Factors and Their Impact on Treatment Effect of Acupuncture in Different Outcomes: A Meta-Regression of Acupuncture Randomized Controlled Trials / 中国结合医学杂志

BACKGROUND@#The effects of acupuncture have varied in different randomized controlled trials (RCTs), and there are many factors that influence treatment effect of acupuncture in different outcomes, with conflicting results.@*OBJECTIVE@#To identify factors and their impact on the treatment effect of acupuncture in different outcomes.@*METHODS@#Acupuncture RCTs were searched from 7 databases including Medline (PubMed), Embase, Cochrane Central Register of Controlled Trials, China National Knowledge Infrastructure, Wanfang Database, VIP Database, and China Biology Medicine disc between January 1st, 2015 and December 31st, 2019. Eligible studies must compare acupuncture to no acupuncture, sham acupuncture, or waiting lists, and report at least 1 patient-important outcome. A multi-level meta-regression was conducted using a 3-level robust mixed model and univariate analyses were performed for all independent variables, even those excluded from the multivariable model due to collinearities. We used thresholds of 0.2 and 0.4 for the difference of standardized mean differences (SMDs), categorising them as small (<0.2), moderate (0.2-0.4), or large (>0.4) effects.@*RESULTS@#The pain construct analysis involved 211 effect estimates from 153 studies and 14 independent variables. High-frequency acupuncture treatment sessions produced larger effects compared to low-frequency sessions [large magnitude, the difference of adjusted SMDs 0.46, 95% confidence interval (CI) 0.07 to 0.84; P=0.02]. The non-pain symptoms construct analysis comprised 323 effect estimates from 231 studies and 15 independent variables. Penetrating acupuncture showed moderately larger effects when compared to non-penetrating acupuncture (0.30, 95% CI 0.06 to 0.53; P=0.01). The function construct analysis included 495 effect estimates from 274 studies and 14 independent variables. Penetrating acupuncture and the flexible acupuncture regimen showed moderately larger effects, compared to non-penetrating acupuncture and fixed regimen, respectively (0.40, 95% CI 0 to 0.80; P=0.05; 0.29, 95% CI 0.06 to 0.53; P=0.01).@*CONCLUSIONS@#High-frequency acupuncture sessions appear to be a more effective approach to managing painful symptoms. Penetrating acupuncture demonstrated greater effect in relieving non-painful symptoms. Both penetrating acupuncture type and flexible acupuncture regimen were linked to significant treatment effects in function outcomes. Future studies should consider the factors that are significantly associated with the effects of acupuncture in patient-important outcomes.

Approach to Assess Adequacy of Acupuncture in Randomized Controlled Trials: A Systematic Review / 中国结合医学杂志

OBJECTIVE@#To summarize and identify the available instruments/methods assessing the adequacy of acupuncture in randomized controlled trials (RCTs) for proposing a new improved instrument.@*METHODS@#A systematic literature search was carried out in 7 electronic databases from inception until 21st November 2022. Any study evaluating the adequacy or quality of acupuncture, specifying specific acupuncture treatment-related factors as criteria of subgroup analysis, or developing an instrument/tool to assess the adequacy or quality of acupuncture in an RCT was included. Basic information, characteristics and contents of acupuncture adequacy assessment were presented as frequencies and percentages.@*RESULTS@#Forty studies were included in this systematic review. Thirty-five studies (87.50%) were systematic reviews, none of which used formal methods to develop the assessment instruments/methods of acupuncture adequacy; of 5 methodological studies, only 1 study used a relatively formal method. Thirty-two studies (82.05%) assessed the components of acupuncture, while 7 (17.95%) assessed the overall quality of acupuncture. An independent assessment instrument/method was used to assess acupuncture adequacy in 29 studies (74.35%), whereas as one part of a methodological quality assessment scale in 10 (25.65%). Only 9 (23.00%) studies used the assessment results for subgroup analysis, sensitivity analysis or the criteria for inclusion in the meta-analysis.@*CONCLUSION@#Assessment contents for adequacy or quality of acupuncture in RCTs hadn't still reached consensus and no widely used assessment tools appeared. The methodology of available assessment instruments/scales is far from formal and rigorous. A new instrument/tool assessing adequacy of acupuncture should be developed using a formal method.

