Systematic review of long-term Xingnao Kaiqiao needling efficacy in ischemic stroke treatment

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1 NEURAL REGENERATION RESEARCH April 2015,Volume 10,Issue 4 Systematic review of long-term Xingnao Kaiqiao needling efficacy in ischemic stroke treatment Zhi-xin Yang 1, *, Jia-hong Xie 2, Yong-ping Liu 2, Guang-xin Miao 1, Ying-han Wang 2, Sheng-mei Wu 3, Yuan Li 3 RESEARCH ARTICLE 1 Department of Traditional Chinese Medicine, Chengde Medical University, Chengde, Hebei Province, China 2 Key Laboratory of Traditional Chinese Medicine Research and Development, Institute of Traditional Chinese Medicine, Chengde Medical University, Chengde, Hebei Province, China 3 Chicheng Hospital of Traditional Chinese Medicine, Chicheng, Hebei Province, China *Correspondence to: Zhi-xin Yang, Ph.D., yzx @163.com. doi: / Accepted: Abstract OBJECTIVE: To systematically evaluate the long-term effect and safety of Xingnao Kaiqiao needling method in ischemic stroke treatment. DATA RETRIEVAL: We retrieved relevant random and semi-random controlled trials that used the Xingnao Kaiqiao needling method to treat ischemic stroke compared with various control treatments such as conventional drugs or other acupuncture therapies. Searched databases included China National Knowledge Infrastructure, Weipu Information Resources System, Wanfang Medical Data System, Chinese Biomedical Literature Database, Cochrane Library, and PubMed, from May 2006 to July SELECTION CRITERIA: Two authors independently conducted literature screening, quality evaluation, and data extraction. The quality of articles was evaluated according to the Cochrane Reviewers Handbook 5.1, and the study was carried out using Cochrane system assessment methods. RevMan 5.2 was used for meta-analysis of the included studies. MAIN OUTCOME MEASURES: Mortality rate, recurrence rate, and disability rate were observed. RESULTS: Nine randomized and semi-randomized controlled trials treating 931 cases of ischemic stroke were included in this review. Meta-analysis results showed that there were no significant differences in mortality reduction (risk ratio (RR) = 0.58, 95% confidence interval (CI): , Z = 0.89, P = 0.37) or recurrence rate (RR = 0.55, 95%CI: , Z = 1.04, P = 0.30) of ischemic stroke patients between the Xingnao Kaiqiao needling and control treatment groups. However, the Xingnao Kaiqiao needling method had a tendency towards higher efficacy in mortality reduction and recurrence rates. The Xingnao Kaiqiao needling method was significantly better than that of the control treatment in reducing disability rate (RR = 0.51, 95%CI: , Z = 2.03, P < 0.05). CONCLUSION: The Xingnao Kaiqiao needling method has a better effect than control treatment in reducing disability rate. The long-term effect of Xingnao Kaiqiao needling against ischemic stroke is better than that of control treatment. However, the limitations of this study limit the strength of the conclusions. Randomized controlled trials with a strict, reasonable design, and multi-center, large-scale samples and follow-up are necessary to draw conclusions about Xingnao Kaiqiao needling. Key Words: nerve regeneration; Xingnao Kaiqiao needling method; ischemic stroke; randomized controlled trial; systemic reviews; meta-analysis; long-term efficacy; mortality; recurrence; disability; adverse reactions; health economics indicators; neural regeneration Funding: This study was financially supported by grants from Hebei Province Engineering Talent Cultivation Project and Hebei Province Science and Technology Research and Development Projects, No D-35. Yang ZX, Xie JH, Liu YP, Miao GX, Wang YH, Wu SM, Li Y (2015) Systematic review of long-term Xingnao Kaiqiao needling efficacy in ischemic stroke treatment. Neural Regen Res 10(4): Introduction The estimated incidence of stroke is cases among every hundred thousand people worldwide, and the majority of these (55 80%) are ischemic stroke. Among ischemic stroke patients, mortality is deaths among every hundred thousand people. In China, there are about 1.5 million new stroke cases each year, which are responsible for approximately 25 billion RMB in healthcare expenditures (Hu and Gong, 2003; Sun et al., 2014). With its high morbidity and mortality, stroke is a serious public health problem. Although 80% of stroke patients survive, only 10% recover normal function, while the majority of patients have left hemiplegia, aphasia, or other sequelae (Zhao et al., 2006). Combined treatment of stroke using integrative medicine is active and effective, but there is no single and effective treatment for stroke (Yang, 2005; Wang et al., 2013; Jiang et al., 583

