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.
Objective To explore the methods used for developing evidence-based clinical practice guidelines for acupuncture. Methods Based on the characteristics of acupuncture in traditional Chinese medicine,and principles of evidence-based medicine, this article introduces and summarizes the processes and methods for developing an evidence-based clinical practice guideline for acupuncture. We analyzed similarities and differences between clinical practice guidelines for acupuncture and for other interventions. We used an evidence-based clinical practice guideline of acupuncture for depression as an example to illustrate the methods of literature search, grading of evidence and recommendations, evidence evaluation and consensus formation. Results Preliminary recommendations on the methods for developing evidence-based clinical practice guidelines for acupuncture were made. Conclusion Based on the optimized rational methodology for developing clinical guidelines, evidence-based high-quality clinical practice guidelines for acupuncture could be established.
ObjectivesTo evaluate the quality of methodology and evidence of the exiting systematic reviews (SRs) of acupuncture therapy for post-stroke spastic paralysis.MethodsCNKI, CBM, The Cochrane Library, PubMed and EMbase databases were electronically searched to collect SRs of acupuncture therapy for post-stroke spastic paralysis from inception to December 16th, 2018. Two reviewers independently screened literature, extracted data, and evaluated the quality of methodology and evidence by AMSTAR 2 scale and GRADE system.ResultsA total of 7 SRs were included. The results showed that acupuncture therapy had obvious advantages in treating post-stroke spastic paralysis without obvious adverse reactions. The results of AMSTAR 2 scale showed that the failure of key items 2 and 7 resulted in extremely low methodological quality. The results of GRADE system showed that 46.15% of which were low-level evidence quality, 42.31% were medium, 11.54% were extremely low, and no evidence quality were high.ConclusionsCurrent evidence shows that acupuncture and moxibustion therapy is effective in treating spastic paralysis after stroke, however, the quality of the SRs is low. The studies are required to be standardized and combined with the characteristics of TCM to obtain high quality evidence in the future.
Objective To assess the efficacy of acupuncture versus western medicine in the treatment of depression in China. Methods Randomized controlled trials (RCTs) involving acupuncture versus western medicine in the treatment of depression in China were identified from CNKI (1979 to 2007), VIP (1989 to 2007), WANFANG Database (1998 to 2007) and CBM (1978 to 2007). We also hand searched relevant journals and conference proceedings. Data were extracted and evaluated by two reviewers independently with a specially designed extraction form. The Cochrane Collaboration’s RevMan4.2.8 software was used for data analyses. Results A total of 8 trials involving 619 patients were included. Meta-analyses showed that the total effective rate in the acupuncture group was similar when compared with fluoxetine (RR 1.03, 95%CI 0.94 to 1.14), doxepin (RR 1.14, 95%CI 0.91 to 1.43), amitriptyline (RR 0.95, 95%CI 0.70 to 1.29) and venlafaxine (RR 1.02, 95%CI 0.90 to 1.16). As for the HAMD score at week 2, no significant difference was noted between acupuncture and fluoxetine (WMD 0.03, 95%CI -1.26 to 1.31) or amitriptyline (WMD –?0.33, 95%CI –?1.88 to 1.23); for the HAMD score at week 4, no significant difference was observed between acupuncture and fluoxetine (WMD –?0.24, 95%CI –?1.85 to 1.37) or amitriptyline (WMD –?0.57, 95%CI –?2.02 to 0.88); for the HAMD score at week 6, acupuncture also had similar effects to fluoxetine (WMD –?0.19, 95%CI –?1.51 to 1.13). In terms of the SDS scores at week 2, 4, 6 and 8, no significant differences were noted between acupuncture and fluoxetine. Two trials reported adverse events and these observed no adverse events in the acupuncture group, but 31 and 25 patients experienced adverse events in the western medicine groups of these two trials. Conclusion Acupuncture is not inferior to western medicine, and it is worth noting that acupuncture is associated with few adverse reactions. Further large-scale trials are required to define the role of acupuncture in the treatment of depression.
