Lang-Lang Cao,Hui Wang

1Shaanxi University of Traditional Chinese Medicine,Xianyang 712046,China.2Xi'an Traditional Chinese Medicine Encephalopathy Hospital,Xi'an 710032,China.

Abstract Objective:To evaluate the clinical efficacy of Xingnao Kaiqiao acupuncture combined therapy in treating infantile cerebral palsy by meta-analysis.Methods:CNKI,VIP,Wanfang knowledge service platform,CBM,PubMed,Embase and Cochrane library databases were searched.The retrieval time period was pushed back to the establishment of the database in March 2021.Through layers of screening and quality evaluation of the included literature,the data were analyzed with Revman 5.4.Results:9 articles were included,a total of 748 cases.The results of meta-analysis showed that compared with other therapies (control group),Xingnao Kaiqiao acupuncture combined therapy (treatment group) could improve the total clinical effective rate (or = 3.32,95% CI [2.14,5.13],P <0.00001),improve the ability of language acceptance (MD = 1.13,95% CI [0.92,1.34],P <0.00001),and improve the ability of language expression(MD=1.28,95% CI[1.03,1.54],P<0.00001),improve gmfm88 score (MD = 23.13,95% CI [18.75,27.51],P <0.00001),improve dysarthria score (MD = 0.33,95% CI [0.26,0.41],P <0.00001),improve MCA of cerebral ultrasound blood flow examination (MD = 13.12,95% CI [9.22,17.01],P <0.00001),and ACA of cerebral ultrasound blood flow examination (MD= 9.45,95% CI[6.28,12.62],P<0.00001).Conclusion:Compared with other therapies,Xingnao Kaiqiao acupuncture combined therapy in the treatment of infantile cerebral palsy can improve the total clinical efficiency,and has obvious advantages in improving language function,gross motor function,dysarthria,MCA and ACA of cerebral ultrasonic blood flow examination,but it still needs more and higher quality literature to prove it.

Keywords:Xingnao Kaiqiao acupuncture;cerebral palsy in children;clinical efficacy;metaanalysis

Background

Pediatric cerebral palsy (CP),referred to as cerebral palsy for short,is often accompanied by various complications,such as intellectual impairment,life ability impairment,motor dysfunction,pointed foot[1],salivation,sleep disorder and so on,which seriously affect children's physical and mental health.Cerebral palsy is classified as a highly disabling disease,and more than 70% of children with cerebral palsy are have cerebral palsy [2].According to statistics,among 1,000 newborns,about 1.5 to 3 newborns are children with cerebral palsy[3].Western medicine's treatment of children with cerebral palsy is mostly rehabilitation exercise,which can reduce the symptoms of children,but can not significantly improve the intelligence and motor function of children with cerebral palsy.Traditional Chinese medicine acupuncture and moxibustion treatment of children with cerebral palsy have significant advantages.At present,there has been some basic research and clinical evidence in the treatment of infantile cerebral palsy with Xingnao Kaiqiao acupuncture.Therefore,this study uses meta-analysis to evaluate its curative effect and provide a basis for clinic.

Data and methods

Data source

CNKI,VIP,Wanfang knowledge service platform,CBM,PubMed,Embase,Cochrane library database,etc.are searched by computer.The retrieval period time is from March 2021 to database establishment.

Literature retrieval strategy

Chinese search: ("infantile cerebral palsy" or "cerebral palsy" or"infantile cerebral palsy" or "cerebral palsy" or "cerebral palsy" or"cerebral palsy" or "infantile cerebral palsy" or "cerebral palsy") and("Xingnao Kaiqiao acupuncture" or "Xingnao Kaiqiao acupuncture" or"Kaiqiao therapy") and ("randomized control" or "randomized" or"RCT").English Search: ("infantile cerebellar palsy" or "cerebellar palsy" or "cerebellar palsy disease") and ("Xingnao Kaiqiao acupunture" or "wake up acupunture" or "Xingnao Kaiqiao therapy")and ("random control" or"random" or "RCT").

Inclusion and exclusion criteria

inclusion criteria(1) Study type: the study was a clinical randomized controlled trial;(2) Study subjects: children with cerebral palsy were clearly diagnosed in the literature.The diagnostic criteria met the diagnostic criteria of the international or national conference on cerebral palsy.The source and age of the cases were not limited.Baseline data comparison was required in the study.The statistical test showed good balance and comparability.(3) Intervention measures:the treatment group used Xingnao Kaiqiao acupuncture combined with other therapies,and the selection of acupoints was not required.The control group used other therapies.There was no significant difference between the general data of the two groups.(4) Outcome measures: total effective rate,language acceptance ability,language expression ability,gmfm88 score,dysarthria score,MCA of cerebral ultrasound blood flow examination,ACA of cerebral ultrasound blood flow examination,etc.Patient informed consent.