2 2014; Tan et al., 2014; Wang et al., 2014). Compared with conventional treatment, 39 41% of stroke patients with hemiplegia may benefit from acupuncture treatment (Li et al., 2002). However, additional evidence from several clinical trials is required to clarify whether acupuncture treatment is equivalent to or better than other therapies, or simply a placebo therapy. Based on traditional Chinese medicine theory, modern medicine theory, and clinical treatment experience over 30 years, the Xingnao Kaiqiao needling method was developed by Xue-min Shi in 1972 for the treatment of stroke, especially ischemic stroke (Guo, 2007). Xingnao Kaiqiao needling is a specific acupuncture therapy that acts to regulate and calm the vitality, and wake up a patient from unconsciousness through rigorous manipulation. Evidence from previous studies (Shi, 2005; Guo and Shi, 2006; Yang and Shi, 2007; Cui, 2008; Sun et al., 2009; Chen and Ni, 2013) has shown that Xingnao Kaiqiao needling achieved satisfactory treatment effects on stroke. Nevertheless, a systematic evaluation of these studies is required to accurately understand its efficacy and safety. Systematic evaluation results of randomized controlled trials are reliable for verifying the validity and safety of certain therapies. This systematic study aimed to evaluate the longterm efficacy of Xingnao Kaiqiao needling based on clinical trials. Our findings can serve as a reference for clinicians seeking clinical treatments for ischemic stroke. Data and Methods Data retrieval Electronic retrieval A computer-based online retrieval of studies from the China National Knowledge Infrastructure, Weipu Information Resources System, Wanfang Medical Data system, Chinese Biomedical Literature, Cochrane Library, ASP, PubMed and MEDLINE databases was performed including dates from May 2006 to July Manual retrieval To supplement the computer retrieval results, we manually checked some journals to ensure that all relevant articles were included in this study. Additional journals searched were: China Acupuncture & Moxibustion, Journal of Traditional Chinese Medicine, Acupuncture Research, Shanghai Journal of Acupuncture and Moxibustion, Clinical Journal of Acupuncture and Moxibustion, New Journal of Traditional Chinese Medicine, Shanghai Journal of Traditional Chinese Medicine, Tianjin Journal of Traditional Chinese Medicine, Jiangsu Journal of Traditional Chinese Medicine, Zhejiang Journal of Traditional Chinese Medicine, and Liaoning Journal of Traditional Chinese Medicine. The English terms: Xingnao Kaiqiao, stroke, apoplexy, cerebrovascular accident, ischemic stroke, and ischemia apoplexy were used as retrieval words for English literature, and the Chinese terms for Xingnao Kaiqiao needling method and stroke (cerebrovascular accidents, apoplexy, ischemic stroke, cerebral infarction, cerebral embolism, cerebral thrombosis and transient ischemic attack) were used as retrieval words for Chinese literature. Inclusion and exclusion criteria Studies were eligible for inclusion if they met all of the following inclusion criteria. (1) Studies were randomized or semi-randomized controlled trials of patients of any gender and age with ischemic stroke. (2) In the included studies, the diagnosis of ischemic stroke had to meet the diagnostic criteria of the WHO or the National Conference of Cerebral Vascular Disease, and is confirmed by CT/MRI. (3) The treatment groups received Xingnao Kaiqiao needling alone or combined with other treatment methods, while the control groups received traditional acupuncture or combination treatment excluding Xingnao Kaiqiao needling. (4) Mortality, recurrence rate, disability rate, safety, health, and economic indicators at the end of treatment or follow-up (more than 3 months) were evaluated in the studies. Studies were excluded if both the treatment and control groups used Xingnao Kaiqiao needling. Data