Extending the CONSORT Statement to moxibustion

The STandards for Reporting Interventions in Clinical Trials Of Moxibustion （STRICTOM）, in the form of a checklist and descriptions of checklist items, were designed to improve reporting of moxibustion trials, and thereby facilitating their interpretation and replication. The STRICTOM checklist included 7 items and 16 sub-items. These set out reporting guidelines for the moxibustion rationale, details of moxibustion, treatment regimen, other components of treatment, treatment provider background, control and comparator interventions, and precaution measures. In addition, there were descriptions of each item and examples of good reporting. It is intended that the STRICTOM can be used in conjunction with the main CONSORT Statement, extensions for nonpharmacologic treatment and pragmatic trials, and thereby raise the quality of reporting of clinical trials of moxibustion. Further comments will be solicited from the experts of the CONSORT Group, the STRICTA Group, acupuncture and moxibustion societies, and clinical trial authors for optimizing the STRICTOM.

Preface to the special issue on international standards of acupuncturemoxibustion by the World Federation of Acupuncture-Moxibustion Societies Looking at the future from a historical perspective:the development and prospects of acupuncture standards

Acupuncture,an essential component of traditional Chinese medicine(TCM),displays a 5,o00-year history in China.Since the 5th century,acupuncture has spread globally and it is currently practiced in 196 countries.In November 2010,the United Nations Educational,Scientific,and Cultural Organization(UNESCO)included"Acupuncture and moxibustion of traditional Chinese medicine"in the Representative List of the Intangible Cultural Heritage of Humanity,signifying its relevance to the culture of humankind worldwide.TCM,as the culmination of ancient Chinese science,relies on standardized practices for acupuncture to ensure its development,growth,and widespread application.As early as two thousand years ago,the shapes and sizes of nine classical needles and 150 specific acupoints,along with their related treatment targets,have already been documented by the Yellow Emperor's Inner Classic.

针刺领域真实世界研究的现状、思考和建议

In recent years,the importance of real-world research based on real-world data has been widely recognized in many countries and regions around the world.Oriented by real-world data,real-world research is conducted to obtain real-world evidence,which becomes a hot spot in clinical study.In such circumstances,how to use the diagnosis and treatment data of clinical practice to evaluate the effect and safety of acupuncture becomes future direction of acupuncture research.This paper analyzed the current situation of the real-world research in the field of acupuncture and put forward the influencing factors and the countermeasures to provide the references for the real-world research of acupuncture.

Placebo response of sham acupuncture in patients with primary dysmenorrhea:A meta-analysis

Background The placebo response of sham acupuncture in patients with primary dysmenorrhea is a substantial factor associated with analgesia.However,the magnitude of the placebo response is unclear.Objective This meta-analysis assessed the effects of sham acupuncture in patients with primary dysmenorrhea and the factors contributing to these effects.Search strategy PubMed,Embase,Web of Science,and Cochrane CENTRAL databases were searched from inception up to August 20,2022.Inclusion criteria Randomized controlled trials(RCTs)using sham acupuncture as a control for female patients of reproductive age with primary dysmenorrhea were included.Data extraction and analysis Pain intensity,retrospective symptom scale,and health-related quality of life were outcome measures used in these trials.Placebo response was defined as the change in the outcome of interest from baseline to endpoint.We used standardized mean difference(SMD)to estimate the effect size of the placebo response.Results Thirteen RCTs were included.The pooled placebo response size for pain intensity was the largest(SMD=−0.99;95%confidence interval[CI],−1.31 to−0.68),followed by the retrospective symptom scale(Total frequency rating score:SMD=−0.20;95%CI,−0.80 to−0.39.Average severity score:SMD=−0.35;95%CI,−0.90 to−0.20)and physical component of SF-36(SMD=0.27;95%CI,−0.17 to 0.72).Studies using blunt-tip needles,single-center trials,studies with a low risk of bias,studies in which patients had a longer disease course,studies in which clinicians had<5 years of experience,and trials conducted outside Asia were more likely to have a lower placebo response.Conclusion Strong placebo response and some relative factors were found in patients with primary dysmenorrhea.PROSPERO registration number:CRD42022304215.