Fidelity in acupuncture-moxibustion clinical research: application and reflection / 中国针灸

As an indicator that measures the degree of implementation of intervention measures during the implementation process, fidelity could be used for monitoring and quality evaluation of the completion degree of intervention measures, and plays an important role in improving the degree of intervention implementation and clarifying the factors that affect intervention implementation. This article aims to introduce the connotation and significance, measurement, control, and current application status of fidelity, as well as the current application status of fidelity in acupuncture-moxibustion clinical research and its inspiration for future research. Meanwhile, based on the existing evaluation tool development methods of fidelity and the characteristics of acupuncture-moxibustion clinical research, a preliminary fidelity evaluation framework is proposed. Introducing fidelity into acupuncture-moxibustion clinical research could improve the implementation quality and compliance of acupuncture-moxibustion in clinical research, increase the credibility and effectiveness of clinical research results, and promote the transformation of acupuncture-moxibustion experience into easily learnable and promotable treatment plans.

Evaluation of the report quality of Chinese and English randomized controlled trials of acupuncture based on CONSORT statement and STRICTA checklist / 中国针灸

OBJECTIVE@#To evaluate the report quality of Chinese and English randomized controlled trials (RCTs) of acupuncture based on the CONSORT statement and STRICTA checklist.@*METHODS@#The Chinese and English RCTs of acupuncture published from January 1, 2015 to December 31, 2019 were searched in 7 databases including PubMed. The report quality of the included RCTs was evaluated with the CONSORT 2010 statement and STRICTA checklist.@*RESULTS@#A total of 506 Chinese RCTs and 76 English RCTs were included. According to the CONSORT statement, in Chinese RCTs, the items with report rate less than 50% accounted for 78.38% of all items, and the report rate of 25 items, such as background and reason, study design, outcome index, and sample size, was less than 10%. In English RCTs, the items with report rate less than 50% accounted for 35.14% of all items, and 5 items had a report rate of less than 10%. The difference of the report rate of 15 items, such as background, reason and study design, was more than 50% between Chinese and English RCTs. The report rate of all items of STRICTA checklist was relatively high in both Chinese and English RCTs. In Chinese RCTs, the items with report rate less than 50% accounted for 29.41% of all items, which included acupuncture rationale and depth of insertion. In English RCTs, only two items had a report rate less than 50%, which were acupuncture rationale, setting and context of treatment. The report rate of five items, including needle retention time, frequency and duration of treatment sessions, details of other interventions administered to the acupuncture group, setting and context of treatment, and precise description of the control or comparator in Chinese RCTs, were higher than in English RCTs.@*CONCLUSION@#The report quality of Chinese acupuncture RCT needs to be improved urgently, and corresponding measures should be taken to further standardize the writing and reporting of acupuncture clinical research.

Improving acupuncture research: progress, guidance, and future directions / 中国针灸

This paper makes an interpretation of the collection Acupuncture: how to improve the evidence base published by BMJ & BMJ Open. Studies show that the quality of randomized controlled trial (RCT) of acupuncture is low, and multivariable Meta-regression analysis fails to confirm most factors commonly believed to influence the effect of acupuncture. The methodological challenges in design and conduct of RCT in acupuncture were analyzed, and a consensus on how to design high-quality acupuncture RCT was developed. The number of acupuncture systematic reviews was huge but the evidence was underused in clinical practice and health policy, and a large number of western clinical practice guidelines recommended acupuncture therapy, but the usefulness of recommendations needed to be improved. In view of the problems in clinical research on acupuncture mentioned in this collection, combined with the analysis of the purpose of clinical research on acupuncture, perspectives, study types, as well as the relationship between evidence and clinical decision-making, a five-stage study paradigm of clinical research on acupuncture is proposed.

Acupuncture for in vitro fertilization-embryo transfer: an overview of systematic reviews / 中国针灸