extraction and quality evaluation According to Cochrane Reviewers Handbook 5.1 software (Julian PT Higgins and Sally Green, 2011), the selected articles were evaluated on six criteria including: sequence generation, allocation concealment, blinding, incomplete outcome data, selective outcome reporting, and other issues. These criteria are categorized as: yes, no, and unclear. Yes indicates a low risk of bias and no indicates a high risk of bias. Unclear indicates that there is not sufficient information for this criterion. Cochrane systematic review software RevMan 5.2 software ( was used to perform the meta-analysis. Evaluation of quality was carried out by two reviewers independently using pre-specified selection criteria, and disagreements were resolved by consensus or by a third reviewer. Main outcome measures The main outcome measures were mortality rate, recurrence rate, disability rate, adverse reactions, and health economics indicators. Statistical analysis Clinical and methodological heterogeneity analysis was performed for the included studies, and then subgroup analysis (RevMan 5.2 software, org) was performed. The chi-square test was used for statistical analysis of heterogeneity, and a probability value of less than 0.10 was considered statistically significant. P < 0.10 indicates that heterogeneity exists between the results of the studies. Meanwhile, I 2 was used for quantitative assessment. Heterogeneity is not obvious when I 2 < 25%, moderate heterogeneity exists when I 2 ranges from 25% to 50%, and excessive heterogeneity exists when I 2 > 50%. Heterogeneous test results were expressed with the random effect model and homogeneous test results were expressed with the fixed effect model. Efficacy effect size was evaluated using interval estimation and hypothesis test. Risk ratio (RR) was used for enumeration data, and weighted mean difference (WMD) 584

3 Yang ZX, et al. / Neural Regeneration Research. 2015;10(4): Figure 2 Meta-analysis of the mortality of ischemic stroke treated with Xingnao Kaiqiao needling. 95%CI: 95% Confidence interval. Figure 3 Meta-analysis of the recurrence rate of ischemic stroke treated with Xingnao Kaiqiao needling. 95%CI: 95% Confidence interval. Figure 4 Meta-analysis of the disability rate of ischemic stroke treated with Xingnao Kaiqiao needling. 95%CI: 95% Confidence interval. 585

4 Table 1 Features of included studies Age (year) Observed object (n) Intervention Study Treatment Control Treatment Control Treatment Control Measurement Liu (2006) 62.7± ± XNKQ, Mortality, Recurrence rate, Disability rate, Security Rao (2006) 67.0± ± XNKQ, Mortality, Disability rate, Security Meng (2006) 62.5± ± XNKQ, Acupuncture, Security Yang (2008a) 61.3± ± XNKQ, Acupuncture, Mortality Yang (2008b) 61.3± ± XNKQ, Acupuncture, Recurrence rate, Security Shi (2010) 61.0± ± XNKQ, Recurrence rate Liu (2012a) 60.3± ± XNKQ, Ozagrel Ozagrel Security Liu (2012b) 58.0± ± XNKQ, Rehabilitation, Tang (2013) 63.1± ± XNKQ, Acupuncture, Acupuncture, Rehabilitation, Acupuncture, Recurrence rate, Security Security XNKQ: Xingnao Kaiqiao. Acupuncture includes tradition acupuncture, conventional acupuncture, and scalp acupuncture, but not XNKQ needling. The baseline information of the included studies is comparable. treatment includes conventional acupuncture or conventional drug therapy. Table 2 Assessment of the quality of the included studies Study Randomization method Allocation concealment Blinding Attrition bias Reporting bias Other bias Liu (2006) Digital table Unclear Unclear No Unclear Unclear Rao (2006) Computer sequence Sealed envelope Unclear Yes Unclear Unclear Meng (2006) Unclear Unclear Unclear Yes Unclear Unclear Yang (2008a) Computer sequence Sealed envelope Assessor Yes Unclear Unclear Yang (2008b) Computer sequence Sealed envelope Assessor Yes Unclear Unclear Shi (2010) Unclear Unclear Unclear Yes Unclear Unclear Liu (2012a) Unclear Unclear Unclear Yes Unclear Unclear Liu (2012b) Unclear Unclear Unclear Yes Unclear Unclear Tang (2013) Unclear Unclear Unclear Yes Unclear Unclear was used for continuous variables. Interval estimation was performed using 95% confidence interval (CI). The U test was used for hypothesis testing, and results are represented by Z and P values. The difference between