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 prevention of moderate to severe seasonal allergic rhinitis: a randomized controlled trial / 中国针灸

OBJECTIVE@#To observe the clinical efficacy of acupuncture for prevention of moderate to severe seasonal allergic rhinitis.@*METHODS@#A total of 105 patients with moderate to severe seasonal allergic rhinitis were randomly divided into an observation group (53 cases, 3 cases dropped off) and a control group (52 cases, 4 cases dropped off). The patients in the observation group were treated with acupuncture at Yintang (GV 24+), Yingxiang (LI 20), Hegu (LI 4), Zusanli (ST 36), Fengchi (GB 20), Feishu (BL 13), etc. 4 weeks before the seizure period, once every other day, 3 times a week for 4 weeks. The patients in the control group were not given any intervention before the seizure period. Emergency drugs can be given appropriately during the seizure period in both groups. After seizure period, the seizure rate was recorded in the two groups; before treatment and on week 1, 2, 4, 6 of seizure period after treatment, the rhinoconjunctivitis quality of life questionnaire (RQLQ) score and total nasal symptom score (TNSS) were observed in the two groups; the rescue medication score (RMS) was recorded on week 1-6 of seizure period in the two groups.@*RESULTS@#The seizure rate of the observation group was 84.0% (42/50), which was lower than 100.0% (48/48) in the control group (P<0.05). After treatment, the scores of RQLQ and TNSS at each time point of seizure period were decreased compared with before treatment in the observation group (P<0.01), which were lower than the control group (P<0.01). The RMS score at each time point of seizure period in the observation group was lower than the control group (P<0.05, P<0.01).@*CONCLUSION@#Acupuncture can reduce the incidence of moderate to severe seasonal allergic rhinitis, relieve the symptoms, improve the quality of life and reduce the use of emergency drugs.

Discussion on "sugar needle - comfortable acupuncture and moxibustion" / 中国针灸

The cases of feeling comfort during acupuncture and moxibustion treatment in literature were summarized and its biological basis was explored. A simple classification of comfort was made, and the importance of obtaining comfort in acupuncture treatment was pointed out. Considering the pursuit of less pain and harmlessness in modern clinical treatment, sugar needle should be advocated and popularized in current clinical practice of acupuncture and moxibustion.

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.

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.

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.

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.

Dilemma and breakthrough of acupuncture-moxibustion department under the situation of rapid expansion of hospital / 中国针灸

Under the situation of the rapid expansion of hospital, the dilemma of acupuncture-moxibustion department, as well as the relevant solutions are explored. The main reasons for the shrinking situation of the service in acupuncture-moxibustion department include: the disease-based department division trends to divert many diseases suitably treated in acupuncture-moxibustion department; the environment pursuing economic benefits restricts the development of acupuncture-moxibustion therapy characterized by "simple and low-cost operation". There are three important approaches for breaking through the dilemma of acupuncture and moxibustion therapy. First, modifying the traditional service mode as waiting for patients in acupuncture-moxibustion department and promoting acupuncture and moxibustion technology to be adopted in other departments rather than limited only in acupuncture-moxibustion department. Second, increasing the charges of acupuncture and moxibustion technology rationally. Third, positioning accurately the role of acupuncture and moxibustion technology in health services based on its own characteristics and advantages and promoting it in community medical institutions. All of these solutions require the guidance of supporting policies.

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.

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.

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.

Improvement in colonic inflammatory injury in rats via activating dorsal cholinergic neurons of vagus with electroacupuncture at sensitized acupoints / 中国针灸

OBJECTIVE@#To observe the effect of electroacupuncture (EA) at sensitized acupoints on choline acetyltransferase positive (ChAT@*METHODS@#A total of 79 male SD rats were randomized into five groups, i.e. a normal group (20 rats), a normal plus sensitized acupoint group (5 rats), a model group (34 rats), an EA@*RESULTS@#The EB extravasating areas were distributed in the segments from T@*CONCLUSION@#The segmental dominance (acupoints) from T

Internationalized background of developing modern acupuncture and moxibustion-on the reform of teaching material of / 中国针灸

