation patient quality of life questionnaire(PAC-QOL),Parkinson's patient quality of life questionnaire(PDQ39),UPDRSIII questionnaire,adverse reactions,relapse rate and other observational indicators were analyzed by Meta-analysis.Results:This study included 19 RCT documents and a total of 1325 subjects.The included literature data was integrated and inputted into Revman5.3 software.The software processed the data,and performed heterogeneity tests,combined effect magnitudes,etc.to draw forest maps and funnel maps,and evaluate the results of the Meta-analysis.Meta analysis results show that:(1)In the comparison between the traditional Chinese medicine group and the blank control group,based on the effectiveness level based on the "Traditional Chinese Medicine Elderly Fibrillation Diagnosis and Efficacy Evaluation Standards",the Meta results showed that the combined effect amount was[OR=13.80,95%CI(3.70,51.40),P<0.0001],the difference between the two groups is statistically significant,that is,the effectiveness of the Chinese medicine group in the treatment of Parkinson's constipation patients is significantly better than that of the blank control group.On the level of reducing the quality of life questionnaire for PD patients with Parkinson's constipation(PDQ39),the Meta results showed that the combined effect amount was [WMD=-3.37,95%CI(-10.04,3.30),P=0.32],and there was no difference between the two groups Statistical significance,that is,the Chinese medicine group has no obvious advantage in reducing the short-term quality of life questionnaire(PDQ39)scores of patients with Parkinson's constipation.At the level of lowering the scores of the Quality of Life Scale(PAC-QOL)for patients with Parkinson's constipation,the Meta results showed that the combined effect size was[WMD=-11.45,95%CI(-22.48,-0.41),P=0.04],The difference between the two groups is statistically significant,that is,the Chinese medicine group is better than the blank control group in reducing the quality of life scale(PAC-QOL)scores of patients with Parkinson's constipation.At the level of reducing the UPDRSIII scale score,the Meta results showed that the combined effect amount was [WMD=-2.59,95%CI(-3.52,-1.66),P<0.00001],and the difference between the two groups was statistically significant,that is,Chinese medicine group was superior to the blank control group in reducing UPDRSIII scores in patients with Parkinson's constipation.At the level of adverse reactions,Meta results showed that the combined effect amount was[OR=0.38,95%CI(0.14,1.08),P=0.07],and the difference between the two groups was not statistically significant.The rate of adverse reactions in patients with Parkinson's constipation was not significantly different from that in the blank control group.(2)In the comparison between the Chinese medicine group and the western medicine group,at the level of effectiveness according to the "Guidelines for Clinical Research of New Drugs in China",the Meta results showed that the combined effect amount was[OR=3.13,95%CI(1.89,5.18),P<0.00001],the difference between the two groups is statistically significant,that is,the traditional Chinese medicine group in the treatment of Parkinson's constipation is more effective than the western medicine group.At the level of effectiveness according to the "Traditional Chinese Medicine Standards for Diagnosis and Efficacy",Meta results showed that the combined effect amount was[OR=2.33,95%CI(1.13,4.81),P=0.02],and the differences between the two groups were statistically significant.That is,the effectiveness of the Chinese medicine group in treating Parkinson's constipation is more obvious than that of the western medicine group.At the level of lowering the PAC-QOL score of patients with constipation,the Meta results showed that the combined effect amount was[WMD=-6.89,95%CI(-10.19,-3.59),P<0.0001],the difference between the two groups There is statistical significance,that is,the Chinese medicine group is superior to the western medicine group in reducing the quality of life scale(PAC-QOL)scores of patients with Parkinson's constipation.At the level of adverse reactions,Meta results showed that the combined effect amount was[OR=0.60,95%CI(0.19,1.89),P=0.38],and the difference between the two groups was not statistically significant,that is,the Chinese medicine group was treating patients with Parkinson's constipation The adverse reaction rate at the time was not significantly different from that of the western medicine group.At the level of recurrence rate,Meta results showed that the combined effect amount was [OR=0.26,95%CI(0.14,0.49),P<0.0001],and the difference between the two groups was statistically significant,that is,the Chinese medicine group was reducing Parkinson's constipation patients.The recurrence rate was significantly better than that of the western medicine group.(3)In the comparison between the traditional Chinese medicine combined western medicine group and the western medicine group,at the level of effectiveness based on the "Guidelines for Clinical Research of New Drugs in China",the Meta results showed that the combined effect amount was [OR=3.29,95%CI(1.51,7.19),P=0.003],the difference between the two groups is statistically significant,that is,the traditional Chinese medicine combined with western medicine group in the treatment of patients with Parkinson's constipation has an obvious advantage over the western medicine group alone.At the level of reducing the symptoms of constipation and the score of the efficacy evaluation questionnaire,it is divided into 6 parts.In terms of improving the properties of stool,the combined effect amount is[WMD=-0.21,95%CI(-0.28,-0.14),P<0.00001],The difference between the two groups was statistically significant.The Chinese medicine combined with western medicine group was significantly better than the western medicine group in improving stool characteristics of patients with Parkinson's constipation.In terms of clinical improvement in defecation frequency,the combined effect amount was [WMD=-0.47,95%CI(-1.47,-0.52),P=0.35],and the difference was not statistically significant,that is,the Chinese medicine combined with western medicine group improved patients with Parkinson's constipation The defecation frequency was comparable to that of the western medicine group alone.In terms of improving the difficulty of defecation,the combined effect amount was[WMD=-0.51,95%CI(-0.76,-0.26),P<0.0001],and the difference between the two groups was statistically significant,that is,the Chinese medicine combined with the western medicine group improved Parkinson's constipation Patients had significantly better defecation than the western medicine group.In terms of improving defecation time,the combined effect was[WMD=-0.36,95%CI(-0.95,0.22),P=0.23].There was no significantdifference between the two groups.That is,the traditional Chinese medicine combined with western medicine group is equivalent to the western medicine group in improving the defecation time of patients with Parkinson's constipation.In terms of relieving bloating,the combined effect amount was[WMD=-0.46,95%CI(-0.53,-0.40),P<0.00001],and the difference between the two groups was statistically significant,that is,the Chinese medicine combined with the western medicine group improved patients with Parkinson's constipation The symptoms of bloating were significantly better than those of the western medicine group alone.In terms of improving defecation endlessness,falling sensation,etc.,the combined effect amount was[WMD=-0.46,95%CI(-1.32,-0.39),P=0.29],and the difference was not statistically significant,that is,the combination of traditional Chinese medicine and western medicine group was improving Patients with Parkinson's constipation were not significantly different from those in the western medicine group in terms of symptoms such as endless defecation and falling sensation.At the level of adverse reactions,the Meta results showed that the combined effect amount was [OR=0.27,95%CI(0.07,1.02),P=0.05],and the difference was not statistically significant,that is,the traditional Chinese medicine combined with western medicine group was used in the treatment of Parkinson's constipation patients.The adverse reactions were not significantly different from those of the western medicine group.Conclusion:Chinese medicine for Parkinson's disease complicated with constipation has a certain effect.It has shown good clinical efficacy in reducing Parkinson's constipation symptoms and curative effect assessment questionnaire scores,PAC-QOL and UPDRSIII scores.Low,and can effectively reduce the recurrence rate,can be applied to the clinic.However,due to the small sample size of the 19 RCT documents included in this Meta study,the strength of the evidence provided is limited,and there are some shortcomings in the outcome indicators.This research conclusion still needs to pass more large samples,multiple centers,and high quality.Clinical trials conduct more rigorous research to verify. |
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