the curative effect was statistically significant when P < Hypothesis test results are listed in a forest plot. Sensitivity analysis was performed for low-quality studies in subgroups. Results Data retrieval A total of 568 articles were retrieved, and 129 articles including random in the title and abstract were selected. Among the 129 selected articles, 85 were excluded because of repetition and 35 were excluded because the intervention and observed subjects did not meet the inclusion criteria. Nine articles (Liu et al., 2006, 2012; Meng et al., 2006; Rao et al., 2006; Yang et al., 2008a, b; Shi, 2010; Liu and Chen, 2012; Tang, 2013) were included in the analysis, all of which were published in Chinese (Figure 1). General characteristics of the included studies The number of enrolled subjects was 20 to 118 for each study, with 931 subjects in total. All studies focused on the Xingnao Kaiqiao needling method, and some were accompanied by conventional therapy. In the included studies, comparisons were performed between the Xingnao Kaiqiao needling method and traditional acupuncture, or conventional therapy. Three studies (Liu et al., 2006; Rao et al., 2006; Yang et al., 2008a) described mortality, four studies (Liu et al., 2006, 2012; Yang et al., 2008b; Shi, 2010; Liu and Chen, 2012) described recurrence rate, two studies (Liu et al., 2006; Rao et al., 2006) described disability rate, and seven studies (Liu et al., 2006, 2012; Meng et al., 2006; Rao et al., 2006; Yang et al., 2008b; Liu and Chen, 2012; Tang, 2013) described safety. Outcome data in one study (Liu et al., 2006) were incomplete, while other studies were integrated. The risk of bias for selective 586

5 Studies identified through database (n = 568) Studies based on review of title and abstract (n = 129) Studies obtained for further evaluation (n = 44) Studies included in meta-analysis (n = 9) Studies excluded: Not random articles (n = 439) Studies excluded: Duplicate articles (n = 85) Studies excluded based on full text review: Dose not meet the inclusion criteria (n = 35) Figure 1 Systematic review and meta-analysis flow diagram. outcome reporting was low in all studies. Other sources of bias were unclear. Details and features of the included studies are shown in Table 1. Quality of included studies Four studies (Liu et al., 2006; Rao et al., 2006; Yang et al., 2008a, b) reported detailed randomization methods. Among these four studies, three (Rao et al., 2006; Yang et al., 2008a, b) used computerized randomization methods, while one (Liu et al., 2006) used randomized digital tables. Allocation concealment was adequately described in three studies (Rao et al., 2006; Yang et al., 2008a, b), whereas the other studies did not report allocation concealment. In addition, assessor blinding was carried out in two studies, but blinding was not described in any other studies (Table 2). Subject drop-outs were reported in one study, whereas other studies were integrated. All studies did not have selective reporting outcomes, and it cannot be determined whether other sources of bias were present. Meta-analysis Mortality at the end of treatment or final follow-up ( 3 months) Mortality at the end of treatment of 6 months was reported in two studies (Liu et al., 2006; Yang et al., 2008a), and mortality at the end of treatment of 3 and 6 months was reported in one study (Rao et al., 2006). Heterogeneous test was performed for four sets of data (P = 0.66, I 2 = 0%), which demonstrated that the included studies are not of clinical or statistical heterogeneity, and can be analyzed us- ing the fixed effect model in meta-analysis. The combined effect size (RR = 0.58, 95%CI: , Z = 0.89, P = 0.37) indicated no statistical significance. However, the Xingnao Kaiqiao needling method trended towards reducing the mortality rate of ischemic stroke (Figure 2). Recurrence rate at the end of treatment or final follow-up ( 3 months) The recurrence rate was reported in four studies (Liu et al., 2006, 2012; Yang et al., 2008b; Shi, 2010). Heterogeneity tests were performed on the included studies and the results (P < 0.01, I 2 = 75%) indicate that they are of statistical heterogeneity. Therefore, the random effects model was used in the meta-analysis. Analysis of combined effect size (RR = 0.55, 95%CI: , Z = 1.04, P = 0.30) indicated that there was not statistical significance in recurrence rate. Analysis of subgroups was performed according to different follow-up periods. The heterogeneity tests of follow-up for 3 months (P = 0.80, I 2 = 0%) showed that included studies were not of clinical and statistical heterogeneity, so the fixed effect model was used in their meta-analysis. Analysis of combined effect size (RR = 0.81, 95%CI: , Z = 0.65, P = 0.52) indicated that there was not statistical significance in recurrence rate. The heterogeneity test of follow-up for 6 months (P = 0.02, I 2 = 82%) indicated that the included studies are of statistical heterogeneity, so the random effects model was used in their meta-analysis. Combined effect size (RR = 0.43, 95%CI: , Z = 0.72, P = 0.47) indicated that there was no statistical significance in recurrence rate. Although no significant difference was found, the Xingnao Kaiqiao needling had a trend towards reduction in recurrence rate of ischemic stroke (Figure 3). Disability rate at the end of treatment or final follow-up ( 3 months) Disability rate 6 months after treatment was reported in one study (Liu et al., 2006), and disability rate 3 and 6 months after treatment reported in one study (Rao et al., 2006). Heterogeneity tests of these data (P = 0.67, I 2 = 0%) showed that the included studies were not of clinical and statistical heterogeneity, so the fixed effect model was used for their meta-analysis. The combined effect size (RR = 0.51, 95%CI: , Z = 2.03, P < 0.05) showed that there was statistical significance in disability rate. Therefore, Xingnao Kaiqiao needling was better at reducing disability rate after ischemic stroke than other treatments in the control group (Figure 4). Adverse reactions One study (Liu et al., 2006) reported that one patient in the treatment group had syncope. In another study (Liu and Chen, 2012), bleeding at the acupuncture site was reported in three patients, and syncope in one patient in the observation group. The same study reported bleeding at the acupuncture site in two patients, and syncope in two patients in the control group. No adverse reactions were reported in other studies. 587

6 Health economics indicators None of the included studies reported the costs or other information of health economics indicators. Discussion Safety analysis Xingnao Kaiqiao needling method is a relatively safe treatment. Fainting during acupuncture treatment was the most common adverse event. Fainting during acupuncture treatment, hematoma, and pain during treatment are related to personal physical differences and acupuncture manipulation. Limitations of meta-analysis in this study The nine studies included in this evaluation mostly failed to describe the randomization methods, allocation concealment, and blinding. Therefore, it is highly likely that there is performance bias, selection bias, and measurement bias. Clinical trials should be strictly randomized, controlled, include allocation concealment, and use blinding to evaluate any experimental results. The use of an international standardization such as CONSORT should be implemented in all clinical trials (David Moher et al., 2006). The blinding methods used in clinical trials are an effective means to reducing bias and improving study quality (Zhang and Liu, 2007). Evaluation criteria should include determination of quality of life, well-defined endpoints, and adverse reactions. In stroke clinical trials, mortality and disability rates are regarded as the most useful endpoints. Because mortality rate is closely related to the follow-up period, conclusions based on this meta-analysis are not strong because only four studies included a 6-month follow-up, and the remaining studies did not describe the follow-up period. In the included clinical trials, analysis was performed based on whether patients were disabled or not, which was based on dichotomous data (Yang and Shi, 2007). Directions for future research Future clinical trials should pay attention to follow-up, and possibly include categorical variables (such as death and disability) to evaluate the curative effect. Furthermore, patients need more time to achieve functional recovery after stroke, so efficacy evaluation should be followed-up for at least 