This paper analyzes the severe challenges posed by the localization process in the internationalization of Chinese acupuncture and moxibustion to Chinese traditional acupuncture and moxibustion, and the ways to deal with the challenges. It is believed that the lack of deep understanding of the challenges in the process of internationalization of acupuncture and moxibustion is mainly due to the lack of knowledge structure of acupuncture and moxibustion, and the innovation of acupuncture and moxibustion teaching materials is the basis of effectively adjusting the knowledge structure. The direction of the reform of acupuncture and moxibustion teaching materials should separate the modern version of acupuncture and moxibustion that conforms to the nature of science and teach it in parallel with the traditional version of acupuncture and moxibustion. The development of modern acupuncture and moxibustion in line with the nature of science is not only an urgent need to meet the challenges of western acupuncture and moxibustion, but also an internal requirement for the development of acupuncture and moxibustion itself.

Discussion on the effect pathways of preventing and treating coronavirus disease 2019 by acupuncture and moxibustion from the regulation of immune inflammatory response / 中国针灸

The effect of acupuncture-moxibustion on respiratory system and systemic immune inflammatory response were reviewed to explore the possible role of neuroimmunomodulation in the control of inflammatory response and the effect mechanism of cholinergic anti-inflammatory pathway on coronavirus disease 2019 (COVID-19). Acupuncture-moxibustion could produce the local and systemic anti-inflammatory effect on COVID-19 through the activation of cholinergic anti-inflammatory pathway. Compared with humoral anti-inflammatory pathway, the neuronal anti-inflammatory pathway has earlier initiation, rapider action, and more localization, which play a more important role in the initial stage of inflammatory response. This may be an important basis for acupuncture-moxibustion intervention in the early stage of COVID-19. In addition to cholinergic anti-inflammatory pathway, acupuncture-moxibustion may also play an anti-inflammatory role in activating sympathetic nerve, hypothalamic-pituitary-adrenal axis and other neural anti-inflammatory pathways. How acupuncture-moxibustion play its role in stimulating the vagus nerve and sympathetic nerve in different periods of inflammatory response, and whether the effect is based on the selection of acupoints and the methods of stimulation, will be the research direction of the transformation from basic research to clinical research for acupuncture-moxibustion.

Thinking on development of acupuncture-moxibustion theory based on theoretical horizon / 中国针灸

At present, the science of acupuncture and moxibustion of traditional Chinese medicine faces to the "difficult circumstances at home and abroad", which needs to be deeply reflected in view of theoretic study. By analyzing the reasons of the difficulties in acupuncture-moxibustion theory and collecting the problems arising from the recognition, understanding and application of acupuncture-moxibustion, the four aspects of the countermeasures are proposed, i.e. strengthening the self-construction of acupuncture-moxibustion theory, intensifying the education and inheritance of acupuncture-moxibustion theory, enhancing the guarantee of the relevant policy mechanism and intensifying the thinking of acupuncture-moxibustion theory. It is believed that the most important, the most basic and the most urgent task is to give intensive consideration to the construction of acupuncture-moxibustion theory in the overall situation of the cause development of acupuncture-moxibusiton at present. Only by constantly consolidating theoretical support and insisting on inheritance and innovation, can the sustainable development of acupuncture-moxibustion medicine and health be promoted.

Research progress of acupuncture and the related adjuvant therapy for promoting pressure ulcer healing in recent 10 years / 中国针灸

OBJECTIVE@#To summarize the research progress of acupuncture-moxibustion and the related adjuvant therapy for promoting pressure ulcer healing in recent 10 years and explore the future research direction.@*METHODS@#By retrieving Chinese Journal Full-text Database (CNKI), VIP Database (VIP) and PubMed database, dated from January 2008 through to December 2017, the articles for the treatment of pressure ulcers with acupuncture-moxibustion and the related adjuvant therapy were collected. In terms of clinical research and experimental research, the research progress and the related effect mechanisms were analyzed and summarized.@*RESULTS@#Through screening, 78 articles for the treatment of pressure ulcer with acupuncture-moxibustion and the adjuvant therapy were collected finally, of which, 71 articles were Chinese and 7 articles were English. The therapies with the highest frequency for pressure ulcer were the simple moxibustion or moxibusiton combined with other adjuvant measures. The local surrounding needling therapy, electroacupuncture, transcutaneous electrical nerve stimulation (TENS), neuromuscular electrical stimulation (NMES) and laser therapy were followed by regarding the use frequency. All of these interventions promoted the healing of pressure ulcers to different degrees. The underlying mechanisms were related to the regulation of the local blood perfusion, differentiation and migration of vascular endothelial growth factor, angiogenesis, superoxide dismutase SOD and eNOS/NO signaling pathway so as to promote tissue migration and proliferation.@*CONCLUSION@#Acupuncture-moxibustion and the related adjuvant therapies achieve the definite therapeutic effects on pressure ulcers. The researches on the treatment of pressure ulcers at home and abroad are diversified, but it is still limited in the research on the effect mechanism.

