The Systematic Review Of Randomized Controlled Trials Of J In’s Three-needle Therapy In Treating Apoplexy

BackgroundJin’s three needle therapy is a acupuncture therapy of unique characteristics, which was founded by the famous acupuncturist professor Jin Rui, who are the chief professor of Guangzhou University of Chinese Medicine in China. He founded this therapy by systematic studying the clinical and experimental repeatedly, summarizing the research results of the clinical experience of acupuncture at home and abroad, collecting the clinical experience of acupuncture and moxibustion in the past dynasties. This therapy is featured with simple, easily to learn and practical. It was hailed as the "new school of acupuncture and moxibustion in south of the Five Ridges".Jin’s three needle therapy originated from the early 70’s of last century, when professor Jin Rui was engaged in the study of cerebral malaria in Hainan province. The real formation of its treatment system is in the middle and late 80’s. After nearly 30 years development, this therapy has become one of the hallmarks of the acupuncture and moxibustion School of the Five Ridges, having accumulated extensive clinical experience.System evaluation is a rigorous evaluation and synthesis of all the relevant studies on a specific problem, using the strategy of limiting bias. It is proposed the earliest by the famous British epidemiologist and physician Archie Cochrane in 1979, and spread widely in foreign countries once formed. Meta analysis is a method of statistical analysis of the results of a separate study, testing the source of differences between the results of the study, and synthesising quantitativly the results with enough similarity to each other. The earliest introduction of system evaluation was in 1995. Since 1998, Chinese evidence based medicine / Cochrane Center held country orientated training classes of Cochrane systematic review in West China hospital, the same as the meta analysis method training courses. Since then, these courses have been held at least once a year.Systematic review and Meta analysis are generally acknowledged to be the best two research methods, and they are also considered to be one of the main sources of clinical evidence. The combination of the best research evidence, clinical experience and the unique value of the patient and the individual situation, formed the evidence-based medicine. They both provide the best evidence for the evidence-based medicine, which is of great significance.ObjectivesIt has been nearly 30 years since Jin’s three-needle therapy was founded in 1980s. Over the past 30 years, Professor Jin Rui and his disciples, and the disciples again provided great improvement and complement to that therapy, lots of research information has been accumulated. But these data are messy and complicated. Further more, some of the studies have faults of small sample size. Both of them reduce the credibility of the information. In order to fully explore the information and to master the clinical practice of Jin’s three needle therapy since its formation, this paper intends to study the data with systematic review or Meta analysis methods to find the answer. But diseases treated with Jin’s three-needle therapy are of kinds of variety, covering almost the whole spectrum of diseases acupuncture can treat. As the limit of space and personal energy, it is impossible to do a specific research to every kind of diseases. Considering that Jin’s three-needle therapy has been made as the clinical pathway to treat the stroke, this paper select stoke as the research target. Treatment of the stroke is considered as the same as the treatment to its apoplexy, this paper choose the studies related with the treatment of stoke apoplexy by Jin’s three-needle therapy as the research object. By using methods of systematic review to evaluate these studies, it is hoped that the difference between Jin’s three-needle therapy with other therapies will be found, and the same as the characteristics of clinical application of this therapy.MethodsThis paper uses systematic review method to evaluate the randomized controlled pilot studies on the treatment of stroke by Jin’s three-needle therapy. This study will be carried out in accordance with the steps proposed by the book, Cocharane Handbook for Systematic Reviews of Intervention, including the following nine steps:put forward the problem to evaluate; make the inclusion and exclusion criteria of the study; make search strategy and search them; screening research and collect the date;assessing the risk of bias in the study; analyze the data and Meta analysis in the appropriate circumstances; resolution of reporting bias; presentation results and production summary tables; interpret the results and draw the conclusions.This paper will evaluate the literature, thesis and conference papers published in various journals, before October lth in 2015. All