The big-data era has arrived, which involves all professions and trades. Its impact on the medical field has gradually revealed. With the characteristics of big data "4V" (volume, velocity, variety, value) and its theory generality with TCM (holistic thinking, correlativity) as well as regularity of disease development, combined with present status of acupuncture clinical research, the influences of big-data era on trial design, data collection, analysis and sharing of acupuncture clinical research are discussed in this paper, aiming to provide references for solving the difficulties of study design and determining the future research direction of acupuncture clinical research.
Acupuncture Therapy ; Biomedical Research ; Clinical Trials as Topic ; Database Management Systems ; Humans ; Medicine, Chinese Traditional

According to foreign and domestic standards of clinical quality and the author team’ experience summary of long-term clinical study, it has been found that quality control in clinical acupuncture operators is closely related to operator’s ability, good communication between doctors and patients, signature for informed consent, implementation of inclusion and exclusion criteria, practice of blind method and random concealment, patient’s compliance, standardized writing and keeping of CRF, management of instruments and consumables, and coordination and association between researchers. The implementation method of quality control in clinical acupuncture operators is explored by the clinical practice of the author team in “973” project, and analysis and discussion of the above key points.

Objective To assess the local anatomy of the Jing Bi with high-frequency ultrasound, and to evaluate the clinical significance of high-frequency ultrasound in acupuncture. Methods A total of 206 healthy subjects were observed with the high-frequency ultrasound. Two common location points of Jing Bi were selected and acupunctured under guidance of high-frequency ultrasound. The sensation of subjects was observed. Brachial plexus diameter, distance between skin and membrana pleuralis, as well as the brachial plexus and the pleura were measured. Results The filiform needle tip to lung, lung tissue and the brachial plexus were all showed, and the brachial plexus diameter, distance between skin and membrana pleuralis, the distance between the brachial plexus and the pleura were obtained. The patients felt when the needle reached the membrane of brachial plexus. All subjects got feeling within 10 seconds after acupuncture, and no pneumothorax occurred. Conclusion The local anatomy of dangerous acupoints can be accurately observed with high-frequency ultrasound. High-frequency ultrasound has important value and significance for acupuncturing the dangerous acupoints.

Literatures on acupuncture-moxibustion treatment of chemotherapy-induced peripheral neuropathy (CIPN) in the recent decade were searched in the databases of Pubmed, MEDLINE, Biological Abstracts, EMBASE, Sinomed, CNKI, Wanfang, VIP, et al. The general situation was comprehensively analyzed and reviewed from experimental design, treatment method, efficacy evaluation, mechanism research and so on. The results showed that acupuncture has a certain therapeutic effect, but the research is still in the preliminary stage, the relative literatures are insufficient and in a low quality. There is still a controversy on the efficacy of acupuncture in the treatment of CIPN. High quality, large sample and multicenter randomized controlled trials and systematic reviews are needed to verify the efficacy of acupuncture. The mechanism of acupuncture treatment of CIPN is still unclear and needs further research and exploration.

The current clinical efficacy evaluation system and evaluation methods of acupuncture have several limitations, and the application status is not optimistic. According to long-term observation, minimum clinically important difference (MCID) is consistent with the characteristics of clinical acupuncture, and has objective quanti- tative standard and wide applicability. Incorporating MCID into acupuncture clinical efficacy evaluation of tradition- al Chinese medicine can truly reflect the clinical effect of acupuncture and improve the disadvantages and shortcom- ings of acupuncture clinical evaluation, which could provide certain reference for building clinical efficacy evaluation system featured with TCM.
Acupuncture Therapy ; standards ; Clinical Trials as Topic ; standards ; Humans ; Moxibustion ; standards

Depression is a major cause of disability and has adverse effects.Despite the many types of anti-depressants,clinical treatments of depression remain poor.Therefore,novel anti-depressant mechanisms need to be explored.The beneficial effects of irisin on the nervous system are gradually being elucidated,and studies have found that irisin has an anti-depressant effect,which may become a new treatment for depression.This study explored the mechanism of irisin and its upstream and downstream anti-depressants by reviewing the existing studies explaining the link between irisin and depression,and proposes that SIRT1/PGC-1α may mediate FNDC5/irisin to regulate BDNF to promote neurogenesis and improve depression,which provides a new idea to study irisin and its upstream and downstream anti-depressants.

Objective This study aimed to develop an experimental animal platform for evaluating the feasibility and safety of intelligent acupuncture robots and to lay the foundation for further research.Methods Six 2-month-old Guangxi Bama miniature pigs were used as experimental subjects for acupuncture verification after anesthesia.First,manual acupuncture verification was carried out.Six acupoints were selected for each experimental animal and the needles were left for 20 min after the lifting,inserting,and twisting manipulation.Before and after controls were included.The experiment was carried out for 28 days,and each experiment was conducted once every 2 days for a total of 10 times.After verification of manual acupuncture,a point 10 mm from each of the six selected acupoints was selected,with a total of 12 points,and acupuncture operations were carried out on the experimental animals using the intelligent acupuncture module of the acupuncture robot at different frequencies and angles,to further verify the stability and feasibility of the animal platform.Results Routine safety-related blood indicators and blood biochemistry indicators after the procedure were normal and stable compared with those before the procedure.The average heart rate of the animals was 124 beats/min,the average blood pressure was 87/36 mmHg,and the average body temperature of was 36℃at a room temperature of 25℃,with no significant change in body temperature during and after the experiment.On the basis of this experimental platform,acupuncture manipulation using the intelligent acupuncture module of the acupuncture robot was completed successfully,with no abnormalities related to acupuncture such as bending,breaking,or stagnation of needles during the experimental process,and the experimental animals showed no obvious abnormalities.Conclusions This study established a stable experimental animal platform for evaluating the feasibility and safety of acupuncture carried out by intelligent acupuncture robots,based on the existing experimental method of miniature pigs.These result lay a foundation for further research related to the use of intelligent acupuncture robots.

The construction of experimental animal models plays an important supporting role in research into the mechanisms of action of Chinese medicines.There have been increasing reports of the construction and evaluation of animal models of spleen deficiency;however,the construction method have involved different standards and there has been insufficient objectification of the evaluation indexes.In this review,we summarize the construction and evaluation method of animal models of spleen deficiency from the aspects of animal selection,model establishment,macroscopic characterization,behavioral experiments,and objective indexes of spleen deficiency,with a view to providing theoretical guidance for the construction of experimental animal models of spleen deficiency and references for the selection of animal model platforms for spleen deficiency.

To explore the application of clinical research coordinator(CRC) in acupuncture and moxibustion study. The present application of CRC in many countries, such as America and Japan, was analyzed, and the critical actions of CRC were summarized. CRCs are crucial party of the clinical research coordinators group (CRCG).It aims to help regulate works among patients, sponsors and researchers with altruism. Now there are problems in clinical acupuncture and moxibustion research management, and the experience of CRC can enhance the efficiency and research level.