Validation and Refinement of Two Interpretable Models for Coronavirus Disease 2019 Prognosis Prediction

Objective:To validate two proposed coronavirus disease 2019(COVID-19)prognosis models,analyze the characteristics of different models,consider the performance of models in predicting different outcomes,and provide new insights into the development and use of artificial intelligence(AI)predictive models in clinical decision-making for COVID-19 and other diseases.Materials and Methods:We compared two proposed prediction models for COVID-19 prognosis that use a decision tree and logistic regression modeling.We evaluated the effectiveness of different model-building strategies using laboratory tests and/or clinical record data,their sensitivity and robustness to the timings of records used and the presence of missing data,and their predictive performance and capabilities in single-site and multicenter settings.Results:The predictive accuracies of the two models after retraining were improved to 93.2% and 93.9%,compared with that of the models directly used,with accuracies of 84.3% and 87.9%,indicating that the prediction models could not be used directly and require retraining based on actual data.In addition,based on the prediction model,new features obtained by model comparison and literature evidence were transferred to integrate the new models with better performance.Conclusions:Comparing the characteristics and differences of datasets used in model training,effective model verification,and a fusion of models is necessary in improving the performance of AI models.

Analysis on the outcomes in randomized controlled trials of perimenopausal syndrome treated with acupuncture and moxibustion

Objective:To search systematically the application situation of the outcomes in the randomized controlled trials(RCTs) of perimenopausal syndrome treated with acupuncture and moxibustion so as to provide the foundation for the core outcome sets in treatment of periomenopausal syndrome with acupuncture and moxibustion.Methods:The articles of RTCs on perimenopausal syndrome treated with acupuncture and moxibustion were searched in China National knowledge Infrastructure(CNKI),Wanfang Data Knowledge Service Platform(Wanfang),VIP Chinese Journal Service Platform(VIP),Pubmed,Excerpt medica database(Embase)and Cochrane central register of controlled trials(CENTRAL) databases from January 1,2010 to December31,2020.Two reviewers screened the articles,extracted data and analyzed the application of outcomes in the eligible trials independently.Results:A total of 9391 articles were retrieved initially and 79 articles of them were eligible,including 43 articles in English and 36 articles in Chinese.115 outcomes were involved totally and collected according to 7 outcome domains,of which,the effective rate was the outcome with the highest use frequency.35 articles reported adverse events and 17 articles reported the effect in followup.Conclusion:At present,the outcomes of RCTs on perimenopausal syndrome in treatment with acupuncture and moxibustion are big in divergence,absent in normalization and lack of indicators for long-term prognosis and economics outcomes,as well as have the issues on the incomplete reports on the differentiation between the primary and the secondary outcomes,safety indicators and followup outcomes.It needs to construct the core outcome sets in line with the characteristics of acupuncture-moxibustion discipline so as to improve the quality of clinical trials of acupuncture and moxibustion.

Electroacupuncture for the prevention of postoperative gastrointestinal dysfunction in patients undergoing vascular surgery under general anesthesia: study protocol for a prospective practical randomized controlled trial

BACKGROUND： Postoperative gastrointestinal dysfunction（PGD） is one of the most common complications following major surgeries under general anesthesia（GA）. Despite ongoing research and new drug treatments, abdominal distension within 24 h postoperatively occurs in 8%–28% of all surgeries. We aim to analyze the effectiveness of preventing PGD by preoperatively stimulating Neiguan（PC6）, Zusanli（ST36） and Shangjuxu（ST37） bilaterally twice a day compared with sham-acupuncture treatment and standard treatment.METHODS AND DESIGN： This is a single-center, prospective practical randomized controlled trial. All groups will be given standard treatments. Patients undergoing vascular surgery under GA will be included from the Vascular Surgery Unit in West China Hospital of Sichuan University, China, and divided into three groups. The experimental group will receive routine treatments and acupuncture at PC6, ST36 and ST37 bilaterally with electrical stimulation twice a day for 20 min preoperatively. The sham-acupuncture group will receive pseudo-electroacupuncture at sham acupoints of PC6, ST36 and ST37, which are 1 cun away from the real acupoints. The routine-treatment group will not receive electroacupuncture. The outcomes include the incidence of abdominal distention, abdominal circumference, the degree of abdominal distension, the fi rst time of fl atus and defecation, and hospitalization duration. DISCUSSION： The results from this study will demonstrate whether preoperative electroacupuncture is an effective method for the prevention of PGD in patients undergoing vascular surgery under GA. This study may also provide a standardized acupuncture treatment for reduction of PGD. TRIAL REGISTRATION： This study is registered with the Chinese Clinical Trial Registry： Chi CTR-TRC-13003649.