studies are aimed to find the curative effect on stroke treated by Jin’s three-needle therapy. The document type should be randomized controlled trials on clinical patients. Stroke contains many kinds of symptoms, the most common ones include hemiplegic, shoulder hand syndrome, dysphagia, aphasia, depression, insomnia and cognitive impairment, etc. This paper will introduce the various types of system evaluation results according to the different symptoms above.To search the studies, databases like the Chinese database selected Chinese journal full text database (CNKI), Chinese biomedical literature database (CBM), VIP journal full text database (VIP) and Wan Fang database (WF) would be chosen to search. Of course, English databases would be searched too, which contains MEDLINE, Cochrane Library and Springer. When searching the CBM database, Sinomed search engine would be used; searching the Medline, PubMed search engine would be used; searching the Cochrane Library, Wiley Online Library would used; searching the Springer, Springer Link would be used.After having retrieved the databases above, import the bibliographical reference or literature into the Reference management software NoteExpress 3.1, to check up and screen, then download the full text and determine the included studies finally. This process should be completed by two reviewers independently, in which strategies to solve divergence should be formulated and the reason studies are excluded should be recorded too. And then, an Excel form should be used to record the data from each included studies. Bias risks of every research will be evaluated by statistical software RevMan 5.3. This progress will be performed by two assessors two.If the included studies are similar in intervention measures, course of treatment and statistical indicators etc, in other word, they have small clinical heterogeneity, they would get a pooled analysis, Meta analysis namely. In the process of analysis, if the heterogeneity is small, fixed effect model would be used to analysis; if not, random effects model would be used. If one of the studies has a large proportion in analysis results, or the result contains obvious abnormity, etc, a sensitivity analysis would be done to assess the stability of the merged results. If the number of included studies is bigger than 10, a funnel plots would be used to detect the publish bias. If a study is of great clinical heterogeneity, it would be descriptive analysis.Systematic review and Meta analysis both are the second study on the completed ones. Their quality depend largely on the original studies. The quality of the new evidence provided by the new study needs be further assessed This paper will use GRADEprofile 3.6.1 as the evidential quality evaluation tools to assess the new evidences come through the Systematic review of the studies on the treatment of stroke by Jin’s three-needle therapy. The assessment will be reported in detail surely.ContentThe specific content of this paper is to evaluate the randomized controlled pilot study related to the treatment of stroke treated by Jin’s three-needle therapy. This content includes the following items1) the systematic review of the randomized controlled trials of the treatment of hemiplegic after stroke;2) The systematic review of the randomized controlled trials on the treatment of of shoulder hand syndrome post stroke;3) The systematic review of the randomized controlled trials on the treatment of false ball paralysis after stroke;4) The systematic review of randomized controlled trials on the treatment of post stroke depression;5) The systematic review of the randomized controlled trials on the treatment of insomnia after stroke;6) The systematic review of the randomized controlled trials on the treatment of cognitive impairment after stroke;7) The systematic review of randomized controlled trials on the treatment of shoulder pain and shoulder dislocation in the treatment of stroke.8) The systematic review of randomized controlled trials on the treatment of the other types of stroke sequela.OutcomeThe main results of this study are as follows:1.Hemiplegia1)In terms of efficiency evaluation, Jin’s three-needle therapy is equal with rehabilitation therapy, there are 4 studies getting included in the pooled analysis, the total sample size contains 437 cases, resulting in a recommend of low intensity. Niesanzhen has the same efficiency with the scalp therapy, with 4 studies involved and a total sample of 308 cases, its recommendation strength is very low. Jin’s therapy is better than conventional drugs, with one study involved and a total sample of 120 cases, its recommendation strength is low. Jin’s therapy is better than conventional acupuncture, with one study involved, and a total sample of 162 cases, and a moderate recommendation strength.Jin’s therapy combining with rehabilitation training are better than rehabilitation therapy, with 4 