| BackgroudAnkylosing spondylitis (AS) is a chronic inflammatory disease characterized by inflammation of the axial skeleton and by entheses, causing pain, stiffness, and occasionally progressing to joint ankylosis。The treatments are mainly centered on:functional exercises, non-steroidal anti-inflammatory drugs, disease-modifying-anti-rheumatic drugs, biological agents and glucocorticoids and so on. NSAIDs combined with DMARDs are most often used to treat patients with ankylosing spondylities. In general, adverse events occurred when the patients with AS have taken those drugs for a long time, and the medication dependence may reduce. In recent years the emergence of biological agents applied to the treatment of AS brought a landmark revolution, and represents a better therapeutic regimen for short term. The long-term efficacy and the possible adverse events still require large-scale studies to verify. Many patients with AS are unable to pay for biological agents, which are so expensive. The long-term treatment leads to the great spiritual and pressure on patients and their families.Lots of effective of treatments and prescriptions of the traditional Chinese medicine(TCM) have been accumulated for Bi-syndrome. A large number of clinical trials reports that the traditional Chinese treatments are effective for AS, such as Syndrome types of TCM, treatment based on syndrome differentiation, Prescriptions, Chinese patent drug have the effects and advantage. The assisted treatment of acupuncture、masso therapy and herbal steaming are effective for the patients with AS too. There are many clinical studies on traditional Chinese medicine are off specification, similar, reproducible, and most studies are single center, nonrandom, non-blind, and the conclusions are difficult to get recognized and promoted.The rise of method of evidence-based medicine poses opportunities and challenges for clinical research in TCM. Even though lack of large-scale clinical randomized controlled trials, the development of evidence-based medicine provides a good way for clinical dispute resolution. The system review is a new method for comprehensive evaluation of the literatures, collecting all the world’s published and unpublished results of clinical studies, using the clinical epidemiology of strict principles and methods to evaluation the literatures, filtering out literatures those meet quality standards, meta-analysis is conducted with software, and then get the conclusion of comprehensive and reliable. The methods of meta-analysis has been using on medical prevention and treatment, causes of disease, risk of disease, prognosis, diagnosis, and economic analysis widely, which are at the top of the " evidence of the pyramid " launched by the in the Downstate Medical Center of State University of New York, United StatesIn recent years, there are more and more clinical studies on treatment of ankylosing spondylitis with combined traditional Chinese and Western medicine, most of which are randomized controlled trials. But there are fewer systematic reviews of therapeutic for AS. The purpose of this study is to give an objective evaluation on the overall efficacy and safety treatment combining both western and Chinese medicineObjectiveThe author will try to give an objective evaluation on the overall efficacy and safety treatment combining both western and Chinese medicine, so as to provide evidence-based support for optimal solutions the treatment of AS.MethodsThe inclusion criteria:①randomized controlled trial (RCT),Blinded and unblended studies were also included;②The studies meet the diagnostic criteria of AS;③Intervention measures:interventions for the control group are western medicine. Interventions for the treatment are western medicine and traditional Chinese medicine combined;④Results:total efficiency; Bath Ankylosing Spondylitis Disease Activity Index(BASDAI), the Bath Ankylosing Spondylitis Functional Index(BASFI), the Bath Ankylosing Spondylitis Gobal Score(BAS-G); morning stiffness; the occiput-wall distance; the chest movement; the Schober Test; the Finger-Ground distance; erythrocyte sedimentation rate; C-reactive protein; and adverse events.The Exclusion criteria:①non-randomized controlled trial;②re-published literature;③literature reviews;④The data is incomplete or the author can’t be contacted to verify the data.Search strategy:Key words for search:The searching terms for the literature included ankylosing spondylitis; Bi Syndrome; Wang Bi; herb; Chinese