Objective To assess the efficacy and safety of acupuncture versus western medicine in the treatment of parkinson disease. Methods Randomized controlled trials (RCTs) involving acupuncture versus western medicines in the treatment of parkinson disease were identified from CBM (1978 to 2008), VIP (1989 to 2008), Wanfang Database (1998 to 2008), CNKI (1979 to 2008), PubMed (1966 to 2008), EMbase (1980 to 2008), and The Cochrane Library (Issue 4, 2008). And some relevant journals were handsearched. Data were extracted and evaluated by two reviewers independently with a specially-designed extraction form. The Cochrane Collaboration’s RevMan 5.0.20 software was used for meta-analyses. Results A total of 13 trials involving 832 patients were included. The result of meta-analyses showed that the total effective rates of the acupuncture group or of the group of acupuncture plus Madopar were similar when compared with Madopar alone in Webster score. (1) The total effective rate: The total effective rate in acupuncture plus Madopar was similar when compared with Madopar alone in UPDRS score at Day 30 (RR=1.33, 95%CI 0.95 to 1.88) and Day 66 (RR=1.38, 95%CI 0.84 to 2.24), but there were significant differences between acupuncture plus Madopar and Madopar alone (RR=1.61, 95%CI (1.19 to 2.17) at Day 84. The total effective rate in acupuncture plus benserazide-levodopa was higher than benserazide-levodopa alone (RR=1.70, 95%CI 1.08 to 2.68) at Day 66. (2)Webster score: There were no significant differences between acupuncture and Madopar at Day 30 (WMD= –2.51, 95%CI –2.83 to –2.19) and at Day 63 (WMD= –2.48, 95%CI –3.01 to –1.95). There were significant differences between acupuncture plus Madopar and Madopar alone at Day 30 (WMD= –13.48, 95%CI –15.35 to –11.61), but not at Day 42 (WMD= 0.50, 95%CI –1.22 to 2.22). (3) UPDRS score: There were no significant differences between acupuncture and Madopar at Day 60 (WMD= –7.19, 95%CI –14.49 to 0.11). There were significant differences between acupuncture plus Madopar and Madopar alone at Day 30 (WMD= 7.07 and 95%CI 2.95 to 11.19) and at Day 84 (WMD= –12.49,95%CI –16.75 to –8.23), but no significant differences were found at Day 66 and Day 33 (WMD= –14.90, 95%CI –31.89 to 2.09; WMD= –8.60, 95%CI –21.51 to 4.31).But there were statistical differences between acupuncture plus Madopar and Madopar alone at Day 30 (WMD= 7.07, 95%CI 2.95 to 11.19). There were no differences between acupuncture plus benserazide-levodopa and benserazide-levodopa alone at Day 66 (WMD=-10.80,95%CI-21.78 to 0.18) and at Day 33 (WMD=-15.60,95%CI-28.38 to -2.82). (4) Adverse reaction: Three trials reported adverse reactions including dizziness, heartbeat acceleration, slight mouth drying and nausea, but all of these were relieved or disappeared in the course of treatment. Conclusion Acupuncture is safe and effective in the treatment of parkinson disease. Acupuncture plus western drugs may be superior to western drugs alone. Because of the defects in the methodological quality of the included trials, the conclusion is to be confirmed by more high-quality RCTs.
ObjectiveTo evaluate the reporting quality of systematic reviews (SRs)/meta-analyses on acupuncture focusing on literature screening results and explore the influencing factors of the complete reporting.MethodsPubMed, EMbase, CNKI, WanFang Data, and VIP databases were searched to collect SRs/meta-analyses on acupuncture from inception to December 31st, 2019. Two reviewers independently screened literature, extracted data and evaluated the reporting quality of literature screening results of SRs/meta-analyses on acupuncture based on PRISMA statement. Logistic regression model analysis was applied to explore the influencing factors of the complete reporting rate of literature screening results. Statistical analysis was performed by using Excel 2016 and SPSS 16.0 software.ResultsA total of 1 227 SRs/meta-analyses were included. Only 62.3% SRs fully reported the four parts of literature screening results. The parts with a low reporting rate included the number of studies assessed for eligibility (73.2%) and the reasons for exclusions at each stage (67.0%). And the reporting rate of the literature screening flowchart was also low (63.6%). The reporting rate of literature screening results in Chinese SRs was lower than that in English SRs, and there was significantly statistical difference (P<0.001). Multivariate logistic regression analysis showed that the type of published journal, publication year, pages of article and the number of searched databases were correlated with the complete reporting rate of literature screening results (P<0.001).ConclusionsThe complete reporting rate of the literature screening results of SRs on acupuncture is low, especially in Chinese SRs. The complete reporting rate of literature screening results is significantly higher for SRs published after PRISMA statement, in SCI journals, with longer length and more searched databases.