OBJECTIVES@#To evaluate the report quality, methodological quality and evidence quality of the systematic reviews and meta-analyses (SRs/MAs) of acupuncture for in vitro fertilization-embryo transfer (IVF-ET).@*METHODS@#The SRs/MAs of acupuncture for IVF-ET were searched electronically from databases of CNKI, Wanfang, VIP, SinoMed, PubMed, Embase, Cochrane Library, from inception of each database to September 27th, 2022. Two reviewers independently screened the literature and extracted the data. Using PRISMA statement, the AMSTAR 2 scale and the GRADE system, the report quality, methodological quality and evidence quality of the included SRs/MAs were assessed.@*RESULTS@#A total of 28 SRs/MAs were included, with PRISMA scores ranging from 8.5 points to 27 points. The problems of report quality focused on protocol and registration, retrieval, risk of bias in studies, additional analysis, limitations and funding. The methodological quality of included studies was generally low, reflecting on items 2, 3, 7, 10, 12 and 16. A total of 85 outcome indexes were included in the GRADE system for evidence grade evaluation. Most of the evidences were low or very low in quality. The reasons for the downgrade were related to study limitations, inconsistency, imprecision and publication bias.@*CONCLUSIONS@#Acupuncture therapy improves the outcomes of IVF-ET, but the methodological quality and evidence quality of related SRs/MAs are low. It is recommended to conduct more high-quality studies in the future to provide more reliable evidences.

Overview of systematic reviews of acupuncture clinical research published in international journals / 中国针灸

The systematic reviews (SRs) of acupuncture published before December 31 of 2020 in PubMed, Cochrane and EMbase databases were searched, and the publication overview of international acupuncture SRs were analyzed. As a result, a total of 717 SRs were included, and the overall number of published SRs showed a fluctuating upward trend. A total of 15 categories of diseases were involved, of which 113 SRs suggested that acupuncture was effective, and 12 SRs did not support acupuncture, and the remaining SRs showed uncertain conclusions. It is suggested that the standard of evidence-based medicine should be adopted to standardize the design of acupuncture trial and improve the level of clinical research; SRs should include high-quality literature that met the standards according to the principles and methods of PRISMA, so as to provide reliable clinical evidence for acupuncture.

Analysis on influencing factors of acupuncture curative effect based on experts' experience / 中国针灸

To explore the influencing factors of acupuncture curative effect in literature of experts' experience. The journal literature of experts' experience was retrieved from China National Knowledge Infrastructure (CNKI) and PubMed, starting from inception to September 4, 2020, and the influencing factors of acupuncture curative effect were extracted and analyzed. A total of 499 articles were included, involving 495 articles in Chinese and 4 articles in English. The influencing factors of acupuncture curative effect mainly include five aspects: diagnostic method, acupoint selection of acupuncture, acupuncture manipulation, regulating mind of acupuncture and acupuncture time, and provide reference for acupuncture protocol design in clinical trials.

Clinical study on acupuncture and moxibustion for frozen shoulder: an evidence map / 中国针灸

The clinical evidences on acupuncture and moxibustion for the treatment of frozen shoulder were sorted and summarized systematically. The relevant articles of frozen shoulder treated with acupuncture and moxibustion were searched from PubMed, EMbase, Cochrane database of systematic review (CDSR), Cochrane database of controlled trials register (CENTRAL), China national knowledge infrastructure (CNKI), Wanfang, VIP, and Chinese biomedical literature databases (SinoMed), from database inception to May 31, 2021. Using AMSTAR-2, the methodological quality of the included systematic reviews was evaluated. With evidence map, the current status of clinical evidence was summarized on acupuncture and moxibustion in treatment of frozen shoulder. A total of 266 original studies and 6 systematic reviews were included finally. At present, many randomized controlled trials are designed with small sample size and the simple acupuncture and moxibustion therapy is dominant as the intervention, e.g. warm acupuncture, acupuncture with filiform needle, acupotomy and electroacupuncture. The outcomes considered in the current trials focus on clinical effective rate, the score of shoulder pain, the score of shoulder function and the score of quality of life. Most of the studies have shown that acupuncture and moxibustion is advantageous as an adjunctive therapy for frozen shoulder, but its clinical evidence is few in terms of the recurrence rate and safety. Moreover, it needs to improve the evidence quality of the relevant studies on acupuncture and moxibustion for frozen shoulder.