Exclusion criteria(1) Literatures that do not conform to the research object: such as non-randomized controlled trials,reviews,etc.(2)Unqualified Literature: such as repeatedly published literature,the original literature does not explain the specific number of examples,the curative effect observation index is not representative,the literature with improper statistical methods,etc.(3) Intervention measures: for example,Xingnao Kaiqiao acupuncture is also used in the control group;(4) The observed indexes are inconsistent with the literature of this study.

Literature quality evaluation

Using Cochrane's risk bias assessment tool: (1) random grouping method;(2) Whether blind method is used;(3) Assign hidden schemes;(4) Whether the result data is complete;(5) Whether there is selective reporting of research results;(6) Other bias.

Statistical treatment

Use Cochrane's Revman 5.4 software.If it conforms to the dichotomous variable,the odds ratio (or) is selected.In addition,95%confidence interval (CI) is used to represent each effect quantity;If the continuity variable is consistent,mean difference (MD) is selected,and 95% confidence interval (CI) is used to represent each effect quantity.I2test is used to test the heterogeneity between various studies.If it is suggested that: (P>0.10,I2<50%),the fixed effect model is selected;If it is suggested that: (P<0.10,I2>50%),then the random effect model is selected.Hypothesis testP<0.05,then it has statistical significance.The bias of the included study was described by an inverted funnel diagram.

Results

Literature search results

Figure 1 above shows the detailed process of literature screening.A total of 16,611 articles were obtained.Through database retrieval,268 articles were obtained through preliminary screening.After layer by layer screening,9 articles were finally obtained,all of which were Chinese documents.

Figure 1 Document screening process

Basic information of included documents

Nine literatures were selected,including 412 cases in the treatment group and 336 cases in the control group,a total of 748 cases.See Table 1 for details.

Table 1 Basic information of included literature

Quality evaluation of included documents

Cochrane's risk bias assessment tool was used.[5-7,11]and[12] these studies do not specify what random allocation method is used.The word "random" can only be found in the literature,so it can be considered as a high risk;It is clearly mentioned that [4-9] and [10]studies using the random number table method,so it is evaluated as low risk;The specific allocation concealment scheme has not been explicitly mentioned in the study,and whether to use blind method has not been explicitly mentioned in this study,so it can be considered as high risk;The results of selective reports were not explicitly mentioned in this study,and the data collected are relatively complete,so it can be considered as low risk;Other bias is unknown,so it is evaluated as unknown risk.See Figure 2 and Figure 3.

Use review Manager5 4.Meta analysis results of analysis

Total effective rateThere are 8 documents in total.Bian Jinling 2001[6] the efficacy evaluation criteria of this study are: (1) motor function and IQ (2) EEG topographic map.The author separately analyzed the total efficiency of these two indicators,but did not analyze the clinical efficacy,so it was not included in this study.This observation index belongs to two classification variables.The heterogeneity test shows that: (I2= 0% <50%,P= 0.78 >0.10),the fixed effect model is selected.The results are shown in Figure 4,and a diamond can be seen on the right side of the vertical line.The comparison results of the two groups were: (or = 3.32,95% CI [2.14,5.13]).The overall effect test showed that: (Z = 5.38,P<0.00001),which was statistically significant.It can be seen from the above that the total effective rate of the treatment group is higher than that of the control group,so it can be considered that the combined therapy of Xingnao Kaiqiao acupuncture is better than other therapies in the clinical efficacy of treating infantile cerebral palsy.

Figure 2 Bias risk assessment of included studies

Figure 3 Summary of risk assessment included in the study

Figure 4 Forest map of total efficiency

Language acceptanceThere are two literatures in total.This observation index belongs to continuous variable.The heterogeneity test shows that: (I2= 20% <50%,P= 0.26 >0.10),the fixed effect model is selected.The results are shown in Figure 5,and a diamond can be seen on the right side of the vertical line.The comparison results of the two groups were: (MD=1.13,95%CI[0.92,1.34]).The overall effect test showed that: (Z = 10.54,P<0.00001),which was statistically significant.It can be seen from the above that the language acceptance ability of the treatment group is higher than that of the control group,so it can be considered that the combination therapy of Xingnao Kaiqiao acupuncture is better than other therapies in the treatment of language acceptance ability of children with cerebral palsy.