studies involved, and a total sample of 500 cases, and a high recommendation strength. Niesanzhen combining with routine body acupuncture are better than routine body acupuncture therapy,with 3 studies involved, and a total sample of 394 cases, and a very low recommendation strength.Curative effect of Jin’s therapy combined with rehabilitation is the same with Jin’s therapy only, with 2 studies involved, and a total sample of 403 cases, and a low recommendation strength.Curative effect of Jin’s therapy combined with Xingnao Kaiqiao method is the same with traditional acupuncture therapy only, with 3 studies involved, and a total sample of 253 cases, and a very low recommendation strength.2) In the aspect of DNS score, Jin’s curative effect is better than rehabilitation, with 9 studies involved, and a total sample of 908 cases, and a moderate recommendation strength. Curative effect of Jin’s therapy combined with rehabilitation training are better than rehabilitation therapy, with 10 studies involved, and a total sample of 1058 cases, and a low recommendation strength. Curative effect of Jin’s therapy combined with rehabilitation is better than Jin’s therapy only, with 6 studies involved, and a total sample of 548 cases, and a low recommendation strength.3) In the aspect of FMA score, Jin’s curative effect is better than rehabilitation, with 9 studies involved, and a total sample of 1078 cases, and a moderate recommendation strength. Curative effect of Niesanzhen is the same with rehabilitation, with 2 studies involved, and a total sample of 118 cases, and a moderate recommendation strength.Jin’s therapy combining with rehabilitation training are better than rehabilitation therapy,with 11 studies involved, and a total sample of 1316 cases, and a moderate recommendation strength.Jin’s therapy combining with rehabilitation training are better than Jin’s therapy, with 9 studies involved, and a total sample of 903 cases, and a low recommendation strength.4) In the aspect of CSI score, Jin’s curative effect is worse than rehabilitation, with 3 studies involved, and a total sample of 266 cases, and a low recommendation strength.Jin’s therapy combining with rehabilitation training are better than rehabilitation therapy,with 3 studies involved, and a total sample of 221 cases, and a low recommendation strength.Jin’s therapy combining with rehabilitation training are better than Jin’s therapy, with 4 studies involved, and a total sample of 241 cases, and a low recommendation strength.5) In the aspect of BI score, Jin’s curative effect is better than rehabilitation, with 7 studies involved, and a total sample of 806 cases, and a moderate recommendation strength. Curative effect of Niesanzhen is the same with scalp acupuncture, with 2 studies involved, and a total sample of 118 cases, and a very low recommendation strength.2. Hhoulder hand syndrome1) In terms of efficiency evaluation, Jin’s three-needle therapy is equal with rehabilitation therapy, there are 2 studies getting included in the pooled analysis, the total sample size contains 139 cases, resulting in a recommend of low intensity.Jin’s therapy combining with rehabilitation training are better than rehabilitation therapy,with 4 studies involved, and a total sample of 251 cases, and a low recommendation strength.2) In the aspect of VAS score, Jin’s curative effect combined with rehabilitation is better than rehabilitation, with 4 studies involved, and a total sample of 296 cases, and a low recommendation strength which can be trust weakly.3) In the aspect of FMA score, Jin’s curative effect combined with rehabilitation is better than rehabilitation, with 4 studies involved, and a total sample of 264 cases, and a low recommendation strength and a low reliability.3. Pseudobulbar palsy1) In the aspect of evaluation of effective on apoplectic aphasia, Jin’s therapy is better than conventional acupuncture, with 7 studies involved, and a total sample of 472 cases, and a moderate recommendation strength and a moderate reliability. Adding Jin’s therapy to the basic treatment on pseudobulbar palsy, will get a better effect, with one study involved, and a total sample of 188 cases, and a low recommendation strength and a low reliability. Jin’s three-needle therapy is equal with rehabilitation therapy, there are 1 study getting included in the pooled analysis, the total sample size contains 128 cases, resulting in a recommend of low intensity.Jin’s three-needle therapy combining with rehabilitation is better than rehabilitation therapy, there are 3 studies get included in the pooled analysis, the total sample size contains 303 cases, resulting in a recommend of very low intensity.Shesanzhen combined with conventional acupuncture and rehabilitation is better than rehabilitation only, with one study involved, and a total sample of 130 cases, and a low recommendation strength and a low reliability.Shesanzhen combined with rehabilitation