針刺平行隨機對照試驗通常沒有準確報告試驗組和對照組的干預方法.為促進標準化,國際上有經驗的針刺醫師和研究者組成的小組制定了一些原則,即針刺臨床對照試驗中干預措施報告的標準(縮寫為STRICTA).在征求意見過程中,一些期刊編輯協助對此標準進行了修改,使之與隨機對照試驗報告的標準(CON-SORT)格式一致,作為該指南對針剌研究報告的延伸.參與此事的雜志編輯已確定要發表該標準,建議其作者群按照此標準準備論文,并將邀請更多雜志采用該標準.目的是使針剌對照試驗的干預措施充分報告,從而有利于對這些研究的嚴格評價、分析及這些措施的推廣.
Objective To systematically review the efficacy and safety of acupuncture for the treatment of tumor-related cognitive dysfunction. Methods The PubMed, The Cochrane Library, EMbase, CNKI, WanFang Data, VIP and CBM databases were electronically searched to collect studies on acupuncture for the treatment of tumor-related cognitive dysfunction from the establishment of the database to February 13th, 2022. Two reviewers independently screened the literature, extracted data, and assessed the risk of bias of the included studies. Meta-analysis was then performed using RevMan 5.4.1 software. Results A total of 16 studies involving 1 361 patients were included. The results of meta-analysis showed that the mini-mental state examination (MD=1.82, 95%CI 1.49 to 2.15, P<0.000 01) and Montreal cognitive assessment (MD=1.56, 95%CI 0.83 to 2.29, P<0.0001) scores of the acupuncture treatment group were superior to those in the control group. Furthermore, the acupuncture treatment group showed a reduced incidence of postoperative cognitive dysfunction (RR=0.50, 95%CI 0.39 to 0.63, P<0.000 01) and decreased levels of interleukin-6 (MD=?10.43, 95%CI ?14.91 to ?5.95, P<0.000 01), interleukin-1β (MD=?47.14, 95%CI ?63.92 to ?30.36, P<0.000 01), and tumor necrosis factor-α (MD=?9.13, 95%CI ?12.38 to ?5.89, P<0.000 01). In contrast, the visual analog scale score of the acupuncture treatment group (MD=?1.26, 95%CI ?2.06 to ?0.47, P=0.002) was better than that of the control group. No significant difference was found in the level of central nervous system-specific protein (S100β) (MD=?0.06, 95%CI ?0.13 to 0.01, P=0.12) between the two groups. Conclusion Acupuncture therapy can improve tumor-related cognitive function in patients. Its curative effect is better than that of non-acupuncture therapy; however, its ability to reduce S100β levels is not significantly different from that of non-acupuncture therapy. Due to the limited quantity and quality of the included studies, more high-quality studies are needed to verify the above conclusion.
Based on the conclusion of recent clinical research conducted by foreign countries, there is no statistical difference in outcomes between real and placebo acupuncture. This paper analyzes the weaknesses of methods currently being used by foreign countries to compare the effects of real and placebo acupuncture, striving for a new way to test for the placebo effect; a way that is more scientific, more suitable for the current conditions of China, while at the same time capable of being recognized internationally. This paper describes a new acupuncture placebo-controlled method. Under the condition of complete patient trust, we may ensure an ideal placebo effect to the greatest extent by minimizing the potential curative effects in the placebo group. From the actual clinical practice, by randomized controlled trial comparing acupuncture and medicine, using the concept as the double-dummy clinical trail, this paper explores the “double-dummy – non-specific sites – random sampling” method in the clinical setting as a way to form a new acupuncture clinical research model of comparison between acupuncture and medicine.