Language expression abilityThere are 3 literatures in total.This observation index belongs to continuous variable.The heterogeneity test shows that: (I2= 80% >50%,P= 0.006 <0.10),the random effect model is selected.The results are shown in Figure 6,and a diamond can be seen on the right side of the vertical line.The comparison results of the two groups were: (MD = 1.10,95% CI[0.76,1.45]).The overall effect test showed that: (Z = 6.24,P<0.00001),which was statistically significant.Through sensitivity analysis,it can be found that if the study of Wang Yelin [4] is excluded,it shows that the observation index belongs to continuous variable,and the heterogeneity test shows:(I2=0%<50%,P=0.91>0.10),it can be seen that the heterogeneity of language expression ability may come from the study of Wang Yelin [4],using fixed effect model.The results are shown in Figure 7.A diamond can be seen on the right side of the vertical line.The comparison results of the two groups were:(MD=1.28,95% CI[1.03,1.54]).The overall effect test showed that: (Z = 9.99,P<0.00001),which was statistically significant.It can be seen from the above that the language expression ability of the treatment group is higher than that of the control group,so it can be considered that the combination therapy of Xingnao Kaiqiao acupuncture is better than other therapies in the treatment of children with cerebral palsy.

GMFM88 scoreThere are two literatures in total.This observation index belongs to continuous variable.The heterogeneity test shows that: (I2= 20% <50%,P= 0.26 >0.10),the fixed effect model is selected.The results are shown in Figure 8,and a diamond can be seen on the right side of the vertical line.The comparison results of the two groups were (MD = 23.13,95% CI [18.75,27.51]).The overall effect test showed that: (Z = 10.35,P<0.00001),which was statistically significant.It can be seen from the above that the gmfm88 score of the treatment group is higher than that of the control group,so it can be considered that the combined therapy of Xingnao Kaiqiao acupuncture is better than other therapies in the treatment of gross motor function of infantile cerebral palsy.

Figure 5 Forest map of language acceptance ability

Figure 6 Forest map of language expression ability (before sensitivity analysis)

Figure 7 Forest map of language expression ability (after sensitivity analysis)

Figure 8 Forest map of GMFM88 score

Assessment of dysarthriaThere are 3 literatures in total.This observation index belongs to continuous variable.The heterogeneity test shows that: (I2= 0% <50%,P= 0.63 >0.10),the fixed effect model is selected.The results are shown in Figure 9,and a diamond can be seen on the right side of the vertical line.The comparison results of the two groups were(MD =0.33,95% CI[0.26,0.41]).The overall effect test showed that: (Z = 8.53,P<0.00001),statistically significant.The results showed that the score of dysarthria in the treatment group was higher than that in the control group,so it can be considered that the combined therapy of Xingnao Kaiqiao acupuncture is better than other therapies in the treatment of dysarthria in children with cerebral palsy.

MCA of cerebral ultrasound blood flow examinationThere are two literatures in total.This observation index belongs to continuous variable.The heterogeneity test shows that: (I2= 0% <50%,P=0.69 >0.10),the fixed effect model is selected.The results are shown in Figure 10,and a diamond can be seen on the right side of the vertical line.The comparison results of the two groups were (MD =13.12,95% CI [9.22,17.01]).The overall effect test showed that: (Z= 6.60,P<0.00001),which was statistically significant.It can be seen from the above that the MCA of cerebral ultrasound blood flow examination in the treatment group is higher than that in the control group,so it can be considered that the combined therapy of Xingnao Kaiqiao acupuncture is better than other therapies in the MCA of cerebral ultrasound blood flow examination in the treatment of infantile cerebral palsy.

ACA of cerebral ultrasound blood flow examinationThere are two literatures in total.This observation index belongs to continuous variable.The heterogeneity test shows that: (I2= 0% <50%,P=1.00 >0.10),the fixed effect model is selected.The results are shown in Figure 11,and a diamond can be seen on the right side of the vertical line.The comparison results of the two groups were (MD =9.45,95% CI [6.28,12.62]).The overall effect test showed that: (Z =5.84,P<0.00001),which was statistically significant.It can be seen from the above that the ACA of cerebral ultrasound blood flow examination in the treatment group is higher than that in the control group,in the ACA of cerebral ultrasonic blood flow examination for the treatment of cerebral palsy in children,the combined therapy of"Xingnao Kaiqiao"acupuncture is superior to other therapies.

Analysis of literature publication biasThe total effective rate of the observation index is analyzed for literature bias,as shown in Figure 12 below.Most of the included literatures are distributed at the waist of the inverted funnel,but the distribution is asymmetric,so the publication bias cannot be excluded.