Acupuncture randomized controlled trials: comparing China-based vs. Western-based studies / 中国针灸

With the worldwide spread of acupuncture as a therapeutic modality and the rapid development of acupuncture clinical research, the number of acupuncture randomized controlled trial (RCT) studies is steadily increasing in China and around the world. However, the results of these studies seem to come from two different worlds indeed. Chinese RCT studies overwhelmingly demonstrate positive outcomes from acupuncture, whereas Western-based studies generally conclude that there is no discernible difference between acupuncture and a placebo. Why should there be such different outcomes when the same scientific method is being used? This paper analyzes factors that may be contributing to the different outcomes between China-based and Western-based RCT studies by considering and comparing starting points, purpose, study design, investigators, acupuncture treatment regimen, methodological quality, results, conclusions, and deficiencies in acupuncture RCT. Based on these comparisons, this paper examines the value of acupuncture RCT in general, and the methodological confusion which seems to have propagated from study to study. We propose the following suggestions to remediate the acupuncture clinical research paradigm: First, acupuncture clinical researches should be carried out step-by-step according to universal, agreed-upon research protocols. Second, norms for reporting outcome metrics need to be standardized for each stage of a study.

Effect of Acupuncture on Outcomes of in vitro Fertilisation: A Scoping Review / 中国结合医学杂志

OBJECTIVES@#To identify, examine and summarize the available evidence on the effectiveness and safety of acupuncture for in vitro fertilisation (IVF) outcomes.@*METHODS@#Eight electronic databases, including PubMed, EMBASE, Cochrane Database of Systematic Review, Cochrane Central Register of Controlled Trials, China National Knowledge Infrastructure, Wanfang Database, Chinese Biomedical Database and VIP Database, were searched, supplemented by manual searches. Two researchers independently conducted the literature screening, data extraction, and methodological quality assessments. A narrative description was provided to show the general information and specific characteristics of the included studies. A bubble plot was used to visually display the overall effects of acupuncture on IVF outcomes.@*RESULTS@#Eighty-two studies were identified, including 64 primary studies and 18 systematic reviews. Transcutaneous electrical acupoint stimulation, electric acupuncture and manual acupuncture were applied in most studies and compared with no acupuncture, sham acupuncture and placebo acupuncture control groups. Sixty-three (98.4%) primary studies reported clinical pregnancy rate, and positive effects of acupuncture were found in 34 studies (54.0%). Live birth rate was reported in only 18 (28.1%) primary studies, of which 10 (55.6%) showed positive results. In addition, only 8 and 2 systematic reviews showed that acupuncture could increase clinical pregnancy events and live birth events, respectively. However, none of these reviews was of high methodological quality.@*CONCLUSIONS@#Available evidence suggests that acupuncture therapy could improve clinical pregnancy rates. However, whether acupuncture could increase live birth events was difficult to determine based on the few studies that have reported this outcome indicator. Furthermore, the methodological quality of most systematic reviews was assessed as critically low or low. Studies with a rigorous design and standardized implementation should be performed to refine the available evidence.

Assessing the adequacy of acupuncture in clinical trials: current status and suggestions / 中国针灸

In recent years, some large rigorous acupuncture randomized controlled trials (RCTs) frequently draw the conclusion that the therapeutic effects of acupuncture is equivalent to placebo effect, which has aroused wide attention and controversy. Thus, some studies attempted to assess the adequacy of acupuncture regimen in clinical trials. In this study, the concept of acupuncture regimen adequacy in clinical trials is clarified and the research status and limitations are summarized. Moreover, the suggestions in the future researches are proposed in association with clinical practice characteristics of acupuncture, i.e. classifying assessment according to different types of acupuncture; conducting the assessment according to the treatment characteristics of different types of acupuncture; assessing the maturity of acupuncture regimens; evaluating the rationality of the control group according to the purpose of the study; and focusing on domains evaluation.

Defining Acupuncture-Moxibustion: A Delphi Study Protocol / 中国结合医学杂志

<p><b>BACKGROUND</b>With the worldwide use and modern development of acupuncture-moxibustion, there is disagreement on its basic definition. There has been an obstacle for clinical practice, research, and legislation. Considering this challenge, the World Federation of Acupuncture-Moxibustion Societies proposes to develop the definition and basic scope of acupuncture-moxibustion with a Delphi study.</p><p><b>METHODS</b>A reactive Delphi method will be used to ask a group of experts to rate the relevance and clarity of a predesigned initial item list. This list was generated by the steering committee through a literature review and group discussion. Forty experts will be selected from many disciplines and continents to ensure appropriate representation. Predefined rules will be applied to modify the items until a consensus is achieved. After achieving the consensus on all items through the survey round, the steering committee will form the definition and basic scope of acupuncture-moxibustion by organizing a literal statement with a detailed explanation.</p>

Is acupuncture actually not effective for polycystic ovary syndrome? : Analysis of the trial published in jama / 中国结合医学杂志