ObjectiveTo systematically sort out acupuncture therapy research report specification issues and provide a reference for the selection of key problems in the specification of acupuncture therapy network meta-analysis reports. MethodsComputer searches of PubMed, Embase, Web of Science, Cochrane Library, CNKI, WanFang Data, and VIP databases were conducted to collect studies related to reporting norms for acupuncture therapy, with a search time from inception to November 2022. Questions were constructed according to the SPIDER model and inclusion and exclusion criteria were developed. CASP was used to evaluate the methodological quality of the included literature, and a qualitative systematic evaluation thematic synthesis method was used to analyze, summarize, and integrate the questions on reporting norms for acupuncture therapy research evidence to create a pool of question entries. ResultsA total of 66 papers covering four countries were included, including 17 papers from qualitative studies and 49 papers from quantitative studies. The CASP evaluation results showed that the overall quality of the included studies was high, and the quality of the English studies was higher than that of the Chinese studies. The thematic synthesis method resulted in 22 question entries in 7 categories. The 7 categories of questions included title, abstract, preface, methods, results, discussion and other report specification questions. The 22 entries included "Is there a need to report specific types of acupuncture therapy", "Is there a need to report based on the type of original study and its number", etc. ConclusionThere are many problems with reporting norms in existing acupuncture studies, so it is necessary to collate and summarize the key issues of reporting norms for acupuncture network meta-analysis to provide a scientific and theoretical basis for the development of reporting guidelines for acupuncture network meta-analysis.
Objective To assess the quality of randomized controlled trials (RCTs) on acupuncture for treating acute migraine attacks. Methods With the searching terms of acupuncture and migraine, the Cochrane Controlled Trials Register (CCTR), PubMed, MEDLINE, EMbase, CBM, CMCC, CNKI and VIP were searched. The reports quality of the included trials, including the quality of methodology, diagnostic criteria, inclusion/exclusion criteria, acupuncture/control interventions, outcome measures, observing time, and adverse effects reports, was evaluated. Results A total 23 RCTs involving 2645 patients were included, of which only 3 RCTs were of high quality with Jadad scores equal to or more than 4. At present, only a few high quality trials on treating acute attacks of migraine with acupuncture had been reported at home and abroad. The international recognized diagnostic criteria and common evaluation methods had not been used generally, and the design of control was kind of irrational. Conclusion Based on current clinical reports, acupuncture may be effective in the management of acute migraine attacks, but some relevant proof is still required. The further domestic studies should be designed strictly following the international recommended diagnosis and evaluation criteria of migraine, and rational control methods as well.
Objective To assess the effectiveness of acupuncture for tension-type headache. Methods A systematic review of the relevant randomized controlled trials (RCTs) of acupuncture for tension-type headache was performed using the methods of The Cochrane Collaboration. Trials were collected from The Cochrane Library, Issue 4, 2003, MEDLINE (1966 to March 2004), CBM (1978 to August 2003), VIP (1989 to April 2003) and handsearched all related articles published in Chinese in 2003. The quality of literature was reviewed, and data were extracted by two reviewers independently. Meta-analysis was conducted using RevMan 4.2 software. Results Thirteen RCTs involving 571 patients were included, of the thirteen RCTs, six were of high methodological quality according to Jadad scale (the Jadad score≥3), and “sham acupuncture” was used as controlled intervention in eight trials. Meta-analysis indicated that no statistical difference was detected between acupuncture and sham acupuncture groups on effectiveness with RR 1.55, 95%CI 0.97 to 2.47 and P=0.07 at the end of treatment. No statistical difference was detected between acupuncture and sham acupuncture groups on visual analogue scale at the end of treatment with WMD －0.55, 95%CI －1.20 to 0.09 and P=0.09; at the end of follow-up of less than 2 months with WMD －0.22, 95%CI －0.87 to 0.42 and P= 0.50 and at the end of follow-up of more than 2 months with WMD －0.65, 95% CI －1.41 to 0.11 and P=0.09. Conclusions Comparing acupuncture with sham acupuncture and other treatments, current evidence can not evaluate whether acupuncture is significantly effective for tension-type headache, more RCTs of high methodological quality are required.
To explore clinical design methods that suit the characteristics of acupuncture science, this article mainly analyzes the design features of pragmatic randomized controlled trials and the advantages and current problems in clinical research on acupuncture. We discuss the differences between pragmatic randomized controlled trials and explanatory randomized controlled trials and the application status of clinical research about acupuncture. We consider that pragmatic randomized controlled trials suit the characteristics of in clinical research on acupuncture with complicated interventions. Exploring the application of pragmatic randomized controlled trials clinical research on acupuncture is beneficial to exploring appropriate clinical research methods that suit the specific characteristics of acupuncture subject, and to objectively and comprehensively assessing clinical efficacy and safety of acupuncture.