3 to 6 months (Yang and Shi, 2007). In the future, randomized controlled trials that are reasonably designed, strictly implemented, and include multiple centers with large sample sizes and adequate follow-up are necessary. Then, updated systematic reviews may provide more useful information. Author contributions: ZXY and JHX participated in the study concept, design and wrote the manuscript. YPL, GXM, YHW, SMW, and YL were responsible for data integration and analysis. All authors approved the final version of the manuscript. Conflicts of interest: None declared. References Chen ZL, Ni GX (2013) New process of the clinical applications of Xingnao Kaiqiao needling method. Tianjin Zhongyi 30: Cui PX (2008) Clinical research on the treatment of apoplexy with Xingnao Kaiqiao needling method. Jilin Zhongyi 28: David Moher, Kenneth F, Schulz, Douglas G. Altman (2006). The CON- SORT statement: revised recommendation for improving the quality of reports of parallel-group randomised trials. Zhongguo Kangfu Lilun yu Shijian 12:117. Guo L, Shi XM (2006) The treatment of 750 cases of apoplexy with Xingnao Kaiqiao needling method. Zhongguo Chuangtong Yixue Zazhi 47:523. Guo YP (2007) Contribution of Xingnao Kaiqiao acupuncture on acupuncture and moxibustion treatment of apoplexy. Zhenjiu Linchuang 11:1-3. Higgins JPT, Green S (2011) Cochrane Handbook for Systematic Reviews of Interventions Version ( Hu SL, Gong XG (2003) Economic burden of ischemic stroke in China. Zhongguo Weisheng Jingji 12: Jiang XF, Zhang JW, Luo ZM (2014) Research about panaxtrial saponins on the relationship between cerebral ischemic tolerance and proliferation of endogenous neural stem cells. Zhongguo Zuzhi Gongcheng Yanjiu 18: Li N, Feng B, Zhou J, Liu Y (2002) Meta-analysis of acupuncture for semiplegia caused by stroke. Chengdu Zhongyiyao Daxue Xuebao 25: Liu CM, Chen JQ (2012) Effect of modified Xingnao Kaiqiao acupuncture combined with low molecular weight heuarin calcium injection on progressive cerebral infarction. Hebei Zhongyi 3: Liu H, Wang Y, Ren H, Wang WM, Ma SP (2006) An effect of acupuncture on ADL and cognitive function in patients with ischemic stroke. Zhongguo Kangfu Yixue 21: Liu XL, Yao HJ, Xu GY, Wang YW, Wang X (2012) Early intervention of Xingnao Kaiqiao needling method on stroke neural function. Yixue Xinxi 25: Meng SY, Cheng SQ, Zhang H, Ren LH, Zhang J, Zhang XJ, Xue SF (2006) Observation on Xingnao kaiqiao acupuncture for treatment of cerebral infarction. Zhongguo Xiyi Jiehe Jijiu Zazhi 13: Rao P, Zhou L, Mao M, Bai Y, Wen TM, Tang YH, Guo Wl (2006) A randomized controlled trial of acupuncture treatment of acute ischemic stroke. Zhongguo Zhen Jiu 26: Shi JF (2010) Clinical observation of transient ischemic attack treated with Xingnao Kaiqiao needling method and medicine. Xiandai Zhongxi Jiehe 19: Shi XM (2005) Clinical research on the treatment of 9005 cases of apoplexy with the acupuncture method of sharpening mind and inducing consciousness. Zhongyiyao Daobao 11:3-5. Sun LJ, Zhang ZL, Ji XQ (2009) Clinical advancement of needling method of open the orifices on each stage of wind stroke. Liaoning Zhongyi 36: Sun NX, Gao WJ, Yi ZL (2014) Improved suture occlusion method to prepare focal cerebral ischemia reperfusion models in Sprague-Dawley rats. Zhongguo Zuzhi Gongcheng Yanjiu 18: Tan RF, Xia AH, Wu XG, Cao NN, Li MM, Zhang TG, Wang YR, Yue ZL (2014) Total Flavone of Hawthorn Leaf inhibits neuronal apoptosis in brain tissue of rat models of chronic cerebral ischemia. Zhongguo Zuzhi Gongcheng Yanjiu 18: Tang JJ (2013) Clinical effect analysis of cerebral infarction in restoration stage treated with combination of Xingnao Kaiqiao needling method and scalp acupuncture. Zhongyi Zhongyao 1: Wang Y, Xiong J (2013) Traditional Chinese medicine intervention for stem cell transplantation in the treatment of cerebrovascular diseases. Zhongguo Zuzhi Gongcheng Yanjiu 17: Wang YR, Mao HF, Chen JQ (2014) Effects of huwentoxin on tumor necrosis factor apoptotic pathway in the hippocampus of a rat model of cerebral ischemia. Zhongguo Zuzhi Gongcheng Yanjiu 18: Yang ZX (2005) Apoplexy in acute stage treated with combination of traditional Chinese and Western medicine. Zhongguo Linchuang Yisheng 33:2-5. 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