Figure 9 Forest diagram of dysarthria score

Figure 10 Forest diagram of MCA by cerebral ultrasound blood flow examination

Figure 11 forest diagram of ACA in cerebral ultrasound blood flow examination

Figure 12 inverted funnel diagram of total efficiency

Safety assessment

Among the 9 studies included in this study,the combination therapy of brain resuscitation acupuncture in this clinical observation was mentioned in [12] as safe and reliable,the possible adverse reactions were mentioned in [4],[5] and [11],and no adverse reactions were recorded in [6],[7],[8],[9] and [10].Only 3 of the 9 studies mentioned possible adverse reactions,indicating that the combination of Xingnao Kaiqiao acupuncture is safe in the treatment of infantile cerebral palsy.Three items mentioned possible adverse reactions,but did not mention the specific adverse reactions and the number of cases of adverse reactions,so meta-analysis was not possible.

Discussion

Cerebral palsy,referred to as cerebral palsy,has about 750,000 CP patients in the United States [13].There are many children with cerebral palsy in China,with an annual increase of about 60,000 [14].CP has a serious impact on children's physical and mental health and families,which is worthy of attention.In recent years,acupuncture therapy has been used to treat infantile cerebral palsy at home and abroad.Some studies have shown that [15] acupuncture at the acupoints of the head can reduce the tension of blood vessels,which is of great significance for the recovery of brain tissue.Xingnao Kaiqiao acupuncture method was created by Professor Shi Xuemin.Shuigou point,Neiguan point and other points are commonly used.The main pathogenesis of pediatric cerebral palsy in traditional Chinese medicine is lack of talent and deficiency of brain pulse.Therefore,the treatment of infantile cerebral palsy is to awaken the brain and open the orifices.The governor's vessel commands all yang meridians and stimulates people's essence,Qi and spirit.The governor vessel can regulate the Qi and blood of all yang meridians.The governor vessel is mainly responsible for the brain,spirit and kidney.Shuigou point is the point of governor's pulse.If there is confusion,it should be treated urgently.Acupuncture Shuigou can open and close the orifices and awaken the yuan God.Acupuncture at Neiguan acupoint can achieve the effect of calming the mind and blood.Acupuncture at the acupoint Sanyinjiao can regulate the function of the three yin meridians of the foot,so the brain marrow metaplasia is active.In addition,acupuncture at Tianzhu point,Fengchi point and Wangu point can achieve the clinical effect of tonifying brain and marrow.At present,in clinical practice,Xingnao Kaiqiao acupuncture is mostly combined with modern rehabilitation methods such as language training and rehabilitation exercise to achieve the purpose of treating infantile cerebral palsy.Compared with western medicine,Xingnao Kaiqiao acupuncture has unique advantages,and the clinical research reports of Xingnao Kaiqiao acupuncture in the treatment of infantile cerebral palsy are gradually increasing.Therefore,this study collects and analyzes the clinical randomized controlled trials of Xingnao Kaiqiao acupuncture combined with western medicine in the treatment of infantile cerebral palsy,More reliable results are obtained.

Conclusion

A total of 9 studies were included,including 412 cases in the treatment group and 336 cases in the control group,a total of 748 cases.The results of meta-analysis showed that: compared with other therapies,Xingnao Kaiqiao acupuncture combined therapy in the treatment of infantile cerebral palsy can improve the total clinical effective rate.In addition,the treatment group has obvious advantages in the treatment of language function,gross motor function,dysarthria,MCA and ACA of cerebral ultrasonic blood flow examination.The bias analysis of the total clinical effective rate of the observation index showed that the publication bias could not be ruled out.The safety evaluation showed that the treatment group had better safety in the treatment of infantile cerebral palsy.Three items mentioned possible adverse reactions,but did not mention the specific adverse reactions and the number of cases of adverse reactions,so meta-analysis was not possible.Sensitivity analysis shows that the heterogeneity of language expression ability may come from the study of Wang Yelin 2016 [4],but the author did intensive reading on its general information,treatment methods,observation indicators,statistical methods,results,discussion and other items,and found no source of heterogeneity.Therefore,Wang Yelin 2016 [4] is still included in the evaluation of total effective rate and dysarthria for meta-analysis.At present,there has been some basic research and clinical evidence on the treatment of infantile cerebral palsy with Xingnao Kaiqiao acupuncture.According to the literature finally included in this study,more than half of the literature published in recent 6 years,a total of 5 [4,8-10,12],indicating that the combination therapy of Xingnao Kaiqiao acupuncture has been affirmed by more and more clinical workers in recent years and has been applied to the treatment of infantile cerebral palsy.