Objective To examine the efficacy of acupuncture in hastening recovery and reducing long-term morbidity from Bell’s palsy. Methods We searched the Cochrane Neuromuscular Disease Group Register Group (Till Feb. 2002), MEDLINE (Jan. 1966 to Dec. 2002); EMBASE (Jan. 1980 to Dec. 2002), LILACS (Jan. 1982 to Dec. 2002) and Chinese Biomedical Retrieval System (Jan. 1978 to Dec. 2002). We also searched grey literature. We identified all randomised or quasi-randomised controlled trials involving acupuncture in the treatment of Bell’s palsy, selected the trials ment the inclusion criteria, assessed the methodological quality, extracted data on trials’ patients, interventions, outcome measurements and results and undertook analysis. Results Three small randomised controlled trials were included but due to some flaws in study designs or reporting and clinical differences between trials, data from trials were not combined in a meta-analysis，and a descriptive analysis was performed.The result indicated a positive effect of acupuncture (all Plt;0.01). Conclusions Three small studies in this review suggested a beneficial effect but the poor quality of the trials precludes us from drawing firm conclusions. There is a need for high quality randomized controlled trials (RCTs) using a study design which assures high internal validity.
Objective To evaluate the reporting quality of randomized controlled trials (RCTs) on acupuncture for acute ischemic stroke. Methods Six databases including The Cochrane Central Register of Controlled Trials (CENTRAL, Issue 4, 2005), MEDLINE (1966 to December 2005), EMbase (1984 to December 2005), China National Knowledge Infrastructure (CNKI, 1994 to December 2005), China Biomedicine Database disc (CBMdisc, 1980 to December 2005), VIP (a full text issues database of China, 1989 to December 2005) were searched systematically. Handsearch for further references was conducted. Language was limited to Chinese and English. We identified 74 RCTs that used acupuncture as an intervention and assessed the quality of these reports against the Consolidated Standards for Reporting of Trials (CONSORT) statement and Standards for Reporting Interventions in Controlled Trials of Acupuncture (STRICTA).Results In regard to the items in the CONSORT statement, 54 (73%) RCTs described baseline demographic and clinical characteristics in each group. Twenty-six (35%) mentioned the method of generating the random sequence, with 4 (5%) using a computer allocation. Only 6 (8%) RCTs had adequate allocation concealment, with 5 RCTs using sealed opaque envelopes and 1 RCT using centralized computer allocation. Only 8 (11%) RCTs used blinding, including 5 described as double-blind. Four (5%) RCTs reported the sample size calculation and 5 (7%) RCTs reported that an intention-to-treat (ITT) analysis. In regard to the items in STRICTA , only 4 (5%) RCTs reported the numbers of needles inserted. In 35 (47%) RCTs the needle type was reported, but only 26 (35%) mentioned the depths of insertion. Only 1 (1%) RCT mentioned the length of clinical experience and 6 (8%) RCTs reported the background of the acupuncture practitioners, but none stated the duration of their training.Conclusion The reporting quality of RCTs of acupuncture for acute ischemic stroke was low. The CONSORT statement and STRICTA should be used to standardize the reporting of RCTs of acupuncture.
Objective To assess the effectiveness of acupunctures in treatment of primary dysmenorrhea by using network meta-analysis. Methods Databases including the PubMed, EMbase, The Cochrane Library (Issue 6, 2016), CBM, CNKI and WanFang Data were searched for relevant clinical randomized controlled trials (RCTs) comparing acupunctures with ibuprofen or other kinds of acupuncture from inception to July 6th 2016. Two reviewers independently screened literature, extracted data and assessed the risk of bias of included studies. Then meta-analysis was performed by using Stata 13.0 and WinBugs 1.43 software. Results A total of 56 RCTs involving 4 600 PD patients were included. The results of network meta-analysis showed that: for the clinical effects: simple acupuncture, acupuncture plus moxa-moxibustion, acupuncture plus indirect-moxibustion, electroacupuncture, warm-acupuncture and electroacupuncture plus warm-acupuncture were superior to ibuprofen, acupuncture plus moxa-moxibustion, acupuncture plus indirect-moxibustion and warm-acupuncture were superior to simple acupuncture. For VAS score, there was no significant difference among all treatments. Simple acupuncture and ibuprofen were superior to acupuncture plus indirect-moxibustion in dysmenorrhea symptom scores. Conclusion The included 6 kinds of acupunctures are superior to ibuprofen and different acupunctures have different advantages in the treatment of PD. When selecting treatment regimen, it is better to consider the clinical situation and TCM syndrome differentiation.