In recent years, acupuncture has been applied to treat more and more patients suffering from polycystic ovary syndrome (PCOS). On June 27, 2017 a paper titled "Effect of acupuncture and clomiphene in Chinese women with polycystic ovary syndrome: a randomized clinical trial" was published in Journal of the American Medical Association (JAMA). The results did not support acupuncture as an effective therapy for improving the live births in PCOS. The aim of this article was to analyze the therapeutic regimen and design of the clinical trial. The primary outcome and the conclusion of the paper were discussed as well. There are 5 doubts in the paper. (1) The therapeutic regimen decided by trigger points in the paper was different from that of the traditional Chinese acupuncture. (2) The live birth as the primary outcome was limited during the PCOS recovery. (3) In addition the period of the treatment was too short to reflect the therapeutic effect. (4) Although there was no significant difference between active acupuncture and control acupuncture, the conclusion that acupuncture was not effective for PCOS was not confirmed because the control acupuncture plus clomiphene was also more effective than that of clomiphene alone. (5) The proposal and the statistics were not in accordance with the one planned before. Therefore the result was worth to be discussed so as to provide some suggestions and references for improving the clinical research of acupuncture.

Research of bleeding volume and method in blood-letting acupuncture therapy based on data mining / 中国针灸

Through computer-based technology and data mining method, with treatment in cases of bloodletting acupuncture therapy in collected literature as sample data, the association rule in data mining was applied. According to self-built database platform, the data was input, arranged and summarized, and eventually required data was acquired to perform the data mining of bleeding volume and method in blood-letting acupuncture therapy, which summarized its application rules and clinical values to provide better guide for clinical practice. There were 9 kinds of blood-letting tools in the literature, in which the frequency of three-edge needle was the highest, accounting for 84.4% (1239/1468). The bleeding volume was classified into six levels, in which less volume (less than 0.1 mL) had the highest frequency (401 times). According to the results of the data mining, blood-letting acupuncture therapy was widely applied in clinical practice of acupuncture, in which use of three-edge needle and less volume (less than 0.1 mL) of blood were the most common, however, there was no central tendency in general.

Exploration on the application characteristics of bloodletting therapy for the diseases relevant with soft tissue infection by data mining technology / 中国针灸

<p><b>OBJECTIVE</b>Using the data mining technology to analyze the application law of bloodletting therapy for the diseases relevant with soft tissue infection and explore the effect specificity of bloodletting therapy.</p><p><b>METHODS</b>The variety of diseases treated with bloodletting therapy was taken as the sample data by collecting the reports from the periodical literatures. The network database of bloodletting literature was set up. The association rule of data mining technology was adopted to extract the information on the diseases relevant with soft tissue infection in the periodical literatures. The frequency item of the superiority disease category was calculated. And the deep mining was done in terms of the needle device, point selection and the bleeding amount separately. The application law of bloodletting therapy was summarized in the treatment of the diseases relevant with soft tissue infection.</p><p><b>RESULTS</b>Fourteen kinds of relevant diseases of soft tissue infection treated with bloodletting therapy were included in the contemporary periodical literatures, of which, the reported case number and the reporting frequency were the highest for hordeolum and breast abscess. The three-edged needle was used the most frequently in the manipulation. The acupoints selected were the local Ashi points, combined with the symptomatic acupoints. The bleeding amount was not normalized by the ideas of different physicians.</p><p><b>CONCLUSION</b>The bloodletting therapy achieves the better curative effect on some diseases relevant with soft tissue infection and this therapy deserves to be further promoted in clinical practice.</p>

Analysis of the nominations of acupuncture and moxibustion of traditional Chinese medicine for inscription on the Representative List of the Intangible Cultural Heritage of Humanity / 中国针灸

The definition of intangible cultural heritage and the Representative List of the Intangible Cultural Heritage of Humanity in Convention for Safeguarding of the Intangible Cultural Heritage is discussed. Nominations of elements should be prepared in accordence with the Guidelines provided in each section. The explaination methods and the determining process of the Nominations for Acupuncture and Moxibustion on the Representative List are analyzed, such as the name of the element, characteristics, identification and definition, value and safeguarding measures, photos and video of the element. The Nominations should be prepared according to the Convention and Guidelines closedly and focus on discussing the cultural, the content, the communities and individuals, safeguarding measures of element.