is better than Shesanzhen only, with one study involved, and a total sample of 130 cases, and a low recommendation strength and a low reliability.2) In the aspect of improving the abilities of spontaneous conversation function, and comprehension ability, and repetition ability, and naming ability evaluated by ABS, Jin’s curative effect is better than conventional acupuncture, with 2 studies involved, and a total sample of 136 cases, and a low recommendation strength which can be trust weakly.3) In the aspect of the evaluation of curative effect on dysphagia, Jin’s curative effect is better than conventional acupuncture, with 4 studies involved, and a total sample of 285 cases, and a moderate recommendation strength which can be trust moderately. Jin’s curative effect is the same with the Vitalstim swallowing disorder therapeutic instrument, with 3 studies involved, and a total sample of 235 cases, and a very low recommendation strength which can be trust weakly. Jin’s curative effect is the same with rehabilitation, with 3 studies involved, and a total sample of 252 cases, and a very low recommendation strength which can be trust weakly.4) In the aspect of the evaluation of Kubota’s test score on dysphagia, Jin’s curative effect is the same with conventional acupuncture, with 2 studies involved, and a total sample of 140 cases, and a moderate recommendation strength which can be trust moderately.4.Depression1) In the aspect of curative effect, Jin’s curative effect is better than conventional acupuncture, with 2 studies involved, and a total sample of 113 cases, and a low recommendation strength which can be trust weakly.2) In the aspect of HAMD score, Jin’s curative effect is the same with oral Prozac, with 2 studies involved, and a total sample of 197 cases, and a low recommendation strength which can be trust weakly. Jin’s curative effect is better than conventional acupuncture, with 3 studies involved, and a total sample of 175 cases, and a low recommendation strength which can be trust weakly.3) In the aspect of SDS score, Jin’s curative effect is better than oral Prozac, with 1 studies involved, and a total sample of 117 cases, and a low recommendation strength which can be trust weakly.Other sequelae such as insomnia, cognitive impairment, shoulder pain and dislocation of the shoulder, due to the small number of the included stud ies, have been analyzed descriptively. There will not be detailed introdu ction to the new evidences as the low reliability. Other studies on the o ther types of sequelae would not get evaluated due to none of them meetin g the inclusion criteria can be retrieved.ConclusionSince the formation,Jin’s three-needle therapy has been widely applied in clinical. Its curative effect has been proved to be a safe and effective. In the treatment of stroke, Jin’s therapy has obviously advantages over the other common clinical therapies. For example, compared with traditional acupuncture, it showed a better effect, and compared with western medicine, especially antidepressants, showing absolute safety and no side effects. But in the treatment of some other sequelae, it may show some disadvantage. For example, its effect is not as well as rehabilitation training in the treatment to spastic paralysis, etc. In addition, new evidences also show that under normal circumstances, Jin’s three-needle combined with another therapy will get better curative effect compared with using this therapy singly or using Jin’s therapy singly. This suggests that, in clinical application, a variety of effective therapies should be combined to use as much as possible to obtain the best curative effect.At the same time, this study also exposed the defects of the included researches. Among them, the most common ones are the performance bias and detection bias. The vast majority of studies did nothing to blind the perpetrators, the research object. Surely, it is unreasonable to bind the perpetrators. However, it is easy to bind the observers, while there were so little studies performing that. Another serious flaw is that most studies have not provide the method used to generate random programs, or provide a wrong method such as the order get treated. In addition, it has been done too little to the allocation concealment. All of these lead to a great selection bias, which ultimately leads to the low quality of the new evidence.Finally, through the analysis of the features of the included studied, it was found that in recent years, especially in the last five years, the number of the studies related to Jin’s therapy increased significantly, and it has the trend to accelerate. Besides, from the point of view of regional, the application of Jin’s three-needle therapy is no longer limited in Guangdong Province, the related research had gradually appeared around the country, suggests that the promotion of this therapy has been nationwide, its extension has made some success.