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.

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.

Entity of acupoint: kinetic changes of acupoints in histocytochemistry / 中国针灸

The present study aims to investigate the kinetic histocytochemical changes of acupoints in different condition. The expression of tryptase (+) mast cells, histamine (HA) , serotonin (5-HT) and nociceptive neuropeptides including calcitonin gene-related peptide (CGRP) and substance P (SP) were observed by immunohistochemistry combined with confocal technology. Mast cells were labeled with anti-mast cell tryptase antibody and simultaneously with HA or 5-HT primary antibodies to observe their co-expression. The results showed that: (1) SP and CGRP were expressed more highly on the cutaneous nerve fibers of "Hegu" (LI 4) after acupuncture stimulation than that of the control. Mast cells aggregated in close proximity to the blood vessels in intra-epidermis and dermis, and some of them with degranulation in the lower dermis and subcutaneous tissue of "Hegu" (LI 4). Both mast cells and their granules appeared with HA (+) and 5-HT (+) expression at stimulated LI 4 sites, while a few intact mast cells with a little expression of 5-HT and HA were distributed in areas of non-stimulated Ll 4. (2) The acupoints in different locations such as Baihui (GV 20), Weishu (BL 21), Zhongwan (CV 12) and LI 4 had the same constituent but the contents were different. (3) The histocytochemical responses of acupoints sensitized by the Gastric mucosa injury (GMI) were also investigated. GMI resulted in neurogenic plasma extravasation by Evans Blue (EB) in the skin of the acupoints over the back and abdomen, which mostly occurred in the T9-T11 dermatomere. The EB extravasation dots just like acupoints sensitization appeared after GMI and disappeared gradually during the natural self-recovery of the gastric mucosa. More SP and CGRP positive nerve fibers were distributed in EB dots than in regions beside EB dots and in the control, mostly distributed in the nerve fibers around both the vessels and root of hair follicle. Mast cells also aggregated and degranulated to release algogenic substances of 5-HT and HA around the vessels in areas of the EB dots. Collectively the acupoints displayed the same histocytochemical responses due to either acupuncture stimulation or GMI. This may potentially be the histocytochemical basis in the local acupoints and acupoints displayed kinetic changes in different condition.

The expression of calcitonin gene-related peptide on the neurons associated Zusanli (ST 36) in rats / 中国结合医学杂志

<p><b>OBJECTIVE</b>To investigate the biochemical characteristic of the neurons associated Zusanli (ST 36) in the rat by using Alexa Fluor 594 conjugated cholera toxin subunit B (AF594-CTB) neural tracing and calcitonin gene-related peptide (CGRP) fluorescent immunohistochemical techniques.</p><p><b>METHODS</b>Four male Sprague Dawley rats were injected with AF594-CTB into the corresponding area of the Zusanli in the human body. After 3 surviving days, the rat's spinal cord and dorsal root ganglia (DRGs) at lumbar segments were dissected following perfusion with 4% paraformaldehyde, cut into sections, and then stained with CGRPfluorescent immunohistochemical method.</p><p><b>RESULTS</b>AF594-CTB labeled sensory neurons were detected in the L3-L6 DRGs with high concentration in L4 DRG, and the labeled motor neurons located in the dorsolateral and intermediate regions of lamina IX from L3-L5 segments with high concentration at L4. Meanwhile, CGRPpositive neural labeling distributed symmetrically on both sides of DRGs, anterior and dorsal horns of spinal cord. In the AF594-CTB labeled neurons, 37% sensory neurons and 100% motor neurons expressed CGRPpositive.</p><p><b>CONCLUSION</b>These findings present the morphological evidence to demonstrate that the sensory and motor neurons associated Zusanli in the rat distributed with segmental and regional patterns, and contained CGRP-expression.</p>