medicine; acupuncture;manipulation;herbal steaming; Sacroiliac joint injection;Randomized, Controlled Trial.Electronic databases:PUBMED database (from1950), EMBASE-ASP database (from1974), Cochrane Library (from1991) Elsevier sciences database (from1990), OVID full text database (from1997), Springer-link database (from1997); Chinese databases:Such database as CNKI, VIP, Wanfang and CBM, ect, were searched from the date of their establishment to January2012.Quality of StudiesTwo researchers independently read the literatures titles and abstract, then evaluate the literatures, which is for a Randomized Controlled Trial. Eligibility of studies was assessed by the researchers independently. Disagreement was resolved by consensus or a third party. The methodological quality for the eligible articles was evaluated based on the Cochrane Handbook for Systematic Reviews of Interventions5.0version, which takes into account whether a study described randomization, blinding, and withdrawals/dropouts. The contents of articles mainly include:stochastic method; hide and blind methods; risk of bias and so on.Statistical AnalysisThe Review Manage Software5.0provided by Cochrane was used for statistical analysis. The data is inputted by two researchers. For continuous data, we calculated the weighted mean difference (WMD) or standardization mean difference (SMD), expressed by point estimation and95%confidence interval. Subgroup will be analyzed according to the possible heterogeneity. When the test for heterogeneity could be done among the studies,(P≧0.1,I2≤50%) the fixed effect model was used; in view of significant heterogeneity(P≤0.1, I2≥50%), random-effect models were used for pooling. The potential bias of literatures will be shown by the funnel plot.Results1、A total of1632literatures were searched, and finally35randomly controlled studies of traditional Chinese medicine combined with Western intervention in ankylosing spondylitis were included. The methodological quality of included literatures is low.Effect of TCMW on total efficiency:TCMW VS NSAIDs:3articles with197individuals were included. The heterogeneity analysis shows:P=0.47,I2=0%,fixed-effect models were used for pooling. The result of the meta-analysis shows that the total efficiency in TCMW group is higher than the NSAIDs group, The significant difference can be seen between the two groups[OR=4.98,95%CI(1.75,14.18)].TCMW VS SASP:16articles with1439individuals were included. The heterogeneity analysis shows:P=0.89,I2=0%,fixed-effect models were used for pooling. The result of the meta-analysis shows that the total efficiency in TCMW group is higher than the SASP group, The significant difference can be seen between the two groups[OR=3.95,95%CI(2.81,5.56)]. TCMW VS MTX:4articles with332individuals were included. The heterogeneity analysis shows:P=0.13,I2=48%,fixed-effect models were used for pooling The result of the meta-analysis shows that the total efficiency in TCMW group is higher than the MTX group, The significant difference can be seen between the two groups[OR=4.86,95%CI(2.36,10.00)].TCMW VS MTX and SASP:5articles with316individuals were included. The heterogeneity analysis shows:P=0.67,I2=0%,fixed-effect models were used for pooling The result of the meta-analysis shows that the total efficiency in TCMW group is higher than the MTX and SASP group, The significant difference can be seen between the two groups[OR=3.63,95%CI(1.71,7.71)].Effect of TCMW on BASDAI:6articles with332individuals were included. The heterogeneity analysis shows:P<0.1,I2=92%,random-effect models were used for pooling The result of the meta-analysis shows that the total efficiency in TCMW group is higher than the control group, The significant difference can be seen between the two groups[MD=-0.95,95%CI(-1.75,-0.15)].Effect of TCMW on BASFI:5articles with693individuals were included. The heterogeneity analysis shows:P<0.1,I2=96%,random-effect models were used for pooling The result of the meta-analysis shows The significant difference can be seen between the two groups[MD=-2.18,95%CI(-3.04,-1.31)].Effect of TCMW on BAS-G:2articles with339individuals were included. The heterogeneity analysis shows:P=0.01,I2=83%,random-effect models were used for pooling The result of the meta-analysis shows that the total efficiency in TCMW group is higher than the control group, The significant difference can be seen between the two groups[MD=-1.10,95%CI(-1.96,-0.24)].Morning stiffnessEffect of TCMW on Morning stiffness:12articles