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.
Objectives To evaluate the methodological bias and the reliability of the conclusions of systematic reviews on acupuncture for polycystic ovary syndrome. Methods We comprehensively searched PubMed, EMbase, The Cochrane Library, CBM, CNKI and WanFang Data to collect systematic reviews on acupuncture for polycystic ovary syndrome from the establishment time of databases to January 5th, 2018. The AMSTAR tool was applied for methodological quality assessment of included studies and the GRADE system was applied for evidence quality assessment of included outcomes of systematic reviews. Results A total of 11 systematic reviews were included. The results of assessment using AMSTAR showed that, among the 11 items, most problems occurred in Item 5 " Were there any lists of research articles included and excluded”, followed by Item 1" Was an‘a prior’design provided?”and Item 11" Were potential conflict of interest included?”. GRADE grading results showed that quality of evidence for the outcome measure were" low”or" very low”. Conclusions Current acupuncture treatment of polycystic ovary syndrome has a certain effect, however, the quality of evidence is low. Thus, physicians should apply the evidence to make decision on acupuncture for polycystic ovary syndrome with caution in clinical practice and consider the actual situation, combined with the patient’s value preferences and economic factors.
Objective To assess the quality reports on acupuncture in the treatment of postherpetic neuralgia. Methods MEDLINE, CBM, CMCC and CNKI from 1994 to 2006 were searched electronically. Handsearching was also done. The retrieved articles were assessed in terms of several factors, including the type of clinical research, methodology, diagnostic criteria, inclusion/exclusion criteria, effectiveness measurements, calculation of sample size, follow-up, etc. Results Among the 109 included articles, only 6 were true randomized controlled trials. There were 17 quasi-randomized controlled trials, 13 non-randomized concurrent controlled trials, 1 case-control study and 63 narrative studies. 29 of the reports clearly described the diagnostic criteria, 14 mentioned the inclusion/exclusion criteria, 79 reported the effectiveness measurements, none mentioned the calculation of sample size, 24 reported the follow-up outcomes, and only 1 mentioned adverse reactions. Conclusion More prospective, multicenter, large-scale, high-quality randomised trials are needed, and recommendations should also be made for future evaluations of methodological quality.
Objectives We aimed to assess the methodological qual ity of RCT on acupuncture for migraine prophylaxis. Methods With the searching terms including acupuncture, migraine, prophylaxis and prevent, etc, the database of the Cochrane Library (Issue 4, 2007), MEDLINE (1966-2007), EMBase (1966-2007), CBM (1978-2007) and CMCC (1994-2007) were searched from their date of start publ ication. Chinese medical journals and relevant academic conference proceedings were hand searched as well. Several items in included trials were assessed, including methodology, diagnostic criteria, inclusion/exclusion criteria, acupuncture/control interventions, outcome measures and follow-up, etc. Result Among the 12 included trials, 9 trials overseas were high-qual ity and 3 in China were low-quality. Frequency or days of migraine attacks and SF-36/SF-12 were often evaluated as outcome measures in western countries, while headache index was used in China. Among the 12 trials, 9 reported the follow-up outcomes and 8 mentioned adverse events. Conclusion There was no high qual ity trial on acupuncture for migraine prophylaxis in China. The outcome measures in trials published in China by now can not evaluate the outcomes of acupuncture for migraine prophylaxis accurately. To study designs, advantages of trials oversea can be used for reference. To Chinese cl inical physicians, prophylactic therapy and abortive therapy of migraine should be distinguished in order to design high-qual ity study on acupuncture for migraine prophylaxis.