with1071individuals measured the change of Morning stiffness before and after TCMW. The heterogeneity analysis shows:P<0.01,I2=94%, random-effect models were used for pooling The result of the meta-analysis shows that the improvement of Morning stiffness in TCMW group is higher than the control group, The significant difference can be seen between the two groups[MD=-6.01,95%CI(-8.95,-3.08)].The occiput-wall distanceEffect of TCMW on the occiput-wall distance:9articles with803individuals measured the change of the occiput-wall distance before and after TCMW. The heterogeneity analysis shows:P=0.07,I2=45%, fixed-effect models were used for pooling The result of the meta-analysis shows that the improvement of the occiput-wall distance in TCMW group is higher than the control group, The significant difference can be seen between the two groups[MD=-0.41,95%CI(-0.61,-0.21)]。The chest movementEffect of TCMW on the chest movement:11articles with961individuals measured the change of Chest movement before and after TCMW. The heterogeneity analysis shows:P<0.01,I2=89%, random-effect models were used for pooling The result of the meta-analysis shows that the improvement of the chest movement in TCMW group is higher than the control group, The significant difference can be seen between the two groups[MD=0.67,95%CI(0.32,1.02)]。The Schober TestEffect of TCMW on Schober Test:13articles with1136individuals measured the change of Chest movement before and after TCMW. The heterogeneity analysis shows:P<0.01,I2=84%, random-effect models were used for pooling The result of the meta-analysis shows that the improvement of Schober Test in TCMW group is higher than the control group, The significant difference can be seen between the two groups[MD=0.68,95%CI(0.40,0.97)]。The Finger-Ground distanceEffect of TCMW on the Finger-Ground distance:7articles with546individuals measured the change of Chest movement before and after TCMW. The heterogeneity analysis shows:P=0.10,I2=44%, fixed-effect models were used for pooling. The result of the meta-analysis shows that the improvement of the Finger-Ground distance in TCMW group is higher than the control group, The significant difference can be seen between the two groups[MD=-2.63,95%CI(-3.84,-1.43)],Effect of TCMW on the ESR:10articles with971individuals measured the change of ESR before and after TCMW. The heterogeneity analysis shows:P=0.03, I2=52%, random-effect models were used for pooling. The result of the meta-analysis shows that the improvement of the ESR in TCMW group is higher than the control group, The significant difference can be seen between the two groups[MD=-6.67,95%CI(-8.99,-4.35)]=4articles with277individuals measured the change of ESR before and after TCMW. The heterogeneity analysis shows:P=0.93, I2=0, fixed-effect models were used for pooling. The result of the meta-analysis shows that The significant difference can be seen between the two groups [MD=-0.26,95%CI(-3.22,2.59)]。Effect of TCMW on the CRP:10articles with971individuals measured the change of ESR before and after TCMW. The heterogeneity analysis shows:P<0.001, I2=82%, random-effect models were used for pooling. The result of the meta-analysis shows that the improvement of the CRP in TCMW group is higher than the control group, The significant difference can be seen between the two groups[MD=-4.70,95%CI(-6.16,-3.24)]。4articles with277individuals measured the change of CRP before and after TCMW. The heterogeneity analysis shows: P=0.001,I2=81%, random-effect models were used for pooling. The result of the meta-analysis shows that the improvement of the CRP in TCMW group is higher than the control group, The significant difference can be seen between the two groups[MD=-2.56,95%CI(-4.86,-0.27)]。The Meta-analysis shows that the incidence of adverse events are lower than the control group too.Conclusion1、The meta-analysis showed that TCWM had a higher total effective rate of disease-modifying antirheumatic drugs (DMARDs), and showed improvements in the Bath Ankylosing Spondylitis Disease Activity Index, the Bath Ankylosing Spondylitis Functional Index, the Bath Ankylosing Spondylitis Gobal Score, the axis functions, ESR, CPR, and the incidence of adverse events are lower than the control group too.2、Method of evidence-based medicine:Use high quality clinical trials to further prove the clinical effects and safety of integrated traditional Chinese and western medicine of AS is necessary promptly. |
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